Urges Swift Action to Finalize Proposal

CHICAGO, July 17, 2023 The Alzheimer’s Association commends the Centers for Medicare & Medicaid Services (CMS) for taking action today to expand coverage of brain amyloid positron emission tomography (PET) imaging for the diagnosis of Alzheimer’s disease. The proposed new policy will remove unnecessary barriers to this important diagnostic and patient safety tool.

“This new era of Alzheimer’s treatments requires confirmation of amyloid beta and today’s action by CMS is a major step forward demanded by recent treatment advances. It will mean one less barrier for people to get an early and accurate diagnosis,” said Maria C. Carrillo, Ph.D., chief science officer, Alzheimer's Association. 

An early and accurate diagnosis of Alzheimer’s has a positive impact on health outcomes, access to treatments, and eligibility for research trials, plus much-needed support and services. This draft policy will expand access to PET scans beyond clinical trials and removes the current limitation of one scan per lifetime. On the heels of the Food and Drug Administration (FDA) traditional approval of Leqembi®, and as new treatments advance, access to this important diagnostic tool becomes more important. In the new era of treatment, multiple amyloid PET scans may be needed to test for eligibility, establish a baseline, track changes in a person's amyloid levels over time, and even to determine that treatment should be terminated because lower amyloid levels have been achieved.

Amyloid PET is an important diagnostic tool for neurologists and other clinicians. This imaging tool enables clinicians to distinguish Alzheimer’s from other forms of dementia or memory loss, and help ensure appropriate medical care and treatment. The Alzheimer’s Association has had a leading role in the development and implementation of amyloid PET scans in Alzheimer’s research, diagnosis and care. For more than eight years the Alzheimer’s Association and CMS have worked together on both the Imaging Dementia — Evidence for Amyloid Scanning (IDEAS) Study and the New IDEAS Study to create better ways to diagnose and care for people with memory concerns by using brain imaging. 

The Alzheimer’s Association encourages swift action to finalize this proposal. We look forward to working with CMS to ensure all people living with Alzheimer’s disease have easy, affordable access to high quality diagnostic tools, treatments and care.

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