National Coverage Analysis (NCA) Tracking Sheet

Screening for Colorectal Cancer - Blood-Based Biomarker Tests

CAG-00454N

Issue

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 proColonĀ®- one example of a blood-based biomarker screening test for colorectal cancer.

CMS is soliciting public comment 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.

National Coverage Determinations

Benefit Category

No Benefit Category

Requestor Information

Requestor NameRequestor Letter
Jorge Garces, Ph.D., President and Chief Scientific Officer, Epigenomics View Letter

Important Dates

Formal Request Accepted and Review Initiated
02/28/2020
Expected NCA Completion Date
01/14/2021
Public Comment Period
02/28/2020 - 03/29/2020
Proposed Decision Memo Released
10/16/2020
Proposed Decision Memo Public Comment Period
10/16/2020 - 11/15/2020
Decision Memo Released
01/19/2021
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Kimberly Long
kimberly.long@cms.hhs.gov
410-786-5702
Lead Medical Officers
Carl Li, MD, MPH

Actions Taken

February 28, 2020

CMS initiates this national coverage analysis for screening for colorectal cancer using Epi proColon; a blood-based test . The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

October 16, 2020

January 19, 2021