National Coverage Analysis (NCA) Tracking Sheet

Anti-Cancer Chemotherapy for Colorectal Cancer

CAG-00179R

Issue

With the goal of accelerating development of evidence for emerging cancer treatment regimens, CMS established national coverage determination (NCD) 110.17 for Anti-Cancer Chemotherapy for Colorectal Cancer in 2005 to cover off-label uses of oxaliplatin, irinotecan, cetuximab and bevacizumab in colorectal and other cancer types in nine National Cancer Institute (NCI) sponsored trials.

CMS internally generated the opening of this NCD analysis to assess other coverage mechanisms, like the Clinical Trials Policy (CTP, NCD 310.1), beyond NCD 110.17 under which coverage may be available for the off-label use of these anti-cancer drugs. CMS is considering if other coverage mechanisms are viable options for coverage of these drugs, and if NCD 110.17 is unnecessarily redundant to these other mechanisms and therefore appropriate for removal from the NCD manual.

CMS posted a proposed decision memo simultaneously to the opening of this NCD analysis and is soliciting public comment on our proposals.

Benefit Category

To Be Determined

Requestor Information

Requestor Name Requestor Letter
Internally generated N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
12/08/2025
Expected NCA Completion Date
03/08/2026
Public Comment Period
12/08/2025 - 01/07/2026
Proposed Decision Memo Due Date
Proposed Decision Memo Released
12/08/2025
Proposed Decision Memo Public Comment Period
12/08/2025 - 01/07/2026
Decision Memo Released

Contacts

Lead Analysts
Sarah Fulton, MHS
SARAH.FULTON@CMS.HHS.GOV
410-786-2749
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

December 8, 2025

CMS initiates this national coverage analysis for Anti-Cancer Chemotherapy for Colorectal Cancer and simultaneously posts the proposed decision memo. 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: https://www.cms.gov/medicare/coverage/determination-process/public-comments. 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.