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Colorectal Cancer Screening
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Defines Oscar Health's coverage stance, indications, and limits for colorectal cancer screening modalities (stool-based tests, blood/plasma tests, and related proprietary assays) for members, including age-based recommendations and tests considered not covered.
No material clinical or coverage changes in this revision.
Coverage criteria and test-specific coverage
Covered and not covered by age/test
The policy explicitly excludes several screening modalities from meeting criteria due to insufficient published evidence. Screening for anal cytological abnormalities (anal Pap smear) and screening for anal HPV infection are listed as techniques that do not meet criteria. The policy also specifically excludes screening using cell-free DNA techniques (for example, Guardant Shield™) from meeting criteria for colorectal cancer screening in average-risk, asymptomatic individuals aged 45–75 years. These exclusions apply to screening indications and reflect the policy's assessment of the available evidence.
The FDA labeling for Cologuard and Cologuard Plus includes specific intended uses and contraindications that should be followed when ordering these tests. Cologuard is indicated to screen adults 50 years or older at average risk and a positive result should be followed by diagnostic colonoscopy; it is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals. The FDA notes populations not clinically evaluated for Cologuard use, including those with a prior history of colorectal cancer or adenomas, a positive result from another screening method within the prior 6 months, inflammatory bowel disease, familial cancer syndromes, or other high-risk conditions. The Cologuard Plus FDA indication extends screening to adults 45 years or older at average risk and lists contraindications including a personal history of colorectal cancer or advanced precancerous lesions, recent positive results from other screening tests (with specified timeframes: 6 months for most tests; 12 months for FOBT/FIT; 36 months for FIT-DNA), a first-degree relative with CRC, and diagnoses associated with high CRC risk or hereditary cancer syndromes. Providers should document and follow these FDA labeling guidance when considering Cologuard/Cologuard Plus for screening.
The policy provides procedural descriptions and corresponding CPT/HCPCS references for colorectal cancer screening tests. Examples include CPT 81528 describing an oncology (colorectal) stool-based screening that amplifies multiple DNA markers (KRAS mutations and promoter methylation of NDRG4 and BMP3) plus fecal hemoglobin and reports an algorithmic positive/negative result, CPT 82270 and 82274 for guaiac and immunoassay fecal occult blood testing, CPTs 87624–87626 for HPV nucleic acid detection, and CPT 88112 for cytopathology selective cellular enhancement techniques (liquid-based preparations, except cervical/vaginal). Proprietary test names (for example, Cologuard, Cologuard Plus, ColoSense) are referenced in the descriptive text associated with these codes and should be used on authorizations and claims as appropriate.
The policy identifies several blood-based/plasma cell-free DNA tests and assays that are considered not to meet coverage criteria because of limited published validation. Named examples include ColoVantage®, a plasma SEPT9 methylation assay, and Guardant Shield™, a Guardant Health blood-based screening assay. The policy also references other plasma SEPT9 assays (blood-based SEPT9/SEPTIN 9 tests) as not meeting criteria. These tests are noted in the document as lacking sufficient evidence to support routine colorectal cancer screening in average-risk, asymptomatic individuals.
The section of the policy that lists procedure codes and descriptive text does not itself apply explicit 'not medically necessary' labels to specific tests. Instead, it provides coding references and descriptive language for stool- and laboratory-based tests; determinations that a test does or does not meet criteria are described elsewhere in the coverage sections rather than in the code listing block.
Applicable procedure codes and proprietary identifiers
| 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 |
| 82270 | Blood, occult, by peroxidase activity (eg, guaiac), qualitative; feces, consecutive collected. specimens with single determination, for colorectal neoplasm screening (ie, patient was provided 3 cards or single triple card for consecutive collection) |
| 82274 | Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations |
| 87624 | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types, pooled result |
| 87625 | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed |
| 87626 | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types, separate or pooled result |
| 88112 | Cytopathology, selective cellular enhancement technique with interpretation (eg, liquid-based slide preparation method), except cervical or vaginal |
| 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 |
| 82270 | Blood, occult, by peroxidase activity (eg, guaiac), qualitative; feces, consecutive collected. specimens with single determination, for colorectal neoplasm screening (ie, patient was provided 3 cards or single triple card for consecutive collection) |
| 82274 | Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3. Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations |
| 87624 | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68), pooled result |
| 87625 | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed |
| 87626 | Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types (eg, 16, 18, 31, 45, 51, 52), separate or pooled result |
| 88112 | Cytopathology, selective cellular enhancement technique with interpretation (eg, liquid-based slide preparation method), except cervical or vaginal |
| Proprietary | References to Proprietary Tests: Colosense™, Cologuard Plus™; Lab/Manufacturer attribution included in CPT descriptive text (eg, Geneoscopy, Inc; Exact Sciences Laboratories, LLC) |
Provider responsibilities, authorization, and billing guidance
Authorization depends on member benefit
Coverage and any authorization depend on the member's benefit plan and applicable medical necessity/authorization policies; services must meet authorization and medical necessity guidelines for the procedure, diagnosis, and member's state of residence.
- Coverage does not guarantee reimbursement; other factors (legislative mandates, provider contracts, member benefit documents, and other policies) may modify determinations.
Use listed CPT/HCPCS codes on prior authorization and claims
When requesting authorization or submitting claims, include the applicable CPT/HCPCS procedure code for the stool- or blood-based colorectal screening test being performed (see Applicable CPT/HCPCS Procedure Codes section).
Prior authorization depends on member/plan; codes provided for reference
The policy lists specific CPT/HCPCS procedure codes for reference but does not specify additional, separate prior authorization rules in this section; confirm member-specific prior authorization requirements at time of request.
- Procedure codes are provided for billing and reference; prior authorization requirements are determined by member benefit and plan rules.
Order tests only for members meeting covered indications and sequencing limits
Ensure testing is ordered only for members who meet the policy's covered indications and intervals; do not substitute multi-target stool tests within restricted intervals (a different multi-target stool test performed within the prior 3 years does not meet criteria).
- Multi-target stool-based tests performed within the last 3 years: use of a different approved multi-target stool-based test does not meet criteria.
- For ages 45–75 follow recommended screening intervals; >75 years does not meet criteria for average-risk screening.
Use guideline-informed modality and frequency sequencing
Follow guideline-informed sequencing and intervals when selecting screening modalities: annual FIT or high-sensitivity gFOBT, colonoscopy every 10 years, and sDNA-FIT (mt-sDNA) every 1–3 years; consider guideline tradeoffs (sensitivity vs specificity) when choosing modality.
- FIT and high-sensitivity gFOBT: annual screening.
- Colonoscopy: every 10 years for average-risk screening.
- sDNA-FIT (mt-sDNA): every 1–3 years; note higher sensitivity but lower specificity compared with FIT.
Document FDA indications and contraindications when ordering proprietary tests
Document clinical rationale and patient selection consistent with FDA indications and contraindications when ordering proprietary stool tests (e.g., Cologuard/Cologuard Plus); specifically document absence of FDA-listed contraindications if using these tests.
- FDA contraindications include prior colorectal cancer or advanced precancerous lesions, positive result from another CRC screening within specified timeframes, inflammatory bowel disease, certain hereditary cancer syndromes, and family history as defined by FDA labeling.
- Epi proColon and Cologuard/Cologuard Plus FDA indications and labeling should be documented where applicable.
Provider responsibility: accurate documentation and standard coding
Maintain accurate medical record documentation and apply industry-standard coding (CPT, HCPCS, ICD-10) when submitting claims; providers are responsible for submission of accurate documentation of services performed.
- Follow AMA CPT, HCPCS, ICD-10-CM/PCS, and CMS coding guidance (including NCCI edits) when coding claims.
- Retain documentation supporting the service and medical necessity in the medical record.
Reference government policies and document FDA test indications
If a government policy (NCD/LCD or state Medicaid) conflicts with this policy for a specific member, the government policy governs; when ordering FDA-cleared/approved tests, document FDA test indications (e.g., Epi proColon, Cologuard, Cologuard Plus) as part of the record.
- Use Medicare LCD/NCD or state Medicaid coverage rules where applicable.
- Document FDA-approved test indication (age and intended population) when ordering these tests.
Include the specific CPT/HCPCS code on claims and documentation
When submitting claims, reference the specific CPT/HCPCS procedure code listed in the policy's Applicable CPT/HCPCS Procedure Codes section corresponding to the test performed.
Failure to follow coding/billing guidelines risks denial or recoupment
Claims may be denied or recouped if coding/billing guidelines or current reimbursement policies are not followed; services must meet authorization, medical necessity, and benefit criteria to be reimbursed.
- Noncompliance with coding/billing guidance (CPT, HCPCS, NCCI) or failure to document medical necessity can result in denial or recoupment.
Avoid testing populations contraindicated by FDA labeling for Cologuard/Cologuard Plus
Do not order Cologuard or Cologuard Plus for populations not clinically evaluated per FDA labeling (examples include patients with prior colorectal cancer or advanced precancerous lesions, recent positive other screening tests within specified timeframes, inflammatory bowel disease, or certain hereditary cancer syndromes).
- Cologuard contraindications listed by FDA include history of colorectal cancer, adenomas, positive result from another CRC screening within last 6 months (or 12 months for FOBT/FIT, 36 months for FIT‑DNA), IBD (chronic ulcerative colitis, Crohn's), and specified familial/hereditary cancer syndromes.
Missing or incorrect CPT/HCPCS coding may cause denial
Ensure the claim includes the required CPT/HCPCS procedure code for the screening test performed; failure to include the appropriate code or submitting an incorrect code may trigger claim denial or miscoding issues.
- Absence of the required CPT/HCPCS code (e.g., 81528 for mt-sDNA) or use of an inappropriate code on the claim can lead to denial or administrative issues.
Clinical background and policy context
Colorectal cancer (CRC) arises in the colon or rectum and population screening aims to detect cancer at an earlier stage and to remove adenomatous polyps to reduce incidence and mortality. Screening is targeted to average-risk, asymptomatic adults and is based on age and risk assessment. For average-risk individuals, this policy supports screening beginning at age 45 and continuing through age 75, with modality-specific intervals intended to balance sensitivity, specificity, and practicality: annual FIT or gFOBT (preferred FIT) and mt-sDNA/mt-sRNA every 3 years. Screening beyond age 75 for average-risk asymptomatic individuals does not meet criteria. Risk factors such as a first-degree relative with early-onset CRC, personal history of colorectal neoplasia, inflammatory bowel disease, or hereditary cancer syndromes increase risk and warrant alternative management outside of average-risk screening algorithms.
Definitions and test terminology
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