National Coverage Determination (NCD)

Colorectal Cancer Screening Tests


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Tracking Information

Publication Number
Manual Section Number
Manual Section Title
Colorectal Cancer Screening Tests
Version Number
Effective Date of this Version
Ending Effective Date of this Version
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Colorectal Cancer Screening Tests

Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A.    General

Section 4104 of the Balanced Budget Act of 1997 provides for coverage of screening colorectal cancer procedures under Medicare Part B. Medicare currently covers: (1) annual fecal occult blood tests (FOBTs); (2) flexible sigmoidoscopy over 4 years; (3) screening colonoscopy for persons at average risk for colorectal cancer every 10 years, or for persons at high risk for colorectal cancer every 2 years; (4) barium enema every 4 years as an alternative to flexible sigmoidoscopy, or every 2 years as an alternative to colonoscopy for persons at high risk for colorectal cancer; and, (5) other procedures the Secretary finds appropriate based on consultation with appropriate experts and organizations.

Coverage of the above screening examinations was implemented in regulations through a final rule that was published on October 31, 1997 (62 FR 59079), and was effective January 1, 1998. At that time, based on consultation with appropriate experts and organizations, the definition of the term “FOBT” was defined in 42 CFR §410.37(a)(2) of the regulation to mean a “guaiac-based test for peroxidase activity, testing two samples from each of three consecutive stools.”

In the 2003 Physician Fee Schedule Final Rule (67 FR 79966) effective March 1, 2003, the Centers for Medicare & Medicaid Services (CMS) amended the FOBT screening test regulation definition at 42 CFR §410.37(a)(2) to provide that it could include either: (1) a guaiac-based FOBT, or, (2) other tests determined by the Secretary through a national coverage determination.

Indications and Limitations of Coverage

B.    Nationally Covered Indications

Fecal Occult Blood Tests (FOBT) (effective for services performed on or after January 1, 2004)

1.    History

The 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, CMS evaluated colorectal cancer screening using immunoassay FOBTs in general.

2.    Expanded Coverage

Medicare covers one screening FOBT per annum for the early detection of colorectal cancer. This means that Medicare will cover one guaiac-based (gFOBT) or one immunoassay-based (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 50 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 Social Security Act) 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.)

C.    Nationally Non - Covered Indications

All other indications for colorectal cancer screening not otherwise specified above remain non-covered.

D.    Other


(This NCD last reviewed April 2008.)

Cross Reference
Also see NCD for Fecal Occult Blood Test (§190.34).

Transmittal Information

Transmittal Number
Revision History

08/2008 - Following reconsideration of the current national coverage determination (NCD) for colorectal cancer screening, CMS proposes not to expand the colorectal cancer screening benefit to include coverage of PreGen-Plus, a commercially available screening DNA stool test. The FDA determines that this test requires premarket review and approval. A subsequent request for reconsideration will be considered once FDA approval is obtained. Effective date 04/28/2008. Implementation date 08/25/2008. (TN 92) (CR6145)

12/2003 - Expanded Medicare coverage for screening for early detection of colorectal cancer by adding additional fecal occult blood test (iFOBT, immunoassay-based) that can be used as alternative to existing gFOBT, guaiac-based test. Medicare coverage continues to allow one FOBT per year for beneficiaries aged 50 and over. Effective date 1/01/04. Implementation date 1/05/2004 for coverage & HCPCS codes and 4/05/2004 for frequency edits. (TN 5) (CR 2996)


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Colorectal Cancer Screening Tests 7 01/01/2023 - N/A View
Colorectal Cancer Screening Tests 6 01/19/2021 - 01/01/2023 View
Colorectal Cancer Screening Tests 5 10/09/2014 - 01/19/2021 View
Colorectal Cancer Screening Tests 4 01/27/2014 - 10/09/2014 View
Colorectal Cancer Screening Tests 3 05/12/2009 - 01/27/2014 View
Colorectal Cancer Screening Tests 2 04/28/2008 - 05/12/2009 You are here
Colorectal Cancer Screening Tests 1 01/01/2004 - 04/28/2008 View
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.