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Centers for Medicare & Medicaid Services

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.

Colorectal Cancer Screening Tests
Requestor Name(s)EXACT Sciences Corporation, Dr. Sidney Winawer, Dr. Bert Vogelstein, Dr. Paul Schroy, Dr. Jonathan Terdiman, Dr. David Johnson, Dr. Bernard Levin, Senator (Ret) Connie Mack, and Ms. Carolyn Aldige
Formal Request Accepted and Review Initiated08/01/2007
Expected NCA Completion Date04/29/2008
Public Comment Period08/01/2007 - 08/31/2007
Proposed Decision Memo Released01/30/2008
Proposed Decision Memo Public Comment Period: 01/30/2008 - 02/29/2008 
Decision Memo Released04/28/2008
Comments for this NCA:View Public Comments
Lead Analyst(s)
  • William Larson
Lead Medical Officer(s)
  • Joseph Chin, M.D.

August 1, 2007

CMS initiates this national coverage analysis for the use of EXACT Sciences' screening DNA stool test. The public has 30 days to submit comments on this topic. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information related to the technology under review.

Instructions on submitting public comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp. We strongly urge that all public comments be submitted through this website.

September 19, 2007

Posted comments [PDF, 13MB] received.

View comments received through the website.

January 9, 2008

CMS posts a technology assessment, including a cost effectiveness analysis for use of this test as a screening test, which was requested from the Agency for Healthcare Research and Quality.

January 30, 2008

CMS posts a proposed decision memo indicating our intent to not expand the colorectal cancer screening benefit to include coverage of this test. The final public comment period begins.

CMS is particularly interested in comments that address CMS' proposed decision.

To submit comments, please use the orange "comment" button at the top of the page.

April 28, 2008

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