The Centers for Medicare & Medicaid Services proposed revising its National Coverage Determination for non-invasive colorectal cancer (CRC) screening tests: expanding coverage to beneficiaries aged 45–85 and tightening test performance thresholds. The draft requires FDA authorization, CLIA processing, and a post-approval study for continued coverage. Under the proposal, covered tests must meet either ≥90% sensitivity with ≥87% specificity or ≥79% sensitivity with ≥90% specificity versus standard of care. The change aligns Medicare policy with USPSTF guidance lowering screening age to 45 and is likely to affect makers of stool and blood-based assays such as Exact Sciences, Guardant Health, Geneoscopy and Freenome. The comment period runs until April 9; manufacturers will weigh the updated performance standards and post-market evidence requirements as they plan submissions and market access strategies.
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