CurrentIndependent HealthPolicy M20161122035

Fecal DNA Testing for Colorectal Cancer

Defines medical necessity, coverage, and frequency limits for fecal DNA (Cologuard and Cologuard Plus) screening tests for average-risk colorectal cancer screening across Independent Health lines of business, including commercial, Medicare Advantage, and specific NY State plans.

Policy Summary

PayerIndependent Health

PolicyFecal DNA Testing for Colorectal Cancer

Policy CodePolicy M20161122035

Key ActionDocument that the patient is asymptomatic and at average CRC risk and confirm member meets the covered age range before performing fecal DNA testing.

Change TypeMaterial updates and clarifications (added Cologuard Plusclarified age ranges and billing constraints)

Effective DateJan 1, 2017

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Cologuard Plus™ (FDA approval October 2024) is included as a defined fecal DNA test and recommended to be followed by colonoscopy if positive.

Screening age for commercial/self-funded members specified as 45 to 75 years with testing frequency once every 1-3 years; Medicare Advantage aligns with Medicare preventive guidance (ages 45-85, every 3 years).

For State products CPT code 0464U will not be reimbursed; only billable Cologuard code is 81528.

every 1-3 yrscommercial frequency

every 3 yrsMedicare Advantage frequency

45-75commercial age range

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Coverage Criteria for Fecal DNA Screening

Commercial/Self-Funded Coverage

Covered when ALL of the following are met

Commercial/Self-Funded Eligibility: Member is age 45 to 75 yearsage 45-75

From Independent Health policy

Asymptomatic: Documentation supports patient is asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test (gFOBT) or fecal immunochemical test (iFOBT))asymptomatic

Required documentation

Average risk: Member is at average risk for colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease including Crohn's disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer)average risk

Excludes high-risk individuals

Frequency: Fecal DNA testing performed once every 1-3 years1-3 years

See policy guidance

Medicare Advantage Coverage

Covered when ALL of the following are met per Medicare Preventive Service guidance

Medicare Age: Member aged 45 to 85 yearsage 45-85

Aligns with Medicare preventive services

Asymptomatic: Member is asymptomaticasymptomatic

Medicare requirement

Average risk: Member at average colorectal cancer riskaverage risk

Medicare requirement

State Plan Screening Recommendations

Covered as part of New York State Department of Health criteria for average-risk screening

Recommended age: All men and women between ages 45 to 75 years at average risk should be screened with one of the recommended testsage 45-75

State DOH recommendation

Test frequency per Table 1: Fecal DNA testing (e.g., Cologuard and Cologuard Plus) recommended once every 3 years3 years

Table 1 entry

These fecal DNA multitarget stool tests (Cologuard® and Cologuard Plus™) are not appropriate for individuals with a personal history of colorectal cancer or colorectal adenomas, those with a hereditary cancer predisposition syndrome associated with colorectal cancer, or patients with chronic colorectal disorders such as inflammatory bowel disease or Crohn’s disease. A positive result from either test should be followed by colonoscopy.

New York State Medicaid regards colorectal cancer screening by any method that is not listed in the policy’s Table 1 as experimental and investigational and therefore not considered a covered screening method under NYS Medicaid at this time.

Use of colorectal cancer screening methods that are not included in Table 1 is classified by NYS Medicaid as experimental and investigational, and such methods are not covered for screening purposes under the State program.

Coding, Frequency and Billing Notes

Covered CPT/HCPCS Codes and state-specific billing notesmixedCovered

81528	Cologuard multitarget stool DNA with fecal immunochemical test
0464U	Not reimbursed for State products (code referenced as non-billable here)

Screening frequency (by product)

Commercial / Self‑Funded frequencyOnce every 1–3 years for eligible members (age 45–75 years) — test performed once every 1–3 years

Medicare Advantage frequencyOnce every 3 years per Medicare Preventive Service guidance (eligible age 45–85 years)

FIT (contextual)Fecal immunochemical test (FIT) — recommended annually as an alternative screening method

Colonoscopy (contextual)Colonoscopy — recommended every 10 years as an alternative screening strategy

Provider Actions, Authorization and Documentation

Prior Authorization

Pre-authorization is not required. Criteria above will be utilized upon retro-review when applicable.

Step Therapy

Not applicable; no step therapy requirements specified.

Documentation Required

Required Clinical Documentation

Documentation must support that the patient is asymptomatic and at average risk for colorectal cancer, and must verify the member meets the covered age ranges for the product being billed (Commercial/Self-Funded: ages 45–75; Medicare Advantage: ages 45–85). Documentation should explicitly note absence of signs or symptoms of colorectal disease (for example, no lower gastrointestinal pain, no blood in stool, no positive gFOBT or iFOBT). Documentation must confirm the patient does not have exclusionary conditions including personal history of colorectal cancer or adenomatous polyps, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), hereditary colorectal cancer syndromes, or a qualifying family history of colorectal cancer or adenomatous polyps.

Definitions

Definition — Fecal DNA testing

Test types includedCologuard® and Cologuard Plus™ multitarget stool DNA (mt‑sDNA / fecal DNA) tests using an at‑home stool collection kit to detect multiple biomarkers and fecal hemoglobin

Specimen and processingFull stool sample collected at home and returned to the laboratory in a collection kit for multitarget stool DNA and fecal hemoglobin analysis

Alternate names / abbreviationsAlso referred to as mt‑sDNA, MT‑sDNA, FIT‑DNA, FIT plus sDNA, sDNA‑FIT

Follow‑up for positive resultA positive result for either Cologuard or Cologuard Plus should be followed by colonoscopy

Definition / importance — Colorectal Cancer (CRC)

Clinical importanceColorectal cancer (CRC) is a leading cause of cancer death — removal of premalignant adenomas can prevent cancer and reduce CRC‑related mortality

Background

Fecal DNA multitarget stool tests (often called mt-sDNA, FIT-DNA, or fecal DNA tests) such as Cologuard® and Cologuard Plus™ use an at-home stool collection kit submitted to a laboratory to evaluate multiple genetic biomarkers associated with colorectal cancer and premalignant adenomas, together with a fecal hemoglobin immunoassay. A positive result indicates detection of abnormal gene methylation, sequence variants, and/or elevated hemoglobin; a negative result indicates none of these were identified. Both tests are intended for average-risk, asymptomatic screening and a positive test should be followed by diagnostic colonoscopy. Cologuard received FDA approval in August 2014 and Cologuard Plus received FDA approval in October 2024.