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National Coverage Analysis (NCA) Tracking Sheet for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R)

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 November 8, 2000, The Health Care Financing Administration (HCFA) announced its decision to cover OPT with verteporfin for AMD patients with predominately classic subfoveal choroidal neovascularization (CNV) lesions (where the area of classic CNV occupies = 50% of the area of the entire lesion) as determined by a fluorescein angiogram. (CNV lesions are made up of classic and/or occult components). This policy will take effect July 1, 2001. Recently, HCFA has become aware of new evidence suggesting the therapy's effectiveness in AMD patients with subfoveal occult CNV with no classic CNV (i.e. patients with 0% classic CNV). HCFA will review the new evidence to determine if Medicare's national coverage decision on OPT with verteporfin should include this indication.

Drugs and Biologicals
Physicians' Services
Requestor Name(s)Kirk H. Packo, M.D.; President, The Vitreous Society
Formal Request Accepted and Review Initiated05/21/2001
Expected NCA Completion Date10/17/2001
Public Comment Period06/20/2001 - 07/20/2001
Decision Memo Released10/17/2001
Lead Analyst(s)
  • Poppy S. Kendall
  • Samantha Richardson
Lead Medical Officer(s)
  • Michael Londner, MD, MPH
  • Ronald Dei Cas, MD

May 21, 2001

Request for reconsideration accepted by Coverage and Analysis Group.

August 8, 2001

Due date extended to October 1, 2001.

October 10, 2001

Additional time is needed to complete internal CMS review of the draft decision memorandum. The due date will be extended to October 19, 2001.

October 17, 2001

Decision Memorandum  posted which announces CMS's intent to issue an NCD for OPT with verteporfin for AMD patients with 100% occult subfoveal CNV lesions, as determined by a fluorescein angiogram.

October 29, 2001

After posting this 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. CMS believes that further review is needed to fully understand the new concerns raised regarding the clinical trial data and decide if this will impact our coverage determination. CMS will not implement the October 17, 2001 memorandum until the reconsideration is completed.