Usual Care of Chronic Wounds

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=28 | meeting_date=2005-03-29

Chronic wounds are wounds that have failed to proceed through an orderly and timely series of events to produce a durable, structural and cosmetic closure. These non-healing wounds have substantial public health impact within the Medicare population each year, including discomfort, loss of mobility, serious morbidity and mortality. CMS has identified this important issue for long-term examination. The task of evaluating evidence for the treatment of these wounds is difficult since the quality of available scientific evidence is often found to be inadequate. The purpose of this project is to outline the extent of the knowledge base for treatment of chronic wounds and to promote research initiatives within the healthcare community. CMS plans to focus on the magnitude of the wound care issue, to identify meaningful outcomes and measures, and to encourage an increase in the overall quality of evidence for wound care interventions. As an initial step, CMS will review the evidence on the usual care provided when a chronic wound is diagnosed. We will refer this issue to the Medicare Coverage Advisory Committee (MCAC). The MCAC will review and discuss usual care modalities. The discussion will focus on usual care, gaps in knowledge, and the public health strategies for improving the delivery of wound care to Medicare population. Specific products will not be discussed at this time. Notice of this action is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)).

Actions Taken: February 4, 2005 A Federal Register [PDF, 39KB] on January 28, 2005 announced an MCAC for March 29, 2005. Questions to be addressed to the MCAC panel will be posted soon with instructions and deadlines. February 15, 2005 Posted questions to be addressed to the MCAC panel. Due to the late posting of the questions, the deadline for receiving public comments has been extended to close of business on March 14, 2005. Individuals wishing to make scheduled public comments should ensure that their presentations focus on these questions. March 21, 2005 Posted Agenda , Roster , Speaker List , and Appendices. May 23, 2005 Transcript and Minutes [PDF, 184KB] posted. Agenda: Federal Register Notice March 29, 2005 7:30 AM - 4:30 PM CMS Auditorium Agenda Ronald M. Davis, MD, Chairperson Barbara J. McNeil, MD, PhD, Vice-Chairperson Steve Phurrough, MD, MPA, Coverage and Analysis Group Kimberly Long, Executive Secretary 7:30 - 8:00 AM Registration 8:00 - 8:20 AM Opening Remarks— K.Long / S. Phurrough, MD, MPA/R. Davis, MD 8:20 - 8:40 AM CMS Summary and Presentation of Voting Questions: James Rollins, MD 8:40 - 9:00 AM Presentation of the TA Tom O’Donnell, MD-Tufts/New England Medical Center EPC 9:00 - 9:10 AM Presentation: Susan D. Horn, PhD 9:10 - 9:20 AM Presentation: Elizabeth A. Ayello, PhD, RN 9:20 - 9:30 AM Presentation: David J. Margolis, MD, PhD 9:30 - 9:45 AM BREAK 9:45 - 11:00 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. 11:00 - 11:30 AM Questions to Presenters 11:30 - 12:00 PM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 12:00 - 1:00PM LUNCH (on your own) 1:00 - 3:15 PM Open Panel Deliberations: Dr. Davis 3:15 - 4:15 PM Formal Remarks and Vote The Chairperson will ask each panel member to state his or her position on the voting questions 4:15 - 4:30 PM Closing Remarks / Adjournment: K. Long /Dr. Phurrough 4:30 PM ADJOURN Issue: Chronic wounds are wounds that have failed to proceed through an orderly and timely series of events to produce a durable, structural and cosmetic closure. These non-healing wounds have substantial public health impact within the Medicare population each year, including discomfort, loss of mobility, serious morbidity and mortality. CMS has identified this important issue for long-term examination. The task of evaluating evidence for the treatment of these wounds is difficult since the quality of available scientific evidence is often found to be inadequate. The purpose of this project is to outline the extent of the knowledge base for treatment of chronic wounds and to promote research initiatives within the healthcare community. CMS plans to focus on the magnitude of the wound care issue, to identify meaningful outcomes and measures, and to encourage an increase in the overall quality of evidence for wound care interventions. As an initial step, CMS will review the evidence on the usual care provided when a chronic wound is diagnosed. We will refer this issue to the Medicare Coverage Advisory Committee (MCAC). The MCAC will review and discuss usual care modalities. The discussion will focus on usual care, gaps in knowledge, and the public health strategies for improving the delivery of wound care to Medicare population. Specific products will not be discussed at this time. Notice of this action is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). Minutes: Download Minutes . Other Material: Transcript 1 CMS Presentation [ZIP, 23KB] Panel Voting Questions: Medicare Coverage Advisory Committee Usual care of chronic wounds March 29, 2005 Usual care for chronic wounds 1 commonly includes debridement, cleansing, dressing, compression, antibiotics and off-loading. Is there sufficient evidence to assess the health benefit of these modalities? Are there other modalities that provide a health benefit? Using complete healing as the desired outcome, the following process measures are commonly used to assess healing of chronic wounds: Time to complete healing Partial healing rate Recurrence Elimination of infection Amputation Reduction of pain Resumption of normal activity Are these appropriate main or intermediate outcome measures to be considered when assessing the benefits of usual care of chronic wounds? Are there other outcome measures that should be considered? As new technologies arise, are new outcomes needed to demonstrate a benefit in the treatment of chronic wounds? Based on evidence reviewed, how likely is it that the treatments discussed in Question 1 will positively affect the outcomes discussed in Question 2? Based on the evidence reviewed, do the treatments reviewed in Question 1, singly or in combination, produce clinically significant net health benefits in the treatment of chronic wounds? Based on the evidence reviewed, how likely is it that usual care used to treat chronic wounds can be generalized to: The Medicare population (aged 65+) Providers (facilities/physicians) in community practice What are the knowledge gaps in current evidence pertaining to the usual care of chronic wounds? What trial designs will support the development of sufficient evidence to determine the appropriate treatment of chronic wounds? What units of analysis and covariates can be considered? 1 Chronic wounds are wounds taking longer than 30 days for complete healing. For purposes of this meeting, the wounds under consideration are venous ulcers, arterial ulcers, pressure ulcers and diabetic ulcers. Roster: Chairperson Ronald M. Davis, MD Director, Center for Health Promotion & Disease Prevention, Henry Ford Health System Vice-Chairperson Barbara J. McNeil, MD, PhD Department of Health Care Policy Harvard Medical School Voting Members Edgar R. Black, MD Regional Vice President, Chief Medical Officer Excellus BlueCross BlueShield, Rochester Region David J. Margolis, MD, PhD University of Pennsylvania-School of Medicine Catherine A. Glennon, RN Private Diagnostic at Duke Oncology Services Health Center Administrator, Hematology/Oncology Angus M. McBryde, Jr., MD Professor, Department of Orthopaedic Surgery University of South Carolina School of Medicine Harry B. Burke, MD, PhD Associate Professor of Medicine George Washington University School of Medicine Steven N. Goodman, MD, MHS,PhD Depart of Oncology, Division of Biostatistics John Hopkins School of Medicine Deborah Shatin, PhD Senior Research Director Center for Health Care Policy and Evaluation UnitedHealth Group Jonathan P. Weiner, PhD Professor & Deputy Director Health Services Research & Development Center The Johns Hopkins University Bloomberg School of Public Health Consumer Representative: Charles J. Queenan, III Independent Management Consultant Industry Representative: Kim K. Kuebler, MN, RN Palliative Care Nurse Practitioner Private Practice: Adjuvant Therapies Guest Panelists: Harod Brem, MD Director, Wound Healing Program Columbia University Medical Center New York Presbyterian Hospital Susan D. Horn, PhD Senior Scientist, Institute for Clinical Outcomes Research Vice President, Research, International Severity Information Systems, Inc. William B. Greenough, III, M.D. Division of Geriatric Medicine/Gerontology The Johns Hopkins University School Of Medicine Elizabeth A. Ayello, PhD, RN Senior Advisor The John A Hartford Foundation Institute for Geriatric Nursing CMS Liaison Steve E. Phurrough, MD, MPA Director, Coverage and Analysis Group Executive Secretary Kimberly Long Coverage and Analysis Group Speaker List: *EACH PRESENTER HAS 2 MINUTES TO SPEAK* Alliance of Wound Care Stakeholder Diane Krasner, PhD, RN; Alliance of Wound Care Stakeholder John MacDonald, MD; Alliance of Wound Care Laura Edsberg, PhD; National Pressure Ulcer Advisory Panel Robert Warriner, III, MD; Undersea and Hyperbaric Medical Society William Marston, MD; American Venous Forum Larry Lavery, DPM, MPH; Foot Council of the American Diabetes Association Dot Weir, RN; Coalition of Wound Care Manufacturers WHCG-Wound Healing Cooperative Group Vincent W. Li, MD Vickie R. Driver, DPM William J. Ennis, DO, MBA Stephen A. Brigido, DPM; Foot and Ankle Center at Coordinated Health Vincent Falanga, MD; Boston University, Roger Williams Medical Center Pam G. Unger, PT, CWS; American Physical Therapy Association David G. Armstrong, MD; The American Podiatric Medical Association TBA; American College of Surgeons Lisa Ovington, PhD, CWS; Johnson & Johnson Wound Management Maryangela Stokes; Juzo Joseph Gatewood; AdvaMed