Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
L39806
Skin substitute grafts/CTP are covered only as adjunctive treatment for chronic, non‑infected DFUs and VLUs that have failed to show ≥50% ulcer area reduction after ≥4 weeks of documented standard-of-care (debridement, infection control, offloading for DFU or sustained compression for VLU, moisture management) with adequate ulcer bed preparation and continued compression for VLU; products lacking peer‑reviewed evidence (listed in Table 3) and certain topically applied bioengineered treatments are not supported. Coverage requires documentation of SOC and patient compliance, serial wound measurements, appropriate vascular/venous testing, record of product, dates and number of applications, use within labeled indications and absence of contraindications (e.g., infected/ischemic/necrotic wound).
"For purposes of this LCD, SOC treatment includes: Comprehensive patient assessment (history, exam, vascular assessment) and diagnostic tests indicated as part of the implemented treatment plan."