The page could not be loaded. The CMS.gov Web site currently does not fully support browsers with
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.
August 11, 2014
CMS initiates this national coverage analysis for screening for colorectal cancer using CologuardTM - 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 http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. 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