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
Media@legacymedicalconsultants.com
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SOURCE Legacy Medical Consultants