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The bill expands Medicare coverage and offers short-term payment stability for FDA-cleared multi-cancer blood screening tests, but access is narrowed by age and frequency limits, payment caps, and agency discretion that may delay or restrict availability and create uncertainty.
Medicare beneficiaries who meet the bill's age criteria will gain Medicare coverage for FDA-cleared multi-cancer early detection (MCED) blood tests starting in 2028, expanding access to earlier cancer detection.
Providers and hospitals will receive an explicit Medicare payment rate for MCED tests through 2030, providing short-term reimbursement stability while CMS determines long-term rates.
MCED tests that later receive a USPSTF A or B recommendation will be exempt from the bill's age and frequency limits, allowing broader preventive coverage when strong evidence supports clinical benefit.
Many Medicare beneficiaries below the bill's initial age cutoff (beginning at 68 in 2028) will be ineligible for Medicare-paid MCED screening until they reach that threshold, delaying access for younger seniors.
Payment rates are capped at the multi-target stool DNA test rate (and may be lower after 2031), which could underpay newer or higher-cost MCED tests, discourage provider adoption, and reduce incentives for developer investment.
An 11-month restriction bars Medicare payment for repeat MCED testing within a year, limiting clinicians' flexibility and potentially forcing patients to pay out-of-pocket if more frequent testing is clinically recommended.
Based on analysis of 2 sections of legislative text.
Requires Medicare NCD review and creates coverage/payment rules for FDA-cleared multi-cancer early detection tests starting Jan 1, 2028, with phased age/frequency limits and payment changes in 2031.
Adds Medicare coverage and payment rules for FDA-cleared multi-cancer early detection (MCED) screening tests (genomic sequencing blood tests and comparable biologic-sample tests) furnished on or after January 1, 2028. It requires the Secretary to use the Medicare national coverage determination process to evaluate whether such tests are reasonable and necessary, sets temporary and then permanent payment rules, phases in age and frequency limits starting at age 68 in 2028 (increasing by one year annually), and exempts tests that later receive a USPSTF A or B preventive recommendation from the age/frequency limits. Also updates Medicare payment and exclusion statutes to reference the new coverage authority and adds an exclusion allowing Medicare to deny payment for tests the Secretary finds not reasonable and necessary for concurrent multi-site cancer detection.
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