MEDCAC Meeting

Lower Extremity Peripheral Artery Disease

07/22/2015

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Issue

On July 22, 2015, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC panel will examine the scientific evidence of existing interventions that aim to improve health outcomes in the Medicare population, and address areas where evidence gaps exist, related to lower extremity peripheral artery disease (PAD). For purposes of this MEDCAC, we will focus on three categories along the disease progression continuum (asymptomatic, intermittent claudication, and critical limb ischemia).

Clinical outcomes of interest to the Medicare program include reduction in pain; avoidance of amputation; improvement in quality of life and/or functional capacity including walking distance; wound healing; avoidance of cardiovascular events, including myocardial infarction, stroke, cardiovascular death, and all-cause mortality; and avoidance of harms from the interventions. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the extent to which it may wish to use existing evidence as the basis for any future determinations about Medicare coverage for interventions related to lower extremity peripheral artery disease. MEDCAC panels do not make coverage determinations, but CMS often benefits from their advice.

Actions Taken

Tree/Earth - CMS Goes Green

CMS WILL NOT PROVIDE PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED HERE.



April 27, 2015

CMS announces MEDCAC meeting. Posts FR Notice and registration link.

May 4, 2015

Posted questions to panel

July 15, 2015

July 17, 2015

July 24, 2015

Posted scoresheet [28KB, PDF] from meeting.

September 4, 2015

Posted transcript and minutes from meeting.

  • Webcast of meeting (NO REGISTRATION REQUIRED)
  • Registration
  • Information about visiting CMS
  • Driving directions to CMS
  • Recommended hotels
  • Agenda

    Agenda
    Medicare Evidence Development & Coverage Advisory Committee
    July 22, 2015
    7:30 AM - 4:30 PM
    CMS Auditorium

    Peter Bach, MD, Vice Chair
    Tamara Syrek Jensen, JD, Director, Coverage and Analysis Group
    Maria Ellis, Executive Secretary


    7:30 - 8:00 AM

    Registration

    8:00 - 8:10 AM

    Opening Remarks— Maria Ellis/Tamara Syrek Jensen, JD/Peter Bach, MD

    8:10 - 8:20 AM

    CMS Presentation & Voting Questions - Jamie Hermansen

    8:20 - 9:20 AM

    TA Presentation: Schuyler Jones, MD, Assistant Professor of Medicine, Duke University Medical Center and Manesh Patel, MD, Associate Professor of Medicine, Cardiology, Duke University Medical Center

    9:20 - 9:40 AM

    Jack L. Cronenwett, MD, Medical Director, Society for Vascular Surgery Patient Safety Organization, Professor of Surgery and The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth-Hitchcock Medical Center

    9:40 - 10:00 AM

    Matthew T. Menard, MD, Co-Director, Endovascular Surgery, Program Director, Vascular Surgery Fellowship, Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital

    10:00 - 10:10 AM

    BREAK

    10:10 - 11:45 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.

    ********************************************************************************************

    11:45 - 11:50 AM

    Open Public Comments

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

    11:50 - 12:35 PM

    LUNCH (on your own)

    12:35 - 1:35 PM

    Questions to Presenters

    1:35 - 2:35 PM

    Initial Open Panel Discussion: Dr. Bach

    2:35 - 3:35 PM

    Formal Remarks and Voting Questions

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

    3:35 - 4:25 PM

    Final Open Panel Discussion: Dr. Bach

    4:25 - 4:30 PM

    Closing Remarks/Adjournment: Tamara Syrek Jensen & Dr. Bach

    Minutes

    Download meeting minutes.

    Panel Voting Questions

    Medicare Evidence Development and Coverage Advisory Committee (MEDCAC)
    Lower Extremity Peripheral Artery Disease
    July 22, 2015

    This MEDCAC meeting will examine the scientific evidence of existing interventions that aim to improve health outcomes in the Medicare population, and address areas where evidence gaps exist related to lower extremity peripheral artery disease (PAD). Lower extremity PAD is vessel narrowing that occurs over time due to atherosclerosis of the lower extremities. Vessel narrowing can reduce blood flow, which can cause pain when the need for blood flow in the lower extremities increases (e.g., walking, climbing stairs, or exercising) and, in worse circumstances, pain at rest. Accurate ascertainment of symptoms is important as the burden of disease by anatomic imaging may correlate poorly with function.

    Symptoms of PAD exist on a continuum from no symptoms to disabling symptoms. Individuals can have narrowing of the arteries and be asymptomatic. As atherosclerosis in the lower extremities progresses, symptoms can present as exertional lower extremity pain, also referred to as intermittent claudication (IC). If narrowing progresses to a critical diameter, it can cause significant disability even at rest, sometimes leading to limb amputation; this stage of the disease is referred to as critical limb ischemia (CLI). For purposes of this MEDCAC we will focus on these three categories along the disease progression continuum (asymptomatic, IC, and CLI).

    Existing interventions for lower extremity PAD are grouped into three main categories: medical therapy, exercise training, and revascularization (surgery and endovascular techniques including angioplasty, stenting, and atherectomy). Clinical outcomes of interest to the Medicare program include reduction in pain; avoidance of amputation; improvement in quality of life and/or functional capacity including walking distance; wound healing; avoidance of cardiovascular events, including myocardial infarction, stroke, cardiovascular death, and all-cause mortality; and avoidance of harms from the interventions.

    Voting Questions

    For each voting question, 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

    1. For adults with asymptomatic lower extremity PAD, how confident are you that there is sufficient evidence for an intervention that improves:
      1. Immediate/near-term health outcomes?
      2. Long-term health outcomes?

      Discussion:

      • If intermediate confidence (≥ 2.5), please identify the specific intervention(s) and associated outcome(s).
      • Considering the heterogeneity of the Medicare population, discuss which subgroups of the Medicare population the evidence shows are likely to benefit or likely not to benefit from intervention.
    2. For adults with lower extremity intermittent claudication (IC), how confident are you that there is sufficient evidence for an intervention that improves:
      1. Immediate/near-term health outcomes?
      2. Long-term health outcomes?

      Discussion:

      • If intermediate confidence (≥ 2.5), please identify the specific intervention(s) and associated outcome(s).
      • Considering the heterogeneity of the Medicare population, discuss which subgroups of the Medicare population the evidence shows are likely to benefit or likely not to benefit from intervention.
    3. For adults with lower extremity critical limb ischemia (CLI), how confident are you that there is sufficient evidence for an intervention that improves:
      1. Immediate/near-term health outcomes?
      2. Long-term health outcomes?

      Discussion:

      • If intermediate confidence (≥ 2.5), please identify the specific intervention(s) and associated outcome(s).
      • Considering the heterogeneity of the Medicare population, discuss which subgroups of the Medicare population the evidence shows are likely to benefit or likely not to benefit from intervention.

    Additional Discussion Topics

    1. Discuss the important evidence gaps that have not been previously or sufficiently addressed.

    2. Discuss any apparent lower extremity PAD treatment disparities and how they may affect the health outcomes of Medicare beneficiaries.

    Download scoresheet [28KB, PDF].

    Other Material

    Roster

    Committee Vice Chair

    Peter Bach, MD, MAPP
    Attending Physician & Director
    Center for Health Policy and Outcomes
    Memorial Sloan-Kettering Cancer Center

    MEDCAC Members

    Doug Campos-Outcalt, MD, MPA
    Medical Director
    Mercy Care Plan

    John Jeffrey Carr, MD
    Professor of Radiology
    Biomedical Informatics and Cardiovascular Medicine
    Vanderbilt University

    Aloysius B. Cuyjet, MD, MPH
    Medical Director
    HealthCare Partners, IPA

    Richard A. Deyo, MD, MPH
    Professor
    OHSU Family Medicine
    Department of Medicine
    Department of Public Health and Preventive Medicine
    Oregon Health & Science University

    Peter F. Lawrence, MD
    Chief of Vascular Surgeon
    University of California, Los Angeles

    Frank V. Lefevre, MD
    Medical Director
    Center for Clinical Policy
    Technology Evaluation Center
    BlueCross BlueShield Association

    Sandra J. Lewis, MD, FACC
    Clinical Associate Professor of Medicine
    Oregon Health and Science University in Portland
    Director, Research and Prevention
    Northwest Cardiovascular Institute

    Marcel Salive, MD, MPH
    Medical Officer
    National Institute on Aging
    National Institute of Health

    Julie Ann Swain, MD
    Professor of Cardiothoracic Surgery
    Director of Clinical Research
    Department of Cardiothoracic Surgery
    Icahn School of Medicine at Mount Sinai
    Director, Center for Medical Devices
    Mount Sinai Heart Institute at Icahn School of Medicine

    Diana Zuckerman, PhD
    President
    National Center for Health Research
    Cancer Prevention and Treatment Fund

    Representative

    Robert L. Kormos, MD, FRCS(C), FACS
    Brack G. Hattler Professor
    Cardiothoracic Transplantation
    Director, Artificial Heart Program
    Co-Director, Heart Transplantation
    Department of Cardiothoracic Surgery
    Heart and Vascular Institute
    University of Pittsburgh Medical Center

    Industry Representative

    Theodore C. Lystig, PhD
    Lead Corporate Biostatistician
    Strategic Scientific Operations
    Medtronic, Inc.

    Guest Panel Members

    Alan T. Hirsch, MD
    Professor of Medicine
    Epidemiology and Community Health
    Director, Vascular Medicine Program
    Cardiovascular Division
    University of Minnesota Medical School

    Invited Guest Speakers

    Jack L. Cronenwett, MD
    Medical Director
    Society for Vascular Surgery Patient Safety Organization
    Professor of Surgery and The Dartmouth Institute for Health Policy and Clinical Practice
    Dartmouth-Hitchcock Medical Center

    Matthew T. Menard, MD
    Co-Director, Endovascular Surgery
    Program Director, Vascular Surgery Fellowship
    Division of Vascular and Endovascular Surgery
    Brigham and Women's Hospital

    CMS Liaison

    Tamara Syrek Jensen, JD
    Director
    Coverage and Analysis Group

    Executive Secretary

    Maria Ellis
    Coverage and Analysis Group

    Speakers List

    Medicare Evidence Development & Coverage Advisory Committee
    July 22, 2015

    SPEAKER LIST


    *4 MINUTES PER SPEAKER*

    • Gary Gibbons, MD, Medical Director, South Shore Hospital, Center for Wound Healing, and Professor of Surgery, Boston University School of Medicine – Representing: Association for the Advancement of Wound Care
    • Jeffrey Carr, MD, Board Member, CardioVascular Coalition Immediate Past President, Outpatient Endovascular and Interventional Society
    • Paul S. van Bemmelen, MD, PhD, FACS, Professor of Vascular Surgery, Temple University
    • Margaret Doucette, DO, Chief, Physical Medicine and Rehabilitation, Boise VA Medical Center
    • Michael D. Dake, MD, Department of Cardiothoracic Surgery, Stanford University School of Medicine - Representing:Cook Medical
    • Ronald Fairman, MD, Clyde F. Barker-William Maul Measey Professor of Surgery, Chief, Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania
    • Michael Conte, MD, Professor and Chief, Division of Vascular & Endovascular Surgery, University of California, San Francisco
    • Joseph Mills, MD, Chief, Division of Vascular and Endovascular Surgery, Director, Vascular Fellowship and Residency Programs, Professor of Surgery, Department of Surgery, The University of Arizona
    • Oscar M. Alvarez, PhD, CCT, FAPWCA, Director, Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, NY
    • Gary Ansel, MD, Executive Board Member, VIVA Physicians
    • Kenneth Rosenfield, MD, President-Elect, Society for Cardiovascular Angiography and Interventions
    • Joshua Beckman, MD, MS, American Heart Association
    • John R. Bartholomew, MD, President Elect, Society of Vascular Medicine
    • Robert Lookstein, MD, Society of Interventional Radiology
    • Michael R. Jaff, DO, President, VIVA Physicians
    • Herb Aronow, MD, MPH, Chair, American College of Cardiology
    • Mehdi H. Shishehbor, DO, MPH, PhD, Director, Endovascular Services, and Staff, Interventional Cardiology and Vascular Medicine, Cleveland Clinic
    • Sanjay Misra, MD FSIR, FAHA, Professor of Radiology, Mayo Clinic Rochester
    • James B. Froehlich, MD, MPH, President, Society for Vascular Medicine
    • Daphne W. Denham, MD, FACS, FACCWS, Comprehensive Wound Care, LLC
    • Mark Turco, MD, Medical Director, Aortic and Peripheral Vascular, Medtronic – Representing: Medtronic, Abbott Vascular, Boston Scientific, C. R. Bard, and Gore Medical
    • Terry Foust Litchfield, Vice President, Clinical Operations, Lifeline
    • Robert J. Thatcher, Chief Healthcare Policy Officer, Cardiovascular Systems, Inc.