Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39759
Covers specific sheet-form skin substitute grafts/CTPs (non‑autologous human, xenograft or synthetic biologics) for chronic diabetic foot ulcers (DFU) and venous leg ulcers (VLU) only when the specific product has peer‑reviewed evidence of net positive wound‑closure outcomes; excludes liquid/gel products, application to infected/ischemic/necrotic wounds, or use in patients with uncontrolled/exacerbating conditions. Key requirements: documented failure of ≥4 weeks of standard of care (DFU: failure to demonstrate >50% ulcer area reduction; VLU: lack of substantial improvement), adherence to SOC (debridement, vascular assessment/ABI, off‑loading for DFU or compression >20 mmHg for VLU, infection control), FDA‑consistent use, product‑specific evidence and medical‑necessity documentation, limits of ≤4 applications per 12‑week episode (rare exceptions with justification), and no repeat same‑site application deemed unreasonable within 12 months or after an unsuccessful prior application.