Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39823
Skin substitute grafts/CTPs (sheet-form non‑autologous human, xenogeneic, or biological products) are covered as adjunctive therapy for chronic diabetic foot ulcers and venous leg ulcers that fail to show improvement after a minimum of 4 weeks of documented standard of care, and are not reasonable for use with uncontrolled infection/ischemia, uncontrolled diabetes/other contraindications, repeated unsuccessful applications, excessive wastage, or beyond 12 weeks or more than four applications per 12‑week episode except in well‑documented exceptional cases. Coverage requires product‑specific peer‑reviewed evidence of safety and effectiveness and thorough documentation of medical necessity and compliance with continued SOC (including debridement, off‑loading for DFU or sustained compression for VLU, ABI/vascular and diabetes assessments, ulcer measurements before/after ≥4 weeks SOC), qualified provider oversight, and informed‑consent/risks documentation.
"Standard of care (SOC) must be continued throughout the course of treatment with skin substitute grafts/CTP."