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Medical Policy: 09.03.03
Original Effective Date: September 2000
Reviewed: December 2007
Revised: March 2007
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
Description:
Age-related macular degeneration (ARMD) is a disease of unknown etiology, which affects the outer aspects of the retina and portions of the choroid. There are two types of ARMD, atrophic or "dry" and neovascular or "wet", both characterized by the growth of excessive choroidal blood vessels. The abnormal new blood vessel formations leak fluid and protein, leading to scarring of the macula and impaired vision.
Verteporfin, marketed under the trade name Visudyne™, is a type of photodynamic therapy for the treatment of exudative ARMD. The drug is injected intravenously over a precise period of 10 minutes. After an additional five minute waiting period, a laser is used to activate the drug. Free radicals are released which damage the endothelial cells resulting in localized vascular occlusion of the abnormal vessels.
Pegaptanib, marketed under the trade name Macugen®, is an injectable drug for the treatment of ARMD caused by choroidal neovascularization. The drug is injected into the vitreous cavity of the effected eye every six weeks. The limited amount of research on pegaptanib shows decreased efficacy after the first year, and no trials have investigated it for bilateral treatment. It's safety and efficacy for longer than two years has not been established.
Ranibizumab, marketed under the trade name LucentisTM, is another drug for intravitreal injection. The FDA approved labeled indication is for the treatment of patients with neovascular ARMD. The recommended dosage and frequency of treatment is 0.5 mg/0.05mL (10mg/mL), administered by intravitreal injection once in 30 days. Treatment may be continued monthly or reduced to one injection every three months after the first four injections, if monthly treatments are not feasible.
Anecortave, with the trade name RetaaneTM, is currently being investigated in clinical trials. It is injected directly behind the eye instead of into the eyeball. This treatment may become available on the market in the near future, pending final FDA approval.
Bevacizumab, marketed under the trade name Avastin®, has been employed in the off-label use of intravitreal injection to treat neovascularization associated with ARMD. Improvements in visual acuity and decreased retinal thickness by optical coherence tomography have been reported.
Policy:
Photodynamic therapy with verteporfin may be considered medically necessary for the treatment of neovascular ARMD, and for choroidal neovascularization secondary to pathologic myopia and presumed ocular histoplasmosis.
Photodynamic therapy is considered investigational for other ophthalmologic disorders, including choroidal neovascularization secondary to central serous chorioretinopathy.
The use of pegaptanib may be considered medically necessary for exudative ARMD. The use of pegaptanib for any other application is considered investigational.
The use of ranibizumab may be considered medically necessary for the treatment of neovascular ARMD. The use of ranibizumab for any other application is considered investigational.
The use of anecortave acetate or any other drug not yet approved by the FDA for the treatment of neovascular ARMD, or any other application, is considered investigational.
The use of bevacizumab intravitreal injections for the treatment of neovascularization associated with ARMD may be considered medically necessary.
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Procedure Codes and Billing
Guidelines:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- CPT code 67221; Destruction of localized lesion of choroid (eg, choroidal neovascularization); photodynamic therapy (includes intravenous infusion).
- CPT code 67225; Photodynamic therapy, second eye, at single session
- HCPCS code J3396; for verteporfin 0.1mg.
- HCPCS code J3590; Unclassified biologic may be used to report ranibizumab
- HCPCS code J2503; Injection pegaptanib sodium, 0.3 mg
- HCPCS code J9035; Injection, bevacizumab, 10 mg
- HCPCS code J2778; Injection, ranibizumab, 0.1 mg
- HCPCS code 0124T; Conjunctival incision with posterior juxtascleral placement of pharmacological agent (does not include supply of medication)
- CPT code 67028; intravitreal injection of a pharmacologic agent. Report modifier RT or LT with this code, as appropriate. If both eyes are treated on the same date, then the intravitreal injection must be reported on a single claim line using the bilateral modifier (-50), rather than on separate claims lines as for the drug.
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Selected References:
- The Medical Policy Reference Manual (MPRM) developed by the Blue Cross Blue Shield Association Health Management Systems, based on the Technology Evaluation Center (TEC) criteria.
- Hays alert summary. Photodynamic therapy drug for vision loss approved. Hays alert® critical development in medical technology assessment. Volume III, number 4 April 2000.
- Fong D, Benson WE, Bloome MA, Frambach DA, Krieger AE, Williams GA, Murphy RP, Cruckshanks K. Ophthalmic procedure preliminary assessment photodynamic therapy using verteporfin for age-related macular degeneration: Draft #2-June 7, 2000, prepared by the committee on ophthalmic procedures assessment retina panel. American Academy of Ophthalmology June 7,2000.
- Hayes Alert technology assessment brief. Photodynamic therapy with verteporfin (Visudyne™) for neovascular age related macular degeneration. Hays Alert® critical development in medical technology assessment. Volume III numbers 9, September 2000.
- Rubin GS, Bressler NM, The treatment of age-related macular degeneration with photodynamic therapy (TAP) study group. Retina 2002 Oct.;22(5):536-544.
- Azab M, Benchaboune M, et al. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trial: Treatment Of Age-Related Macular Degeneration With Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report No. 4. Retina. 2004 Feb;24(1):1-12.
- Gragoudas ES, Adamis AP, et al. Pegaptanib for Neovascular Age-Related Macular Degeneration. N Engl J Med. 2004 Dec 30;351(27):2805-16.
- Cunningham ET Jr, Adamis AP et al. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology. 2005 Oct;112(10):1747-57.
- D'Amico DJ, Goldberg MF,et al. Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes. Ophthalmology. 2003 Dec;110(12):2372-83.
- Heier JS, Antoszyk AN, et al. Ranibizumab for treatment of neovascular age-related macular degeneration: a phase I/II multicenter, controlled, multidose study. Ophthalmology. 2006 Apr;113(4):642.e1-4. Epub 2006 Feb 14.
- Avery RL, Pieramici DJ, Rabena MD et al. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmology 2006;113:363-72 e5.
- Maturi RK, Bleau LA, Wilson DL. Electrophysiologic findings after intravitreal bevacizumab (Avastin) treatment. Retina 2006;26:270-4.
- Spaide RF, Laud K, Fine HF et al. Intravitreal bevacizumab treatment of choroidal neovascularization secondary to age-related macular degeneration. Retina 2006; 26:383-90.
- Bashshur ZF, Bazarbachi A, Schakal A et al. Intravitreal bevacizumab for the management of choroidal neovascularization in age-related macular degeneration. Am J Ophthalmol 2006;142:1-9.
- Rich RM, Rosenfeld PJ, Puliafito CA et al. Short-term safety and efficacy of intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Retina 2006;26:496-511.
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave.
Des Moines, IA 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
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and, therefore, cannot guarantee any results or outcomes.
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