Medicare will remove limits on covering PET scans used to help diagnose Alzheimer's disease, allowing broader access to new treatments on the U.S. market.
The Centers for Medicare and Medicaid Services (CMS) said in a memo it was removing a previous once-in-a-lifetime limit. But instead of making a broad decision about how many scans Medicare will cover, CMS said it was leaving coverage up to its regional contractors.
The non-invasive PET scans detect the presence of a brain plaque called amyloid and can be used as a way 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 pricey drug, but it requires patients to be diagnosed with mild cognitive impairment or mild Alzheimer’s disease with documented evidence of amyloid on the brain.
Leqembi is part of a new class of so-called anti-amyloid drugs because they target amyloid brain plaque, which has been shown in studies as a cause of Alzheimer's.
PET scans could “not only help select patients suitable for treatment, but also demonstrate treatment response,” the Centers for Medicare and Medicaid Services said in a memo published Friday.
The decision removes a significant barrier to anti-amyloid therapies. Providers can screen patients for eligibility and then also monitor for potential side effects like brain swelling.
People on Medicare generally 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 far less invasive than other diagnostic tools, like a spinal tap.
The decision aligns with a proposal the agency issued over the issue and is part of a broader move to ease access to Alzheimer's treatments. The move was applauded by advocacy groups that have been pushing the agency to expand treatment coverage.
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