ModifiedHealthfirstPolicy PO-RE-080v3

Colorectal Cancer Screening

Defines coverage, indications, limitations, scientific background, guidelines, and applicable codes for colorectal cancer screening for Healthfirst members, including recommended screening modalities and age-based coverage rules.

Policy Summary

PayerHealthfirst

PolicyColorectal Cancer Screening

Policy CodePolicy PO-RE-080v3

Change TypeCoverage revisions and coding updates (material)

Effective DateJul 1, 2025

Next Review Date

Key ActionUse updated coverage rules: FIT-DNA (Cologuard) is covered for average-risk members 45–75 every 3 years per client variance; apply age and high-risk exclusions when authorizing or billing.

SourceLink

POLICY UPDATE CHANGES

Added Cologuard Plus to CC2 and language stating FIT-DNA (Cologuard™, Cologuard Plus™) and methylated Septin 9 (ColoVantage) do not meet coverage criteria.

Added screening using cell-free DNA techniques (e.g., Guardant Shield™) as a new CC4.c.

Added CPT code 0537U (effective 2025-04-01) to coding.

Off-cycle coding modification: Added CPT code 0464U (effective 2024-07-01).

Removed CC2.

Client requested variance: FIT-DNA (Cologuard) meets coverage criteria for average-risk individuals aged 45-75 once every three years, excluding high-risk individuals.

10 yrsRecommended interval for colonoscopy

45-75Age range with covered stool-based screening

annual

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Recommended frequency for FIT

every 3 yrsCoverage interval for FIT-DNA

Not coveredScreening for >75 years (average risk)

Coverage Criteria for Colorectal Cancer Screening

Coverage by age and modality

Covered and not-covered scenarios per age and modality

Average-risk ages 45-75 — FIT or gFOBT: For asymptomatic individuals 45 to 75 years of age, annual screening for colorectal cancer with a fecal immunochemical test (FIT) (preferred) or a guaiac fecal occult blood test (gFOBT) MEETS COVERAGE CRITERIA.annual

FIT preferred; gFOBT acceptable if indicated.

Average-risk ages 45-75 — FIT-DNA (Cologuard): Colorectal cancer screening using FIT-DNA (Cologuard) MEETS COVERAGE CRITERIA for average-risk individuals aged 45-75 (excluding high-risk individuals) once every three years.every 3 years

Excludes individuals classified as high-risk per policy exclusions.

Average-risk over 75: For average-risk, asymptomatic individuals over 75 years of age, colorectal cancer screening DOES NOT MEET COVERAGE CRITERIA.age >75

Screening in this age group may be denied.

Techniques that do not meet coverage: The following screening techniques do not meet coverage criteria due to insufficient evidence: screening for anal cytological abnormalities (anal pap smear); screening for anal HPV infection; screening using cell-free DNA techniques (e.g., Guardant Shield™).N/A

Not covered as screening modalities.

Guideline-based coverage criteria

Guideline-based screening recommendations and intervals from USPSTF, ACS, ACG, Multi-Society Task Force, and NCCN

Initiation age for average-risk screening: Begin colorectal cancer screening at age 45 for average-risk individuals; some organizations (ACG) give a conditional suggestion for ages 45–49 while recommending strongly for ages 50–75.age >=45

Sources: ACS, USPSTF, ACG, Multi-Society Task Force, NCCN.

Acceptable screening modalities and recommended intervals: Acceptable modalities and intervals include: annual FIT or high-sensitivity gFOBT; multitarget stool DNA (sDNA-FIT / FIT-DNA) commonly every 3 years (1–3 year range noted); colonoscopy every 10 years; CT colonography every 5 years; flexible sigmoidoscopy every 5 years (or 5–10 years per some guidance).intervals per modality

Modalities and intervals summarized from USPSTF, ACS, ACG, Multi-Society Task Force, NCCN.

Follow-up of abnormal noninvasive tests:

Revised coverage statements and client variance

Revisions to coverage criteria reported in revision history (07/01/2025):

Client-requested variance permitting FIT-DNA: Client requested variance: Colorectal cancer screening using FIT-DNA (Cologuard) MEETS COVERAGE CRITERIA for average-risk individuals aged 45-75 (excluding high-risk individuals) once every three years.age 45-75; every 3 years

This variance overrode prior language that removed FIT-DNA from coverage; high-risk individuals remain excluded.

Tests added as not meeting coverage in revision: Revision added language stating that methylated Septin 9 (ColoVantage) and FIT-DNA (Cologuard™, Cologuard Plus™) do not meet coverage criteria (CC2), though CC2 was later removed when the client variance permitted FIT-DNA for average-risk 45–75.N/A

Reflects sequence of changes documented in revision history.

Addition of cell-free DNA category:

For asymptomatic, average-risk members older than 75 years, colorectal cancer screening does not meet coverage criteria and screening requests for this population may be denied. This exclusion applies to routine screening (not diagnostic evaluation) and reflects the policy's age-based coverage limits for average-risk individuals.

The policy excludes certain screening techniques due to insufficient evidence. Specifically, screening using anal cytology (anal Pap smear), screening for anal HPV infection, and screening using cell-free DNA techniques (e.g., Guardant Shield™) do not meet coverage criteria.

FDA-labeled contraindications and intended use statements affect coverage for specific tests. For Epi proColon (Septin 9), the FDA indicates it is intended for adults ≥50 who have declined recommended screening and that positive results should be followed by diagnostic colonoscopy; the FDA also specifies populations not clinically evaluated. For Cologuard/Cologuard Plus, the FDA indicates the tests are intended for average-risk adults (Cologuard: ≥50; Cologuard Plus: ≥45) and lists contraindications including a personal history of colorectal cancer or advanced precancerous lesions, a positive result from another CRC screening method within specified look-back windows (eg, 36 months for FIT-DNA; 12 months for FOBT/FIT), family history qualifying as first-degree relative with CRC, inflammatory bowel disease, hereditary cancer syndromes, and other high-risk conditions. Tests used in FDA-contraindicated populations are not appropriate uses and may affect coverage or trigger denials.

A client-requested variance permits coverage of FIT-DNA (Cologuard) for average-risk individuals aged 45–75 years once every three years. This variance explicitly excludes high-risk individuals; the FIT‑DNA coverage under this variance applies only to average-risk members within the specified age range.

The policy does not recommend or consider covered cell-free DNA blood-based screening tests that lack sufficient validation. Examples called out include Guardant Shield™ and other blood-based or laboratory-developed cell‑free DNA assays (including some marketed SEPT9/ColoVantage tests). The source documents note these tests are intended to be complementary and not replacements for recommended CRC screening methods and that evidence for detection of early precancerous lesions is limited; accordingly, such tests are categorized as not meeting coverage criteria absent adequate validation.

The FDA states that tests such as Epi proColon (methylated Septin 9) and certain stool-based tests are indicated for screening in average-risk populations only and are not a replacement for diagnostic or surveillance colonoscopy in high‑risk individuals. The FDA further advises that patients with positive blood-based or stool screening results should be referred for diagnostic colonoscopy, and that other recommended screening tests should be offered and declined prior to offering some blood‑based options.

Revision history documents an operational change in how methylated Septin 9 and FIT‑DNA tests are referenced. The 07/01/2025 update added language stating that use of methylated Septin 9 (ColoVantage) or FIT‑DNA (Cologuard™, Cologuard Plus™) did not meet coverage criteria, and also added cell‑free DNA techniques as a coverage category. The revision later included a client-requested variance reinstating coverage for Cologuard for average‑risk individuals aged 45–75 every 3 years, and removed the prior CC2 statement.

Coding and Procedure Codes

Molecular/Oncology screening codesCPT

81327	SEPT9 (Septin9) (eg, colorectal cancer) promoter methylation analysis.
81528	Oncology (colorectal) screening, quantitative real-time target, and signal amplification of 10 DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and.

Stool/blood test and related codesmixed

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 (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68).
87625	Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed.
88112	Cytopathology, selective cellular enhancement technique with interpretation (eg, liquid-based slide preparation method), except cervical or vaginal.
0500T	Infectious agent detection by nucleic acid (DNA or RNA), Human Papillomavirus (HPV) for five or more separately reported high-risk HPV types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) (ie, genotyping).
0464U	Oncology (colorectal) screening, quantitative real-time target and signal amplification, methylated DNA markers, plus protein marker (fecal hemoglobin), utilizing stool, algorithm reported as a positive or negative result — Proprietary Test: Cologuard PlusTM.

Proprietary lab codesCPT

0537U

Oncology (colorectal cancer), analysis of cell-free DNA for epigenomic patterns, next-generation sequencing, >2500 differentially methylated regions (DMRs), plasma, algorithm reported as positive or negative — Proprietary Test: ShieldTM.

Added CPT CodesCPT

0537U	CPT code added (effective 4/1/2025)
0464U	CPT code added (effective 07/01/2024)

FIT threshold and modeling

FIT hemoglobin threshold (modeling)20 μg hemoglobin per gram of feces

FIT specimen handlingSingle stool sample returned to lab within 24 hours for processing (quantitative or qualitative)

FIT frequency (guideline)Every year

Provider Actions, Documentation, and Billing Guidance

Prior Authorization

Prior authorization not specified in available chunks

The provided policy sections do not specify any prior authorization requirements or code-level PA rules for colorectal cancer screening tests in the available content.

Billing Rule

Codes to use for stool- and blood-based CRC screening

Use the listed procedure and proprietary test codes when submitting claims or for prior authorization processes; these codes correspond to stool- and blood-based CRC screening tests referenced in the policy.

CPT/HCPCS: 81327, 81528, 82270, 82274, 88112
Other: 0500T
Proprietary/Proprietary CPT: 0464U (Cologuard Plus), 0537U (Shield™)

Background and Clinical Rationale

Colorectal cancer arises in the colon or rectum and screening reduces both incidence and mortality by detecting adenomas and early cancers. Established screening options include stool‑based tests (eg, FIT, gFOBT, and multitarget stool DNA) and direct visualization (eg, colonoscopy), and guideline-based screening beginning at age 45 for average‑risk adults has been endorsed by multiple societies. FIT is preferred over gFOBT for convenience and sensitivity, and appropriate screening intervals (eg, annual FIT, colonoscopy every 10 years, or multitarget stool DNA every 3 years) are used to balance benefits and harms.

Definitions and Test Descriptions

FIT — definition and typical use

DefinitionFecal immunochemical test (FIT): stool test that directly measures human hemoglobin in feces (quantitative or qualitative)

Specimen and processingTypically single-sample collection; specimen returned to lab and processed within 24 hours

Typical use and frequencyUsed for average-risk CRC screening; recommended annually

Advantages vs gFOBTImproved accuracy and higher sensitivity; greater patient convenience and participation

gFOBT — test details

DefinitionGuaiac-based fecal occult blood test (gFOBT): reagent-based stool card test that detects hemoglobin via a peroxidase reaction turning guaiac paper blue

Policy Revision History

2025-07-01policy_revisionLatest

Reviewed and updated background, guidelines, and evidence; revised coverage criteria including addition of Cologuard Plus and creation of CC4.c for cell-free DNA techniques.

2025-07-01coverage_change

Added language stating that methylated Septin 9 (ColoVantage) or FIT-DNA (Cologuard, Cologuard Plus) does not meet coverage criteria, and concurrently removed CC2.

2025-07-01client_variance

Policy Summary

PayerHealthfirst

PolicyColorectal Cancer Screening

Policy CodePolicy PO-RE-080v3

Change TypeCoverage revisions and coding updates (material)

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Any abnormal stool- or blood-based screening test requires diagnostic colonoscopy for evaluation; harms from noninvasive screening largely arise from follow-up colonoscopy and its complications.

Consistent across guideline sources and FDA considerations.

Stopping and individualization of screening: Continue regular screening through age 75 for those in good health; ages 76–85 should be individualized based on life expectancy, comorbidities, prior screening history, and patient preference; do not screen after age 85.<=75 recommended; 76-85 individualized; >85 not recommended

Recommendations per ACS, Multi-Society Task Force, NCCN, and ACG.

Screening using cell-free DNA techniques (e.g., Guardant Shield™) was added as a new coverage category (CC4.c.) in the revision history and is listed among techniques that do not meet coverage criteria due to insufficient evidence.

New test category added 07/01/2025.

Listed lab/test codes: 87624, 87625

Billing Rule

Updated CPT codes

Two CPT codes were added/updated in the revision history and should be used when applicable: 0464U (effective 07/01/2024) and 0537U (effective 04/01/2025); these updates may affect prior authorization or billing.

0464U — Cologuard Plus (effective 07/01/2024).
0537U — Shield™ (effective 04/01/2025).

Step Therapy

Step therapy not specified

No step therapy requirements or mandated sequencing (step-based coverage) for CRC screening modalities are specified in the provided content.

Note

Sequencing for Epi proColon

Per the FDA, the Epi proColon (Septin 9) test should be offered only after patients have been offered and declined recommended USPSTF-listed CRC screening tests, implying sequencing that other recommended tests be offered first.

FDA statement: 'Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered and declined prior to offering the Epi proColon test.'
A positive Epi proColon result should be followed by diagnostic colonoscopy.

Prior Authorization

FIT-DNA coverage variance (Cologuard)

A client-requested variance permits FIT-DNA (Cologuard) for average-risk individuals aged 45–75 once every three years; this coverage explicitly excludes high-risk individuals.

Policy: 'Colorectal cancer screening using FIT-DNA (Cologuard) MEETS COVERAGE CRITERIA for average risk individuals aged 45-75 (excluding high risk individuals) once every three years.'
Revision history confirms client requested variance adding this coverage.

Documentation Required

Risk assessment and FIT specimen handling

Screening should occur after an individualized risk assessment during a preventive visit; FIT specimens are collected by the patient and must be returned to the laboratory for processing within 24 hours of collection.

FIT: single-sample collection, returned to lab within 24 hours; may be quantitative or qualitative.
Screening initiation occurs during a preventive visit with individual risk assessment.

Documentation Required

Post-test interval documentation after negative colonoscopy

If a high-quality colonoscopy is negative after a positive FIT or mt-sDNA and the patient is asymptomatic, document the high-quality colonoscopy and prior test results to support returning the patient to average-risk screening intervals (for example, 10 years).

NCCN: 'If the colonoscopy is negative after a FIT or mt-sDNA, no symptoms are present, and the colonoscopy was a high-quality examination, patients can return to average-risk screening intervals beginning at 10 years after the colonoscopy.'
Documentation of colonoscopy quality and prior test result is required to support interval.

Documentation Required

Documentation and coding standards

Follow national industry coding standards (NCCI, NCD/LCD), CPT/HCPCS/ICD-10 principles, appropriate modifier usage, and any state-specific coding/billing rules; reimbursement decisions are based on evidence of coverage and provider agreements.

Healthfirst claim edits align with NCCI, NCD/LCD, AMA/CMS CPT, HCPCS, and ICD-10 coding principles.
Failure to follow these standards may affect payment determinations.

Denial Risk

Age >75 exclusion — denial risk

Screening for average-risk, asymptomatic individuals older than 75 years does not meet coverage criteria and may be denied; do not submit claims for routine average-risk screening in this age group.

Policy: 'For average risk, asymptomatic individuals over 75 years of age, colorectal cancer screening DOES NOT MEET COVERAGE CRITERIA.'

Denial Risk

FDA contraindications may affect coverage

Tests used in populations the FDA lists as contraindicated (for example, personal history of CRC or advanced precancerous lesions; recent positive results within specified lookback windows; family history or hereditary syndromes; inflammatory bowel disease) may trigger non-indication or denial of coverage.

FDA contraindications include personal history of CRC/adenomas, positive result from another screening within specified intervals, family history of CRC, IBD, hereditary cancer syndromes, and other listed high-risk conditions.
Cologuard/Cologuard Plus and Epi proColon labeling note these contraindicated populations.

Denial Risk

Coding and billing noncompliance — denial/recoupment risk

Failure to follow proper coding, billing, and reimbursement guidelines (including the coding standards detailed in the policy) could result in claim denial and/or recoupment of payment.

Healthfirst warns that failure to follow coding/billing/reimbursement policy guidelines could result in denial and/or recoupment.
Reimbursement decisions depend on evidence of coverage, state/federal requirements, and provider participation agreements.

Specimen collectionCollects samples from three consecutive bowel movements on a test card mailed to the laboratory

Testing considerationsRequires dietary restrictions for some reagents; high-sensitivity guaiac variants (eg, Hemoccult SENSA) have better performance

LimitationsLower sensitivity for advanced adenomas and right-sided lesions compared with FIT

FIT-DNA / mt-sDNA / Cologuard — description

DefinitionFIT-DNA (multi-target stool DNA; mt-sDNA; Cologuard): a composite stool test combining an immunochemical FIT with molecular DNA assays for KRAS mutations and methylation markers

Specimen and logisticsWhole stool collection using a kit mailed to the vendor; should arrive within 72 hours of collection

ComponentsMolecular assays for DNA alterations (eg, KRAS), methylation marker amplification, plus an immunochemical hemoglobin assay

IndicationIntended for average-risk adults (Cologuard labeled for age 45+ or 50+ depending on version); positive results require diagnostic colonoscopy

FIT — annual frequency and accuracy

FrequencyFIT is typically performed annually

Single-sample testFIT usually requires one stool sample versus three for gFOBT

AccuracyCertain FIT types (quantitative) have improved accuracy compared with gFOBT and high-sensitivity gFOBT

sDNA-FIT (mt-sDNA / Cologuard) — performance and interval

Sensitivity vs FITsDNA-FIT (mt-sDNA/Cologuard) has improved sensitivity per single application compared with FIT but lower specificity, leading to more false positives

Recommended intervalCommonly recommended every 3 years (sDNA-FIT every 1–3 years per guidelines)

Downstream impactLower specificity results in more follow-up colonoscopies and associated adverse events per test compared with FIT

Epi proColon / Septin 9 — blood-based assay

Test and targetEpi proColon: qualitative blood-based test detecting methylated Septin 9 DNA (SEPT9) in plasma using real-time PCR

Indication and ageFDA-indicated for screening adults 50 years or older who are average risk and have not completed other CRC screening

Sequencing recommendationFDA states recommended stool-based tests should be offered and declined prior to offering Epi proColon; positive results require diagnostic colonoscopy

RoleIntended as an alternative for those who decline USPSTF-recommended tests, not a replacement for colonoscopy in high-risk individuals

FIT-DNA (Cologuard, Cologuard Plus) — definition & policy notes

DefinitionFIT-DNA (Cologuard, Cologuard Plus): stool-based combined fecal immunochemical and DNA test for colorectal screening

Coverage historyPolicy language was revised to state FIT-DNA did not meet coverage criteria, but a client-requested variance later permitted Cologuard for average-risk individuals 45–75 every 3 years

Regulatory noteCologuard/Cologuard Plus FDA labeling indicates positive results should be followed by diagnostic colonoscopy and lists contraindicated high-risk populations

methylated Septin 9 (ColoVantage) — policy reference

Reference to testMethylated Septin 9 (ColoVantage) is referenced in revision history as not meeting coverage criteria

ContextListed alongside FIT-DNA as tests that were stated not to meet coverage in the July 1, 2025 revision (CC language)

ImplicationAs stated in revision history, these blood-based tests are not covered due to insufficient evidence unless policy is changed

Cell-free DNA techniques — emerging approaches

Emerging category addedCell-free DNA techniques (eg, Guardant Shield™) were added to the policy as a new screening category (CC4.c.) in the July 1, 2025 revision

Proprietary exampleGuardant Shield™ is cited as an example of cell-free DNA-based screening added to the document

Coverage stanceThese emerging cell-free DNA techniques are listed separately and are not established as covered in standard criteria

Client requested variance added: FIT-DNA (Cologuard) meets coverage criteria for average-risk individuals aged 45–75 (excluding high-risk) once every three years.

2025-04-01coding_update

Added CPT code 0537U (effective 2025-04-01) to the policy coding list.

2024-07-01off_cycle_coding_update

Off-cycle coding modification added CPT code 0464U (effective 2024-07-01).