National Coverage Analysis (NCA) Tracking Sheet for Screening DNA Stool Test for Colorectal Cancer (CAG-00144N)

CMS covers colorectal cancer screening for average risk individuals age 50 years and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema (42 CFR 410.37).  On June 12, 2007, the Centers for Medicare & Medicaid Services (CMS) received a formal request from EXACT Sciences Corporation asking that we initiate a national coverage determination (NCD) on the use of a screening DNA stool test (the PreGen-Plus test, version 1.1) for average risk individuals. The requestor asks CMS to cover their test every 5 years as an alternative to a screening colonoscopy that may be covered every 10 years or as an alternative to a screening flexible sigmoidoscopy that may be covered  every 4 years for such individuals as provided in 42 CFR 410.37 (e) and (g). Neither the law nor the regulations identify the screening DNA stool test as a possible coverage option under the colorectal cancer screening benefit.  However, under 42 CFR 410.37 (a)(1), CMS is allowed to use the NCD process to determine coverage of other types of colorectal cancer screening tests that are not specifically identified in the law or regulations as it determines to be appropriate, in consultation with appropriate organizations.