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

The bill would add multi-cancer early detection (MCED) screening tests to the list of Medicare-covered services beginning January 1, 2028. To qualify for coverage, a test must be FDA-cleared or approved, must analyze cell-free nucleic acids in blood or a comparable biological sample, and must be determined by the Secretary of Health and Human Services to be reasonable and necessary for early cancer detection. The Centers for Medicare & Medicaid Services (CMS) would use the existing national coverage determination process to evaluate each qualifying test. Payment before 2031 would be set at the rate used for multi-target stool DNA screening tests; starting in 2031, the payment would drop to the lesser of that rate or the rate determined under the advanced diagnostic laboratory test payment system.

Coverage would be restricted to beneficiaries under age 68 as of January 1, 2028, with that threshold rising by one year each subsequent year, and no more than one test per 11-month period would be covered. However, if the U.S. Preventive Services Task Force later grades an MCED test A or B, those age and frequency restrictions would be lifted and coverage would instead follow Medicare's standard preventive-services rules. The bill also clarifies that MCED coverage does not displace or limit other existing cancer-screening benefits.

Medicare beneficiaries under the rolling age threshold (under 68 in 2028, rising one year annually) who seek to be screened for multiple cancers simultaneously via a blood test. Manufacturers and laboratories offering FDA-cleared MCED tests would gain a Medicare payment pathway. CMS would bear new responsibilities for coverage determinations and payment-rate-setting.

For eligible Medicare beneficiaries, this bill would create the first federal reimbursement pathway for blood tests designed to detect many cancer types at once — a category of test not currently covered under Medicare. Earlier detection can improve treatment outcomes. The age cap and once-per-11-months limit also define meaningful boundaries around how broadly and how often the benefit could be used in its initial years.

CMS would evaluate individual MCED tests through the national coverage determination (NCD) process, requiring each test to clear a "reasonable and necessary" standard before Medicare will pay for it. FDA clearance or approval is a prerequisite. Payment for tests furnished before 2031 is pegged to an existing rate (multi-target stool DNA test); after 2031, CMS would apply the lower of that benchmark or the advanced diagnostic laboratory test rate under Section 1834A. The bill imposes an age threshold and 11-month frequency limit automatically; those restrictions would dissolve by statute if USPSTF grants the test an A or B grade, shifting coverage to Medicare's standard preventive-services framework.