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MEDCAC Meeting 1/25/2012 - Management of Carotid Atherosclerosis

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The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence on various clinical strategies for the management of carotid atherosclerosis. Carotid artery atherosclerosis can increase the risk of disabling or fatal stroke. Stroke, according to the Centers for Disease Control (CDC), is the third leading cause of death and the leading cause of serious long-term disability in the United States. Treatments and technologies used in the management of carotid atherosclerosis include medical therapy, carotid endarterectomy (CEA) and carotid artery stenting (CAS).

Medical therapy may involve utilization of anti-platelet drugs, statins, antihypertensives, risk factor modification (smoking cessation and diabetic control), plus lifestyle modification (exercise). CEA is an open surgical procedure in which fatty deposits or plaques are excised from the atherosclerotic segment of the carotid artery. CAS is a catheter-based procedure in which a stent is placed within the atherosclerotic carotid artery. CAS strategies include use of an embolic protection device helps to minimize debris that may dislodge during the procedure.

The meeting will focus on the impact on patient health outcomes of these strategies for management of carotid atherosclerosis and prevention of stroke in both symptomatic and asymptomatic patients, as well as evaluating generalizability of the available evidence to patients of different age, gender, and racial/ethnic backgrounds. Medicare addresses coverage of CAS in section 20.7 of the national coverage determination (NCD) manual (Pub. 100-03) entitled Percutaneous Transluminal Angioplasty (PTA). Sections B2, B3 and B4 of this NCD address coverage of CAS. The NCD is available at http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=201&ncdver=9.

Tree/Earth - CMS Goes Green

CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED HERE.



November 18, 2011

Posted Federal Register Notice announcing meeting.

November 22, 2011

Posted questions to panel.

January 20, 2012

Posted agenda, roster and speakers list. Also posted presentations for meeting [ZIP, 13MB].

January 26, 2012

Posted scoresheet [PDF, 69KB] from meeting.

January 31, 2012

Posted written comments [PDF, 2MB] from meeting.

May 10, 2012

Posted minutes [PDF, 116KB] and transcript [PDF, 485KB] from meeting.
Federal Register Notice
Agenda
Medicare Evidence Development & Coverage Advisory Committee
January 25, 2012
7:30 AM – 4:30 PM
CMS Auditorium

Clifford Goodman, PhD, Chair
Steve Phurrough, MD, Vice Chair
Louis Jacques, MD, Director, Coverage and Analysis Group
Maria Ellis, Executive Secretary


7:30 – 8:00 AM

Registration

8:00 – 8:15 AM

Opening Remarks—Maria Ellis/Patrick Conway, MD/Louis Jacques, MD/Clifford Goodman, PhD

8:15 - 8:25 AM

CMS Presentation & Voting Questions – Sarah McClain Fulton, MHS

8:25 – 9:10 AM

TA Presentation: Mark Grant, MD, MPH, Associate Director, Technology Evaluation Center, Blue Cross Blue Shield Association

9:10 – 9:30 AM

William A. Gray, MD, Director, Endovascular Services, Columbia University Medical Center, New York-Presbyterian Hospital, Assistant Professor, Clinical Medicine, Columbia University College of Physicians and Surgeons

9:30 – 9:50 AM

Wesley Moore, MD, Professor and Chief Emeritus, Division of Vascular Surgery, David Geffen School of Medicine at UCLA, Gonda (Goldschmied) Vascular Center

9:50 – 10:10 AM

Anne L. Abbott, MD, PhD, Senior Research Fellow, Baker IDI Heart and Diabetes Institute, Victoria Australia

10:10 – 10:25 AM

Thomas G. Brott, MD, Professor of Neurology, Dean for Research, Mayo Clinic

10:25 – 10:30 AM

BREAK

10:30 – 11:20 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.


11:20 – 11:30 AM

Open Public Comments

Public Attendees who wish to address the panel will be given that opportunity p

11:30 – 12:00 PM

Questions to Presenters

12:00 – 1:00 PM

LUNCH (on your own)

1:00 – 2:00 PM

Initial Open Panel Discussion: Dr. Goodman

2:00 – 3:00 PM

Formal Remarks and Voting Questions

The Chairperson will ask each panel member to state his or her position on the voting questionsp

3:00 – 4:00 PM

Final Open Panel Discussion: Dr. Goodman

4:00 – 4:30 PM

Closing Remarks/Adjournment: Dr. Jacques & Dr. Goodman



Download PDF [PDF, 16KB] of agenda.
Download meeting minutes [PDF, 116KB]
January 25, 2012 MEDCAC
Management of Carotid Atherosclerosis

Questions

The primary focus of this MEDCAC meeting is on whether or not carotid artery stenting (CAS), carotid endarterectomy (CEA) and best medical therapy (BMT) improve outcomes in symptomatic and asymptomatic persons with carotid atherosclerosis.

In discussing the management of such individuals, CMS is most interested in stroke prevention; and the health outcomes of interest are stroke (all stroke) and death (all cause mortality).

Symptomatic means: (1) the presence or absence of focal signs or symptoms of a transient ischemic attack (reversible and lasting < 24 hours), (2) amaurosis fugax (sudden loss of vision in one eye) or (3) an ischemic stroke in either cerebral hemisphere. Asymptomatic means the absence of all of these events.

We also seek the panel’s input on whether or not the published evidence for these strategies is generalizable to the Medicare population – for both men and women, as well as persons of different racial/ethnic backgrounds.

Voting Questions

Please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence.

1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

  1. How confident are you that there is adequate evidence to determine if persons in the Medicare population who are asymptomatic for carotid atherosclerosis can be identified as being at high risk for stroke in either cerebral hemisphere?
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

    Discussion: If there is at least intermediate confidence (score ≥ 2.5 above), are there ethical concerns to conducting randomized controlled trials of CAS/CEA/BMT in the general asymptomatic population? Would such trials only be appropriate for those identified to be at high risk for stroke?
  1. How confident are you that there is adequate evidence to determine if persons in the Medicare population, who are considering carotid revascularization, can be identified as being at high risk for adverse events from CEA?
1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

    Discussion: If there is at least intermediate confidence (score ≥ 2.5 above), how does one reliably (across medical and surgical specialties) identify these individuals?
  1. For persons with symptomatic carotid atherosclerosis and carotid narrowing ( ≥ 50% by angiography or ≥ 70% by ultrasound) who are not generally considered at high risk for adverse events from CEA:

    1. How confident are you that there is adequate evidence to determine whether or not either CAS or CEA is the favored treatment strategy, as compared to BMT alone, to decrease stroke or death in the Medicare population?
    2. If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that
      1. CAS is the favored treatment strategy in this population?
      2. CEA is the favored treatment strategy in this population?
      3. BMT alone is the favored treatment strategy in this population?

1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

    Discussion: If there is at least intermediate confidence (score ≥ 2.5 above) for questions 3.b.i, ii or iii above, please discuss the impact of the following on your conclusions:
    1. Patient age, gender, and racial/ethnic background
    2. Time to treatment, e.g., < 2 weeks or > 2 weeks from onset of symptoms
  1. For persons with asymptomatic carotid atherosclerosis and carotid narrowing ( ≥ 60% by angiography or ≥ 70% by ultrasound) who are not generally considered at high risk for adverse events from CEA:

    1. How confident are you that there is adequate evidence to determine whether or not either CAS or CEA is the favored treatment strategy, as compared to BMT alone, to decrease stroke or death in the Medicare population?
    2. If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that
      1. CAS is the favored treatment strategy in this population?
      2. CEA is the favored treatment strategy in this population?
      3. BMT alone is the favored treatment strategy in this population?

1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

    Discussion: If the there is at least intermediate confidence (score ≥ 2.5 above), please discuss the impact of the following on your conclusions:
    1. Patient age, gender, and racial/ethnic background (for questions 4.b.i,ii or iii)
    2. Concurrent BMT (for questions 4.b.i or ii)
  1. For persons with asymptomatic carotid atherosclerosis who are not generally considered at high risk for stroke in either cerebral hemisphere:

    1. How confident are you that there is adequate evidence to determine whether or not CAS or CEA or BMT alone is the favored treatment strategy to decrease stroke or death in the Medicare population?
    2. If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that
      1. CAS is the favored treatment strategy in this population?
      2. CEA is the favored treatment strategy in this population?
      3. BMT alone is the favored treatment strategy in this population?

1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

    Discussion: If the there is at least intermediate confidence (score ≥ 2.5 above), please discuss the impact of the following on your conclusions:
    1. Patient age, gender, and racial/ethnic background (for questions 5.b.i,ii or iii)
    2. Concurrent BMT (for questions 5.b.i or ii)
  1. In the general Medicare population:

    1. How confident are you that there is adequate evidence to determine whether or not carotid artery screening of asymptomatic persons decreases stroke or death?
    2. If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that carotid artery screening of asymptomatic persons decreases stroke or death?

1      —      2      —      3      —      4     —      5
Low                   Intermediate                      High
Confidence                   Confidence                       Confidence

Additional Discussion Question
  1. What unmet research needs, specific to the following issues, are important to consider and explore further?

    1. Should future stroke prevention trials

      1. Be powered to evaluate only symptomatic or asymptomatic patients?
      2. Be powered to draw conclusions regarding gender?
      3. Evaluate outcomes for more racially/ethnically diverse patient populations?

    2. So as to help delineate those who require carotid revascularization from those who do not, how should future trials best utilize and validate for the Medicare population the following tools to identify persons with asymptomatic carotid atherosclerosis who are at high risk for stroke?

      1. Advanced imaging, such as 3D ultrasound, for plaque morphology
      2. Transcranial Doppler (TCD) for cerebral microembolization
      3. Pre- and post-procedure diffusion weighted MRI (DW-MRI) for silent infarcts
      4. Risk assessment tools and predictive stroke models

Download Scoresheet [PDF, 69KB]

MEDCAC Roster
January 25, 2012

Clifford Goodman, PhD CHAIR
Senior Vice President
The Lewin Group

Steve E. Phurrough, MD Vice Chair
Chief Operating Officer/Senior Clincal Director
Center for Medical Technology Policy

Jeptha P. Curtis, MD
Assistant Professor
Department of Internal Medicine
Yale University School of Medicine

Philip B. Gorelick, MD, MPH
John S. Garvin, Professor & Head
Department of Neurology and Rehabilitation
University of Illinois at Chicago
College of Medicine

Mark A. Hlatky, MD
Professor
Health Research and Policy and
Cardiovascular Medicine
Stanford University School of Medicine

Pearl Moore, RN, MN, FAAN
Adjunct Assistant Professor
University of Pittsburgh School of Nursing

William R. Phillips, MD, MPH
Clinical Professor
Family Medicine and Health Services
University of Washington

Art Sedrakyan, MD, PhD
Associate Professor
Director
Patient Centered Comparative
Outcomes Research Program
Weill Cornell Medical School

Robert L. Steinbrook, MD
Adjunct Associate Professor of Medicine and Community and Family Medicine
Dartmouth Medical School

Robert K. Zeman, MD
Professor and Chairman of Radiology
George Washington University School of Medicine
Diagnostic Radiology Residency Program
Director
Radiologist-in-chief (Radiology and Radiation Oncology)
George Washington University Medical
Faculty Associates, Inc., and Hospital

Industry Representative

Peter Juhn, MD, MPH
President
Therapeutic Resource Centers
Medco Health Solutions, Inc.

Guest Panel Members

Larry B. Goldstein, MD, FAAN, FAHA
Professor of Medicine (Neurology)
Director, Duke Stroke Center

A. Mark Fendrick, MD
Professor
Division of General Medicine
Department of Internal Medicine and Department of Health Management and Policy
Co-Director
University of Michigan Center for Value-Based Insurance Design
Director
Health Services Research Core Lab

J. David Spence, BA, MBA, MD, FRCPC, FAHA
Professor of Neurology and Clinical Pharmacology
University of Western Ontario
Director, Stroke Prevention & Atherosclerosis Research Centre
Robarts Research Institute

Invited Guest Speakers

Anne L. Abbott, MD, PhD
Senior Research Fellow
Baker IDI Heart and Diabetes Institute

Thomas G. Brott, MD
Professor of Neurology
Dean for Research
Mayo Clinic

Mark D. Grant, MD, MPH
Director
Technology Evaluation Center
Blue Cross Blue Shield Association

William A. Gray, MD
Director
Endovascular Services
Columbia University Medical Center
New York-Presbyterian Hospital
Assistant Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Columbia University Medical Center

Wesley S. Moore, MD
Professor and Chief Emeritus
Division of Vascular Surgery
David Geffen School of Medicine at UCLA
Gonda (Goldschmied) Vascular Center

CMS Liaison

Louis Jacques, MD
Director
Coverage and Analysis Group

Executive Secretary

Maria Ellis
Coverage and Analysis Group

Medicare Evidence Development & Coverage Advisory Committee
January 25, 2012

SPEAKER LIST
*4 MINUTES PER SPEAKER*

  • Timothy P. Murphy, MD, FSIR, FAHA, FSVMB, President, Society of Interventional Radiology – No Powerpoint Presentation

  • Joshua A. Beckman, MD, President, Society for Vascular Medicine - No Powerpoint Presentation

  • Peter Gloviczki, MD, The Joe M. and Ruth Roberts Professor of Surgery, Chair Emeritus,Division of Vascular and Endovascular Surgery, Director Emeritus, Gonda Vascular Center, Mayo Clinic

  • Donald Heck, MD, Representing: The Society of NeuroInterventional Surgery

  • Daniel Clair, MD, Chairman, Department of Vascular Surgery, Professor of Surgery, Cleveland Clinic Lerner, College of Medicine

  • Julie Freischlag, MD, The William Stewart Halsted Professor, Chair, Department of Surgery, Surgeon-in-Chief, The Johns Hopkins Hospital

  • Richard P. Cambria, MD, President, Society for Vascular Surgery, Chief, Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Professor of Surgery, Harvard Medical School, Boston, MA

  • Robert M. Zwolak MD, PhD, Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

  • Kenneth Rosenfield, MD, FACC, Representing: The American College of Cardiology

  • John J. Ricotta, MD, FACS, Secretary, Society for Vascular Surgery, Professor of Surgery, Georgetown University, Chair of Surgery, Washington Hospital Center

  • Charles Simonton, MD, Chief Medical Officer, Abbott Vascular

  • John A. Wilson, MD, FACS, Department of Neurosurgery, Wake Forest University School of Medicine, Representing: The American Association of Neurological Surgeons/ Congress of Neurological Surgeons

  • Ty Collins, MD, FSCAI, Chairman of SCAI’s Carotid and Neurovascular Committee & Director of Interventional Cardiology, Ochsner Heart & Vascular Institute, Ochsner Medical Center in New Orleans - No Powerpoint Presentation



Download PDF [PDF, 11KB] of speakers list
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