Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39805
Medicare covers non‑autologous human, non‑human, or synthetic sheet-form skin substitute grafts/CTPs (not liquid/gel or dressing-type products) as adjunctive therapy for chronic, non‑infected DFU and VLU that have failed to demonstrate >50% area reduction after ≥4 weeks of documented standard of care (placement on infected, ischemic, or necrotic wounds is excluded). Coverage requires peer‑reviewed evidence of product efficacy, documented failed SOC with pre/post 4‑week ulcer measurements, continued SOC (debridement, off‑loading for DFU, compression for VLU, ABI/vascular and infection assessments), physician/NPP oversight, efficient product sizing, and is limited to ≤4 applications within a 12‑week episode (no repeat after unsuccessful treatment) except in documented exceptional cases.
"All liquid or gel skin substitute products or CTPs for ulcer are not considered grafts and are not covered: 'Liquid or gel preparations are not considered grafts. Their fluidity does not allow graf..."