Medicare colorectal biomarker coverage: June 8 effective date, January 4 claims implementation
Oct 4, 2026 edition · GC-2026-0013 · Published 2026-10-04 · Version 2 · Final
Qualifying non-invasive colorectal biomarker screening is covered from June 8, 2026; January 4, 2027 is claims implementation, with specific patient, ordering and test conditions.
What happened
CMS's August 27, 2026 NCD 210.3 instructions and September 2 MM14581 explain coverage for qualifying non-invasive biomarker colorectal screening from June 8, with claims-system implementation January 4, 2027. Coverage is once every three years for asymptomatic, average-risk patients aged 45–85 who meet all remaining criteria. A physician, physician assistant, nurse practitioner or clinical nurse specialist must order the test and use the results for management. Patients must receive information about performance and the importance of colonoscopy after a positive result. The NCD defines average risk through specified personal and family-history exclusions, rather than age alone.
The test must have FDA market authorization for colorectal screening, meet applicable FDA post-approval study requirements and be processed in a CLIA-certified lab. Its FDA-labeling performance must meet either sensitivity of at least 90% with specificity at least 87%, or sensitivity at least 79% with specificity at least 90%, compared with colonoscopy. MM14581 identifies ColoSense code 0421U, waived deductible and coinsurance, and bill types 13X,14X or 85X. MACs will not automatically search for affected June 8-onward claims, but may adjust claims brought to their attention. These conditions distinguish effective coverage, test eligibility and retrospective claim handling from the later systems release.
Scope and timing
- Authority status
- Final
- Applicability
- Directly applicable
- Audience
- Health systems, Provider networks
- Jurisdiction
- Federal
- Affected functions
- Coding, Revenue Cycle, Clinical Operations, IT, Quality
- Responsible owner
- Coding
- Recorded date
- 2027-01-04
- Date type
- implementation
Why it matters
Claims and ordering screens need the full coverage criteria while preserving the earlier service-date entitlement and later implementation timing.
Recommended action
Validate patient, ordering, counseling and test criteria under NCD 210.3. Review eligible June 8-onward 0421U claims for contractor adjustment requests and prepare the January 4 systems changes.
Sources
- Transmittal R13921NCD, change request 14581, NCD 210.3 Screening for Colorectal Cancer, non invasive biomarker testsOfficial · Centers for Medicare & Medicaid Services · 2026-08-27 · Source review 2026-09-06
- Transmittal R13921CP, change request 14581, claims processing instructions for NCD 210.3Official · Centers for Medicare & Medicaid Services · 2026-08-27 · Source review 2026-09-06
- MLN Connects newsletter, August 27, 2026Official · Centers for Medicare & Medicaid Services · 2026-08-27 · Source review 2026-08-30
- MLN Connects, September 3, 2026Official · CMS · 2026-09-03 · Source review 2026-09-06
- MM14581: colorectal non-invasive biomarker testingOfficial · CMS · 2026-09-02 · Source review 2026-09-06
- Official retained source documentOfficial · Official issuing agency · Source review 2026-10-16
Complete edition and supplemental material
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