LCD/NCD MedicationsL29266-LCD

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Local Coverage Determination (LCD) for Ranibizumab (Lucentis ®) (L29266)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29266

LCD Title Ranibizumab (Lucentis ®)

Contractor's Determination Number J2778

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 02/02/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 08/10/2012

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:

N/A

Indications and Limitations of Coverage and/or Medical Necessity

Ranibizumab (Lucentis ®), a recombinant humanized immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody fragment designed for intraocular use is a vascular endothelial growth factor A (VEGF-A) antagonist. Ranibizumab binds to active forms of human VEGF-A, including the cleaved form (VEGF 110), and inhibits their biologic activity.

VEGF-A induces neovascularization (angiogenesis) and increases vascular permeability, which appears to play a role in the pathogenesis and progression of the neovascular (wet) form of age-related macular degeneration (AMD), a leading cause of blindness in adults older than 60 years of age in developed countries. Binding of ranibizumab to VEGF-A prevents VEGF-A from binding to VEGF receptors (i.e., VEGFR-1, VEGFR-2) on the surface of endothelial cells, reducing endothelial cell proliferation, angiogenesis, and vascular permeability.

Ranibizumab was approved by the Food and Drug Administration (FDA) on June 30, 2006 for the treatment of patients with exudative senile macular degeneration. The recommended dosage and frequency of treatment is

0.5 mg/0.05mL (10mg/mL), administered by intravitreal injection once a month (approximately 28 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. Compared to monthly dosing, however, it is expected that quarterly dosing may be less effective, and as such, patients should be evaluated regularly.

First Coast Service Options,Inc.(FCSO) Medicare will consider ranibizumab (Lucentis ®) medically reasonable and necessary for patients with established exudative senile macular degeneration for services rendered on or after the FDA approval date of June 30, 2006.

Ranibizumab was approved by the FDA on June 22, 2010 for the treatment of patients with macular edema following retinal vein occlusion (RVO). The recommended dosage and frequency of treatment is 0.5 mg/0.05 mL (10mg/mL), administered by intravitreal injection once a month (approximately 28 days) for six months.

FCSO Medicare will consider ranibizumab (Lucentis ®) medically reasonable and necessary for patients with established macular edema following retinal vein occlusion (RVO) for services rendered on or after the FDA approval date of June 22, 2010.

Ranibizamab (Lucentis®) was approved for the treatment of Diabetic Macular Edema (DME) by the Food and Drug Administration (FDA) on August 10, 2012. First Coast will consider patients with Diabetic Macular Edema (DME) medically reasonable and necessary for use of Lucentis® effective for the FDA approval date of August 10, 2012. Lucentis 0.3 mg (0.5 mg) is recommended to be administered intravitreally once a month (approximately 28 days).

Lucentis® (ranibizumab) is covered for the following indications:

• Treatment of neovascular (wet) age-related macular degeneration (ARMD) in patients without ocular or periocular infections. Effective June 30, 2006; OR

• Treatment of macular edema following retinal vein occlusion (RVO). Effective June 22, 2010; OR

• Diabetic Macular Edema (DME) Effective 08/10/2012.

Limitations

Ranibizumab (Lucentis ®) is supplied as a preservative-free, sterile solution in a single-use glass vial designed to provide 0.05 mL of 10 mg/mL solution for intravitreal injection. Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used.

Ranibizumab (Lucentis ®) is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the inactive ingredients in ranibizumab. It is not uncommon for patients with age-related macular degeneration (AMD) to have chronic blepharitis generally as a more inflammatory nature as opposed to an infectious (typically staph) blepharitis. Unless the physician has clearly indicated in the medical record the patient has an acute ocular or an acute periocular infection, intravitreal injection would not be considered contraindicated.

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.

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.

999x Not Applicable

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.

99999 Not Applicable

CPT/HCPCS Codes

67028 INTRAVITREAL INJECTION OF A PHARMACOLOGIC AGENT (SEPARATE PROCEDURE) J2778 INJECTION, RANIBIZUMAB, 0.1 MG

ICD-9 Codes that Support Medical Necessity For procedure code J2778

Macular edema following retinal vein occlusion (RVO) should be reported as follows:

• Report macular edema with one of the following ICD-9-CM codes: 362.07*, 362.53 or 362.83; AND

• Report retinal vein occlusion (RVO) with one of the following ICD-9-CM codes: 362.35 or 362.36.

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

362.07 DIABETIC MACULAR EDEMA

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

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

Documentation in the medical record maintained by the performing physician must support the following:

• The diagnosis of exudative senile macular degeneration has been firmly established by optical coherence tomography (OCT) or fluorescein angiography.

• Actual dose administered in milligrams.

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 FDA News Release, June 30, 2006.

Genentech Full Prescribing Information Lucentis® (ranibizumab injection)

Genentech Lucentis Corporation press release, “FDA Approves Lucentis for the treatment of patients neovascular (wet) age-related macular degeneration (AMD),” June 30, 2006.

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, December 2006.

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, August 10, 2012. 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 09/01/2010

Revision History Number 3

Revision History Explanation Revision Number:3 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2012 Revision Effective Date:08/10/2012

LCR B2012-069

September 2012 Connection

Explanation of Revision: Under the ‘Indications and Limitations Coverage and /or Medical Necessity’ section of the LCD, the new FDA label indication for Diabetic Macular Edema (DME) was added and clarification was made to the ‘Limitations“section related to blepharitis versus eye infection. In addition, the ‘Sources of Information and Basis for Decision’ section of the LCD was also updated. The effective date of this revision is for claims processed on or after 08/10/2012 for dates of service on or after 08/10/2012.

Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:07/01/2011 Revision Effective Date:06/14/2011

LCR B2011-065

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 1

Start Date of Comment Period:N/A Start Date of Notice Period:09/01/2010 Revision Effective Date:10/03/2010

LCR B2010-068

August 2010 Update

LCD revised in the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section to add language related to the FDA approval of Lucentis for macular edema following retinal vein occlusion (RVO). The ‘ICD-9 Codes that Support Medical Necessity’ section has also been revised to add the following ICD-9-CM codes: 362.07, 362.35, 362.36, 362.53 and 362.83 and the following language was added to this section of the LCD: To report macular edema following retinal vein occlusion (RVO), bill the following: 362.07*, 362.53 or 362.83 AND EITHER 362.35 or 362.36. *In addition, when reporting ICD-9-CM code 362.07: 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). This revision is effective for claims processed on or after 10/03/2010 for dates of service on or after 06/22/2010.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29266) replaces LCD L26327 as the policy in notice. This document (L29266) is effective on 02/02/2009.

Reason for Change Typographical Correction