Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

Coverage is limited to specific non‑autologous skin substitute grafts/CTPs (human, xenogeneic, or biologic scaffolds) for chronic, non‑infected diabetic foot ulcers (DFU) and venous leg ulcers (VLU) only when the individual product has published, robust clinical-trial evidence of wound closure and is used as an adjunct after ≥4 weeks of documented, compliant standard of care (DFU: <50% area reduction after SOC; VLU: failed response), including debridement, infection control, off‑loading for DFU and sustained compression for VLU. Products lacking product‑specific trial evidence, products that function only as removable dressings (not incorporated), uses outside the trial‑defined populations, or exceeding expected use (diminishing benefit after ~5–7 applications; typical limit ~8 applications/16 weeks) are excluded or limited, and medical records must document serial wound measurements, number/timing of applications, optimization of comorbidities, and management by a qualified multidisciplinary provider.