Ocular Photodynamic Therapy (OPT) is a new treatment for age-related macular degeneration (AMD), a common eye disease among the elderly. AMD is the leading cause of blindness in adults over the age of 50. OPT involves the infusion of an intravenous (IV) photosensitizing drug called verteporfin followed by exposure to a laser. The laser activates verteporfin, which selectively targets and treats the pathologic ocular tissue.
On October 17, 2001 The Centers for Medicare and Medicaid Management (CMS) announced its intent to cover OPT with verteporfin for AMD patients with occult but no classic subfoveal choroidal neovascularization (CNV) lesions. After posting this Decision Memorandum, CMS discovered new issues concerning the data from the clinical trial upon which it based its analysis. In order to further examine the clinical trial data, CMS has internally generated a request for reconsideration of this indication.