Medicare colorectal biomarker coverage: June 8 effective date, January 4 claims implementation
Sep 20, 2026 edition · GC-2026-0013 · Published 2026-09-20 · Version 2 · Final
Medicare covers qualifying colorectal biomarker screening under detailed patient and test criteria; January 4 claims implementation follows the June 8 coverage effective date.
What happened
CMS issued R13921NCD and R13921CP on August 27 under CR 14581, with coverage effective for services on or after June 8, 2026, and claims-system implementation on January 4, 2027. NCD 210.3 covers noninvasive colorectal biomarker screening once every three years when ordered by a physician, physician assistant, nurse practitioner or clinical nurse specialist who will use the results to manage the patient. Patients must be aged 45 through 85, asymptomatic, and at average risk. The exclusions include a personal history of adenomatous polyps, colorectal cancer or inflammatory bowel disease and a family history of colorectal cancer, adenomatous polyps, familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer. A positive result from a previous noninvasive biomarker screening test also falls outside the asymptomatic criterion. Patients must receive counseling on test performance and the importance of follow-on colonoscopy after a positive result.
The test must have FDA marketing authorization with a colorectal screening indication, meet required FDA postapproval-study conditions for continued coverage, and be processed in a CLIA-certified laboratory. Its FDA-labeled performance against the recognized standard must meet either sensitivity of at least 90% with specificity of at least 87%, or sensitivity of at least 79% with specificity of at least 90%. Other indications not otherwise specified in the Act, regulations or the NCD remain nationally noncovered. The claims instructions identify ColoSense code 0421U and waive its deductible and coinsurance when the NCD criteria are met. Frequency edits require at least 35 months since the last covered screening, implementing the three-year interval. Contractors will not search their files for affected June 8 onward claims, but may adjust claims brought to their attention; the January systems date therefore does not promise automatic retrospective payment.
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
Ordering eligibility, laboratory/test qualification and claims edits must agree. Treating the January systems date as the start of coverage, or promising waived cost sharing without the NCD criteria, can misdirect patients and billing staff.
Recommended action
Have clinical and coding owners verify patient risk, symptoms, counseling, test eligibility and the screening interval. Align 0421U cost-sharing logic with the NCD, track January 4 implementation, and refer potentially affected June 8 onward claims to the MAC for possible adjustment without assuming an automatic search or guaranteed adjustment.
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
- R13921NCD complete CMS transmittalOfficial · Centers for Medicare & Medicaid Services · 2026-08-27 · Source review 2026-10-15
- R13921CP complete CMS transmittalOfficial · Centers for Medicare & Medicaid Services · 2026-08-27 · Source review 2026-10-15
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