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The bill expands Medicare coverage and short-term payment stability for FDA-cleared multi-cancer early detection blood tests, improving access for eligible seniors, but it delays access for younger beneficiaries, restricts testing frequency, caps payments in ways that may discourage some tests, and leaves coverage subject to CMS determinations.
Medicare beneficiaries who meet the bill's eligibility will gain Medicare coverage for FDA-cleared multi-cancer early detection (MCED) blood tests beginning in 2028, increasing access to earlier cancer detection for older adults.
Hospitals and provider organizations will have an explicit Medicare payment rate for these tests through 2030, providing short-term reimbursement stability while CMS establishes permanent rates.
If MCED tests later receive a USPSTF A or B recommendation, they would be exempt from the bill's age and frequency limits, allowing broader preventive coverage once the USPSTF endorses them.
Medicare beneficiaries younger than the bill's rising age threshold (which starts at 68 in 2028) will be ineligible for Medicare-paid MCED screening until they reach that age, delaying access for many younger seniors.
Capping Medicare payment rates at the multi-target stool DNA (mt-sDNA) test rate — and potentially lower after 2031 — may underpay for some MCED tests, discouraging availability, provider adoption, and developer investment.
The 11-month restriction that bars payment for repeat MCED testing within a year could limit clinicians' flexibility to recommend more frequent testing when clinically appropriate, potentially forcing patients to pay out-of-pocket.
Based on analysis of 2 sections of legislative text.
Establishes Medicare coverage, payment rules, age/frequency limits, and NCD review for FDA-cleared multi-cancer early detection tests beginning Jan 1, 2028.
Adds Medicare coverage and payment rules for FDA-cleared multi-cancer early detection screening tests (blood or similar biologic-sample genomic tests) beginning January 1, 2028. It directs the Medicare national coverage determination process to evaluate whether such tests are reasonable and necessary for prevention or early detection and sets temporary and longer-term payment methods and limits on age and frequency of covered testing. Tests furnished from 2028 through 2030 are paid at the same rate then used for multi-target stool DNA tests; tests from 2031 forward are paid at the lesser of that stool-DNA rate or a rate set under the physician-fee-schedule-equivalent payment method. The bill phases in an initial minimum screening age (starting at 68 in 2028 and increasing by one year each subsequent year), bars payment for repeat tests within 11 months, and exempts tests that later receive a USPSTF A or B preventive recommendation from those age/frequency limits once preventive coverage begins.
Official title: To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.
Introduced January 31, 2025 by Jodey Cook Arrington · Last progress January 31, 2025