CMS approves reimbursement for PET in Alzheimer's disease
The government's decision yesterday to allow Medicare reimbursement for PET imaging of suspected Alzheimer's patients comes after four years and many failed attempts by the nuclear medicine community to convince the agency of the technique's value in this patient population.
"It's a historic step in the right direction," said Dr. R. Edward Coleman, president of the Academy of Molecular Imaging, an organization that has played a leading role in gaining reimbursement for PET.
The Centers for Medicare and Medicaid Services found sufficient evidence in the literature to conclude that FDG-PET is beneficial in patients recently diagnosed with dementia. The agency also will reimburse for PET imaging of patients with a documented cognitive decline of at least six months. The patients must meet diagnostic criteria for both Alzheimer's disease and frontotemporal dementia, and the cause of their clinical symptoms must remain uncertain.
"CMS held us to evidence and we provided it," said Dr. Michael Phelps, chair of molecular and medical pharmacology at the University of California, Los Angeles.
Other conditions that must be met for reimbursement include an expectation that PET will help clarify the diagnosis and/or help guide future treatment, and that the scan be read by an expert in nuclear medicine, radiology, neurology, or psychiatry.
CMS rejected coverage for patients diagnosed with mild cognitive impairment or early dementia, saying the literature did not support the use of PET. PET may be used in these patients, however, if they are enrolled in trials that compare them with others who do not receive PET scans.
The draft decision memorandum by CMS announced that the agency will help fund the development of clinical trials to address unanswered questions about PET's role in diagnosing mild cognitive impairment and early dementia.
"That is revolutionary," Phelps said. "For the first time, CMS is saying, 'We'll do the experiment.' This is a group that has traditionally placed roadblocks in the development of medicine. Now it will be a force to help shape the future of medicine."
PET proponents in the past have complained that CMS micromanaged PET's approval process. In 2001, the agency granted broad coverage for many oncological indications and heart disease but passed on neurological disorders.
In 2002, CMS rejected coverage for PET imaging of patients with mild cognitive impairment or AD, saying the peer-reviewed literature did not support its use over traditional imaging. Proponents submitted a new request in 2003 that basically repackaged the evidence for clarity, with indications limited to a more specific patient population. The present decision by CMS is in response to that 2003 request.
CMS relied on input from the National Institute on Aging, the Alzheimer's Association, the Agency for Healthcare Research and Quality, and other medical professional organizations to inform its decision.
Organizations have been split in their support of coverage for PET imaging for Alzheimer's. The Society of Nuclear Medicine and the National Electrical Manufacturers Association have endorsed the concept for several years. The Alzheimer's Association recently came on board, while the American Academy of Neurology and the American College of Radiology have not supported coverage.
After a cursory reading of the CMS decision, Dr. Milton Guiberteau, chair of the ACR commission on nuclear medicine, said the ACR still hasn?t changed its position.
?We are still wary of the clinical value and effectiveness of PET in the setting of minimal cognitive impairment and dementia,? Guiberteau told Diagnostic Imaging.
He stressed that he and other members of the commission must fully digest the document before they can comment with any authority. If they find something that leads them to believe there is a role for PET that will help in the management of patients with dementia, they will support the decision, he said.
CMS will accept public comments on the draft decision memorandum for 30 days and will make the decision final within 90 days.
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