Lower Extremity Chronic Venous Disease

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=72 | meeting_date=2016-07-20

On July 20, 2016, 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 underpinning the benefit and risk of existing lower extremity chronic venous disease treatments that aim to improve health outcomes in the Medicare population. This meeting will also identify evidence gaps that exist related to lower extremity chronic venous disease. Clinical outcomes of interest to the Medicare program include: reduction in pain; reduction in edema; improvement in functional capacity; improvement in quality of life; avoidance of acute and chronic venous thromboembolism; avoidance of chronic thromboembolic pulmonary hypertension; avoidance of initial venous skin ulceration and recurrent ulceration; improvement in wound healing; reduction in all-cause mortality; and avoidance of repeat interventions and 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 venous disease. MEDCAC panels do not make coverage determinations, but CMS often benefits from their advice.

Actions Taken: May 6, 2016 CMS posts MEDCAC meeting announcement and questions to panel. July 13, 2016 Posted agenda , roster and speakers list for meeting. Also posted presentations ( A-L , M-Z ) and written comments . July 22, 2016 Posted scoresheet from meeting. September 6, 2016 Posted minutes and transcript from meeting Webcast of meeting Registration Information about visiting CMS Driving directions to CMS Recommended hotels Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee July 20, 2016 7:30 AM – 4:30 PM CMS Auditorium Rita Redberg, MD , Committee Chair Art Sedrakyan, MD , Acting Committee Vice Chair Lori Ashby, MA , Director, Division of Medical and Surgical Services, Coverage and Analysis Group Maria Ellis , Executive Secretary 7:30 – 8:00 AM Registration 8:00 – 8:15 AM Opening Remarks - Maria Ellis/Lori Ashby, MA/Rita Redberg, MD 8:15 - 8:25 AM CMS Presentation & Voting Questions – Jyme Schafer, MD, MPH 8:25 – 8:45 AM Matthew Allison, MD, MPH, FAHA, Professor, Department of Family Medicine and Public Health, University of California San Diego 8:45 – 9:35 AM TA Presentation: Schuyler Jones, MD, Lead Clinical Investigator and Sreekanth Vemulapalli, MD, Clinical Expert, Duke University Medical Center 9:35 – 9:55 AM Thomas W. Wakefield, MD, Stanley Professor of Surgery, Section of Vascular Surgery, University of Michigan, Director, Samuel and Jean Frankel Cardiovascular Center, University of Michigan Health System 9:55 – 10:05 AM Fedor Lurie, MD, PhD, RPVI, President, American Venous Forum Foundation, Associate Director, Jobst Vascular Institute, Adjunct Research Professor, Division of Vascular Surgery, University of Michigan 10:05 – 10:15 AM BREAK 10:15 – 11:50 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. 11:50 – 12:00 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 12:00 - 1:00 PM LUNCH (on your own) 1:00 – 2:00 PM Questions to Presenters 2:00 – 3:00 PM Initial Open Panel Discussion: Dr. Redberg 3:00 – 4:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions. 4:00 – 4:20 PM Final Open Panel Discussion: Dr. Redberg 4:20 – 4:30 PM Closing Remarks/Adjournment: Lori Ashby & Dr. Redberg Issue: On July 20, 2016, 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 underpinning the benefit and risk of existing lower extremity chronic venous disease treatments that aim to improve health outcomes in the Medicare population. This meeting will also identify evidence gaps that exist related to lower extremity chronic venous disease. Clinical outcomes of interest to the Medicare program include: reduction in pain; reduction in edema; improvement in functional capacity; improvement in quality of life; avoidance of acute and chronic venous thromboembolism; avoidance of chronic thromboembolic pulmonary hypertension; avoidance of initial venous skin ulceration and recurrent ulceration; improvement in wound healing; reduction in all-cause mortality; and avoidance of repeat interventions and 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 venous 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: Download scoresheet . Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) Lower Extremity Chronic Venous Disease July 20, 2016 This MEDCAC meeting will examine the scientific evidence underpinning the benefit and risk of existing lower extremity chronic venous disease interventions that aim to improve health outcomes in the Medicare population. This meeting will also identify evidence gaps that exist related to lower extremity chronic venous disease. Lower extremity chronic venous disease is distinct from lower extremity peripheral artery disease as it is characterized by a different pathophysiology, epidemiology, set of clinical manifestations, and outcomes. Lower extremity chronic venous disease includes heterogeneous disorders that encompasses a variety of primary etiologies. Nevertheless, common to most of these venous conditions is a permanent alteration in venous structure and function, which leads to altered venous hemodynamics. Causes of altered venous blood flow include venous dilation and venous valvular reflux (venous valvular incompetence or “chronic venous insufficiency”) or venous obstruction (from prior venous thrombosis or mechanical compression). Patients with any of these venous structural alterations may be asymptomatic or symptomatic, suffering from mild pain to severe discomfort, with or without edema. Chronic venous disease can lead to major decrements in quality of life, and be associated with quality-of-life altering physical stigmata, including telangiectasias and varicose veins. Venous obstruction, venous insufficiency, and post-thrombotic syndrome patients may suffer from significant dependent edema and loss of ambulatory function. When venous insufficiency is associated with untreated (sustained) venous hypertension, the skin may be permanently damaged with initial and recurrent skin ulceration. Existing therapies to improve outcomes for individuals with lower extremity chronic venous disease are grouped into four main categories: medical therapy, lifestyle interventions (including exercise, smoking cessation, and weight reduction), mechanical compression therapies (support garments, bandaging and pneumatic compressive devices), and invasive procedures (endovascular techniques including venous angioplasty, stenting and ablation; and surgical interventions, including venous thrombectomy, venous bypass, venous ligation, and venous excision). Clinical outcomes of interest to the Medicare program include: reduction in pain; reduction in edema; improvement in functional capacity; improvement in quality of life; avoidance of acute and chronic venous thromboembolism; avoidance of chronic thromboembolic pulmonary hypertension; avoidance of initial venous skin ulceration and recurrent ulceration; improvement in wound healing; reduction in all-cause mortality; and avoidance of repeat interventions and 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 varicose veins and/or other clinical symptoms or signs of chronic venous insufficiency, how confident are you that there is sufficient evidence for an intervention that improves: Immediate/near-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with physical signs? Long-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with signs? Discussion: If intermediate confidence (≥ 2.5), please identify the specific intervention(s) that are associated with evidence-based clinical benefit and identify the associated beneficial outcome(s). Considering the heterogeneity of the Medicare population, discuss for which subgroups of the Medicare population the evidence demonstrates likely benefit or which subgroups are not likely to benefit from intervention. For adults with chronic venous thrombosis and venous obstruction (including individuals with post-thrombotic syndrome), how confident are you that there is sufficient evidence for an intervention that improves: Immediate/near-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with signs? Long-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with signs? Discussion : If intermediate confidence (≥ 2.5), please identify the specific intervention(s) that are associated with evidence-based clinical benefit and identify the associated beneficial outcome(s). Considering the heterogeneity of the Medicare population, discuss for which subgroups of the Medicare population the evidence demonstrates likely benefit or which subgroups are not likely to benefit from intervention. Immediate/near-term health outcomes? Long-term health outcomes? Additional Discussion Topics Discuss important venous disease evidence gaps that have not been previously or sufficiently addressed. Discuss any current venous disease treatment disparities and how they may affect the health outcomes of Medicare beneficiaries. Discuss any mechanisms that might be supported by CMS that would more quickly generate an improved evidence base that would underpin improved care for the Medicare population affected by lower extremity chronic venous diseases. Table 1. Definitions of Terms Term Definition Venous obstruction Defined as partial or complete blockage of venous flow in any venous segment; can result from internal blockage (e.g., thrombosis) or external compression of the vein Venous reflux Used to describe any retrograde venous flow in any venous segment; typically classified as (a) primary/idiopathic, (b) secondary (typically due to trauma, thrombosis, or mechanical/chemical/thermal etiologies), or (c) congenital Venous thrombosis Defined as the formation of a blood clot in any segment of the venous system; typically classified as deep or superficial Chronic venous insufficiency or incompetence (CVI) Reserved for advanced venous disease, indicated by C3-C6 on the CEAP classification, and defined as morphological abnormalities of the venous system that lead to symptoms/signs (specifically, moderate-severe LE edema, skin changes, and/or venous ulcers) Post-thrombotic syndrome Describes chronic venous symptoms and/or signs that occur as a result of DVT and its sequelae Abbreviations: CEAP = Clinical, Etiologic, Anatomic, Pathophysiologic DVT = deep vein thrombosis LE = lower extremity Roster: MEDCAC Roster Committee Chair Rita Redberg, MD, MSC Professor of Medicine UCSF School of Medicine Division of Cardiology University of California, San Francisco Medical Center Committee Acting Vice Chair Art Sedrakyan, MD, PhD Professor and Director Patient Centered Comparative Outcomes Research Program Weill Cornell Medical School 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 Peter F. Lawrence, MD Chief of Vascular Surgeon University of California, Los Angeles Roger J. Lewis, MD, PhD, FACEP Professor and Vice Chair, Academic Affairs Department of Emergency Medicine Harbor-UCLA Medical Center 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 A. Swain, MD Vice Chair for Clinical Performance Director of Clinical Research Department of Cardiovascular Surgery Icahn School of Medicine at Mount Sinai New York City Director, Center for Medical Devices (CMeD) at Mount Sinai Heart Due to unforeseen circumstances, Dr. Swain is unable to attend the meeting Diana Zuckerman, PhD President National Center for Health Research Cancer Prevention and Treatment Fund Industry Representative Leslie Wise Vice President Global Healthcare Economics Guest Panel Members Teresa L. Carman, MD Director Vascular Medicine University Hospitals Case Medical Center Anthony J. Comerota, MD, FACS, FACC Jobst Vascular Institute Toledo, Ohio Adjunct Professor of Surgery University of Michigan Invited Guest Speakers Matthew Allison, MD, MPH, RPVI Professor Family Medicine and Public Health University of California San Diego Director, Vascular Laboratory Veterans Affairs San Diego Healthcare System Fedor Lurie, MD, PhD, RPVI President American Venous Forum Foundation Associate Director Jobst Vascular Institute Adjunct Research Professor Division of Vascular Surgery University of Michigan Thomas Wakefield, MD Section Head Stanley Professor of Vascular Surgery Director Samuel & Jean Frankel Cardiovascular Center University of Michigan CMS Liaison Lori Ashby, MA Director Division of Medical and Surgical Services Coverage and Analysis Group Executive Secretary Maria Ellis Coverage and Analysis Group Speakers List: Medicare Evidence Development & Coverage Advisory Committee July 20, 2016 SPEAKER LIST *4 MINUTES PER SPEAKER* Oscar M. Alvarez, PhD, CCT, FAPWCA , Director, University Wound Care Centers and Professor, Department of Medicine, New York Medical College Marlin W. Schul, MD, RVT, FACP , Owner, Indiana Vascular Associates, LLC dba Lafayette Regional Vein & Laser Center – Representing: ACP PRO Venous Registry K. Francis Lee, MD, PC, Founder and Medical Director of Advanced Vein Care Center – No PowerPoint Nick Morrison, MD, FACPh, FACS, RPhS , President, International Union of Phlebology - Representing: United States Compression Alliance 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 Cynthia K. Shortell, MD , Professor of Surgery, Duke University Peter Henke, MD, Leland Ira Doan Professor of Surgery, Section of Vascular Surgery, University of Michigan Michael C. Dalsing, MD , Professor of Surgery, Division of Vascular Surgery, Indiana University School of Medicine – Representing: The Society for Vascular Surgery and The American Venous Forum Thomas F. O’Donnell, Jr., MD, Benjamin Andrews Emeritus Professor of Surgery, Tufts University School of Medicine, Senior Surgeon Tufts Medical Center Brajesh K. Lal, MD , Professor of Surgery, Division of Vascular Surgery, University of Maryland School of Medicine – strong>Representing: The Society for Vascular Surgery and The American Venous Forum Janice Smiell, MD , Chief Medical Officer, Alliqua BioMedical, Inc. - Due to unforeseen circumstances, she was unable to attend the meeting. Suman Rathbun, MD, MS, FSVM, FACP, Professor of Medicine, Director, Vascular Medicine, University of Oklahoma Health Sciences Center Mark H. Meissner, MD , Professor of Surgery, University of Washington School of Medicine Suresh Vedantham, MD, President-Elect, Society of Interventional Radiology, Principal Investigator, ATTRACT & C-TRACT Trials, Professor of Radiology & Surgery, Mallinckrodt Institute of Radiology, Washington University in St. Louis Gregory Piazza, MD, MS, FACC, FSVM , Cardiovascular Medicine Division, Brigham and Women’s Hospital Joshua A. Beckman, MD , Director, Section of Vascular Medicine, Vanderbilt University Medical Center, Chair, PVD Council, American Heart Association Sean P. Lyden MD, Chairman, Vascular Surgery, Cleveland Clinic - Representing: VIVA Physicians Mark Turco, MD , Medical Director, Aortic and Peripheral Vascular, Medtronic Mark J. Garcia, MD, MS, FSIA , EndoVascular Consultants, LLC Gary Gibbons, MD , Medical Director, South Shore Hospital, Center for Wound Healing, and Board Member, Association for the Advancement of Wound Care Eric Lullove DPM, CWS, FACCWS, Medical Director, West Boca Center for Wound Healing, and Board Member, Association for the Advancement of Wound Care R. Daniel Davis, DPM , President, American Podiatric Medical Association Jim Harmon , Vice President of Global Market Access, BTG International, Inc. Caroline Fie, MD , Executive Director of the US Wound Registry (USWR) Technology Assessment: http://www.ahrq.gov/research/findings/ta/index.html