Does C9354 require prior authorization?

No, C9354 does not require prior authorization (medium confidence). Covered without prior authorization by at least one policy, though another does not cover it.

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`C9354`, Acellular pericardial tissue matrix of non-human origin (veritas), per square

HCPCS/CPT

Prior Authorization

No Prior Auth Required

Covered without prior authorization by at least one policy, though another does not cover it (medium 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.

For nerve conduit/wrap use (NeuroMatrix/NeuroMend): documentation of nerve injury characteristics demonstrating suitability (no substantial loss of nerve tissue; ability to achieve gap closure by flexion) and surgical details.

Clinical monitoring and follow-up documentation: serial wound assessments, photographic documentation, monitoring for adverse events (e.g., infection beneath dressings or grafts), and documentation of healing progress (percent area reduction, time to re-epithelialization).

Many products require: 'after the wound bed is prepared with standard debridement methods' — documentation of wound bed preparation and debridement prior to product application is required by product labeling/descriptions.

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 [...]

6 Active Policies

AETNA-CPB-0244, Skin and Soft Tissue Substitutes

BCBSIL-SUR704.012, Bioengineered Skin and Soft Tissue Substitutes

BCBSMT-SUR704.012, Bioengineered Skin and Soft Tissue Substitutes

BCBSNM-SUR704.012, Bioengineered Skin and Soft Tissue Substitutes

BCBSOK-SUR704.012, Bioengineered Skin and Soft Tissue Substitutes

CIGNA-0178, Breast Reconstruction Following Mastectomy or Lumpectomy

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C9354, Acellular pericardial tissue matrix of non-human origin (veritas), per square