Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39763
Covered: Medicare will pay for sheet-form skin substitute grafts/CTP (non‑autologous human, xenograft, or synthetic/xenogeneic products that integrate and scaffold skin growth) as an adjunct for DFU or VLU that have stalled or failed to heal after ≥4 weeks of documented standard of care; excluded are liquid/gel/flowable products, simple dressings, placement on infected/ischemic/necrotic wounds, and products without product‑specific peer‑reviewed evidence. Key requirements: documentation of ≥4 weeks of compliant SOC with objective wound measurements pre/post‑SOC and at each placement (DFU: ≤50% area reduction or “stalled”; VLU: lack of substantial improvement), continued SOC during treatment (debridement, offloading/compression, infection control, smoking cessation counseling), product‑specific evidence of safety/effectiveness, efforts to minimize wastage, and restrictions on repeat applications after failure or recurrence within 12 months.
"This document chunk is a Proposed LCD (not final) (inferred from title and text referencing Proposed LCD and public comment process)."