Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39828
Covered: specific non‑autologous skin substitute grafts/CTPs (e.g., EpiFix for VLU; Grafix/Stravix/Grafix Prime and GraftJacket for DFU) are covered as adjuncts to standard of care for chronic diabetic foot or venous leg ulcers that have failed to heal or shown <50% area reduction after ≥4 weeks; liquid/gel products, non‑incorporating dressings, and products without product‑specific high‑quality evidence are excluded. Key requirements: documented optimization of SOC (debridement, infection control, off‑loading/compression, vascular assessment), ulcer bed preparation, single‑layer label‑consistent application by a treating clinician, product‑specific RCT plus confirmatory evidence, detailed documentation of product and wound response, and a practical limit of up to 8 applications within 16 weeks with discontinuation if no progressive improvement.
"If the patient meets all criteria as outlined in this LCD, application of a skin substitute graft/CTP in the treatment of DFU and VLU is considered reasonable and necessary:"