In April 2022, the Centers for Medicare & Medicaid Services (CMS) issued an unprecedented decision that blocks Medicare coverage of FDA-approved treatments that target amyloid for Alzheimer's disease. This policy applies to all currently FDA-approved monoclonal antibody treatments, including lecanemab (Leqembi™) and aducanumab (Aduhelm™), and others that may receive approval in the coming months.
Now the agency is planning to continue unprecedented restrictions, saying they’ll provide coverage only through a registry — something Medicare has never before done for an FDA-approved drug. Yet with a deadline only weeks away, CMS has yet to explain the barriers patients will face or the steps doctors must take to prepare to deliver long-delayed treatment.
Medicare must do better for beneficiaries with Alzheimer’s.
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A barrier to treatment
The CMS decision blocks Medicare coverage of FDA-approved medications for Alzheimer’s disease. This decision prevents people who could benefit from treatments today from receiving them even if their doctor prescribes them.
On Dec. 19, 2022, the Alzheimer’s Association filed a formal request asking CMS to provide full and unrestricted coverage for FDA-approved Alzheimer’s treatments. The Association is asking CMS to remove the requirements that Medicare recipients must be enrolled in a clinical trial in order to be eligible for these FDA-approved treatments.
Medicare has always covered FDA-approved treatments for those living with other conditions like cancer, heart disease and HIV/AIDS. For CMS to treat those with Alzheimer’s disease differently than those with other diseases is unprecedented and unacceptable.
Alzheimer’s disease is a national crisis. With this approach, only the privileged few with access to clinical trials have access to treatment — a move that exacerbates and creates further health inequities among those who are already disproportionately impacted by this fatal disease.