National Coverage Analysis (NCA) Tracking Sheet for Screening for Colorectal Cancer – Blood-Based Biomarker Tests (CAG-00454N)

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 add coverage of other colorectal cancer screening tests or procedures through a national coverage determination, with such frequency and payment limits as CMS determines appropriate, in consultation with appropriate organizations.

CMS received a formal request for a national coverage determination from Epigenomics to consider coverage of Epi proColon®- one example of a blood-based biomarker screening test for colorectal cancer.

CMS is soliciting public comments relevant to the request. We are particularly interested in comments that include scientific evidence and that address appropriate test characteristics of colorectal cancer screening tests.

Formal Request Accepted and Review Initiated:  02/28/2020

Expected NCA Completion Date:  11/26/2020

Public Comment Period:  02/28/2020 – 03/29/2020

Proposed Decision Memo Due Date:  08/28/2020

Source: https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=299