View Public Comments for Positron Emission Tomography (CAG-00065R2)

August 9, 2012

Jeffrey Roche, MD, MPH
Lead Medical Officer

Stuart Caplan, RN, MAS
Lead Analyst

Centers for Medicare and Medicaid Services
Coverage Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Roche and Mr. Caplan:

The Association of Community Cancer Centers (ACCC) is pleased to submit these comments on the request for reconsideration of the National Coverage Determination (NCD) for the use of positron emission tomography (PET) at Section 220.6 of the Medicare National Coverage Determinations Manual.¹ ACCC represents more than 17,000 cancer care professionals from approximately 900 hospitals and more than 1,200 private practices nationwide. It is estimated that 60 percent of cancer patients nationwide are treated by a member of ACCC.

At the front line in fighting cancer, we have a unique perspective on how PET affects patient care and often improves health outcomes. Accordingly, ACCC strongly supports the request for reconsideration and urges CMS to remove the current blanket non-coverage language of the PET NCD as applied to new PET radiopharmaceuticals approved by the Food and Drug Administration (FDA). This revision will allow new and improved tracers to reach patients battling cancer much sooner than would be possible under the current language that requires CMS to reopen the NCD in order to cover each new PET radiopharmaceutical approved by the FDA. Our patients cannot afford to wait so long for technologies that, under the FDA’s rigorous approval process, already have demonstrated meaningful clinical benefit.

Over the past few years, ACCC has submitted to CMS a number of comments laying out the clinical benefits of expanding Medicare coverage of PET and PET tracers and affirming our belief that patients should have access to these critical diagnostic technologies. With FDA approval of a new generation of PET radiopharmaceuticals on the horizon, we believe it is more important than ever that the latest and most advanced PET agents reach providers and patients as quickly as possible.

Without this revision removing the current blanket non-coverage language of the PET NCD, a new PET tracer that has undergone rigorous clinical evaluation and demonstrated considerable benefit to patients will not be covered by Medicare anywhere in the country until CMS revises the NCD allowing for coverage, a process that takes at least nine months. Patients with lifethreatening illnesses should not be forced to wait this long to gain access to a technological advance with proven benefit in diagnosing their disease, helping them and their physicians better assess treatment options. Accordingly, we urge CMS to revise the language of the PET NCD to remove the current blanket non-coverage language of the PET NCD as applied to new PET radiopharmaceuticals approved by the FDA to ensure that Medicare beneficiaries suffering from cancer and other serious diseases will continue to have access to the best possible diagnostic tools.

ACCC appreciates the opportunity to submit these comments on this important matter. If you have any questions about our comments, please contact Matthew Farber, Director, Provider Economics and Public Policy, at 301-984-9496, ext. 221.

Sincerely,

1 Medicare National Coverage Determinations Manual, ch. 1, § 220.6.