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CMS explains limits on Medicare coverage for asymptomatic Alzheimer's screening and how CED works
Summary
CMS officials told the NAPA council that Medicare coverage rests on statutory benefit categories and that Coverage with Evidence Development (CED) has been used for amyloid‑directed antibody studies; expanding coverage for screening or drugs beyond Parts A/B would require congressional action or other pathways.
Dr. Sherry Ling of the Centers for Medicare & Medicaid Services provided a detailed overview of how Medicare coverage decisions intersect with clinical evidence generation and statutory benefit categories. She told the council that Medicare coverage must meet a "reasonable and necessary" standard and that CED (Coverage with Evidence Development) has been the mechanism used to allow coverage while additional data are gathered for amyloid‑directed therapies. "CED, coverage with evidence development, is a national coverage policy that 1 can arrive at and if the evidence is promising, but not necessarily sufficient as it applies to Medicare beneficiaries," she said.
Ling explained practical constraints: CED applies to Parts A and B (hospital and physician services), and while clinical trial routine care can be paid for under some policies, drug coverage under Part D follows a different administrative path. On the physician fee schedule side she called attention to an RFI seeking input on lifestyle interventions: "These comments are due, so September 14," Ling said, inviting public comment that could shape future payment policies. Council members asked whether Medicare could be used to underwrite large registries or population screening; Ling replied that for coverage of drugs under Part D or creation of new benefit categories, Congress would have to act.
Why it matters: the council is debating both upstream screening and downstream access to disease‑modifying therapies. CMS framed the policy levers available now (CED, routine‑care payments in clinical trials, quality incentives) and the limits that require legislative change (new benefit categories or Part D scope). Any plan to scale screening to asymptomatic Medicare beneficiaries must reconcile statutory benefit definitions with pathways for evidence generation and payment.
