Ocular Photodynamic Therapy (OPT) with Verteporfin for Macular Degeneration

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Proposed Decision Memo for Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration (CAG-00066R4). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

General Comments

AHIP and our member health plans encourage CMS to ensure that all patients receive safe, effective and evidence-based treatments. Photodynamic therapy with verteporfin is an established treatment option for classic subfoveal choroidal neovascularization due to wet age-related macular degeneration, pathological myopia, or presumed ocular histoplasmosis. After reviewing the studies cited in CMS’ analysis, we agree that optical coherence tomography (OCT) can play a useful role in monitoring treatment of macular degeneration. Our members support the proposed decision to revise the requirements for testing to permit either OCT or fluorescein angiography (FA) to assess treatment response. However, as noted in the discussion of the evidence, there are scenarios when FA is more appropriate and scenarios where OCT is more appropriate. We suggest that CMS provide guidelines on when FA or OCT is more appropriate in monitoring treatment of macular degeneration.

Thank you for the opportunity to comment on this important issue.

Sincerely,

Carmella Bocchino
Executive Vice President

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The American Optometric Association (AOA) represents approximately 36,000 doctors of optometry, optometry students and paraoptometric assistants and technicians. Optometrists provide covered physician services to millions of Medicare beneficiaries annually, including more than 5 million Medicare patients in 2006, in 2007, in 2008, and in 2009. Approximately 30,000 optometrists are enrolled as physicians to serve the Medicare program with their professional services (medical eye care), and approximately 14,000 optometrists are enrolled as DMEPOS suppliers serving the Medicare program with prosthetics (primarily covered eyeglasses following cataract surgery).

The AOA appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposal to expand coverage of ocular photodynamic therapy (OPT) with verteporfin for “wet” age-related macular edema (AMD). Verteporfin is an effective treatment and tolerable by most patients.

Currently, fluorescein angiography (FA) testing is required for coverage of follow-up treatments. The AOA strongly supports the proposal to revise the requirements for testing to permit either optical coherence tomography (OCT) or FA to assess treatment necessity and response. The AOA believes that physicians should be given the authority to determine which approach is most appropriate for a patient. Many optometrists throughout the country currently have OCTs in their offices and are effectively assessing treatment necessity and response with these safer and noninvasive technologies making follow-up quality care, especially for rural patients, more convenient. Revising the coverage policy as proposed would help to ensure that patients are appropriately monitored and receive the timely and effective care they need.

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I am a retina specialist and have been in practive for 33 years. I am past president of the American Society of Retina Specialists. I was part of the Visudyne Clinical Trial and continue to use PDT in my practice today. At the time of the trial OCT was not universally available. Although it is important in most cases to obtain a preoperative FA, it is not always necessary post operatively. OCT is sufficient for the purpose of the test is to determine leakage, which is better accomplished with OCT than a FA. If there is persistent leakage a FA should be considered to determine where the leakage site is so that a treatment plan can be made.In most cases a post op FA is not needed in the first month or two after the PDT procedure.

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