Wound Care Evidence Summit to Gain Payer and Regulator Perspectives on Clinical Evidence and Coverage Challenges

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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 (NPWT) 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? What is the path forward for the acceptance of real-world evidence for regulatory approvals and payer coverage?

Wound Care Evidence Summit, May 19-20, 2022, in Bethesda, MD

Taking steps to address this clarity gap, this May the Alliance is bringing together payers (Humana, Aetna, UnitedHealthcare, CareFirst Blue Cross Blue Shield, Medicare), Federal regulators/policymakers (FDA, NIH, AHRQ), evidence analysis experts (Hayes), researchers, medical societies, and manufacturers at the Wound Care Evidence Summit.

The summit will be dialogue-driven as speakers, panelists and participants tackle issues spanning clinical practice guidelines, clinical trials endpoints, real-world evidence. One key overall focus: establish shared clarity around how much and what type of clinical evidence regulators and payers need to give a positive approval and coverage decision for products and procedures.

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 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 Endpoint and Real-World Evidence
  • National Institutes of Health on Wound Care Research, Data, and Grant Funding

Payer and policymaker speakers includes:

  • Aetna: Dr. Nancy Awadullah, Senior Medical Director, National Medical Policy & Operations
  • Aetna: Dr. Bob McDonough, Head of Clinical Policy Research
  • CareFirst Blue Cross Blue Shield: Dr. Kevin Park, Medicare Medical Director, Coverage Policy
  • Humana: Dr. Charles Stemple, former Vice President, Health Guidance Organization
  • UnitedHealthcare: Dr. Wendolyn Bell, Senior Medical Director, retired
  • AHRQ: Dr. David Niebuhr, Medical Officer, Center for Evidence and Practice Improvement
  • CMS: Dr. James Rollins, Acting Deputy Director, Division of Policy and Evidence Review
  • FDA: Dr. Cynthia Chang, Branch Chief, Plastic and Reconstructive Surgery Devices, Center for Devices and Radiological Health
  • FDA: Dr. Rosa Sherafat, Acting Lead Physician, Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissue and Advanced Therapies
  • NIH: Dr. Teresa Jones, Program Director for Diabetes Complications, National Institute of Diabetes and Digestive and Kidney Diseases
  • NIH: Dr. Marcel Salive, Medical Officer, Division of Geriatrics & Clinical Gerontology

See the full agenda and list of speakers.

Everyone in the room – speakers and attendees alike - will participate in collaboratively identifying and forging action steps. Space will be limited to ensure that the meeting is interactive and dialogue-focused. Grab your spot at the table. Learn more and register here.

The Alliance of Wound Care Stakeholders leverages the collective power of the wound care clinician community to promote quality wound care and protect access to products and services for people with wounds. Learn more about the Alliance and its Wound Care Evidence Summit here.

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

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