Colorectal Cancer Screening Tests

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.

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.)

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

D.    Other

N/A

(This NCD last reviewed April 2008.)

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)