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National Coverage Determination (NCD) for Photodynamic Therapy (OPT) (80.2)

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Publication Number

100-3

Manual Section Number

80.2

Manual Section Title

Photodynamic Therapy (OPT)


Version Number

2

Effective Date of this Version

4/1/2004

Implementation Date

4/1/2004



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

Photodynamic therapy is a medical procedure which involves the infusion of a photosensitive (light-activated) drug with a very specific absorption peak. This drug is chemically designed to have a unique affinity for the diseased tissue intended for treatment. Once introduced to the body, the drug accumulates and is retained in diseased tissue to a greater degree than in normal tissue. Infusion is followed by the targeted irradiation of this tissue with a non-thermal laser, calibrated to emit light at a wavelength that corresponds to the drug’s absorption peak. The drug then becomes active and locally treats the diseased tissue.


Indications and Limitations of Coverage

Ocular photodynamic therapy (OPT)

The OPT is used in the treatment of ophthalmologic diseases. OPT is only covered when used in conjunction with verteporfin (see §80.3, “Photosensitive Drugs”).

  • Classic Subfoveal Choroidal Neovascular (CNV) Lesions - OPT is covered with a diagnosis of neovascular age-related macular degeneration (AMD) 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. Subsequent follow-up visits will require a fluorescein angiogram prior to treatment. There are no requirements regarding visual acuity, lesion size, and number of re-treatments.
  • Occult Subfoveal Choroidal Neovascular (CNV) Lesions - OPT is noncovered for patients with a diagnosis of age-related macular degeneration (AMD) with occult and no classic CNV lesions.
  • Other Conditions - Use of OPT with verteporfin for other types of AMD (e.g., patients with minimally classic CNV lesions, atrophic, or dry AMD) is noncovered. OPT with verteporfin for other ocular indications such as pathologic myopia or presumed ocular histoplasmosis syndrome, is eligible for coverage through individual contractor discretion.

Cross Reference
Also see NCD on Verteporfin §80.3.
Transmittal Number

9

Coverage Transmittal Link

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

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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