Medicare 2007 and Beyond – Impact on AMD William T. Koch, COA, COE, CPC Associate Consultant...

Medicare 2007 and Beyond Medicare 2007 and Beyond – –

Impact on AMDImpact on AMD

William T. Koch, COA, COE, CPCWilliam T. Koch, COA, COE, CPC

Associate ConsultantAssociate ConsultantCorcoran Consulting GroupCorcoran Consulting GroupSan Bernadino, CaliforniaSan Bernadino, California

History of AMD TreatmentHistory of AMD Treatment

Focal laser treatmentFocal laser treatment

– ““Hot” laserHot” laser

– PhotocoagulationPhotocoagulation

Ocular photodynamic therapyOcular photodynamic therapy

– Intravenous injection of verteporfinIntravenous injection of verteporfin

– ““Cold” laser used to activate drugCold” laser used to activate drug

Anti-VEGF agentsAnti-VEGF agents

– Intravitreal injectionIntravitreal injection

– Antiangiogenic therapyAntiangiogenic therapy

ChallengesChallenges

Genesis of new treatmentsGenesis of new treatments

– Ocular photodynamic therapyOcular photodynamic therapy

– Intravitreal antiangiogenic therapiesIntravitreal antiangiogenic therapies

Coding and reimbursement challengesCoding and reimbursement challenges

Ocular Photodynamic TherapyOcular Photodynamic TherapyCodingCoding

CPT: 67221 Unilateral treatmentCPT: 67221 Unilateral treatment

CPT: 67225 Second eye, single sessionCPT: 67225 Second eye, single session

HCPCS: J3396 (verteporfin)HCPCS: J3396 (verteporfin)

Description of drug in comment field Description of drug in comment field (box 19)(box 19)

Intravitreal Injections for Wet AMDIntravitreal Injections for Wet AMDAnti-VEGF AgentsAnti-VEGF Agents

Antiangiogenic therapyAntiangiogenic therapy

Pegaptanib sodium injectionPegaptanib sodium injection

– On-labelOn-label

Ranibizumab injectionRanibizumab injection

– On-labelOn-label

HOPD: Use C9128

Pegaptanib Sodium InjectionPegaptanib Sodium Injection

Received FDA approval in December of Received FDA approval in December of 20042004

Launched in January of 2005Launched in January of 2005

Treatment of wet AMD (362.52)Treatment of wet AMD (362.52)

Payment based on Average Selling Payment based on Average Selling Price + 6%Price + 6%

Pegaptanib Sodium InjectionPegaptanib Sodium InjectionCodingCoding

CPT: 67028 – Intravitreal injectionCPT: 67028 – Intravitreal injection

HCPCS : J2503 – Injection, pegaptanib HCPCS : J2503 – Injection, pegaptanib sodiumsodium


1. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01405.html

Ranibizumab InjectionRanibizumab Injection

FDA approval June 30, 2006FDA approval June 30, 200611

Treatment of wet AMD (362.52)Treatment of wet AMD (362.52)

Payment based on Average Selling Payment based on Average Selling Price + 6%Price + 6%

Ranibizumab InjectionRanibizumab InjectionCodingCoding

CPT: 67028 – Intravitreal injectionCPT: 67028 – Intravitreal injection

HCPCS: J3590 – Unclassified biologicsHCPCS: J3590 – Unclassified biologics


Intravitreal Injections for Wet AMDIntravitreal Injections for Wet AMDAnti-VEGF AgentsAnti-VEGF Agents

Antiangiogenic therapyAntiangiogenic therapy

– BevacizumabBevacizumab

Off-labelOff-label

Intravitreal Injection of BevacizumabIntravitreal Injection of BevacizumabTreatment of Wet AMDTreatment of Wet AMD

Carriers without published guidelines for wet Carriers without published guidelines for wet AMDAMD

– Wheatlands (KS, NE, MO, West)Wheatlands (KS, NE, MO, West)

– NHIC (CA, ME, MA, NH, VT)NHIC (CA, ME, MA, NH, VT)

Proceed with cautionProceed with caution

– Carrier may reimburse for wet AMD (362.52)Carrier may reimburse for wet AMD (362.52)

– Carrier may follow “unlabeled use of drug” policyCarrier may follow “unlabeled use of drug” policy

Monitor carrier websiteMonitor carrier website

““If a medication is determined not to be reasonable If a medication is determined not to be reasonable and necessary for diagnosis or treatment of an and necessary for diagnosis or treatment of an illness or injury according to these guidelines, the illness or injury according to these guidelines, the carrier excludes the entire charge (ie, carrier excludes the entire charge (ie, for both the for both the drug and its administrationdrug and its administration). Also, carriers exclude ). Also, carriers exclude from payment any charges for other services (from payment any charges for other services (such such as office visitsas office visits) which were primarily for the purpose ) which were primarily for the purpose of administering a noncovered injection (i.e., an of administering a noncovered injection (i.e., an injection that is not reasonable and necessary for the injection that is not reasonable and necessary for the diagnosis or treatment of an illness or injury). . . ”diagnosis or treatment of an illness or injury). . . ”

Source: MBPM Chapter 15, §50.4.2

Unlabeled Use of DrugUnlabeled Use of Drug

Intravitreal Injection of BevacizumabIntravitreal Injection of Bevacizumab

Off-label use when injected in the eyeOff-label use when injected in the eye

– Wet age-related macular degenerationWet age-related macular degeneration

– Clinically significant diabetic macular edemaClinically significant diabetic macular edema

– Macular edema from central retinal vein Macular edema from central retinal vein occlusion (CRVO) or branch retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)occlusion (BRVO)

Vigorous informed consent needed Vigorous informed consent needed

– Off-label statusOff-label status

– Absence of clinical studies for ophthalmic useAbsence of clinical studies for ophthalmic use

*Some Medicare carriers require 67299-GA

Intravitreal Injection of BevacizumabIntravitreal Injection of Bevacizumab

Utilize an Advance Beneficiary Notice (ABN)Utilize an Advance Beneficiary Notice (ABN)

CodingCoding

– CPT: 67028 GA – Intravitreal injection*CPT: 67028 GA – Intravitreal injection*

– HCPCS: J3490 GA – Unclassified drugsHCPCS: J3490 GA – Unclassified drugs

– HCPCS: J3590 GA – Unclassified biologicsHCPCS: J3590 GA – Unclassified biologics

– HCPCS: J9035 GA – Injection, bevacizumabHCPCS: J9035 GA – Injection, bevacizumab

– Description of drug in comment field (box 19)Description of drug in comment field (box 19)

Minor or Major Procedure?Minor or Major Procedure?

Minor procedureMinor procedure

– Postoperative period of Postoperative period of 0 or 10 days0 or 10 days

Major ProcedureMajor Procedure

– Postoperative period of Postoperative period of 90 days90 days

Intravitreal InjectionIntravitreal Injection

Minor procedureMinor procedure

– CPT Code 67028CPT Code 67028

– Postoperative period = 0 daysPostoperative period = 0 days

Source: MCPM, Chapter 12, §40.1C

Minor ProcedureMinor Procedure

Included in surgery packageIncluded in surgery package

– Same-day exam Same-day exam usuallyusually bundled bundled

– Includes suppliesIncludes supplies

““CPT Modifier 25 – Significant Evaluation and CPT Modifier 25 – Significant Evaluation and Management Service By Same Physician On Management Service By Same Physician On Date of Global ProcedureDate of Global Procedure

Pay for an evaluation and management service Pay for an evaluation and management service provided on the day of a procedure with a global fee provided on the day of a procedure with a global fee period if the physician indicates that the service is for period if the physician indicates that the service is for a significant, separately identifiable evaluation and a significant, separately identifiable evaluation and management service that is above and beyond the management service that is above and beyond the pre- and post-operative work of the procedure.”pre- and post-operative work of the procedure.”

Source: MCPM, Chapter 12, §40.2.A8

Billing Office Visit Billing Office Visit with Minor Procedurewith Minor Procedure

““Evaluation and Management Service Evaluation and Management Service Resulting in the Initial Decision to Perform Resulting in the Initial Decision to Perform SurgerySurgery

……..where the decision to perform the minor ..where the decision to perform the minor procedure is typically done immediately before the procedure is typically done immediately before the service, it is considered a routine preoperative service, it is considered a routine preoperative service and a visit or consultation is not billed in service and a visit or consultation is not billed in addition to the procedureaddition to the procedure.”.”

Source: MCPM, Chapter 12, §40.2A4

Billing Office Visit Billing Office Visit with Minor Procedurewith Minor Procedure

Significant separateSignificant separate E/M services E/M services on on the daythe day of a of a minorminor surgery, surgery, ie, ie, new new patientpatient to practice to practice

9924399243-25-25 362.52 wet AMD362.52 wet AMD

6702867028 362.52 wet AMD362.52 wet AMD

Modifier -25Modifier -25

CC:CC: S/P intravitreal S/P intravitreal injection x 4 wk OD; injection x 4 wk OD; recheck recheck wet AMD OD,wet AMD OD,patient states visionpatient states visionstill poorstill poor

Dx:Dx: wet AMD OD wet AMD OD unresolved unresolved

Tx:Tx: intravitreal injectionintravitreal injectionOD todayOD today

Hx: healthyHx: healthy

Exam: VA, SLE, DFEExam: VA, SLE, DFE

CPT = 67028 RT

Office Visit—EstablishedOffice Visit—EstablishedWet AMDWet AMD

S/P = status post; OD = right eye; VA = visual acuity; SLE = slit lamp examination; DFE = dilated fundus examination.

Significant separateSignificant separate E/M services E/M services on on the daythe day of a of a minorminor surgery, surgery, ie, ie, to cope to cope with with bilateral bilateral diseasedisease

9201292012-25-25 362.51 dry AMD 362.51 dry AMD RTRT

6702867028 362.52 wet AMD 362.52 wet AMD LTLT

Modifier -25Modifier -25

National Correct Coding Initiative National Correct Coding Initiative (NCCI)(NCCI)

NCCINCCI

– BundlesBundles

– Mutually exclusive Mutually exclusive

– Quarterly publicationQuarterly publication

Published at Published at www.cms.gov/physicians/cciedits/ www.cms.gov/physicians/cciedits/

67500 Retrobulbar injection; medication

NCCI EditsNCCI Edits

Procedure Bundles

67028 36000 36410 37202 62318 62319 64415 64416 64417 64450 64470 64475 67500 69990 90760 90765 90772 90774 90775 J2001

ParacentesisParacentesis

Some ophthalmologists remove aqueous humor Some ophthalmologists remove aqueous humor from the anterior chamber prior to an intravitreal from the anterior chamber prior to an intravitreal injectioninjection

Paracentesis (CPT 65800 or 65805) is performed as Paracentesis (CPT 65800 or 65805) is performed as a prophylactic measure to avoid elevating a prophylactic measure to avoid elevating intraocular pressureintraocular pressure

Since both of these CPT codes carry the Since both of these CPT codes carry the “separate “separate procedure”procedure” designation, and the paracentesis is designation, and the paracentesis is only performed as prelude to the intravitreal only performed as prelude to the intravitreal injection, the paracentesis is considered to be an injection, the paracentesis is considered to be an incidental part of the total service and no incidental part of the total service and no additional claim is meritedadditional claim is merited

Source: MCPM, Chapter 12, §40.1A

Injection for ComplicationInjection for Complication

Performed during postoperative period of another surgeryPerformed during postoperative period of another surgery

Performed in officePerformed in office

– Included in global surgery packageIncluded in global surgery package

Performed in the ORPerformed in the OR

– CoveredCovered

– Modifier 78 (return to the OR)Modifier 78 (return to the OR)

Staged (preplanned)Staged (preplanned)

– CoveredCovered

– Modifier 58 (staged or related)Modifier 58 (staged or related)

Wet AMD Wet AMD

Dx: submacular hemorrhage AMD ODDx: submacular hemorrhage AMD OD

Tx: pars plana vitrectomy (PPV)Tx: pars plana vitrectomy (PPV)

Plan: intravitreal injection following PPV Plan: intravitreal injection following PPV in officein office

Can you be reimbursed?Can you be reimbursed?

For what?For what?

Wet AMD Wet AMD

Dx: submacular hemorrhage AMD ODDx: submacular hemorrhage AMD OD

Tx: pars plana vitrectomyTx: pars plana vitrectomy

Plan: intravitreal injection following PPV Plan: intravitreal injection following PPV in officein office

Claim: 67038 for surgeryClaim: 67038 for surgery

Claim: 67028 58RT (intravitreal injection)Claim: 67028 58RT (intravitreal injection)pegaptanib/ranibizumab/bevacizumab pegaptanib/ranibizumab/bevacizumab

Modifier 58: Modifier 58: stagedstaged or related procedure during or related procedure during the postoperative periodthe postoperative period

Wet AMD Wet AMD

Dx: wet AMD ODDx: wet AMD OD

Tx: intravitreal injection Tx: intravitreal injection


For what?For what?

Wet AMD Wet AMD

Dx: wet AMD ODDx: wet AMD OD

Tx: intravitreal injectionTx: intravitreal injection

Claim: 67028 RT (intravitreal injection)Claim: 67028 RT (intravitreal injection)J2503 (pegaptanib)J2503 (pegaptanib)J3590 (ranibizumab)J3590 (ranibizumab)J3490/J3590/J9035 J3490/J3590/J9035

(bevacizumab)(bevacizumab)

Wet AMD Wet AMD

Hx: S/P intravitreal injection OD x Hx: S/P intravitreal injection OD x 5 weeks5 weeks

Dx: wet AMD OD, unresolvedDx: wet AMD OD, unresolved

Tx: intravitreal injection ODTx: intravitreal injection OD


For what?For what?

Why?Why?

Wet AMD Wet AMD

Hx: S/P intravitreal injection OD x Hx: S/P intravitreal injection OD x 5 weeks5 weeks

Dx: wet AMD OD, unresolvedDx: wet AMD OD, unresolved

Tx: intravitreal injection ODTx: intravitreal injection OD

Claim:Claim: 67028 RT (intravitreal injection)67028 RT (intravitreal injection) J2503 (pegaptanib)J2503 (pegaptanib)

J3590 (ranibizumab)J3590 (ranibizumab) J3490/J3590/J9035 (bevacizumab)J3490/J3590/J9035 (bevacizumab)

67028 = 0 days postoperative period67028 = 0 days postoperative period

Wet AMD Wet AMD

Dx: wet AMD OSDx: wet AMD OS

Tx: intravitreal injection OS, return Tx: intravitreal injection OS, return 1 wk for PDT OS1 wk for PDT OS


For what?For what?

Why?Why?

OS = left eye; PDT = photodynamic therapy.

Wet AMD Wet AMD


Tx: intravitreal injection OS, return Tx: intravitreal injection OS, return 1 wk for PDT OS1 wk for PDT OS

Claim: 67028 LT (intravitreal injection)Claim: 67028 LT (intravitreal injection) J2503 (pegaptanib) J2503 (pegaptanib)

J3590 (ranibizumab)J3590 (ranibizumab)J3490/J3590/J9035 (bevacizumab)J3490/J3590/J9035 (bevacizumab)

Wet AMD Wet AMD

Hx: S/P intravitreal injection 1 week OSHx: S/P intravitreal injection 1 week OS


Tx: photodynamic therapy OSTx: photodynamic therapy OS


For what?For what?

Why? Why?

Wet AMD Wet AMD

Hx: S/P intravitreal injection 1 week OSHx: S/P intravitreal injection 1 week OS


Tx: photodynamic therapy (PDT) OSTx: photodynamic therapy (PDT) OS

Claim: 67221 LT (PDT)Claim: 67221 LT (PDT) J3396 (verteporfin)J3396 (verteporfin)

Operative Reports Operative Reports

Pre- and postoperative Pre- and postoperative diagnosesdiagnoses

Indications for surgeryIndications for surgery

Description of surgeryDescription of surgery

Discharge instructionsDischarge instructions

ConclusionConclusion

Laser treatmentsLaser treatments

– Focal laserFocal laser

CPT: 67220CPT: 67220

– Photodynamic therapyPhotodynamic therapy

CPT: 67221/67225CPT: 67221/67225

HCPCS: J3396 (verteporfin)HCPCS: J3396 (verteporfin)


Antiangiogenic therapiesAntiangiogenic therapies

– Pegaptanib sodiumPegaptanib sodium CPT: 67028 (intravitreal injection)CPT: 67028 (intravitreal injection)

HCPCS: J2503 (pegaptanib sodium) HCPCS: J2503 (pegaptanib sodium)

– RanibizumabRanibizumab CPT: 67028 (intravitreal injection)CPT: 67028 (intravitreal injection)

HCPCS: J3590 (ranibizumab)HCPCS: J3590 (ranibizumab)

– BevacizumabBevacizumab CPT: 67028 (intravitreal injection)CPT: 67028 (intravitreal injection)

HCPCS: J3490/J3590/J9035HCPCS: J3490/J3590/J9035 Bevacizumab/carrier specificBevacizumab/carrier specific


Future of AMD treatmentFuture of AMD treatment

Clinical research ongoingClinical research ongoing

– Private sectorPrivate sector

– NEI/NIHNEI/NIH

Improvement of existing therapiesImprovement of existing therapies

Combination therapies using current Combination therapies using current methodsmethods

Overview of AMD TherapyOverview of AMD Therapy

Sharam Danesh, MDSharam Danesh, MD

Vitreoretinal SurgeonVitreoretinal SurgeonAssociated Retina Consultants, Ltd.Associated Retina Consultants, Ltd.

Associate ProfessorAssociate ProfessorDepartment of Ophthalmology Retina ServicesDepartment of Ophthalmology Retina Services

University of ArizonaUniversity of ArizonaPhoenix, ArizonaPhoenix, Arizona

IntroductionIntroduction

Definition of age-related macular Definition of age-related macular degeneration (AMD)degeneration (AMD)

A constellation of degenerative macular A constellation of degenerative macular abnormalities, strongly associated with abnormalities, strongly associated with age age

These degenerative abnormalities are These degenerative abnormalities are along a spectrum of changes from normal along a spectrum of changes from normal aging to severe AMDaging to severe AMD

ClassificationsClassifications

Dry AMDDry AMD

– Non-neovascular changesNon-neovascular changes

DrusenDrusen

Abnormalities of the retinal pigment Abnormalities of the retinal pigment epitheliumepithelium

Wet AMDWet AMD

– Neovascular changes Neovascular changes

Choroidal neovascularizationChoroidal neovascularization

Dry AMDDry AMD

Dry AMD is more common Dry AMD is more common

– Dry AMDDry AMD 85%85%

– Wet AMDWet AMD 15%15%

Severe visual lossSevere visual loss

– Dry AMDDry AMD 15%15%

– Wet AMDWet AMD 85% 85%

DrusenDrusen Round and yellow lesions Round and yellow lesions

Located in the outer retina of the posterior poleLocated in the outer retina of the posterior pole

Accumulation of material in Bruch’s membraneAccumulation of material in Bruch’s membrane

Failure of the debris from the retinal pigment Failure of the debris from the retinal pigment epithelium cells to cross the Bruch’s membrane into epithelium cells to cross the Bruch’s membrane into the choriocapillaristhe choriocapillaris

Courtesy of Dr. S. Danesh.

Dry AMDDry AMD

Geographic atrophyGeographic atrophy The end result of the atrophic form of AMDThe end result of the atrophic form of AMD

Round oval area of hypopigmentation and Round oval area of hypopigmentation and apparent absence of the retinal pigment apparent absence of the retinal pigment epitheliumepithelium

Choroidal vessels are more visibleChoroidal vessels are more visible


Available at: http://health.yahoo.com/media/mayoclinic/images/image_popup/r7_wetmacdegen.jpg. Accessed June 26, 2007.

Neovascular AMDNeovascular AMD Choroidal neovascular membrane Choroidal neovascular membrane

is the hallmark of wet AMDis the hallmark of wet AMD

Neovascular vessels grow Neovascular vessels grow through the Bruch’s membrane through the Bruch’s membrane into the sub–retinal pigment into the sub–retinal pigment epithelium and sub–retinal spaceepithelium and sub–retinal space

The fibrovascular complex can The fibrovascular complex can destroy the normal structure of destroy the normal structure of the RPE and retinathe RPE and retina

Secondary exudation or Secondary exudation or hemorrhage from neovascular hemorrhage from neovascular vessels may occurvessels may occur

Mayo Foundation for Medical Education and Research. All rights reserved.Reprinted with permission.


Neovascular AMDNeovascular AMD

Clinical finding of choroidal neovascular membraneClinical finding of choroidal neovascular membrane A grey subretinal membraneA grey subretinal membrane

Subretinal hemorrhageSubretinal hemorrhage

Subretinal fluidSubretinal fluid


Symptoms of choroidal neovascular membraneSymptoms of choroidal neovascular membrane

Blurred central visionBlurred central vision

Central scotomaCentral scotoma

Metamorphopsia (distortion)Metamorphopsia (distortion)



Disciform scarDisciform scar End-stage choroidal End-stage choroidal

neovascular neovascular membranemembrane

A fibrovascular scar is A fibrovascular scar is formed in the formed in the subretinal spacesubretinal space

Associated with severe Associated with severe loss of central visionloss of central vision

Not yet amenable to Not yet amenable to any treatmentsany treatments



Severe Visual Loss in AMDSevere Visual Loss in AMD

Geographic atrophy in Geographic atrophy in the center of maculathe center of macula

Choroidal neovascular Choroidal neovascular membranemembrane

Risk Factors and PreventionsRisk Factors and Preventions Excellent evidence Excellent evidence

– AgeAge– Race/ethnicityRace/ethnicity– Family historyFamily history– SmokingSmoking– Antioxidant vitamins: C, E, beta caroteneAntioxidant vitamins: C, E, beta carotene– ZincZinc

Some evidenceSome evidence– Lifelong exposure to blue lightLifelong exposure to blue light– Lutein/zeaxanthinLutein/zeaxanthin– Omega 3 long chain fatty acidsOmega 3 long chain fatty acids

No evidenceNo evidence– Exposure to UV lightExposure to UV light

Current and Potential TreatmentsCurrent and Potential Treatments

Verteporfin is activated by lightVerteporfin is activated by light

Oxygen radicalsOxygen radicals

Endothelial damage and thrombus formationEndothelial damage and thrombus formation

Occlusion of neovascular vesselsOcclusion of neovascular vessels

Photodynamic TherapyPhotodynamic Therapy

Treatment with a photosensitizing dyeTreatment with a photosensitizing dye

Proposed mechanism of action:Proposed mechanism of action:

TAP Study Group. Arch Ophthalmol.1999;117:1329.

Treatment of AMD with Photodynamic Treatment of AMD with Photodynamic Therapy (TAP) StudyTherapy (TAP) Study

ConclusionsConclusions

Photodynamic therapy is clinically beneficial Photodynamic therapy is clinically beneficial for patients with choroidal neovascular for patients with choroidal neovascular membrane with >50% classic componentmembrane with >50% classic component

This beneficial effect only slows visual loss at This beneficial effect only slows visual loss at bestbest

oAvastin

oVEGF-trap

*Approved by FDA for AMD

The Eye Digest. http://www.agingeye.net/maculardegen/maculardegennewdevelopments.php

Anti-VEGF Therapies in Eye DiseasesAnti-VEGF Therapies in Eye Diseases

Pegaptanib*Pegaptanib*

Ranibizumab*Ranibizumab*

BevacizumabBevacizumab

VEGF-trapVEGF-trap

siRNAssiRNAs

VEGF = vascular endothelial growth factor; siRNAs = small interfering RNAs; PDT = photodynamic therapy; TTT = transpupillary thermotherapy; EBRT = external beam radiation.

PegaptanibRanibizumabBevacizumap

Squalamine lactateSqualamine lactateAnecortave

The Eye Digest. www.agingeye.net. University of Illinois Eye & Ear Infirmary.

Chakravarthy U, et al. Ophthalmology. 2006;113:1508.

Pegaptanib—VISION ResultsPegaptanib—VISION Results

In 2 combined randomized, double-In 2 combined randomized, double-masked, sham-controlled trials, masked, sham-controlled trials, pegaptanibpegaptanib

Significantly reduced the proportion of Significantly reduced the proportion of patients who lost >15 letters patients who lost >15 letters

Reduced the progression to legal blindnessReduced the progression to legal blindness

Ranibizumab* and BevacizumabRanibizumab* and Bevacizumab


MouseAnti-VEGF-A mAb

(~150 kDa)

RANIBIZUMAB48 kDa

Affinitymaturation

(140×)

(rhu Fab v1)

Humanization

(Fab-12)

Constructionof full length

antibody BEVACIZUMAB149 kDa

*FDA approved for AMD.

Ranibizumab—MARINA ResultsRanibizumab—MARINA Results

Month 24Month 12

Sham(n = 238)

Ranibizumab0.5 mg

(n = 240)

Sham(n = 238)

Ranibizumab0.5 mg

(n = 240)

<15-Letter Loss from Baseline<15-Letter Loss from Baseline

0102030405060708090

100

33.8

% o

f S

ub

jec

ts

4.6 3.8

33.3

Month 12 Month 24

Sham (n = 238)Ranibizumab0.5 mg (n = 240)

≥≥15-Letter Gain from Baseline15-Letter Gain from Baseline

MARINA = Minimally Classic/Occult Trial of Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration. With permission from Rosenfeld PJ, et al. N Engl J Med. 2006;355:1419-1431. Copyright 2006. Massachusetts Medical Society. All rights reserved.

102030405060708090

10094.6*

% o

f S

ub

jec

ts

62.2

90.0*

52.9

0

Ranibizumab—MARINA ResultsRanibizumab—MARINA Results

With permission from Rosenfeld PJ, et al. N Engl J Med. 2006;355:1419-1431. Copyright 2006. Massachusetts Medical Society. All rights reserved.

Month

ET

DR

S L

ette

rs

-14.9-15

-10

10 +6.6+7.2

-10.4

2 4 6 8 10 12 14 16 18 20 22 24

-5

0

5

Sham (n = 238) Ranibizumab 0.5 mg (n = 240)

Mean Change in Visual Acuity Over Time Through Month 24Mean Change in Visual Acuity Over Time Through Month 24

ETDRS = Early Treatment of Diabetic Retinopathy Study.

Ranibizumab—ANCHOR ResultsRanibizumab—ANCHOR Results

With permission from Brown DM, et al. N Engl J Med. 2006;355:1432-1444. Copyright 2006. Massachusetts Medical Society. All rights reserved.

PDT = photodynamic therapy.

PDT(n = 143)

Ranibizumab 0.5 mg

(n = 139)

96.4

64.3

<15<15--Letter Loss From Letter Loss From Baseline at Month 12Baseline at Month 12

0

10

20

30

40

50

60

70

80

90

100

≥≥1515--Letter Gain From Letter Gain From Baseline at Month 12Baseline at Month 12

40.3

% o

f S

ub

jec

ts5.6

PDT(n = 143)

Ranibizumab0.5 mg

(n = 139)

0

10

20

30

40

50

60

70

80

90

100

% o

f S

ub

jec

ts

Ranibizumab—ANCHOR ResultsRanibizumab—ANCHOR ResultsMean Change in Visual Acuity Over Time Through Month 12

+11.3

–9.5

PDT (n = 143)

ET

DR

S L

ette

rs

Month

-15

-10

-5

0

5

10

15

1 2 3 4 5 6 7 8 9 10 11 12

Ranibizumab 0.5 mg (n = 139)

PDT = photodynamic therapy; ETDRS = Early Treatment of Diabetic Retinopathy Study.

With permission from Brown DM, et al. N Engl J Med. 2006;355:1432-1444. Copyright 2006. Massachusetts Medical Society. All rights reserved.

Multicentered randomized clinical trial involving 40 centers

Group 1Ranibizumab q 4 wk x

1 y then randomize to bevacizumab PRN

or q 4 wk

Group 2Bevacizumab q 4 wk x

1 ythen randomize to ranibizumab PRN

or q 4 wk

Group 3Ranibizumab

PRN

Group 4Bevacizumab

PRN

CATTCATT Comparison of AMD Treatments TrialComparison of AMD Treatments Trial

Kaiser PK. Presented at: 2006 Retinal Physician Symposium. Paradise Island, Bahamas, May 31, 2006.

http://www.retinalphysician.com/article.aspx?article=100264


VEGF TrapVEGF Trap

Fusion protein of key domains Fusion protein of key domains from human VEGF receptors 1 from human VEGF receptors 1 and 2 with human IgG1 Fcand 2 with human IgG1 Fc

High affinity: binds VEGF High affinity: binds VEGF more tightly than native more tightly than native receptors or monoclonal receptors or monoclonal antibodiesantibodies

Blocks all VEGF-A isoforms Blocks all VEGF-A isoforms and placental growth factor and placental growth factor (PIGF)(PIGF)

Smaller than an antibodySmaller than an antibody Kd 10–30 pM Kd 100–300 pM

Phase II study of intravitreous

VEGF trap in patient with

neovascular AMD

Initial 12 weeks

0.5 mgq 4 wk

0.5 mgq 12 wk

2 mgq 4 wk

2 mgq 12 wk

4 mgq 4 wk

Followed by 9 months of PRN dosing

VEGF TrapVEGF Trap

Cand5: VEGF Cand5: VEGF SiRNASiRNA

Sirna-027: VEGF receptor Sirna-027: VEGF receptor siRNAsiRNA

The Eye Digest. http://agingeye.net/maculardegen/maculardegennewdevelopments.php

The Eye Digest. www.agingeye.net. University of Illinois Eye & Ear Infirmary.

Sarnow P, et al. Nat Rev Microbiol. 2006;4:651.

Small Interfering RNAsSmall Interfering RNAs

PegaptanibRanibizumab

Squalamine lactateAnecortave

Natural pathway

Future Directions—Combination/Triple Future Directions—Combination/Triple TherapiesTherapies

Early trial of photodynamic therapy Early trial of photodynamic therapy with verteporfin + bevacizumab + with verteporfin + bevacizumab + dexamethasonedexamethasone

Visual acuity improved in most of the 59 Visual acuity improved in most of the 59 patients treatedpatients treated

1 cycle only required, with occasional 1 cycle only required, with occasional supplementation with intravitreal injections supplementation with intravitreal injections of bevacizumabof bevacizumab

Augustin AJ, et al. Presented at: Joint Meeting of AAO and APAO. Las Vegas, Nevada; November 11-14, 2006.


Photodynamic therapy is beneficial for Photodynamic therapy is beneficial for patients with choroidal neovascular patients with choroidal neovascular membrane with >50% classic component, membrane with >50% classic component, but only slows visual loss at bestbut only slows visual loss at best

Pegaptanib maintains visual acuityPegaptanib maintains visual acuity

Ranibizumab maintains and improves Ranibizumab maintains and improves visual acuityvisual acuity

Potential future therapies for AMD include Potential future therapies for AMD include bevacizumab, VEGF trap, siRNAs, and bevacizumab, VEGF trap, siRNAs, and combination/triple regimenscombination/triple regimens

AMD Best Practice for Best AMD Best Practice for Best Patient Care: Patient Care:

Improving Patient ProcessesImproving Patient Processes

Angela M. Chambers, RN, MBAAngela M. Chambers, RN, MBA

Executive DirectorExecutive DirectorAssociated Retina Consultants, Ltd.Associated Retina Consultants, Ltd.

Phoenix, ArizonaPhoenix, Arizona

Improving Patient FlowImproving Patient Flow

Establish a defined practice protocol for treatmentEstablish a defined practice protocol for treatment

Educate staff on protocolEducate staff on protocol

Provide injections and therapies in a defined Provide injections and therapies in a defined room; removing this task from clinic will improve room; removing this task from clinic will improve regular clinic flowregular clinic flow

Establish a separate schedule for this procedure Establish a separate schedule for this procedure area that runs in conjunction with the established area that runs in conjunction with the established clinic scheduleclinic schedule

Schedule patients every 15 minutesSchedule patients every 15 minutes

Improving Patient FlowImproving Patient Flow

Schedule 1 person to handle the procedure Schedule 1 person to handle the procedure areaarea

Define a protocol that addresses patient Define a protocol that addresses patient education pre- and postprocedureeducation pre- and postprocedure

Make sure to provide written educational Make sure to provide written educational information to the patient; this will information to the patient; this will eliminate unnecessary phone callseliminate unnecessary phone calls

Establish uniformity in set-up for Establish uniformity in set-up for procedure to streamline costprocedure to streamline cost

Improving Patient FlowImproving Patient Flow Call doctor to the procedure Call doctor to the procedure

room after patient is prepped room after patient is prepped and ready for the procedureand ready for the procedure

Follow defined protocol for Follow defined protocol for patient follow-uppatient follow-up

Total time for patient from Total time for patient from check-in to check out is 15–20 check-in to check out is 15–20 minutesminutes

Have patient complete Have patient complete satisfaction survey to satisfaction survey to determine areas of determine areas of improvement improvement

Processing of Claims and CollectionsProcessing of Claims and Collections

Verify patient eligibilityVerify patient eligibility

Collect co-pays and deductible Collect co-pays and deductible amounts at time of serviceamounts at time of service

Educate all staff on proper coding for Educate all staff on proper coding for AMDAMD

Utilize pharmaceutical Utilize pharmaceutical reimbursement management team for reimbursement management team for problems with specific carriers problems with specific carriers regarding drug reimbursementregarding drug reimbursement

Identify proper Medicare Secondary Identify proper Medicare Secondary Payer (MSP) type prior to claim Payer (MSP) type prior to claim submittal to avoid rejections submittal to avoid rejections

Drug InventoryDrug Inventory

Establish a system to track drug Establish a system to track drug inventoryinventory

Have all drugs delivered to 1 central Have all drugs delivered to 1 central location; disburse to other locations location; disburse to other locations after labelingafter labeling

Label each drug with a specific Label each drug with a specific identifier number that will correspond identifier number that will correspond to inventory logto inventory log

Make 1 person in each office Make 1 person in each office responsible for drug inventory receivedresponsible for drug inventory received

Drug should not be dispensed till payer Drug should not be dispensed till payer source is identifiedsource is identified

Reimbursement StrategiesReimbursement Strategies

Contact insurance carriers and requestContact insurance carriers and requesta written response regarding payment a written response regarding payment policy on drug and procedurepolicy on drug and procedure

Establish a timeline for response, ie, Establish a timeline for response, ie, 5 days 5 days

Outline in your request what your action Outline in your request what your action will be if you do not get a response in will be if you do not get a response in identified timeframe, eg, collect from identified timeframe, eg, collect from patient prior to procedure etc.patient prior to procedure etc.


Patients not treated until payer source Patients not treated until payer source is identifiedis identified

Payment requested upfront for Payment requested upfront for noninsured patientsnoninsured patients

Billing department should check Billing department should check appointment logs and verify eligibility at appointment logs and verify eligibility at least 24 hours prior to procedureleast 24 hours prior to procedure


Utilize your State Department of Insurance to Utilize your State Department of Insurance to intercede in disputes with your insurance carriersintercede in disputes with your insurance carriers

Every insurance carrier has an appeals processEvery insurance carrier has an appeals process

Patient is required to initiate the process Patient is required to initiate the process

The final stage of the appeals process requires an The final stage of the appeals process requires an outside review outside review

The majority of the time when an outside review The majority of the time when an outside review is done they err on the side of the provider is done they err on the side of the provider


Insurance carriers do not like having the Insurance carriers do not like having the State Department of Insurance involved in the State Department of Insurance involved in the claims process claims process

Once they are called in to investigate a claims Once they are called in to investigate a claims issue they can expand their focusissue they can expand their focus

The Department of Insurance notifies the The Department of Insurance notifies the patient, provider, and carrier of the decisionpatient, provider, and carrier of the decision

If the carrier is found to be at fault, they If the carrier is found to be at fault, they require the carrier to pay the claim with require the carrier to pay the claim with interest within 5 daysinterest within 5 days

Efficiencies that Ensure OptimalEfficiencies that Ensure OptimalPatient CarePatient Care

Maximize your space to create better patient flowMaximize your space to create better patient flow

Remove bottlenecks in the back office by providing Remove bottlenecks in the back office by providing procedures in a separate areaprocedures in a separate area

Redefine scheduling scenarios to fast-track patients Redefine scheduling scenarios to fast-track patients and decrease wait times in clinicand decrease wait times in clinic

Redefine the check-in process to assure an efficient Redefine the check-in process to assure an efficient streamlined process streamlined process

Mail, e-mail, or post on website, information about Mail, e-mail, or post on website, information about required paperwork for patient check-in process; on required paperwork for patient check-in process; on appointment day, patients arrive with information in appointment day, patients arrive with information in hand hand

Reminder Form Example Reminder Form Example (Printed on Brightly Colored Paper)(Printed on Brightly Colored Paper)

You are scheduled for an intravitreal injection in our You are scheduled for an intravitreal injection in our Fast-Track ClinicFast-Track Clinic

Date_______ Time______Location_____Date_______ Time______Location_____

Please do not wear any cosmetics on appointment Please do not wear any cosmetics on appointment datedate

We advise that you arrange for a driver to transport We advise that you arrange for a driver to transport you home following injectionyou home following injection

You have been given a prescription for an antibiotic, You have been given a prescription for an antibiotic, which will need to be filled prior to the injection datewhich will need to be filled prior to the injection date

If you have any questions, please telephone us at 602-If you have any questions, please telephone us at 602-242-4928242-4928


Look at all your clinic processes criticallyLook at all your clinic processes critically

Identify areas of the greatest bottleneck to Identify areas of the greatest bottleneck to patient process and flowpatient process and flow

Think outside of the boxThink outside of the box

Solicit suggestions and information from all Solicit suggestions and information from all parties involved, ie, providers, staff, patients, parties involved, ie, providers, staff, patients, outside observers. Some of our best outside observers. Some of our best solutions have come from this process solutions have come from this process


Streamline your work space and maximize Streamline your work space and maximize space that can be used for revenue-space that can be used for revenue-producing endeavorsproducing endeavors

Paperwork is the largest waste of labor. By Paperwork is the largest waste of labor. By streamlining the paper process, efficiencies streamlining the paper process, efficiencies improve and costs decreaseimprove and costs decrease

Develop instructional information for patients Develop instructional information for patients regarding procedures and processes. This regarding procedures and processes. This will decrease questions and calls to the office will decrease questions and calls to the office as well as labor costs as well as labor costs


By restructuring work processes, you By restructuring work processes, you will improve efficiency, increase will improve efficiency, increase revenue, decrease cost, increase revenue, decrease cost, increase productivity, and streamline workflow, productivity, and streamline workflow, while improving the overall patient while improving the overall patient experience in your practiceexperience in your practice

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Medicare 2007 and Beyond – Impact on AMD William T. Koch, COA, COE, CPC Associate Consultant...

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