Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39864
Covered: adjunctive use of non‑autologous sheet-form skin substitute grafts/CTPs (homograft/allograft, xenograft, or synthetic/xenogeneic scaffolds intended to remain in place) for chronic, non‑infected DFUs and VLUs that have failed to improve (>50% area reduction) after a documented minimum 4‑week course of standard of care (debridement, vascular assessment, infection control, moisture management, plus off‑loading for DFU or sustained compression for VLU); liquid/gel preparations and products lacking peer‑reviewed clinical‑trial evidence of wound closure are excluded. Key requirements: product-specific published evidence of effectiveness, detailed documentation of SOC and serial wound measurements, vascular and infection assessment, qualified clinician oversight, and limits generally to 4 applications/12 weeks (expandable to 8/16 with KX modifier and medical-necessity documentation), with any extra applications requiring a modifier and justification.