Summary

Requires Medicare to cover certain FDA-cleared or approved multi-cancer early detection (MCED) screening tests furnished on or after January 1, 2028, and sets specific payment rules, age and frequency limits, and review procedures. Coverage decisions for new MCED tests must use the Medicare National Coverage Determination process, payments are pegged to an existing multi-target stool DNA test amount until 2031 then tied to standard payment rules, and provisions defer to USPSTF A/B grading if applicable.

• Medicare will cover FDA-cleared/approved multi-cancer early detection (MCED) screening tests furnished on or after Jan 1, 2028.
• Coverage decisions for new MCED tests must use the Medicare National Coverage Determination (NCD) process.
• Transitional payment before Jan 1, 2031 is set equal to the payment amount for a multi-target stool DNA test; after 2031 payment follows section 1834 rules or the lesser benchmark.
• Annual payment is denied if the beneficiary has reached a statutory age threshold (68 in 2028, rising each year) or received an MCED test within the prior 11 months.
• If USPSTF issues an A or B grade and coverage starts under that USPSTF pathway, the MCED-specific payment and limit rules do not apply.
• Defines qualifying MCED tests as certain FDA-authorized genomic sequencing or comparable tests analyzing cell-free nucleic acids.
• Adds statutory exclusions and conforming edits to existing Medicare payment and necessity provisions.
• Affirms that MCED coverage does not change coverage rules for established cancer screening tests and allows MCEDs to be used diagnostically/confirmatorily without altering other screening coverage.