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

Covered: non‑autologous human, xenograft, or synthetic/xenogeneic sheet-form skin substitute grafts/CTPs with peer‑reviewed evidence of safety and effectiveness for DFU or VLU used adjunctively after a chronic ulcer has failed ≥4 weeks of documented standard of care (DFU must not have demonstrated >50% area reduction; VLU must be “stalled”); excluded are liquid/gel products, products lacking sufficient evidence, wounds with active infection/ischemia/necrosis, and repeat applications within 12 months. Key requirements: documentation of a qualified provider, prior and ongoing SOC (debridement, offloading for DFU or continuous compression for VLU, infection control, moisture/exudate management), vascular assessment, validated wound measurements pre/post‑SOC and at each application, product labeling/evidence matching the treated population, adherence to application limits (generally up to ~8 applications/16 weeks with additional uses requiring KX attestation and clinical rationale); this is a proposed LCD.