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MEDCAC Meeting 11/18/2009 - Lymphedema

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CMS has called this meeting for the panel to discuss the adequacy of the available evidence that supports the diagnostic and treatment methods used in the management of secondary lymphedema. Medicare currently has a national coverage determination for the use lymphedema pumps related to the treatment of this condition.

Lymphedema occurs due to dysfunction of the lymphatic transport system. As a result of this abnormality, fluid (containing mostly water, protein, fatty acids, white blood cells, salts and debris/microorganisms) accumulates within the interstitial tissue of various areas of the body. The fluid accumulation can cause subclinical disease (that which cannot be seen on clinical examination) to gross enlargement of a body part. Complications of lymphedema include intradermal fibrosis, infection, pain and impaired functioning of the affected body part.

Lymphedema can be classified as either primary (due to abnormal development or growth of the lymphatic system) or secondary (due to injury to the lymphatic system). In the United States, the most common form of secondary lymphedema is that associated with the surgery and radiation of cancer treatment.

Strategies for the treatment of secondary lymphedema are directed at preventing or minimizing the fluid accumulation in the affected body parts, restoring any lost function and providing education to avoid the potential of anticipated complications.

October 1, 2009 Posted Federal Register notice.
October 5, 2009 Posted questions to panel.
November 2, 2009 Posted Technology Assessment
November 17, 2009 Posted agenda, roster and speaker list for meeting.
November 30, 2009 Posted scoresheet [PDF, 3MB] from meeting.
January 19, 2010 Posted transcript [PDF, 362KB] from meeting.
February 16, 2010 Posted minutes from meeting [PDF, 122KB]
Federal Register Notice
Agenda
Medicare Evidence Development & Coverage Advisory Committee
November 18, 2009
7:30 AM – 4:30 PM
CMS Auditorium

Clifford Goodman, PhD, Chair
Saty Satya-Murti, MD, Vice Chair
Tamara Syrek Jensen, JD, Deputy Director, Coverage and Analysis Group
Maria Ellis, Executive Secretary

 
7:30 – 8:00 AM Registration
8:00 – 8:15 AM Opening Remarks—Maria Ellis/ Tamara Syrek Jensen, JD/Clifford Goodman, PhD
8:15 - 8:30 AM CMS Presentation & Voting Questions – Jean Stiller/Susan Miller, MD
8:30 – 9:15 AM Presentation: Mark Oremus, PhD, McLaughlin Foundation Professor of Population and Public Health, Assistant Professor of Department of Clinical Epidemiology & Biostatistics, Co-Associate Director, McMaster Evidence-based Practice Centre
9:15 – 9:45 AM Stanley G. Rockson, MD, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Chief of Consultative Cardiology, Stanford University Medical School
9:45 – 10:15 AM Jane M. Armer, PhD, RN, FAAN, Professor, Sinclair School of Nursing, Director, Nursing Research, Ellis Fischel Cancer Center, Director, American Lymphedema Framework Project
10:15 – 10:30 AM  BREAK
10:30 – 11:50 PM 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.
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11:50 – 12:00 PM 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 – 2:45 PM   Initial Open Panel Discussion: Dr. Goodman
2::45 – 3:45 PM Formal Remarks and Voting Questions
The Chairperson will ask each panel member to state his or her position on the voting questions
3:45 – 4:15 PM   Final Open Panel Discussion: Dr. Goodman
4:15 – 4:30 PM  Closing Remarks/Adjournment: Ms. Syrek Jensen & Dr. Goodman

Download meeting minutes [PDF, 122KB]

MEDCAC Questions: November 2009
Diagnosis and Treatment of Secondary Lymphedema

  1. How confident are you that there is sufficient evidence to determine if the listed diagnostic strategies can reliably identify and stratify the severity of secondary lymphedema, including subclinical disease? 

    1. Imaging techniques
      1. Lymphoscintigraphy/lymphangioscintigraphy
      2. MRI/CT
      3. Ultrasound
      4. (99m)Tc-hexakis-2-methoxy isobutyl isonitrile (MIBI) scan
    2. Quantitative techniques to determine limb volume/ skin elasticity
      1. Tissue tonometry
      2. Perometry
      3. Circumferential measurements
      4. Water displacement
      5. Bioimpedance
    3. Patient reported symptomatology
    4. Physical exam
    5. Other

    2. 1
    Low
    confidence
    2
    3
    Intermediate
    confidence
    4
    5
    High confidence

  2. For only those items where the answer to Question 1 is at least in the Intermediate range (mean score ≥ 2.5 on Question 1), how confident are you that each of the listed diagnostic strategies reliably identifies and stratifies the severity of secondary lymphedema, including subclinical disease?  
    1. Imaging techniques
      1. Lymphoscintigraphy/lymphangioscintigraphy
      2. MRI/CT
      3. Ultrasound
      4. (99m)Tc-hexakis-2-methoxy isobutyl isonitrile (MIBI) scan
    2. Quantitative techniques to determine limb volume/ skin elasticity
      1. Tissue tonometry
      2. Perometry
      3. Circumferential measurements
      4. Water displacement
      5. Bioimpedance
    3. Patient reported symptomatology
    4. Physical exam
    5. Other

    3. 1
    Low
    confidence
    2
    3
    Intermediate
    confidence
    4
    5
    High confidence

  3. How confident are you that secondary lymphedema can be classified into prognostic stages of severity, i.e., staging that is useful to guide choice of therapy or predict response to therapy?

    4. 1
    Low
    confidence
    2
    3
    Intermediate
    confidence
    4
    5
    High confidence

  4. In clinical studies of treatment(s) for secondary lymphedema, how confident are you that there is sufficient evidence that an improvement in each of the following measures is, or is strongly associated with, an improved health outcome?

    1. Affected limb circumference
    2. Affected limb volume
    3. Symptom assessment
    4. Affected limb function (strength, endurance, range of motion, sensation, etc.)
    5. ADL (Activities of Daily Living) abilities
    6. Frequency of skin breakdown or ulceration
    7. Frequency of occurrence of local infection
    8. Quality of life assessment
    9. Other

    5. 1
    Low
    confidence
    2
    3
    Intermediate
    confidence
    4
    5
    High confidence

  5. How confident are you that there is sufficient evidence to determine if each of the following treatment strategies produces clinically meaningful improved health outcomes for patients with secondary lymphedema?

    1. Pneumatic compression devices
    2. Exercise based activities
    3. Massage based treatment
    4. Compression bandaging/compression garments
    5. Psychosocial support
    6. Other

    6. 1
    Low
    confidence
    2
    3
    Intermediate
    confidence
    4
    5
    High confidence

    Please answer Question 6 ONLY for those treatments where the panel had at least Intermediate range confidence (mean score ≥ 2.5 on Question 5) that there was sufficient evidence to address this issue.

  6. How confident are you that each of the following treatment methods produces clinically meaningful improved health outcomes for patients with secondary lymphedema?

    1. Pneumatic compression devices
    2. Exercise based activities
    3. Massage based treatment
    4. Compression bandaging/compression garments
    5. Psychosocial support
    6. Other

    7. 1
    Low
    confidence
    2
    3
    Intermediate
    confidence
    4
    5
    High confidence

  7. How confident are you that the conclusions regarding the diagnostic strategies as a group (Q2) and the treatment methods as a group (Q6) are generalizable to Medicare beneficiaries with secondary lymphedema? 

    8. Diagnostic Strategies:
    1
    Low
    confidence    		 2 3
    Intermediate
    confidence    		 4 5
    High
    confidence
    Treatment Methods:
    1
    Low
    confidence    		 2 3
    Intermediate
    confidence    		 4 5
    High
    confidence

  8. Please discuss any clinically important evidence gaps pertaining to the diagnosis and/or treatment of secondary lymphedema.  What trial designs would support the closure of such existing evidence gaps?

    9.  

    Download Scoresheet [PDF, 3MB]

November 18, 2009
MEDCAC Roster

Clifford Goodman, PhD Chair
Senior Vice President
The Lewin Group

Saty Satya-Murti, MD, FAAN Vice Chair
Health Policy Consultant

Catherine Eng, MD, FACP
Medical Director
On Lok Lifeways
On Lok Senior Health Services

John Cox, DO, FACP
Texas Oncology, PA
Methodist Charlton Cancer Center

Philip B. Gorelick, MD, MPH
John S. Garvin Professor & Head
Department of Neurology and Rehabilitation University of Illinois at Chicago College of Medicine

Josef E. Fischer, MD
Chairman
Department of Surgery
Beth Israel Deaconess Medical Center

Nora A. Janjan, MD, MPSA
Navasota, TX

Norman S. Kato, MD
Chief Medical Officer
Cardiac Care Medical Group, Inc.

Stephen Pauker, MD, MACP, FACC
Professor of Medicine
Division of Clinical Decision Making
Tufts University School of Medicine
Tufts Medical Center, Box 302

Gurkirpal Singh MD
Adjunct Clinical Professor of Medicine
Division of Gastroenterology & Hepatology
Stanford University School of Medicine
Chief Science Officer
Institute of Clinical Outcomes Research and Education

Craig Umscheid, MD, MSCE
University of Pennsylvania
School of Medicine

Patient Advocate

Susan Kendig, JD, MSN
Coordinator, Woman’s Health Nurse Practitioner Program
Associate Teaching Professor
College of Nursing
University of Missouri-St. Louis

Industry Representative

Kim K. Kuebler, MN, APRN-BC
Medical Pharmaceutical Consultant

Guest Panel Members

Janice Cormier, MD
Associate Professor
University of Texas M.D. Anderson Cancer Center

Naomi Lynn Hurwitz Gerber, MD
Director
Center for Chronic Illness and Disability
George Mason University

Lucinda A. Pfalzer, PT, PhD
Professor
Associate Director
Research and Post-Professional Education
Physical Therapy Department
School of Health Professions & Studies
University of Michigan-Flint

Guest Speakers

Jane M. Armer, PhD, RN, FAAN
Professor, Sinclair School of Nursing
Director, Nursing Research, Ellis Fischel Cancer Center
Director, American Lymphedema Framework Project

Stanley G. Rockson, MD
Allan and Tina Neill Professor of Lymphatic Research and Medicine
Chief of Consultative Cardiology
Stanford University Medical Center

CMS Liaison

Tamara Syrek Jensen, JD
Deputy Director
Coverage and Analysis Group

Executive Secretary

Maria A. Ellis

Medicare Evidence Development & Coverage Advisory Committee
November 18, 2009
SPEAKER LIST
                       

*5 MINUTES PER SPEAKER*
  • Robert Weiss, MS, Lymphedema Patient Advocate, National Lymphedema Network
  • Kathleen Francis, MD, Lymphedema Physician Services, PC, Medical Director, St. Barnabas ACC Lymphedema Treatment Center, Livingston, New Jersey, Medical Director, Klose Training and Consulting, LLC, Chair, Medical Advisory Committee, national Lymphedema Network
  • Linda T. Miller, PT, Clinical Director, Breast Cancer Physical Therapy Center, Ltd.
  • Walton A. Taylor, MD, FACS, General And Breast Surgery, Dallas, Texas
  • Steven Schonholz, MD, FACS, Mercy Medical Center, Springfield, Massachusetts
  • Oscar M. Alvarez, PhD, Director, Center for Curative and Palliative Wound Care, Calvary Hospital, Bronx, New York, Professor, Department of Medicine, New York Medical College, Valhala, New York
  • Maureen McBeth, PT, CLT-LANA, The Center for Restorative Therapies at Weinberg, Mercy Medical Center, Cancer Center Program Manager
  • Shelia H. Ridner, PhD, RN, Assistant Professor, Vanderbilt University School of Nursing
  • Steven M. Dean, Do, FACP, RPVI, on behalf of the Society of Vascular Medicine, Associate Professor of Internal Medicine, Program Director, Vascular Medicine, Division of Cardiovascular Medicine, The Ohio State University College of Medicine
  • Caroline Fife, MD, Director of Clinical Research, Memorial Hermann Center for Lymphedema Therapy, Associate Professor Medicine, Cardiology Division, University of Texas Health Science Center
  • Paula Stewart, MD, MS, CLT-LANA, Vice-President, Lymphedema Association of North America
  • Pat Whitworth, MD, Director, Nashville Breast Center
  • Susan Morgan, Director, Lymphedema & Wound Care Institute
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