Bioengineered Skin and Soft Tissue Substitutes

This policy covers the use of bioengineered skin and soft tissue substitutes for medically necessary reconstructive services (including post‑mastectomy breast reconstruction and implant/expander coverage), treatment of chronic noninfected lower‑extremity ulcers (e.g., full‑thickness diabetic ulcers, venous ulcers after ≥1 month of failed conventional therapy), nonhealing pressure/vascular wounds, second‑ and third‑degree burns, and select indications such as dystrophic epidermolysis bullosa and FDA‑approved products like Integra and Epicel. Coverage is limited to the specifically listed products and FDA/HDE‑approved indications, requires ulcers to be noninfected and prior conservative therapy when specified, and is subject to the member’s benefit plan, state/geographic and product‑type applicability (including policy effective date and ASO exceptions); unspecified or off‑label uses are considered experimental and not covered.

"Medically necessary reconstructive services intended to restore the physical appearance of body structures damaged by trauma."