CMS Proposes Lift of Coverage Restrictions on PET Imaging for Alzheimer's Disease

Acknowledging the “accelerating” advances with anti-amyloid treatments for Alzheimer’s disease and conceding the “outdated” nature of limiting Medicare beneficiary coverage to one amyloid positron emission tomography (PET) scan per lifetime, the Centers for Medicare and Medicaid (CMS) has proposed the removal of previous PET coverage restrictions that may broaden access to newer therapies for Alzheimer’s disease.

In the recently issued proposal, the CMS indicated that Medicare coverage of PET beta amyloid imaging would no longer be limited to clinical trial participants and one PET beta amyloid scan per a patient’s lifetime.

In a recent interview prior to the CMS announcement, Mark Hibberd, M.D., the head of global medical services and chief medical officer of life sciences at GE HealthCare, said PET amyloid scans are a “best-in-class” method for amyloid detection and questioned the coverage limitation of one PET beta amyloid scan per lifetime for Medicare beneficiaries.

“Once might be enough to make a diagnosis. The first time you receive such a scan, of course, you may not have any amyloid. But later in your life, you might. That would be a problem if you were denied coverage for a scan later in your life if you develop dementia,” noted Dr. Hibberd.

“On the other hand, it may become necessary to follow the removal of amyloid from the brain to decide on how therapies, especially expensive therapies or therapies that may have significant side effects, are managed. If follow-up scans were necessary, barriers to having more than one scan in your life might be an issue.”

In the proposed changes, CMS said emerging research on anti-amyloid treatments for Alzheimer’s disease have made the aforementioned lifetime coverage limit on amyloid PET imaging obsolete.

“Stakeholders and patients have specifically noted that the once in a lifetime limit on amyloid PET is outdated and not clinically appropriate due to the development of anti-amyloid treatments, and the need to confirm the presence of amyloid to start these treatments and to possibly discontinue treatments when brain amyloid has been completely removed to avoid unnecessary harms,” noted the authors of the CMS proposal.

Newer treatments, such as the recently FDA-approved lecanemab (Legembi, Eisai), require pre-treatment testing to assess the presence of amyloid plaque. In a recent statement, Helen Nadel, M.D., the president of the Society of Nuclear Imaging and Molecular Imaging (SNMMI), said the amyloid PET scan is “an essential tool” for ensuring appropriate patient selection for Legembi as well as post-treatment monitoring.

In new research published earlier this week looking at the use of donanemab (Eli Lilly) in patients with early symptomatic Alzheimer’s disease, the use of amyloid PET scans demonstrated amyloid clearance in 76 percent of the treatment group at 76 weeks. The study authors also noted that “early significant changes” on brain amyloid PET scans … “suggest opportunities for clinical monitoring of therapy.”

In a recent interview, Jacob G. Dubroff, M.D., Ph.D, said the amyloid PET scan provides “an elegant, well-tolerated safe test to measure whether or not this abnormal protein accumulation is there in the first place and whether the medication has been efficacious over time.”

(Editor’s note: For related content, see “Hybrid PET/MRI Assessment with Hippocampal Radiomics May Facilitate Early Alzheimer’s Diagnosis” and “Ultra-High Resolution Brain PET: a ‘Quantum Leap’ for Neuroradiology.”)

Dr. Dubroff says the CMS proposal offers more hope for Medicare coverage of amyloid PET scans for patients with Alzheimer’s disease but navigating the significant costs of anti-amyloid treatments and imaging is going to be particularly challenging.

“If you open the floodgates and allow all the testing and all the treatment, that is going to be a lot of money. How do we do this in a way that makes sense where we can get the most benefit out of imaging and the drug?,” questioned Dr. Dubroff, the modality chief of nuclear medicine and therapy, and associate professor of radiology at the Hospital of the University of Pennsylvania. “Certainly, no longer limiting the coverage to one scan per lifetime, I think that is a reaction to these trials (of anti-amyloid therapies) showing longitudinal (benefits) with more than one scan and the clearing of the amyloid over time.”

The CMS noted that decisions about Medicare coverage of amyloid PET imaging will be made by local Medicare Administrative Contractors (MACs). Dr. Dubroff noted this may lead to considerable regional variability in Medicare coverage decisions.

“It’s going to be very heterogeneous because it’s going to be by region. It’s not going to happen all at once. There may be differences if you live in California versus if you live in New York based on what those administrators decide,” noted Dr. Dubroff.

The CMS noted a 30-day comment period, which began July 17, for the proposed changes. One can post comments on the CMS proposal at: https://www.cms.gov/medicare-coverage-database/view/national-submit-public-comment.aspx?DocID=308&commentDocType=nca&fromPage=pmemo&proposed=Y