S-3267-119
Read twice and referred to the Committee on Finance. (Sponsor introductory remarks on measure: CR S8278-8279)
Sponsored by Susan Collins (R-ME)
What it does
This bill would amend Title XVIII of the Social Security Act to add blood-based Alzheimer's disease and related dementia screening tests as a covered Medicare benefit, effective January 1, 2028. Covered tests would include genomic sequencing blood tests and equivalent alternatives — such as protein expression panels, whole genome sequencing, and cell-free nucleic acid analysis — provided they have received FDA clearance or approval. Payment would be made through Medicare's existing clinical laboratory fee schedule.
Who benefits
Medicare-eligible individuals (generally age 65+) who would gain access to covered early-detection dementia screening without out-of-pocket cost for the test itself. Patients with a family history of Alzheimer's disease who seek pre-symptomatic screening. Diagnostic laboratory companies and test developers who have received or are seeking FDA clearance for blood-based dementia tests, as Medicare coverage would expand their market. Caregivers and families who may benefit from earlier diagnosis and planning. Pharmaceutical companies developing early-stage Alzheimer's treatments, as earlier detection could expand the eligible patient population for those therapies.
Who is hurt
Medicare trust funds and federal taxpayers, who would bear the cost of covering these tests at scale. Private insurers, who may face pressure to match Medicare coverage. Competing diagnostic approaches (e.g., PET scans, cerebrospinal fluid tests) whose utilization and reimbursement could decline if blood-based tests become the standard. Patients who receive false-positive results and undergo unnecessary follow-up procedures, potentially facing anxiety and additional costs. Providers who currently offer non-covered screening services at out-of-pocket rates may see pricing pressure.
Supporters argue
Supporters argue that Alzheimer's disease affects an estimated 6.9 million Americans age 65 and older, and that early detection is critical to accessing emerging treatments — including recently FDA-approved therapies like lecanemab and donanemab — that are most effective in the pre-symptomatic or early stages. They contend that blood-based tests are less invasive and far less expensive than current gold-standard diagnostics like PET scans (which can cost $3,000–$5,000), making Medicare coverage a cost-effective way to expand access to timely diagnosis for a population that disproportionately relies on Medicare.
Opponents argue
Opponents argue that the clinical utility of population-wide pre-symptomatic dementia screening remains uncertain, with major medical societies not yet recommending routine screening for asymptomatic individuals due to limited evidence that early detection improves outcomes at scale. They contend that adding coverage before clinical guidelines are established could expose millions of Medicare beneficiaries to false positives, psychological harm, and costly follow-up testing — while adding significant, potentially open-ended costs to an already strained Medicare trust fund without a defined spending cap or utilization limit in the bill's text.
Constitutional context
Congress has broad authority to establish and modify Medicare benefits under the Taxing and Spending Clause (Art. I, §8, cl. 1), which was affirmed in NFIB v. Sebelius (2012). This bill modifies an existing federal spending program and raises no novel constitutional questions.
Checks and balances
Congress expands Medicare's covered benefits; the Secretary of Health and Human Services retains authority to determine which equivalent tests qualify, subject to FDA clearance requirements; the Medicare Payment Advisory Commission (MedPAC) provides independent oversight of payment rates.
Historical precedent
Medicare coverage of colorectal cancer screening tests (added in 1998) and lung cancer screening CT scans (added in 2015) established precedent for covering preventive and early-detection tests for high-prevalence diseases affecting older Americans.