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Response to Comments: Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
A59824
First Coast Service Options, Inc. (J09)
Updated: December 6, 2025
Policy Summary
The LCD response clarifies Medicare covers cellular and tissue‑based skin substitute grafts for diabetic foot and venous leg ulcers only when use meets the LCD’s clinical indications and excludes non‑indicated uses; commenter feedback was reviewed and incorporated into the final policy. Key requirements include documented failure of appropriate conservative wound care, appropriate debridement and infection control, product‑specific selection/application, and adherence to the LCD’s documentation and frequency limits.