Medicare expands multi‑cancer screens
A bipartisan law now expands Medicare coverage for multi‑cancer screening tests, broadening access for older patients and likely increasing demand for liquid‑biopsy and cytology‑linked screening workflows. That policy change will push labs to update triage, reporting, and billing practices for new screening modalities. (walb.com)
The Nancy Gardner Sewell Medicare Multi‑Cancer Early Detection Screening Coverage Act was signed into law on February 3, 2026 as part of the FY2026 appropriations package. (preventcancer.org) The statute defines a “multi‑cancer early detection screening test” as a test furnished on or after January 1, 2028 that is cleared under FDA 510(k), classified under 513(f)(2), or approved under 515 and that is a genomic sequencing blood or blood‑product test analyzing cell‑free nucleic acids (or a biological‑material test the Secretary deems comparable). (govtrack.us) The law creates a standalone Medicare benefit category for MCED tests and instructs CMS to use an evidence‑based coverage process — including determinations of beneficiary eligibility, testing frequency, and medical‑necessity criteria via a National Coverage Determination — rather than guaranteeing automatic coverage of any particular test. (advi.com) Medicare billing and claims handling will follow existing lab payment rules, so hospitals and reference labs must align new MCED orders with CPT/HCPCS coding, National Correct Coding Initiative edits, and the Medicare Claims Processing requirements to avoid denials and improper claims. (cms.gov) Industry response has been immediate: Exact Sciences publicly applauded the law as establishing a clear Medicare coverage pathway for MCED tests, framing the change as critical for detecting cancers that currently lack recommended screening. (investor.exactsciences.com) CMS is already generating real‑world evidence — for example the REACH study evaluating GRAIL’s Galleri in Medicare populations, which reports cancer signal detection and tissue‑of‑origin predictions that will inform downstream diagnostic triage and reporting workflows. (beckershospitalreview.com) As of March 2026 no MCED test has full FDA approval, so Medicare coverage under the new law will depend on future FDA clearances and subsequent CMS evidentiary and payment decisions. (cancertherapyadvisor.com)
