MEDICAL POLICY ndash 701519
Treatment of Varicose VeinsVenous Insufficiency
BCBSA Ref Policy 701124
Effective Date March 1 2017
Last Revised Jan 23 2018
Replaces 70155
70176 701515 and 701124
RELATED MEDICAL POLICIES
1001514 Cosmetic and Reconstructive Services
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POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING
RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY
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Introduction
Varicose veins are swollen twisted veins that are visible just below the skin They most often
occur in the legs but can develop in other parts of the body Veins have valves that keep the
blood moving toward the heart If the valves are weak or damaged blood can pool in the veins
Itrsquos this pooling that causes the veins to swell and appear twisted Most varicose veins do not
result in physical symptoms On occasion they can cause symptoms such as pain an achy
feeling bleeding or skin ulcers (sores) Varicose veins usually can be treated without surgery by
activities such as exercising raising the legs or wearing compression stockings This policy
describes when varicose vein surgery or other procedures may be considered medically
necessary
Note The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria The
rest of the policy uses specific words and concepts familiar to medical professionals It is intended for
providers A provider can be a person such as a doctor nurse psychologist or dentist A provider also can
be a place where medical care is given like a hospital clinic or lab This policy informs them about when a
service may be covered
Policy Coverage Criteria
Page | 2 of 41 infin
Documentation Requirements
Review of this procedure requires the provider to specifically indicate the following in the clinical
notes submitted with the request
The CPT codes for the procedures being requested
AND
The name of the vein to be treated with each CPT code
Vein(s) Medical Necessity Greater or lesser (small)
saphenous veins
Treatment of the greater or lesser (small) saphenous veins by
surgery (ligation and stripping) endovenous radiofrequency
ablation laser ablation or microfoam sclerotherapy (eg
Varithena) may be considered medically necessary for
symptomatic varicose veinsvenous insufficiency when the
following criteria have been met
There is moderate to severe (greater than 05 second)
saphenous reflux documented on venous studies and CEAP
[Clinical-Etiology-Anatomy-Pathophysiology] class C2 or
greater (see Definition of Terms)
AND
There is documentation of one or more of the following four
indications
o Ulceration secondary to venous stasis
OR
o Recurrent superficial thrombophlebitis
OR
o Hemorrhage or recurrent bleeding episodes from a
ruptured superficial varicosity
OR
o Persistent pain swelling itching burning or other
symptoms are associated with saphenous reflux
AND
These symptoms significantly interfere with activities of
daily living
AND
Page | 3 of 41 infin
Vein(s) Medical Necessity Conservative management including compression
therapy (see Definition of Terms) for at least 3
months has not improved the symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of the greater or lesser (small) saphenous veins
using the following techniques is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Accessory saphenous veins Treatment of accessory saphenous veins by surgery (ligation
and stripping) endovenous radiofrequency ablation laser
ablation or microfoam sclerotherapy may be considered
medically necessary for symptomatic varicose veinsvenous
insufficiency when the following criteria have been met
The greater or lesser (small) saphenous veins have been
previously eliminated (at least 3 months) when the greater or
lesser (small) saphenous veins had reflux
OR
There is no reflux documented in both the greater and lesser
(small) saphenous veins
AND
There is moderate to severe (greater than 05 second )
accessory saphenous reflux documented on venous studies
AND
Page | 4 of 41 infin
Vein(s) Medical Necessity There is documentation of one or more of the following 4
indications
o Ulceration secondary to venous stasis
OR
o Recurrent superficial thrombophlebitis
OR
o Hemorrhage or recurrent bleeding episodes from a
ruptured superficial varicosity
OR
o Persistent pain swelling itching burning or other
symptoms are associated with saphenous reflux
AND
These symptoms significantly interfere with activities of
daily living
AND
Conservative management including compression
therapy (see Definition of Terms) for at least 3
months has not improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of accessory saphenous veins by surgery
endovenous radiofrequency laser ablation or microfoam
sclerotherapy that does not meet the criteria described above
is considered not medically necessary
Treatment of the accessory saphenous veins using the
following techniques is considered investigational including
but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
Page | 5 of 41 infin
Vein(s) Medical Necessity ClariVein)
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Symptomatic varicose
tributaries
The following treatments are considered medically necessary
as a component of the treatment of symptomatic varicose
tributaries when performed concurrently with or within 10
days of treatment (surgical radiofrequency or laser) of the
saphenous veins (none of these techniques has been shown to
be superior to another)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
When stab avulsion hook phlebectomy sclerotherapy or
transilluminated powered phlebectomy (TIPP) is requested
more than 10 days following a prior surgical radiofrequency
or laser treatment it may be considered medically necessary
when there is documentation of one or more of the following
4 indications
Ulceration secondary to venous stasis
OR
Recurrent superficial thrombophlebitis
OR
Hemorrhage or recurrent bleeding episodes from a ruptured
superficial varicosity
OR
Persistent pain swelling itching burning or other symptoms
are associated with saphenous reflux
AND
o These symptoms significantly interfere with activities of
daily living
AND
o Conservative management including compression therapy
Page | 6 of 41 infin
Vein(s) Medical Necessity (see Definition of Terms) for at least 3 months has not
improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of symptomatic varicose tributaries when
performed either at the same time or following prior
treatment of saphenous veins using any other techniques than
noted above is considered investigational including but not
limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Endovenous radiofrequency or laser ablation
Perforator veins Surgical ligation (including subfascial endoscopic perforator
surgery) or endovenous radiofrequency or laser ablation of
incompetent perforator veins may be considered medically
necessary as a treatment of active or healed leg ulcers with
documented persistent reflux when ALL of the following
conditions have been met
The superficial saphenous veins (greater lesser or accessory
saphenous and symptomatic varicose tributaries) have been
previously eliminated
AND
Three months after superficial vein treatment and compression
therapy (see Definition of Terms) the perforator veins have
BOTH an outward flow of greater than or equal to 500 ms
duration AND a diameter of greater than or equal to 35mm
AND
The perforator veins are located underneath healed or active
ulcers
Page | 7 of 41 infin
Vein(s) Medical Necessity AND
The venous insufficiency is not secondary to deep venous
thromboembolism
Ligation or ablation of incompetent perforator veins
performed concurrently with superficial venous surgery is not
medically necessary
Treatment of incompetent perforator veins using any other
techniques than noted above is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Telangiectasia Treatment by any method of small telangiectasia such as
spider veins (1mm or less) superficial reticular veins (1-2 mm)
angiomata and hemangiomata is considered cosmetic
Treatment Coverage Criteria Ultrasound guidance It should be noted that the bulk of the literature discussing the
role of ultrasound guidance refers to sclerotherapy of the
saphenous vein as opposed to the varicose tributaries When
ultrasound guidance is used to guide sclerotherapy of the
varicose tributaries it would be considered either not
medically necessary or incidental to the injection procedure
Documentation Requirements Written documentation in the medical record must include
1 CPT codes for the procedures being requested and the name of the vein to be treated with
Page | 8 of 41 infin
Documentation Requirements each CPT code
2 Copy of the venous studies (ultrasound studies evaluating blood flow in the veins)
3 CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class C2 or greater (Clinical classification
large varicose veins)
4 One or more indications
o Ulceration secondary to venous stasis (leg ulcers caused by poor blood flow in the veins)
o Recurrent superficial thrombophlebitis (recurrent blood clots or inflammation in a small
veins near the surface of the skin)
o Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity (bleeding
from a varicose vein)
o Persistent pain swelling itching burning or other symptoms are associated with
saphenous reflux (pooling of the blood caused by valves that donrsquot work correctly)
AND
These symptoms significantly interfere with activities of daily living
Conservative management including compression therapy for at least 3 months has
not improved the symptoms
Coding
Code Description
CPT 36465 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring single incompetent extremity truncal vein (eg great saphenous vein
accessory saphenous vein) (new code effective 1118)
36466 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring multiple incompetent truncal veins (eg great saphenous vein accessory
saphenous vein) same leg (new code effective 1118)
36468 Single or multiple injections of sclerosing solutions spider veins (telangiectasia) limb
or trunk
36470 Injection of sclerosing solution single vein
36471 Injection of sclerosing solution multiple veins same leg
36473 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
Page | 9 of 41 infin
Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
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Documentation Requirements
Review of this procedure requires the provider to specifically indicate the following in the clinical
notes submitted with the request
The CPT codes for the procedures being requested
AND
The name of the vein to be treated with each CPT code
Vein(s) Medical Necessity Greater or lesser (small)
saphenous veins
Treatment of the greater or lesser (small) saphenous veins by
surgery (ligation and stripping) endovenous radiofrequency
ablation laser ablation or microfoam sclerotherapy (eg
Varithena) may be considered medically necessary for
symptomatic varicose veinsvenous insufficiency when the
following criteria have been met
There is moderate to severe (greater than 05 second)
saphenous reflux documented on venous studies and CEAP
[Clinical-Etiology-Anatomy-Pathophysiology] class C2 or
greater (see Definition of Terms)
AND
There is documentation of one or more of the following four
indications
o Ulceration secondary to venous stasis
OR
o Recurrent superficial thrombophlebitis
OR
o Hemorrhage or recurrent bleeding episodes from a
ruptured superficial varicosity
OR
o Persistent pain swelling itching burning or other
symptoms are associated with saphenous reflux
AND
These symptoms significantly interfere with activities of
daily living
AND
Page | 3 of 41 infin
Vein(s) Medical Necessity Conservative management including compression
therapy (see Definition of Terms) for at least 3
months has not improved the symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of the greater or lesser (small) saphenous veins
using the following techniques is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Accessory saphenous veins Treatment of accessory saphenous veins by surgery (ligation
and stripping) endovenous radiofrequency ablation laser
ablation or microfoam sclerotherapy may be considered
medically necessary for symptomatic varicose veinsvenous
insufficiency when the following criteria have been met
The greater or lesser (small) saphenous veins have been
previously eliminated (at least 3 months) when the greater or
lesser (small) saphenous veins had reflux
OR
There is no reflux documented in both the greater and lesser
(small) saphenous veins
AND
There is moderate to severe (greater than 05 second )
accessory saphenous reflux documented on venous studies
AND
Page | 4 of 41 infin
Vein(s) Medical Necessity There is documentation of one or more of the following 4
indications
o Ulceration secondary to venous stasis
OR
o Recurrent superficial thrombophlebitis
OR
o Hemorrhage or recurrent bleeding episodes from a
ruptured superficial varicosity
OR
o Persistent pain swelling itching burning or other
symptoms are associated with saphenous reflux
AND
These symptoms significantly interfere with activities of
daily living
AND
Conservative management including compression
therapy (see Definition of Terms) for at least 3
months has not improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of accessory saphenous veins by surgery
endovenous radiofrequency laser ablation or microfoam
sclerotherapy that does not meet the criteria described above
is considered not medically necessary
Treatment of the accessory saphenous veins using the
following techniques is considered investigational including
but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
Page | 5 of 41 infin
Vein(s) Medical Necessity ClariVein)
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Symptomatic varicose
tributaries
The following treatments are considered medically necessary
as a component of the treatment of symptomatic varicose
tributaries when performed concurrently with or within 10
days of treatment (surgical radiofrequency or laser) of the
saphenous veins (none of these techniques has been shown to
be superior to another)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
When stab avulsion hook phlebectomy sclerotherapy or
transilluminated powered phlebectomy (TIPP) is requested
more than 10 days following a prior surgical radiofrequency
or laser treatment it may be considered medically necessary
when there is documentation of one or more of the following
4 indications
Ulceration secondary to venous stasis
OR
Recurrent superficial thrombophlebitis
OR
Hemorrhage or recurrent bleeding episodes from a ruptured
superficial varicosity
OR
Persistent pain swelling itching burning or other symptoms
are associated with saphenous reflux
AND
o These symptoms significantly interfere with activities of
daily living
AND
o Conservative management including compression therapy
Page | 6 of 41 infin
Vein(s) Medical Necessity (see Definition of Terms) for at least 3 months has not
improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of symptomatic varicose tributaries when
performed either at the same time or following prior
treatment of saphenous veins using any other techniques than
noted above is considered investigational including but not
limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Endovenous radiofrequency or laser ablation
Perforator veins Surgical ligation (including subfascial endoscopic perforator
surgery) or endovenous radiofrequency or laser ablation of
incompetent perforator veins may be considered medically
necessary as a treatment of active or healed leg ulcers with
documented persistent reflux when ALL of the following
conditions have been met
The superficial saphenous veins (greater lesser or accessory
saphenous and symptomatic varicose tributaries) have been
previously eliminated
AND
Three months after superficial vein treatment and compression
therapy (see Definition of Terms) the perforator veins have
BOTH an outward flow of greater than or equal to 500 ms
duration AND a diameter of greater than or equal to 35mm
AND
The perforator veins are located underneath healed or active
ulcers
Page | 7 of 41 infin
Vein(s) Medical Necessity AND
The venous insufficiency is not secondary to deep venous
thromboembolism
Ligation or ablation of incompetent perforator veins
performed concurrently with superficial venous surgery is not
medically necessary
Treatment of incompetent perforator veins using any other
techniques than noted above is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Telangiectasia Treatment by any method of small telangiectasia such as
spider veins (1mm or less) superficial reticular veins (1-2 mm)
angiomata and hemangiomata is considered cosmetic
Treatment Coverage Criteria Ultrasound guidance It should be noted that the bulk of the literature discussing the
role of ultrasound guidance refers to sclerotherapy of the
saphenous vein as opposed to the varicose tributaries When
ultrasound guidance is used to guide sclerotherapy of the
varicose tributaries it would be considered either not
medically necessary or incidental to the injection procedure
Documentation Requirements Written documentation in the medical record must include
1 CPT codes for the procedures being requested and the name of the vein to be treated with
Page | 8 of 41 infin
Documentation Requirements each CPT code
2 Copy of the venous studies (ultrasound studies evaluating blood flow in the veins)
3 CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class C2 or greater (Clinical classification
large varicose veins)
4 One or more indications
o Ulceration secondary to venous stasis (leg ulcers caused by poor blood flow in the veins)
o Recurrent superficial thrombophlebitis (recurrent blood clots or inflammation in a small
veins near the surface of the skin)
o Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity (bleeding
from a varicose vein)
o Persistent pain swelling itching burning or other symptoms are associated with
saphenous reflux (pooling of the blood caused by valves that donrsquot work correctly)
AND
These symptoms significantly interfere with activities of daily living
Conservative management including compression therapy for at least 3 months has
not improved the symptoms
Coding
Code Description
CPT 36465 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring single incompetent extremity truncal vein (eg great saphenous vein
accessory saphenous vein) (new code effective 1118)
36466 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring multiple incompetent truncal veins (eg great saphenous vein accessory
saphenous vein) same leg (new code effective 1118)
36468 Single or multiple injections of sclerosing solutions spider veins (telangiectasia) limb
or trunk
36470 Injection of sclerosing solution single vein
36471 Injection of sclerosing solution multiple veins same leg
36473 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
Page | 9 of 41 infin
Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
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Vein(s) Medical Necessity Conservative management including compression
therapy (see Definition of Terms) for at least 3
months has not improved the symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of the greater or lesser (small) saphenous veins
using the following techniques is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Accessory saphenous veins Treatment of accessory saphenous veins by surgery (ligation
and stripping) endovenous radiofrequency ablation laser
ablation or microfoam sclerotherapy may be considered
medically necessary for symptomatic varicose veinsvenous
insufficiency when the following criteria have been met
The greater or lesser (small) saphenous veins have been
previously eliminated (at least 3 months) when the greater or
lesser (small) saphenous veins had reflux
OR
There is no reflux documented in both the greater and lesser
(small) saphenous veins
AND
There is moderate to severe (greater than 05 second )
accessory saphenous reflux documented on venous studies
AND
Page | 4 of 41 infin
Vein(s) Medical Necessity There is documentation of one or more of the following 4
indications
o Ulceration secondary to venous stasis
OR
o Recurrent superficial thrombophlebitis
OR
o Hemorrhage or recurrent bleeding episodes from a
ruptured superficial varicosity
OR
o Persistent pain swelling itching burning or other
symptoms are associated with saphenous reflux
AND
These symptoms significantly interfere with activities of
daily living
AND
Conservative management including compression
therapy (see Definition of Terms) for at least 3
months has not improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of accessory saphenous veins by surgery
endovenous radiofrequency laser ablation or microfoam
sclerotherapy that does not meet the criteria described above
is considered not medically necessary
Treatment of the accessory saphenous veins using the
following techniques is considered investigational including
but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
Page | 5 of 41 infin
Vein(s) Medical Necessity ClariVein)
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Symptomatic varicose
tributaries
The following treatments are considered medically necessary
as a component of the treatment of symptomatic varicose
tributaries when performed concurrently with or within 10
days of treatment (surgical radiofrequency or laser) of the
saphenous veins (none of these techniques has been shown to
be superior to another)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
When stab avulsion hook phlebectomy sclerotherapy or
transilluminated powered phlebectomy (TIPP) is requested
more than 10 days following a prior surgical radiofrequency
or laser treatment it may be considered medically necessary
when there is documentation of one or more of the following
4 indications
Ulceration secondary to venous stasis
OR
Recurrent superficial thrombophlebitis
OR
Hemorrhage or recurrent bleeding episodes from a ruptured
superficial varicosity
OR
Persistent pain swelling itching burning or other symptoms
are associated with saphenous reflux
AND
o These symptoms significantly interfere with activities of
daily living
AND
o Conservative management including compression therapy
Page | 6 of 41 infin
Vein(s) Medical Necessity (see Definition of Terms) for at least 3 months has not
improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of symptomatic varicose tributaries when
performed either at the same time or following prior
treatment of saphenous veins using any other techniques than
noted above is considered investigational including but not
limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Endovenous radiofrequency or laser ablation
Perforator veins Surgical ligation (including subfascial endoscopic perforator
surgery) or endovenous radiofrequency or laser ablation of
incompetent perforator veins may be considered medically
necessary as a treatment of active or healed leg ulcers with
documented persistent reflux when ALL of the following
conditions have been met
The superficial saphenous veins (greater lesser or accessory
saphenous and symptomatic varicose tributaries) have been
previously eliminated
AND
Three months after superficial vein treatment and compression
therapy (see Definition of Terms) the perforator veins have
BOTH an outward flow of greater than or equal to 500 ms
duration AND a diameter of greater than or equal to 35mm
AND
The perforator veins are located underneath healed or active
ulcers
Page | 7 of 41 infin
Vein(s) Medical Necessity AND
The venous insufficiency is not secondary to deep venous
thromboembolism
Ligation or ablation of incompetent perforator veins
performed concurrently with superficial venous surgery is not
medically necessary
Treatment of incompetent perforator veins using any other
techniques than noted above is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Telangiectasia Treatment by any method of small telangiectasia such as
spider veins (1mm or less) superficial reticular veins (1-2 mm)
angiomata and hemangiomata is considered cosmetic
Treatment Coverage Criteria Ultrasound guidance It should be noted that the bulk of the literature discussing the
role of ultrasound guidance refers to sclerotherapy of the
saphenous vein as opposed to the varicose tributaries When
ultrasound guidance is used to guide sclerotherapy of the
varicose tributaries it would be considered either not
medically necessary or incidental to the injection procedure
Documentation Requirements Written documentation in the medical record must include
1 CPT codes for the procedures being requested and the name of the vein to be treated with
Page | 8 of 41 infin
Documentation Requirements each CPT code
2 Copy of the venous studies (ultrasound studies evaluating blood flow in the veins)
3 CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class C2 or greater (Clinical classification
large varicose veins)
4 One or more indications
o Ulceration secondary to venous stasis (leg ulcers caused by poor blood flow in the veins)
o Recurrent superficial thrombophlebitis (recurrent blood clots or inflammation in a small
veins near the surface of the skin)
o Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity (bleeding
from a varicose vein)
o Persistent pain swelling itching burning or other symptoms are associated with
saphenous reflux (pooling of the blood caused by valves that donrsquot work correctly)
AND
These symptoms significantly interfere with activities of daily living
Conservative management including compression therapy for at least 3 months has
not improved the symptoms
Coding
Code Description
CPT 36465 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring single incompetent extremity truncal vein (eg great saphenous vein
accessory saphenous vein) (new code effective 1118)
36466 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring multiple incompetent truncal veins (eg great saphenous vein accessory
saphenous vein) same leg (new code effective 1118)
36468 Single or multiple injections of sclerosing solutions spider veins (telangiectasia) limb
or trunk
36470 Injection of sclerosing solution single vein
36471 Injection of sclerosing solution multiple veins same leg
36473 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
Page | 9 of 41 infin
Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
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Vein(s) Medical Necessity There is documentation of one or more of the following 4
indications
o Ulceration secondary to venous stasis
OR
o Recurrent superficial thrombophlebitis
OR
o Hemorrhage or recurrent bleeding episodes from a
ruptured superficial varicosity
OR
o Persistent pain swelling itching burning or other
symptoms are associated with saphenous reflux
AND
These symptoms significantly interfere with activities of
daily living
AND
Conservative management including compression
therapy (see Definition of Terms) for at least 3
months has not improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of accessory saphenous veins by surgery
endovenous radiofrequency laser ablation or microfoam
sclerotherapy that does not meet the criteria described above
is considered not medically necessary
Treatment of the accessory saphenous veins using the
following techniques is considered investigational including
but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
Page | 5 of 41 infin
Vein(s) Medical Necessity ClariVein)
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Symptomatic varicose
tributaries
The following treatments are considered medically necessary
as a component of the treatment of symptomatic varicose
tributaries when performed concurrently with or within 10
days of treatment (surgical radiofrequency or laser) of the
saphenous veins (none of these techniques has been shown to
be superior to another)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
When stab avulsion hook phlebectomy sclerotherapy or
transilluminated powered phlebectomy (TIPP) is requested
more than 10 days following a prior surgical radiofrequency
or laser treatment it may be considered medically necessary
when there is documentation of one or more of the following
4 indications
Ulceration secondary to venous stasis
OR
Recurrent superficial thrombophlebitis
OR
Hemorrhage or recurrent bleeding episodes from a ruptured
superficial varicosity
OR
Persistent pain swelling itching burning or other symptoms
are associated with saphenous reflux
AND
o These symptoms significantly interfere with activities of
daily living
AND
o Conservative management including compression therapy
Page | 6 of 41 infin
Vein(s) Medical Necessity (see Definition of Terms) for at least 3 months has not
improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of symptomatic varicose tributaries when
performed either at the same time or following prior
treatment of saphenous veins using any other techniques than
noted above is considered investigational including but not
limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Endovenous radiofrequency or laser ablation
Perforator veins Surgical ligation (including subfascial endoscopic perforator
surgery) or endovenous radiofrequency or laser ablation of
incompetent perforator veins may be considered medically
necessary as a treatment of active or healed leg ulcers with
documented persistent reflux when ALL of the following
conditions have been met
The superficial saphenous veins (greater lesser or accessory
saphenous and symptomatic varicose tributaries) have been
previously eliminated
AND
Three months after superficial vein treatment and compression
therapy (see Definition of Terms) the perforator veins have
BOTH an outward flow of greater than or equal to 500 ms
duration AND a diameter of greater than or equal to 35mm
AND
The perforator veins are located underneath healed or active
ulcers
Page | 7 of 41 infin
Vein(s) Medical Necessity AND
The venous insufficiency is not secondary to deep venous
thromboembolism
Ligation or ablation of incompetent perforator veins
performed concurrently with superficial venous surgery is not
medically necessary
Treatment of incompetent perforator veins using any other
techniques than noted above is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Telangiectasia Treatment by any method of small telangiectasia such as
spider veins (1mm or less) superficial reticular veins (1-2 mm)
angiomata and hemangiomata is considered cosmetic
Treatment Coverage Criteria Ultrasound guidance It should be noted that the bulk of the literature discussing the
role of ultrasound guidance refers to sclerotherapy of the
saphenous vein as opposed to the varicose tributaries When
ultrasound guidance is used to guide sclerotherapy of the
varicose tributaries it would be considered either not
medically necessary or incidental to the injection procedure
Documentation Requirements Written documentation in the medical record must include
1 CPT codes for the procedures being requested and the name of the vein to be treated with
Page | 8 of 41 infin
Documentation Requirements each CPT code
2 Copy of the venous studies (ultrasound studies evaluating blood flow in the veins)
3 CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class C2 or greater (Clinical classification
large varicose veins)
4 One or more indications
o Ulceration secondary to venous stasis (leg ulcers caused by poor blood flow in the veins)
o Recurrent superficial thrombophlebitis (recurrent blood clots or inflammation in a small
veins near the surface of the skin)
o Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity (bleeding
from a varicose vein)
o Persistent pain swelling itching burning or other symptoms are associated with
saphenous reflux (pooling of the blood caused by valves that donrsquot work correctly)
AND
These symptoms significantly interfere with activities of daily living
Conservative management including compression therapy for at least 3 months has
not improved the symptoms
Coding
Code Description
CPT 36465 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring single incompetent extremity truncal vein (eg great saphenous vein
accessory saphenous vein) (new code effective 1118)
36466 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring multiple incompetent truncal veins (eg great saphenous vein accessory
saphenous vein) same leg (new code effective 1118)
36468 Single or multiple injections of sclerosing solutions spider veins (telangiectasia) limb
or trunk
36470 Injection of sclerosing solution single vein
36471 Injection of sclerosing solution multiple veins same leg
36473 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
Page | 9 of 41 infin
Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
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If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
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Vein(s) Medical Necessity ClariVein)
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Symptomatic varicose
tributaries
The following treatments are considered medically necessary
as a component of the treatment of symptomatic varicose
tributaries when performed concurrently with or within 10
days of treatment (surgical radiofrequency or laser) of the
saphenous veins (none of these techniques has been shown to
be superior to another)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
When stab avulsion hook phlebectomy sclerotherapy or
transilluminated powered phlebectomy (TIPP) is requested
more than 10 days following a prior surgical radiofrequency
or laser treatment it may be considered medically necessary
when there is documentation of one or more of the following
4 indications
Ulceration secondary to venous stasis
OR
Recurrent superficial thrombophlebitis
OR
Hemorrhage or recurrent bleeding episodes from a ruptured
superficial varicosity
OR
Persistent pain swelling itching burning or other symptoms
are associated with saphenous reflux
AND
o These symptoms significantly interfere with activities of
daily living
AND
o Conservative management including compression therapy
Page | 6 of 41 infin
Vein(s) Medical Necessity (see Definition of Terms) for at least 3 months has not
improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of symptomatic varicose tributaries when
performed either at the same time or following prior
treatment of saphenous veins using any other techniques than
noted above is considered investigational including but not
limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Endovenous radiofrequency or laser ablation
Perforator veins Surgical ligation (including subfascial endoscopic perforator
surgery) or endovenous radiofrequency or laser ablation of
incompetent perforator veins may be considered medically
necessary as a treatment of active or healed leg ulcers with
documented persistent reflux when ALL of the following
conditions have been met
The superficial saphenous veins (greater lesser or accessory
saphenous and symptomatic varicose tributaries) have been
previously eliminated
AND
Three months after superficial vein treatment and compression
therapy (see Definition of Terms) the perforator veins have
BOTH an outward flow of greater than or equal to 500 ms
duration AND a diameter of greater than or equal to 35mm
AND
The perforator veins are located underneath healed or active
ulcers
Page | 7 of 41 infin
Vein(s) Medical Necessity AND
The venous insufficiency is not secondary to deep venous
thromboembolism
Ligation or ablation of incompetent perforator veins
performed concurrently with superficial venous surgery is not
medically necessary
Treatment of incompetent perforator veins using any other
techniques than noted above is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Telangiectasia Treatment by any method of small telangiectasia such as
spider veins (1mm or less) superficial reticular veins (1-2 mm)
angiomata and hemangiomata is considered cosmetic
Treatment Coverage Criteria Ultrasound guidance It should be noted that the bulk of the literature discussing the
role of ultrasound guidance refers to sclerotherapy of the
saphenous vein as opposed to the varicose tributaries When
ultrasound guidance is used to guide sclerotherapy of the
varicose tributaries it would be considered either not
medically necessary or incidental to the injection procedure
Documentation Requirements Written documentation in the medical record must include
1 CPT codes for the procedures being requested and the name of the vein to be treated with
Page | 8 of 41 infin
Documentation Requirements each CPT code
2 Copy of the venous studies (ultrasound studies evaluating blood flow in the veins)
3 CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class C2 or greater (Clinical classification
large varicose veins)
4 One or more indications
o Ulceration secondary to venous stasis (leg ulcers caused by poor blood flow in the veins)
o Recurrent superficial thrombophlebitis (recurrent blood clots or inflammation in a small
veins near the surface of the skin)
o Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity (bleeding
from a varicose vein)
o Persistent pain swelling itching burning or other symptoms are associated with
saphenous reflux (pooling of the blood caused by valves that donrsquot work correctly)
AND
These symptoms significantly interfere with activities of daily living
Conservative management including compression therapy for at least 3 months has
not improved the symptoms
Coding
Code Description
CPT 36465 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring single incompetent extremity truncal vein (eg great saphenous vein
accessory saphenous vein) (new code effective 1118)
36466 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring multiple incompetent truncal veins (eg great saphenous vein accessory
saphenous vein) same leg (new code effective 1118)
36468 Single or multiple injections of sclerosing solutions spider veins (telangiectasia) limb
or trunk
36470 Injection of sclerosing solution single vein
36471 Injection of sclerosing solution multiple veins same leg
36473 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
Page | 9 of 41 infin
Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 6 of 41 infin
Vein(s) Medical Necessity (see Definition of Terms) for at least 3 months has not
improved these symptoms
Note If compression therapy is successful it should be continued for as long
as it is working Failure of conservative therapy is defined as pain
swelling itching burning or other symptoms associated with vein reflux
despite conservative therapy severe enough to require daily pain
medicines and causing inability to manage daily activities at home or at
work
Treatment of symptomatic varicose tributaries when
performed either at the same time or following prior
treatment of saphenous veins using any other techniques than
noted above is considered investigational including but not
limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous cryoablation
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Endovenous radiofrequency or laser ablation
Perforator veins Surgical ligation (including subfascial endoscopic perforator
surgery) or endovenous radiofrequency or laser ablation of
incompetent perforator veins may be considered medically
necessary as a treatment of active or healed leg ulcers with
documented persistent reflux when ALL of the following
conditions have been met
The superficial saphenous veins (greater lesser or accessory
saphenous and symptomatic varicose tributaries) have been
previously eliminated
AND
Three months after superficial vein treatment and compression
therapy (see Definition of Terms) the perforator veins have
BOTH an outward flow of greater than or equal to 500 ms
duration AND a diameter of greater than or equal to 35mm
AND
The perforator veins are located underneath healed or active
ulcers
Page | 7 of 41 infin
Vein(s) Medical Necessity AND
The venous insufficiency is not secondary to deep venous
thromboembolism
Ligation or ablation of incompetent perforator veins
performed concurrently with superficial venous surgery is not
medically necessary
Treatment of incompetent perforator veins using any other
techniques than noted above is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Telangiectasia Treatment by any method of small telangiectasia such as
spider veins (1mm or less) superficial reticular veins (1-2 mm)
angiomata and hemangiomata is considered cosmetic
Treatment Coverage Criteria Ultrasound guidance It should be noted that the bulk of the literature discussing the
role of ultrasound guidance refers to sclerotherapy of the
saphenous vein as opposed to the varicose tributaries When
ultrasound guidance is used to guide sclerotherapy of the
varicose tributaries it would be considered either not
medically necessary or incidental to the injection procedure
Documentation Requirements Written documentation in the medical record must include
1 CPT codes for the procedures being requested and the name of the vein to be treated with
Page | 8 of 41 infin
Documentation Requirements each CPT code
2 Copy of the venous studies (ultrasound studies evaluating blood flow in the veins)
3 CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class C2 or greater (Clinical classification
large varicose veins)
4 One or more indications
o Ulceration secondary to venous stasis (leg ulcers caused by poor blood flow in the veins)
o Recurrent superficial thrombophlebitis (recurrent blood clots or inflammation in a small
veins near the surface of the skin)
o Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity (bleeding
from a varicose vein)
o Persistent pain swelling itching burning or other symptoms are associated with
saphenous reflux (pooling of the blood caused by valves that donrsquot work correctly)
AND
These symptoms significantly interfere with activities of daily living
Conservative management including compression therapy for at least 3 months has
not improved the symptoms
Coding
Code Description
CPT 36465 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring single incompetent extremity truncal vein (eg great saphenous vein
accessory saphenous vein) (new code effective 1118)
36466 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring multiple incompetent truncal veins (eg great saphenous vein accessory
saphenous vein) same leg (new code effective 1118)
36468 Single or multiple injections of sclerosing solutions spider veins (telangiectasia) limb
or trunk
36470 Injection of sclerosing solution single vein
36471 Injection of sclerosing solution multiple veins same leg
36473 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
Page | 9 of 41 infin
Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 7 of 41 infin
Vein(s) Medical Necessity AND
The venous insufficiency is not secondary to deep venous
thromboembolism
Ligation or ablation of incompetent perforator veins
performed concurrently with superficial venous surgery is not
medically necessary
Treatment of incompetent perforator veins using any other
techniques than noted above is considered investigational
including but not limited to
Cyanoacrylate adhesivecyanoacrylate embolization (CAE) (eg
VenaSeal System)
Endovenous mechanochemical ablation (MCA) (eg MOCA
ClariVein)
Sclerotherapy
Stab avulsion
StabHookMicro-phlebectomy
Transilluminated powered phlebectomy (TIPP) (eg TRIVEX
System)
Telangiectasia Treatment by any method of small telangiectasia such as
spider veins (1mm or less) superficial reticular veins (1-2 mm)
angiomata and hemangiomata is considered cosmetic
Treatment Coverage Criteria Ultrasound guidance It should be noted that the bulk of the literature discussing the
role of ultrasound guidance refers to sclerotherapy of the
saphenous vein as opposed to the varicose tributaries When
ultrasound guidance is used to guide sclerotherapy of the
varicose tributaries it would be considered either not
medically necessary or incidental to the injection procedure
Documentation Requirements Written documentation in the medical record must include
1 CPT codes for the procedures being requested and the name of the vein to be treated with
Page | 8 of 41 infin
Documentation Requirements each CPT code
2 Copy of the venous studies (ultrasound studies evaluating blood flow in the veins)
3 CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class C2 or greater (Clinical classification
large varicose veins)
4 One or more indications
o Ulceration secondary to venous stasis (leg ulcers caused by poor blood flow in the veins)
o Recurrent superficial thrombophlebitis (recurrent blood clots or inflammation in a small
veins near the surface of the skin)
o Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity (bleeding
from a varicose vein)
o Persistent pain swelling itching burning or other symptoms are associated with
saphenous reflux (pooling of the blood caused by valves that donrsquot work correctly)
AND
These symptoms significantly interfere with activities of daily living
Conservative management including compression therapy for at least 3 months has
not improved the symptoms
Coding
Code Description
CPT 36465 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring single incompetent extremity truncal vein (eg great saphenous vein
accessory saphenous vein) (new code effective 1118)
36466 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring multiple incompetent truncal veins (eg great saphenous vein accessory
saphenous vein) same leg (new code effective 1118)
36468 Single or multiple injections of sclerosing solutions spider veins (telangiectasia) limb
or trunk
36470 Injection of sclerosing solution single vein
36471 Injection of sclerosing solution multiple veins same leg
36473 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
Page | 9 of 41 infin
Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
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Documentation Requirements each CPT code
2 Copy of the venous studies (ultrasound studies evaluating blood flow in the veins)
3 CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class C2 or greater (Clinical classification
large varicose veins)
4 One or more indications
o Ulceration secondary to venous stasis (leg ulcers caused by poor blood flow in the veins)
o Recurrent superficial thrombophlebitis (recurrent blood clots or inflammation in a small
veins near the surface of the skin)
o Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity (bleeding
from a varicose vein)
o Persistent pain swelling itching burning or other symptoms are associated with
saphenous reflux (pooling of the blood caused by valves that donrsquot work correctly)
AND
These symptoms significantly interfere with activities of daily living
Conservative management including compression therapy for at least 3 months has
not improved the symptoms
Coding
Code Description
CPT 36465 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring single incompetent extremity truncal vein (eg great saphenous vein
accessory saphenous vein) (new code effective 1118)
36466 Injection of non-compounded foam sclerosant with ultrasound compression
maneuvers to guide dispersion of the injectate inclusive of all imaging guidance and
monitoring multiple incompetent truncal veins (eg great saphenous vein accessory
saphenous vein) same leg (new code effective 1118)
36468 Single or multiple injections of sclerosing solutions spider veins (telangiectasia) limb
or trunk
36470 Injection of sclerosing solution single vein
36471 Injection of sclerosing solution multiple veins same leg
36473 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
Page | 9 of 41 infin
Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
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之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
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Code Description
guidance and monitoring percutaneous mechanochemical first vein treated
36474 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous mechanochemical subsequent vein(s) treated
in a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36475 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency first vein treated
36476 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous radiofrequency second and subsequent veins
treated in a single extremity each through separate access sites (List separately in
addition to code for primary procedure)
36478 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser first vein treated
36479 Endovenous ablation therapy of incompetent vein extremity inclusive of all imaging
guidance and monitoring percutaneous laser second and subsequent veins treated in
a single extremity each through separate access sites (List separately in addition to
code for primary procedure)
36482 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous first vein treated (new code effective
1118)
36483 Endovenous ablation therapy of incompetent vein extremity by transcatheter delivery
of a chemical adhesive (eg cyanoacrylate) remote from the access site inclusive of all
imaging guidance and monitoring percutaneous subsequent vein(s) treated in a
single extremity each through separate access sites (List separately in addition to code
for primary procedure) (new code effective 1118)
37500 Vascular endoscopy surgical with ligation of perforator veins subfascial (SEPS)
37700 Ligation and division of long saphenous vein at saphenofemoral junction or distal
interruptions
37718 Ligation division and stripping short saphenous vein
37722 Ligation division and stripping long (greater) saphenous veins from saphenofemoral
junction to knee or below
37735 Ligation and division and complete stripping of long and short saphenous veins with
radical excision of ulcer and skin graft andor interruption of communicating veins of
lower leg with excision of deep fascia
37760 Ligation of perforator veins subfascial radical (Linton type) including skin graft when
performed open 1 leg
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Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
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Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
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Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
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saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
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sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
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Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 10 of 41 infin
Code Description
37761 Ligation of perforator vein(s) subfascial open including ultrasound guidance when
performed 1 leg
37765 Stab phlebectomy of varicose veins 1 extremity 10-20 stab incisions
37766 Stab phlebectomy of varicose veins 1 extremity more than 20 stab incisions
37780 Ligation and division of short saphenous vein at saphenopopliteal junction (separate
procedure)
37785 Ligation division andor excision of varicose vein cluster(s) one leg
37799 Unlisted procedure vascular surgery (eg MOCA ClariVein Varithena TRIVEX System)
Note CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) HCPCS
codes descriptions and materials are copyrighted by Centers for Medicare Services (CMS)
Related Information
Definition of Terms
Accessory saphenous veins Veins that travel in parallel with the greater and lesser saphenous
veins and are generally 2 to 25 mm in their normal state
Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification Considers the clinical
etiologic anatomic and pathologic (CEAP) characteristics of venous insufficiency See table
below
Class Clinical Classification
C0 No visible or palpable signs of venous disease
C1 Telangiectasies or reticular veins
C2 Varicose veins
C3 Edema
C4a Pigmentation and eczema
C4b Lipodermatosclerosis and atrophie blanche
C5 Healed venous ulcer
C6 Active venous ulcer
S Symptoms including ache pain tightness skin irritation heaviness muscle cramps and other
Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
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Page | 11 of 41 infin
Class Clinical Classification
complaints attributable to venous dysfunction
A Asymptomatic
C0 No visible or palpable signs of venous disease
Compression Therapy Compression hosiery or stockings are often the first line of treatment
for varicose veins Compression stockings are generally thought to be effective in a range of 20
mmHg to 40mmHg The Society for Vascular SurgeryAmerican Venous Forum recommends
compression therapy of 20-30 mmHg for patients with symptomatic varicose veins
Compression stockings of 20-30mmHg are available over the counter without a prescription
Greaterlong saphenous vein Superficial vein running the entire length of the leg and is
generally 3 mm in its normal state A typical GSV contains an average of 7 valves throughout its
entire length and it is the most common superficial vein to develop venous reflux
Lesser (small)short saphenous veins Superficial vein of the calf and is generally 25 mm in its
normal state The small saphenous vein originates at the back of the ankle near the outer
malleous bone and usually runs up the back of the lower leg to the popliteal vein behind the
knee
Moderate to severe reflux In current practice most vascular laboratories consider the
presence of venous flow reversal for greater than 05 second with proximal compression
Valsalva maneuver or distal compression and release to represent pathologic reflux
Perforator veins These connect superficial veins to deep veins They contain one-way valves to
direct the blood from the superficial system to the deep system and are generally less than 3mm
in their normal state
Stab avulsion This technique is also known as stabhook phlebectomy Stab avulsion results in
removal of the varicose veins through incisions that are 2-3 mm in length The veins are hooked
with a tiny hook-like instrument and pulled out The wounds are closed with tapes not sutures
and the leg is wrapped in elastic compression support Once healed the incision sites are almost
invisible
Telangiectasiaspider veins Very small (le1 mm in diameter) thread veins found commonly just
under the surface of the skin usually not distorting skin or surrounding tissues
Tributary veins Veins that empty into a larger vein
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
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ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 12 of 41 infin
Evidence Review
Description
A variety of treatment modalities are available to treat varicose veinsvenous insufficiency
including surgical approaches thermal ablation and sclerotherapy The application of each of
these treatment options is influenced by the severity of the symptoms type of vein source of
venous reflux and the use of other (prior or concurrent) treatments
Based on the available evidence clinical input and clinical practice guidelines the use of
endovenous radiofrequency laser ablation and microfoam sclerotherapy are considered to
improve outcomes when used in the saphenous veins For treatment of saphenous tributaries at
the same time or following treatment of the saphenous vein stab avulsion hook phlebectomy
sclerotherapy or transilluminated powered phlebectomy improve outcomes
Background
The venous system of the lower extremities consists of the superficial veins (this includes the
greater and lesser saphenous and accessory or duplicate veins that travel in parallel with the
greater and lesser saphenous veins) the deep system (popliteal and femoral veins) and
perforator veins that cross through the fascia and connect the deep and superficial systems
One-way valves are present within all veins to direct the return of blood up the lower limb
Because venous pressure in the deep system is generally greater than that of the superficial
system valve incompetence at any level may lead to backflow (venous reflux) with pooling of
blood in superficial veins Varicose veins with visible varicosities may be the only sign of venous
reflux although itching heaviness tension and pain may also occur Chronic venous
insufficiency secondary to venous reflux can lead to thrombophlebitis leg ulcerations and
hemorrhage The CEAP classification considers the clinical etiologic anatomic and pathologic
(CEAP) characteristics of venous insufficiency ranging from class 0 (no visible sign of disease) to
class 6 (active ulceration)
Treatment of venous refluxvenous insufficiency is aimed at reducing abnormal pressure
transmission from the deep to the superficial veins Conservative medical treatment consists of
elevation of the extremities graded compression and wound care when indicated Conventional
surgical treatment consists of identifying and correcting the site of reflux by ligation of the
incompetent junction followed by stripping of the vein to redirect venous flow through veins
with intact valves While most venous reflux is secondary to incompetent valves at the
Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
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Page | 13 of 41 infin
saphenofemoral or saphenopopliteal junctions reflux may also occur at incompetent valves in
the perforator veins or in the deep venous system The competence of any single valve is not
static and may be pressure-dependent For example accessory saphenous veins may have
independent saphenofemoral or saphenopopliteal junctions that become incompetent when the
greater or lesser saphenous veins are eliminated and blood flow is diverted through the
accessory veins
Saphenous Veins and Tributaries
Saphenous veins include the greater and lesser saphenous and accessory saphenous veins that
travel in parallel with the greater or lesser (small) saphenous veins Tributaries are veins that
empty into a larger vein Treatment of venous reflux typically includes the following
Identification by preoperative Doppler ultrasonography of the valvular incompetence
Control of the most proximal point of reflux traditionally by suture ligation of the
incompetent saphenofemoral or saphenopopliteal junction
Removal of the superficial vein from circulation for example by stripping of the greater
andor lesser saphenous veins
Removal of varicose tributaries (at the time of the initial treatment or subsequently) by stab
avulsion (phlebectomy) or injection sclerotherapy
Minimally invasive alternatives to ligation and stripping have been investigated These include
sclerotherapy transilluminated-powered phlebotomy and thermal ablation using cryotherapy
high frequency radiowaves (200ndash300 kHz) or laser energy
Sclerotherapy
The objective of sclerotherapy is to destroy the endothelium of the target vessel by injecting an
irritant solution (either a detergent osmotic solution or chemical irritant) ultimately resulting in
the occlusion of the vessel The success of the treatment depends on accurate injection of the
vessel an adequate injectate volume and concentration of sclerosant and compression
Historically larger veins and very tortuous veins were not considered to be good candidates for
sclerotherapy due to technical limitations Technical improvements in sclerotherapy have
included the routine use of Duplex ultrasound to target refluxing vessels luminal compression
of the vein with anesthetics and a foamsclerosant injectate in place of liquid sclerosant Foam
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 14 of 41 infin
sclerosants are commonly produced by forcibly mixing a gas (eg air or carbon dioxide) with a
liquid sclerosant (eg polidocanol or sodium tetradecyl sulfate) The foam is produced at the
time of treatment Varithena (previously known as Varisolve BTG PLC London) is a proprietary
microfoam sclerosant that is dispersed from a canister with a controlled density and more
consistent bubble size
Endovenous Mechanochemical Ablation (MCA)
Endovenous mechanochemical ablation (MOCAtrade) utilizes both sclerotherapy and mechanical
damage to the lumen Following ultrasound imaging a disposable catheter with a motor drive is
inserted into the distal end of the target vein and advanced to the saphenofemoral junction As
the catheter is pulled back a wire rotates at 3500 rpm within the lumen of the vein abrading the
lumen At the same time a liquid sclerosant (sodium tetradecyl sulfate) is infused near the
rotating wire It is proposed that mechanical ablation allows for better efficacy of the sclerosant
and results in less pain and risk of nerve injury without need for the tumescent anesthesia used
with thermal endovenous ablation techniques (radiofrequency ablation [RFA] and endovenous
laser treatment [EVLT])
Thermal Ablation
Radiofrequency (RFA) ablation is performed by means of a specially designed catheter inserted
through a small incision in the distal medial thigh to within 1ndash2 cm of the saphenofemoral
junction The catheter is slowly withdrawn closing the vein Laser ablation is performed similarly
a laser fiber is introduced into the greater saphenous vein under ultrasound guidance the laser
is activated and slowly removed along the course of the saphenous vein Cryoablation uses
extreme cold to cause injury to the vessel The objective of endovenous techniques is to cause
injury to the vessel causing retraction and subsequent fibrotic occlusion of the vein Technical
developments since thermal ablation procedures were initially introduced include the use of
perivenous tumescent anesthesia which allows successful treatment of veins larger than 12 mm
in diameter and helps to protect adjacent tissue from thermal damage during treatment of the
lesser saphenous vein
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
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之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
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ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
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تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
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ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 15 of 41 infin
Cyanoacrylate Adhesive for Embolization (CAE)
Cyanoacrylate adhesive is a clear free-flowing liquid that polymerizes in the vessel via an anionic
mechanism (ie polymerizes into a solid material on contact with body fluids or tissue) The
adhesive is gradually injected along the length of the vein in conjunction with ultrasound and
manual compression The acute coaptation halts blood flow through the vein until the
implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the
treated vein Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of
indications including gastrointestinal bleeding embolization of brain arteriovenous
malformations and to seal surgical incisions or other skin wounds
Transilluminated Powered Phlebectomy (TIPP)
Transilluminated powered phlebectomy (TIPP) is an alternative to stab avulsion or hook
phlebectomy This procedure uses 2 instruments an illuminator which also provides irrigation
and a resector which has an oscillating tip and can perform suction Following removal of the
saphenous vein the illuminator is introduced via a small incision in the skin and tumescence
solution (anesthetic and epinephrine) is infiltrated along the course of the varicosity The
resector is then inserted under the skin from the opposite direction and the oscillating tip is
placed directly beneath the illuminated veins to fragment and loosen the veins from the
supporting tissue Irrigation from the illuminator is used to clear the vein fragments and blood
through aspiration and additional drainage holes The illuminator and resector tips may then be
repositioned thereby reducing the number of incisions needed when compared with stab
avulsion or hook phlebectomy It has been proposed that TIPP might result in decreased
operative time decreased complications such as bruising and faster recovery compared to the
established procedures
Treatment of Perforator Veins
Perforator veins cross through the fascia and connect the deep and superficial venous systems
Incompetent perforating veins were originally addressed with an open surgical procedure called
the Linton procedure which involved a long medial calf incision to expose all posterior medial
and paramedial perforators While this procedure was associated with healing of ulcers it was
largely abandoned due to a high incidence of wound complications The Linton procedure was
subsequently modified by using a series of perpendicular skin flaps instead of a longitudinal skin
flap to provide access to incompetent perforator veins in the lower part of the leg The modified
Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
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ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
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در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
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Page | 16 of 41 infin
Linton procedure may occasionally be used for the closure of incompetent perforator veins that
cannot be reached by less invasive procedures Subfascial endoscopic perforator surgery is a
less-invasive surgical procedure for treatment of incompetent perforators and has been
reported since the mid-1980s Guided by Duplex ultrasound scanning small incisions are made
in the skin and the perforating veins are clipped or divided by endoscopic scissors The
operation can be performed as an outpatient procedure Endovenous ablation of incompetent
perforator veins with sclerotherapy and RFA has also been reported
Other
Deep vein valve replacement is being investigated Outcomes of interest for venous
interventions include healing and recurrence recannulation of the vein and neovascularization
Recannulation (recanalization) is the restoration of the lumen of a vein after it has been
occluded this occurs more frequently following treatment with endovenous techniques
Neovascularization is the proliferation of new blood vessels in tissue and occurs more frequently
following vein stripping Direct comparisons of durability for endovenous and surgical
procedures are complicated by these different mechanisms of recurrence Relevant safety
outcomes include the incidence of paresthesia thermal skin injury thrombus formation
thrombophlebitis wound infection and transient neurologic effects
Review of Evidence
Treatment of Saphenous Reflux
Compression Therapy
A 2009 Cochrane review on compression for venous leg ulcers included a total of 39 randomized
controlled trials (RCTs) with 47 different comparisons1 The review was updated in 2012 and
included 48 RCTs with 59 different comparisons2 Most of the RCTs were small Objective
measures of healing were the time to complete healing the proportion of ulcers healed within
the trial period (typically 12 weeks) the change in ulcer size and the rate of change in ulcer size
Evidence from 8 trials indicated that venous ulcers healed more rapidly with compression than
without Findings suggested that multicomponent systems (bandages or stockings) were more
effective than single-component compression In addition multicomponent systems containing
an elastic bandage appeared more effective than those composed mainly of inelastic
constituents Although these meta-analyses did not include time to healing studies included in
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
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ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 17 of 41 infin
the review reported that the mean time to ulcer healing was approximately 2 months while the
median time to healing in other reports was 3 to 5 months
A Cochrane review on compression stockings for the initial treatment of varicose veins in
patients without venous ulceration was published in 20113 Included in the review were 7 studies
involving 356 participants with varicose veins without healed or active venous ulceration (CEAP
[clinical etiology anatomy pathophysiology] classification C2 to C4) Six of the studies
compared different types or pressures of stockings Subjectively participantsrsquo symptoms
improved but results were not compared with a control arm Due primarily to inadequate
reporting the methodologic quality of the included trials was unclear Meta-analyses were not
performed due to inadequate reporting and suspected heterogeneity The authors concluded
that there is insufficient high-quality evidence to determine whether or not compression
stockings are effective as the sole and initial treatment of varicose veins in patients without
venous ulceration or whether any type of stocking is superior to any other type
This Cochrane review was updated in 201364 The authors stated ldquoConclusions from the
individual studies regarding the optimum pressure provided by stockings were conflicting
although the results of one study suggested that lower pressured stockings (20 mmHg) may be
as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms Conclusions
regarding the optimum length of the stockings were inconclusive No severe or long lasting side
effects were notedrdquo
The Clinical Practice Guidelines for the Society for Vascular Surgery and the American Venous
Forum (Gloviczki 2011) includes the following recommendations for compression therapy
We suggest compression therapy using moderate pressure (20-30 mm Hg) for patients with
symptomatic varicose veins (GRADE 2C)
We recommend against compression therapy as the primary treatment of symptomatic
varicose veins in patients who are candidates for saphenous vein ablation (GRADE 1B)
We recommend compression as the primary therapeutic modality for healing venous ulcers
(GRADE 1B)
We recommend compression as an adjuvant treatment to superficial vein ablation for the
prevention of ulcer recurrence (GRADE 1A)52
Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
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Page | 18 of 41 infin
Ligation and Stripping
Systematic literature reviews published in 2008 indicate a similar healing rate of venous ulcers
with superficial vein surgery and conservative compression treatments but a reduction in ulcer
recurrence rate with surgery4 5 In general recurrence rates after ligation and stripping are
estimated at around 20 Jones et al reported on the results of a study that randomized 100
patients with varicose veins to undergo either ligation alone or ligation in conjunction with
stripping6 At 1 year reflux was detected in 9 of patients rising to 26 at 2 years Rutgers and
Kitslaar reported on the results of a trial that randomized 181 limbs to undergo either ligation
and stripping or ligation combined with sclerotherapy7 At 2 years Doppler ultrasound
demonstrated reflux in approximately 10 of patients after ligation and stripping increasing to
15 at 3 years
Comparison of Endovenous Ablation and Sclerotherapy with Ligation and Stripping
An updated Cochrane review from 2014 compared endovenous ablation (radiofrequency and
laser) and foam sclerotherapy versus ligationstripping for saphenous vein varices8 Included in
the review were 13 randomized studies with a combined total of 3081 patients The overall
quality of the evidence was moderate There was no significant difference between
sclerotherapy and surgery in the rate of recurrence as rated by clinicians (odds ratio [OR] 174
p=006) or for symptomatic recurrence (OR=128) For endovenous laser ablation (EVLA) versus
surgery there were no significant differences between the treatment groups for clinician noted
or symptomatic recurrence or for recanalization Neovascularization and technical failure were
reduced in the laser group (OR=005 plt0001 and OR=029 plt0001 respectively) For
endovenous radiofrequency ablation (RFA) versus surgery there were no significant differences
between the groups in clinician noted recurrence recanalization neovascularization or technical
failure The authors concluded that sclerotherapy EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose veins
In 2014 Brittenden et al reported a multicenter randomized trial that compared foam
sclerotherapy EVLA and surgical treatment in 798 patients9 The study was funded by UKrsquos
Health Technology Assessment Programme of the National Institute for Health Research Veins
greater than 15 mm were excluded from the study At the 6-week follow-up visit patients who
were assigned to treatment with foam or laser had the option of treatment with foam for any
residual varicosities this was performed in 38 of patients in the foam group and 31 of
patients in the EVLA group Six months after treatment mean disease-specific quality of life was
slightly worse after sclerotherapy than after surgery (p=0006) and there were more residual
varicose veins although the differences were small Disease-specific quality of life was similar for
Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
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Page | 19 of 41 infin
the laser and surgery groups The frequency of procedural complications was similar for the
foam sclerotherapy (6) and surgery (7) groups but was lower in the laser group (1) The
rate of complications at 6 months (primarily lumpiness and skin staining) was highest for the
sclerotherapy group
Endovenous Radiofrequency Ablation (RFA)
In 2008 Luebke et al reported a meta-analysis of 8 studies that included a total of 224 patients
who underwent RFA and 204 patients who underwent stripping10 There was no significant
difference between RFA and surgery in immediate or complete greater saphenous vein
occlusion incomplete greater saphenous vein closure freedom from reflux recurrent varicose
veins recanalization or neovascularization between the 2 treatments There were significant
reductions in tenderness and ecchymosis at 1 week and fewer hematomas at 72 hours 1 week
and 3 weeks with RFA Quality-of-life results including return to normal activity and return to
work favored RFA over surgery The authors noted that rates of recanalization retreatment
occlusion and reflux may alter with longer follow-up and that further RCTs with longer follow-
up are needed
Long-term outcomes of endovenous RFA were reported from the Closure Study Group clinical
registry in 200511 Thirty-four centers (1006 patients 1222 limbs) participated in the registry
with 12 centers contributing 5-year data (406 limbs) The registry included data on the treatment
of 52 lesser saphenous veins and 16 accessory saphenous veins Follow-up at 1 week showed a
97 anatomic success rate and a decrease in pain in 50 (from 85 to 30) of patients An
additional 162 failures were identified over the 5 years of follow-up 129 veins were found to
have recanalization and 33 limbs had reflux in the groin Logistic regression analysis (risk factors
of sex age body mass index [BMI]) vein diameter and catheter pullback speed) showed that
BMI was associated with long-term failure The rate of pull-back speed of the catheter during
treatment was associated with failure to occlude or recanalization
Endovenous Laser Ablation (EVLA)
The largest trial on EVLA is the 2012 RELACS study which was a practical design that
randomized 400 patients to EVLA performed by a surgeon at 1 site or to ligation and stripping
performed by a different surgeon at a second location12 At 2-year follow-up there was no
significant difference between the groups for clinically recurrent varicose veins medical
condition on the Homburg Varicose Vein Severity Score or disease-related quality of life
Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
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Page | 20 of 41 infin
Saphenofemoral reflux was detected by ultrasonography more frequently after endovenous
laser treatment (EVLT) (178 vs 13) This study will follow patients for 5 years Another trial
compared EVLA with ligation and stripping in 200 limbs (100 in each group)13 At 1-year follow-
up 98 of the limbs were reported to be free of symptoms At 2-year follow-up the EVLA
group had 2 veins completely reopened and 5 partially reopened which was significantly
greater than in the ligation and stripping group In the 2013 MAGNA trial 223 consecutive
patients (240 legs) with great saphenous vein reflux were randomized to EVLA ligation and
stripping or foam sclerotherapy14 At 1-year follow-up the anatomic success rates were similar
between EVLA and stripping (885 and 882 respectively) which were superior to foam
sclerotherapy (722) Ten percent of the stripping group showed neovascularization Health-
related quality of life improved in all groups The CEAP classification improved in all groups with
no significant difference between the groups Transient adverse events were reported in 11
patients after stripping 7 after EVLA and 5 after sclerotherapy At 5-year follow-up Kaplan-
Meier analysis showed obliteration or absence of the great saphenous vein in 85 of patients
who underwent conventional surgery and 77 of patients who underwent EVLA (not
significantly different)15 Grade I neovascularization was higher in the conventional surgery
group (27 vs 3 plt0001) while grade II neovascularization was similar in the 2 groups (17
vs 13)
Literature on isolated treatment of the anterior accessory saphenous vein is limited In a 2009
study outcomes from a cohort of 33 patients who underwent EVLA of the anterior accessory
saphenous vein were compared with 33 matched controls undergoing EVLA of the greater
saphenous vein15 In 21 of the patients (64) in the accessory saphenous vein group there had
been no previous treatment of the greater saphenous vein At 12-month follow-up there was no
evidence of reflux in these patients and the treated accessory saphenous vein was not visible
with ultrasound The Aberdeen Varicose Vein Symptom Severity Score had improved in both
groups with no significant difference between the 2 groups Patient satisfaction scores were also
similar
Sclerotherapy
In the 2013 MAGNA trial (previously described) 223 consecutive patients (240 legs) with great
saphenous vein reflux were randomized to EVLA ligation and stripping or physician
compounded foam sclerotherapy (1 cc aethoxysclerol 3 3 cc air)14 At 1-year follow-up the
anatomic success rate of foam sclerotherapy (722) was inferior to both EVLA and stripping
(885 and 882 respectively) Twenty-one patients in the sclerotherapy group had partial
occlusion with reflux though the clinical complaint was completely relieved At 5-year follow-up
Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
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さい健康保険や有料サポートを維持するには特定の期日までに行動を
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Page | 21 of 41 infin
obliteration or absence of the greater saphenous vein was observed in only 23 of patients
treated with sclerotherapy compared to 85 of patients who underwent conventional surgery
and 77 of patients who underwent EVLA15 Thirty-two percent of legs treated initially with
sclerotherapy required 1 or more reinterventions during follow-up compared with 10 in the
conventional surgery and EVLA groups However clinically relevant grade II neovascularization
was higher in the conventional surgery and EVLA groups (17 and 13 respectively) compared
with the sclerotherapy group (4) EuroQol-5D scores improved equally in all groups A 2012
study was a noninferiority trial of foam sclerotherapy versus ligation and stripping in 430
patients17 Analysis was per protocol Forty patients (17) had repeat sclerotherapy At 2 years
the probability of clinical recurrence was similar in the 2 groups (113 sclerotherapy vs 90
ligation and stripping) although reflux was significantly more frequent in the sclerotherapy
group (35 vs 21) Thrombophlebitis occurred in 74 of patients after sclerotherapy There
were 2 serious adverse events in the sclerotherapy group (deep venous thrombosis and
pulmonary emboli) that occurred within 1 week of treatment
In 2013 Varithenatrade microfoam was approved under a new drug application for the treatment of
varicose veins Efficacy data were from 2 randomized blinded multicenter studies18 One
evaluated Varithenatrade at 05 10 and 20 polidocanol and the second evaluated
Varithenatrade at 05 and 10 polidocanol compared with endovenous placebo or a
subtherapeutic dose of polidocanol foam The primary end point was improvement in symptoms
at week 8 as measured by the Varicose Vein Symptoms Questionnaire The improvement in
symptoms was greater in the pooled Varithenatrade treatment group (plt0001) and in each of the
individual dose-concentration groups compared with vehicle alone Secondary and tertiary end
points (appearance duplex ultrasound response quality of life) were also significantly better for
the Varithenatrade groups compared with controls This second study called VANISH-2 was
published in 201419 At the 8-week assessment there was elimination of reflux andor occlusion
of the previously incompetent vein in 856 of the combined 05 and 10 groups 596 of
patients in the 0125 group and 18 of the placebo group Analysis of data from both studies
showed a dose response from 05 to 20 for improvement in appearance and from 05 to
10 for Duplex responders The 10 dose of Varithenatrade was selected for the FDA approval
Safety analysis found deep vein thrombosis detected by ultrasound in 28 of Varithenatrade-
treated patients with 1 of patients having proximal symptomatic thrombi these were treated
with anticoagulants There was no signal of an increase in neurological adverse events and there
were no adverse cardiac or cardiopulmonary effects following treatment with Varithenatrade
injectable foam Rates of occlusion with Varithenatrade are similar to those reported for EVLA or
stripping A randomized trial comparing EVLA and stripping with this new preparation of foam
sclerotherapy is needed to evaluate its comparative effectiveness Evaluation out to 5 years is
continuing
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
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េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
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Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
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លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 22 of 41 infin
Mechanochemical Ablation (MCA)
Several prospective series and cohort studies have been reported One prospective multicenter
series evaluated the efficacy of mechanochemical ablation (MCA) of the great saphenous vein in
126 patients in a community setting20 Veins were selected that were greater than 4 mm and less
than 12 mm in diameter with an average diameter of 73 mm Closure rates were 100 at 1
week 98 at 3 months and 94 at 6 months The venous clinical severity score decreased from
a score of approximately 9 pretreatment to about 3 at 6 months In 2012 Elias and Raines
reported an industry-sponsored safety and efficacy study of MCA with the ClariVeinreg system21
Thirty greater saphenous veins in 29 patients were treated with this device Greater saphenous
veins with diameters greater than 12 mm were excluded At 6-month follow-up 1 vein had
recanalized for a primary closure rate of 967 No pain during the procedure or adverse events
was reported Another prospective series evaluated MCA of the small saphenous vein in 50
consecutive patients22 Only patients with a vein diameter of 25 to 11 mm were included The
dose of sclerosant was increased after the first 15 patients At the 6-week assessment all treated
veins were occluded and at 1-year follow-up 94 remained occluded The median visual analog
scale score for pain during the procedure was 2 of 10 There were no major complications
Controlled studies with a greater number of subjects and longer follow-up are needed
A 2013 review of MCA notes that a 5-year 840 patient randomized trial comparing ClariVein with
RFA began in 2012 in Europe23 This trial will provide needed data on the comparative
effectiveness of MCA measured at a longer duration and in a larger population Early results
from this trial (119 patients) indicate that intra-procedural pain is slightly lower with MCA (134
mm on a 100-mm scale) compared with RFA (244 p=0001)24
Cyanoacrylate Adhesion
The VenaSealtrade pivotal study (VeClose) was a multicenter noninferiority trial with 222 patients
that compared VenaSealtrade versus RFA for the treatment of venous reflux25 26 The primary end
point the proportion of patients with complete closure of the target GSV at 3 months measured
by ultrasound was non-inferior to RFA with a 99 closure rate for VenaSealtrade compared with
96 for RFA The secondary endpoint of intraoperative pain was similar for the 2 groups (22 on
a 10-point scale for VenaSealtrade and 24 for RFA p=011) Ecchymosis at day 3 was significantly
lower in the cyanoacrylate group 676 of patients treated with cyanoacrylate had no
ecchymosis compared with 482 of patients following RFA (plt001) Scores on the AVVQ and
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 23 of 41 infin
Venous Clinical Severity Score improved to a similar extent in the 2 groups Longer term follow-
up is needed to permit conclusions regarding the durability of this procedure
Twenty-four-month follow-up was reported for 24 of 38 patients enrolled in a study by Almeida
et al27 Thirty-three month follow-up was reported in 467 veins out of a series of 795 veins
(587) treated at 1 institution in Germany28 An inflammatory reddening of the skin was
observed at approximately 1 week after treatment in 117 of cases No permanent skin
responses were observed Of the 467 veins re-examined the sealing rate was 977 This series
is limited by the high loss to follow-up
Endovenous Cryoablation
Klem et al reported a randomized trial in 2009 that found endovenous cryoablation (n=249) to
be inferior to conventional stripping (n=245) for treating patients with symptomatic varicose
veins29 The percentage of patients with greater saphenous vein remaining was 44 in the
endovenous cryoablation group and 15 in the conventional stripping group The Aberdeen
Varicose Vein Questionnaire also showed better results for conventional stripping (score 117) in
comparison with cryoablation (score 80) There were no differences between the groups in SF-
36 subscores and neural damage was the same (12) in both groups
Disselhoff et al reported 2 and 5 year outcomes from a randomized trial that compared
cryostripping with EVLA30 31 Included were 120 patients with symptomatic uncomplicated
varicose veins (CEAP C2) with saphenofemoral incompetence and greater saphenous vein reflux
At 10 days after treatment EVLA had better results than cryostripping with respect to pain score
over the first 10 days (29 vs 44) resumption of normal activity (75 vs 45) and induration
(15 vs 52) At 2-year follow-up freedom from recurrent incompetence was observed in 77
of patients after EVLA and 66 of patients after cryostripping (not significantly different) At 5
years 367 of patients were lost to follow-up freedom from incompetence and
neovascularization was found in 62 of patients treated with EVLA and 51 of patients treated
with cryostripping (not significantly different) Neovascularization was more common after
cryostripping but incompetent tributaries were more common after EVLA There was no
significant difference between groups in the Venous Clinical Severity Score or Aberdeen
Varicose Vein Severity Score at either 2 or 5 years
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
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ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
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در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
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تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
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ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 24 of 41 infin
Other Treatments
Both steam injection and microwave ablation for endovenous treatment of varicose veins were
reported outside of the United States32-34 These procedures have not been approved or cleared
for marketing by FDA
Section Summary
There are a number of large randomized trials on endovenous ablation of the saphenous veins
Comparison with ligation and stripping at 2-year follow-up supports use of both RFA and EVLA
Evidence suggests that ligation and stripping may lead to neovascularization while thermal
ablation may lead to recanalization Controlled studies with longer follow-up are needed to
determine the long-term efficacy of these treatments with greater certainty Two RCTs suggest
that cryotherapy is not as effective as available alternatives For physician-compounded
sclerotherapy there is high variability in success rates of the procedure and reports of serious
adverse events Rates of occlusion with the FDA-approved microfoam sclerotherapy are similar
to those reported for EVLA or stripping MCA is a combination of liquid sclerotherapy with
mechanical abrasion A potential advantage of this procedure compared with thermal ablation
techniques is that it does not require tumescent anesthesia and may result in less postoperative
pain To date the ClariVein procedure has been assessed in relatively few patients and for short
durations Thus there is insufficient evidence to permit conclusions regarding the safety and
efficacy of MCA Short-term efficacy of cyanoacrylate adhesion has been shown to be
noninferior to RF in a large multicenter RCT Longer term follow-up is needed to determine
durability of this treatment
Treatment of Tributary Varicosities
Sclerotherapy and Phlebectomy
Early studies established ligation and stripping as the criterion standard for the treatment of
saphenofemoral incompetence based on improved long-term recurrence rates with
sclerotherapy used primarily as an adjunct to treat varicose tributaries A 2006 Cochrane Review
based primarily on RCTs from the 1980s concluded that ldquoThe evidence supports the current
place of sclerotherapy in modern clinical practice which is usually limited to treatment of
recurrent varicose veins following surgery and thread veinsrdquo35 Sclerotherapy and phlebectomy
are considered appropriate in the absence of reflux of the saphenous system eg post- or
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
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េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
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ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
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លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
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حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 25 of 41 infin
adjunctive treatment to other procedures such as surgery36 In 2014 El-Sheikha et al reported a
small randomized trial of concomitant or sequential (if needed) phlebectomy following EVLA for
varicose veins37 Quality of life and clinical severity scores were similar between the groups by 1
year with 16 of 24 patients (67) in the sequential phlebectomy group receiving a secondary
intervention
A small proportion of patients may present with tributary varicosities in the absence of
saphenous reflux For example of 1009 patients recruited for an RCT 64 patients were found to
have minor varicose veins without reflux 34 of whom agreed to be randomized to sclerotherapy
or conservative treatment38 At baseline 92 had symptoms of heaviness 69 had cosmetic
concerns 53 reported itching and 30 reported relief of symptoms through the use of
compression hosiery At 1-year follow-up there was an improvement in cliniciansrsquo assessment of
the anatomic extent of varicose veins with 85 of patients in the sclerotherapy group improved
compared with 29 of patients in the conservative-therapy group Symptoms of aching were
better or eliminated in 69 of the sclerotherapy group and 28 of the group treated with
conservative therapy Cosmetic concerns were improved in 85 of the sclerotherapy patients
and 14 of controls
The bulk of the literature discussing the role of ultrasound guidance refers to sclerotherapy of
the saphenous vein as opposed to the varicose tributaries In 2012 Yamaki et al reported a
prospective RCT that compared visual foam sclerotherapy versus ultrasound-guided foam
sclerotherapy of the greater saphenous vein together with visual foam sclerotherapy for varicose
tributary veins39 A total of 51 limbs in 48 patients were treated with ultrasound-guided foam
sclerotherapy plus visual foam sclerotherapy of the varicose tributaries and 52 limbs in 49
patients were treated with foam sclerotherapy alone At 6-month follow-up complete occlusion
was found in 23 limbs (451) treated with ultrasound-guided and visual-guided foam
sclerotherapy and in 22 limbs (423) treated with visual sclerotherapy alone Reflux was absent
in 30 limbs (588) treated with ultrasound and visual guidance and in 37 (712) treated with
visual guidance alone (not significantly different) The authors note that for the treatment of
tributary veins in clinical practice most patients receive direct injection of foam without
ultrasound guidance
Transilluminated Powered Phlebectomy (TIPP)
A 2008 meta-analysis included 5 studies that compared TIPP with conventional surgery40 Results
showed a significant advantage of TIPP over the conventional treatment for number of incisions
mean cosmetic score and duration of the procedure However TIPP also increased the incidence
of hematoma and resulted in worse mean pain scores Included in the meta-analysis was an RCT
Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
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در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
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تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
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Page | 26 of 41 infin
by Chetter et al that compared TIPP (n=29) with a multiple stab incision procedure (n=33)41 A
single surgeon performed all but 2 of the procedures and there was no difference in operating
time Patients treated with TIPP had an average of 5 incisions compared with 20 for the multiple
stab procedure However blinded evaluation revealed that bruising or discoloration was higher
for the TIPP group at both 1 and 6 weeks after surgery At 6 weeks after surgery patients in the
TIPP group showed no improvement in pain (-2 points on the Burford pain scale) while patients
in the multiple stab incision group had a significant improvement in pain score compared with
presurgical baseline (-20 points) Six weeks after surgery quality-of-life measures had improved
in the multiple-stab incision group but not in the TIPP group Thus although TIPP had the
advantage of fewer surgical incisions in this single-center study it was associated with a more
prolonged recovery due to more extensive bruising prolonged pain and reduced early
postoperative quality of life The current literature does not show an advantage of TIPP over
conventional treatment
Section Summary
The literature indicates that sclerotherapy of tributaries following occlusion of the
saphenofemoral or saphenopopliteal junction and saphenous veins may be considered
medically necessary Evidence is insufficient to evaluate the health benefit of sclerotherapy as a
sole treatment of varicose tributaries without prior or concurrent treatment of the saphenous
veins No studies have been identified that compare RF or laser ablation of tributary veins with
standard procedures (microphlebectomy andor sclerotherapy) Transilluminated powered
phlebectomy (TIPP) is effective at removing varicosities outcomes are comparable with available
alternatives such as stab avulsion and hook phlebectomy However there is limited evidence
that TIPP is associated with more pain bruising discoloration and a longer recovery
Treatment of Perforator Reflux
A systematic literature review published in 2008 indicates insufficient evidence for the role of
incompetent perforator vein surgery5 These conclusions were based on 4 RCTs published since
2000 that compared superficial vein surgery with conservative therapy in advanced chronic
venous insufficiency (CEAP category C5 to C6) The 4 trials included 2 level I (large subject
population) and 2 level II (small subject population) studies Two of the trials combined surgical
treatment of the incompetent perforator veins with concurrent or prior treatment of the
superficial saphenous veins the other 2 treated the greater saphenous vein alone The 2
randomized studies in which the greater saphenous vein alone was treated (including the
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
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تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 27 of 41 infin
ESCHAR trial) showed a significant reduction in ulcer recurrence in comparison with conservative
therapy42 43 A 2011 community hospital-based multicenter double-blind randomized trial
found no clinical benefit (self-reported symptoms) from adding subfascial endoscopic perforator
surgery (SEPS) to saphenous surgery in 75 patients with varicose ulcers (CEAP C5 or C6) and
incompetent perforators44
Treatment of the great saphenous vein alone has been reported to improve perforator function
For example 1 study showed that reversal of perforator vein incompetence (41 of 68
previously incompetent perforators) was more common than new perforator vein incompetence
(22 of 183 previously competent perforators) following superficial vein surgery45 OrsquoDonnell
discusses additional (lower quality) evidence to suggest deep venous valvular involvement
rather than incompetent perforators in venous insufficiency5 Thus although incompetence of
perforator veins is frequently cited as an important etiologic factor in the pathogenesis of
venous ulcer current evidence does not support the routine ligation or ablation of perforator
veins
Subfascial Endoscopic Perforator Surgery (SEPS)
In 2004 Tenbrook et al published a review of the literature of SEPS which included 19 case
series and 1 randomized trial46 In total the reviewed studies included 1031 patients with 1140
treated limbs The authors concluded that SEPS was associated with excellent results in terms of
ulcer healing and prevention of recurrence However the authors also noted that randomized
trials are required to define the relative contributions of compression therapy superficial venous
surgery and SEPS in the management of severe venous disease In 2015 Van Gent et al reported
10-year follow-up of a randomized trial that compared conservative treatment versus SEPS for
venous leg ulcers47 Patients (196 legs) returned to the clinic on an annual basis and analysis was
conducted with the last-observation carried-forward The primary outcome incidence ulcer-free
was significantly higher in the surgical group compared with the conservative treatment group
(589 vs 396 p=0007) The number of incompetent perforator veins at follow-up was a risk
factor for not being ulcer free (OR=185 plt0001) The relatively high rate of recurrence of the
surgically treated group may be due to limitedno stripping of the superficial veins at the time
of SEPS
A 2009 meta-analysis of SEPS for chronic venous insufficiency concludes that ldquoIts [SEPS] use
should not be employed routinely and could only be justified in patients with persistent
ulceration thought to be of venous origin and in whom any superficial reflux has already been
ablated and postthrombotic changes excludedrdquo48 The authors also state that ldquointroduction of
Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
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之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
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Page | 28 of 41 infin
less invasive techniques for perforator vein ablation such as ultrasound-guided sclerotherapy or
radiofrequency ablation may diminish the role of SEPS in the future
Other Treatments
A 2008 review of procedures for management of varicose veins recommends duplex-guided
foam sclerotherapy microincision phlebectomy or thermal ablation using a new short RFA
catheter for the treatment of symptomatic residual perforator vein incompetence49 Ablation of
incompetent perforator veins with laser or RFA had been shown to be technically feasible
although no studies had been identified that showed an improvement in clinical outcomes (eg
ulcer healing or recurrence) The 2011 literature update identified 1 study of EVLA for
perforating veins in 33 patients with a CEAP classification of 4 (skin changes) 5 (healed ulcer) or
6 (active ulcer)50 All incompetent saphenous trunks were treated simultaneously (63 of limbs)
At 3-month follow-up occlusion was achieved in 78 of the perforating veins Five patients
(15) had active ulcers at baseline 4 of the 5 ulcers had healed by 6 weeks after EVLA Evidence
regarding the treatment of perforator veins with ultrasound-guided sclerotherapy is limited and
there is a risk of deep venous occlusion51
Summary of Evidence
Although randomized controlled trials (RCTs) with longer follow-up are needed to evaluate
long-term durability and repeat treatments may be required evidence indicates that
endovenous treatment of saphenous veins with radiofrequency or laser ablation improves short-
term clinical outcomes (eg pain and return to work) in comparison with surgery Ultrasound-
guided foam sclerotherapy (physician compounded) leads to success rates that approach that of
surgery There are no trials comparing the recently US Food and Drug Administration (FDA)
approved microfoam sclerotherapy with other treatments of varicose veins Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping There
is insufficient evidence on mechanochemical ablation
The literature indicates that the routine ligationablation of incompetent perforator veins is not
medically necessary for the treatment of varicose veinsvenous insufficiency at the time of
superficial vein procedures However when combined superficial vein procedures and
compression therapy have failed to improve symptoms treatment of perforator vein reflux may
be as beneficial as any alternative (eg deep vein valve replacement) Therefore treatment of
incompetent perforator veins may be considered medically necessary in this specific situation
Page | 29 of 41 infin
Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
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Comparative studies are needed to determine the most effective method of ligatingablating
incompetent perforator veins SEPS has been shown to be as effective as the Linton procedure
with a reduction in adverse events Although only 1 case series has been identified showing an
improvement in health outcomes endovenous ablation with specialized laser or radiofrequency
probes has been shown to effectively ablate incompetent perforator veins with a potential
decrease in morbidity in comparison with surgical interventions For sclerotherapy concerns
have been raised about the risk of deep vein occlusion and evidence is currently insufficient to
evaluate the safety or efficacy of this treatment for incompetent perforator veins
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 1
Table 1 Summary of Key Trials
NCT No Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT01807585a Randomized Control Trial Comparing VenaSeal Sapheon
Closure System With Radiofrequency Ablation (Pivotal
Study)
244 Sep 2016
NCT01459263 Mechanochemical Endovenous Ablation of Great
Saphenous Vein Incompetence Using the ClariVeintrade
Device a Prospective Study
100 Dec 2017
NTR4613a Mechanochemical endovenous ablation versus
radiofrequency ablation in the treatment of primary small
saphenous vein insufficiency (MESSI trial)
160 Apr 2020
NCT national clinical trial NTR Netherlands Trial Registry a Denotes industry-sponsored or cosponsored trial
Summary of Evidence
The evidence on mechanochemical ablation cyanoacrylate adhesive and cryoablation in
patients with varicose veinsvenous insufficiency includes randomized controlled trials (RCTs)
and multicenter series Relevant outcomes are symptoms morbid events functional outcomes
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 30 of 41 infin
and change in disease status Several series have been reported on mechanochemical ablation
(MCA) and a large RCT comparing MCA with radiofrequency RF ablation is ongoing Efficacy of
cyanoacrylate adhesion at 3 months has been shown to be noninferior to RF in a multicenter
RCT Longer term follow-up is needed to determine durability of this treatment Results from a
recent RCT of cryoablation indicate that this therapy is inferior to conventional stripping The
evidence is insufficient to determine the effects of the technology on health outcomes
Practice Guidelines and Position Statements
The Society for Vascular Surgery and the American Venous Forum (AVF)
The Society for Vascular Surgery and the American Venous Forum (AVF) published clinical
practice guidelines in 201146 The recommendations are rated as strong = 1 or weak = 2 based
on a level of evidence that is either high quality = A moderate quality = B or low quality = C
and include the following
Compression therapy for venous ulcerations and varicose veins Compression therapy is
recommended as the primary treatment to aid healing of venous ulceration (GRADE 1B
strong recommendation moderate quality evidence) To decrease the recurrence of venous
ulcers they recommend ablation of the incompetent superficial veins in addition to
compression therapy (GRADE 1A strong recommendation high quality evidence) They
recommend use of compression therapy for patients with symptomatic varicose veins
(GRADE 2C weak recommendation low-quality evidence) but recommend against
compression therapy as the primary treatment if the patient is a candidate for saphenous
vein ablation (GRADE 1B strong recommendation moderate quality evidence)
Treatment of the incompetent great saphenous vein Endovenous thermal ablation
(radiofrequency or laser) is recommended over chemical ablation with foam (GRADE 1B
strong recommendation moderate quality evidence) or high ligation and stripping (GRADE
1B strong recommendation moderate quality evidence) due to reduced convalescence and
less pain and morbidity Cryostripping is a technique that is new in the United States and it
has not been fully evaluated
Varicose tributaries Phlebectomy or sclerotherapy are recommended to treat varicose
tributaries (GRADE 1B strong recommendation moderate quality evidence)
Transilluminated powered phlebectomy using lower oscillation speeds and extended
tumescence is an alternative to traditional phlebectomy (GRADE 2C weak recommendation
low quality evidence)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
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ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
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លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 31 of 41 infin
Perforating vein incompetence Selective treatment of perforating vein incompetence in
patients with simple varicose veins is not recommended (CEAP class C2 GRADE 1B strong
recommendation moderate quality evidence) but there is a GRADE 2B recommendation
(weak recommendation moderate quality evidence) for treatment of pathologic perforating
veins (outward flow of gt 500 ms duration with a diameter of gt 35 mm) located underneath
healed or active ulcers (CEAP class C5-C6) by subfascial endoscopic perforating vein surgery
sclerotherapy or thermal ablations (GRADE 1C weak recommendation low quality
evidence)
American College of Radiology (ACR)
In 2012 the American College of Radiology published their latest version of appropriateness
criteria for the treatment of lower-extremity venous insufficiency52 The following is a summary
of treatment options
Compression stockings Graduated compression stockings are routinely used to control
venous insufficiency symptoms They provide external support that can constrict dilated
veins and restore competence to incompetent valves Compression stockings are particularly
helpful during pregnancy and they are frequently used following venous ablation treatment
Surgery Great saphenous vein (GSV) stripping with branch ligation had historically been the
primary treatment option for venous insufficiency The GSV is ligated near the groin Ligation
alone can preserve the vein for subsequent harvesting in case of arterial bypass however
ligation alone has proven unsatisfactory for preventing the occurrence of reflux so it is often
supplemented by vein stripping Ambulatory phlebectomy is primarily used to treat surface
varicose veins It can be performed as an adjunct to endovenous ablation or stripping This
procedure involves making tiny punctures or incisions through which the varicose veins are
removed Other surgical methods to treat venous insufficiency have been described
including SEPS for treating venous ulcers and valvular surgery for treating reflux caused by
incompetent valves of the deep veins
Injection sclerotherapy Injection sclerotherapy is a common treatment for telangiectasias
and can be used to treat smaller varicose veins The sclerotherapy solution can be in liquid
form or can be injected as foam (mixed with a gas such as air) Sclerotherapy has not been
shown to have long-term effectiveness for large veins such as the GSV
Endovenous ablation Endovenous ablation is a minimally invasive alternative to surgery It
is a percutaneous procedure that can be used to treat the GSV small saphenous vein (SSV)
and other superficial veins Endovenous ablation uses RFA or laser energy (EVLA) applied
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
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េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
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ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
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លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 32 of 41 infin
inside the vein to cause occlusion Small prospective trials comparing EVLA and RFA with
conventional surgery in patients with GSV reflux have shown favorable results One study
demonstrated that EVLA is comparable to surgery in abolishing reflux and improving
disease-specific quality of life and that it allows earlier return to normal activity A recent
systematic literature review comparing the safety and efficacy of EVLA and surgery involving
saphenous ligation and stripping as treatments for varicose veins showed few differences in
clinical effectiveness outcomes although long-term follow-up was lacking A meta-analysis
suggested that EVLA and RFA are at least as effective as surgery in treating lower-extremity
varicose veins After 3 years the estimated pooled success rates for treatment were 78 for
surgical stripping 77 for foam sclerotherapy 84 for RFA and 94 for laser therapy
Adjunctive treatments Adjunctive treatments may be required to help eliminate venous
insufficiency Patients with venous insufficiency and associated venous occlusion or stenosis
of the common iliac vein (eg May-Thurner syndrome) may require venous recanalization
with angioplasty and stenting to achieve a patent conduit for venous return Patients with
pelvic venous insufficiency may require percutaneous embolization of the ovarian veins
Patients with deep venous thrombosis are typically treated with anticoagulation to reduce
the risk of thrombus propagation embolization and post-thrombotic syndrome One study
suggested that endovenous ablation of the saphenous vein can be considered as a viable
treatment alternative in patients with venous insufficiency and previous deep venous
thrombosis
Complications All forms of lower-extremity venous insufficiency treatment are subject to
recurrence Additional risks of vein ligation and stripping surgery include anesthetic risk
scarring pain bleeding deep venous injury or thrombosis nerve injury and infection
Complications of the endovenous ablation procedure include bruising swelling transient
numbness and rarely deep venous thrombosis
Society of Interventional Radiography (SIR)
In 2003 the Society of Interventional Radiography (SIR) published a position statement53 that
considered endovenous ablation therapy using either laser or radiofrequency devices under
imaging guidance and monitoring an effective treatment of extremity venous reflux and
varicose veins under the following conditions
1 The endovenous treatment of varicose veins may be medically necessary when one of the
following indications (a - e) is present
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
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ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
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លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 33 of 41 infin
a Persistent symptoms interfering with activities of daily living in spite of
conservativenonsurgical management Symptoms include aching cramping burning
itching andor swelling during activity or after prolonged standing
b Significant recurrent attacks of superficial phlebitis
c Hemorrhage from a ruptured varix
d Ulceration from venous stasis where incompetent varices are a contributing factor
e Symptomatic incompetence of the great or small saphenous veins (symptoms as in lsquoarsquo
above)
AND
2 A trial of conservative nonoperative treatment has failed This would include mild exercise
avoidance of prolonged immobility periodic elevation of legs and compressive stockings
AND
3 The patients anatomy is amenable to endovenous ablation
In a joint statement published in 2007 AVF and SIR recommended reporting standards for
endovenous ablation for the treatment of venous insufficiency55 The document recommended
that reporting in clinical studies should include the symptoms of venous disease history of
disease and prior treatment the presence of major comorbidities and any exclusion criteria It
was noted that potential candidates for endovenous ablation may include patients with reflux in
an incompetent greater saphenous vein or smaller saphenous vein or in a major tributary branch
of the greater or smaller saphenous veins such as the anterior thigh circumflex vein posterior
thigh circumflex vein or anterior accessory greater saphenous vein The presence of reflux in
these veins is important to document using duplex ultrasound imaging and the ultrasound
criteria used to define reflux should be indicated It was also stated that in current practice most
vascular laboratories consider the presence of venous flow reversal for greater than 05 to 10
second with proximal compression Valsalva maneuver or distal compression and release to
represent pathologic reflux
National Institute for Health and Care Excellence (NICE)
In 2003 and 2004 the UKrsquos National Institute for Health and Care Excellence (NICE) published
guidance on radiofrequency ablation of varicose veins and on endovenous laser treatment of
the long saphenous vein56 57 NICE concluded that the evidence on the safety and efficacy
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
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effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
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(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
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さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
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េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
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ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
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លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
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تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 34 of 41 infin
appeared adequate to support the use of these procedures provided that the normal
arrangements were in place for consent audit and clinical governance The evidence on efficacy
at this time was limited to case series with limited follow-up Clinicians were encouraged to
collect longer-term follow up data
NICE issued updated guidance on ultrasound-guided foam sclerotherapy for varicose veins in
201358 The guidance states that
ldquo11 Current evidence on the efficacy of ultrasound-guided foam sclerotherapy for varicose
veins is adequate The evidence on safety is adequate and provided that patients are
warned of the small but significant risks of foam embolization (see section 12) this
procedure may be used with normal arrangements for clinical governance consent and
audit
12 During the consent process clinicians should inform patients that there are reports of
temporary chest tightness dry cough headaches and visual disturbance and rare but
significant complications including myocardial infarction seizures transient ischaemic
attacks and strokerdquo
NICE issued guidance on endovenous mechanochemical ablation in 2013 concluding that
current evidence on the safety and efficacy of endovenous mechanochemical ablation for
varicose veins is inadequate in quantity and quality59 Therefore this procedure should only be
used with special arrangements for clinical governance consent and audit or research
In 2013 NICE published practice guideline on the diagnosis and management of varicose veins
in the leg60 NICE recommends a study of the clinical and cost effectiveness of
Concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal
endothermal ablation for varicose veins
Truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy
Truncal endothermal ablation with phlebectomies or foam sclerotherapy if needed 6-12
weeks later
In 2015 NICE published a technology assessment on the clinical effectiveness and cost-
effectiveness of foam sclerotherapy endovenous laser ablation and surgery for varicose veins61
Cost-effectiveness was based on a large multicenter randomized trial comparing treatments for
varicose veins (described previously)9 Five-year trial results are currently being evaluated
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 35 of 41 infin
Medicare National Coverage
There is no national coverage determination (NCD) In the absence of an NCD coverage
decisions are left to the discretion of local Medicare carriers
Regulatory Status
In 2015 the VenaSealreg Closure System (Sapheon a part of Medtronic) was approved by the
US Food and Drug Administration (FDA) through the premarket approval process for the
permanent closure of clinically significant venous reflux through endovascular embolization with
coaptation The VenaSeal Closure System seals the vein using a cyanoacrylate adhesive agent
FDA product code PJQ
In 2013 Varithenatrade (formerly known as Varisolvereg (BTG PLC London) is a sclerosant microfoam
made with a proprietary gas mix It was approved by the FDA in 2013 under a new drug
application (NDA) for the treatment of incompetent great saphenous veins accessory
saphenous veins and visible varicosities of the great saphenous vein system above and below
the knee
The following devices have received specific US Food and Drug Administration (FDA) marketing
clearance for the endovenous treatment of superficial vein reflux
In 1999 the VNUSreg Closuretrade system (a radiofrequency device) received FDA clearance
through the 510(k) process for endovascular coagulation of blood vessels in patients with
superficial vein reflux The VNUS RFS and RFSFlex devices received FDA clearance in 2005
for ldquouse in vessel and tissue coagulation including treatment of incompetent (ie refluxing)
perforator and tributary veins The modified VNUSreg ClosureFASTtrade Intravascular Catheter
received FDA clearance through the 510(k) process in 2008 FDA product code GEI
In 2002 the Diomed 810 nm surgical laser and EVLTtrade (endovenous laser therapy) procedure
kit received FDA clearance through the 510(k) process hellip for use in the endovascular
coagulation of the greater saphenous vein of the thigh in patients with superficial vein
reflux FDA product code GEX
In 2005 a modified Erbe Erbokryoreg cryosurgical unit (Erbe USA) received FDA clearance for
marketing A variety of clinical indications are listed including cryostripping of varicose veins
of the lower limbs FDA product code GEH
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
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applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
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If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 36 of 41 infin
In October 2003 the Trivex system received FDA clearance through the 510(k) process The
manufacturer LeMaitre Vascular describes it as a transilluminated powered phlebectomy
system (TIPP) According to the label the intended use is for ldquoambulatory phlebectomy
procedures for the resection and ablation of varicose veinsrdquo FDA product code DNQ
In 2008 The ClariVeinreg Infusion Catheter (Vascular Insights) received marketing clearance
through the 510(k) process (K071468) It is used for mechanochemical ablation Predicate
devices were listed as the Trellisreg Infusion System (K013635) and the Slip-Cathreg Infusion
Catheter (K882796) The system includes an infusion catheter motor drive stopcock and
syringe and is intended for the infusion of physician-specified agents in the peripheral
vasculature FDA product code KRA
References
1 OMeara S Cullum NA Nelson EA Compression for venous leg ulcers Cochrane Database Syst Rev 2009 (1)CD000265 PMID
19160178
2 OMeara S Cullum N Nelson EA et al Compression for venous leg ulcers Cochrane Database Syst Rev 201211CD000265
PMID 23152202
3 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2011 11CD008819 PMID 23152202
4 Howard DP Howard A Kothari A et al The role of superficial venous surgery in the management of venous ulcers a systematic
review Eur J Vasc Endovasc Surg 2008 36(4)458-65 PMID 18675558
5 ODonnell TF Jr The present status of surgery of the superficial venous system in the management of venous ulcer and the
evidence for the role of perforator interruption J Vasc Surg 2008 48(4)1044-52 PMID 18992425
6 Jones L Braithwaite BD Selwyn D et al Neovascularisation is the principal cause of varicose vein recurrence results of a
randomised trial of stripping the long saphenous vein Eur J Vasc Endovasc Surg 1996 12(4)442-5 PMID 8980434
7 Rutgers PH Kitslaar PJ Randomized trial of stripping versus high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein Am J Surg 1994 168(4)311-5 PMID 7943585
8 Nesbitt C Eifell RK Coyne P et al Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional
surgery for great saphenous vein varices Cochrane Database Syst Rev 2011 (10)CD005624 PMID 25075589
9 Brittenden J Cotton SC Elders A et al A randomized trial comparing treatments for varicose veins N Engl J Med Sep 25
2014371(13)1218-1227 PMID 25251616
10 Luebke T Gawenda M Heckenkamp J et al Meta-analysis of endovenous radiofrequency obliteration of the great saphenous
vein in primary varicosis J Endovasc Ther 2008 15(2)213-23 PMID 18426271
11 Merchant RF Pichot O Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for
superficial venous insufficiency J Vasc Surg 2005 42(3)502-9 discussion 509 PMID 16171596
12 Rass K Frings N Glowacki P et al Comparable effectiveness of endovenous laser ablation and high ligation with stripping of
the great saphenous vein two-year results of a randomized clinical trial (RELACS study) Arch Dermatol Jan 2012148(1)49-58
PMID 21931012
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 37 of 41 infin
13 Christenson JT Gueddi S Gemayel G et al Prospective randomized trial comparing endovenous laser ablation and surgery for
treatment of primary great saphenous varicose veins with a 2-year follow-up J Vasc Surg Nov 201052(5)1234-1241 PMID
20801608
14 Biemans AA Kockaert M Akkersdijk GP et al Comparing endovenous laser ablation foam sclerotherapy and conventional
surgery for great saphenous varicose veins J Vasc Surg Sep 201358(3)727-734 e721 PMID 23769603
15 van der Velden SK Biemans AA De Maeseneer MG et al Five-year results of a randomized clinical trial of conventional surgery
endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins Br J
Surg Jul 1 2015 PMID 26132315
16 Theivacumar NS Darwood R Gough MJ Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein
(AAGSV) abolition of sapheno-femoral reflux with preservation of the great saphenous vein Eur J Vasc Endovasc Surg Apr
200937(4)477-481 PMID 19201621
17 Shadid N Ceulen R Nelemans P et al Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the
incompetent great saphenous vein Br J Surg Aug 201299(8)1062-1070 PMID 22627969
18 US Food and Drug Administration Center for Drug Evaluation and Research 205098 Varithena Summary Review 2013
httpwwwaccessdatafdagovdrugsatfda_docsnda2013205098Orig1s000SumRpdf Accessed February 2017
19 Todd KL 3rd Wright D for the V-IG The VANISH-2 study a randomized blinded multicenter study to evaluate the efficacy and
safety of polidocanol endovenous microfoam 05 and 10 compared with placebo for the treatment of saphenofemoral
junction incompetence Phlebology Oct 201429(9)608-618 PMID 23864535
20 Bishawi M Bernstein R Boter M et al Mechanochemical ablation in patients with chronic venous disease A prospective
multicenter report Phlebology Jul 2 2013 PMID 23820117
21 Elias S Raines JK Mechanochemical tumescentless endovenous ablation final results of the initial clinical trial Phlebology Mar
201227(2)67-72 PMID 21803800
22 Boersma D van Eekeren RR Werson DA et al Mechanochemical endovenous ablation of small saphenous vein insufficiency
using the ClariVein((R)) device one-year results of a prospective series Eur J Vasc Endovasc Surg Mar 201345(3)299-303 PMID
23312507
23 Mueller RL Raines JK ClariVein mechanochemical ablation background and procedural details Vasc Endovascular Surg Apr
201347(3)195-206 PMID 23509062
24 Bootun R Lane T Dharmarajah B et al Intra-procedural pain score in a randomised controlled trial comparing
mechanochemical ablation to radiofrequency ablation The Multicentre Venefit versus ClariVein(R) for varicose veins trial
Phlebology Sep 5 2014 PMID 25193822
25 US Food and Drug Administration VenaSeal Closure System - P140018 2015
httpwwwaccessdatafdagovscriptscdrhcfdocscfTopicpmapmacfmnum=P140018 Accessed February 2017
26 Morrison N Gibson K McEnroe S et al Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation
for incompetent great saphenous veins (VeClose) J Vasc Surg Apr 201561(4)985-994 PMID 25650040
27 Almeida JI Javier JJ Mackay EG et al Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of
saphenous vein incompetence Phlebology Jul 201530 (6)397-404 PMID 24789750
28 Zierau U Sealing Veins with the VenaSeal Sapheon Closure System Results for 795 Treated Truncal Veins after 1000 Days
Vasomed 201527124-127
29 Klem TM Schnater JM Schutte PR et al A randomized trial of cryo stripping versus conventional stripping of the great
saphenous vein J Vasc Surg 2009 49(2)403-409 PMID 19028042
30 Disselhoff BC der Kinderen DJ Kelder JC et al Randomized clinical trial comparing endovenous laser with cryostripping for
great saphenous varicose veins Br J Surg 2008 95(10)1232-1238 PMID 18763255
Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
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Page | 38 of 41 infin
31 Disselhoff BC der Kinderen DJ Kelder JC et al Five-year results of a randomized clinical trial comparing endovenous laser
ablation with cryostripping for great saphenous varicose veins Br J Surg 2011 98(8)1107-1111 PMID 21633948
32 Milleret R Huot L Nicolini P et al Great saphenous vein ablation with steam injection results of a multicenter study Eur J Vasc
Endovasc Surg Apr 201345(4)391-396 PMID 23410966
33 Yang L Wang XP Su WJ et al Randomized clinical trial of endovenous microwave ablation combined with high ligation versus
conventional surgery for varicose veins Eur J Vasc Endovasc Surg Oct 201346(4)473-479 PMID 23911734
34 van den Bos RR Malskat WS De Maeseneer MG et al Randomized clinical trial of endovenous laser ablation versus steam
ablation (LAST trial) for great saphenous varicose veins Br J Surg Aug 2014101(9)1077-1083 PMID 24981585
35 Tisi PV Beverley C Rees A Injection sclerotherapy for varicose veins Cochrane Database Syst Rev 2006 (4)CD001732 PMID
17054141
36 Leopardi D Hoggan BL Fitridge RA et al Systematic review of treatments for varicose veins Ann Vasc Surg Mar
200923(2)264-276 PMID 19059756
37 El-Sheikha J Nandhra S Carradice D et al Clinical outcomes and quality of life 5 years after a randomized trial of concomitant
or sequential phlebectomy following endovenous laser ablation for varicose veins Br J Surg Aug 2014101(9)1093-1097 PMID
24916467
38 Michaels JA Campbell WB Brazier JE et al Randomised clinical trial observational study and assessment of cost-effectiveness
of the treatment of varicose veins (REACTIV trial) Health Technol Assess 2006 10(13)1-196 iii-iv PMID 16707070
39 Yamaki T Hamahata A Soejima K et al Prospective Randomised Comparative Study of Visual Foam Sclerotherapy Alone or in
Combination with Ultrasound-guided Foam Sclerotherapy for Treatment of Superficial Venous Insufficiency Preliminary Report
Eur J Vasc Endovasc Surg 2012 PMID 22230599
40 Luebke T Brunkwall J Meta-analysis of transilluminated powered phlebectomy for superficial varicosities J Cardiovasc Surg
(Torino) 2008 49(6)757-764 PMID 19043390
41 Chetter IC Mylankal KJ Hughes H et al Randomized clinical trial comparing multiple stab incision phlebectomy and
transilluminated powered phlebectomy for varicose veins Br J Surg 2006 93(2)169-174 PMID 16432820
42 Barwell JR Davies CE Deacon J et al Comparison of surgery and compression with compression alone in chronic venous
ulceration (ESCHAR study) randomised controlled trial Lancet 2004 363(9424)1854-1859 PMID 15183623
43 Gohel MS Barwell JR Taylor M et al Long term results of compression therapy alone versus compression plus surgery in
chronic venous ulceration (ESCHAR) randomised controlled trial BMJ 2007 335(7610)83 PMID 17545185
44 Nelzen O Fransson I Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic
perforator surgery in patients with a venous ulcer Br J Surg 2011 98(4)495-500 PMID 21656715
45 Blomgren L Johansson G Dahlberg-Akerman A et al Changes in superficial and perforating vein reflux after varicose vein
surgery J Vasc Surg 2005 42(2)315-320 PMID 16102633
46 Tenbrook JA Jr Iafrati MD ODonnell T F Jr et al Systematic review of outcomes after surgical management of venous disease
incorporating subfascial endoscopic perforator surgery J Vasc Surg 2004 39(3)583-589 PMID 14981453
47 van Gent WB Catarinella FS Lam YL et al Conservative versus surgical treatment of venous leg ulcers 10-year follow up of a
randomized multicenter trial Phlebology Mar 201530(1 Suppl)35-41 PMID 25729066
48 Luebke T Brunkwall J Meta-analysis of subfascial endoscopic perforator vein surgery (SEPS) for chronic venous insufficiency
Phlebology 2009 24(1)8-16 PMID 19155335
49 Hirsch SA Dillavou E Options in the management of varicose veins 2008 J Cardiovasc Surg (Torino) 2008 49(1)19-26 PMID
18212684
50 Hissink RJ Bruins RM Erkens R et al Innovative treatments in chronic venous insufficiency endovenous laser ablation of
perforating veins a prospective short-term analysis of 58 cases Eur J Vasc Endovasc Surg 2010 40(3)403-406 PMID 20547462
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 39 of 41 infin
51 Myers KA Jolley D Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins
Eur J Vasc Endovasc Surg Nov 200836(5)602-605 PMID 18718772
52 Gloviczki P Comerota AJ Dalsing MC et al The care of patients with varicose veins and associated chronic venous diseases
clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum J Vasc Surg 2011 53(5
Suppl)2S-48S PMID 21536172
53 Silberzweig JE Funaki BS Ray CE Jr et al ACR appropriateness criteria treatment of lower-extremity venous insufficiency 2013
Available online at httpwwwguidelinegovcontentaspxid=43869 Accessed February 2017
54 Society of Interventional Radiology Position Statement on Endovenous Ablation 2003 Available online at
httpswwwsirweborgglobalassetssociety-of-interventional-radiology-home-pagepractice-
resourcesstandards_pdfssir_venous_ablation_statement_final2015pdf Accessed February 2017
55 Kundu S Lurie F Millward SF et al Recommended reporting standards for endovenous ablation for the treatment of venous
insufficiency joint statement of the American Venous Forum and the Society of Interventional Radiology J Vasc Interv Radiol
2007 18(9)1073-1080 PMID 17804767
56 National Institute for Health and Clinical Excellence (NICE) Radiofrequency Ablation of Varicose Veins Interventional Procedure
Guidance IPG8 2003 Available online at httpswwwniceorgukGuidanceIPG8 Accessed February 2017
57 National Institute for Health and Clinical Excellence (NICE) Endovenous Laser Treatment of the Long Saphenous Vein
Interventional Procedure Guidance IPG52 2004 Available online at httpswwwniceorgukGuidanceIPG52 Accessed
February 2017
58 National Institute for Health and Care Excellence (NICE) Ultrasound-guided foam sclerotherapy for varicose veins IPG314
2009 Available online at httpwwwniceorguknicemediapdfIPG314Guidancepdf Accessed February 2017
59 National Institute for Health and Care Excellence (NICE) Endovenous mechanochemical ablation for varicose veins
Interventional Procedure Guidance IPG435 2013 Available online at httpswwwniceorgukguidanceipg557 Accessed
February 2017
60 National Institute for Health and Care Excellence (NICE) Varicose veins diagnosis and management NICE guidelines CG168
2013 Available online at httpwwwniceorgukguidancecg168 Accessed February 2017
61 Brittenden J Cotton SC Elders A et al Clinical effectiveness and cost-effectiveness of foam sclerotherapy endovenous laser
ablation and surgery for varicose veins results from the Comparison of LAser Surgery and foam Sclerotherapy (CLASS)
randomised controlled trial Health Technol Assess Apr 201519(27)1-342 PMID 25858333
62 Hayes Inc Endovenous Mechanochemical Ablation (MOCA) (ClariVein Occlusion Catheter Nonthermal Vein Ablation System
[Vascular Insights LLC]) for Treatment of Varicose Veins March 12 2015
63 BlueCross BlueShield Association (BCBSA) Treatment of Varicose VeinsVenous Insufficiency Medical Policy Reference Manual
Policy No 701124 2015
64 Shingler S Robertson L Boghossian S et al Compression stockings for the initial treatment of varicose veins in patients without
venous ulceration Cochrane Database Syst Rev 2013 12CD008819
History
Date Comments 121112 Replace policy Formatting changed to now organize procedures by type of vein Policy
statement extensively revised with additional medically necessary criteria for each
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 40 of 41 infin
Date Comments procedure Sclerotherapy now considered medically necessary only for accessory and
tributary veins Policy on hold for provider notification the effective date is May 19
2013
040813 Policy statement clarification In criteria for sclerotherapy of accessory saphenous veins
when not done concurrently with other listed treatments the moderate to severe
saphenous reflux criterion has been removed To clarify the definition of
ldquosymptomaticrdquo for treatment of tributaries not done concurrently with other listed
treatments specific criteria added for stab avulsion hook phlebectomy sclerotherapy
or transilluminated powered phlebectomy treatment of tributaries Tributary criterion
for moderate to severe saphenous reflux when not done concurrently with other listed
treatments has been removed
061413 Minor clarification Hook phlebectomy clarified to indicate that it is also known as stab
phlebectomy or micro-phlebectomy
101413 Replace policy CPT codes for sclerotherapy (36468 36469 36470 36471) TIPP (37765
or 37766 stab avulsion (37765 or 37799) etc added to Policy Guidelines section
022714 Update Related Policies Add 1001514
060914 Interim update Criteria for vein size removed from policy statement Minor edit to
change definition of ldquomoderate to severe refluxrdquo to greater than 05 second Coding
update ICD-9 and ICD-10 diagnosis and procedure codes removed ndash these are not
utilized for adjudication
021015 Annual Review Policy updated with literature review through September 23 2014
reference 8-9 18 24 33 added and some references removed policy statement revised
to allow sclerotherapy as medically necessary when criteria are met Information added
regarding FDA approval of Varithena sclerotherapy Documentation requirements
added to Policy Guidelines
051215 Interim Update Policy statement clarified Treatment of tributaries by sclerotherapy
stab avulsion stabhook phlebectomy or transilluminated powered phlebectomy may
now be considered medically necessary up to 10 days after saphenous veins have been
treated Definition of moderate to severe saphenous reflux and abbreviation ldquoTIPPrdquo
added to the policy statement
060915 Interim Update Policy statement clarified TRIVEX listed as an example of TIPP
Exercises and pain relievers removed from conservative management requirement
TRIVEX manufacturer website added to Reference section CPT codes 76942 93970-71
and HCPCS code S2202 removed these are not reviewed
111015 Interim Update Policy updated with clarification to coverage criteria for the accessory
saphenous vein indicating parameters around treatment of the greater or lesser
saphenous veins and the presence of reflux
011216 Annual Review Added statement that cyanoacrylate adhesiveembolization (CAE) (eg
VenaSeal closure system) and endovenous mechanochemical ablation (MOCA) (eg
ClariVein) of any vein is considered investigational The failure of compression therapy
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
مھمة قد تكون ھناك تواريخ Premera Blue Cross خالل من التغطية التي تريد الحصول عليھا للمساعدة أو الصحية تغطيتك على للحفاظ معينة تواريخ في إجراء التخاذ تحتاج اإلشعار وقد ھذا فياتصل تكلفة أية دون تكبد بلغتك والمساعدة ھذه المعلومات على يحق لك الحصول التكاليف دفع في (TTY 800-842-5357) 1471-722-800بـ
中文 (Chinese) 本通知有重要的訊息本通知可能有關於您透過 Premera Blue Cross 提交的
申請或保險的重要訊息本通知內可能有重要日期您可能需要在截止日期
之前採取行動以保留您的健康保險或者費用補貼您有權利免費以您的母
語得到本訊息和幫助請撥電話 800-722-1471 (TTY 800-842-5357)
Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
日本語 (Japanese) この通知には重要な情報が含まれていますこの通知にはPremera Blue Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
りますこの通知に記載されている可能性がある重要な日付をご確認くだ
さい健康保険や有料サポートを維持するには特定の期日までに行動を
取らなければならない場合がありますご希望の言語による情報とサポー
トが無料で提供されます800-722-1471 (TTY 800-842-5357)までお電話
ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
Page | 41 of 41 infin
Date Comments removed from the policy statements on venous stasis and thrombophlebitis
References added Policy updated with literature review through July 7 2015
100116 Interim Update approved September 13 2016 Perforator vein criteria revised
Requirement of active ulcers changed to ldquohealed or active ulcersrdquo and ldquodemonstrated
perforator refluxrdquo is more clearly defined with measurements of outward flow and vein
diameter
120116 Policy moved to new format Policy statements unchanged Added Prior Authorization
Requirements section
010117 Coding update added CPT codes 36473 and 36474 effective 1117
030117 Annual Review approved February 14 2017 No change to policy statement
Compression Therapy added to Definition of Terms Reference 64 added Removed
CPT code 36469 from policy as it terminated as of 01012015
110217 Minor formatting edits made
011618 Minor edit added Documentation Requirements table to the Policy Coverage Criteria
section
012318 Coding update added CPT codes 36465 36466 36482 and 36483 (new codes
effective 1118)
Disclaimer This medical policy is a guide in evaluating the medical necessity of a particular service or treatment The
Company adopts policies after careful review of published peer-reviewed scientific literature national guidelines and
local standards of practice Since medical technology is constantly changing the Company reserves the right to review
and update policies as appropriate Member contracts differ in their benefits Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply
CPT codes descriptions and materials are copyrighted by the American Medical Association (AMA) copy2018 Premera
All Rights Reserved
Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures drugs or devices Coverage for medical services is subject to
the limits and conditions of the member benefit plan Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply This medical policy does not apply to Medicare Advantage
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
(Arabic) العربيةأو طلبك بخصوص مھمة معلومات اإلشعار ھذا قد يحوي ھامة معلومات اإلشعار ھذا يحوي
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
037338 (07-2016)
Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race color national origin age disability or sex Premera does not exclude people or treat them differently because of race color national origin age disability or sex Premera bull Provides free aids and services to people with disabilities to communicate
effectively with us such as bull Qualified sign language interpreters bull Written information in other formats (large print audio accessible
electronic formats other formats) bull Provides free language services to people whose primary language is not
English such as bull Qualified interpreters bull Information written in other languages
If you need these services contact the Civil Rights Coordinator If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race color national origin age disability or sex you can file a grievance with Civil Rights Coordinator - Complaints and Appeals PO Box 91102 Seattle WA 98111 Toll free 855-332-4535 Fax 425-918-5592 TTY 800-842-5357 Email AppealsDepartmentInquiriesPremeracom You can file a grievance in person or by mail fax or email If you need help filing a grievance the Civil Rights Coordinator is available to help you You can also file a civil rights complaint with the US Department of Health and Human Services Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal available at httpsocrportalhhsgovocrportallobbyjsf or by mail or phone at US Department of Health and Human Services 200 Independence Avenue SW Room 509F HHH Building Washington DC 20201 1-800-368-1019 800-537-7697 (TDD) Complaint forms are available at httpwwwhhsgovocrofficefileindexhtml Getting Help in Other Languages This Notice has Important Information This notice may have important information about your application or coverage through Premera Blue Cross There may be key dates in this notice You may need to take action by certain deadlines to keep your health coverage or help with costs You have the right to get this information and help in your language at no cost Call 800-722-1471 (TTY 800-842-5357) አማሪኛ (Amharic) ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎትበስልክ ቁጥር 800-722-1471 (TTY 800-842-5357) ይደውሉ
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Oromoo (Cushite) Beeksisni kun odeeffannoo barbaachisaa qaba Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandarsquoa Guyyaawwan murteessaa tarsquoan beeksisa kana keessatti ilaalaa Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandarsquoa Kaffaltii irraa bilisa haala tarsquoeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu Lakkoofsa bilbilaa 800-722-1471 (TTY 800-842-5357) tii bilbilaa Franccedilais (French) Cet avis a dimportantes informations Cet avis peut avoir dimportantes informations sur votre demande ou la couverture par lintermeacutediaire de Premera Blue Cross Le preacutesent avis peut contenir des dates cleacutes Vous devrez peut-ecirctre prendre des mesures par certains deacutelais pour maintenir votre couverture de santeacute ou daide avec les coucircts Vous avez le droit dobtenir cette information et de lrsquoaide dans votre langue agrave aucun coucirct Appelez le 800-722-1471 (TTY 800-842-5357) Kreyogravel ayisyen (Creole) Avi sila a gen Enfogravemasyon Enpogravetan ladann Avi sila a kapab genyen enfogravemasyon enpogravetan konsegravenan aplikasyon w lan oswa konsegravenan kouvegraveti asirans lan atravegrave Premera Blue Cross Kapab genyen dat ki enpogravetan nan avi sila a Ou ka gen pou pran kegravek aksyon avan segraveten dat limit pou ka kenbe kouvegraveti asirans sante w la oswa pou yo ka ede w avegravek depans yo Se dwa w pou resevwa enfogravemasyon sa a ak asistans nan lang ou pale a san ou pa gen pou peye pou sa Rele nan 800-722-1471 (TTY 800-842-5357) Deutsche (German) Diese Benachrichtigung enthaumllt wichtige Informationen Diese Benachrichtigung enthaumllt unter Umstaumlnden wichtige Informationen bezuumlglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung Sie koumlnnten bis zu bestimmten Stichtagen handeln muumlssen um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten Sie haben das Recht kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten Rufen Sie an unter 800-722-1471 (TTY 800-842-5357) Hmoob (Hmong) Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj Hu rau 800-722-1471 (TTY 800-842-5357) Iloko (Ilocano) Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo Tumawag iti numero nga 800-722-1471 (TTY 800-842-5357) Italiano (Italian) Questo avviso contiene informazioni importanti Questo avviso puograve contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross Potrebbero esserci date chiave in questo avviso Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente Chiama 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
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حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)
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ください 한국어 (Korean) 본 통지서에는 중요한 정보가 들어 있습니다 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 800-722-1471 (TTY 800-842-5357) 로 전화하십시오
ລາວ (Lao) ແຈງການນມຂມນສາຄນ ແຈງການນອາດຈະມຂມນສາຄນກຽວກບຄາຮອງສະໝກ ຫ ຄວາມຄມຄອງປະກນໄພຂອງທານຜານ Premera Blue Cross ອາດຈະມວນທສາຄນໃນແຈງການນ ທານອາດຈະຈາເປນຕອງດາເນນການຕາມການດເວລາສະເພາະເພອຮກສາຄວາມຄມຄອງປະກນສຂະພາບ ຫ ຄວາມຊວຍເຫອເລອງຄາໃຊຈາຍຂອງທານໄວ ທານມສດໄດຮບຂມນນ ແລະ ຄວາມຊວຍເຫອເປນພາສາຂອງທານໂດຍບເສຍຄາ ໃຫໂທຫາ 800-722-1471 (TTY 800-842-5357) ភាសាែខមរ (Khmer)
េសចកត ជនដណងេនះមានពតមានយាងសខាន េសចកត ជនដណងេនះរបែហល
ជាមានពតមានយាងសខានអពទរមងែបបបទ ឬការរាបរងរបសអនកតាមរយៈ
Premera Blue Cross របែហលជាមាន កាលបរេចឆទសខានេនៅកន ងេសចកត ជន
ដណងេនះ អនករបែហលជារតវការបេញចញសមតថភាព ដលកណតៃថងជាកចបាស
នានា េដើមបនងរកសាទកការធានារាបរងសខភាពរបសអនក ឬរបាកជនយេចញៃថល
អនកមានសទធទទលពតមានេនះ នងជនយេនៅកន ងភាសារបសអនកេដាយមនអស
លយេឡើយ សមទរសពទ 800-722-1471 (TTY 800-842-5357)
ਪਜਾਬੀ (Punjabi)
ਇਸ ਨਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ ਇਸ ਨਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤਹਾਡੀ ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ ਇਸ ਨਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ ਜਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ਇਛਕ ਹ ਤਾ ਤਹਾਨ ਅਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾ ਕ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ਤਹਾਨ
ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ਕਾਲ
800-722-1471 (TTY 800-842-5357)
(Farsi) فارسی فرم درباره مھم اطالعات ممکن است حاوی اعالميه اين ميباشد مھم اطالعات یوحا اعالميه اين
در مھم ھای تاريخ به باشد Premera Blue Crossشما از طريق ای بيمه پوشش يا و تقاضابيمه تان يا کمک در پرداخت ھزينه پوشش حقظ برای است ممکن شما نماييد توجه اعالميه اين
حق شما خاصی احتياج داشته باشيد انجام کارھای مشخصی برای ھای تاريخ به درمانی تانھای نماييد برای کسب رايگان دريافت طور به خود زبان به را کمک و اطالعات اين که داريد را اين
تماس )800-842-5357تماس باشماره TTY(کاربران 800-722-1471 اطالعات با شماره نماييدبرقرار
Polskie (Polish) To ogłoszenie może zawierać ważne informacje To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross Prosimy zwroacutecic uwagę na kluczowe daty ktoacutere mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminoacutew w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami Macie Państwo prawo do bezpłatnej informacji we własnym języku Zadzwońcie pod 800-722-1471 (TTY 800-842-5357) Portuguecircs (Portuguese) Este aviso conteacutem informaccedilotildees importantes Este aviso poderaacute conter informaccedilotildees importantes a respeito de sua aplicaccedilatildeo ou cobertura por meio do Premera Blue Cross Poderatildeo existir datas importantes neste aviso Talvez seja necessaacuterio que vocecirc tome providecircncias dentro de determinados prazos para manter sua cobertura de sauacutede ou ajuda de custos Vocecirc tem o direito de obter esta informaccedilatildeo e ajuda em seu idioma e sem custos Ligue para 800-722-1471 (TTY 800-842-5357)
Romacircnă (Romanian) Prezenta notificare conține informații importante Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross Pot exista date cheie icircn această notificare Este posibil să fie nevoie să acționați pacircnă la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri Aveți dreptul de a obține gratuit aceste informații și ajutor icircn limba dumneavoastră Sunați la 800-722-1471 (TTY 800-842-5357) Pусский (Russian) Настоящее уведомление содержит важную информацию Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross В настоящем уведомлении могут быть указаны ключевые даты Вам возможно потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами Вы имеете право на бесплатное получение этой информации и помощь на вашем языке Звоните по телефону 800-722-1471 (TTY 800-842-5357) Farsquoasamoa (Samoan) Atonu ua iai i lenei farsquoasilasilaga ni farsquoamatalaga e sili ona taua e tatau ona e malamalama i ai O lenei farsquoasilasilaga o se fesoasoani e farsquoamatala atili i ai i le tulaga o le polokalame Premera Blue Cross ua e tau fia maua atu i ai Farsquoamolemole ia e iloilo farsquoalelei i aso farsquoapitoa olorsquoo iai i lenei farsquoasilasilaga taua Masalo o lersquoa iai ni feau e tatau ona e faia ao lersquoi aulia le aso ua tarsquoua i lenei farsquoasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olorsquoo e iai i ai Olorsquoo iai iate oe le aia tatau e maua atu i lenei farsquoasilasilaga ma lenei farsquomatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe Vili atu i le telefoni 800-722-1471 (TTY 800-842-5357) Espantildeol (Spanish) Este Aviso contiene informacioacuten importante Es posible que este aviso contenga informacioacuten importante acerca de su solicitud o cobertura a traveacutes de Premera Blue Cross Es posible que haya fechas clave en este aviso Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura meacutedica o ayuda con los costos Usted tiene derecho a recibir esta informacioacuten y ayuda en su idioma sin costo alguno Llame al 800-722-1471 (TTY 800-842-5357) Tagalog (Tagalog) Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross Maaaring may mga mahalagang petsa dito sa paunawa Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos Tumawag sa 800-722-1471 (TTY 800-842-5357) ไทย (Thai)
ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกนสขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตองดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอทมคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไมมคาใชจาย โทร 800-722-1471 (TTY 800-842-5357) Український (Ukrainian) Це повідомлення містить важливу інформацію Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross Зверніть увагу на ключові дати які можуть бути вказані у цьому повідомленні Існує імовірність того що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того щоб зберегти Ваше медичне страхування або отримати фінансову допомогу У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові Дзвоніть за номером телефону 800-722-1471 (TTY 800-842-5357) Tiếng Việt (Vietnamese) Thocircng baacuteo nagravey cung cấp thocircng tin quan trọng Thocircng baacuteo nagravey coacute thocircng tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quyacute vị qua chương trigravenh Premera Blue Cross Xin xem ngagravey quan trọng trong thocircng baacuteo nagravey Quyacute vị coacute thể phải thực hiện theo thocircng baacuteo đuacuteng trong thời hạn để duy trigrave bảo hiểm sức khỏe hoặc được trợ giuacutep thecircm về chi phiacute Quyacute vị coacute quyền được biết thocircng tin nagravey vagrave được trợ giuacutep bằng ngocircn ngữ của migravenh miễn phiacute Xin gọi số 800-722-1471 (TTY 800-842-5357)