MEDICAL POLICY 5.01.19
Injectable Clostridial Collagenase for Fibroproliferative
Disorders BCBSA Ref. Policy: 5.01.19
Effective Date: Feb. 1, 2018
Last Revised: Jan. 30, 2018
Replaces: 5.01.524
RELATED MEDICAL POLICIES:
None
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POLICY CRITERIA | CODING | RELATED INFORMATION
EVIDENCE REVIEW | REFERENCES | HISTORY
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Introduction
Dupuytrens contracture is a hand condition where knots of tissue form beneath the skin of the
palm. Over time these knots create a cord, which pulls on one or more fingers. The cord is
inflexible, causing the fingers to curl into a bent position. The ring finger and pinky fingers are
usually affected, with the middle finger affected less often. Its rare that the index finger and
thumb are affected. The condition advances slows and usually starts with a thickening of skin on
the palm. A knot then forms, followed by another and another. Men older than 50 and of
northern European descent have the highest incidence of Dupuytrens contracture. There are a
few treatment options, one of which calls for injecting a specific enzyme (clostridial collagenase)
into the cord. The enzyme makes the cord softer, allowing it to stretch and break as a doctor
straightens the fingers. The enzyme also has been used to try to treat other conditions. This
policy describes the conditions for which injections of this enzyme 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.
Page | 2 of 13
Policy Coverage Criteria
Indication Medical Necessity Dupuytren contracture Injectable clostridial collagenase may be considered medically
necessary for the treatment of Dupuytren contracture in adult
patients with a palpable cord, for up to 3 injections at intervals
of at least 30 days.
Physicians should treat no more than 2 joints in the same hand
for Dupuytren contracture per treatment visit, consistent with
U.S. Food and Drug Administration (FDA) labeling.
Note: Product name: Xiaflex (collagenase clostridium histolyticum)
Indication Investigational Peyronie disease
Adhesive capsulitis
Other indications
Injectable clostridial collagenase is considered investigational
for all other indications including, but not limited to, Peyronie
disease and adhesive capsulitis.
Note: Product name: Xiaflex (collagenase clostridium histolyticum)
Coding
Code Description
CPT 20527 Injection, enzyme (eg, collagenase), palmar fascial cord (ie, Dupuytrens contracture)
26341 Manipulation, palmar fascial cord (ie, Dupuytrens cord), post enzyme injection (eg,
collagenase), single cord
54200 Injection procedure for Peyronie disease
HCPCS
J0775 Injection, collagenase clostridium histolyticum, 0.01 mg
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).
Page | 3 of 13
Related Information
Benefit Application
Some plans may require prior authorization before injection of collagenase clostridium
histolyticum. For questions about benefit information, providers should contact customer service
using the telephone number on the back of the members identification card.
Evidence Review
Description
Clostridial collagenase is a bacterial collagenase, derived from Clostridium histolyticum, which
has been evaluated for the treatment of fibroproliferative disorders such as Dupuytren
contracture, Peyronie disease, and adhesive capsulitis.
Background
Fibroproliferative Disorders
Fibrotic tissue disorders, characterized by excessive collagen deposits, can affect the
musculoskeletal system, causing pain and limiting movement and reducing joint range of
motion. Examples of fibroproliferative disorders include Dupuytren disease, Peyronie disease,
and adhesive capsulitis. The mechanisms that contribute to the pathology are poorly
understood.
Dupuytren Disease
In Dupuytren disease, collagen deposits in nodules and cords in the palm and fingers and results
in pitting of the overlying cutis and flexion contractures. The mechanisms that contribute to the
pathology are poorly understood. The prevalence of Dupuytren disease is estimated at 3% to
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6% in the general population and increases with advancing age. The disease is more common in
people with diabetes or thyroid disease and among men.1 The standard of care for Dupuytren
disease is surgery, most commonly open fasciectomy. Other surgical procedures are
percutaneous fasciotomy and needle fasciotomy. Surgery is recommended in patients with
functional impairment and metacarpophalangeal joint contractures of 30 or more. There is no
effective pharmacotherapy.
Peyronie Disease
Peyronie disease is the development of abnormal scar tissue, or plaques, in the tunica albuginea
layer of the penis causing distortion, curvature, and pain (usually during erection). It occurs in
3% to 9% of men, most commonly between the ages of 45 and 60 years. In some cases, plaque
does not cause severe pain or curvature, and the condition resolves on its own. In severe cases,
erectile dysfunction can occur. The goal of treatment is to reduce pain and maintain sexual
function. Treatments in early stages (before calcification) include vitamin E or para-
aminobenzoate tablets (eg, Potaba), although studies of oral therapies have demonstrated
inconsistent benefit. Intralesional injection therapy consisting of injection of interferon--2b or
calcium channel-blockers (eg, verapamil) is the current standard of therapy.2 Surgical procedures
involve the excision of hardened tissue and skin graft, the removal or pinching (plication) of
tissue opposite the plaque to reduce curvature (the Nesbit procedure), penile implant, or a
combination of these.
Adhesive Capsulitis
Adhesive capsulitis or frozen shoulder is treated with physical therapy and mobilization in
combination with analgesics or nonsteroidal anti-inflammatory drugs. Corticosteroid injection is
used with caution. The prevalence of adhesive capsulitis is estimated at 2% to 3% in the general
population and increases with advancing age; additionally, adhesive capsulitis is more common
in people with diabetes or thyroid disease and among women.1
Treatment
Injection with clostridial collagenase is intended to provide a nonoperative treatment option for
fibroproliferative disorders. Clostridial collagenase histolyticum is an enzyme produced by the
bacterium Clostridium histolyticum, which has the physiologic effect of breaking down collagen.
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It has been developed and marketed pharmacologically as a treatment for disorders associated
with collagen overdevelopment.
Summary of Evidence
For individuals who have Dupuytren contracture who receive local clostridial collagenase
injection(s), the evidence includes several placebo-controlled, randomized trials, nonrandomized
comparative studies, and single-arm studies along with systematic reviews of these studies.
Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of
life. The evidence from clinical trials has suggested that injectable clostridial collagenase
provides short-term release of contracture. A comparison of overall outcomes compared with
surgical intervention may be useful; however, randomized studies with direct comparisons are
not available. Some nonrandomized studies comparing clostridial collagenase with surgery
reported similar outcomes with faster return-to-work and return-to-usual activities rates with
clostridial collagenase, but 1 study reported poorer contraction improvement though lower
adverse event rates. Evidence on long-term recurrence rates is somewhat limited, but 3- and 5-
year follow-ups from 1 large registry reported high recurrence rates (47% at 5 years). Although
clostridial collagenase offers the potential benefit of less-invasive treatment for Dupuytren
contracture, gaps in the evidence base related to treatment durability exist. The evidence is
insufficient to determine the effects of the technology on health outcomes.
For individuals who have Peyronie disease who receive local clostridial collagenase injection(s),
the evidence includes two randomized trials and several noncomparative studies. Relevant
outcomes are symptoms, change in disease status, functional outcomes, and quality of life. The
available double-blind, placebo-controlled randomized trials have demonstrated short-term
improvement in penile curvature and self-reported distress from symptoms related to Peyronie
disease. However, evidence demonstrating health outcome improvements is lacking. In addition,
studies comparing clostridial collagenase with other therapies for Peyronie disease are lacking.
The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have adhesive capsulitis who receive local clostridial collagenase injection(s),
the evidence is very limited. Relevant outcomes are symptoms, change in disease status,
functional outcomes, and quality of life. No published literature that addressed the treatment of
adhesive capsulitis with clostridial collagenase was identified. The evidence is insufficient to
determine the effects of the technology on health outcomes.
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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
NCT02301078 Comparing Short-term Function and Pain After Treatment
With Collagenase Clostridium Histolyticum or
Percutaneous Needle Aponeurotomy for Dupuytrens
Disease
60 Nov 2017
(ongoing)
NCT02725528 A Multi-Center, Randomized Controlled Trial Comparing
The Clinical Effectiveness and Cost-Effectiveness of
Collagenase Injection (Xiaflex) and Palmar Fasciectomy in
the Management of Dupuytrens Disease
128 Nov 2018
NCT03000114 Comparison of Collagenase Injection and Percutaneous
Needle Aponeurotomy for Treatment of Dupuytrens
Disease
334 Jan 2021
ISRCTN18254597 Dupuytren's interventions surgery vs collagenase 710 Oct 2021
Unpublished
NCT02193828a
A Phase 2a, Double-blind, Randomized, Placebo-
Controlled, Dose-Ranging Study to Evaluate the Safety and
Effectiveness of AA4500 in the Treatment of Dupuytren's
Disease Nodules
76 Mar 2014
(completed)
NCT02006719a A Randomized, Double-blind, Placebo-controlled Study of
the Safety and Efficacy of AA4500 for the Treatment of
Adhesive Capsulitis of the Shoulder
322 Dec 2014
(completed)
NCT01538017 Comparing Injectable Collagenase (CI) and Percutaneous
Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC)
Affecting Proximal Interphalangeal Joints (PIP). A
Randomised Controlled Trial
50 Nov 2015
(completed)
NCT02267460a
A Phase 3b, Open-label Pilot Study to Evaluate the Safety
and Effectiveness of up to Four Treatment Cycles of
AA4500 in Combination With the ErecAid Esteem
Manual Vacuum Therapy System in Men With Peyronie's
Disease
30 Mar 2016
(completed)
https://clinicaltrials.gov/ct2/show/NCT02301078?term=NCT02301078&rank=1https://clinicaltrials.gov/ct2/show/NCT02725528?term=NCT02725528&rank=1https://clinicaltrials.gov/ct2/show/NCT03000114?term=NCT03000114&rank=1http://www.isrctn.com/ISRCTN18254597https://clinicaltrials.gov/ct2/show/NCT02193828?term=NCT02193828&rank=1https://clinicaltrials.gov/ct2/show/NCT02006719?term=NCT02006719&rank=1https://clinicaltrials.gov/ct2/show/NCT01538017?term=NCT01538017&rank=1https://clinicaltrials.gov/ct2/show/NCT02267460?term=NCT02267460&rank=1
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ISRCTN: International Standard Randomised Controlled Trials Number;
NCT: national clinical trial a Denotes industry-sponsored or cosponsored trial
Clinical Input Received from Physician Specialty Societies and Academic
Medical Centers
While the various physician specialty societies and academic medical centers may provide
appropriate reviewers who collaborate with and make recommendations during this process,
input received does not represent an endorsement or position statement by the physician
specialty societies or academic medical centers, unless otherwise noted.
2011 Input
In response to requests, input was received from 2 physician specialty societies (2 reviews) and 5
academic medical centers (6 reviews) while this policy was under review in 2011. Two reviewers
indicated injectable clostridium collagenase is investigational for the treatment of Dupuytren
contracture, noting lack of long-term data and head-to-head trials comparing collagenase with
surgical options. However, despite considering this treatment investigational due to insufficient
long-term evidence of effectiveness, one reviewer noted that injectable clostridial collagenase
for Dupuytren contracture is approved by the U.S. Food and Drug Administration, and there is
evidence of short-to-medium-term effectiveness available. Five reviewers indicated injectable
clostridial collagenase for Dupuytren contracture may be considered medically necessary. These
reviewers noted this is a treatment alternative to surgery. This was considered to be near-
uniform support for the medical necessity of injectable clostridial collagenase for the treatment
of Dupuytren contracture.
Four reviewers agreed that injectable clostridium collagenase is investigational for the treatment
of Peyronie disease. One of these reviewers also commented that, while this treatment is
considered investigational, it may be indicated for Peyronie disease when it is bothersome,
noting that surgery is intrusive. Four reviewers also agreed injectable clostridium collagenase is
investigational for the treatment of adhesive capsulitis. Finally, 6 reviewers agreed injectable
clostridium collagenase is investigational for all other indications.
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2010 Input
In response to requests, input was received from 6 academic medical centers while this policy
was under review in 2010. The input was mixed, with half of those providing input agreeing that
use of this agent is investigational. While there was support for use in Dupuytren contracture,
comments were made about the limited amount of data on long-term outcomes and durability.
Practice Guidelines and Position Statements
Dupuytren Contracture
National Institute for Health and Care Excellence
In 2017, the National Institute for Health and Care Excellence recommended the use of
collagenase Clostridium histolyticum to treat adults with Dupuytren contracture in cases of
moderate disease where percutaneous needle fasciotomy is not an option.40 The Institute
advised that the decision to use collagenase clostridium rather than limited fasciectomy should
be made only after thorough discussion between the patient and caregiver; the Institute further
defined appropriate outpatient treatment as consisting of a single injection at a time, and
administered by a qualified hand surgeon.
American Urological Association
In 2015, the American Urological Association (AUA) issued a guideline for the diagnosis and
treatment of Peyronie disease.42 For patients with stable Peyronie disease, penile curvature
greater than 30 and less than 90, and intact erectile function (with or without the use of
medications), AUA recommends intralesional collagenase clostridium histolyticum in
combination with modeling (Moderate recommendation; Evidence Strength Grade B).
European Association of Urology
The 2012 European Association of Urology guidelines on penile curvature indicate injectable
collagenase is a treatment option for Peyronie disease based on evidence rated as Level 2b
(Evidence obtained from at least one other type of well-designed quasi-experimental study)
and Grade C (Made despite the absence of directly applicable clinical studies of good
quality).43
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Adhesive Capsulitis
National Institute for Health Research
In 2012, the National Institute for Health Research published a health technology assessment
(HTA) on the management of adhesive capsulitis.44 In this assessment, collagenase injections
were not included in the treatments considered for adhesive capsulitis.
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
Table 2 lists indications for clostridial collagenase (Xiaflex; Auxilium Pharmaceuticals
[Norristown, PA]) that have been approved by the Food and Drug Administration.
Table 2. FDA-Approval History For Clostridial Collagenase (Xiaflex)3
Indication Approved Initial Indication Additional Information
Dupuytren
contracture
2010 Treatment of adult patients with
Dupuytren contracture with a
palpable cord
Up to 3 injections at 4-week
intervals may be given into a
palpable Dupuytren cord with a
contracture of a
metacarpophalangeal joint or a
proximal interphalangeal joint
Approval accompanied by REMS. The
manufacturer must:
o Evaluate and mitigate risks and serious
adverse events
o Instruct health care providers on
procedure to inject Xiaflex and perform
finger extension procedures
o Inform patients of potential risks of
treatment
In 2014, indication expanded: up to 2
joints in the same hand may be treated
during a treatment visit
Peyronie
disease
2013 Treatment of men with a
palpable penile plaque and
penile curvature more than 30
degrees
Treatment course consists of a
maximum of 4 cycles, each of
Approval accompanied by black box
warning of corporal rupture
Only available through a restricted
program, Xiaflex REMS, due to risk of
corporal rupture. REMS requirements:
o Prescribers must enroll and complete
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Indication Approved Initial Indication Additional Information
which consists of 2 Xiaflex
injection procedures
training in the administration of Xiaflex
for the treatment of Peyronie disease
o Health care sites must be certified with
the program and ensure that only
certified prescribers administer Xiaflex
Adapted from Food and Drug Administration (2017).3
FDA: Food and Drug Administration; REMS: Risk Evaluation and Mitigation Strategy
References
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3. Food and Drug Administration (FDA). Xiaflex: Label. 2017; Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf Accessed January 2018.
4. Smeraglia F, Del Buono A, Maffulli N. Collagenase clostridium histolyticum in Dupuytren's contracture: a systematic review. Br
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systematic review and economic evaluation. Health Technol Assess. Oct 2015;19(90):1-202. PMID 26524616
6. Chen NC, Srinivasan RC, Shauver MJ, et al. A systematic review of outcomes of fasciotomy, aponeurotomy, and collagenase
treatments for Dupuytren's contracture. Hand (N Y). Sep 2011;6(3):250-255. PMID 22942847
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8. Hurst LC, Badalamente MA, Hentz VR, et al. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J
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Dupuytren's Contracture: secondary analysis of the randomized, double-blind, placebo-controlled CORD I study. Clin Drug
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10. Holzer LA, Holzer G. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. Dec 24
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12. McGrouther DA, Jenkins A, Brown S, et al. The efficacy and safety of collagenase clostridium histolyticum in the treatment of
patients with moderate Dupuytren's contracture. Curr Med Res Opin. Apr 2014;30(4):733-739. PMID 24397625
13. Badalamente MA, Hurst LC. Efficacy and safety of injectable mixed collagenase subtypes in the treatment of Dupuytren's
contracture. J Hand Surg Am. Jul-Aug 2007;32(6):767-774. PMID 17606053
14. Raven RB, 3rd, Kushner H, Nguyen D, et al. Analysis of efficacy and safety of treatment with collagenase Clostridium
histolyticum among subgroups of patients with Dupuytren contracture. Ann Plast Surg. Sep 2014;73(3):286-290. PMID
23511746
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf
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15. Naam NH. Functional outcome of collagenase injections compared with fasciectomy in treatment of Dupuytren's contracture.
Hand (N Y). Dec 2013;8(4):410-416. PMID 24426958
16. Povlsen B, Povlsen SD. What is the better treatment for single digit Dupuytren's contracture: surgical release or collagenase
clostridium histolyticum (Xiapex) injection? Hand Surg. Aug 25 2014:1-4. PMID 25155703
17. Zhou C, Hovius SE, Slijper HP, et al. Collagenase Clostridium histolyticum versus limited fasciectomy for dupuytren's
contracture: outcomes from a multicenter propensity score matched study. Plast Reconstr Surg. Jul 2015;136(1):87-97. PMID
25829153
18. Witthaut J, Jones G, Skrepnik N, et al. Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren
contracture: short-term results from 2 open-label studies. J Hand Surg Am. Jan 2013;38(1):2-11. PMID 23218556
19. Peimer CA, Blazar P, Coleman S, et al. Dupuytren contracture recurrence following treatment with collagenase clostridium
histolyticum (CORDLESS study): 3-year data. J Hand Surg Am. Jan 2013;38(1):12-22. PMID 23200951
20. Peimer CA, Blazar P, Coleman S, et al. Dupuytren contracture recurrence following treatment with Collagenase Clostridium
histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5-Year Data.
J Hand Surg. Aug 2015;40(8):1597-1605. PMID 26096221
21. Badalamente MA, Hurst LC, Benhaim P, et al. Efficacy and safety of collagenase clostridium histolyticum in the treatment of
proximal interphalangeal joints in dupuytren contracture: combined analysis of 4 phase 3 clinical trials. J Hand Surg. May
2015;40(5):975-983. PMID 25843533
22. Gaston RG, Larsen SE, Pess GM, et al. efficacy and safety of concurrent collagenase clostridium histolyticum injections for 2
dupuytren contractures in the same hand: a prospective, multicenter study. J Hand Surg. Oct 2015;40(10):1963-1971. PMID
26216077
23. Watt AJ, Curtin CM, Hentz VR. Collagenase injection as nonsurgical treatment of Dupuytren's disease: 8-year follow-up. J Hand
Surg Am. Apr 2010;35(4):534-539, 539 e531. PMID 20353858
24. Alberton F, Corain M, Garofano A, et al. Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren
contracture: report of 40 cases. Musculoskelet Surg. Dec 2014;98(3):225-232. PMID 24254968
25. Warwick D, Arner M, Pajardi G, et al. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from
POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol. Feb 2015;40(2):124-132. PMID
24470559
26. Verheyden JR. Early outcomes of a sequential series of 144 patients with Dupuytren's contracture treated by collagenase
injection using an increased dose, multi-cord technique. J Hand Surg Eur Vol. Feb 2015;40(2):133-140. PMID 24698852
27. McMahon HA, Bachoura A, Jacoby SM, et al. Examining the efficacy and maintenance of contracture correction after
collagenase clostridium histolyticum treatment for Dupuytren's disease. Hand (N Y). Sep 2013;8(3):261-266. PMID 24426932
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29. Atroshi I, Nordenskjold J, Lauritzson A, et al. Collagenase treatment of Dupuytren's contracture using a modified injection
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the treatment of Peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. Jul
2013;190(1):199-207. PMID 23376148
35. Lipshultz LI, Goldstein I, Seftel AD, et al. Clinical efficacy of collagenase Clostridium histolyticum in the treatment of Peyronie's
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History
Date Comments 11/11/13 New Policy. Policy replaces 5.01.524. Considered medically necessary to treat
Dupuytrens contracture in adult patients when criteria are met.
12/17/14 Annual Review. Policy updated with literature review through September 5, 2014.
References 3, 5, 10, 13-14, 17-22, 27 added; others renumbered/removed. Rationale
section reorganized. Policy statements unchanged. ICD-9 and ICD-10 diagnosis and
procedure codes removed; these do not relate to policy adjudication.
12/08/15 Annual Review. Policy updated with literature review through September 10, 2015;
references 16, 19-21, 28, 33, 35, and 37-38 added. Policy statements unchanged.
https://www.nice.org.uk/guidance/TA459/chapter/1-Recommendationshttp://www.auanet.org/guidelines/peyronies-disease-(2015)
Page | 13 of 13
Date Comments 12/01/16 Annual Review, approved November 8, 2016. Policy updated with literature review
through August 2016; references added. Policy statements unchanged.
12/01/17 Annual Review, approved November 9, 2017. Policy updated with literature review
through October 2017. Reference added. Policy statements unchanged.
02/01/18 Annual Review, approved January 30, 2018. Policy updated with literature review
through November, 2017; reference 40 added. Policy statements unchanged.
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). 2018 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: Provides free aids and services to people with disabilities to communicate
effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible
electronic formats, other formats) Provides free language services to people whose primary language is not
English, such as: Qualified interpreters 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 [email protected] 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 U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. 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). (Amharic): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357)
:(Arabic) .
Premera Blue Cross. . . . (TTY: 800-842-5357) 1471-722-800
(Chinese): Premera Blue Cross
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 dandaa. Guyyaawwan murteessaa taan beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandaa. Kaffaltii irraa bilisa haala taeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. Franais (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermdiaire de Premera Blue Cross. Le prsent avis peut contenir des dates cls. Vous devrez peut-tre prendre des mesures par certains dlais pour maintenir votre couverture de sant ou d'aide avec les cots. Vous avez le droit d'obtenir cette information et de laide dans votre langue aucun cot. Appelez le 800-722-1471 (TTY: 800-842-5357). Kreyl ayisyen (Creole): Avi sila a gen Enfmasyon Enptan ladann. Avi sila a kapab genyen enfmasyon enptan konsnan aplikasyon w lan oswa konsnan kouvti asirans lan atrav Premera Blue Cross. Kapab genyen dat ki enptan nan avi sila a. Ou ka gen pou pran kk aksyon avan sten dat limit pou ka kenbe kouvti asirans sante w la oswa pou yo ka ede w avk depans yo. Se dwa w pou resevwa enfmasyon 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 enthlt wichtige Informationen. Diese Benachrichtigung enthlt unter Umstnden wichtige Informationen bezglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie knnten bis zu bestimmten Stichtagen handeln mssen, 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 pu 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).
(Japanese): Premera Blue Cross
800-722-1471 (TTY: 800-842-5357) (Korean): . Premera Blue Cross . . . . 800-722-1471 (TTY: 800-842-5357) . (Lao): . Premera Blue Cross. . . . 800-722-1471 (TTY: 800-842-5357). (Khmer):
Premera Blue Cross
800-722-1471 (TTY: 800-842-5357) (Punjabi): . Premera Blue Cross . . , , 800-722-1471 (TTY: 800-842-5357).
:(Farsi) .
. Premera Blue Cross .
. .
)800-842-5357 TTY( 800-722-1471 .
Polskie (Polish): To ogoszenie moe zawiera wane informacje. To ogoszenie moe zawiera wane informacje odnonie Pastwa wniosku lub zakresu wiadcze poprzez Premera Blue Cross. Prosimy zwrcic uwag na kluczowe daty, ktre mog by zawarte w tym ogoszeniu aby nie przekroczy terminw w przypadku utrzymania polisy ubezpieczeniowej lub pomocy zwizanej z kosztami. Macie Pastwo prawo do bezpatnej informacji we wasnym jzyku. Zadzwocie pod 800-722-1471 (TTY: 800-842-5357). Portugus (Portuguese): Este aviso contm informaes importantes. Este aviso poder conter informaes importantes a respeito de sua aplicao ou cobertura por meio do Premera Blue Cross. Podero existir datas importantes neste aviso. Talvez seja necessrio que voc tome providncias dentro de determinados prazos para manter sua cobertura de sade ou ajuda de custos. Voc tem o direito de obter esta informao e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).
Romn (Romanian): Prezenta notificare conine informaii importante. Aceast notificare poate conine informaii importante privind cererea sau acoperirea asigurrii dumneavoastre de sntate prin Premera Blue Cross. Pot exista date cheie n aceast notificare. Este posibil s fie nevoie s acionai pn la anumite termene limit pentru a v menine acoperirea asigurrii de sntate sau asistena privitoare la costuri. Avei dreptul de a obine gratuit aceste informaii i ajutor n limba dumneavoastr. Sunai la 800-722-1471 (TTY: 800-842-5357). P (Russian): . Premera Blue Cross. . , , . . 800-722-1471 (TTY: 800-842-5357). Faasamoa (Samoan): Atonu ua iai i lenei faasilasilaga ni faamatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei faasilasilaga o se fesoasoani e faamatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Faamolemole, ia e iloilo faalelei i aso faapitoa oloo iai i lenei faasilasilaga taua. Masalo o lea iai ni feau e tatau ona e faia ao lei aulia le aso ua taua i lenei faasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo oloo e iai i ai. Oloo iai iate oe le aia tatau e maua atu i lenei faasilasilaga ma lenei famatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Espaol (Spanish): Este Aviso contiene informacin importante. Es posible que este aviso contenga informacin importante acerca de su solicitud o cobertura a travs 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 mdica o ayuda con los costos. Usted tiene derecho a recibir esta informacin 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). (Thai): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357) (Ukrainian): . Premera Blue Cross. , . , , . . 800-722-1471 (TTY: 800-842-5357). Ting Vit (Vietnamese): Thng bo ny cung cp thng tin quan trng. Thng bo ny c thng tin quan trng v n xin tham gia hoc hp ng bo him ca qu v qua chng trnh Premera Blue Cross. Xin xem ngy quan trng trong thng bo ny. Qu v c th phi thc hin theo thng bo ng trong thi hn duy tr bo him sc khe hoc c tr gip thm v chi ph. Qu v c quyn c bit thng tin ny v c tr gip bng ngn ng ca mnh min ph. Xin gi s 800-722-1471 (TTY: 800-842-5357).