Medicare to remove limits on PET scans used with new Alzheimer’s drugs

Medicare will remove limits on coverage of PET scans used to diagnose Alzheimer’s disease, allowing broader access to new treatments in the U.S. market.

The Centers for Medicare and Medicaid Services (CMS) said in a memo that it was removing a previous one-time limit. But instead of making a blanket decision on how many tests Medicare will cover, CMS said it is leaving coverage to its regional contractors.

Noninvasive PET scans detect the presence of a brain plaque called amyloid and can be used to determine whether a patient will be a good candidate for potentially promising drugs like Leqembi, which was approved by the Food and Drug Administration in July. .

Medicare will cover the expensive drug, but it requires patients to be diagnosed with mild cognitive impairment or mild Alzheimer’s disease with documented evidence of amyloid in the brain.

Leqembi is part of a new class of drugs called anti-amyloid drugs because they target brain amyloid plaque, which has been shown in studies to be a cause of Alzheimer’s disease.

PET scans could “not only help select patients suitable for treatment, but also demonstrate response to treatment,” the Centers for Medicare and Medicaid Services said in a memo released Friday.

The decision removes a significant barrier to anti-amyloid therapies. Providers can check patients for eligibility and then monitor for potential side effects such as brain swelling.

People with Medicare typically pay 20 percent of the cost of a PET scan after meeting their deductible. Patients generally prefer a PET scan to determine the presence of amyloid plaque because it is much less invasive than other diagnostic tools, such as a lumbar puncture.

The decision aligns with a proposal issued by the agency on the issue and is part of a broader movement to improve access to treatments for Alzheimer’s disease. The move was applauded by advocacy groups who pushed the agency to expand coverage of the treatment.