The Centers for Medicare & Medicaid Services (CMS) has decided to remove the national coverage determination (NCD) that limits patients’ ability to qualify for new drugs, giving people with Alzheimer’s disease symptoms a better path to treating the condition.
The policy means amyloid PET scans will no longer be limited and will give patients a better chance of being prescribed a drug like Eisai's Leqembi, which clears beta amyloid proteins from the brain to slow the advances of Alzheimer’s.
CMS has provided coverage for amyloid PET scan imaging since 2013 in the context of clinical studies. It’s anticipated that more than one scan may be needed per patient in a clinical study. After a public comment period, most respondents said they were in favor of removing the NCD and the limit the number of scans per patient to one.
Coverage decisions will be made by regional Medicare administrative contractors, or MACs. Providers will screen patients to ensure they have plaques in the brain that would necessitate receiving a drug like Leqembi. Physicians can then screen patients again to see how effectively the drug is working, Stat reported.
Alzheimer’s affects more than 6 million Americans, CMS said in its decision memo. Black and Hispanic people are more likely than white people to have Alzheimer’s, but minorities are underrepresented in Alzheimer’s-related research.
The federal agency teased the move in July in a memo. It stated that removal of the NCD would allow “appropriate coverage of amyloid PET scans” and reduce provider and patient burden.
Beta amyloid presence is regarded as a hallmark of Alzheimer’s, even after an investigation found flaws in previous Alzheimer’s studies, but it’s unclear whether it is a cause or simply a sign of the disease, the memo states.