Alliance Announces Wound Care Evidence Summit to Gain Payers and Regulator Perspectives on Clinical Evidence and Coverage Challenges Protection Status
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By Shelley Ducker, Alliance of Wound Care Stakeholders

Coverage trends indicate that wound patients are increasingly being denied access to important products/services/procedures – or are being limited in receiving them – because of restrictions in payer coverage policies. Many times, restrictions – or utilization parameters – are out of step with clinical guidelines and current clinical practice.

For years, wound care advocates such as the Alliance of Wound Care Stakeholders and its membership of 20+ clinical associations and specialty medical societies have been submitting comment after comment to restrictive payer coverage policies to flag issues, point to supportive evidence and articulate the impacts to patient care. Problematic coverage policies have spanned debridement to surgical dressings to cellular and tissue-based products (CTPs) to negative pressure wound therapy and more.

Connecting with Payers on Wound Care Evidence "Clarity Gaps"

Regardless of the product category, many of today's evolving coverage challenges link back to a lack of shared clarity across payers, regulators, researchers and manufacturers surrounding wound care clinical evidence.

What specific type of evidence do payers need to cover wound care products and procedures? How much? What endpoints and outcomes are generalizable to typical chronic wound care patients…and acceptable to regulators, clinicians and payers?

Wound Care Evidence Summit, April 1-2 in Washington, DC

Taking steps to address this clarity gap, this April the Alliance is bringing together payers (Humana, Aetna, Kaiser Permanente, Noridian), regulators/policymakers (FDA, NIH, AHRQ), evidence analysis experts (Hayes, Milliman Care Guidelines), researchers, manufacturers, and medical societies at an inaugural Wound Care Evidence Summit.

The focus:
Establishing shared clarity around how much and what type of clinical evidence payers need to give a positive coverage decision for products and procedures.

The summit will be dialogue and discussion driven as we tackle clinical guidelines, clinical trials, endpoints, real-world evidence, evidentiary requirements for coverage and more 'hot button' topics. Sessions include:

  • Payer Panel on Clinical Practice Guidelines and Current State of Wound Care Research
  • Payer Panel on Coverage, Process Issues and Evidentiary Requirements
  • Payer Panel on FDA Endpoints and Real World Evidence Opportunities
  • Payers Panel on Clinical Trial Design and Possible Solutions
  • Agency for Healthcare Research and Quality on Wound Care Data
  • FDA on Wound Care Endpoints in Clinical Trial Design
  • FDA on Real World Evidence and Modernization of Clinical Trials
  • National Institutes of Health on Wound Care Research
  • Hayes Inc. and Milliman Care Guidelines on clinical practice guidelines and impact with payers

Payer and policymaker speakers includes:

  • Dr. Elise Berliner, Director, Technology Assessment Program, AHRQ
  • Dr. Cynthia Chang, Branch Chief, Plastic and Reconstructive Surgery Devices, Center for Devices and Radiological Health, FDA
  • Dr. Laurence Clark, Medical Director, Noridian Healthcare Solutions
  • Dr. Raymond J. Fabius, former Medical Director, Aetna / US Healthcare
  • Dr. Wini Hayes, Founder and CEO Emeritus, Hayes Inc.
  • Dr. Stacey Popko, Managing Editor, Ambulatory Care and Behavioral Health guidelines, MCG Health (formerly Milliman Care Guidelines)
  • Dr. Marcel Salive, Medical Officer, Division of Geriatrics & Clinical Gerontology, NIH
  • Dr. Charles Stemple, Vice President, Health Guidance Organization, Humana
  • Dr. Isaac Rodriguez-Chavez, Officer, Clinical Research Methodology, Regulatory Compliance & Policy Development, FDA

See the full agenda and expert speakers.

Registration will be capped at 100 attendees to enable participation and dialogue. Everyone in the room – speakers and attendees alike - will participate in collaboratively identifying and forging action steps.

Grab your spot at the table. Learn more and register at

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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