LCD/NCD Portal

L29216

 

MACUGEN (PEGAPTANIB SODIUM INJECTION)

 

 

01/01/2011

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

• The intended dose and regimen for Macugen is 0.3 mg administered once every six weeks by aseptic intravitreal injection into the eye to be treated.

• Macugen® is contraindicated in patients with ocular or periocular infections.

FDA Indication for Macugen®

• FCSO Medicare will consider Macugen (pegaptanib sodium injection) medically reasonable and necessary for the treatment of neovascular (wet) AMD for services rendered on or after the FDA-approval date of December 17, 2004.

 

Off-Label Indication for Macugen®

• FCSO Medicare will consider Macugen® (pegaptanib sodium injection) medically reasonable and necessary for the treatment of diabetic macular edema.

 

 

CPT/HCPCS Codes

 

J2503 INJECTION, PEGAPTANIB SODIUM, 0.3 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

362.07* DIABETIC MACULAR EDEMA

362.52 EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA

*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).

 

 

ICD-9 Codes that DO NOT Support Medical Necessity

 

362.50 MACULAR DEGENERATION (SENILE) OF RETINA UNSPECIFIED

362.51 NONEXUDATIVE SENILE MACULAR DEGENERATION OF RETINA

 

 

Documentation Requirements

 

• Medical record documentation maintained by the performing physician must include the clinical indication/medical necessity for the Macugen injection.

• For treatment of AMD, the office records should also indicate that fluorescein angiography (CPT code 92235) was performed prior to the initial injection.

• For diabetic macular edema, the office records should indicate test results to firmly establish diagnosis by fluoroscein angiogram or optical coherence tomography (OCT).

• Fluorescein angiography and/or scanning computerized ophthalmic diagnostic imaging (92134) may be performed prior to each subsequent injection as medically indicated.

• Documentation will not be required with the submission of each claim.

 

 

Treatment Logic

 

• Age-related macular degeneration (AMD) is the leading cause of irreversible severe vision loss in Americans over 55 years of age.

o While the non-neovascular or dry form of the disease is more prevalent, neovascular or wet AMD is responsible for the majority of cases of vision loss.

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.

• Macugen (pegaptanib sodium injection) is an FDA-approved, treatment for neovascular (wet) age-related macular degeneration.

o Macugen is a sterile, aqueous solution, containing pegaptanib sodium, which is an aptamer consisting of a covalent conjugate of twenty-eight modified oligonucleotides.

o Pegylation has been added to increase the half-life of pegaptanib sodium in the vitreous.

• Pegaptanib sodium binds selectively and with high affinity to extracellular VEGF165, the pathogenic VEGF isoform most directly linked to the pathogenesis of neovascular (wet) age-related macular degeneration (AMD).

o Pegaptanib sodium inhibits VEGF165 binding to its cognate receptors.

 

 

Sources of Information and Basis for Decision

 

Facts and Comparisons.

 

Gragoudas, E., Adamis, A., Cunningham, Jr., E., Feinsod, M., & Guyer, D. (2004). Pegaptanib for neovascular age-related macular degeneration. N Engl J Med, 351(27), 2805-2816.

 

Macugen Diabetic Retinopathy Study Group. (2005). A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology, 112, 1747-1757.

 

Macugen Diabetic Retinopathy Study Group. (2006). Changes in retinal neovascularization after pegaptanib (Macugen) therapy in diabetic individuals. Ophthalmology, 113, 23-28.

 

MICROMEDEX HEALTHcare Series: DRUGDEX® Drug Point.

 

Rosenfeld, P., Rich., R., & Lalwani, G. (2006). Ranibizumab: Phase III clinical trial results. Ophthalmology Clinics of North America, 19(3). Retrieved April 20, 2009 from www.md consult.com (132656407).

 

Ruckman, J., Green, L., Beeson, J., Waugh, S., Gillette, W., Henninger, D., Claesson-Welsh, L., & Janjic, N. (1998). 2-Fluoropyrimidine RNA-based aptamers to the 165-amino acid form of vascular endothelial growth factor (VEGF165). J Bio Chem, 273(32), 20556-20567.

 

The Eye Diseases Prevalence Research Group. (2004). Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol, 122, 477-485.

 

The Eyetech Study Group. (2003). Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration. Phase II study results. Ophthalmology, 110, 979-986.

 

The Eyetech Study Group. (2002). Preclinical and phase 1A Clinical evaluation of an anti-VEGF-pegylated aptamer (EYE001) for the treatment of exudative age-related macular degeneration. Retina, 22, 143-152.

 

01/01/2011

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

 

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 L29216 MACUGEN (PEGAPTANIB SODIUM INJECTION)