Screening Immunoassay Fecal-Occult Blood Test

CMS covers colorectal cancer screening using fecal-occult blood testing (FOBT), sigmoidoscopy, colonoscopy and barium enema (42 CFR 410.37).  On July 11, 2002, the Centers for Medicare  & Medicaid Services (CMS) received a formal request from Enterix, Inc. and a number of physicians, asking that we initiate a national coverage determination (NCD) on the use of its screening immunoassay fecal-occult blood test kit, Insure®, that includes the use of a special brush for the collection of stool samples.  However, we were unable to accept that request since 42 CFR 410.37(a)(2) defined FOBT as a guaiac-based test only.  On December 31, 2002, CMS published the 2003 Physician Fee Schedule final rule (CMS-1204-FC), which included a provision that amends section 410.37(a)(2) allowing CMS to use the NCD process to determine coverage of other types of FOBTs.  This rule change has an effective date of March 1, 2003.  Therefore, we have accepted the Enterix, et. al. request that we include coverage of its screening immunoassay FOBT product under the Medicare screening FOBT benefit.  However, our formal evaluation of this issue will not begin until the effective date of the rule change.  We will accept public comments on this issue until that time.

January 17, 2003

March 3, 2003

August 26, 2003

November 4, 2003