CMS Updates to Coverage Pages

CMS initiates "Screening for Colorectal Cancer - Stool DNA Testing" National Coverage Analysis for screening for colorectal cancer using Cologuard^TM - a multitarget stool DNA test, and posts the related Proposed Decision Memorandum, http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=277.

Please visit the NCA tracking sheet to submit comments, http://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=277.  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.  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.

Background:

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.