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We Can Help Drive Acceptance of Real-World Evidence
Nurses, physician assistants, physical therapists, podiatrists, and physicians are on the front line of wound care for patient treatment and management. We should also be on the front line of policy development regarding wound care coverage and reimbursement. We can be with effective advocacy. Although we are not lobbyists, our voices, expertise, and direct clinical experience as trained patient care providers can carry weight and impact. Now is a particularly crucial time to apply our real-world experience to help drive payer, regulator, and policymaker acceptance of real-world evidence (RWE) for wound care.
Why now? Because with new policies from the US Food & Drug Administration (FDA), the doors are finally opening to greater acceptance of real-world data (RWD). This can have a substantial impact on wound care. The FDA is seeking clinician input, which presents a unique opportunity for wound care providers to help shape policy by communicating the value of RWD and encouraging broader acceptance of RWD/RWE by regulators and payers.
IMPACT ON WOUND CARE
For decades, the evidence gold standard has been randomized controlled clinical trials (RCTs). Regulators and payers traditionally base evaluations on them and rate the quality of evidence based on RCTs, discounting the value of evidence from registries and other RWD sources. This has been a particular challenge in wound care, limiting not only the innovation of new products but also limiting payer coverage of current ones.
Decisions about which wound care products and services are covered under Medicare are made either by the Centers for Medicare and Medicaid Services (CMS) or its regional contractors, each of which makes local coverage determinations for the parts of the country they cover. The effect of these policies is significant: If a product or service is not covered, providers cannot be reimbursed for it when treating Medicare patients. As a result, treatment decisions often follow coverage policies rather than best practices. Moreover, commercial payers commonly consider and replicate Medicare determinations in their coverage policies.
These coverage policies have generally been guided by evidence analyses based on RCTs. Yet those of us in the trenches know that the RCTs serving as the basis for approval and coverage are often not reflective of the patients we treat. Patients with chronic wounds often have multiple and serious comorbidities commonly not represented in clinical trials due to strict enrollment and exclusion criteria. For example, a trial may enroll only individuals with diabetes who are within a specific age range, weight limit, and have a certain type of wound, thus excluding more complex patients.
The US Wound Registry evaluated the exclusion criteria of all major RCTs performed in wound care from 1998 to 2008 and compared those with the comorbidities, wound characteristics, and medications documented among 3201 patients in 18 hospital-based outpatient wound centers. It was found that approximately 50% to 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 comorbidities.1 Therefore, although policy decision-makers may regard RCTs as the highest level of evidence-based medicine, the patients participating in clinical trials may not be the same type of patients we treat in our offices, hospitals, clinics, and home care visits—especially in Medicare and minority populations. This is why RWD are instrumental in the wound care space and why we clinicians need to speak to their value.
Real-world data are abundant and contained in electronic health records, claims and billing datasets, and product and disease registries. If used appropriately, RWD can generate valuable RWE that can close persistent evidence gaps. RWD provide rich insights into everyday practice and open doors for comparative evaluations from real-patient, real-practice settings. This can help support decision-making, reduce costs, speed innovation, improve safety and effectiveness, and ultimately improve patient outcomes.
EVOLVING OPPORTUNITY
In 2016, Congress passed the 21st Century Cures Act to modernize clinical trial designs and clinical outcome assessments.2 Among other provisions, the Act directed the FDA to focus on using RWE to support regulatory decision-making. Progress has been slow but evolving. In 2018, the FDA released a framework for its RWE Program.3 In late 2021, the FDA published two draft guidance documents.4,5 Although these cover drug and biologic products generally, the FDA is also addressing the use of RWD to generate RWE for wound care. The Agency recently identified nonhealing chronic wounds as “an area warranting prioritization” and announced it is convening a public (virtual) Wound Healing Scientific Workshop on April 28-29, 2022, to address issues including “the lack of alternative endpoints to complete wound closure, limited standardization between clinical trials, high rate of clinical trial failures…and a complex reimbursement environment.”6 The FDA is soliciting input from clinicians and researchers as part of the workshop. The administration put forth a series of questions spanning inquiries about wound types, clinical challenges, unmet needs, and reimbursement hurdles. The administration is also asking patients to submit comments addressing quality of life and clinical outcomes. It is critical to take advantage of this opportunity and make clinicians’ voices heard. See the FDA’s list of questions at https://bit.ly/FDAwoundmtg and submit comments to https://bit.ly/FDAwoundmtgcomments. The FDA has specifically invited our input. Let’s respond!
BUILD CLARITY WITH PAYERS
The battle for RWD/RWE acceptance does not start and stop with the FDA. The FDA’s acceptance of RWD and RWE will have little impact if payers do not accept this as a basis for coverage decisions. The Alliance of Wound Care Stakeholders has focused on aligning thinking among the FDA, payers, and providers so that acceptance of RWE can evolve in tandem. Proactively addressing payer perspectives on the acceptance of RWE in coverage decisions will serve as a "secret sauce" to ensure that this opportunity can truly have an impact.
At its Wound Care Evidence Summit on May 19-20, 2022, the Alliance will expand on the topics addressed at the FDA workshop with a focus on the input of payers (eg, Humana, UnitedHealthcare, Aetna, Blue Cross/Blue Shield, Medicare). Payer medical directors will join federal policymakers and regulators (FDA, CMS, National Institutes of Health, Agency for Healthcare Research and Quality), evidence analysis experts, researchers, clinicians, medical societies, and manufacturers to build aligned understanding around the opportunity and acceptability of new evidence approaches and, importantly, around the evidentiary standards needed by payers for positive coverage decisions. Rarely have the clinician, researcher, and manufacturer communities had the opportunity to discuss issues face to face with medical directors from private payers and Medicare, together with federal policymakers around the same table. Wound care leaders across all areas of focus can “be in the room where it happens” at the summit’s collaborative, solution-oriented discussions. Learn more at woundcarestakeholders.org.
Ultimately, the acceptability of RWD to generate valuable and reliable RWE can have huge implications for wound care product development, approval, and coverage as well as patient care and outcomes. By taking advantage of opportunities to elevate your voice and share your perspectives, you can play a role in making that happen.
IMPACT OF CLINICIAN ADVOCACY
Advocacy has impact. The Alliance—an umbrella organization representing 20+ clinical associations and physician specialty societies (including the Wound, Ostomy & Continence Nurses Society; Wound Healing Society; Association for the Advancement of Wound Care; American Association of Nurse Practitioners; and the American Professional Wound Care Association)—has been successful in improving a broad number of important coding, coverage, and payment policies since its founding 20 years ago. Visit www.woundcarestakeholders.com to see how advocacy has directly impacted the accessibility of debridement, surgical dressings, negative pressure wound therapy, and cellular and tissue-based products for wounds.
Policymakers at CMS and the FDA are particularly interested in the voice of health care providers. Individual clinicians, clinical associations, specialty societies, wound clinics, and health systems all have valuable perspectives to share. We encourage our clinician colleagues to take advantage of these opportunities to share real-world experiences at this exciting time of evidence, coverage, and policy evolution. Articulate the realities and complexities of wound care so that policymakers and payers can understand impacts and forge better-informed policies. The opportunity for RWE in wound care is at hand; now is the time to make our voices heard.
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 at www.woundcarestakeholders.org.
The opinions and statements expressed herein are specific to the respective author and not necessarily those of Wound Management & Prevention or HMP Global. This article was not subject to the Wound Management & Prevention peer-review process.
REFERENCES
1. Carter MJ, Fife CE, 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):316-324. doi:10.1097/01.ASW.0000305486.06358.e0
2. Real-World Evidence & The 21st Century Cures Act–What You Need To Know. Clinical Leader. September 19, 2017. Accessed March 15, 2022. https://www.clinicalleader.com/doc/real-world-evidence-the-st-century-cures-act-what-you-need-to-know-0001
3. US Food & Drug Administration. Framework for FDA’s Real-world Evidence Program. FDA; 2018.
4. US Food & Drug Administration. Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products. FDA; 2021.
5. US Food & Drug Administration. Real-world Data: Assessing Registries to Support Regulatory Decision Making for Drug and Biological Products. FDA; 2021.
6. US Food & Drug Administration. Wound Healing Scientific Workshop; Public Workshop; Request for Comments. Federal Register. 2021.
