Sponsors (102)
The bill expands Medicare coverage for FDA‑cleared/approved early Alzheimer’s screening tests to improve early detection and reduce seniors' out‑of‑pocket costs, but it will raise Medicare spending and may delay or create uncertainty around coverage for tests that fall outside the specified FDA pathways.
Medicare beneficiaries will gain Medicare coverage for FDA‑cleared or -approved early Alzheimer’s screening tests furnished on or after Jan 1, 2028.
People at risk for dementia (including Medicare beneficiaries) could receive earlier diagnosis and care planning because covered genomic and equivalent early detection tests enable earlier detection.
Seniors who need approved screening tests may face lower out‑of‑pocket costs and improved access because Medicare coverage reduces direct expenses for these tests.
Expanded coverage for early Alzheimer’s screening tests could increase Medicare spending, raising costs for taxpayers and putting pressure on premiums or the Medicare trust fund.
Limiting coverage to tests that follow specific FDA clearance/approval pathways may delay access to promising tests that use other regulatory pathways or are still pending approval.
Allowing CMS to deem non‑genomic methods "equivalent" to genomic tests could create uncertainty for providers and patients about which tests will be covered and under what criteria.
Based on analysis of 2 sections of legislative text.
Adds Medicare coverage for FDA-cleared/approved or Secretary-designated equivalent early-detection tests for Alzheimer’s and related dementias, effective Jan 1, 2028.
Introduced November 19, 2025 by Vernon G. Buchanan · Last progress November 19, 2025
Adds a new Medicare coverage category for early-detection screening tests for Alzheimer’s disease and related dementias, covering tests that meet specified FDA clearance or approval pathways and that are genomic sequencing blood tests or other tests the Secretary finds equivalent. Coverage applies to tests furnished on or after January 1, 2028. The bill also inserts a payment-related provision tied to the new coverage (language not provided) and makes a minor conforming punctuation edit to an existing Medicare provision.