To provide Alzheimer’s patients with greater access to newly released therapies, the Centers for Medicare and Medicaid is removing its once-in-a-lifetime limit on Medicare coverage for amyloid PET scans used to diagnose the condition.

In a memo issued on October 13, CMS said that local Medicare Administrative Contractors and Medicare Advantage plans would determine coverage, potentially allowing patients to be diagnosed earlier at stages where they may be eligible for new drugs on the market, such as Eisai and Biogen's Leqembi, which was approved in July.

This and other pharmaceuticals are a new class of anti-amyloid drugs that target and destroy amyloid brain plaques that contribute to the onset of Alzheimer’s. While Medicare will cover these drugs, patients must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease and have documented evidence of amyloid on the brain, reported The Hill.
Additionally, CMS is ending its coverage with evidence development (CED), which requires that patients must be enrolled in a clinical study or patient registries to qualify for coverage.

“As new treatments directed against amyloid for patients with AD — whether monoclonal antibodies, inhibitor drugs, nanotechnology or other new technology — are developed and approved by the FDA, the MACs are able to promptly respond to the evidence on proven treatments for individual patients,” said CMS in its memo.

It also said that PET scans could additionally “demonstrate treatment response.”

In a statement, the Medical Imaging & Technology Alliance (MITA) welcomed the decision, calling the technology “critically important” and saying that it would work with CMS “to educate Medicare contractors for transparency, clarity, and seamless coverage for all Medicare beneficiaries.”

CMS previously suggested removing the restrictions in July. This was followed by a public comment period, in which organizations and companies said the restrictions forced patients to undergo the only other CMS-authorized method for amyloid detection, an invasive cerebrospinal fluid test that requires a lumbar puncture, reported Reuters.

Some companies, including GE HealthCare, commented that there should be a national coverage policy put in place, as local decision-making could lead to regional variations in coverage.

MACs are expected to compile their own reimbursement terms over the next few months.

MITA encourages CMS and the MACs to work with neurology and Alzheimer’s disease stakeholders to ensure coverage is seamless and consistent.

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