LCD/NCD Portal

NCD80.3.1

 

VERTEPORFIN

 

Effective Date of this Version

4/1/2004

 

Benefit Category

• Drugs and Biologicals.

• Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

 

Item/Service Description

General

• Verteporfin, a benzoporphyrin derivative, is an intravenous lipophilic photosensitive drug with an absorption peak of 690 nm.

• Verteporfin was first approved by the Food and Drug Administration on April 12, 2000, and subsequently approved for inclusion in the United States Pharmacopoeia on July 18, 2000, meeting Medicare’s definition of a drug as defined under §1861(t)(1) of the Social Security Act.

• Verteporfin is only covered when used in conjunction with ocular photodynamic therapy OPT) when furnished intravenously incident to a physician’s service.

 

Indications and Limitations of Coverage

 

Covered Indications

• Effective April 1, 2004, OPT with verteporfin is covered for patients with a diagnosis of neovascular age-related macular degeneration (AMD) with:

o Predominately classic subfoveal choroidal neovascularization (CNV) lesions (where the area of classic CNV occupies > 50% of the area of the entire lesion) at the initial visit as determined by a fluorescein angiogram. (CNV lesions are comprised of classic and/or occult components.) Subsequent follow-up visits require a fluorescein angiogram prior to treatment.

• There are no requirements regarding visual acuity, lesion size, and number of retreatments when treating predominantly classic lesions.

o Subfoveal occult with no classic associated with AMD.

o Subfoveal minimally classic CNV: CNV (where the area of classic CNV occupies < 50% of the area of the entire lesion) associated with AMD.

o These indications are considered reasonable and necessary only when:

 The lesions are small (4 disk areas or less in size) at the time of initial treatment or within the 3 months prior to initial treatment.

 The lesions have shown evidence of progression within the 3 months prior to initial treatment.

• Evidence of progression must be documented by

o Deterioration of visual acuity (at least 5 letters on a standard eye examination chart).

o Lesion growth (an increase in at least 1 disk area).

o The appearance of blood associated with the lesion.

 

Noncovered Indications

• Other uses of OPT with verteporfin to treat AMD not already addressed by CMS will continue to be noncovered.

• These include, but are not limited to, the following AMD indications:

o Juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea).

o Inability to obtain a fluorescein angiogram.

o Atrophic or “dry” AMD.

 

Other

• The OPT with verteporfin for other ocular indications, such as pathologic myopia or presumed ocular histoplasmosis syndrome, continue to be eligible for local coverage determinations through individual contractor discretion.

• (This NCD last reviewed March 2004.)

 

Coverage Transmittal Link

• http://www.cms.gov/transmittals/downloads/R9NCD.pdf

 

National Coverage Analyses (NCAs)

• This NCD has been or is currently being reviewed under the National Coverage Determination process.

• The following are existing associations with NCAs, from the National Coverage Analyses database.

• Fourth reconsideration for Ocular Photodynamic Therapy (OPT) with Verteporfin for Macular Degeneration (CAG-00066R4) opens in new window

• Original consideration for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066N) opens in new window

• First reconsideration for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R) opens in new window

• Second reconsideration for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R2) opens in new window

• Third reconsideration for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R3) opens in new window

 

Medicare NCD Link