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Words on Wounds

A forum to discuss the latest news and ideas in skin and wound care.

Thursday, February 27, 2020

Addressing the Wound Care Evidence "Clarity Gap" and Impact on Payer Coverage

Coverage trends indicate that patients with wounds are increasingly denied access to important products, services, and procedures–or are 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 practice.

Wound care advocates such as the Alliance of Wound Care Stakeholders and its membership of 20 clinical associations and specialty medical societies have submitted comment after comment to problematic payer coverage policies flagging issues, pointing to supportive evidence, and articulating the impacts to patient care. Coverage policies inconsistent with clinical practice have touched on nearly every aspect of skin and wound care, from debridement to surgical dressings to cellular and/or tissue-based products to negative-pressure wound therapy and more.

"Many of today's evolving coverage challenges link back to a lack of shared clarity across payers, regulators, researchers, and manufacturers surrounding wound care evidence," notes Executive Director of the Alliance, Marcia Nusgart, RPh. "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 also acceptable to regulators, clinicians, and payers?" 

Taking steps to address this clarity gap, this April 1 and 2 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 creates a unique space for payers and regulators and manufacturers and practitioners to candidly and collaboratively address challenges. Sessions include:

  • Payer Perspectives on Clinical Practice Guidelines and Current State of Wound Care Research
  • Payer Perspectives on Coverage, Process Issues, and Evidentiary Requirements 
  • Payer Perspectives on FDA Endpoints and Real World Evidence Opportunities 
  • Payer Perspectives 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/National Evaluation System for Health Technology on Real World Evidence and Modernization of Clinical Trials
  • National Institutes of Health on Wound Care Research

"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," said Marcia Nusgart. "We are allowing only about 100 participants to enable participation and dialogue. Everyone in the room – speakers and attendees alike - will participate in collaboratively identifying and forging action steps." 

For more information, visit https://www.woundcarestakeholders.org/meetings/wound-care-evidence-summit.

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