Medicare's New MCED Coverage Law: What Labs Need to Know Before 2028

Short answer: The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, signed February 3, 2026, authorizes Medicare to cover blood-based MCED tests - but coverage cannot start before January 1, 2028, applies first only to beneficiaries age 68 and younger, and requires an FDA-approved or FDA-authorized test to exist. As of enactment, none does; every MCED product on the market today, including Grail's Galleri, is sold as a laboratory-developed test.

What the law actually authorizes

The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 842 / S. 339, 119th Congress) gives the Centers for Medicare & Medicaid Services statutory authority to add blood-based multi-cancer early detection tests to the Medicare Part B benefit. It does not mandate coverage of any specific test or company's product. CMS still determines coverage parameters through its own evidence-based process, and a test still has to clear the FDA before that process can even start.

President Trump signed the bill on Tuesday, February 3, 2026, as part of a broader government funding package - one day before World Cancer Day, a timing Rep. Terri Sewell (D-AL), the bill's lead House sponsor, highlighted in her signing statement. The legislation was co-sponsored by Reps. Jodey Arrington (R-TX), Richard Hudson (R-NC), Raul Ruiz (D-CA), and Mariannette Miller-Meeks (R-IA) in the House, and Sens. Mike Crapo (R-ID), Michael Bennet (D-CO), Tim Scott (R-SC), and Ron Wyden (D-OR) in the Senate.

It took three separate Congresses to get here. The bill was first introduced in 2021 (S. 1873 / H.R. 1946, 117th Congress), reintroduced in 2023 (H.R. 2407, 118th Congress), and reintroduced again in 2025 (H.R. 842 / S. 339, 119th Congress) before finally passing with 320 House cosponsors and 65 Senate cosponsors - a bipartisan margin unusual for any Medicare coverage bill.

Coverage can't start before 2028 - and it starts narrow

Even with the law signed, Medicare cannot begin paying for MCED tests before January 1, 2028. And when it does, coverage phases in by age rather than opening to every beneficiary at once. Starting in 2028, the law makes coverage available to beneficiaries age 68 and younger; the upper age limit then rises by one year every year, reaching beneficiaries age 75 and younger by 2035. Testing frequency is capped at once every 11 months per beneficiary, and the screening is designed to complement - not replace - existing single-cancer screenings such as mammography, colonoscopy, and low-dose CT. Beneficiary cost-sharing for MCED tests is unchanged from standard Part B cost-sharing rules.

The piece nobody's advertising: no MCED test is FDA-approved yet

The coverage authority in this law only activates once a test has FDA approval or authorization and demonstrates clinical benefit through CMS's evidence-based review. As of the bill's signing, zero multi-cancer early detection tests meet that bar. Every MCED product currently marketed in the U.S. - including the best-known example, Grail's Galleri - is offered as a laboratory-developed test (LDT), not an FDA-cleared or FDA-approved in vitro diagnostic.

That gap matters more than it would have two years ago, because the regulatory path an LDT would take to get FDA marketing authorization is itself unsettled. The FDA's 2024 final rule asserting device authority over LDTs was vacated by a federal district court in April 2025 on Loper Bright grounds, and the agency has not replaced it with a new oversight framework. Congress has legislative proposals in play - building on the long-running VALID Act debate - but none has passed. In practice, an MCED test developer has no single, settled regulatory track to follow toward the FDA approval this new Medicare law requires as a precondition.

How much Medicare will pay, and when that changes

The law also sets the starting price. Once a test qualifies for coverage, Medicare pays the Clinical Laboratory Fee Schedule (CLFS) rate in effect for the multi-target stool DNA test - Cologuard - at the time the MCED Act was enacted, reported at $509. That peg holds through December 31, 2030. Starting January 1, 2031, the payment methodology shifts to whichever is lower: the original Cologuard-pegged rate, or the CLFS rate for multi-target stool DNA testing current at that time. For labs modeling reimbursement scenarios, that means the early years of MCED coverage carry a payment ceiling set by a colorectal cancer screening test's price, not by an MCED-specific rate-setting process.

Not everyone is celebrating

The bill's supporters point to a real gap: nearly 70% of annual U.S. cancer cases and deaths occur in cancer types with no recommended screening today, according to Exact Sciences, whose modeling suggests MCED technology could meaningfully reduce late-stage diagnoses when added to standard-of-care screening. But clinical caution has followed the law closely. In a January 2026 STAT News op-ed, Dr. Barbara Levy (chief medical officer, Visana Health) and Dr. Badrinath Konety (president, Allina Health Cancer Institute) urged oncologists and patients to approach widespread MCED adoption cautiously, writing that the tests are "not a one-stop shop for cancer detection." Their core concern - shared broadly in the oncology literature - is that a coverage pathway existing on paper says nothing about the evidence quality, false-positive rate, or downstream workup burden of whatever test eventually walks through it.

What labs, clinicians, and RCM teams should do now

For molecular labs and ordering clinicians, the practical takeaway is timing, not urgency. There is no MCED CPT/PLA code to bill against a Medicare Part B claim today, and there will not be one until an FDA-authorized test exists and CMS finishes its coverage determination - a process that historically takes months once triggered. Labs developing or distributing MCED-adjacent LDTs should track two things in parallel: FDA's evolving (and currently unsettled) LDT oversight posture, and CMS's forthcoming national coverage determination process once a qualifying test is authorized. RCM and managed care teams should not build 2027 or early-2028 revenue models around MCED reimbursement, and should flag any current MCED-adjacent LDT claims submitted under unrelated codes for compliance review - CMS's broader program-integrity push (see our coverage of the CRUSH rule) has flagged genetic and molecular testing spending specifically. The earliest realistic date to plan around for an actual paid claim is 2028, for a narrow age band, at a price pegged to an unrelated colorectal screening test - and that is the optimistic case, contingent on an FDA authorization that does not yet have a clear path.

Frequently asked questions

What is the Nancy Gardner Sewell Medicare MCED Screening Coverage Act?
It's a federal law, signed February 3, 2026, that gives CMS authority to cover FDA-approved or FDA-authorized blood-based multi-cancer early detection tests under Medicare Part B. It doesn't mandate coverage of a specific test; CMS still runs its own evidence-based coverage process before any claim gets paid.

When will Medicare actually start paying for MCED tests?
No earlier than January 1, 2028, and only for beneficiaries age 68 and younger in that first year. The age ceiling rises by one year annually, reaching 75-and-younger by 2035. The 2028 date also assumes an FDA-authorized test exists by then, which is not yet the case.

Is Grail's Galleri test covered under this law?
Not currently. Galleri and every other MCED product on the market today are laboratory-developed tests without FDA approval or authorization, which this law requires before Medicare coverage can attach.

How much will Medicare pay for a covered MCED test?
Through December 31, 2030, payment is pegged to the CLFS rate for the multi-target stool DNA test (Cologuard), reported at $509. From January 1, 2031 onward, payment becomes the lesser of that pegged rate or the then-current Cologuard CLFS rate.

Does MCED coverage replace mammograms, colonoscopies, or other cancer screenings?
No. The law explicitly positions MCED testing as complementary to, not a replacement for, existing recommended single-cancer screenings, and beneficiary cost-sharing for those screenings is unaffected.

Educational disclaimer: This article summarizes federal legislation and Medicare coverage policy as of August 2026 for general informational purposes. Coverage determinations, CLFS payment methodology, FDA regulatory status for laboratory developed tests, and implementation timelines are subject to change through further CMS rulemaking, FDA action, and legislation. This is not billing, legal, financial, or medical advice; verify against current CMS and FDA guidance and consult qualified reimbursement and regulatory professionals. ScreenMyGene is clinical decision support and does not replace independent professional judgment.

Sources: Congress.gov, bill records for H.R. 842 and S. 339 (119th Congress), H.R. 2407 (118th Congress), and S. 1873 / H.R. 1946 (117th Congress); Rep. Terri Sewell, press release on the Act's signing, Feb. 4, 2026; AZBio, "Long Awaited Legislation on Multi Cancer Early Detection Tests for Medicare Beneficiaries Becomes Law," Feb. 2026; Fight Colorectal Cancer / MCED coalition legislative fact sheet, 119th Congress; 360Dx, "FDA-Approved MCED Tests Set for Medicare Coverage as Federal Spending Bill Passes"; Exact Sciences, press release on passage of Medicare MCED coverage legislation; STAT News, Levy & Konety op-ed, Jan. 28, 2026; Association for Diagnostics & Laboratory Medicine (ADLM), "District court strikes down the FDA's final laboratory developed tests rule," 2025; Congress.gov CRS product IF11389, "FDA Regulation of Laboratory-Developed Tests (LDTs)."

For the compliance side of genetic and molecular test spending, see our guide to the CRUSH program-integrity rule now at OMB and our overview of Medicare coverage pathways for genetic testing. ScreenMyGene helps labs match orders to documented indications and the governing coverage policy before a claim is filed - work that will matter as much for MCED tests in 2028 as it does for hereditary cancer panels today.