National Coverage Analysis (NCA) Tracking Sheet

Screening for Colorectal Cancer-Non-Invasive Biomarker Tests

CAG-00440R

Issue

Medicare covers certain colorectal cancer screening tests and procedures for Medicare beneficiaries that meet 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. CMS may add coverage through a national coverage determination, with frequency and other limits.

CMS received a complete, formal request to provide coverage for ColoSense, an FDA-approved multi-target stool RNA (mt-sRNA) colorectal cancer (CRC) screening test.

This NCA will focus on coverage of CRC non-invasive biomarker screening tests among Medicare beneficiaries, including mt-sRNA tests and a review of sensitivity and specificity cut points. We do not intend to review the long-standing coverage for fecal occult blood tests (FOBT).

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of stool-based RNA colorectal cancer screening tests and sensitivity and specificity cut points for non-invasive biomarker colorectal cancer screening tests.

National Coverage Determinations

Benefit Category

Colorectal Cancer Screening Tests

Requestor Information

Requestor Name Requestor Letter
Geneoscopy View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
09/10/2025
Expected NCA Completion Date
06/08/2026
Public Comment Period
09/10/2025 - 10/10/2025
Proposed Decision Memo Due Date
Proposed Decision Memo Released
03/10/2026
Proposed Decision Memo Public Comment Period
03/10/2026 - 04/09/2026
Decision Memo Released
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Kimberly Long
kimberly.long@cms.hhs.gov
Olivia Harbison
Olivia.harbison@cms.hhs.gov
Lead Medical Officers
Carl Li, M.D.

Medicare Benefit Category Determination Date

Actions Taken

September 10, 2025

CMS initiates this national coverage analysis for Colorectal Cancer Screening. The 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 blue "Comment" button at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.

March 10, 2026