AAWC Update

Eric Lullove, DPM, CWS, FACCWS; and Peg Dotson, RN, BS

The AAWC is involved in many activities that support you and the Association, often accomplished through organized task forces, specialty projects, and ongoing committees.  One such committee is the Healthcare Public Policy Committee (HPPC), comprised of dedicated volunteers representing physicians, podiatrists, nurse practitioners, physical therapists, and nurses, along with industry reimbursement specialists.

Our mission for the AAWC is to identify issues that may impact you and your patients concerning product coverage, product access, and payment for products or to providers. The HPPC prepares the AAWC responses to government or private insurers when new regulations or coverage decisions are detrimental to patients and providers. To do this, the team has the daunting task of reviewing the Centers for Medicare and Medicaid Services (CMS) Proposed Rules, issued annually between April and July. These regulations contain the next year’s rules for payment and coverage. Once each Proposed Rule is released, the AAWC has the opportunity to send feedback via comment letters to the CMS. Later in the August-October timeframe, all rules are re-released with updates — the rules may have changed, which requires a second review to ensure the issues AAWC addressed in prior versions have been accepted; if not, a second comment letter is sent before the Rules are finalized.

The HPPC also deals with eQM regulations, new United States Food and Drug Administration guidelines and reviews, Medicare Payment Advisory Panel issues, and revised Local Coverage Determinations coverage policies generated by the 15 Medicare Administrative Contractors (MACs) and the 4 durable medical equipment  (DME)-MACs throughout the year. At times, we also tackle state legislation issues. Our partnership and involvement in the Alliance of Wound Care Stakeholders provides us the opportunity to address broad issues and develop comments in unison for the whole wound care clinical industry. Medicare/Medicaid issues by far demand the most time; collectively, they provide medical insurance coverage for more than 125 million people and growing.  

To give some perspective, our committee had to evaluate, identify issues and concerns, and prepare comments for the AAWC to respond to the CMS for:
•    Skilled Nursing Facility Prospective Payment System (PPS), issued April 27;
•    Acute Hospital & Long Term Care Hospitals’ PPS, issued June 5;
•    Physician Fee Schedule, issued July 12;
•    Hospital Outpatient and Ambulatory Surgery Center PPS, issued July 26; and
•    Home Health PPS, issued July 12.

Important this year were the massive changes the CMS proposed to the Physician Fee Schedule Rule regarding how clinicians are to be paid for their services in 2019 and beyond. If the Rule is not amended, the impact could be devastating to physicians, podiatrists, nurse practitioners, and physician assistants. The AAWC’s voice was loud and clear, not only in our comment letter to the CMS, but also in our support for letters generated by the American Podiatric Medicine Association, our support for a multimedical society/association letter signed by key Senators sent to the CMS, and our input into the Alliance joint letter to the CMS for wound care specialty associations/societies. During the same timeframe, private insurer United Healthcare (UHC) issued a problematic coverage policy that severely limited the choices of cellular and/or tissue-based products (CTPs) clinicians would be able to use for chronic wounds. The AAWC participated with the Alliance in preparing and submitting comments to UHC to request changes to this policy.

These collaborations are critical in presenting a unified voice to the CMS and private insurers to ensure patients have, and will continue to have, access to the most appropriate care and providers. Working together in this way reinforces the importance of the AAWC as a multiprofessional wound care specialists’ organization that can bring input to lawmakers, regulators, and insurers.  

The AAWC always is striving to work for you and the association so the patients you serve receive the best possible quality and evidence-based wound care.

Kara Couch, MS, CRNP, CWS, CWCN-AP

The International Consolidated Guidelines Task Force (ICGTF) has had a very productive year.  Dr. Lisa Corbett and Kara Couch, NP, are now the co-chairs of the task force. We wholeheartedly thank Dr. Laura Bolton for her tireless and sterling leadership over the past 15 years. Although she has earned a well-deserved retirement, she remains one of our faithful worker bees. Dr. Bolton was instrumental in forging working relationships with Wounds Canada, the Canadian Association for Enterostomal Therapists (CAET), the Wound Healing Society (WHS), the American Professional Wound Care Society (APWCA), and the Asociacion Mexicana Para El Cuidado Integral Y Cicatrizacion de Heridas (AMCICHAC).  

Currently, 4 subgroups are dedicated to guideline creation and updates on Wound Infection, Diabetic Ulcers, Pressure Ulcers, and Venous Ulcers. Work on our International Consolidated Wound Infection Guidelines was completed in May. However, we were unable to submit to the National Guidelines Clearinghouse; that site closed down in July.  Dr. Corey Kalbaugh graciously provided a medical editor to the project to ensure formatting and structure were accurate. Fortunately, we found a new avenue to share our work with the world; we will be partnered with Trip Database (www.tripdatabase.com) that will post our guidelines on their website for all to access for free.

We started work on a new International Consolidated Diabetic Ulcer Guideline. Led by a methodologist, Dr. Valerie Marmolejo, with Kara Couch, NP, and Anthony Tickner, DPM, as co-chairs, work on this project commenced in the fall of 2018. We are aiming for final completion in early-mid 2019.  

In addition, we have started work on an update to our pressure ulcer guideline, which was last published in 2010. Our updated guideline endeavor is being led by Drs. Linda Cowan and Aimee Garcia. They are holding periodic meetings throughout this fall and gathering their resources to create the most up-to-date, evidence-based guideline for our members.

The Guidelines Task Force is pursuing a new endeavor this year. We plan to look at specific wound treatments commonly used in health facilities, such as total contact casting and negative pressure wound therapy, and publish specific recommendations on where and when to use those products as a guide for clinicians. Using the GRADE methodology (www.gradeworkinggroup.org) ensures that the highest level of evidence is presented in a succinct format. The ICGTF will be collaborating with wound care societies on this new project; we anticipate that we will be providing a valuable resource for members and for the community as a whole.

Please contact Kara Couch, NP, at secretary@aawconline.org with further questions.

Renee Cordrey, PT, PhD(c), MSPT, MPH, CWS

Have you ever thought about what it would be like to practice wound care in a very different environment or wondered how you could make a difference beyond your own community? Consider becoming a volunteer with the AAWC’s Global Alliance. The AAWC partners with Health Volunteers Overseas (HVO) to help improve the quality of wound care practice in resource-poor countries. While some other groups focus on direct care delivery, we emphasize building capacity within a facility. Our philosophy is to teach the local clinicians so the knowledge remains after we have left, knowledge that can benefit any patient any time and is not dependent on the presence of a visiting clinician to provide care. Our sites are also teaching facilities, so the next generation of clinicians and their colleagues can spread knowledge throughout their communities.

A typical day for a volunteer may include rounding with staff, consulting in the operating room, presenting a lecture (prepared weeks in advance or the night before), or problem-solving with the local team. Changes in practice don’t happen overnight, and you won’t change the world in 1 week, but as practices are updated in our partner sites, the clinicians and patients we help express appreciation for the benefits of our collaboration.

Because our model is based on teaching, not hands-on care (in fact, you will probably never touch a patient), we are looking for volunteers with significant experience in wound care practice and in teaching others. That educational experience does not need to be as part of a formal program; it can involve scenarios such as clinical teaching, giving inservices, overseeing student interns, and team training.

If you are resourceful and adaptable (you’re a wound care practitioner. Of course you are!), visit www.HVOusa.org, and look at the wound and lymphedema program page. We currently have programs in Cambodia (both adult and pediatric care), India, and Haiti. Complete the interest form and talk with our HVO liaison, Barbara, about which program is your best fit. The Alliance has a curriculum and informs you of which topics should be focused on during your trip. We have resources to share to help you with your educational materials, and we have a site director for each location to answer your questions and help you prepare.

If you are concerned your budget won’t allow it right now, the AAWC and the Wound REACH Foundation have generously provided travel funds to help you make the trip possible. Talk with Barbara at HVO about it when you call.

We hope you can join us in helping to improve the care of people with and risk for wounds across the world.

Vickie Driver, DPM, MS FACFAS; and Peggy Dotson, RN, BS

For the past 4 years, many dedicated members from the AAWC and Wound Healing Society (WHS) volunteered and collaborated to answer a specific key patient-centric question: How do we conduct research to identify “clinically relevant, reproducible, and meaningful” wound care endpoints to help our field progress and improve the care of our patients?  

In early 2014, a plan was developed and discussed with the newly formed United States Food and Drug Administration (FDA) Inter-Center Wound Healing Working Group (ICWHWG). After receiving their input, the Wound-care Experts/ FDA-Clinical Endpoints Project (WEF-CEP) was initiated. The objectives of the project were 1) identify scientifically achievable, clinically relevant, and patient-centered wound primary endpoints; 2) determine the content validity of the endpoints by surveying the wound care community; and 3) validate the results through a literature review.

Throughout the remainder of 2014, teams of wound care experts worked to provide data/research to the FDA about issues in wound care and developed a list of 28 literature-based wound care endpoints they considered important. Based on these endpoints, a survey was developed to reach out to other clinicians to confirm their findings.

In 2015, funding grants from interested parties were secured and the Clinician Survey on endpoints was pilot-tested and then expanded to the broad wound care community. Six hundred, twenty-eight (628) clinicians from 13 specialties and 9 clinical settings completed the Survey. An independent statistician evaluated the results and concluded that 22 of the 28 endpoints evaluated had content validity indexes (CVI) ≥0.75; 15 of these with CVI ≥0.85 were selected as priority endpoints by a team of wound care experts as the most clinically meaningful. These top 15 highest priority endpoints were included in Phase II of the project, which evaluated the evidence in the literature to support the 15 endpoints.

Throughout 2016, 5 teams of volunteer clinicians and researchers reviewed the literature. This was no simple review of published articles; the teams conducted structure reviews based on the FDA criteria for accepting a wound care outcome used to measure effects of a new agent for human use, which included content validity, reliability, construct validity, ability to detect change, and responder analysis. They identified that data were ample to support all 15 of the endpoints.

A Patient Survey was developed in 2017 with selected endpoints related to quality of life and patient-centered issues, squarely based on the survey taken by clinicians mentioned above. Institutional Review Board approval was obtained, a pilot test conducted, and the full Survey completed by more than 400 patients on October 1, 2018. Data are currently in the review stage and will be published once available.

Results from the Clinical Survey were published in the online and print versions of Wound Repair & Regeneration. Due to the importance of the research process and findings, the WEF-CEP team was asked to present the WEF-CEP project as an educational seminar to the FDA on July 27, 2017.

The Phase II evidence and resulting analysis has just been accepted for publication by Wound Repair & Regeneration and will appear in their fall 2018 issue. In addition, the WEF-CEP team was invited back to present the Phase II evidence review results to the FDA on October 30, 2018.  

A few key milestones still remain for acceptance of new endpoints in the FDA Guidance for Industry that dictates how research is conducted to approve new wound care devices and technologies through the FDA. Dissemination of the research results of the WEF-CEP initiative is underway though publications of both Phase I and II of the project, the Patient Survey results (2019), and in presentations at major wound healing research conferences including:

• Dr. Driver’s presentation at the Harvard Transatlantic Diabetic Lower Extremity & Chronic Wound Symposium, October 19, 2018, in Greece;
• Dr. Gould’s presentation at the 5th Annual NE Wound Care & HBO Medicine Conference, October 13, 2018, in Manchester, New Hampshire;
• Dr. Driver’s presentation at the Wound Healing: Innovation and Discovery Symposium, Scientific Session 6, December 6–9, 2018, Key West, Florida; and
• Drs. Driver and Gould and Peg Dotson’s presentation at SAWC Spring 2019, May 7–11, 2019, San Antonio, Texas.

Once new endpoints are adopted for research and FDA approvals, clinically relevant, patient-centered, meaningful endpoints will be measured during clinical trials, which will allow more advanced treatments (devices, drugs, and diagnostics) to become accessible for the care of our patients with nonhealing wounds.

We are very proud of our accomplishment and hopeful that this effort will make a real change in the lives of our patients.