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

Covered: non‑autologous sheet-form skin substitute grafts/CTPs (human, xenograft or biologic) as an adjunct to standard of care for chronic (≥4 weeks) diabetic foot ulcers and venous leg ulcers that are “stalled” or have failed ≥4 weeks of SOC (≤50% area reduction); excluded are autografts, injectable/flowable/liquid/gel products, products lacking peer‑reviewed evidence of net clinical benefit, application to infected/ischemic/necrotic wounds, and excessive product wastage. Key requirements: documented comprehensive assessment including vascular testing and etiologic management, documented SOC trial with serial wound measurements and evidence of offloading/compression, product‑specific published evidence of safety/effectiveness, appropriate provider qualifications, continuation of SOC during treatment, limits on number/duration of applications (commonly ≤4–8 applications/12–16 weeks) with >4 applications requiring KX modifier attestation and clinical justification.