Response to Comments: Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

This document finalizes Novitas LCD DL35041 by summarizing public comments and contractor responses and confirms coverage of skin substitute grafts/cellular and tissue‑based products for diabetic foot ulcers and venous leg ulcers only when used as specified in the final LCD, excluding uses that do not meet those criteria. Key requirements are adherence to the LCD’s clinical and documentation criteria—including prior conservative wound care, appropriate wound characteristics, and use consistent with FDA‑cleared indications and product‑specific coding/billing rules.