Association Encourages Regional MACs To Ensure No Delays

CHICAGO, Oct. 13, 2023 A valuable Alzheimer’s disease diagnostic tool will now be more accessible across the country thanks to a policy change today by the Centers for Medicare & Medicaid Services (CMS). The Alzheimer’s Association applauds CMS for taking action to expand coverage of brain amyloid positron emission tomography (PET) imaging for the diagnosis of Alzheimer’s disease. In issuing its new policy, CMS said the specific details of the coverage will be made by the Medicare Administrative Contractors (MACs). The Alzheimer’s Association urges the MACs to quickly implement broad and equitable coverage for all Medicare beneficiaries. 

“Amyloid PET scans are a proven tool and can be an important part of Alzheimer’s diagnosis and treatment,said Maria C. Carrillo, Ph.D., chief science officer, Alzheimer’s Association. “Broader access to amyloid PET scans will enable earlier and more accurate diagnosis, and better care management. Their use can lead to better health outcomes for people living with Alzheimer’s or another dementia. This decision reflects the FDA’s confidence in this technology after many years of evaluation. It is essential that the MACs continue the CMS practice of covering PET scans in support of treatment.”

Since the Food and Drug Administration’s (FDA) traditional approval of Leqembi® (lecanemab) in July, CMS has covered PET scans when used to determine whether this treatment is appropriate for a patient. It is crucial that all MACs, as well as other payers, continue this evidence-based precedent established by CMS.

The Alzheimer’s Association has led the development and implementation of amyloid PET scans in Alzheimer’s research, diagnosis and care. For example, 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 better understand how amyloid PET improves accurate diagnosis and appropriate treatment of Alzheimer’s and other dementias in real clinical situations and in diverse and underserved populations. In the IDEAS Study, patient management changed in 60.2% of MCI and 63.5% of dementia patients. The Association is committed to continuing our work with CMS on the New IDEAS Study to further expand our understanding of the importance of accurate diagnosis and PET as a biomarker in traditionally underrepresented individuals. 

“In the new era of treatment, amyloid PET scans become even more valuable as they are used to determine diagnosis and eligibility for FDA-approved treatments,” Carrillo said.  “Additionally, recent clinical trial results tell us it is also useful to track changes in a person's level of beta amyloid throughout the course of treatment because it may be possible to pause treatment, as the amyloid beta levels decrease.”

Amyloid PET imaging enables clinicians to distinguish Alzheimer’s disease from other causes of dementia or memory loss, and help ensure appropriate medical care and treatment. The new CMS policy to pay for amyloid PET scans beyond clinical trials also removes the current limitation of one scan per lifetime. 

The Alzheimer’s Association will continue to work with CMS, the MACs and other payers to ensure all people living with Alzheimer’s disease have easy, affordable access to high quality diagnostic tools, treatments and care.