National Coverage Analysis (NCA) Tracking Sheet

Screening for Colorectal Cancer - Stool DNA Testing



Medicare covers certain colorectal cancer screening tests and procedures for Medicare beneficiaries that meet certain eligibility criteria, as authorized by Sections 1861(s)(2)(R) and 1861(pp) of the Social Security Act and regulations at 42 CFR 410.37. Under 42 CFR 410.37(a)(2), CMS is allowed to include coverage of other colorectal cancer screening tests as determined by the Secretary through a national coverage determination.

Exact Sciences Corporation is participating in the FDA - CMS Parallel Review Pilot Program. CMS received a formal request for a national coverage determination from Exact Sciences Corporation, to consider coverage of CologuardTM - a multitarget sDNA colorectal cancer screening test.

National Coverage Determinations

Benefit Category

No Benefit Category

Requestor Information

Requestor Name Requestor Letter
Maneesha Arora, Chief Operating Officer, Exact Sciences Corporation View Letter
Barry Berger, MD, Chief Medical Officer, Exact Sciences Corporation N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
11/09/2014 - 11/09/2014
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
08/11/2014 - 09/10/2014
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Jamie Hermansen, MPP
Lead Medical Officers
Joseph Chin, MD, MS

Medicare Benefit Category Determination Date

Actions Taken

August 11, 2014

CMS initiates this national coverage analysis for screening for colorectal cancer using Cologuard™ - a multitarget stool DNA test and posts the proposed decision memorandum.

The 30-day public comment period on the proposed decision begins with this posting date, and ends after 30 calendar days. CMS considers all public comments and is particularly interested in comments that include clinical studies and other scientific evidence.

Instructions on submitting public comments can be found at You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

October 9, 2014