LCD/NCD Portal

L29959

 

INTRAVITREAL BEVACIZUMAB (AVASTIN®)

 

 

06/14/2011

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Indications

 

• FCSO Medicare will consider bevacizumab (Avastin®) given by intravitreal injection medically reasonable and necessary for patients who are deemed by their treating ophthalmologist to have failed U.S. Food & Drug Administration (FDA) approved therapies, or in the judgment of the treating ophthalmologist, based on his/her experience, are likely to have a therapeutic response from the use of intravitreal bevacizumab which is comparable to results from other approved treatments for conditions outlined in this local coverage determination (LCD).

• Current literature indicates anticipated dosage is 1.25 mg (0.05ml) or less, on a yearly average of every 4 to 6 weeks, as needed, by aseptic intravitreal injection into affected eye.

o Treatment continues on a monthly basis until the abnormal neovascularization, vitreous hemorrhage, macular edema, subretinal fluid, and/or pigment epithelial detachment is resolved.

 

 

Limitations

 

• The CMS On-line Manual System, Pub. 100-08, Program Integrity Manual, Chapter 13, Section 13.5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf ) outlines that " reasonable and necessary" services are " ordered and/or furnished by qualified personnel."

o A qualified physician for this service/procedure is defined as follows:

 Physician is properly enrolled in Medicare.

 Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty society in the United States.

• Bevacizumab is CONTRAINDICATED in patients with ocular or periocular infections or known hypersensitivity to bevacizumab or any of the inactive ingredients in bevacizumab.

 

 

CPT/HCPCS Codes

 

C9257 INJECTION, BEVACIZUMAB, 0.25 MG

J3490 UNCLASSIFIED DRUGS

 

 

ICD-9 Codes that Support Medical Necessity

 

362.02 PROLIFERATIVE DIABETIC RETINOPATHY

362.07* DIABETIC MACULAR EDEMA

362.16 RETINAL NEOVASCULARIZATION NOS

362.29 OTHER NONDIABETIC PROLIFERATIVE RETINOPATHY

362.35 CENTRAL RETINAL VEIN OCCLUSION

362.36 VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA

362.52 EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA

362.53 CYSTOID MACULAR DEGENERATION OF RETINA

362.83 RETINAL EDEMA

364.42 RUBEOSIS IRIDIS

365.63 GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE

* Per the ICD-9-CM coding manual, ICD-9-CM code 362.07 requires a dual diagnosis. ICD-9-CM code 362.07 must be used with a code for diabetic retinopathy (ICD-9-CM codes 362.01-362.06).

 

 

Documentation Requirements

 

• Medical record documentation maintained by the performing ophthalmologist must include the following:

o The clinical indication/medical necessity for the bevacizumab injection and the frequency of its usage.

o The actual dosage of bevacizumab given, site of injection and route of administration.

o Test results to firmly establish diagnosis by fluoroscein angiogram or optical coherence tomography (OCT), for individuals with proliferative diabetic retinopathy, diabetic macular edema, retinal neovascularization, central retinal vein occlusion, venous tributary (branch) occlusion, exudative macular degeneration, and retinal edema.

 Tests to confirm the established diagnosis are not required for rubeosis iridis, or in the case of a vitreous hemorrhage in which the neovascularization cannot be visualized.

o Indication that the patient has been provided appropriate informed consent regarding the benefits and risks of this therapy and off-label use of this drug.

Treatment Logic:

• Neovascular age-related macular degeneration (AMD), when untreated or refractory to usual therapies, almost always leads to permanent blindness.

o Neovascular (wet) AMD is characterized by choroidal neovascularization (CNV) beneath the retina.

o The neovascular tissue often leaks blood and fluid, and when untreated, eventually progresses to scarring with destruction of the macula and loss of vision.

o As such, additional therapeutic interventions have been pursued in order to try and salvage the vision of AMD patients who have failed to respond to the usual therapies.

• One of these options is the use of bevacizumab (Avastin®), a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of vascular endothelial growth factor (VEGF, also known as vascular permeability factor [VPF] or VEGF-A) with receptors on the surface of endothelial cells; thereby, preventing cell proliferation and new blood vessel formation (i.e., angiogenesis).

• VEGF is the major angiogenic stimulus responsible for the formation of CNV and, therefore, represents a new paradigm in the treatment of retinovascular disease.

• Intravitreal injection of bevacizumab delivers the drug to the site of neovascularization, occurring in the retina or within the retina, while minimizing systemic exposure and interference with the normal extraocular roles of VEGF.

• Based on published reports and widespread clinical use, there is compelling evidence of bevacizumab’s safety and efficacy for CNV in AMD and also in proliferative diabetic retinopathy, neovascular glaucoma, macular edema, retinal and iris neovascularizations and branch and central retinal vein occlusions, due to common VEGF-induced pathogenic pathways.

o The ophthalmology community is increasingly using intravitreal bevacizumab in the treatment of these conditions that have not responded to other accepted therapies.

 

 

Sources of Information and Basis for Decision

 

Avery, R., Pearlman, J., Pieramici, D., Rabena, M., Castellarin, A., Nasir, M., Giust, M., Wendel, R., & Patel, A. (2006). Intravitreal bevacizumab (Avastin®) in the treatment of proliferative diabetic retinopathy. Ophthalmology, 113(10), 1695-1705.

 

Diabetic Retinopathy Clinical Research Network. (2007). A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema. Ophthalmology, 114, 1860-1867.

 

Ehlers, J., Spirn, M., Lam, A., Sivalingam, A., Samuel, M., & Tasman, W. (2008). Combination intravitreal bevacizumab/panretinal photocoagulation versus panretinal photocoagulation alone in the treatment of neovascular glaucoma. Retina, 28, 696-702.

 

Falkenstein, I., Cheng, L., Morrison, V., Kozak, I., Tammewar, A., & Freeman, W. (2007). Standardized visual acuity results associated with primary versus secondary bevacizumab (Avastin) treatment for choroidal neovascularization in age-related macular degeneration. Retina, 27, 701-706.

 

FCSO LCD 29959, Intravitreal Bevacizumab (Avastin®), 06/14/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Ghazi, N., Knape, R., Kirk, T., Tiedeman, J., & Conway, B. (2008). Intravitreal bevacizumab (Avastin®) treatment of retinal angiomatous proliferation. Retina, 28(5), 689-695.

 

Goff, M., Johnson, R., McDonald, H., Ai, E., Jumper, J., & Fu, A. (2007). Intravitreal bevacizumab for previously treated choroidal neovascularization from age-related macular degeneration. Retina, 27, 432-438.

 

Hsu, J., Kaiser, R., Sivalingam, A., Abraham, P., Fineman, M., Samuel, M., Vander, J., Regillo, C., & Ho, A. (2007). Intravitreal bevacizumab (Avastin®) in central retinal vein occlusion. Retina, 27(8), 1013-1019.

 

Iturralde, D., Spaide, R., Meyerle, C., Klancnik, J., Yannuzzi, L., Fisher, Y., Sorenson, J., Slakter, J., Freund, K., Cooney, M., & Fine, H. (2006). Intravitreal bevacizumab (Avastin®) treatment of macular edema in central retinal vein occlusion. Retina, 26(3), 279-284.

 

Mason III, J., Nixon, P., & White, M. (2006). Intravitreal injection of bevacizumab (Avastin®) as adjunctive treatment of proliferative diabetic retinopathy. Am J Ophthalmol, 142(4), 685-688.

 

Mason III, J., Yunker, J., Vail, R., & McGwin Jr., G. (2008). Intravitreal bevacizumab (Avastin®) prevention of panretinal photocoagulation-induced complications in patients with severe proliferative diabetic retinopathy. Retina, 28(9), 1319-1324.

 

Michels, S., Rosenfeld, P., Puliafito, C., Marcus, E., & Venkatraman, A. (2005). Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: Twelve-week results of an uncontrolled open-label clinical study. Ophthalmology, 112, 1035-1047.

 

Moshfeghi, A., Rosenfeld, P., Puliafito, C., Michels, S., Marcus, E., Clenches, J., & Venkatraman, A. (2006). Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: Twenty-four-week results of an uncontrolled open-label clinical study. Ophthalmology, 113, 2002-2011.

 

Schadlu, R., Blinder, K., Shah, G., Holekamp, N., Thomas, M., Grand, M., Engelbrecht, N., Apte, R., Joseph, D., Prasad, A., Smith, B., &Sheybani, A. (2008). Intravitreal bevacizumab for choroidal neovascularization in ocular histoplasmosis. Am J Ophthalmol, 145, 875-878.

 

Spaide, R., Laud, K., Fine, H., Klancnik, J., Meyerle, C., Yannuzzi, L., Sorenson, J., Slakter, J., Fisher, Y., & Cooney, M. (2006). Intravitreal bevacizumab treatment of choroidal neovascularization secondary to age-related macular degeneration. Retina, 26, 383-390.

 

Wu, L., Arevalo, F., Roca, J., Maia, M., Berrocal, M., Rodriguez, F., Evans, T., Costa, R., & Cardillo, J. (2008). Comparison of two doses of intravitreal bevacizumab (Avastin®) for treatment of macular edema secondary to branch retinal vein occlusion: Results from the Pan-American collaborative retina study group at 6 months of follow-up. Retina, 28(2), 212-219.

 

Yoganathan, P., Deramo, V., Lai, J., Tibrewala, R., & Fastenberg, D. (2006). Visual improvement following intravitreal bevacizumab (Avastin) in exudative age-related macular degeneration. Retina, 26, 994-998.

 

 

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CMS LCD L29959 INTRAVITREAL BEVACIZUMAB (AVASTIN®)