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)).

Ronald M. Davis, MD, Chairperson
Barbara J. McNeil, MD, PhD, Vice-Chairperson
Steve Phurrough, MD, MPA, Coverage and Analysis Group
Kimberly Long, Executive Secretary

Download Minutes.

Medicare Coverage Advisory Committee
Usual care of chronic wounds
March 29, 2005

1. Usual care for chronic wounds¹ commonly includes debridement, cleansing, dressing, compression, antibiotics and off-loading.
   1. Is there sufficient evidence to assess the health benefit of these modalities?
   2. Are there other modalities that provide a health benefit?

2. 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
   1. Are these appropriate main or intermediate outcome measures to be considered when assessing the benefits of usual care of chronic wounds?
   2. Are there other outcome measures that should be considered?
   3. As new technologies arise, are new outcomes needed to demonstrate a benefit in the treatment of chronic wounds?

3. Based on evidence reviewed, how likely is it that the treatments discussed in Question 1 will positively affect the outcomes discussed in Question 2?

4. 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?

5. Based on the evidence reviewed, how likely is it that usual care used to treat chronic wounds can be generalized to:
   1. The Medicare population (aged 65+)
   2. Providers (facilities/physicians) in community practice
6. What are the knowledge gaps in current evidence pertaining to the usual care of chronic wounds?
7. 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.

*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

http://www.cms.hhs.gov/mcd/viewtechassess.asp?where=index&tid=37