Special to OWM: Alliance Successful in Educating the MCAC on Usual Care of Chronic Wounds

    The Alliance of Wound Care Stakeholders (“Alliance”) provided speakers with specific and critical wound care expertise to the Medicare Coverage Advisory Committee (MCAC) meeting, held March 29, which enabled the Committee to make positive recommendations regarding the usual care of chronic wounds to the Centers for Medicare and Medicaid Services (CMS).

The Alliance is a multidisciplinary consortium of more than 15 physician, clinical, provider, manufacturer, and patient organizations that have an interest in wound care. The MCAC was held to focus on the usual care of chronic wounds (cleansing, debridement, dressings, offloading, compression therapy, and antibiotics), gaps in knowledge, and public health strategies for improving the delivery of wound care to the Medicare population. More than 100 representatives of the wound healing community, including clinicians, researchers, industry members, and association representatives in attendance, heard the MCAC vote overwhelmingly that evidence exists to support usual care of chronic wounds. In addition, the MCAC addressed many of the Alliance’s concerns by asking the CMS to revisit the 30-day limitation stated in their definition of chronic wounds and by encouraging support of additional funding for wound care from the National Institutes of Health (NIH).

Background: Medicare Coverage Advisory Committee

    The MCAC is comprised of a cross section of physicians, clinicians, statisticians, epidemiologists, healthcare professionals, and consultants knowledgeable about evaluating clinical evidence regarding medical devices and procedures. Although their usual purpose is to make recommendations to the CMS about national coverage decisions on medical devices and procedures, the MCAC focused this meeting on learning about wound care from the invited speakers addressing and making recommendations to seven questions posed to them by the CMS regarding the evidence base for the usual care for chronic wounds.

The March 29 MCAC Meeting

    The meeting began with an overview of the issues presented by Steve Phurrough, MD, MPA, CMS’ Director, Coverage and Analysis Group; and James Rollins, MD, CMS staff member, who addressed chronic wound statistics, existing wound care national coverage decisions, and goals for the meeting. Their intent to focus on the usual care of chronic wounds rather than acute wounds or any advanced wound care technologies was made clear. Tom O’Donnell, MD, Tufts/New England Medical Center EPC, presented a technology assessment of evidence regarding basic, standard, and usual care modalities, noting that he was not asked to show efficacy of particular treatment modalities. Elizabeth Ayello, PhD, RN; Susan Horn, PhD; and David Margolis, MD, PhD, invited experts, presented clinical evidence related to pressure ulcers, diabetic foot ulcers, and venous stasis ulcers.

    Nineteen speakers representing various organizations and companies presented a summary of the written comments that had been submitted to the MCAC several weeks before the meeting. After the Alliance made introductory remarks, six speakers from the following participating organizations in the Alliance delivered comments on their own specific area of expertise: the Association for the Advancement of Wound Care (AAWC), the American Venous Forum, the National Pressure Ulcer Advisory Panel, the Foot Council of the American Diabetes Association, the Coalition of Wound Care Manufacturers, and the Undersea and Hyperbaric Medical Society. Other healthcare organizations also presenting included the American College of Surgeons, the American Physical Therapy Association, the American Podiatric Medical Association, and the Wound Healing Society.

    The Alliance worked with its participating organizations to develop a coordinated, integrated, comprehensive approach to respond to the MCAC questions, simultaneously educating the Committee on essential aspects of chronic wound care. The association speakers’ focus was to present clinical evidence of the usual care modalities of chronic wounds, make suggestions, and raise concerns.

    Diane Krasner, PhD, RN, CWOCN, CWS, FAAN, President of AAWC, presented the Alliance’s remarks, which addressed the following issues and concerns. The MCAC discussed the following issues in more depth later that day:
  • The data support clinical evidence for usual care of chronic wounds
  • The CMS needs to include the categories of nutritional support, vascular testing, and psychosocial support when describing usual care of chronic wounds
  • The CMS definition of “offloading” may be too narrow a term. In this context, offloading was considered in regard to diabetic foot ulcers. The Alliance suggests the addition of the broader term pressure redistribution to include support surfaces for the prevention and treatment of pressure ulcers
  • The CMS definition of chronic wounds is too narrow and should include other categories, such as:
       • nonhealing surgical and traumatic wounds
       • ischemic, other than arterial, insufficiency
       • vasculitic conditions
       • cancer
       • end-of-life/palliative care
       • mixed etiologies
  • The 30-day time frame included in the CMS definition of chronic wounds is unrealistic. The healing of a “chronic” wound is not a function of time or size; rather, it is physiologically based
  • Chronic wound patients are complex, with multiple comorbidities that vary widely from patient to patient and wound to wound.

    John Macdonald MD, FACS, President-elect of the AAWC, focused his remarks on the interdisciplinary approach to wound care, stating: “Due to the complexity of most chronic wounds, it is imperative that a comprehensive, multidisciplinary approach to care be taken in order to adequately address each contributing factor, to optimize care, and to improve outcomes.”

    Other association presentations reinforced the following issues:
  • the complexity of chronic wound care and its delivery
  • the challenges of wound research and research designs
  • the importance of an interdisciplinary approach to wound care
  • concerns about current Medicare definitions and selected policies related to chronic wound care

    After the public presentations, the remainder of the meeting was devoted to the MCAC questioning the speakers and the MCAC and reaching a consensus on their seven questions (the MCAC questions are listed in Table 1). The discussion topics included the speakers’ presentations as noted above as well as the following:
  • Funding for wound care studies
       • Wound care research attracts a smaller group of people because the field is not as respected as other specialties (ie, cardiology)
       • Manufacturers should not have to bear the cost all the time
       • The CMS staff stated that as a payor they can fund clinical costs in trials but not administrative or experimental costs
  • Discussion on whether non-wound care physicians could be trained well enough to take care of wound care patients. The specialty of wound care, the complexity of the wound care patient, and the training needed to care for these patients with comorbidities was discussed and recognized
  • Discussion about patient noncompliance and wound care therapy
  • Payment (or lack of it) in certain areas (eg, diabetic foot ulcers) was discussed. An MCAC member stated that if treatment began early enough and combined all the healthcare systems, Stage IV ulcers would be eliminated and the amputation rate would decrease. The CMS staff stated that payment issues would not be resolved at this meeting day — the intention was to identify the gaps as to what worked/did not work and what works best

Results of the MCAC Meeting

    This was an extremely positive meeting for all involved. The MCAC voted overwhelmingly that evidence exists to support usual care of chronic wounds. In addition, the MCAC addressed many of the Alliances’ concerns by asking CMS to revisit the 30-day limitation stated in its definition of chronic wounds and encourage support of additional funding for wound care to NIH. The wound care community members attending the meeting were pleased with the open dialogue between the CMS staff, MCAC, and the wound care presenters. The willingness of the MCAC and the CMS staff to be educated and subsequently address the seriousness and complexities of the issues related to the care and research on the usual care of chronic wounds is viewed by the wound care community as a positive step as the CMS determines its course of action on these issues.

CMS’ Next Steps and Implications for the Wound Care Industry

    The CMS staff stated that chronic wounds are an important issue for long-term examination; at this point in time, how the CMS will proceed with its next steps is unclear. The CMS staff stated that it may issue guidance documents for wound care or convene town hall meetings or additional MCAC meetings.

    Rendering national coverage decisions regarding wound care procedures, modalities, and devices is another potential course of action for CMS. Although this may affect some areas of wound care, it was noted that surgical dressings are one facet of wound care where coverage policies, issued through local coverage determinations by the Durable Medical Equipment Regional Carriers, work well and should not be changed.
In the next few months, a transcript of the meeting and the meeting results will be posted on the CMS website: https://www.cms.hhs.gov/mcd/viewmcac.asp?where= index&mid=28

    As Robert Warriner III, MD, who spoke on behalf of the Undersea and Hyperbaric Medical Society, stated, “The MCAC’s positive vote showed an endorsement for fundamentally correct and appropriate principles of wound care which were gratifying and encouraging. The Alliance of Wound Care Stakeholders, along with other wound care professionals, is looking forward to continuing the dialogue with CMS and any next steps they develop in regards to chronic wound care.”