Computed Tomography Colonography (CTC)

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=45 | meeting_date=2008-11-19

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.

Actions Taken: September 26, 2008 Posted Federal Register Notice announcing meeting. October 15, 2008 Posted questions to panel November 12, 2008 Download Technology Assessment [ZIP, 638KB] Download Technology Assessment [PDF, 585KB] November 17, 2008 Posted agenda and roster November 21, 2008 Posted scoresheet [PDF, 77KB]. February 2, 2009 Posted minutes [PDF, 40KB] and transcript [PDF, 893KB] from meeting. Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee November 19, 2008 7:30 AM – 4:30 PM CMS Auditorium Barbara McNeil, MD PhD, Chair Steve Pearson, MD, MSC, Vice-Chair Steve E. Phurrough, MD, MPA, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 – 8:00 AM Registration 8:00 – 8:15AM Opening Remarks— M. Ellis/ S. Phurrough, MD, MPA/Barbara McNeil, MD, PhD 8:15- 8:30 AM CMS Presentation & Voting Questions – William Larson 8:30 – 9:15 AM TA Presentation: Systematic Review - Mary Barton, MD, MPP, Scientific Director, US Preventive Services Task Force, Agency for Healthcare Research and Quality 9:15 – 9:45 AM Ned Calonge, MD, MPH, Chair, US Preventive Services Task Force 9:45 –10:15 AM TA Presentation: Modeling Cost & Outcomes - Ann G. Zauber, PhD, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center 10:15 – 10:30 AM BREAK 10:30 – 11:15 AM Scheduled Public Comments (Refer to Speaker List) Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting. 11:15 – 11:35 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 11:35 – 12:35 PM LUNCH (on your own) 12:35 – 1:35 PM Questions to Presenters 1:35 – 2:45 PM Initial Open Panel Discussion: Dr. McNeil 2:45 – 3:30 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions 3:30 – 4:25 PM Final Open Panel Discussion: Dr. McNeil 4:25 – 4:30 PM Closing Remarks/Adjournment: Dr. Phurrough & Dr. McNeil 4:30 PM ADJOURN Associated Nca: 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. Minutes: Download meeting minutes [PDF, 40KB]. Other Material: Transcript 1 Panel Voting Questions: MEDCAC Questions Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CRC) for Average Risk Individuals Use the following scale response for each of the questions below. 1-No Confidence 2-Little Confidence 3-Equivocal 4-Moderate Confidence 5-High Confidence How confident are you that there is sufficient evidence to determine the sensitivity and specificity of screening CTC using at least 16 slice scanners for average risk individuals compared to optical colonoscopy for: Polyps < 6 mm Polyps 6 to < 10mm Polyps ≥ 10 mm How confident are you that there is sufficient evidence to determine the health benefits of screening CTC using at least 16 slice scanners for average risk individuals compared to optical colonoscopy for: Polyps < 6 mm Polyps 6 to < 10mm Polyps ≥ 10 mm How confident are you that previous evidence and modeling for the treatment of polyps discovered using other screening modalities can be applied to polyps discovered using screening CTC? Based on the following discussion questions, how confident are you that the evidence demonstrates that screening CTC results in a net health benefit for Medicare beneficiaries similar to optical colonoscopy? (Net health benefits include the decrease in morbidity and mortality from the identification and removal of polyps balanced with the risks of the procedure and the identification of extracolonic abnormalities. It does not include costs.) Discussion questions: Does the health benefit depend upon polyp size, referral for colonoscopy and/or interval before subsequent screening? If so, what does the evidence demonstrate to be the appropriate recommendations for these factors? Note: All identified polyps are typically removed during optical colonoscopy regardless of their size. Guidelines for CTC must determine whether to refer all polyps or only those of certain sizes. Does the health benefit depend on the scanner resolution? If so, what does the evidence demonstrate to be the lowest resolution that should be used? Does the health benefit depend upon the skills of the individual performing and interpreting the screening CTC? What should be the minimal training and experience? How should extracolonic findings of CTC screening be reported and treated? At the current Medicare prices, how confident are you that CTC has a similar ratio of cost per LYS (Life Years Saved) as optical colonoscopy? (Note: Interval for CTC screening and referrals for follow up by polyp size will be entered into the CEA modeling.) How confident are you that the evidence demonstrates that the use of CTC screening in the average risk Medicare population will increase overall colorectal cancer screening rates in that population? How confident are you that there is sufficient evidence to determine the appropriate CTC guidelines for referral for polyp removal and for frequency of screening? Discussion question: a. How can adherence to CTC guidelines and compliance with referrals for optical colonoscopy be monitored and maximized? Download scoresheet [PDF, 77KB]. Roster: Barbara McNeil, MD, PhD - Chair Professor Department of Health Care Policy Harvard Medical School Steven Pearson, MD, MSC - Vice Chair President Institute for Clinical and Economic Review Massachusetts General Health and Harvard Medical School Clifford Goodman, PhD Senior Vice President The Lewin Group Robert McDonough, MD Head of Clinical Policy Research and Development Aetna, Inc. Curtis A. Mock, MD, MBA Senior Regional Medical Director Health Services United Healthcare Arden Morris, MD, MPH Assistant Professor of Surgery Chief of General Surgery Ann Arbor VAMC Gerald W. Peden, MD, MA Senior Medical Director Claim Payment Policy Independence Blue Cross David J. Samson, MS Associate Director Technology Evaluation Center Blue Cross Blue Shield Association Gurkirpal Singh, MD Adjunct Cinical Professor of Medicine Division of Gastroenterology and Hepatology Stanford University School of Medicine Chief Science Officer Institute fo Clinical Outcomes Research and Education Steven M. Teutsch, MD, MPH Executive Director U.S. Outcomes Research Merck & Company, Inc. Jonathan P. Weiner, PhD Professor & Deputy Director Health Services Research and Development Center The Johns Hopkins University Bloomberg School of Public Health Jed Weissberg, MD Associate Executive Director Quality and Performance Improvement The Permanente Federation, LLC Consumer Representative Linda A. Bergthold, PhD Santa Cruz, California Industry Representative Michael J. Lacey, MSc Director Reimbursement and Health Economics Acusphere, Inc. Guest Speakers Ned Calonge, MD, MPH Chief Medical Officer Colorado Department of Public Health and Environment