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National Coverage Determination (NCD) for Photosensitive Drugs (80.3)

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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

Photosensitive drugs are the light-sensitive agents used in photodynamic therapy. Once introduced into the body, these drugs selectively identify and adhere to diseased tissue. The drugs remain inactive until they are exposed to a specific wavelength of light, by means of a laser, that corresponds to their absorption peak. The activation of a photosensitive drug results in a photochemical reaction which treats the diseased tissue without affecting surrounding normal tissue.

Verteporfin

Verteporfin, a benzoporphyrin derivative, is an intravenous lipophilic photosensitive drug with an absorption peak of 690 nm. This drug was first approved by the Food and Drug Administration (FDA) 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 when used in conjunction with ocular photodynamic therapy (see § 80.2, "Photodynamic Therapy") when furnished intravenously incident to a physician's service. For patients with age-related macular degeneration, Verteporfin is only covered with a diagnosis of neovascular age-related macular degeneration (ICD-9-CM 362.52) with predominately classic subfoveal choroidal neovascular (CNV) lesions (where the area of classic CNV occupies ≥ 50 percent of the area of the entire lesion) at the initial visit as determined by a fluorescein angiogram (CPT code 92235). Subsequent follow-up visits will require a fluorescein angiogram prior to treatment. OPT with verteporfin is covered for the above indication and will remain noncovered for all other indications related to AMD (see § 80.2). OPT with Verteporfin for use in non-AMD conditions is eligible for coverage through individual contractor discretion.

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Indications and Limitations of Coverage


Cross Reference
See NCD on Occular Photodynamic Therapy §80.2.
Transmittal Number

9

Revision History

02/2001 - Included verteporfin for use in OPT for patients with neovascular AMD with predominately classic subfoveal CNV lesions (where the area of classic CNV occupies = 50% of area of entire lesion), as determined by a fluorescein angiogram. Effective and implementation dates 07/01/2001. (TN 135) (CR 1549)

08/2002 - Provided that Verteporfin when used with OPT for treatment of patients with AMD with occult and no classic lesions remained noncovered. Effective and implementation dates 08/20/2002. (TN 157) (CR 2335)

11/2002 - Deleted code reference for photosensitive drugs because it belongs in claims processing instructions. Effective and implementation dates 01/01/2003. (TN 162) (CR 2438)

04/2004 - Covered for subfoveal occult with no classic CNV associated with AMD; and subfoveal minimally classic CNV (where area of classic CNV occupies <50% of area of entire lesion) associated with AMD, provided certain criteria met.  Effective and implementation dates 04/01/2004. (TN 9) (CR 3191)


Other Versions
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