LCD/NCD MedicationsL29933-LCD

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Local Coverage Determination (LCD) for Intravitreal Bevacizumab (Avastin®) (L29933)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L29933

LCD Title Intravitreal Bevacizumab (Avastin®)

Contractor's Determination Number AIntravitreal Bevacizumab (Avastin®)

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 06/30/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 06/14/2011

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40

CMS Manual System, Pub. 100-08, Program Integrity Manual, Chapter 13, Section 13.5.1. CMS Transmittal 1810, Change Request 6617, dated September 1, 2009

CMS Transmittal 1871, Change Request 6751, dated December 11, 2009

Indications and Limitations of Coverage and/or Medical Necessity

Neovascular age-related macular degeneration (AMD), when untreated or refractory to usual therapies, almost always leads to permanent blindness. Neovascular (wet) AMD is characterized by choroidal neovascularization (CNV) beneath the retina. The neovascular tissue often leaks blood and fluid, and when untreated, eventually progresses to scarring with destruction of the macula and loss of vision. 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. The ophthalmology community is increasingly using intravitreal bevacizumab in the treatment of these conditions that have not responded to other accepted therapies.

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. 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." A qualified physician for this service/procedure is defined as follows: a) Physician is properly enrolled in Medicare. b) 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.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient

085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

C9257 INJECTION, BEVACIZUMAB, 0.25 MG

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).

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

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

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

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

• 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.

• 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.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they

may be subject to review for medical necessity.

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.

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., Lenchus, 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. Advisory

Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the

contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2010

Revision History Number 4

Revision History Explanation Revision Number:4 Start Date of Comment Period:N/A

Start Date of Notice Period:07/01/2011 Revised Effective Date: 06/14/2011

LCR A2010-050

June 2011 Connection

Explanation of Revision: Based on an outside request to clarify training needed for the services described in this LCD, language under the “limitations” section of the LCD has been deleted and replaced with a revised statement regarding qualification and training. The effective date of this revision is based on process date.

Revision Number:3

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/01/2010

LCR A2010-017

January 2010 Bulletin

Explanation of Revision: Annual 2010 HCPCS Update. The “CPT/HCPCS Codes” section of the LCD has been revised to delete HCPCS code Q2024 and add HCPCS code C9257. The effective date of this revision is based on date of service.

The effective date for revision number 2 is 12/08/2009 NOT 12/03/2009. Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:12/01/2009 Revised Effective Date: 12/08/2009

LCR A2009-092

November 2009 Bulletin

Explanation of Revision: LCD revised in the ‘Indications’ section under the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section of the LCD to indicate the 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. Treatment continues on a monthly basis until the abnormal neovascularization, vitreous hemorrhage, macular edema, subretinal fluid, and/or pigment epithelial detachment is resolved. The ‘ICD-9 Codes that Support Medical Necessity’ section has been revised to add ICD-9-CM code 362.29 and the statement under the list of ICD-9-CM codes has been revised to indicate: *Per the American Medical Association (AMA) 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). The third bullet under the ‘Documentation Requirements’ section of the LCD has also been revised to indicate: Test results to firmly establish diagnosis by fluorescein 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. And the ‘Sources of Information and Basis for Decision’ section of the LCD has also been updated. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:11/01/2009 Original Effective Date:10/01/2009

LCR A2009-083

October 2009 Bulletin

Explanation of Revision: In accordance with CMS Transmittal 1810, Change Request 6617, dated 09/01/2009 the ‘CPT/HCPCS Codes’ section of the LCD has been revised to delete HCPCS code J3490 (unclassified drugs) and replace with HCPCS code Q2024 (Injection, bevacizumab, 0.25 mg). The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:02/20/2009 Start Date of Notice Period: 05/01/2009 Original Effective Date: 06/30/2009

LCR B2009-051

April 2009 Bulletin

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0631 was changed 8/1/2010 - The description for Revenue code 0632 was changed 8/1/2010 - The description for Revenue code 0633 was changed 8/1/2010 - The description for Revenue code 0634 was changed 8/1/2010 - The description for Revenue code 0635 was changed 8/1/2010 - The description for Revenue code 0636 was changed 8/1/2010 - The description for Revenue code 0637 was changed

8/1/2010 - Revenue code 0630 was deleted

Reason for Change