Legacy Medical: CMS coverage decision could increase amputations two-to-five-fold in vulnerable patients with diabetes

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Jun 06, 2024, 14:18 ET

FORT WORTH, Texas, June 6, 2024 /PRNewswire/ -- Legacy Medical Consultants (LMC), a leading supplier of tissue-based wound coverings, is urging CMS' Medicare Administrative Contractors (MACs) to reconsider a proposed Local Coverage Determination (LCD) that could lead to a two-to-five-fold increase in preventable amputations for patients with diabetic foot ulcers (DFUs).

"The proposed coverage change will restrict patient access to an entire class of currently covered, effective skin substitute products—products that help tens of thousands of Medicare beneficiaries across the United States," said Jonathan Knutz, CEO of Legacy Medical. "The MAC decision not to cover the vast majority of available product will disproportionately impact patients from marginalized communities, put wound care providers out of business, and set a precedent for making coverage determinations independent of the FDA's clinical evidence requirements."

The proposed LCD – Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers – would limit Medicare coverage to products that have demonstrated efficacy through randomized controlled trials (RCT), which are not required by the U.S. Food and Drug Administration (FDA) or the Tissue Reference Group, nor have they historically been required by the Centers for Medicare and Medicaid Services (CMS). Based on LMC's analysis, this would eliminate patient access to 93% of currently allowed products, increasing risk of hospitalization, amputation, and death for vulnerable patients.

In comment letters sent to each of the seven MACs, LMC urged a 24-month extension before the proposed LCD goes into effect to allow for comprehensive review and necessary revisions to ensure it does not inadvertently harm patients and providers, particularly those within marginalized communities, by limiting access to essential treatments. An extension provides sufficient time to address anticipated supply chain deficits, incorporate diverse clinical evidence and ensure these products continue to be regulated as a class, relying on FDA and CMS to determine the right regulatory and evidentiary standards.

For more information, visit https://legacymedicalconsultants.com/.

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/.

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SOURCE Legacy Medical Consultants