Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39755
Covered: sheet-form, non‑autologous skin substitute grafts/CTPs (homograft, xenograft or synthetic/xenogeneic scaffolds intended to remain and allow skin ingrowth) are covered as adjunctive therapy for diabetic foot ulcers and venous leg ulcers when the specific product has peer‑reviewed DFU/VLU evidence; liquid/gel preparations and products without DFU/VLU‑specific evidence are excluded. Key requirements: documented ≥4 weeks of compliant standard of care (including vascular assessment, debridement, infection control, off‑loading for DFU or continuous compression >20 mmHg for VLU), wound measurements showing a stalled wound (DFU: ≤50% area reduction after 4 weeks), product meets LCD definition and evidence criteria, qualified provider documentation and wastage records, and KX attestation plus medical-necessity documentation for treatment beyond usual limits (typically up to 4 applications/12 weeks; policy allows up to 8 applications/16 weeks with justification).