After much controversy about whether or not Medicare would cover a new class of high-cost Alzheimer’s drugs, Centers for Medicare & Medicaid Services (CMS) appears to have crafted a middle ground—it will cover these drugs under certain circumstances.
First, Medicare will only cover these drugs if the Food and Drug Administration (FDA) grants traditional approval for them. Second, the Medicare beneficiary must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia. And last, the patient’s physician must be participating in a registry to collect evidence of how these drugs work in the real world.
This approach is consistent with an April 7, 2022 National Coverage Determination. The drugs specifically targeted with this announcement are a class referred to as “monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.”
Participating physicians/providers will be required to submit data via a CMS-portal to help CMS determine if the drug is reasonable and necessary for the Medicare population. The information to be submitted is collected as part of routine clinical assessments and follow up care so should not pose a significant additional burden on providers.
Find more details here.