Colorectal cancer screening using stool DNA (FIT-DNA/Cologuard)
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This policy governs reimbursement for colorectal cancer screening using DNA analysis of stool samples (FIT-DNA/Cologuard) for members of Blue Cross Blue Shield of North Carolina, specifying covered intervals and eligible risk status.
No material clinical or coverage changes in this revision.
Coverage Criteria
Covered indications
Covered when ALL of the following are met:
based on USPSTF definition
Reimbursement is allowed every 3 years
Positive FIT‑DNA test results should be followed by diagnostic colonoscopy per standard clinical practice
Reimbursement is not allowed for FIT‑DNA (DNA analysis of stool samples) when used for indications other than average‑risk colorectal cancer screening. Reimbursement is also not allowed when testing is performed at intervals of less than 3 years.
Use of DNA analysis of stool samples (FIT‑DNA) outside the specified screening interval or for non–average‑risk indications is considered not covered and reimbursement will not be provided.
Coding
| 81528 | Oncology (colorectal) screening, quantitative real-time target and signal amplification of 10 DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result. |
Provider Actions & Billing Guidance
Billing code (CPT 81528) — presence not a guarantee of payment
Use CPT code 81528 for FIT‑DNA (Cologuard) testing; inclusion of the code in the policy does not guarantee reimbursement and BCBSNC may request medical records to determine medical necessity.
- CPT 81528: Oncology (colorectal) screening, quantitative real‑time target and signal amplification of 10 DNA markers and fecal hemoglobin (stool).
- Presence of the code in the billing section does not ensure payment; records may be requested to support coverage.
Step therapy / sequencing — no step therapy required
FIT‑DNA (stool DNA testing, e.g., Cologuard) is described as an alternative screening modality to fecal occult blood testing, FIT, and colonoscopy; the policy does not impose any step‑therapy or sequencing requirements prior to FIT‑DNA.
- FIT‑DNA combines fecal immunochemical testing and DNA analysis and is presented as an alternative screening option.
- No prior testing or stepwise failure of other screening modalities is specified as a requirement for coverage.
Medical record request — submit complete documentation when asked
BCBSNC may request medical records to determine medical necessity; when records are requested include all specific information needed for a medical necessity determination (letters of support/explanation alone are not sufficient unless they contain all required details).
- Provide complete medical records as requested to support coverage determinations.
- Letters of support or explanation may be helpful but must include all specific required information to substitute for full documentation.
Denial triggers — intervals <3 years or non–average‑risk indications
Claims for FIT‑DNA will be denied/not reimbursed when performed more frequently than every 3 years or when used for indications other than average‑risk colorectal cancer screening.
- Reimbursement is not allowed for FIT‑DNA testing at intervals less than 3 years.
- Reimbursement is not allowed for FIT‑DNA testing for indications other than average‑risk screening.
Definitions
Background
Colorectal cancer develops through accumulated genetic and epigenetic alterations; tumor DNA from exfoliated intestinal cells can be detected in stool. Stool‑based DNA testing (FIT‑DNA) leverages detection of neoplasia‑associated DNA markers combined with fecal hemoglobin to identify individuals with possible colorectal neoplasia. Because FIT‑DNA has higher sensitivity but lower specificity than fecal immunochemical testing alone, appropriate use at recommended screening intervals is essential to balance benefits and harms; this policy restricts reimbursement to average‑risk screening and specifies an interval of no less than 3 years between tests.
Revision History
Policy effective date established for coverage of colorectal cancer screening using stool DNA (FIT-DNA) with reimbursement allowed every 3 years for average-risk adults.
Policy reviewed on 2025-04-01 (last review and next review dates recorded).
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