Wound Care Community: Let’s Make Our Voices Heard to Drive Payer and Regulator Acceptance of Real-World Evidence

If you treat Medicare patients, you appreciate how a morass of complex coverage and payment regulations can dictate the care you provide. Payer coverage and payment regulations specify which technologies and procedures wound care clinicians can offer their patients, which ones they will (or will not) be reimbursed for, and at what level. Concerningly, coverage policies may be often outdated and/or out of step with scientific guidelines and current clinical practice. Underlying many policies that restrict coverage is a lack of shared clarity across researchers, regulators and payers surrounding what type and how much clinical evidence payers need in order to cover wound care products and procedures.
 
For decades, the evidence gold-standard has been randomized controlled clinical trials (RCTs). Regulators and payers traditionally base evaluations on RCTs and rate the quality, or level, of evidence based on them, discounting the value of other clinical evidence such as real-world data. This has been a particular challenge in the wound care space, where a “successful” RCT is often not reflective of the real-world patients we treat.
 
Real-world data (RWD), contained in electronic health records, claims and billing activities and product and disease registries, if used appropriately, can generate valuable real-world evidence (RWE). This data can be used to answer important questions. In addition to generating real-world evidence, it can be used to analyze practice trends, and utilization trends of how clinicians use procedures and products.
 
While this data has historically been discounted in evidence assessments, today the doors are finally opening to payer and regulator recognition that there is value to real-world data and the use of it to generate real-world evidence. With the upcoming FDA Wound Healing Scientific Workshop (April) and Wound Care Evidence Summit (May), the clinician community has a real-time and meaningful opportunity to make its voice heard by regulators, policymakers and payers as evidence and coverage policies are considered.

Evidence, Coverage, and the Challenge of RCTs in Wound Care

Decisions about which wound care products and services covered under Medicare are made at either the national level by the Centers for Medicare and Medicaid services (CMS) or regionally by Medicare Administrative Contractors (MACs), each of which make local coverage determinations for the parts of the country they cover. The impact of these policies is significant. If something is not covered, health care providers cannot be reimbursed for it when treating Medicare patients. As a result, clinical treatment decisions many times may follow coverage policies rather than best practice. What is more, commercial payers commonly consider—and replicate—Medicare coverage determinations in their own coverage policies, expanding their impact on clinical practice and patients across the U.S.
 
Wound care practitioners generally share frustration about the applicability of the randomized controlled trials that regulators and payers have traditionally looked to as a foundation for approval and coverage decisions. With strict enrollment and exclusion criteria, the patients enrolled in clinical trials tend to bear little resemblance to real-world wound patients—especially in Medicare and minority populations. Patients with multiple and serious comorbidities are commonly not represented in wound care clinical trials but are the bulk of patients treated in offices and clinics. So while RCTs may be regarded as the highest level of evidence-based medicine, in reality the evidence they generate in the wound care space is of diminished value based on the limited applicability to real-world populations.
 
In fact, when the U.S. Wound Registry evaluated the exclusion criteria of all major RCTs performed in wound care between 1998 and 2008 and compared those with the comorbid conditions, wound characteristics, and medications documented among 3,201 patients in 18 hospital-based outpatient wound centers, it found that approximately 50%–75% of real-world patients would have been excluded from every major wound healing RCT that brought new products to market over that decade, based on wound severity and comorbid medical conditions.¹
 
Substantive registry data and other real-world data that is representative of real-world wound patients does exist but has traditionally been ignored or discounted in payer and policymaker evidence considerations. However, across Congress and the Food and Drug Administration (FDA), the doors are finally, slowly opening to greater acceptance of real-world data. This can have substantial impact in wound care, and there are important upcoming opportunities for wound care providers to weigh in, share perspective and encourage acceptance of RWE.

The Opportunity for Real-World Evidence: Congress

As part of efforts to modernize clinical trial designs and clinical outcome assessments, in 2016 Congress passed the 21st Century Cures Act, which, among other provisions, directed the FDA to focus on the use of real-world evidence to support regulatory decision making. Importantly, the Act also contained significant provisions to increase the transparency by which MACs make local coverage decisions. The mandated increase in transparency will be helpful to better understand the evidence the MACs either consider or don’t consider as part of their coverage determinations, and to advocate for expanded consideration of real-world evidence. Real-world evidence is expected to remain a focus as follow-on legislation, referred to as “Cures 2.0,” is developed.

The Opportunity for Real-World Data And Evidence: FDA

Progress has been slow but evolving. In a meaningful stride forward, the FDA released in 2018 a detailed framework for its RWE Program. More recently, the FDA released several draft guidance documents in late 2021 that included: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products,” “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” and “Real-World Data: Assessing Registries to Support Regulatory Decision Making for Drug and Biological Products.” 
 
Beyond evaluating RWD for drugs and biologics generally, the FDA is also specifically considering the use of RWD to generate RWE for wound care. In fact, the Agency recently identified nonhealing chronic wounds as “an area warranting prioritization” in its announcement of the upcoming public Wound Healing Scientific Workshop it is convening April 28–29, 2022. The (virtual) Workshop will specifically address issues including “the lack of alternative endpoints to complete wound closure, limited standardization between clinical trials, high rate of clinical trial failures, difficulties with participant enrollment in clinical trials, and a complex reimbursement environment.”

Make Your Voice Heard: Share Your Perspective With the FDA

As part of its Workshop, the FDA is specifically soliciting input from clinicians, researchers and manufacturers to answer in advance a series of questions spanning wound types, standard of care protocols and reimbursement challenges. The Agency is also encouraging patients and caregivers to submit comments addressing quality of life, outcomes and  “what is clinically meaningful to them (e.g., complete healing of the wound, partial healing of the wound, decreased pain, easier wound care/dressing changes).” 
 
As we see the doors opening to regulators’ acceptance of real-world data and evidence and patient experience data, it is critical to take advantage of this opportunity. The FDA has specifically requested the wound care community’s input. Respond to the FDA’s questions and submit comments here by June 28, 2022.

The Opportunity to Build Clarity With Payers

Ultimately, the acceptability of RWD to generate valuable, reliable real-world evidence can have huge implications for wound care product development and approval. However, the FDA’s acceptance of RWD and RWE will have little impact if payers don’t also accept this as a basis for coverage decisions. This is a key area for advocacy and education to align thinking across the research and health care practitioner community, the FDA, and payers so that acceptance of RWE can evolve in tandem. Proactively addressing payer perspectives on the acceptance of real-world data to generate RWE in coverage decisions will serve as a “secret sauce” to ensuring that this opportunity can truly have impact.

The upcoming Alliance of Wound Care Stakeholders’ “Wound Care Evidence Summit” (May 19–20, 2022) will expand on the topics addressed at the FDA Workshop, with a specific focus on the input of public and private payers (eg, Humana, United Health Care, Aetna, Blue Cross/Blue Shield, Medicare). Payer medical directors will join policymakers and regulators (FDA, CMS, NIH, AHRQ), evidence analysis experts (eg, Hayes, Change Healthcare), prominent researchers, medical specialty societies, wound care clinics, and manufacturers to specifically build shared clarity and aligned understanding around the opportunity and acceptability of new evidence approaches. The Summit will also focus on building clearer understanding of the evidentiary standards needed by payers for positive coverage decisions for products and procedures

Make Your Voice Heard: Have a Seat at the Coverage Policy-Shaping Table

Rarely have manufacturers, clinicians, and wound clinic administrators had the opportunity to discuss these issues face-to-face with medical directors from private payers and Medicare together with leading researchers and Federal policymakers, at the same time and around the same table. The Alliance encourages wound care leaders to be in “the room where it happens” and participate in the Summit’s collaborative, solution-oriented discussions. Learn more here.

The Proven Impact of Advocacy

Advocacy has an impact. In the 20 years since its founding in 2002, the Alliance—an umbrella organization representing more than 20+ clinical associations and physician specialty societies—has been successful in improving and clarifying wound care coding, coverage, and payment policies. Individual wound care clinicians whether working in wound care clinics, private practices, home care, hospitals or skilled nursing facilities all play an important advocacy role in this work. Policymakers at CMS and FDA are particularly interested in the voice of health care providers and patients. With front-line experience, expertise and credibility, individual clinicians and clinics can convey the nuances of their discipline so policymakers can make well-informed decisions.

The Alliance is actively working with the FDA as it plans its Scientific Workshop, convening our Wound Care Evidence Summit, and providing ongoing perspective as a charter member of the new Wound Care Collaborative Community. We have made the acceptance of real-world evidence a priority focus. We encourage the entire wound care provider community to take advantage of opportunities to share your depth of real-world experience at this exciting time of evidence, coverage, and policy evolution.

The opportunity of real-world data and evidence is at hand, and now is the time to make your voice heard.

Marcia Nusgart, RPh, is the executive director of the Alliance of Wound Care Stakeholders—an association of medical specialty societies, clinical and patient associations whose mission is to promote quality care and access to products and services for people with wounds. Through advocacy and educational outreach in the regulatory, legislative, and public arenas, the Alliance unites leading wound care organizations and experts to advocate on public policy issues that may create barriers to patient access to treatments or care.
 
The Alliance unifies the collective voice of wound care providers. Its membership includes physician specialty societies spanning the Association for the Advancement of Wound Care American, American College of Hyperbaric Medicine, American Podiatric Medical Association, American Venous Forum, Wound Healing Society, Wound, Ostomy and Continence Nurses Society and many more. As a unified umbrella organization, the Alliance leverages the collective power of its members to ensure that wound care has a strong voice and a seat at the regulatory table when policies are being developed and decisions that impact wound care are made. Learn more about the Alliance and its Wound Care Evidence Summit at www.woundcarestakeholders.org.

Click here to download a PDF of this article.

Reference
 
1. Carter M, Fife C, Walker D, Thomson B. Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials. Adv Skin Wound Care. 2009; 22(7):316–24. doi: 10.1097/01.ASW.0000305486.06358.e0