Lower Extremity Peripheral Artery Disease

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.

April 27, 2015

May 4, 2015

July 15, 2015

July 17, 2015

July 24, 2015

September 4, 2015

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

7:30 - 8:00 AM

8:00 - 8:10 AM

8:10 - 8:20 AM

8:20 - 9:20 AM

9:20 - 9:40 AM

9:40 - 10:00 AM

10:00 - 10:10 AM

10:10 - 11:45 AM

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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.

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11:45 - 11:50 AM

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

11:50 - 12:35 PM

12:35 - 1:35 PM

1:35 - 2:35 PM

2:35 - 3:35 PM

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

3:35 - 4:25 PM

4:25 - 4:30 PM

Download meeting minutes.

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.

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. 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.

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


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

Download scoresheet [28KB, PDF].

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

• 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.

Treatment Strategies for Patients With Peripheral Artery Disease

Horizon Scan of Invasive Interventions for Lower Extremity Peripheral Artery Disease and Systematic Review of Studies Comparing Stent Placement to Other Interventions