Coverage Requirements

Insurance coverage for colorectal cancer (CRC) screening tests may differ among individuals. Recent changes in federal guidance recommend removal of cost-sharing on health plans for CRC screening tests after a positive stool-based screening test.1 This would enable coverage for follow-up colonoscopy after a positive stool-based test (SBT) result without patient cost share.1-3,a Patients and providers are advised to consult individual insurance companies for more information.

The multitarget stool DNA (mt-sDNA) test is covered by Medicare and most major insurers2,4

~94% of all mt-sDNA patients have no out-of-pocket cost for screening5

The mt-sDNA test should be covered by most private insurers with no copay or deductible for eligible patients. Some exceptions may apply, so it is recommended patients check with their insurer4

The Cologuard® (mt-sDNA) Test Has Broad Payer Coverage

The image summarizes the broad payer coverage for the Cologuard (mt-sDNA) test, with about 94% of patients having no out-of-pocket screening costs. The Cologuard (mt-sDNA) test is covered by Medicare and Medicare Advantage with no copay or deductible for eligible patients. Many national and regional payers have updated their medical policies to begin coverage of colorectal cancer screening at age 45. Regarding billing, Exact Sciences encourages patients who receive a bill with out-of-pocket responsibilities after using the Cologuard (mt-sDNA) test to call the Customer Care Center at 1.844.870.8870 to discuss appeal support.
  • Based on the Affordable Care Act, the Cologuard® (mt-sDNA) test should be covered by most private insurers with no copay or deductible for eligible patients (aged ≥45-75 years; at average risk for colon cancer; without symptoms)1-3,6,c
  • In May 2021, the CMS Quality Measures Voting Members unanimously recommended the addition of CRC screening to the CMS Medicaid Adult Core Set of Quality Measures for adoption in 20227

COVERAGE REQUIREMENTS FOR COLONOSCOPIES AFTER POSITIVE STOOL-BASED TESTS1-4,a

Federal guidance requires commercial health plans under the Affordable Care Act (ACA) to cover follow-up colonoscopy after a positive, non-invasive CRC screening test without patient cost share.1,4

Effective January 1, 2023, Medicare will now cover as a preventive service a screening colonoscopy after a positive non-invasive stool test, with no out-of-pocket costs.3

  • Because all plan and benefit designs are different, and the rules differ if a provider is out-of-network, patients and providers are encouraged to ask their individual insurers about coverage1,2,4

Learn more about the full Indications/Contraindications for the mt-sDNA test. Please see complete prescribing information for the Cologuard® test in the Cologuard Clinician Brochure.

FIT: fecal immunochemical test; mt-sDNA: multitarget stool DNA.

Related Topics

Footnotes

  1. Because all plan and benefit designs are different, and the rules differ if a provider is out-of-network, patients and providers are encouraged to ask their individual insurers about coverage.
  2. Exact Sciences estimate based on recent historical patient billing. Rate of coverage varies by state and region. Exceptions for coverage may apply. Only the patient's insurer can confirm how the Cologuard® test would be covered.
  3. Some exceptions may apply, so it is recommended that patients call their insurer to confirm.

List of definitions

ACA: Affordable Care Act; CMS: Centers for Medicare & Medicaid Services; CRC: colorectal cancer; mt-sDNA: multitarget stool DNA; SBT: stool-based test.


References

  1. US Department of Labor. FAQs about Affordable Care Act implementation part 51, Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation. Updated January 10, 2022. Accessed January 23, 2024. https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf
  2. Centers for Medicare & Medicaid Services. HHS finalizes physician payment rule strengthening access to behavioral health service and whole-person care. January 3, 2024. Accessed January 29,2024. https://www.cms.gov/newsroom/press-releases/hhs-finalizes-physician-payment-rule-strengthening-access-behavioral-health-services-and-whole
  3. Centers for Medicare & Medicaid Services. National Coverage Determination-Colorectal Screening tests. November 1, 2022. Accessed January 23, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx
  4. Data on File. Exact Sciences Corporation. Madison, WI.
  5. Exact Sciences. Cologuard® Helps More People Get Screened In A Cost-Effective Way. September 10, 2019. Accessed April 23, 2024. https://www.exactsciences.com/newsroom/press-releases/cologuard-helps-more-people-get-screened-in-a-cost-effective-way
  6. US Preventive Services Task Force, Davidson KW, Barry MJ, et al. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325(19):1965-1977.
  7. Hitchcock ME, Green BB, Anderson DS. Advancing health equity for Medicaid beneficiaries by adding colorectal cancer screening to the Centers for Medicare and Medicaid Services Adult Core Set. Gastroenterology. 2022;162(3):710-714.