National Coverage Analysis (NCA) Tracking Sheet

Screening Computed Tomography Colonography (CTC) for Colorectal Cancer

CAG-00396N

Issue

CMS covers colorectal cancer screening for average risk individuals age 50 and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema (42 CFR 410.37). On March 5, 2008, the American Cancer Society, the US Multi Society Task Force on Colorectal Cancer, and the American College of Radiology issued new cancer screening guidelines, including a recommendation that computed tomography colonography (CTC) be considered an acceptable option for colorectal cancer screening for such individuals. CTC, also referred to as virtual colonoscopy, uses computed tomography (CT) to acquire images and advanced 2-dimensional (3D) -image display techniques for interpretation. Neither the Medicare law nor the regulations identify the CTC test as a possible coverage option under the colorectal cancer screening benefit. However, under 42 CFR 410.37(a)(1), CMS is allowed to use the NCD process to determine coverage of other types of colorectal cancer screening tests that are not specifically identified in the law or regulations as it determines to be appropriate, in consultation with appropriate organizations.

This NCA will evaluate the available evidence for screening CTC and determine if a national coverage determination is warranted.

National Coverage Determinations

Benefit Category

Colorectal Cancer Screening Tests

Requestor Information

Requestor Name Requestor Letter
Internally Generated N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
05/19/2008
Expected NCA Completion Date
02/19/2009
Public Comment Period
05/19/2008 - 06/18/2008
Proposed Decision Memo Due Date
Proposed Decision Memo Released
02/11/2009
Proposed Decision Memo Public Comment Period
02/11/2009 - 03/13/2009
Decision Memo Released
05/12/2009
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
William Larson, MA
Sandra Jones, RN, MS
Lead Medical Officers
Joseph Chin, MD

Medicare Benefit Category Determination Date

Actions Taken

May 19, 2008

CMS initiates this national coverage analysis for the use of screening CTC for colorectal cancer. The public has 30 days to submit comments on this topic. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information related to the technology under review. We are especially interested as to the types of studies needed if the evidence is determined to be premature for coverage or if the appropriate frequency interval is uncertain.

Instructions on submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. 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.

September 26, 2008

CMS will convene the Medicare Evidence Development and Coverage Advisory Committee on November 19, 2008. The panel will review the available evidence on the use of CTC as a screening test for colorectal cancer for average risk individuals, including test characteristics, screening frequency, cost effectiveness, safety and training requirements.

Due date amended.

October 15, 2008

February 11, 2009

CMS posts a proposed decision memo indicating our intent not to expand the colorectal cancer screening benefit to include coverage of this test. We are also posting a technology assessment, including a cost effectiveness analysis for use of this test as a screening test which was requested from the Agency for Healthcare Research and Quality. As with all national coverage analyses, the public may submit comments or additional evidence that cause us to reassess our evidentiary review and arrive at different conclusions. If that should occur during finalization of this decision memorandum and we determine that CT colonography is clinically effective, then we would need to determine, using current or additional cost information, if CT colonography is cost effective. We are asking for public comment on the cost effectiveness of screening CT colonography for the Medicare population if we were to alter our clinical decision. The final comment period begins.

To submit a comment, please use the orange "comment" button at the top of the page.

May 12, 2009