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National Coverage Determination (NCD) for Ocular Photodynamic Therapy (OPT) (80.2.1)

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Benefit Category
Physicians' Services

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

Item/Service Description

General

The OPT is used in the treatment of ophthalmologic diseases; specifically, for age-related macular degeneration (AMD), a common eye disease among the elderly. OPT involves the infusion of an intravenous photosensitizing drug called verteporfin followed by exposure to a laser. OPT is only covered when used in conjunction with verteporfin. Effective July 1, 2001, OPT with verteporfin was approved for a diagnosis of neovascular 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.

On October 17, 2001, CMS announced its “intent to cover” OPT with verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by a fluorescein angiogram. The October 17, 2001, decision was never implemented.

On March 28, 2002, after thorough review and reconsideration of the October 17, 2001, intent to cover policy, CMS determined that the current noncoverage policy for OPT for verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by a fluorescein angiogram should remain in effect.

Effective August 20, 2002, CMS issued a noncovered instruction for OPT with verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by a fluorescein angiogram.


Indications and Limitations of Coverage

Covered Indications

Effective April 1, 2004, OPT with verteporfin continues to be approved for a diagnosis of neovascular AMD with predominately classic subfoveal 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 re-treatments when treating predominantly classic lesions.

In addition, after thorough review and reconsideration of the August 20, 2002, noncoverage policy, CMS determines that the evidence is adequate to conclude that OPT with verteporfin is reasonable and necessary for treating:

  1. Subfoveal occult with no classic CNV associated with AMD; and,
  2. Subfoveal minimally classic 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.

C - 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,
  • Atrophic or “dry” AMD.

D - Other

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.)


Transmittal Number

9

Revision History

2/01 - Covered when used in conjunction with verteporfin for patients with neovascular age-related macular degeneration with predominately classic subfoveal choroidal neovascular lesions (where the area of classic CNV occupies  ≥50% of the area of the entire lesion), as determined by a fluorescein angiogram. Effective and implementation dates 07/01/2001. (TN 135) (CR 1549)

8/02 - Remained noncovered for patients with occult and no classic lesions. Effective and implementation dates 08/20/2002. (TN 157) (CR 2335) 

4/04 - Covered for 1) subfoveal occult with no classic CNV associated with AMD; and 2) subfoveal minimally classic CNV (where area of classic CNV occupies <50% of area of entire lesion) associated with AMD, provided certain criteria are met. Effective and implementation dates 04/01/2004. (TN 9) (CR 3191)


Other Versions
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