If the Food and Drug Administration (FDA) grants traditional approval, then Medicare will cover the Alzheimer’s disease drug in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare.
CMS.gov’s recent article entitled, “CMS announces new details of plan to cover new Alzheimer’s drugs,” says specifically that 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 have “robust privacy protections” by 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 help people.
The approach is consistent with CMS’ National Coverage Determination (NCD) issued on April 7, 2022.
To get Medicare coverage, people will need to:
- Be enrolled in Medicare
- Be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia; and
- Have a physician participate in a registry with an appropriate clinical team and follow-up care.
CMS is working with several organizations preparing to open their registries.
Reference: CMS.gov (June 22, 2023) “CMS announces new details of plan to cover new Alzheimer’s disease drugs”
