Comparative Effectiveness of Amniotic and Chorionic Grafts in the Treatment of Lower-Extremity Diabetic Ulcers Using U.S. Medicare Real-World Evidence (2018-2022): A Retrospective Observational Cohort.

Abstract

Objective: Lower-extremity diabetic ulcers (LEDUs) affect more than 500,000 U.S. Medicare beneficiaries each year. Dehydrated human amnionic and chorionic allografts (DHACAs) are clinically effective complements to standard of care (SoC; e.g., surgical debridement, offloading, infection, and moisture control) when treating LEDUs. However, Medicare and commercial payer coverage have restricted access to DHACAs. Our objective was to compare the effectiveness of DHACAs versus SoC among Medicare beneficiaries with LEDUs for reduction of adverse outcomes such as mortality, recurrency, and major amputation. Approach: We analyzed a retrospective cohort of U.S. Medicare claims for LEDUs between 2018 and 2022. LEDU claims were collapsed into episodes of care (EOC). Frequency distribution of characteristics was compared using univariate and bivariate statistics. Zero-inflated binomial regression with 1:1 nearest-neighbor propensity score matching evaluated six main outcome measures: mortality; wound recurrence; major amputation; minor amputation; emergency department (ED) utilization; and readmission. Results: There were 25,760 Medicare EOCs between 2018 and 2022 representing 12,880 matched samples in the DHACA and SoC cohorts. DHACAs were associated with a 20% reduction in 30-day mortality (95% confidence interval [CI]:10%, 29%), 28% reduction in risk of major amputation (95% CI: 19%, 36%), 9% reduction in ED utilization (95% CI: 3%,14%), and 8% reduction in 30-day readmission (95% CI: 2%, 13%). DHACAs were noninferior for minor amputation rates and wound recurrence compared to SoC cohort. Conclusion: Beneficiaries with LEDUs benefit significantly from DHACAs on multiple outcomes, including a lower risk of mortality. Providers should examine the appropriateness of DHACAs for patients with LEDU as part of wound management. Medicare and commercial payers should consider improved outcomes when defining coverage policies that restrict access to DHACAs given the observed benefits.