At the World Union of Wound Healing Societies meeting held in September 2016, the Alliance of Wound Care Stakeholders convened an expert panel to discuss the “Current state of wound care in Europe and the US — clinicians and manufacturers’ challenges of balancing good clinical practice with government policy changes.”
In addition to my inclusion as Executive Director of the Alliance, the participating panelists included: Matthew Garoufalis, DPM, Co-chair, Alliance of Wound Care Stakeholders (President, International Federation of Podiatrists, and Past President, American Podiatric Medical Association); Greg Bohn, MD, President, Association for the Advancement of Wound Care; Laura Bolton, PhD, Co-chair, International Consolidated Guideline Task Force (ICGTF); Marissa Carter, PhD, President, Strategic Solutions; Christopher M. Fashek, Chief Executive Officer, Atteris Healthcare LLC, and Vice Chairman, Rochal Industries LLC; Robin Martin, PhD, Senior Director, Scientific and Medical Affairs, Advanced Wound Management, Smith & Nephew; and Michael Baur, Vice President, Biom’Up, and Managing Partner, MSM Medical GmbH and Covaleo.
The key issues discussed by the panelists included:
- Elections matter. Who controls the White House selects the leadership of the regulatory agencies (Centers for Medicare and Medicare Services and the US Food and Drug Administration) that impact wound care policies. I discussed the role of the White House, Congress, Health and Human Services, and other agencies that create policies affecting wound care. I emphasized the transformational changes in payment reform — in particular, how the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 would impact clinicians.
- Wound care unified international consolidated interdisciplinary guidelines are important. Laura Bolton stated a goal was to contain all recommendations from all relevant guidelines that meet standardized content validity or evidence-based standards. She invited all associations to participate in this process, especially for content validation, adding that the ICGTF evidence-based content validated guidelines inform clinical wisdom and close the gap between research and practice.
- Physicians must learn to practice effectively and more economically due to payer cost containment. Dr. Greg Bohn emphasized: 1) using evidence-based guidelines and practicing in an organized fashion will afford the physician the best chance of cost-effective care with measured outcomes, 2) knowing the patient and the physiology of the wound can aid in the selection of products best suited for the situation, and 3) cost-effective wound care therapy selections of greatest value will need to be identified and utilized.
- When podiatrists are involved in treating wound care patients, tremendous cost savings are realized. Dr. Matt Garoufalis addressed 3 different studies, including 2 independent, large-scale retrospective reviews demonstrating care by podiatrists of persons with diabetes resulted in fewer lower extremity complications including amputations, with significant cost savings to payers. This important data can be presented to governments around the world to highlight the vital role podiatrists play in treating diabetic foot ulcers and preventing amputations.
- Clinical studies present challenges for wound care researchers throughout the world. Dr. Marissa Carter noted most biologics, drugs, and devices utilized in wound care are relatively low risk and may have potential benefits. Most clinical studies are conducted under controlled conditions, resulting in findings that may not be applicable to real world wound care populations. Post-market studies are important especially if the approval route did not involve trials. She questioned whether prospective studies or retrospective electronic health record-based studies should be conducted to determine endpoints versus claims and advocated for more creative trial design, such as pragmatic randomized, controlled trials; cohort designs; patient-selected controlled trials; and retrospective analyses from registries or large health care databases.
- Where will the next big innovation in wound care come from? Many on the panel led by Chris Fashek believed innovations would come from new startups with breakthrough technologies and then commercialized by larger companies. Personalized wound care initiatives from Amazon, Apple, or Google also were suggested. The panelists agreed feedback and ideas from physicians and nurses were the keys for innovations to be brought to market.
- What are some strategies for wound care product launch? Robin Martin stated manufacturers do not launch their products in only one place. Depending on the device category, the order would be Europe, the US, and then Japan based on regulatory hurdles. Michael Baur added that in his experience, it was easier to obtain FDA clearance for a product if the company/product was based in the US rather than Europe.
- Research and sound science are important to clinicians when they consider adopting a new wound care product. The clinician panelists agreed — they review the study design as well as the reimbursement of the product, especially if the clinician works in a managed care environment and only has a certain number of dollars to spend, to determine what makes sense economically if the products are equally effective. Manufacturers pondered if a new device doesn’t bring more value than a currently marketed product, does it pay to bring it to market?
In summary, the panelists found the current state of balancing good clinical practice with governmental policy changes is complex and challenging. They agreed payers and decision-making organizations listen to physicians and clinicians when creating policies. For their continued leadership and advocacy efforts on behalf of their members, the panelists reiterated the need for the support of the Alliance of Wound Care Stakeholders.