Skin and Soft Tissue Substitutes (non-ophthalmologic) — Coverage Criteria
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This policy describes when bioengineered skin, soft tissue substitutes, amniotic membrane/placenta products (non-ophthalmic), processed nerve allografts, and nerve conduits are considered medically necessary, investigational, or not covered for BCBS North Carolina members; it applies to providers treating members with these products.
Multiple HCPCS and CPT codes were added to the Billing/Coding section on various effective dates (e.g., A2011-A2013, Q4224-Q4225 effective 4/1/2022; many additions effective 2023–2026).
Added clarification that Kerecis (formerly MariGen) is a 2nd-degree burn product.
Updated coverage criteria format to remove tables and use list format and replaced 'patient' with 'individual'.
Added TheraSkin to approved products for treatment of diabetic ulcers when criteria are met.
Added medical necessity statement that autologous cell harvesting with manual preparation is medically necessary for specific thermal burn and full-thickness defects with age specifications.
Policy clarified to address only non-ophthalmologic indications for amniotic membrane and placenta products and added cadaver-derived skin grafts as potentially medically necessary when wounds are too large for autograft.
Updated When Covered to include processed nerve allografts and synthetic nerve conduits and restricted other uses for peripheral nerve gaps as investigational unless specified.
Coverage Criteria
Medically Necessary Indications
Products and applications considered medically necessary when specific clinical conditions and any product-specific limitations are met.
Products listed in policy (e.g., AlloDerm, AlloMend, Cortiva/AlloMax, DermACELL, DermaMatrix, FlexHD, GraftJacket).
Products include: AlloPatch, AmnioBand Membrane, Apligraf, Biovance, Dermagraft, EpiCord, EpiFix, GrafixCore/Prime, Integra Omnigraft Dermal Regeneration Matrix, Integra Flowable Wound Matrix, PuraPly, TheraSkin.
Applies to chronic, noninfected venous stasis ulcers.
OrCel listed under HDE-specified use.
Epicel is HDE-approved for deep dermal/full-thickness burns ≥30% TBSA; other products are listed as burn‑indication specific.
Added as medically necessary in policy updates.
Dural substitutes (eg, DuraGen, Durepair) added to covered indications in updates.
Added in policy implementation updates.
Maximum allograft length 70 mm; see Policy Guidelines for details.
See Policy Guidelines for scenario details.
Diabetic lower-extremity ulcers — selected products
Coverage stance varies by product based on available evidence
RCT evidence cited in Policy Guidelines.
Diabetic lower-extremity ulcers — other products with insufficient comparative evidence
Products with insufficient comparative evidence
Policy Guidelines indicate insufficient evidence for these products compared with standard care.
HAM (amniotic/placental membrane) for diabetic ulcers
Products with RCTs and supportive registry data
Trials used wound closure as primary outcome with blinded assessment and ITT in some studies.
Venous insufficiency lower-extremity ulcers
Mixed evidence depending on product
Specified in Policy Guidelines as supported by RCTs.
Policy Guidelines summarize inconsistent trial results and need for better‑designed studies.
Deep dermal and full-thickness burns — biosynthetic and living cell therapies
Biosynthetic and living cell therapies
Policy lists multiple products approved or indicated for burn care.
Dystrophic epidermolysis bullosa — OrCel use
OrCel use
Policy Guidelines reference small series and HDE approval.
Peripheral nerve repair — processed allografts and synthetic conduits
Evidence summary and limitations
Policy Guidelines note registry durability data but call for randomized comparisons to autograft.
Policy lists specific conduit scenarios (digital nerve gaps <15 mm, 15–25 mm when allograft unavailable, major nerve gaps ≤6 mm in select contexts).
When Covered (examples and historical criteria)
Coverage has historically been defined for specific products and indications when medical necessity criteria are met.
From 3/20/12 policy update; illustrative of historical criteria structure.
Burns and reconstructive uses
Certain products are covered for burns and breast reconstruction when FDA indication or medical necessity criteria are met.
Multiple implementation updates reference burn‑specific product lists (eg, Epicel, Integra, TransCyte).
Added to When Covered section in 4/1/14 and updated subsequently.
Dural reconstruction and peripheral nerve grafting
Policy includes coverage criteria for dural reconstruction/repair and discusses peripheral nerve grafting; product coverage changed over time.
Added in 3/9/21 and clarified 6/1/21.
Policy implementation history includes multiple updates related to nerve products.
Autologous cell harvesting — medically necessary indications
Selected medically necessary indications added or clarified in updates
Added to When Covered section on 12/31/24 implementation update.
Scope and product-specific coverage
Policy scope and product lists
Scope limitation added in policy updates.
Added in 9/10/25 implementation update.
Added to product list in 9/18/24 update.
Nerve allografts/conduits — investigational uses and limitations
Processed nerve allografts and synthetic nerve conduits
Updated 12/31/25 to specify investigational status for applications not listed as medically necessary.
Skin and soft tissue substitutes are not covered when the application site is infected or the member has a known allergy to the product. These situations are listed explicitly in the “When Skin and Soft Tissue Substitutes Are not covered” section and will result in denial of coverage for the product application.
Any products or clinical applications that are not specifically listed in the policy section titled “When Skin and Soft Tissue Substitutes Are Covered” are considered investigational and not covered. Providers should confirm that the product and intended use are included in the covered list before submitting a request for reimbursement.
The policy notes there is no clear guideline evidence for synthetic nerve conduits for peripheral nerve injuries because the evidence base is heterogeneous and trials have important limitations. Meta-analyses and multiple RCTs exist but variability in injury types, conduits studied, comparators, and outcomes limits definitive conclusions about net health benefit.
Products and applications listed in the policy’s When Not Covered/Investigational lists are not covered for those indications. The policy reiterates that many uses of skin and soft tissue substitutes remain investigational unless explicitly included in the When Covered criteria; FDA approval for a specific use does not automatically remove investigational status except for certain burn and rare-condition indications described in the policy history.
This policy explicitly excludes ophthalmic uses: it applies only to non-ophthalmologic indications for amniotic membrane and placenta products. For ophthalmic indications, providers should refer to the separate related policy on amniotic membrane and amniotic fluid injections for ophthalmic indications.
All skin and soft tissue substitutes and clinical applications that are not specified as covered in the policy are considered investigational and not covered. Requests for uses outside the listed covered indications should be expected to be denied unless new evidence and policy updates explicitly add the product and indication to the covered list.
Use of processed nerve allografts and synthetic nerve conduits for peripheral nerve gaps is considered investigational when the application is not specifically listed as medically necessary in the When Covered section. The policy was updated to add specified covered scenarios for nerve allografts and conduits; all other peripheral nerve gap applications remain investigational.
The policy identifies that certain acellular dermal matrices (ADM), some cryopreserved allografts (for example, TheraSkin), xenogenic substitutes (eg, Oasis), and some formulations of human amniotic membrane (HAM) for venous ulcers have insufficient or mixed randomized controlled trial evidence to support clear improvement in health outcomes. When RCT data are limited or methodologically inconsistent, those products or indications are considered investigational or not medically necessary until better evidence is available.
Over time the policy has routinely designated many specific products as investigational or not covered; the document’s When Not Covered lists and update logs include numerous named devices that have been added or removed across updates. Providers should consult the current investigational lists in the policy for product-specific coverage status.
Consistent with the policy updates, all other uses of processed nerve allografts and synthetic nerve conduits for peripheral nerve gaps that are not explicitly listed as medically necessary are considered investigational (not medically necessary). Claims for such off‑label or unlisted applications are subject to denial.
Billing and Coding
| 1042T | Applicable service code (listed) |
| 1044T | Applicable service code (listed) |
| 1045T | Applicable service code (listed) |
| 1046T | Applicable service code (listed) |
| 1047T | Applicable service code (listed) |
| 1048T | Applicable service code (listed) |
| 1049T | Applicable service code (listed) |
| 15011 | Applicable service code (listed) |
| 15012 | Applicable service code (listed) |
| 15013 | Applicable service code (listed) |
| 15040-15278 | Application of skin replacements and skin substitutes |
| G0681-G0684 | Application of skin replacements and skin substitutes |
| 15271-15278 | Skin substitute graft specific codes |
| 15040-15261 | Autografts and tissue-cultured autografts |
| 15777 | Add-on code for use of these materials as an implant |
| J7342 | HCPCS code added historically (example from update logs) |
| Q4100 | HCPCS code added historically (example from update logs) |
| C9368 | HCPCS code added historically (example from update logs) |
| A2001 | HCPCS code added 12/30/21 effective 1/1/2022 |
| Q4279 | HCPCS code added 12/29/23 effective 1/1/2024 |
| C1762 | HCPCS code added 4/1/24 (later removed per 9/18/24 update) |
Provider Actions and Requirements
Comply with HDE/PMA/tissue-bank specifications for burn products
Certain products are covered for burn indications only when provided in accordance with FDA HDE, FDA PMA, or American Association of Tissue Banks specifications; check prior authorization and document compliance with the specified HDE/PMA or tissue bank requirements before submission.
Submit prior auth and claims with the applicable CPT/HCPCS/product codes
Use the specific CPT, HCPCS and product codes listed in the policy when requesting prior authorization or submitting claims; inclusion of a code in the Billing/Coding section does not guarantee reimbursement and BCBSNC may request records to determine medical necessity.
Bill facility claims with appropriate product-level codes
When billing facility claims for skin substitute application procedures include the correct high-cost or low-cost product codes as specified; follow facility billing requirements referenced in related policies.
- Billing for skin substitute application procedures must also include the appropriate high cost or low cost skin substitute product codes.
- See related 'Facility Billing Requirements' for additional facility-specific rules.
Use current HCPCS/CPT codes after coding updates
After HCPCS/CPT code updates, bill using the most current and correct HCPCS/CPT codes added to the policy; the Billing/Coding section has had many additions—ensure you use the effective codes for the service date.
- Numerous HCPCS and CPT codes were added across 2022–2026 updates (examples listed in implementation notes).
- Providers must bill using the appropriate product and procedure codes effective on the date of service.
Plan may apply cost-effectiveness comparisons
BCBSNC may compare cost-effectiveness of alternative products when determining which products will be covered; non-preferred or less cost-effective alternatives may be restricted.
No step therapy algorithm specified
This policy does not specify a step therapy algorithm for skin and soft tissue substitutes; there is no explicit step therapy sequence defined in the policy.
Use products as an adjunct to clinically appropriate/standard therapy
Coverage for certain products (for example Apligraf, Dermagraft, Oasis) is conditioned on use in conjunction with standard/clinically appropriate wound care and failure to heal by the policy-specified threshold after such therapy.
- Example: venous ulcers — products may be considered medically necessary when used with standard therapy and ulcers have not adequately responded after the required period.
Check policy implementation notes for updates
Follow the updated provider guidance and policy implementation notes when submitting requests or claims—review the policy implementation log for product additions, scope changes, and code effective dates.
Verify member benefits before ordering
Verify member benefits and review the member's Benefit Booklet prior to applying the policy because coverage availability may vary by benefit design.
Use correct procedure codes and retain complete medical records
Report application procedures and nerve repairs using the CPT ranges and codes specified in the policy and include full supporting medical record documentation when requested; letters alone are insufficient unless they contain all information needed for medical necessity determination.
Bill with the policy-specified HCPCS/CPT/Q/A product codes
Use the specific HCPCS/CPT/Q/A product codes listed in the policy for billing; the policy's Billing/Coding section is periodically updated—confirm the correct code set for the service date.
- Billing/Coding section requires use of specific HCPCS/CPT/Q-codes for products; examples and historical additions/removals are noted in implementation logs.
Do not apply products if site infected or member allergic
Do not apply skin or soft tissue substitutes when the application site is infected or the member has a known allergy to the product—such uses are listed as not covered and will be denied.
- Statement: 'Skin and soft tissue substitutes are not covered when application site is infected or member has an allergy to the product.'
Provide requested medical records or risk denial
BCBSNC may request medical records to determine medical necessity; failure to provide the requested documentation or provide sufficient documentation may result in claim denial.
- When medical records are requested, letters of support/explanation are useful but are not sufficient unless they include all specific information needed for medical necessity determination.
Include high-cost or low-cost product codes on application claims
Billing for skin substitute application procedures must include the appropriate high-cost or low-cost skin substitute product codes as required by the policy; ensure auto-fill or default coding does not omit the product-level code.
- Policy: 'Billing for skin substitute application procedures are required to also include the appropriate high cost or low cost skin substitute products.'
- Implementation entries note additions of numerous HCPCS/A-codes—use the applicable product code.
Investigational—nerve allograft/conduit uses outside listed scenarios
The Plan considers use of processed nerve allografts and synthetic nerve conduits outside the specified covered scenarios to be investigational; such uses may be denied as not medically necessary.
- Policy: 'All other uses of processed nerve allografts and synthetic nerve conduits for individuals with peripheral nerve gaps are considered investigational for applications not specified above.'
Background
Bioengineered skin and soft tissue substitutes encompass a range of products from acellular dermal matrices (ADM) to living cellular therapies and processed biologic grafts. These products are used as temporary or permanent wound coverings and may function as scaffolds to support re-epithelialization, provide biologic factors that modulate inflammation and healing (as in human amniotic membrane/placenta products), or replace lost dermal tissue. Common clinical applications include chronic nonhealing wounds (diabetic, venous), burns, surgical reconstruction, and selected reconstructive procedures such as dural repair or peripheral nerve gap repair where specific product criteria are met.
Definitions
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