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Skin and Soft Tissue Substitutes
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Aetna's clinical policy on the medical necessity and investigational status of skin and soft tissue substitute products for wound care, specifying indications where particular products are considered medically necessary and listing products deemed experimental/investigational. Affects providers treating wounds, burns, diabetic foot ulcers, venous ulcers, and surgical reconstruction.
No material clinical or coverage changes in this revision.
Coverage Criteria and Evidence Summaries
Medically Necessary Indications (selected examples)
Covered when ALL of the following are met for the specified product:
All other indications are considered experimental/investigational.
AlloSkin AC and AlloSkin RT have particular processing/usage characteristics; see product-specific entries.
Product-specific HCPCS/Q-codes and matching ICD-10 diagnosis codes must be used when applicable.
Consistent with FDA PMA indications; not medically necessary when inadequate blood supply to the involved foot is present.
Use with standard wound care; contraindicated in infected ulcers and ulcers with sinus tracts and not medically necessary in persons with inadequate blood supply to the involved foot.
Experimental / Investigational Products
Not covered — considered experimental and investigational due to inadequate evidence:
See policy product list for full entries and numbering.
Covered when selection criteria are met for product-specific indications
Products listed with HCPCS/Q-codes are covered when the policy's selection criteria for that product and indication are met.
Examples of covered HCPCS/Q-codes and linked ICD-10 codes are provided in the coding section (chunks 21,23,24,28-31).
Not covered / Experimental or investigational
Products explicitly identified as experimental and investigational in this section are not covered for indications listed.
Many corresponding HCPCS A-codes are listed as not covered; providers should not bill these codes for covered indications.
Evidence limitations for clinical effectiveness
Evidence summary and limitations
Authors concluded better-designed studies with clinically relevant endpoints are needed.
These limitations affect generalizability and strength of coverage conclusions.
Manufacturer indications and evidence notes
Product-specific information (manufacturer-stated indications)
Applied after removal of necrotic debris and biofilm; usually one matrix per application but repeat applications may be used.
Available in multiple vial/pouch sizes per manufacturer labeling.
Clinical trial NCT04185558 listed with estimated completion 2022; lack of peer-reviewed evidence for chronic DFU treatment.
Evidence summaries and considerations
Evidence‑based considerations and product‑specific summaries
Ongoing trial noted; peer-reviewed effectiveness data are lacking.
RCTs exist but broader comparative and long-term data are needed.
Comparative and long-term data are limited; evidence strength is generally low.
Reported failure rates: SIS ~6.7% at 19 months; AHD ~13.6% at 12 months; cumulative recurrence at 3–5 years reported in some cohorts.
Abdominal Wall Reconstruction — evidence-informed considerations
Clinical evidence and outcomes-based considerations when using ADM/biologic mesh for abdominal wall reconstruction
Studies report bridged repair recurrence rates substantially higher (e.g., 56% vs 8%) and HR ~9.5 in some series.
These factors were identified as predictors in multi-variable analyses and cohort studies.
Cumulative recurrence rates reported at 3 and 5 years (e.g., 11.5% and 14.6% in one cohort).
Other indications (breast reconstruction, parotidectomy, tympanoplasty)
Evidence regarding AlloDerm for non-hernia indications
Randomized trials are ongoing.
Further RCTs recommended despite favorable pooled results.
Sample sizes and follow-up are often limited.
Documented clinical indications and evidence
Evidence strength varies by product and indication; randomized data exist for selected products (e.g., HR-ADM in DFUs).
dHACA / AmnioBand evidence-based considerations
dHACA / AmnioBand evidence-based considerations
Trials used a 2-week SOC run-in prior to randomization; healing rates reported up to ~85–90% at 12 weeks in some trials.
Examples: mean product cost to heal DFU reported ~$1,400–$2,200 and wastage percentages reported (e.g., ~36–40%).
These limitations may affect generalizability despite positive RCT results.
Non-dHACA allografts: use and evidence
Other allograft products (AlloSkin, AlloWrap, PureSkin, etc.):
Product sizes, supply formats, and processing (e.g., e-beam irradiation) vary and affect clinical handling.
Providers should consider evidence availability when proposing use of these products.
Background and evidence summaries (no coverage rules in this segment)
Refer to product-specific coverage entries elsewhere in the policy.
Apligraf – FDA-indicated use context
Covered when ALL of the following are met
Insufficient evidence to extend Apligraf coverage to pressure sores, dermatologic surgery wounds, or burns at this time.
Amniotic/placental-derived products – investigational/conditional
Considered investigational or insufficient evidence when used for:
Further clinical trials are required to define safe and effective indications.
Artelon – insufficiency of evidence for many indications
Not established/insufficient evidence for coverage for the following surgical indications
Use is considered unestablished pending higher-quality data.
Evidence summaries — informational
Evidence summaries and intended indications described for individual products (informational):
Evidence level is modest and often limited to nonrandomized series.
Product-specific trial support exists for the burn grafting indication.
CMS non-coverage and subsequent reconsiderations cited lack of sufficient evidence.
These summaries are informational and not coverage rules.
Described intended uses (informational)
Intended clinical uses described (informational):
Clinical effectiveness evidence varies by product; product size, formulation, and hydration state affect application and dosing.
Product-specific intended use and evidence considerations
Coverage depends on product-specific intended indications, demonstrated safety/effectiveness, and adequate documentation of clinical need.
Product is supplied in specific sizes; evidence insufficiency may limit coverage to specified indications and documented medical necessity.
Evidence and product forms vary; powder form evidence is limited.
Requests for coverage should include robust supporting documentation when available.
Consider conservative management prior to plug use.
Use of AlloDerm for indications other than the specific reconstructive and repair uses listed in this policy (for example, off‑label applications not enumerated under the product’s covered indications) is considered experimental/investigational and is not supported by the clinical evidence presented in this document.
Examples of ICD‑10 conditions called out in the policy as not appropriate for coverage of skin and soft tissue substitute applications include gangrene (I96), necrotizing fasciitis (M72.6), osteomyelitis (M86.x), and osteonecrosis (M87.x); these and other specified infectious, malignant, or otherwise excluded diagnoses are listed in the CPB as not covered for the indicated substitute uses.
The policy enumerates numerous procedure and HCPCS/CPT/ICD‑10 codes that are specifically flagged as not covered for the CPB indications. Examples cited include HCPCS codes such as Q4108 and Q4114, certain C‑codes (e.g., C9358), broad CPT ranges for surgical procedures (e.g., 20100–29999, 10040–19499), and ICD‑10 code groups for pressure ulcers and selected musculoskeletal or ocular wound codes; use of these codes for excluded indications may result in denial.
ActiGraft is described as an FDA‑cleared system that creates an autologous in‑vitro blood clot tissue scaffold, but the document states there is a lack of evidence to support ActiGraft for the treatment of chronic diabetic foot ulcers or other indications; a clinical trial was recruiting as of the cited update but peer‑reviewed effectiveness data are not available.
When planning abdominal wall reconstruction, the policy emphasizes that bridged repairs (mesh used to span fascial edges without primary fascial coaptation) are associated with substantially higher recurrence and complication rates and therefore should be avoided when primary fascial coaptation with mesh reinforcement is feasible; documentation should support the planned technique and rationale if bridged repair is proposed.
A contemporary UpToDate review on operative management of anorectal fistulas does not list AlloDerm or acellular cadaveric dermis as a management option, indicating the literature and guideline sources cited in this policy do not support AlloDerm for anorectal fistula repair.
Several amniotic/placental‑derived products are noted as having no peer‑reviewed published studies evaluating safety or efficacy. Examples specifically called out as lacking published evidence include AmnioArmor, AmnioBind, and AmnioCyte Plus.
This segment of the document does not provide blanket exclusions for all named products, but it repeatedly documents that many individual products are described as having a lack of supporting peer‑reviewed evidence; absent adequate clinical data, these products are presented as investigational or unsupported for routine coverage.
Although Apligraf has FDA‑approved indications for certain venous and diabetic ulcers, the policy indicates there is insufficient information to extend coverage for other uses such as treatment of pressure sores, dermatologic surgery wounds, and burns at this time.
The policy references the CMS national non‑coverage determination and subsequent CMS decisions concluding insufficient evidence for platelet‑derived wound healing formulas; autologous platelet‑rich plasma and similar platelet‑derived products are cited as having insufficient evidence for coverage in chronic non‑healing cutaneous wounds per the CMS determinations.
Biobrane is described as a biosynthetic dressing that requires adherence to the wound bed; the policy notes that very deep wounds or wounds with high bacterial counts will not allow Biobrane adherence, making it unsuitable for those clinical situations.
The document identifies multiple products for which there is a stated lack of evidence regarding effectiveness. Examples include carePATCH and Celera products (e.g., celera Dual Membrane and celera Dual Layer), which the policy flags as unsupported by peer‑reviewed data.
Several products are noted as having no peer‑reviewed published studies evaluating safety and efficacy and therefore are described as lacking evidence; examples include Cellesta Amniotic Membrane, Cellesta Flowable Amnion, Cellesta Cord, Coll‑e‑Derm, and Cogenex.
Conexa Reconstructive Matrix is specifically noted to have insufficient evidence beyond case reports to support its safety and effectiveness; the policy indicates Conexa may be considered unsupported absent higher‑quality data.
Dermagraft is considered not medically necessary in persons with inadequate blood supply to the involved foot and is contraindicated in infected ulcers and ulcers with sinus tracts; other products such as Epicel are recognized as covered only for their specific listed indications, with other uses considered investigational.
Products and HCPCS codes that are explicitly listed in the policy’s experimental/investigational lists or the HCPCS codes not covered sections are treated in the document as not medically necessary for the CPB‑listed indications and may be denied if billed for those uses.
The policy highlights limited and low‑quality evidence across many skin and soft tissue substitute products, noting that few studies report clinically important patient‑centered outcomes (amputation, recurrence, pain, function) and that better‑designed trials are needed before broad clinical adoption.
Use of AlloDerm and other biologic meshes for some hernia and abdominal wall repairs is associated in cited reports with disappointing long‑term results in some series and with high cost and variable failure/recurrence rates; these evidence limitations are emphasized as reasons for cautious use and may influence coverage decisions.
For breast reconstruction, the policy states that AlloDerm lacks comparative evidence
Several studies cited in the policy have methodological limitations (risk of bias, small sample sizes, animal‑model data) that the document notes may preclude generalizing results and support the designation of some applications as investigational until higher‑quality evidence is available.
The policy explicitly states there is insufficient evidence to establish effectiveness for products such as AmnioArmor, AmnioBind, and AmnioCyte Plus, and repeatedly flags multiple amniotic‑derived products as lacking peer‑reviewed support.
Throughout the document multiple products are listed with statements of limited or absent evidence (for example, AmnioBind, AmnioCyte Plus, Amnio‑Maxx, Amniorepair/AltiPly, Amniotext), underscoring the policy’s conclusion that many commercial offerings lack peer‑reviewed data supporting clinical effectiveness.
Billing Codes and Code Lists
| Q4101 | Apligraf, per sq cm |
| Q4182 | Transcyte, per sq cm |
| Q4100 | Skin substitute, not otherwise specified |
| Q4105 | Integra Dermal Regeneration Template (DRT), per sq cm |
| C9363 | Integra Meshed Bilayer Wound Matrix, per sq cm |
| Q4104 | Integra Bilayer Matrix Wound Dressing (BMWD), per sq cm |
| Q4116 | Alloderm, per sq cm |
| Q4102 | Oasis Wound Matrix, per sq cm |
| Q4107 | Graftjacket, per sq cm |
| Q4115 | AlloSkin, per sq cm |
| E08.621 | Diabetes mellitus due to underlying condition with foot ulcer |
| E09.621 | Drug or chemical induced diabetes mellitus with foot ulcer |
| E10.621 | Type 1 diabetes mellitus with foot ulcer |
| E11.621 | Type 2 diabetes mellitus with foot ulcer |
| E13.621 | Other specified diabetes mellitus with foot ulcer |
| T20.011A - T25.799S | Burns (various extensions) |
| I83.001 - I83.229 | Varicose veins of lower extremities with ulcer (with/without inflammation) |
| C5271 - C5278 | Application of low cost skin substitute grafts (various sites) |
| C7500 | Debridement, bone including epidermis, dermis, subcutaneous tissue, muscle and/or fascia, first 20 sq cm or less with manual preparation and insertion of deep drug-delivery device(s) |
| A4100 | Skin substitute, FDA cleared as a device, not otherwise specified |
| A4575 | Topical hyperbaric oxygen chamber, disposable |
| A6196 - A6199 | Alginate or other fiber gelling dressing |
| A6206 - A6211 | Contact layer and foam dressings |
| C1781 | Mesh (implantable) |
| C9352 - C9354 | Various implantable collagen/pericardial tissue matrices |
| G0428 | Collagen meniscus implant procedure |
| P9020 | Platelet rich plasma, each unit |
| A2001 | InnovaMatrix AC, per sq cm (not covered) |
| A2002 | Mirragen Advanced Wound Matrix, per sq cm (not covered) |
| A2003 | Bio-connekt wound matrix, per sq cm (not covered) |
| A2004 | XCelliStem, per sq cm (not covered) |
| A2005 | Microlyte Matrix, per sq cm (not covered) |
| A2006 | NovoSorb SynPath dermal matrix, per sq cm (not covered) |
| A2007 | Restrata, per sq cm (not covered) |
| A2008 | TheraGenesis, per sq cm (not covered) |
| A2009 | Symphony, per sq cm (not covered) |
| A2010 | Apis, per sq cm (not covered) |
| (various)—see list | Numerous named products listed in policy considered experimental/investigational when used outside supported indications |
| 10040 - 19499 | Surgery, integumentary system (not covered for certain indications) |
| 20100 - 29999 | Musculoskeletal system (not covered for prevention of adhesions after orthopedic surgery) |
| 29806 - 29828 | Arthroscopy, shoulder, surgical (selected not covered) |
| 29806-29828 | Arthroscopy shoulder range listed in policy |
| 11950 - 11954 | Subcutaneous injection of filling material (cosmetic) |
| L89.000 - L89.95 | Pressure ulcer (not covered) |
| H18.821 - H18.829 | Corneal disorder due to contact lens (not covered) |
| T20.011A – T25.799S | Burns (not covered for some listed indications) |
| C43.0 - C43.9 | Malignant melanoma of skin (not covered) |
| M86.00 - M86.9 | Osteomyelitis (listed in exclusions) |
Prior Authorization, Documentation, and Billing Guidance
Coverage conditional on selection criteria
Coverage of specific HCPCS/Q codes and products is conditional on meeting product-specific selection criteria; prior authorization may be required to confirm the indication and that selection criteria are met.
- Confirm linkage of billed HCPCS/CPT codes to the documented diagnosis and selection criteria (e.g., Q4101 for Apligraf requires DFU or VLU diagnosis codes and meeting prior-therapy requirements).
- Prior authorization should verify that product-specific eligibility rules (wound type, duration, depth, absence of exposed tendon/capsule/bone, and prior conservative care) are satisfied.
Codes not covered for listed indications
Certain CPT/HCPCS and ICD-10 codes are listed as not covered for the indications in this CPB; billing these codes or codes that are non-covered for the listed indications may result in claim denial.
- Review the policy's code lists: examples of not-covered HCPCS/CPT include L8658 and specified CPT codes (see CPB code list).
- ICD-10 codes enumerated as not covered (e.g., pressure ulcers L89.x, certain infection codes) should not be used to justify coverage for listed products.
Limited evidence; prior authorization prudent
Evidence for many products and indications is limited, heterogeneous, or based on small series/retrospective studies; when evidence is insufficient or of low quality, prior authorization and additional documentation are prudent.
- Products with limited supporting evidence (e.g., CoreCyte, Coll-e-Derm, Conexa, Cryo-Cord, Corplex, Corplex P) typically require case-specific review and may be denied without adequate clinical justification.
- Evidence gaps (including for powder formulations such as MatriStem/Cytal powder) may trigger requests for supplemental information or noncoverage determinations.
Preauthorization considerations for ADM/biologic mesh
For acellular dermal matrices (ADM) and other biologic meshes used in abdominal wall reconstruction and similar surgeries, prior authorization is recommended to confirm indication, planned surgical approach, and rationale for choosing biologic material over alternatives.
- Document whether primary fascial coaptation will be attempted or whether a bridged repair is planned; preference is for mesh-reinforced primary fascial coaptation when feasible.
- If an implantable or size-specific allograft/mesh is proposed, provide the product name, 510(k)/PMA status, size, and intended use to support medical necessity.
Prior conservative therapy and trial-based evidence
Randomized trials of several advanced skin substitutes required a trial of standard of care (SOC) during a pre-randomization screening period; prior conservative therapy should be documented before authorizing advanced products.
- Trials typically required a 2-week (or 4-week for venous ulcers) SOC screening period with offloading, debridement, and standard moist wound care prior to randomization.
- Prior authorization should confirm documentation of failed conservative therapies for the required duration (e.g., DFU >6 weeks of inadequate response; VLU >4 weeks failed compression therapy).
- Apligraf and similar products have FDA-labeled indications that align with requiring prior conservative therapy — authorization should reflect FDA labeling when applicable.
Prior authorization aligns with FDA-approved indications
Authorization decisions should align with FDA-approved indications (for devices with PMA/approved labeling). Requests for off-label indications should be supported by robust peer-reviewed evidence or will be considered investigational.
- Apligraf approval requires use with standard diabetic foot ulcer care or for venous leg ulcers per labeling; prior authorization should confirm labeled indication.
- Document when a product is being used within FDA-approved indication versus off-label use; off-label requests warrant additional clinical justification.
Clinical suitability and documentation
Clinical suitability and comprehensive documentation must accompany requests for coverage of skin and soft tissue substitutes.
- Document wound characteristics (anatomic site, dimensions in cm2, depth), presence/absence of exposed tendon/capsule/muscle/bone, signs of infection, vascular status (e.g., ABIs), and comorbidities impacting healing.
- Describe prior standard-of-care measures attempted and their duration (debridement, offloading, compression, glycemic control).
- Specify number of anticipated applications and prior product usage (if any).
Prior authorization recommended for implantable/size-specific allografts
Implantable or size-specific allografts and sheets often require prior authorization to confirm the intended implant indication, size, and rationale for use.
- Provide product-specific information: device name, formulation, size used, and whether implantation or reinforcement is intended (e.g., Strattice, AlloDerm, Conexa).
- For Cytal/MatriStem and similar products, specify the exact variant (wound sheet, surgical matrix, micromatrix, or powder) and the wound indication.
Prior authorization: product-specific indication required
Some products have 510(k) clearances, PMA approvals, or product-specific intended uses; prior authorization should confirm the product is being used consistent with its cleared/approved intended use.
- Identify the product and its regulatory status and provide the intended use to demonstrate concordance with the clearance/approval.
- If product labeling limits use to specific wound types, document that the request matches labeling; if not, provide clinical evidence supporting off-label use.
Specify Cytal/MatriStem variant and wound indication
Specify the exact Cytal/MatriStem variant and wound indication in authorization requests; different formulations (sheets, micromatrix, powder, surgical matrix) have different intended uses and evidence bases.
- State whether the request is for MatriStem/Cytal wound sheets, surgical matrix (implantable), micromatrix, or powder and provide the wound type, size, and depth.
- Note that MatriStem/Cytal powder has limited published evidence and may be subject to additional review or noncoverage.
Indication mismatch / Experimental or investigational risk
Use of a product for indications not listed as medically necessary in this CPB is considered investigational; such requests are at high risk for denial absent compelling evidence.
- If the indication is not among those the policy deems medically necessary (e.g., AlloDerm for hernia repair in some contexts), include strong peer-reviewed clinical evidence to support the request.
- Be aware that experimental/investigational designations in the CPB will often result in denial unless exceptional circumstances are documented.
Products with evidence-related denial risk
Specific products named in the CPB have been identified as lacking sufficient evidence; claims for these products may trigger denial or requests for additional clinical information.
- Examples include carePATCH, Celera products, Cogenex, Coll-e-Derm, Conexa, CoreCyte, Corplex/Corplex P, Cryo-Cord, and other products listed under 'experimental and investigational' in the CPB.
- For carePATCH and Celera, the CPB notes a lack of evidence; prior authorization should be supported by robust outcome data or will likely be denied.
Noncovered codes and evidence limitations may trigger denial
Noncovered or unsupported codes and evidence limitations may lead to claim denial or retrospective review; accurate coding and robust documentation reduce denial risk.
- CMS noncoverage determinations (e.g., for platelet-derived wound healing formulas/PRP) should be considered when submitting claims; these products have historical noncoverage.
- Coding-dependent coverage: ensure CPT/HCPCS codes reflect the product and the clinical setting (application codes vs implantable mesh codes) and that ICD-10 diagnosis codes support the medical necessity.
Evidence quality and utilization considerations
When randomized trial evidence exists, the quality and risk-of-bias assessments affect coverage determinations; cite trial design elements and assessments in authorization requests.
- AHRQ and other evidence assessments have judged some trials (e.g., Zelen et al.) at moderate risk of bias — include trial limitations and comparative data when relying on published studies.
- Utilization and cost findings (e.g., high wastage rates, product costs to closure) from trials should be documented as part of the clinical and economic rationale for use.
Insufficient published evidence / evidence gap for powder form
Products or formulations with insufficient published evidence (including powder forms) may require additional review and are candidates for noncoverage absent persuasive data.
- MatriStem/Cytal powder and other powder formulations are noted to have limited evidence and may be denied or require supplemental clinical documentation.
- Products with only case reports or manufacturer claims (e.g., some novel allografts) will commonly be subject to denial or clinical review.
Adjunctive use and contraindications
Adjunctive use and contraindications: many products are intended to be used in addition to standard wound care and have product-specific contraindications that must be documented.
- Document that advanced products are being used as adjuncts to standard care (debridement, offloading, compression, infection control) as required by labeling (e.g., Dermagraft, Apligraf).
- Contraindications such as inadequate blood supply, active infection, or presence of sinus tracts should be explicitly evaluated and recorded.
Code-to-diagnosis linkage
Code-to-diagnosis linkage: ensure claims link the product/application code to appropriate ICD-10 wound or burn diagnosis codes and match selection criteria.
- Examples: Q4101 (Apligraf) must be linked to diabetes with foot ulcer (E10.621 etc.) or venous ulcer codes (I83.x) when used for those indications.
- Avoid using excluded ICD-10 codes (e.g., infection codes, pressure ulcer codes when not covered) to justify advanced graft application.
Wound preparation documentation
Wound preparation and application documentation expected by manufacturers and reviewers should be provided with authorization requests.
- Record wound bed preparation steps (debridement, removal of devitalized tissue and biofilm) and that hemostasis and appropriate cleansing were achieved prior to graft application.
- Describe fixation/attachment method (sutures, adhesives) and whether graft was applied wet or dry, and number/size of grafts used.
Suggested documentation to support use
Suggested documentation to support use: include long-term follow-up data, defect size, comorbidities, prior therapies, product lot/size, and number of applications to substantiate medical necessity.
- Provide wound dimensions (length, width, calculated cm2), exposed structures, vascular assessment (ABI/TBI), HbA1c, and smoking status.
- List product name, manufacturer, lot number (if available), formulation (sheet, injectable, powder), size/volume used, and number of applications.
Surgical reconstruction documentation
For surgical reconstruction uses (e.g., skull base, mastoid lining), include detailed operative documentation demonstrating the role of AlloDerm or similar products and expected outcomes.
- Document indication (e.g., CSF leak repair), graft size, placement technique (endoscopic/trans-nasal), adjuncts used (fibrin glue, packing), and postoperative follow-up demonstrating graft success.
- Provide pre- and post-operative imaging or operative notes when available to support reconstructive use.
Product identification and application details
Product identification and application details should be provided: name, processing (cryopreserved vs dehydrated), formulation, and application method influence coverage and coding.
- State whether product is cryopreserved, aseptically processed, dehydrated, or viable cellular; list whether applied topically, injected, or implanted.
- For products with multiple formulations (e.g., Grafix Core vs Grafix Prime; Cytal/MatriStem variants), specify the exact formulation and intended use.
Document wound characteristics and prior SOC
Document wound characteristics and prior SOC explicitly when requesting coverage for products with limited evidence; many trials required SOC failure prior to enrollment.
- Describe prior SOC measures and durations (e.g., 2-week SOC with offloading and moist wound care or 4-week compression trial for VLUs).
- For wounds excluded from trials (e.g., tendon/muscle/bone exposure), provide additional rationale and evidence if requesting use in those settings.
Application and product documentation
Application and product documentation: record how the product was prepared, dosed, and administered; manufacturers’ instructions (e.g., hydration, rehydration, fixation) should be followed and noted.
- For injectable/flowable products and particulates (e.g., ClarixFlo, Corplex P), document dose (mg or cc), reconstitution method, and volume administered.
- For sheet products, note whether applied wet or dry and how many square centimeters were used.
Documentation for Artiss use
When Artiss fibrin sealant is used for skin graft attachment, include indication, graft size, formulation, and method of application in documentation for authorization or claims.
- Document that Artiss is being used for skin graft attachment in burn patients (FDA-approved use), include graft size and whether pre-filled frozen or lyophilized form was used.
- Record comparator fixation methods if relevant (e.g., staples) and expected benefit (reduced hematoma/seroma, improved adherence).
Document product and size
Document product and size: authorization and claims should include the exact product name, size/volume used, and number of units to allow correct coding and payment.
- For sheet-based allografts, state product size in cm2 and whether single-use kit components were used.
- For implantable meshes and biologic plugs, include device size, configuration, and number implanted.
Suggested documentation elements
Suggested documentation elements to include with prior authorization requests: device description, indication, wound dimensions, exposed structures, comorbidities, prior therapies, number of applications, and anticipated follow-up.
- Include clinical photographs when available, baseline and interval wound measurements, and expected timeframe to reassess healing.
- Supply cost/utilization estimates if relevant (number of grafts expected, approximate product cost) to inform case review.
Dose and administration details
Dose and administration details: for particulate, injectable, or flowable products, provide dose (mg or cc), preparation steps, and route of administration.
- ClarixFlo dosing is supplied as 25 mg, 50 mg, and 100 mg vials — document dose and preparation for injection or placement.
- For flowable or particulate formulations, include reconstitution volume and technique and whether the product was injected or applied topically.
Application and product size
Application and product size: for sheet products, state exact size and whether applied wet or dry; for injectable/packable products, indicate volume/cc used and number of units.
- Record the surface area treated in cm2 and the number of sheets or units applied.
- Document whether product was trimmed or customized and whether fixation (sutures, glue) was used.
Product formulation and size documentation
Product formulation and size documentation: manufacturers supply multiple formulations and sizes; authorization requests must specify the formulation (sheet, tri-layer, injectable, powder) and size.
- Examples: Biovance Tri-Layer (multiple sizes) vs single-layer Biovance — specify which was used.
- For Cytal/MatriStem surgical matrix (implantable) versus wound sheet (topical), indicate the exact product line and size.
Step therapy, alternatives, and preferred approach
Step therapy and alternatives: evidence and CPB guidance imply a stepwise approach where standard of care is attempted before advanced/allograft products; document alternatives tried and reasons for escalation.
- SOC-first approach was used in many trials (2-week SOC screening) — prior authorization should confirm SOC trial and failure.
- Preferred surgical approach: for abdominal wall repair, preferentially document attempts at primary fascial coaptation with mesh reinforcement rather than planned bridged repairs when feasible.
Conservative care before biologic plug and comparative evidence guidance
Conservative care is often effective (e.g., non-operative management for fistulas closes many cases over 6–8 weeks); biologic plugs and advanced interventions should be reserved for failures of conservative care.
- For enteric or anal fistulas, document a period of non-operative management (6–8 weeks) before considering biologic plug placement.
- Comparative evidence may inform product selection: cite head-to-head or registry/claims analyses when available (e.g., MatriStem vs Dermagraft trials or claims-based comparisons).
Background and Policy Scope
Background: Skin and soft tissue substitutes encompass acellular dermal matrices, allogeneic skin grafts, amniotic membranes, cultured skin equivalents, biosynthetic dressings, and other biologic or engineered products applied to burns, traumatic wounds, diabetic foot ulcers, venous stasis ulcers, and reconstructive surgical sites; indications and the strength of evidence vary widely by product and intended use.
Definitions and Key Terms
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