S. 339 — Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

This section establishes Medicare Part B coverage for multi-cancer early detection screening tests furnished on or after January 1, 2028, defined as FDA-cleared or approved genomic sequencing blood (or comparable biological sample) tests for concurrent detection of multiple cancers that the Secretary determines reasonable and necessary via the national coverage determination process. (As background, Medicare Part B covers outpatient services, including certain preventive cancer screenings such as for colorectal, breast, cervical, lung, and prostate cancers.) This section sets payment for such tests equal to the amount in effect on enactment for the multi-target stool DNA colorectal cancer screening test (i.e., Cologuard) for tests furnished before January 1, 2031, and thereafter the lesser of that amount or the clinical laboratory fee schedule amount under section 1834A; limits coverage to once every 12 months (i.e., no test in the previous 11 months); and excludes tests furnished to individuals who, as of January 1 of the year, have attained an age that begins at 68 in 2028 and increases by one year annually (thus, initially limiting to those under age 68 and gradually expanding the maximum eligible age). If the U.S. Preventive Services Task Force (USPSTF) recommends the test with an A or B grade, standard coverage rules apply instead. This section makes conforming amendments to payment provisions in section 1833(a) and (h) to reference the new payment rules and to exclusions in section 1862(a)(1) for tests not meeting the reasonable and necessary standard. This section includes a rule of construction clarifying that coverage of these tests does not affect Part B coverage of other specific cancer screenings (e.g., breast, cervical, colorectal, lung, prostate) or their use with multi-cancer tests.