CMS proposes expanding coverage for PET scans related to Alzheimer’s disease

The Centers for Medicare & Medicaid Services has proposed broadening coverage for PET scans related to Alzheimer’s disease.

CMS announced the decision on Monday, proposing to lift the longstanding national coverage determination that restricts patients to one amyloid-detecting positron emission tomography exam in their lifetime. The agency is instead considering ending the “coverage with evidence development” for PET and permitting local Medicare Administrative Contractors to make the payment determination.

“Today's announcement about Medicare coverage of amyloid PET scans fulfills CMS’ commitment to allow broader coverage of this diagnostic test,” Administrator Chiquita Brooks-LaSure said in a statement. “We know there is significant interest in the medical community about new treatments that may be effective in slowing the development of Alzheimer's disease. PET scans are an important part of diagnosis and treatment of Alzheimer's disease, and this decision is an important part of CMS' mission to help improve the lives of Americans we serve.”

The announcement comes after the U.S. Food and Drug Administration granted traditional approval for Leqembi (lecanemab-irmb), indicated to treat Alzheimer’s, on July 6. It works by targeting and eliminating the protein that builds up in the brains of individuals with the degenerative disease and requires beta-amyloid PET imaging to pinpoint patients who are candidates. Industry trade groups such as the Medical Imaging & Technology Alliance praised the FDA’s decision earlier this month, but questioned why the PET scan restriction persisted.

CMS first issued its PET national coverage determination in September 2013, refusing to pay for amyloid PET for dementia and neurodegenerative disease. However, coverage was later granted in the context of clinical studies.

“CMS internally generated the opening of this NCD analysis based on stakeholder feedback, including public comments received during the finalization of NCD 200.3 (Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease, available at https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305) because it is anticipated that clinical study protocols may involve more than one PET Aß scan per patient,” the agency said.

The Society of Nuclear Medicine & Molecular Imaging praised the decision on Tuesday. 

“SNMMI is delighted that CMS is planning to allow coverage for beta amyloid PET imaging at the discretion of Medicare contractors," SNMMI President Helen Nadel, MD, said in a statement. "Amyloid PET scans are an essential tool for effectively staging and managing the treatment of patients with Alzheimer’s and other dementias—and specifically for selecting patients for new FDA-approved anti-amyloid drugs, such as lecanamab, and determining if therapy has been effective. This decision would help ensure that this important nuclear medicine test is accessible to all patients who can benefit from it.“

The federal government is accepting comment on the proposed decision for the next 30 days.

A May study in JAMA Internal Medicine estimated that Leqembi’s traditional approval could spur upward of $500 million in annual Medicare spending on imaging. This would include one PET scan per year for those prescribed the drug, along with three routine MRI exams of the brain.