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National Coverage Analysis (NCA) Tracking Sheet for Ocular Photodynamic Therapy (OPT) with Verteporfin for Macular Degeneration (CAG-00066R4)

Ocular Photodynamic Therapy (OPT) is a 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. Verteporfin therapy is neither a cure nor a preventative for AMD; it is meant to slow progression of the disease. Medicare's OPT national coverage determination (NCD) is at 80.3.1 of the NCD manual.

The Centers for Medicare & Medicaid Services (CMS) on May 25, 2012 received a formal written request from the American Academy of Ophthalmology for review and rescission of NCD 80.3.1. The requestors note that the current coverage decision for OPT is from 2004, prior to the emergence of targeted anti-VEGF intravitreal treatments. The requestors say these newer therapies have largely supplanted OPT as initial management of AMD, and that OPT is largely relegated to patients in whom the newer therapies have failed. The requestors believe that the current NCD requirement for followup fluorescein angiography with OPT is not supportable for these "end-stage" patients.

Drugs and Biologicals
Physicians' Services
Requestor Name(s)Michael Repka; American Academy of Ophthalmology
Requestor Letter(s)View Letter
Formal Request Accepted and Review Initiated07/24/2012
Expected NCA Completion Date04/17/2013
Public Comment Period07/24/2012 - 08/23/2012
Proposed Decision Memo Released01/17/2013
Proposed Decision Memo Public Comment Period: 01/17/2013 - 02/16/2013 
Decision Memo Released04/03/2013
Comments for this NCA:View Public Comments
Lead Analyst(s)
Lead Medical Officer(s)
  • James Rollins, MD

July 24, 2012

CMS opens this national coverage determination reconsideration request to review the coverage of verteporfin. We are particularly interested to receive evidence speaking to the need for fluorescein angiography with OPT in patients for whom targeted anti-VEGF intravitreal therapy has failed. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. After considering the public comments and reviewing relevant evidence, we will release a proposed decision memorandum. Instructions for submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

January 17, 2013

April 3, 2013

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