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Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) Meetings Index

MEDCAC Meeting 7/20/2016 - Lower Extremity Chronic Venous Disease

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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.

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

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

Minutes

Download meeting minutes.

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).

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:
1. Immediate/near-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with physical signs?
2. 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:
1. Immediate/near-term health outcomes in patients presenting with symptoms? In patients presenting without symptoms but with signs?
2. 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.
1. Immediate/near-term health outcomes?
2. 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

Contact Information

Lori Ashby
lori.ashby@cms.hhs.gov

Jyme Schafer, MD, MPH
Jyme.Schafer@cms.hhs.gov

Other Material

Transcript 1

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

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