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Jay Reinstein, who has Alzheimer’s disease, sits on a bed after receiving a PET scan at MedStar Georgetown University Hospital in Washington, DC on June 20, 2023.

Michael Robinson Chavez | Washington Post | Getty Images

Medicare plans to expand coverage of PET scans that are used to help diagnose Alzheimer’s disease, a major policy shift that could make it easier for patients to access new treatments entering the US market.

The proposal would abolish the current Medicare policy nationwide. Currently, the Seniors Program will cover one PET scan per age for patients participating in clinical trials.

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Medicare’s proposal would allow regional organizations, called Medicare Administrative Contractors, to decide whether to cover the diagnostic tool. These regional contractors make coverage decisions based on whether the services are “reasonable and necessary” for a diagnosis.

Chiquita Brooks Lashore, president of the Centers for Medicare and Medicaid Services, said in a statement Monday that proposed policy “Fulfills CMS’s commitment to allow broader coverage of this diagnostic test.” It remains unclear when a decision on PET scans will be finalised.

Positron emission tomography scans are an important diagnostic tool for detecting the presence of a protein amyloid in the brain associated with Alzheimer’s disease. Screenings are the most common way to help diagnose patients.

People on Medicare in general pay 20% of the cost of the positron emission tomography after collecting the deductible. The cost of a single examination would come to about $313 per patient, according to one estimate in a study published in the medical journal JAMA Internal Medicine.

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Medicare’s coverage of PET scans should make it easier for patients to access new treatments like Leqembi, which was approved by the Food and Drug Administration earlier this month.

Medicare agreed to cover Leqembi’s treatment for Eisai and Biogen’s Alzheimer’s, but requires patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease with documented evidence of amyloid on the brain.

Most patients choose positron emission tomography to confirm the presence of amyloid because imaging is less invasive than alternative diagnostic tools such as spinal taps. Blood tests are also under developmentAnd With some already in limited use, but not widely deployed yet.

Medicare said it would also cover other antibody therapies for Alzheimer’s with the same terms if they receive approval from the Food and Drug Administration. Eli Lilly The US Food and Drug Administration (FDA) expects to make a decision on its treatment, donanemab, by the end of the year.

The Alzheimer’s Association, a pressure group that advocates for people living with the disease, said the new policy proposed by Medicare would remove unnecessary barriers for patients. Maria Carrillo, the consortium’s chief scientific officer, called the decision “a huge step forward”.

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