NCD 210.3: Colorectal Cancer Screening Tests

A. General

Sections 1861(s)(2)(R) and 1861(pp) of the Social Security Act (the Act) and regulations at 42 CFR 410.37 authorize Medicare coverage for screening colorectal cancer tests under Medicare Part B. The statute and regulations authorize the Secretary to add other tests and procedures (and modifications to tests and procedures for colorectal cancer screening) as the Secretary finds appropriate based on consultation with appropriate organizations.

B. Nationally Covered Indications

1. Fecal Occult Blood Tests (FOBT) (effective January 1, 2004)

Fecal occult blood tests (FOBTs) are generally divided into two types: immunoassay and guaiac types. Immunoassay (or immunochemical) fecal occult blood tests (iFOBT) use “antibodies directed against human globin epitopes. While most iFOBTs use spatulas to collect stool samples, some use a brush to collect toilet water surrounding the stool. Most iFOBTs require laboratory processing.

Guaiac fecal occult blood tests (gFOBT) use a peroxidase reaction to indicate presence of the heme portion of hemoglobin. Guaiac turns blue after oxidation by oxidants or peroxidases in the presence of an oxygen donor such as hydrogen peroxide. Most FOBTs use sticks to collect stool samples and may be developed in a physician’s office or a laboratory. In 1998, Medicare began reimbursement for guaiac FOBTs, but not immunoassay type tests for colorectal cancer screening. Since the fundamental process is similar for other iFOBTs, the Centers for Medicare & Medicaid Services evaluated colorectal cancer screening using immunoassay FOBTs in general.

Medicare covers one screening FOBT per annum for the early detection of colorectal cancer. This means that Medicare will cover one gFOBT or one iFOBT at a frequency of every 12 months; i.e., at least 11 months have passed following the month in which the last covered screening FOBT was performed, for beneficiaries aged 45 years and older. The beneficiary completes the existing gFOBT by taking samples from two different sites of three consecutive stools; the beneficiary completes the iFOBT by taking the appropriate number of stool samples according to the specific manufacturer’s instructions. This screening requires a written order from the beneficiary’s attending physician (“Attending physician” means a doctor of medicine or osteopathy (as defined in §1861(r)(1) of the Act), physician assistant, nurse practitioner, or clinical nurse specialist who is fully knowledgeable about the beneficiary’s medical condition, and who would be responsible for using the results of any examination performed in the overall management of the beneficiary’s specific medical problem.)

The minimum age for FOBT is reduced to 45 years and older.

2. Non-Invasive Biomarker Tests

Biomarker testing detects molecular markers shed by colorectal cancer and pre- malignant colorectal epithelial neoplasia into blood, bodily secretions, or directly into the intestinal lumen. Through the use of selective enrichment and amplification techniques, tests are designed to detect very small amounts of markers to identify colorectal cancer or pre-malignant colorectal neoplasia.

Non-Invasive Biomarker tests are covered once every 3 years under the following conditions:

• Ordering Criteria

• When ordered by the physician, physician assistant, nurse practitioner, or clinical nurse specialist who will use the results in the management of the patient.

• Patient Criteria

• Age 45 to 85 years; and,

• Asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive non-invasive biomarker colorectal cancer screening test); and,

• At average risk of developing 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); and,

• Provided with information about the test performance and the importance of a follow-on colonoscopy if the test returns a positive result.

• Test Criteria

• The test must be Food and Drug Administration (FDA) market authorized and indicated for colorectal cancer screening; and,

• The test must achieve the requirements of the FDA-required post-approval study as specified in the Safety and Effectiveness Data (SSED) to continue coverage ; and

• The test must be processed in a CLIA certified laboratory; and,

• The test must demonstrate performance characteristics that meet EITHER Criteria 1 , a sensitivity of greater than or equal to 90% and a specificity greater than or equal to 87%, OR Criteria 2 , a sensitivity of greater than or equal to 79% and a specificity of greater than or equal to 90% in the detection of colorectal cancer compared to the recognized standard (accepted as colonoscopy at this time), based on the FDA labeling.

Test Performance

Criteria 1

Test Performance

Criteria 2

Sensitivity for CRC

≥ 90%

≥ 79%

Specificity for CRC

≥ 87%

≥ 90%

C. Nationally Non-Covered Indications

All other indications for colorectal cancer screening not otherwise specified in the Act and regulations, or otherwise specified above remain nationally non-covered.

D. Other

(This NCD was last reviewed June 2026 and includes updates finalized in the Calendar Year 2025 Physician Fee Schedule final rule 89 FR 97710)

08/2026 - The purpose of this Change Request (CR) is to inform contractors that CMS has determined that effective June 8, 2026, non-invasive biomarker screening tests are appropriate colorectal cancer screening tests based on specific criteria. ( TN 13921 ) (CR14581)

09/2025 - Transmittal 13400 issued September 05, 2025, is being rescinded and replaced by Transmittal 13438, dated September 30, 2025, to add a new attachment to ensure the functionality of the NCD zip URL is working properly and to update the Policy section. All other information remains the same.

The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 coding changes specific to NCDs. ( TN 13438 ) (CR14197)

08/2025 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 coding changes specific to NCDs. ( TN 13375 ) (CR14197)

03/2025 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. ( TN 13097 ) (CR13939)

10/2024 - The purpose of the Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations(NCDs). No policy is being changed as a result of these updates. ( TN 12904 ) (CR13828)

01/2024 - Transmittal 12350 issued November 03, 2023, is being rescinded and replaced by Transmittal 12440 dated January 3, 2024, to make changes to NCD 90.2, Next Generation Sequencing, spreadsheet to align with revisions being made to CR 13278. All other information remains the same. ( TN 12440 ) (CR13391)

11/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates.( TN 12350 ) (CR13391)

10/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. ( TN 12319 ) (CR13391)

02/2023 - Transmittal 11824 issued January 27, 2023, is being rescinded and replaced by Transmittal 11865, dated, February 16, 2023, to add the Spanish version of MSN Message 18.29 to the IOM for publication 100-04. This correction does not make any revisions to the companion Pubs.100-02 or 100-03; all revisions are associated with Pub. 100-04. All other information remains the same. ( TN 11865 ) (CR13017)

01/2023 - The purpose of this omnibus Change Request (CR) is to make contractors aware of policy updates resulting from changes specified in the Calendar Year (CY) 2023 Physician Fee Schedule (PFS) Final Rule (87 FR 69404), published in the Federal Register on 11/18/2022. The policy updates include removal of one selected National Coverage Determination (NCD) : Ambulatory Electroencephalographic (EEG) Monitoring (NCD 160.22). Separately, the policy updates also include policies to expand colorectal cancer screening coverage by 1) reducing the minimum age for certain CRC screening tests from 50 to 45 years and 2) expanding the regulatory definition of CRC screening tests to include a follow-on screening colonoscopy after a Medicare covered non-invasive stool-based test returns a positive result. ( TN 11824 ) (CR13017)

05/2021 - The purpose of this Change Request (CR) is to inform contractors that CMS has determined effective on January 19, 2021 blood-based biomarker test is an appropriate colorectal cancer screening test based on specific criteria.The Federal government creates NCDs that are binding on the MACs who review and/or adjudicate claims, make coverage determinations, and/or payment decisions, and also binds quality improvement organizations, qualified independent contractors, the Medicare appeals council, and Administrative Law Judges (ALJs) (see 42 Code of Federal Regulations (CFR) section 405.1060(a)(4) (2005)). An NCD that expands coverage is also binding on a Medicare advantage organization. In addition, an ALJ may not review an NCD. (See section 1869(f)(1)(A)(i) of the Social Security Act.) ( TN 10818 ) (CR12280)

02/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html , along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 2427 ) (CR11491)

02/2018 - Transmittal 2033, dated February 16, 2018, is being rescinded and replaced by Transmittal 2039, dated, February 28, 2018 to correct instructions in business requirement 7, NCD210.3, Colorectal Cancer Screening, and its accompanying spreadsheet. All other information remains the same. ( TN 2039 ) (CR10473)

02/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html , along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 2033 ) (CR10473)

02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 1792 ) (CR9861)

06/2016 - Transmittal 1665, dated May 13, 2016, is being rescinded and replaced by Transmittal 1672 to: (1) 9631.1: Remove FISS responsibility and 1st sentence; (2) 9631.2: Remove additional procedure codes, including 0075T, 0076T; (3) 9631.4: Revise descriptor of dx L59.8; (4) 9631.6: Add deletion of dx C49.10, C65.9, remove deletion of dx C54.9, remove deletion of invalid dx C47.90; (5) 9631.8: Remove deletion of invalid dx C51.29, replace with deletion of dx C50.029; (6) 9631.9: Add deletion of 0V504ZZ, 0V500ZZ, override capability, and contractor discretion verbiage. All other information remains the same. ( TN 1672 ) (CR9631)