CMS Treatment Coverage Policy: What It Means for People Living with Alzheimer’s

In April 2022, the Centers for Medicare & Medicaid Services (CMS) issued an unprecedented decision restricting Medicare coverage of Food and Drug Administration (FDA)-approved treatments that target amyloid for Alzheimer's disease. But following extensive efforts by the Alzheimer's Association, bipartisan members of Congress, state attorneys general, clinicians and, most importantly, advocates from communities all across the country, CMS has updated its coverage plan for traditionally approved FDA treatments.

Medicare now will cover FDA-approved monoclonal antibody treatments that receive traditional approval if clinicians participate and enter data in a simple registry. This policy applies to all currently FDA-approved monoclonal antibody treatments, including donanemab (Kisunla™) and lecanemab (Leqembi®), and others that may receive approval.

In addition, in October 2023, CMS issued a new policy that expands coverage of brain amyloid positron emission tomography (PET) imaging for the diagnosis of Alzheimer's disease. Access to amyloid PET imaging for Alzheimer's diagnosis is essential in the new era of treatments.