Lower Extremity Peripheral Artery Disease

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=70 | meeting_date=2015-07-22

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: April 27, 2015 CMS announces MEDCAC meeting. Posts FR Notice and registration link. May 4, 2015 Posted questions to panel July 15, 2015 Posted agenda , roster , speakers list , presentations , and written comments for meeting. July 17, 2015 Posted Reference List 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: Federal Register Notice 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 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. Minutes: Download meeting minutes . Other Material: Transcript 1 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 For adults with asymptomatic lower extremity PAD, how confident are you that there is sufficient evidence for an intervention that improves: Immediate/near-term health outcomes? 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. For adults with lower extremity intermittent claudication (IC) , how confident are you that there is sufficient evidence for an intervention that improves: Immediate/near-term health outcomes? 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. For adults with lower extremity critical limb ischemia (CLI), how confident are you that there is sufficient evidence for an intervention that improves: Immediate/near-term health outcomes? 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 Discuss the important evidence gaps that have not been previously or sufficiently addressed. Discuss any apparent lower extremity PAD treatment disparities and how they may affect the health outcomes of Medicare beneficiaries. Download scoresheet [28KB, PDF]. 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. Technology Assessments: 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