Medicare to Cover Alzheimer’s Drugs with Real-World Evidence: How You Can Benefit

dementiaImage by Gerd Altmann

The Centers for Medicare & Medicaid Services (CMS) released new details about how people can get drugs that may slow the progression of Alzheimer’s disease covered by Medicare. If the Food and Drug Administration (FDA) grants traditional approval, then Medicare will cover the drug in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare.

Specifically, Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Clinicians will be able to submit this information through a nationwide, CMS-facilitated portal. The portal will be available when any product gains traditional approval and will collect information via an easy-to-use format. This method, and any others that may follow, will adhere to robust privacy protections in accordance with applicable federal laws and regulations, including HIPAA. CMS and researchers will have access to the information to conduct studies, furthering knowledge of how these drugs can potentially help people.

The approach is said to be consistent with CMS’ National Coverage Determination (NCD) issued on April 7, 2022. To get Medicare coverage people will need to 1) be enrolled in Medicare, 2) be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, and 3) have a physician participating in a registry with an appropriate clinical team and follow-up care.

CMS stated that it is working with multiple organizations preparing to open their own registries. Once more registries are available, they will also be listed at, and clinicians will be able to choose which registry to participate in.

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