Benefit Category
Colorectal Cancer Screening Tests
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. Non-coverage specifically includes:
(1) Screening DNA (Deoxyribonucleic acid) stool tests, effective April 28, 2008, and,
(2) Screening computed tomographic colonography (CTC), effective May 12, 2009.
D. Other
N/A
(This NCD last reviewed May 2009.)
Cross Reference Also see NCD for Fecal Occult Blood Test (§190.34).
