Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

Summary

Adds Medicare coverage and payment rules for FDA‑cleared multi‑cancer early detection (MCED) screening tests beginning January 1, 2028. It directs CMS to use the national coverage determination process to decide whether such genomic sequencing blood or comparable tests are reasonable and necessary for people enrolled in Part A or B, sets transitional and long‑term payment rules, and phases in age and frequency limits for coverage while allowing full preventive coverage if a test receives a USPSTF A or B recommendation.

• Medicare must apply the national coverage determination process to FDA‑cleared multi‑cancer early detection (MCED) tests starting Jan 1, 2028.
• MCED tests are defined as FDA‑cleared/approved genomic sequencing blood tests (cell‑free nucleic acids) or comparable biologic‑sample tests.
• Transitional payment (through Dec 31, 2030) uses the then‑current multi‑target stool DNA test payment rate; after Jan 1, 2031, payment is the lesser of that rate or the section 1834A amount.
• Annual age and frequency limits phase in starting at age 68 in 2028, increasing by one year each subsequent year, and prohibit repeat testing within 11 months.
• USPSTF A or B recommendations for a test override the phased age and frequency limits once preventive coverage begins.
• CMS may exclude payment for tests it determines are not reasonable and necessary for concurrent multi‑site cancer detection.
• The law changes Medicare coverage/payment rules and makes conforming edits to several Medicare statutes.
• Impacts manufacturers, clinical labs, providers, and Medicare beneficiaries by altering coverage pathways and payment for novel cancer screening tests.