New Data: Tissue-Based Wound Coverings Associated with 28% Reduction in Risk of Major Amputation, 20% Decrease in 30-day Mortality

News provided by

Jun 25, 2024, 13:33 ET

Largest analysis of real-world evidence to date shows products improve chronic wound healing and reduce costs associated with adverse clinical outcomes

FORT WORTH, Texas, June 25, 2024 /PRNewswire/ -- Legacy Medical Consultants (LMC), a leading supplier of tissue-based wound coverings, today released new data in partnership with experts from Stage Analytics and University of Southern California that finds Medicare beneficiaries with lower-extremity diabetic ulcers (LEDUs) benefit significantly from tissue-based wound coverings as part of quality wound management procedures.

The investigation indicates that dehydrated human amniotic and chorionic allografts (DHACAs) significantly lower risk of mortality and reduce risk of major amputation, emergency department visits, and 30-day hospital readmissions. Specifically, DHACAs are associated with a 20% reduction in 30-day mortality, a 28% reduction in the risk of major amputation, a 9% reduction in emergency department utilization, and an 8% reduction in 30-day hospital readmissions compared to standard of care.

"These real-world data make it clear that placental allografts play a critical role in treating hard-to-heal wounds," said William Padula, PhD, lead author of the study who is Principal & Co-Founder of Stage Analytics and a professor of pharmaceutical and health economics at University of Southern California. "The results suggest that limiting access to placental allografts could negatively impact the Medicare population and lead to an increase in mortality and major amputation."

The investigation, which analyzed claims data from a retrospective cohort of 20,188 Medicare beneficiaries, comparing those who received placental allografts to those who received standard of care, comes as CMS' Medicare Administrative Contractors (MACs) are considering a proposal that would restrict Medicare coverage for DHACAs. LMC estimates, if implemented, the proposal would eliminate patient access to 93% of currently allowed products, increasing risk of hospitalization, amputation, and death for vulnerable patients.

"This analysis illustrates what providers and patients have been telling us all along—that placental allografts are critical to improving quality of life for patients with large chronic wounds, preventing amputation and even death for some of the sickest patients," said Jonathan Knutz, CEO of Legacy Medical Consultants. "Any proposed changes to coverage should give consideration to patients who are currently undergoing treatment—particularly seniors, minorities, and lower-income patients who already have a hard time accessing care and are at higher risk for diabetic complications."

Upon approval, the MACs' proposed change could immediately limit coverage to wound care products that have demonstrated efficacy through randomized controlled trials (RCT). These trials are not required by the Food and Drug Administration (FDA) or the Tissue Reference Group, nor historically by the Centers for Medicare and Medicaid Services (CMS). Rather than restricting patient access to these products, LMC is urging MACs to align coverage of products with existing FDA evidence standards, delay implementation of the proposed change for 24 months to allow suppliers to conduct randomized-controlled trials the MACs are asking for, or continue under the current LCD.

The preprint study, titled "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," is currently under review with a medical journal. The full text is available here: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4859518

About Legacy Medical Consultants
Legacy Medical Consultants elevates patient care by addressing unmet clinical needs in patients suffering chronic non-healing wounds. Legacy Medical Consultants' team of dedicated professionals serves both providers and their patients in the field of complex wound care. To learn more about LMC's portfolio of products visit https://www.legacymedicalconsultants.com/.

Media Contact
[email protected]

SOURCE Legacy Medical Consultants