Skin and Soft Tissue Substitutes – Commercial and Individual Exchange Medical Policyopen_in_new

EpiFix and non‑injectable Grafix are covered only for diabetic foot ulcers (not extending to tendon/muscle/bone) and TransCyte is covered only for surgically excised full‑thickness or deep partial‑thickness thermal burns prior to autograft; most other listed skin and soft‑tissue substitutes are considered unproven and not medically necessary. Key requirements: EpiFix/Grafix require documented adequate limb perfusion (palpable pulses/Doppler or ABI 0.7–1.2), HbA1c <12% (recent), failure of ≥4 weeks of standard wound care, absence of contraindications (e.g., Charcot, active infection, malignancy), and are limited to one application/week for up to 12 weeks; TransCyte requires documentation of surgical excision and pre‑autograft use.

"EpiFix or Grafix (GrafixPL, GrafixPRIME, and GrafixPL PRIME) (Non-Injectable) — Proven and medically necessary for treating a diabetic foot ulcer when ALL of the following criteria are met: adequat..."