Medicare National Coverage Determinations (NCD) Manual (Pub. 100-03), Ch. 1 § 80.3
Photosensitive Drugs
80.3 - Photosensitive Drugs
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10,
Implementation: Upon Implementation of ICD-10)
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 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 (OPT) (see section 80.2,
“Photodynamic Therapy”) when furnished intravenously incident to a physician’s
service. For patients with age-related macular degeneration (AMD), verteporfin is only
covered with a diagnosis of neovascular AMD with predominately classic subfoveal
choroidal neovascular (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
(FA). Subsequent follow-up visits will require either an optical coherence tomography or
an FA to access treatment response. OPT with verteporfin is covered for the above
indication and will remain non-covered for all other indications related to AMD (see
section 80.2). OPT with verteporfin for use in non-AMD conditions is eligible for
coverage through individual A/B MAC discretion.