January 23, 2005
The Centers for Medicare & Medicaid Services (CMS) announced today it has expanded Medicare coverage of positron emission tomography (PET) to include some Medicare beneficiaries with suspected Alzheimer's disease (AD) and to include other beneficiaries at risk for AD who are enrolled in a large and easily accessible clinical trial. Medicare beneficiaries who meet specific criteria may participate in the clinical trial and receive a PET scan while CMS continues to review evidence about the benefits of these scans in additional populations.
The National Coverage Decision expands the coverage of PET to include beneficiaries who meet the diagnostic criteria for both AD and fronto-temporal dementia (FTD), who have been evaluated for specific alternate causes of dementia, and for whom the cause of the clinical symptoms remains uncertain. Medicare coverage of PET also includes other patients with suspected AD who enroll in a large, CMS-approved, practical clinical trial.
"Together with outside experts and other agencies we examined the available data and determined that we ought to approve coverage for patients who've been worked up but whose diagnosis is uncertain," said CMS Administrator Mark B. McClellan, MD, PhD. "We also concluded that the technology is promising for patients with early dementia, but is only reasonable and necessary in the context of a peer-reviewed clinical trial that will ensure that the technology is properly used to help families and doctors to diagnose and manage their cases and will develop evidence of the value of the technology for particular populations and the safeguards necessary to ensure patient protection. We're moving forward on both fronts."
CMS posted a draft decision in June after the agency completed an extensive literature review, reviewed position statements from various advocacy groups and organizations, and held meetings and conference calls with the experts regarding the use of PET in the clinical care of patients with AD. CMS, in conjunction with NIH, held a panel meeting with experts skilled in research, clinical practice, or the use of PET.
CMS also requested and received information from the public on PET coverage and how to implement it. A 30-day public comment period followed publication of the draft decision. Relevant comments were considered in the final decision, which includes a summary of the comments received.
"This decision is in keeping with our intention to expand Medicare coverage for promising technologies in peer-reviewed clinical trials that contain sufficient patient protections to ensure that the care given is reasonable and necessary." McClellan said.
This coverage decision was the first under the Medicare Modernization Act of 2003 requirements to post a draft of the decision memorandum, hold a 30-day public comment period, and then post the final decision memorandum and implement the policy within 90 days of posting the draft decision.
Alzheimer's disease is an age-related and irreversible brain disorder that occurs gradually and results in memory loss, behavior and personality changes, and a decline in thinking abilities. An estimated 4.5 million people in the US currently have AD. Each year approximately 350,000 new individuals manifest the disease. It is the most common cause of dementia, representing approximately two-thirds of cases.
"The available evidence supports the conclusion that PET scans help to evaluate patients with progressive symptoms of dementia, but for whom a diagnosis remains unclear despite a thorough standard medical evaluation," added Sean Tunis, MD, CMS' chief medical officer. "We will also support the conduct of additional studies that will determine the value of PET scans required in a broader population of Medicare beneficiaries who develop symptoms of dementia."