Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds

Medicare covers application of FDA-cleared/approved or 361 HCT/P-designated bioengineered skin substitutes for chronic non-healing lower extremity wounds (principally diabetic foot ulcers and venous leg ulcers) that have failed organized conservative wound care, are ≥1.0 cm2, have a clean granular base, adequate perfusion (e.g., ABI ≥0.60 or toe pressure >30 mmHg), and are free of active infection or osteomyelitis. Coverage requires documented concurrent medical management, specific pre-service and ongoing measurements (including baseline and 4-week assessments), patient compliance, and adherence to limits: typically ≤12 weeks of treatment, a maximum of 10 applications per wound per 12-week episode, no simultaneous multiple-product use, and specified contraindications (uncontrolled systemic conditions, active infection, hypersensitivity, or uncounseled continued smoking).

"Application of bioengineered skin substitutes is covered for chronic non-healing lower extremity wounds (including diabetic foot ulcers and venous leg ulcers) that have failed to respond to organiz..."