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MEDCAC Meeting 11/19/2008 - Computed Tomography Colonography (CTC)

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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.

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.
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

Download meeting minutes [PDF, 40KB].

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

  1. 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:

    1. Polyps < 6 mm
    2. Polyps 6 to < 10mm
    3. Polyps ≥ 10 mm

  2. 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:

    1. Polyps < 6 mm
    2. Polyps 6 to < 10mm
    3. Polyps ≥ 10 mm

  3. 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?

  4. 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:

    1. 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.

    2. 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?

    3. 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?

    4. How should extracolonic findings of CTC screening be reported and treated?

  5. 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.)

  6. 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?

  7. 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].

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

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