Unfulfilled Research Gaps in Wound Care Management

Wound specialists and health care professionals across the United States are experiencing unprecedented burnout and moral distress, fueling the great resignation as we search for positions that better support our moral and life goals. One key frustration some have experienced is the feeling of being forced to deliver disparate care because of insurance coverage. When assessing a patient and their wound, instead of recommending treatments based on outcomes and evidence, we have to consider the patient’s insurance coverage and finances instead of their respective needs. This is due not only to the number of patients without insurance but also to an increasing amount of underinsured patients: those who are denied advanced therapies by their insurance companies. If evidence exists that these therapies are effective, why are insurance plans not using them to provide coverage?

Medicare and its regional contractors may play a role in this situation because they decide which products and services are covered, and most commercial payers may follow suit; this problem is explained by Marcia Nusgart, the executive director of the Alliance of Wound Care Stakeholders, in her article on driving the acceptance of real-world evidence.¹ Most wound care research exclusion criteria involves patients with comorbidities and presentations that are commonly seen in wound clinics across the world. Randomized controlled trials (RCTs) exist to stringently evaluate whether an intervention is effective, which is why they have been considered the gold standard for evidence. Patients may be considered a complex case because of wound size or comorbidities; these patients are often excluded so that researchers are sure the trial can determine the successfulness of the intervention. If these patients were included and the results showed the treatment did not work, it could be argued that it was due to the complexity of the patient case rather than the treatment or product that is being researched.

The US Food and Drug Administration (FDA) had previously considered RCTs as the primary research level required when approving coverage for products and therapies. This has had unforeseen consequences, as the exclusion criteria present in those RCTs exclude most of the patients who have wounds. Real-world patients presenting to wound centers often have uncontrolled diabetes, peripheral arterial disease, autoimmune conditions, wound types beyond venous leg ulcers and diabetic foot ulcers, larger wounds, advanced age, osteomyelitis, or exposed structures. These patients are also excluded from RCTs and downstream have been excluded from payer coverage policies, creating vast disparities in access to advanced therapies. In fact, an examination of wound RCTs found 50% to 75% of patients in real-world wound centers would have been excluded from these trials.²

Real-world data and real-world evidence exist to support using advanced therapies in complex patient situations,³ but stakeholders need to agree that these data are used to guide coverage decisions.

Together we hope to find collaborative solutions to reduce disparities in access to advanced wound healing therapies.

References

1. Nusgart M. We can help drive acceptance of real-world evidence. Wound Manag Prev. 2022;68(4):6-7. https://www.hmpgloballearningnetwork.com/site/wmp/guest-editorial/we-can-help-drive-acceptance-real-world-evidence
2. 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
3. Swoboda L. A retrospective analysis of clinical use and outcomes using viable placental membrane allografts in chronic wounds. Wounds. 2021;33(12):329-333. https://www.hmpgloballearningnetwork.com/site/wounds/original-research/retrospective-analysis-clinical-use-and-outcomes-using-viable