LCD/NCD Portal

Local Coverage Determination (LCD) for Macugen (pegaptanib sodium injection) (L29216)

 

 

Contractor Information

 

Contractor Name First Coast Service Options, Inc.

 

Contractor Number 09102

 

Contractor Type MAC - Part B

 

LCD Information

Document Information

 

LCD ID Number L29216

 

LCD Title Macugen (pegaptanib sodium injection)

 

Contractor's Determination Number J2503

 

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 01/01/2011

 

Revision Ending Date

 

CMS National Coverage Policy N/A

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

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

 

Macugen (pegaptanib sodium injection) is an FDA-approved, treatment for neovascular (wet) age-related macular degeneration. Macugen is a sterile, aqueous solution, containing pegaptanib sodium, which is an aptamer consisting of a covalent conjugate of twenty-eight modified oligonucleotides. 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). Pegaptanib sodium inhibits VEGF165 binding to its cognate receptors.

 

The intended dose and regimen for MacugenÒ 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.

 

 

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

 

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).

 

 

Diagnoses that Support Medical Necessity N/A

 

 

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

 

 

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 physician must include the clinical indication/medical necessity for the MacugenÒ 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.

 

 

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

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.

 

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 01/01/2011

 

Revision History Number 3

 

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

Start Date of Notice Period:01/01/2011 Revised Effective Date: 01/01/2011

 

LCR B2011-024

December 2010 Update

 

Explanation of Revision: Annual 2011 HCPCS Update. CPT code 92135 was deleted and replaced with CPT code 92134. The effective date of this revision is based on date of service.

 

Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:06/01/2010 Revised Effective Date:06/01/2010

 

LCR B2010-049

May 2010 Update

 

Explanation of Revision: The LCD has been revised in the ‘ICD-9 Codes that Support Medical Necessity’ section under the list of ICD-9-CM codes to indicate: *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). The effective date of this revision is based on date of service.

10-19-2009 - Corrected effective date for revision #1 to be 10/13/2009 (not 10/12/2009). Revision Number:1

Start Date of Comment Period:N/A

Start Date of Notice Period:11/01/2009 Revised Effective Date: 10/13/2009

 

 

LCR B2009-095

October 2009 Update

 

Explanation of Revision: LCD revised to include coverage of Macugen for the treatment of diabetic macular edema. The following sections of LCD have been revised: ‘Indications and Limitations of Coverage and/or Medical Necessity’, ICD-9 Codes that Support Medical Necessity’, ‘Documentation Requirements’ and ‘Sources of Information and Basis for Decision’. The effective date of the revision is based on date of service.

 

 

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 (L29216) replaces LCD L21637 as the policy in notice. This document (L29216) is effective on 02/02/2009.

 

 

Reason for Change

 

Related Documents

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All Versions

Updated on 05/11/2011 with effective dates 01/01/2011 - N/A Updated on 12/16/2010 with effective dates 01/01/2011 - N/A Updated on 05/20/2010 with effective dates 06/01/2010 - 12/31/2010

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