Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39756
Skin substitute grafts/CTPs (product‑specific allografts/xenografts/biologic sheets such as EpiFix, Grafix, Apligraf, Dermagraft, etc.) are covered as adjunctive therapy for chronic diabetic foot ulcers and venous leg ulcers when supported by product‑specific clinical evidence, while liquid/gel preparations, products that act only as replaceable dressings, and cultured epithelial autografts/allografts for VLU are excluded. Coverage requires documented failure of ≥4 weeks of standard care (≤50% area reduction), thorough wound‑bed preparation and etiologic management (debridement, infection control, moisture management, smoking counseling, offloading for DFU or sustained compression and venous testing for VLU), serial measured wound assessments and application documentation, and is generally limited to up to 8 applications/16 weeks unless justified.
"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:"