Lymphedema

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=51 | meeting_date=2009-11-18

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.

Actions Taken: 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] Agenda: 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. ****************************************************************************** 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 Issue: 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. Minutes: Download meeting minutes [PDF, 122KB] Other Material: Transcript 1 Panel Voting Questions: MEDCAC Questions: November 2009 Diagnosis and Treatment of Secondary Lymphedema 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? Imaging techniques Lymphoscintigraphy/lymphangioscintigraphy MRI/CT Ultrasound (99m)Tc-hexakis-2-methoxy isobutyl isonitrile (MIBI) scan Quantitative techniques to determine limb volume/ skin elasticity Tissue tonometry Perometry Circumferential measurements Water displacement Bioimpedance Patient reported symptomatology Physical exam Other 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? Imaging techniques Lymphoscintigraphy/lymphangioscintigraphy MRI/CT Ultrasound (99m)Tc-hexakis-2-methoxy isobutyl isonitrile (MIBI) scan Quantitative techniques to determine limb volume/ skin elasticity Tissue tonometry Perometry Circumferential measurements Water displacement Bioimpedance Patient reported symptomatology Physical exam Other 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? Affected limb circumference Affected limb volume Symptom assessment Affected limb function (strength, endurance, range of motion, sensation, etc.) ADL (Activities of Daily Living) abilities Frequency of skin breakdown or ulceration Frequency of occurrence of local infection Quality of life assessment Other 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? Pneumatic compression devices Exercise based activities Massage based treatment Compression bandaging/compression garments Psychosocial support Other 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence 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. How confident are you that each of the following treatment methods produces clinically meaningful improved health outcomes for patients with secondary lymphedema? Pneumatic compression devices Exercise based activities Massage based treatment Compression bandaging/compression garments Psychosocial support Other 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? Diagnostic Strategies: 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence Treatment Methods: 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence 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? Download Scoresheet [PDF, 3MB] Roster: 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 Speaker List: 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