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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
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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
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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
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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)
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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
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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%
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Pegaptanib Sodium InjectionPegaptanib Sodium InjectionCodingCoding
CPT: 67028 – Intravitreal injectionCPT: 67028 – Intravitreal injection
HCPCS : J2503 – Injection, pegaptanib HCPCS : J2503 – Injection, pegaptanib sodiumsodium
Description of drug in comment field Description of drug in comment field (box 19)(box 19)
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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%
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Ranibizumab InjectionRanibizumab InjectionCodingCoding
CPT: 67028 – Intravitreal injectionCPT: 67028 – Intravitreal injection
HCPCS: J3590 – Unclassified biologicsHCPCS: J3590 – Unclassified biologics
Description of drug in comment field Description of drug in comment field (box 19)(box 19)
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Intravitreal Injections for Wet AMDIntravitreal Injections for Wet AMDAnti-VEGF AgentsAnti-VEGF Agents
Antiangiogenic therapyAntiangiogenic therapy
– BevacizumabBevacizumab
Off-labelOff-label
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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
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““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
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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
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*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)
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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
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Intravitreal InjectionIntravitreal Injection
Minor procedureMinor procedure
– CPT Code 67028CPT Code 67028
– Postoperative period = 0 daysPostoperative period = 0 days
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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
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““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
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““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
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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
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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.
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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
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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/
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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
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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
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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)
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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?
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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
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Wet AMD Wet AMD
Dx: wet AMD ODDx: wet AMD OD
Tx: intravitreal injection Tx: intravitreal injection
Can you be reimbursed?Can you be reimbursed?
For what?For what?
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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)
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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
Can you be reimbursed?Can you be reimbursed?
For what?For what?
Why?Why?
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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
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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
Can you be reimbursed?Can you be reimbursed?
For what?For what?
Why?Why?
OS = left eye; PDT = photodynamic therapy.
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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
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)
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Wet AMD Wet AMD
Hx: S/P intravitreal injection 1 week OSHx: S/P intravitreal injection 1 week OS
Dx: wet AMD OSDx: wet AMD OS
Tx: photodynamic therapy OSTx: photodynamic therapy OS
Can you be reimbursed?Can you be reimbursed?
For what?For what?
Why? Why?
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Wet AMD Wet AMD
Hx: S/P intravitreal injection 1 week OSHx: S/P intravitreal injection 1 week OS
Dx: wet AMD OSDx: wet AMD OS
Tx: photodynamic therapy (PDT) OSTx: photodynamic therapy (PDT) OS
Claim: 67221 LT (PDT)Claim: 67221 LT (PDT) J3396 (verteporfin)J3396 (verteporfin)
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Operative Reports Operative Reports
Pre- and postoperative Pre- and postoperative diagnosesdiagnoses
Indications for surgeryIndications for surgery
Description of surgeryDescription of surgery
Discharge instructionsDischarge instructions
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ConclusionConclusion
Laser treatmentsLaser treatments
– Focal laserFocal laser
CPT: 67220CPT: 67220
– Photodynamic therapyPhotodynamic therapy
CPT: 67221/67225CPT: 67221/67225
HCPCS: J3396 (verteporfin)HCPCS: J3396 (verteporfin)
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ConclusionConclusion
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
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ConclusionConclusion
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
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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
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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
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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
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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%
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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.
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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
Courtesy of Dr. S. Danesh.
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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.
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Courtesy of Dr. S. Danesh.
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
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Neovascular AMDNeovascular AMD
Symptoms of choroidal neovascular membraneSymptoms of choroidal neovascular membrane
Blurred central visionBlurred central vision
Central scotomaCentral scotoma
Metamorphopsia (distortion)Metamorphopsia (distortion)
Courtesy of Dr. S. Danesh.
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Neovascular AMDNeovascular AMD
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
Courtesy of Dr. S. Danesh.
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Courtesy of Dr. S. Danesh.
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
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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
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Current and Potential TreatmentsCurrent and Potential Treatments
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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:
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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
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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.
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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
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Ranibizumab* and BevacizumabRanibizumab* and Bevacizumab
Courtesy of Dr. S. Danesh.
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.
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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
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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.
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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
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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.
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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
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Kaiser PK. Presented at: 2006 Retinal Physician Symposium. Paradise Island, Bahamas, May 31, 2006.
http://www.retinalphysician.com/article.aspx?article=100264
Courtesy of Dr. S. Danesh.
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
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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
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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
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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.
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ConclusionsConclusions
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
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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
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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
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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
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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
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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
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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
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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.
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Reimbursement StrategiesReimbursement Strategies
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
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Reimbursement StrategiesReimbursement Strategies
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
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Reimbursement StrategiesReimbursement Strategies
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
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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
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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
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ConclusionsConclusions
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
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ConclusionsConclusions
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
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ConclusionsConclusions
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