C9358, Dermal substitute, native, non-denatured collagen, fetal bovine origin
HCPCS/CPT
Prior Authorization
Prior Auth Required
Code explicitly requires prior authorization (high confidence)
Documentation Required
- Product-specific application details: documentation of product lot, size, number of applications, fixation method (sutures, staples, adhesives), and whether single or multiple applications were performed (many devices are single-use and dosage is per cm2 or per mg for particulates).
- For use of biologic implants/allografts/xenografts: documentation of patient allergies or sensitivities (e.g., known porcine sensitivity excludes Mediskin), informed consent noting product source (human, porcine, bovine, ovine), and rationale for selection.
- When using investigational or off-label applications (e.g., TTAX01 for Wagner grade 3-4 DFUs in trials), document enrollment in clinical trial or detailed justification for off-label use, including prior therapies and expected benefit.
Key Coverage Criteria
- Use of acellular human dermal allograft in rhinoplasty
- Healing septal perforations using acellular dermis as bioscaffold
- Artiss is approved for attachment of skin grafts onto burn patients (clinical trial basis described).
- AlloSkin: As an allogeneic human, cadaver-derived skin graft for the management of traumatic skin wounds and burn wounds if the wound is too large for autograft. (Note: not AlloSkin AC or AlloSkin RT, which are different products).
- AmnioBand: For the treatment of: Difficult-to-heal chronic venous partial and full-thickness ulcers of the lower extremity that have failed standard wound therapy of at least 4-weeks duration; Partial and full‐thickness neuropathic diabetic foot ulcers that are greater than 6 weeks in duration with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.
- Apligraf (graftskin), a culture-derived human skin equivalent (HSE): For use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than 6-weeks duration that have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure; or in conjunction with standard therapy to promote effective wound healing of chronic, non-infected, partial and full-thickness [...]
10 Active Policies
ANTHEM-CG-SURG-127, CG-SURG-127 Products for Wound Healing and Soft Tissue Grafting: Medically Necessary Uses
AETNA-CPB-0244, Skin and Soft Tissue Substitutes
AMBETTER-CP.MP.185, Skin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers
BCBSIL-SUR704.012, Bioengineered Skin and Soft Tissue Substitutes
BCBSMT-SUR704.012, Bioengineered Skin and Soft Tissue Substitutes
Related Codes
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