Jay Reinstein, who has Alzheimer’s disease, sits on a bed after undergoing a PET scan at MedStar Georgetown University Hospital on June 20, 2023 in Washington, DC.
Michael Robinson Chavez | The Washington Post | Getty Images
Medicare plans to expand coverage of PET scans used to diagnose Alzheimer’s disease. This is an important policy change that could make it easier for patients to access new treatments coming to the US market.
The proposal would abolish Medicare’s current statewide policy. Currently, the seniors program includes only one PET scan per life for patients enrolled in clinical trials.
The Medicare proposal would allow regional organizations, called Medicare administration contractors, to decide whether to adopt the diagnostic tool. These regional contractors make coverage decisions based on whether a service is “appropriate and necessary” for diagnosing a disease.
Chiquita Brooks-LaSure, director of the Centers for Medicare and Medicaid Services, said in a statement Monday that the proposed policy “delivers on CMS’ commitment to provide broader coverage of this diagnostic test.” A final decision could be made in 90 days, a CMS spokesman said.
PET scans are an important diagnostic tool for detecting an amyloid protein in the brain that is linked to Alzheimer’s disease. The scans are the most common way to diagnose patients.
Medicare beneficiaries generally pay 20% of the cost of a PET exam after meeting their deductible. A study published in May in the medical journal JAMA Internal Medicine estimated the cost of a single scan would be about $313 per patient.
dr Sean Tunis, a former chief medical officer at CMS, said it’s possible regional contractors could make different coverage decisions for PET scans. But these organizations generally work together on important issues and there’s no reason to think their policies on PET scanning would be very different across the US, said Tunis, who is now a consultant at Rubix Health.
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Medicare coverage of PET scans should make it easier for patients to access new treatments like Leqembi, which the Food and Drug Administration approved earlier this month.
Medicare has agreed to cover Eisai and Biogen’s Alzheimer’s treatment Leqembi, but requires patients to be diagnosed with mild cognitive impairment or mild Alzheimer’s disease and have documented signs of amyloid in the brain.
Most patients opt for PET scans to confirm the presence of amyloid because imaging is less invasive than alternative diagnostic methods such as spinal taps. Blood tests are also under development, some of which have had limited use but have not yet become widely available.
Medicare has announced that it will also cover other Alzheimer’s antibody treatments associated with the same conditions if they are approved by the FDA. Eli Lilly expects the FDA to make a decision on her treatment, donanemab, by the end of the year.
The Alzheimer’s Association, the lobby group that advocates for people with the disease, said Medicare’s proposed new policy would remove unnecessary barriers for patients. Maria Carrillo, the scientific director of the association, called the decision a “major step forward”.