National Coverage Analysis (NCA) Tracking Sheet

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.

Benefit Category

Colorectal Cancer Screening Tests

Requestor Information

Requestor Name Requestor Letter
Mr. Robert C. Bruce, Vice President and Chief Operating Officer, Enterix Inc. N/A
James E. Allison, M.D. N/A
Bernard Levin, M.D. N/A
Anthony R. Mattia, M.D. N/A
Ronald E. Myers, Ph.D. N/A
Sidney J. Winawer, M.D. N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
03/01/2003 - N/A
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released


Lead Analysts
William Larson
Lead Medical Officers
Joseph Chin, M.D.
Lawrence Schott, M.D., M.S.

Medicare Benefit Category Determination Date

Actions Taken

January 17, 2003

Request for consideration of Enterix’s immunoassay FOBT product accepted by Coverage and Analysis Group.  Our formal evaluation of this issue will begin after the effective date of the 2003 Physician Fee Schedule Final Rule.  The expected dates entered above will be corrected if necessary at that time.

March 3, 2003

The CMS 2003 Physician Fee Schedule final rule (CMS-1204-FC) is now effective and the formal evaluation of this NCD has begun.   We have referred this issue to the Agency for Healthcare Research & Quality for a technology assessment, which will also include a cost effectiveness analysis for use of this test as a screening test.  We will continue to accept public comments.

August 26, 2003

CMS has received the technology assessment from AHRQ. It can be found at New due date will be in 60 days.

November 4, 2003