LCD/NCD Portal

L29266

 

RANIBIZUMAB (LUCENTIS ®)

 

 

08/10/2012

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• Ranibizumab (Lucentis ®) is considered 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).

o 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.

• Ranibizumab (Lucentis ®) is considered 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.

o Lucentis® is considered medically reasonable and necessary for patients with Diabetic Macular Edema (DME) effective for the FDA approval date of August 10, 2012.

o 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:

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

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

o 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.

o 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.

o 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.

o 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."

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.

 

 

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

 

Diabetic Macular Edema (DME) should be reported as follows:

 

• Report diabetic macular edema with ICD-9-CM code 362.07. 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]).

 

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

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

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

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

*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).

 

 

Documentation Requirements

 

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

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

o Actual dose administered in milligrams.

Treatment Logic

• 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.

o 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.

o 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.

o 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).

o Treatment may be continued monthly or reduced to one injection every three months after the first four injections, if monthly treatments are not feasible.

o Compared to monthly dosing, however, it is expected that quarterly dosing may be less effective, and as such, patients should be evaluated regularly.

 

 

Sources of Information and Basis for Decision

 

FCSO LCD 29266, Ranibizumab (Lucentis ®), 08/10/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

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.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD L28977 RANIBIZUMAB (LUCENTIS ®)