Colorectal cancer screening with stool DNA (FIT‑DNA/Cologuard)
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Coverage and reimbursement policy for use of stool DNA testing (FIT‑DNA, e.g., Cologuard) as a colorectal cancer screening modality for asymptomatic average‑risk adults; applies to BCBSNC providers and members as described in the member benefit booklet.
No material clinical or coverage changes in this revision.
Coverage Criteria — FIT‑DNA (stool DNA) Screening
FIT‑DNA (stool DNA) screening — covered when ALL of the following are met
Covered when ALL of the following are met
Average‑risk definition per USPSTF (see policy).
Test intended as a screening modality; clinical utility and test characteristics described in policy guidelines.
Policy allows reimbursement of FIT‑DNA every 3 years; evidence and modeling addressing interval effectiveness are discussed in policy guidelines.
Inclusion of applicable CPT code in policy does not guarantee payment; adjudication may require review of member benefits and medical records.
Covered when ALL of the following are met: 1) the individual is asymptomatic and at average risk for colorectal cancer (per USPSTF definition); 2) FIT‑DNA testing (eg, Cologuard) is used solely as a screening test (not diagnostic evaluation or surveillance); 3) reimbursement is requested at an interval of every 3 years or longer; and 4) applicable member benefits allow coverage.
Reimbursement is not allowed for colorectal cancer screening with DNA analysis of stool samples for indications other than average‑risk screening. Reimbursement is also not allowed when the screening interval is less than 3 years.
Applicable Service Codes
| 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, Documentation, and Billing Notes
CPT 81528 inclusion does not guarantee reimbursement
Inclusion of CPT code 81528 in the policy does not guarantee reimbursement; adjudication may require review against member benefits and may include medical record requests.
- Applicable service code listed: 81528
- Reimbursement depends on member benefit review and administrative policies
No step therapy requirements specified
No step therapy requirements are specified in the policy text for FIT‑DNA (Cologuard).
- Policy guidelines describe test characteristics and intervals but do not impose prior step-failure requirements.
Medical records may be requested for medical necessity
BCBSNC may request medical records to determine medical necessity; when records are requested include the specific information needed to make the medical necessity determination (letters of support alone are often useful but are not sufficient).
- Provide complete medical records as requested to support coverage decisions
- Letters of support/explanation may be useful but are not sufficient unless they include all required information
Denial risk for non‑average‑risk indications or intervals <3 years
Reimbursement is not allowed for stool DNA screening for indications other than average‑risk screening and is not allowed at intervals less than every 3 years.
- Do not submit claims for FIT‑DNA for diagnostic, surveillance, or other non–average‑risk indications.
- Do not submit claims for FIT‑DNA more frequently than every 3 years.
Background and Clinical Rationale
Colorectal cancer screening with stool DNA targets shed tumor DNA and fecal hemoglobin detectable in stool; however, this policy limits reimbursement to average‑risk screening and specifies interval restrictions. As stated in the policy, screening with DNA analysis of stool samples is not covered for indications other than average‑risk screening and is not covered when performed at intervals of less than 3 years.
Definitions
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