The Wound Care Evidence Summit will convene commercial and government payer medical directors, FDA, AHRQ, and NIH senior staff, wound care researchers, physician specialty societies, clinical associations, wound care providers, researchers, manufacturers, and policymakers to tackle issues including:

  • How can we improve the effectiveness of chronic wound care clinical management?
  • What outcomes are most important to patients, as well as to regulatory, payer and other stakeholders?
  • How can we reduce unnecessary costs and improve the cost-effectiveness of care?
  • What type and quantity of research do payers require to cover wound care products and procedures?
  • What role should real-world data play in research, and what real-world evidence will be acceptable to regulators, clinicians and payers?

Expect lively interactive conversation between panelists, speakers and all Summit attendees - including opportunities for extensive Q&A throughout. Development of collaborative action steps will conclude the conference.
Evidence Summit Banner 1 11.14.19

Evidence Summit Day 1

APRIL 1 - 8:00 AM - 6:30 PM

may be subject to change

8:00-8:30 AM

Breakfast


8:30-8:45

Welcome and Introductions; Opening Remarks and Expectations

Speakers:
  • Marcia Nusgart, R.Ph., Founder and Executive Director, Alliance of Wound Care Stakeholders
  • Lynn Shapiro Snyder, Esq., Senior Member, Epstein Becker and Green, Washington D.C.

8:45-9:45

Panel Discussion: Challenges and Opportunities in Wound Care Research and Coverage

Stakeholders from researcher, provider, payer, physician specialty society/clinical associations will present their views on both challenges and opportunities currently in wound care research and coverage issues.
Speakers:
  • Lynn Shapiro Snyder, Esq., Senior Member, Epstein Becker and Green, Washington D.C. (moderator)
  • Anna Kuang MD, Global Medical Director, Advanced Wound Care, Skin and Surgical Site Management, 3M Health Care
  • Geoffrey Gurtner, MD, FACS, President, Wound Healing Society, Johnson and Johnson Distinguished Professor of Surgery, Professor of Bioengineering and Materials Science, Stanford University
  • Steve McLaughlin, CEO RestorixHealth
  • James Christina, DPM, Executive Director and CEO, American Podiatric Medical Association

9:45-10:15

State of Research in the Wound Care Industry

What are the challenges in wound care research and possible solutions?
Speaker:
  • Marissa Carter, PhD, President, Strategic Solutions

10:15-10:45

Agency for Healthcare Research and Quality (AHRQ) Perspectives on Wound Care Data

AHRQ has conducted many technology assessments over the years on chronic wound care (i.e. cellular and/or tissue based products for skin wounds, negative pressure wound therapy). Obtain a better understanding of how AHRQ performs its technology assessments and the Agency’s view of wound care research.
Speaker:
  • Elise Berliner, PhD, Director of the Technology Assessment Program, Agency for Healthcare Research and Quality

10:45-11:00

Break


11:00 AM - 12:00 Noon

State of Clinical Practice Guidelines: Professional and Commercial

This session will discuss issues regarding various clinical practice guidelines written by physician specialty societies and clinical associations such as: if multiple guidelines exist, is there consensus or gaps? How current are they? How are they developed? How are they used by payers? For the commercial guidelines, the panelists will discuss how the guidelines are developed, how often they are updated and how they interact with payers and stakeholders.
Panelists:
  • Diabetes expert: David Armstrong DPM, MD, PhD, Professor of Clinical Surgery at the University of Southern California.
  • Vascular expert: Joseph Mills M.D., Chief,Division of Vascular Surgery & Endovascular Therapy, Baylor College of Medicine
  • Pressure injury expert: William Padula, PhD, Assistant Professor, Department of Pharmaceutical and Health Economics, University of Southern California School of Pharmacy
  • Evidence analysis for payers:  Michelle Ostrander, PhD, Scientific Director, Evidence Analysis, Hayes - a TractManager Company
  • Evidence analysis for payers:  Stacey Popko, MD, MBA, Managing Editor, Ambulatory Care and Behavioral Health guidelines, MCG Health (formerly Milliman Care Guidelines)

12:00-1:00 PM

Lunch


1:00-2:00

Panel Discussion: Payer Medical Director Perspectives on Clinical Practice Guidelines and Current State of Wound Care Research

This is the first of four sessions where the medical directors from both commercial and government payers will share perspectives. This session will focus on clinical practice guidelines and the current state of wound care research.
Panel Speakers:
  • Charles Stemple, MD, Senior Medical Director, Humana
  • Larry Clark MD, Medical Director, Noridian
  • Ray Fabius, MD, CPE, FACPE, Co-founder and President of HealthNEXT, Former Medical Director US Healthcare/Aetna and Cigna
  • Alan Rosenberg, MD, Former Vice President, Medical and Clinical Pharmacy Policy, Anthem; FormerVice President of Medical Affairs and Medical Director, Aetna

2:00-2:30

State of Coverage of Wound Care Products and Procedures by Commercial and Government Payers

This session gives an overview of the status of coverage of wound care products and procedures by commercial and government payers. How payers view wound care research as written in their coverage policies will also be discussed.
Speaker:
  • Donna Cartwright, Senior Director, Health Policy and Reimbursement Services, Integra Life Sciences Corporation

2:30-2:45

Break


2:45-4:45

Panel Discussion: Payer Medical Director Panel Perspectives on Coverage: Process Issues and Evidentiary Requirements

This is the second of four sessions where the medical directors from both commercial and government payers will address their perspectives. This session will focus on (1) the processes that the medical directors use to create their coverage policies and (2) the type and how much clinical evidence is needed to obtain a positive coverage decision.
Panel Speakers:
  • Charles Stemple, MD, Senior Medical Director, Humana
  • Larry Clark, MD, Medical Director, Noridian
  • Ray Fabius, MD, CPE, FACPE, Co-founder and president of HealthNEXT, Former Medical Director US Healthcare/Aetna and Cigna
  • Alan Rosenberg, MD, Former Vice President, Medical and Clinical Pharmacy Policy, Anthem; FormerVice President of Medical Affairs and Medical Director, Aetna

4:45-5:15

Day 1 Wrap-Up

Moderator:
  • Lynn Shapiro Snyder, Esq., Senior Member, Epstein Becker and Green, Washington D.C.

5:30-6:30

Reception



Evidence Summit Day 2

APRIL 2 - 8:00 AM - 4:00 PM

may be subject to change

8:00-8:30 AM

Breakfast


8:30-8:45

Opening Remarks

Moderator:
  • Lynn Shapiro Snyder, Esq., Senior Member, Epstein Becker and Green, Washington D.C.

8:45-10:15

Panel Discussion: FDA and Wound Care Evidence Issues


Wound Care Endpoints in Clinical Trial Design

Currently, wound care researchers and manufacturers follow the FDA 2006 Guidance Document for Industry-Chronic Cutaneous Ulcers where the sole endpoint is complete wound healing. This discussion will focus on how the FDA views wound care evidence and the latest work done to address the possibility of FDA acceptance of interim endpoints in clinical trial design.
Speakers:
  • Cynthia Chang, PhD, Branch chief for Plastic and Reconstructive Surgery Devices Branch, Centers for Devices and Radiological Health, Food and Drug Administration (FDA)
  • Laura Marquart, MD, Medical Officer, Plastic Surgery Skin and Wound Devices Team, FDA
  • Vickie Driver, DPM, Professor of Surgery, Department of Orthopedics, Brown University

Real World Evidence and Modernization of Clinical Trials

The speakers will explore such topics as: the difference between real world data and real world evidence; the value of real world evidence and its limitations; how potential bias is controlled and where registries fit in.
Speakers:
  • Robbert Zusterzeel, MD, PhD, MPH; Data Network Director, NEST Coordinating Center, Medical Device Innovation Consortium
  • Isaac Rodriguez-Chavez, PhD, MHS, MS; Officer, Clinical Research Methodology, Regulatory Compliance & Policy Development, FDA, Center for Drug Evaluation and Research, Office of Medical Policy, Clinical Methodologies

10:15-10:30

Break


10:30-11:30

Perspectives from Medical Director Payers on FDA Endpoints and Real World Evidence Opportunities

This is the third of four sessions where the medical directors from both commercial and government payers will address their perspectives. This session will focus on their view of FDA endpoints and real world evidence (e.g., what would it take to gain acceptance of real world evidence by these payers?)
Panelists:
  • Charles Stemple, MD, Senior Medical Director, Humana
  • Larry Clark, MD, Medical Director, Noridian
  • Ray Fabius, MD, CPE, FACPE, Co-founder and president of HealthNEXT, Former Medical Director US Healthcare/Aetna and Cigna
  • Alan Rosenberg, MD, Former Vice President, Medical and Clinical Pharmacy Policy, Anthem;FormerVice President of Medical Affairs and Medical Director, Aetna

11:30 - 12:00 noon

National Institutes of Health and Wound Care Research

This session will provide an understanding of the NIH involvement in wound care research and funding.
Speaker:
  • Marcel Salive, MD, MPH, Medical Officer, Division of Geriatrics and Clinical Gerontology, NIH’s National Institute on Aging
  • Teresa L. Z. Jones, MD, Program Director for Diabetes Complications, NIH's National Institute of Diabetes, Digestive and Kidney Diseases

12:00-1:00 PM

Lunch


1:00–2:30

Panel Stakeholder Discussion: Clinical Trial Design, Payers Perspectives and Possible Solutions

This is the fourth of four sessions where the medical directors from both commercial and government payers will join other stakeholders—i.e., wound care researchers and manufacturers, to address elements of clinical trial design (inclusion/exclusion criteria, trial duration, standardization of key variables, number of patients, comparators, standards of care, research methodology standardization) and modifications that can be done to advance the quality and generalizability of our research base.
Panelists:
  • Charles Stemple, MD, Senior Medical Director, Humana
  • Larry Clark, MD, Medical Director, Noridian
  • Ray Fabius, MD, CPE, FACPE, Co-founder and president of HealthNEXT, Former Medical Director US Healthcare/Aetna and Cigna
  • Alan Rosenberg, MD, Former Vice President, Medical and Clinical Pharmacy Policy, Anthem; FormerVice President of Medical Affairs and Medical Director, Aetna
  • Jaideep Banerjee, PhD, Medical Science Liaison, Smith & Nephew
  • Charles Zelen, DPM, Medical Director, Professional Education and Research Institute Inc,
  • John Lantis, MD, FACS, Vice Chair and Professor of Surgery, Mt. Sinai Hospital

2:30-4:00

Summary of Second Day; Identification of Action Items, Closing Remarks

After a summary of the important points from Day 2 of the conference, there will be an interactive discussion of next steps on these critical issues.
Moderators:
  • Lynn Shapiro Snyder, Esq., Senior Member, Epstein Becker and Green, Washington D.C.
  • Marcia Nusgart, R.Ph., Founder and Executive Director, Alliance of Wound Care Stakeholders

4:00 PM

Summit Conclusion

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