NEW YORK – The US Centers for Medicare & Medicaid Services on Friday took a step toward broadening Medicare coverage of beta-amyloid PET scans as a diagnostic test for certain dementia and neurodegenerative diseases, such as Alzheimer's.
The decision, which follows a proposal released in July, was met with cheers from industry groups, which had raised concerns about lack of reimbursement options for beta-amyloid testing necessary for patients to be prescribed newly approved Alzheimer's disease treatments such as Eisai and Biogen's Leqembi (lecanemab).
Under CMS's previous national coverage determination, beta-amyloid PET scans were only covered when performed within certain studies. Now, with the new determination, CMS has removed the requirement related to CMS-approved studies, meaning that coverage decisions will be left to local Medicare administrative contractors (MACs).
CMS, however, stopped short of establishing a national Medicare coverage policy.
"As new treatments directed against amyloid for patients with AD (whether monoclonal antibodies, inhibitor drugs, nanotechnology, or other new technology) are developed and approved by the FDA, the MACs are able to promptly respond to the evidence on proven treatments for individual patients," CMS said in the decision memo.
Another beta-amyloid testing method, cerebrospinal fluid analysis, also lacks national Medicare coverage with decisions left to MACs.
The Alzheimer's Association, in a statement about the decision Friday, urged MACs to quickly implement broad coverage of beta-amyloid PET scans for Medicare beneficiaries. "This decision reflects the FDA's confidence in this technology after many years of evaluation," Alzheimer's Association CSO Maria Carrillo said in a statement.