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National Coverage Determination (NCD) for Verteporfin (80.3.1)

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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

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:

  • 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.

  • Subfoveal occult with no classic associated with AMD.
  • Subfoveal minimally classic CNV CNV (where the area of classic CNV occupies < 50% of the area of the entire lesion) associated with AMD.
  • The above 2 indications are considered reasonable and necessary only when:

1. 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; and,

2. The lesions have shown evidence of progression within the 3 months prior to initial treatment. Evidence of progression must be documented by deterioration of visual acuity (at least 5 letters on a standard eye examination chart), lesion growth (an increase in at least 1 disk area), or 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: juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea), inability to obtain a fluorescein angiogram, or 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.)


Claims Processing Instructions
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
  • Verteporfin - Version 2, Effective between 4/3/2013 - 1/1/0001
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