NEW YORK – The US Centers for Medicare & Medicaid Services on Monday issued a proposal to potentially broaden Medicare coverage of beta-amyloid PET scans, responding to calls from industry to improve reimbursement for testing to be used alongside newly approved Alzheimer's disease treatments.
The US Food and Drug Administration earlier this month granted full approval to Eisai and Biogen's Leqembi (lecanemab), a monoclonal antibody that targets beta-amyloid proteins to slow cognitive decline for patients with the progressive neurodegenerative disease. It's indicated for adults with mild cognitive impairment or mild dementia, as well as beta-amyloid pathology.
However, tests used to confirm the presence of beta-amyloid are not typically reimbursed by Medicare. Under CMS's existing national coverage determination, beta-amyloid PET scans are only covered when performed within certain studies, which industry groups like the Medical Imaging & Technology Alliance have argued will hinder access to treatments.
With its proposed decision memo issued Monday, CMS is proposing to remove the requirement for evidence development through CMS-approved studies, allowing local Medicare Administrative Contractors (MACs) to determine coverage for such imaging as a diagnostic test.
CMS in its proposal stopped short of setting a national Medicare coverage policy for beta-amyloid PET imaging. In its notice, the agency said as new amyloid-targeted treatments continue to emerge, MACs will be able to respond to evidence more promptly for patients in the regions that they have jurisdiction over. That's the same coverage process in place for cerebrospinal fluid analysis, another method of testing for beta-amyloid pathology for which coverage decisions are also left to MACs.
The new proposal would also allow MACs to cover multiple beta-amyloid PET scans. Currently, even for patients enrolled in CMS-approved studies, coverage is limited to only one scan per Medicare patient across their lifetime.
"Today's announcement about Medicare coverage of amyloid PET scans fulfills [CMS's] commitment to allow broader coverage of this diagnostic test," CMS Administrator Chiquita Brooks-LaSure said in an emailed statement. "We know there is significant interest in the medical community about new treatments that may be effective in slowing the development of Alzheimer's disease. PET scans are an important part of diagnosis and treatment of Alzheimer's disease, and this decision is an important part of [CMS's] mission to help improve the lives of Americans we serve."
CMS is accepting feedback from the public on its proposal for the next 30 days.