ModifiedCentenePolicy CP.MP.185

Skin and Soft Tissue Substitutes

Medical necessity criteria, coverage limits, and documentation requirements for skin and soft tissue substitutes (cellular and tissue-based products) used to treat chronic wounds, burns, breast reconstruction, and selected indications; applies to non-Medicare Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicySkin and Soft Tissue Substitutes

Policy CodePolicy CP.MP.185

Change TypeMaterial revisions and coding updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and document a minimum four‑week trial of standard of care plus HbA1c ≤8% or documented improvement before requesting CTPs; initial authorization limited to up to 4 applications with extension to 8 requiring additional justification.

SourceLink

POLICY UPDATE CHANGES

Changed requirement of HbA1c threshold from ≤7% to ≤8% or documented improvement in blood glucose in the last 4 weeks; contraindication changed to HbA1c >8% or with no documented improvement in last 4 weeks.

Specified that criteria I applies to up to four initial applications and created new policy statement II for beyond the initial four up to a total of eight applications.

Added multiple HCPCS codes (many Q4xxx, A2xxx, G068x, etc.) to code tables including new HCPCS Code Table 1 and Table 2 entries and a preferred product list.

Expanded policy to include burn treatment, breast reconstruction, dystrophic epidermolysis bullosa, and post-reconstructive abdominal wall wound indications; added sections for not medically necessary and evidence not supporting certain indications.

up to 4initial applications authorized for DFU or VLU

up to 8maximum applications per wound per 12-week episode

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medical Necessity and Coverage Criteria

Initial Therapy (up to 4 applications)

Covered when ALL of the following are met:

Initial DFU/VLU CTP criteria: Request indicates the specific wound to which the skin substitute/CTP will be applied; wound is not infected; for DFU: failure to achieve ≥50% ulcer area reduction despite compliance with standard of care (SOC) wound treatment for a minimum of four weeks; for VLU: failure to respond despite compliance with SOC wound treatment for a minimum of four weeks; assessment and documentation of diabetes history and management, current blood glucose/HbA1c, nutrition, activity, updated medication history, and relevant comorbidities (e.g., vascular disease, neuropathy, osteomyelitis); physical exam documenting perfusion/off‑loading or compression as applicable; modifiable risk factors being addressed (including smoking cessation or enrollment); request is for a preferred product listed in the policy and requested use complies with the product's labeled indications; only one skin and soft tissue substitute/CTP will be simultaneously in place per wound episode (first application begins episode of care); graft applied in a single layer per labeled application technique; required documentation per application is provided (graphic/photo wound measurements at baseline and follow‑up; procedure note including product/package label or NDC and size; documentation of amount administered and wasted when applicable)

Continuation Therapy (beyond 4, up to 8 applications)

Covered when ALL of the following are met:

Extended DFU/VLU CTP criteria: Request indicates the specific wound to which the skin substitute/CTP will be applied; request is for a preferred product listed in the policy and requested use complies with the product's labeled indications; documentation explains why extended time or additional applications (beyond the initial four) are medically necessary for this specific wound, demonstrates that the initial four applications resulted in healing progress and that continued healing is expected, provides estimated time for extended treatment and anticipated additional applications and a plan if healing is not achieved; modifiable risk factors are being addressed; for VLUs, appropriate consultation/management for venous disease is documented; additional documentation for each prior application is provided (procedure note with product/package label or NDC and size, graphic/photo measurements baseline and follow‑up, confirmation graft applied in single layer per label, documentation of wastage when applicable); only one skin and soft tissue substitute/CTP will be simultaneously in place per wound episode; total applications not to exceed eight per 12‑week episode of care

Burn Treatment

Covered when ALL of the following are met:

Burn CTP criteria: Request indicates the specific burn wound to which the skin substitute/CTP will be applied; sufficient autograft is not available or autograft is not feasible due to the member's physiologic condition at time of excision; no evidence of burn wound infection; burn is deep partial‑thickness or full‑thickness; modifiable risk factors for impaired healing are being addressed (including smoking cessation when applicable); review of current blood glucose/HbA1c if history of prediabetes or diabetes; documentation of diet, nutritional status, activity, and updated medication history; treatment is with allowed allograft, xenograft or listed tissue‑engineered products (policy lists Biobrane, Transcyte, Integra products, Suprathel, Epicel per HDE, etc.); only one skin substitute/CTP will be simultaneously in place per wound episode; graft applied in single layer and documentation requirements per application are met (graphic/photo wound measurements; procedure note with product/package label or NDC and size; wastage documented when applicable)

Breast Reconstruction

Covered when ALL of the following are met:

Breast reconstruction CTP criteria: Request indicates the specific wound to which the skin substitute/CTP will be applied; indication is post‑mastectomy breast reconstruction; no evidence of wound infection; modifiable risk factors for impaired healing are being addressed; review of current blood glucose/HbA1c if history of prediabetes or diabetes; documentation of diet, nutrition, activity, and updated medication history; member is non‑smoker or has completed/is enrolled in smoking cessation therapy; treatment is with listed CTPs for reconstruction (AlloDerm, Cortiva, DermaCell, FlexHD/AllopatchHD); only one skin substitute/CTP will be simultaneously in place per wound episode; graft applied in a single layer per labeled application technique; documentation requirements per application are met (graphic/photo measurements; procedure note with product/package label or NDC and size; wastage documented when applicable)

OrCel (HDE) — Dystrophic Epidermolysis Bullosa

Covered when ALL of the following are met:

OrCel (HDE) criteria: Request indicates the specific wound to which OrCel will be applied for mitten hand deformities due to dystrophic epidermolysis bullosa; use is consistent with the FDA Humanitarian Device Exemption (HDE); no evidence of wound infection; modifiable risk factors for impaired wound healing are being addressed; review of current blood glucose/HbA1c if history of prediabetes or diabetes; member is non‑smoker or has completed/is enrolled in smoking cessation therapy; only one skin substitute/CTP will be simultaneously in place per wound episode; documentation requirements per application are met (graphic/photo measurements; procedure note with product/package label or NDC and size; wastage documented when applicable)

Post‑reconstruction abdominal wall wounds (medical necessity)

Covered when ALL of the following are met specific to the wound:

Post‑reconstruction abdominal wall wound criteria: A. Request indicates the specific wound to which the skin substitute/CTP will be applied; B. Indication is repair of hernia or surgical repair of a complex abdominal wall wound; C. No evidence of wound infection; D. Documentation that modifiable risk factors for impaired wound healing are being addressed (including review of current blood glucose/HbA1c if history of prediabetes/diabetes, diet/nutrition/activity assessment, updated medication history and pertinent medical problems, and non‑smoker or enrolled/completed smoking cessation therapy); E. Treatment with an allowed skin/soft tissue substitute/CTP (examples: AlloDerm Q4116, Phasix ST C1781, Strattice Q4130); F. Only one skin/CTP will be simultaneously in place per wound episode with the first application beginning the episode of care; G. Graft applied in a single layer per labeled application technique

All items A–G must be satisfied

Initial therapy and wound-specific criteria

Covered when ALL of the following are met for a specific wound:

application_limit: Request indicates the specific wound to which the skin substitute/CTP will be applied and is for up to four initial applicationsup to 4 applications

Additional applications require secondary criteria

glycemic_control: For diabetic foot ulcer criteria: HbA1c ≤8% or documented improvement in blood glucose in the last 4 weeksHbA1c ≤8% or documented improvement

HbA1c >8% or no documented improvement is a contraindication

Extended therapy (beyond initial four to up to eight applications)

Covered for additional applications when ALL of the following are met:

extended_application_scope: Requests beyond the initial four and up to a total of eight applications must meet the policy's secondary criteria (II.), including documentation of medical necessity for extended applications, evidence of healing progress with the initial applications, plan for additional applications and contingency if healing does not occur, and full documentation for each prior application; total applications must not exceed eight per 12‑week episode of careup to 8 applications total

See policy for product‑specific and wound‑specific requirements

Specialty indications (burns, reconstruction, dystrophic EB, abdominal wall)

Covered for additional specified indications when criteria specific to those indications are met:

burns: Skin substitutes may be used for burn treatment when the burn‑specific criteria (IV.) are met (e.g., deep partial‑thickness or full‑thickness burns, insufficient or infeasible autograft, no infection, listed allograft/xenograft or tissue‑engineered products used, documentation and single‑layer application and required documentation per application)refer to IV.

Portions IV.B–IV.D and IV.F migrated from CP.MP.186

breast_reconstruction: Skin substitutes may be used in breast reconstruction when the reconstruction‑specific criteria (V.) are met (post‑mastectomy reconstruction, no infection, use of listed CTPs, modifiable risk factors addressed, single‑layer application, documentation per application)refer to V.

New criteria added

dystrophic_EB:

Any use of skin and soft tissue substitutes/CTPs that is not explicitly authorized in policy sections I or II is excluded from coverage. The policy identifies several specific scenarios that will be considered not medically necessary and may be denied, including placement of products on infected, ischemic, or necrotic wound beds and use of liquid or gel formulations. Requests exceeding the allowed counts per episode (see policy limits) or that do not meet the wound‑specific criteria are also subject to denial.

Use of skin and soft tissue substitutes/CTPs for indications not listed as medically necessary in sections I–VII (for example, pressure ulcers and other non‑listed conditions) is considered not medically necessary. The policy also states that any product not listed as medically necessary for a given indication in the policy is excluded from coverage.

Products and HCPCS codes listed in HCPCS Code Table 3 are identified as not supporting medical necessity criteria for any indication and therefore are considered non‑covered. The document enumerates specific A‑ and Q‑codes in Table 3 and notes ongoing additions to that table in revisions.

Uses not described in section II (the extended/secondary criteria) and those listed in the policy's 'not medically necessary' sections (III/VIII) are excluded from coverage. The policy emphasizes that only uses meeting the stated wound‑specific and product‑specific criteria (and associated documentation) may be considered medically necessary.

Some applications—particularly cosmetic or reconstructive uses—may be governed by Centers for Medicare & Medicaid Services local or national coverage determinations. The policy references multiple CMS LCD/NCD documents and indicates providers should be aware of applicable CMS coverage rules when treating reconstructive or cosmetic indications.

The policy explicitly lists uses under section III A–G that are considered not medically necessary. This includes exceeding application limits in an episode (more than eight applications), repeat applications after an unsuccessful initial course, use with inadequate control of underlying conditions, liquid/gel products, and placement on infected, ischemic, or necrotic wound beds.

Specific scenarios the policy identifies as non‑covered include treatment continuing beyond 12 weeks; repeat applications when the initial treatment was unsuccessful for a period of four weeks beyond therapy start (defined by lack of improvement or increase in wound size/depth); and retreatment of healed wounds (those showing > 75% size reduction and <0.5 square cm). These situations are designated not medically necessary.

The policy designates specific A‑codes and an extended list of HCPCS/Q‑codes as not supporting medical necessity criteria. Examples called out include codes such as A2001, A2002, A2004, and A2005, and the policy documents ongoing additions of further codes to the non‑supportive Code Table 3.

Indications not listed among the policy's covered sections (including uses beyond the secondary criteria in section II) are excluded from coverage. The policy cross‑references specific HCPCS code tables and notes that certain listed codes do not support medical necessity for any indication; providers should confirm that the product code being billed is included in the supporting code tables before assuming coverage.

Billing Codes and Coding Guidance

Preferred CTP codes for DFU/VLUHCPCSCovered

A2019	Kerecis Omega3 Margen Shield
Q4101	Apligraf
Q4102	Oasis Wound Matrix
Q4104	Integra Bilayer Matrix Wound Dressing
Q4105	Integra dermal regeneration template or Integra Omnigraft dermal regeneration matrix
Q4431	Dermagraft
Q4107	Graftjacket
Q4121	Theraskin
Q4132	Grafix Core and Grafix PL Core
Q4133	Grafix PRIME, Grafix PL PRIME, Stravix and Stravix PL

1–10 of 12

1/2

CTP codes for burn treatmentHCPCSCovered

A2043	Biobrane
A2044	Biobrane Glove
Q4182	Transcyte
Q4108	Integra Wound Matrix
C9363	Integra meshed Bilayer Wound Matrix
Q4104	Integra bilayer matrix wound dressing
Q4105	Integra Dermal Regeneration Template
A2012	Suprathel
C9399	Epicel (used per FDA HDE)

CTP codes for breast reconstructionHCPCSCovered

Q4116	AlloDerm
Q4433	Cortiva
Q4122	DermaCell
Q4128	FlexHD or AllopatchHD

Covered CPT CodesCPTCovered

15271	Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area.
15272	Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof.
15273	Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children.
15274	Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof.
15275	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area.
15276	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof.
15277	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children.
15278	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof.

Covered HCPCS G‑codesHCPCSCovered

G0681	Application of a PMA/510(k)/361 HCT/P nonsheet form skin substitute for wound surface area up to 100 sq cm; first 25 sq cm or less.
G0682	Application of a PMA/510(k)/361 HCT/P nonsheet form skin substitute for each additional 25 sq cm wound surface area, or part thereof.
G0683	Application of a PMA/510(k)/361 HCT/P nonsheet form skin substitute graft for wound surface area >= 100 sq cm; first 100 sq cm or 1% body area of infants/children.
G0684	Application of a PMA/510(k)/361 HCT/P nonsheet form skin substitute graft for each additional 100 sq cm wound surface area or part thereof, or each additional 1% body area of infants and children.

Covered HCPCS/Product CodesHCPCSCovered

A2012	SUPRATHEL, per sq cm.
A2019	Kerecis Omega3 MariGen Shield, per sq cm.
A2043	BIOBRANE, per sq cm.
A2044	BIOBRANE Glove, each.
A4100*	Nonsheet form skin substitute, FDA-cleared as a device, not otherwise specified [OrCel].
C1781*	Mesh (implantable) [Phasix ST or Alloderm].
C9363	Skin substitute (Integra Meshed Bilayer Wound Matrix), per sq cm.
C9399*	Unclassified drugs or biologicals [Epicel].
Q4101	Apligraf, per sq cm.
Q4102	Oasis wound matrix, per sq cm.

1–10 of 25

1/3

HCPCS codes that support medical necessity criteriaHCPCSCovered

G0684	Application of a PMA, 510(k), 361 HCT/P nonsheet form skin substitute graft for a wound surface >= 100 sq cm; each additional 100 sq cm...
A2012	SUPRATHEL, per sq cm
A2019	Kerecis Omega3 MariGen Shield, per sq cm
A2043	BIOBRANE, per sq cm
A2044	BIOBRANE Glove, each
A4100	Nonsheet form skin substitute, FDA-cleared as a device, not otherwise specified [OrCel]
C1781	Mesh (implantable) [Phasix ST or Alloderm]
C9363	Skin substitute (Integra Meshed Bilayer Wound Matrix), per sq cm
C9399	Unclassified drugs or biologicals [Epicel]
Q4101	Apligraf, per sq cm

1–10 of 27

1/3

HCPCS codes that do not support medical necessity criteria (Table 3 and extended list)HCPCSNot Covered

A2001	InnovaMatrix AC, per sq cm
A2002	Mirragen Advanced Wound Matrix, per sq cm
A2004	XCelliStem, 1 mg
A2005	Microlyte Matrix, per sq cm
A2006	NovoSorb SynPath dermal matrix, per sq cm
A2007	Restrata, per sq cm
A2008	TheraGenesis, per sq cm
A2009	Symphony, per sq cm
A2010	Apis, per sq cm
A2011	Supra SDRM, per sq cm

1–10 of 339

1/34

HCPCS codes listed in document (selected Q4xxx entries shown)HCPCS

Q4400	Polygon3 Membrane, per sq cm.
Q4401	Absolv3 Membrane, per sq cm.
Q4402	XWRAP 2.0, per sq cm.
Q4403	XWRAP Dual Plus, per sq cm.
Q4404	XWRAP Hydro Plus, per sq cm.
Q4405	XWRAP Fenestra Plus, per sq cm.
Q4406	XWRAP Fenestra, per sq cm.
Q4407	XWRAP Tribus, per sq cm.
Q4408	XWRAP Hydro, per sq cm.
Q4409	AmniomatrixF3X, per sq cm.

1–10 of 30

1/3

Additional HCPCS/G-codes addedHCPCS

G0681	HCPCS code added to Code Table 1
G0682	HCPCS code added to Code Table 1
G0683	HCPCS code added to Code Table 1
G0684	HCPCS code added to Code Table 1

A-codes updated/moved between tablesHCPCS

A2002	Previously in not supported list; moved to supporting table in a revision
A4225	Description updated

inv-30: Saphenous valve closure time — clinical threshold

ThresholdSaphenous vein valve closure time > 500 milliseconds prompts vascular referral

ActionIf significant saphenous vein incompetency/reflux (valve closure time >500 ms) is present, refer to vascular surgery or interventional radiology

TherapiesConsider endovascular laser or radiofrequency ablation; sclerotherapy may be appropriate when no significant reflux

inv-31: Wound surface area for G0684 — >= 100 sq cm (additional units per each additional 100 sq cm or per 1% body area in infants/children)

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization, Product Identification, and Plan Terms

Prior authorization is required for requests for skin and soft tissue substitutes/CTPs. Coverage determinations are subject to the member's coverage documents and plan-level administrative policies; providers must verify prior authorization requirements, effective dates, and any plan-specific procedures with the Health Plan before submission.

Providers must obtain prior authorization per the Health Plan for requests that list specific skin substitute products and the associated HCPCS/CPT codes.
When billing, include the specific HCPCS code that corresponds to the skin or soft tissue substitute product (see HCPCS Code Table 1 and Table 2).
PA requirements, effective dates, and submission procedures are determined by the Health Plan — verify with the member's plan prior to ordering or applying product.

Documentation Required

Wound‑Specific Request Documentation

Requests must clearly identify the specific wound to which the skin substitute/CTP will be applied and include wound‑specific clinical documentation. Medical necessity is evaluated for each wound separately; documentation must tie criteria and requested interventions directly to that wound.

Background and Evidence Summary

Skin substitutes vary widely by origin and processing, and comparative evidence across broad product categories is limited. The policy notes that product‑specific clinical evidence may be necessary to support use for particular wounds or specialty indications and that wound care clinicians should manage systemic conditions and modifiable risk factors to optimize healing when CTPs are considered.

Definitions and Terminology

inv-55: CAMPs — Cellular, acellular and matrix-like product categories

CAMPs definedCAMPs = cellular, acellular, and matrix-like products — broad categories of skin substitutes referenced in evidence and policy

Clinical implicationProducts within CAMP categories vary by origin and processing; product-specific evidence should guide selection

Preferred product linkageMedical necessity determinations for preferred products apply to FDA-labeled indications

inv-56: Episode of care — 12-week period allowing up to eight total applications per wound with up to four initial applications

Episode length12-week period defines an episode of care for a wound

Application limitsWithin a 12-week episode up to eight total applications per wound are allowed, with up to four initial applications under primary criteria

Policy Changes and Revision History

03/26coding_update and scope expansion

Added multiple HCPCS/G-codes (G0681–G0684 and numerous Q4xxx/A2xxx entries), reorganized code tables (new HCPCS Code Table 1 and updates to Tables 2–3), and broadened document scope to 'Skin and Soft Tissue Substitutes' including adding specialty indications (burns, breast reconstruction, dystrophic EB, post‑reconstructive abdominal wall).

06/25criteria_restructure and application_limits

Specified that criteria I applies to up to four initial applications, replaced 'FDA approved' with 'labeled' in criteria language, and created new policy statement II for additional applications beyond the initial four up to a total of eight applications per episode.

04/22

Policy Summary

PayerCentene

PolicySkin and Soft Tissue Substitutes

Policy CodePolicy CP.MP.185

Change TypeMaterial revisions and coding updates

Effective Date

Next Review Date

SourceLink

On This Page

Documentation Required

Documentation Requirements Per Application and Episode of Care

Maintain complete documentation for each application and for the episode of care. Documentation supports authorization, billing, and ongoing medical necessity review.

Graphic/photo evidence of wound size, depth, and characteristics at baseline and follow‑up with measurements.
Complete procedure description including product used (include identifying package label or NDC in the chart) and size of product used.
If multiple product sizes are available, document selection of size that best fits the wound to minimize wastage.
If any portion of a single‑use package is discarded, document amount administered and wasted, date/time of wastage, and reason; payment may be made for discarded portion up to package amount.
Document that standard of care (SOC) was tried and failed for the required minimum period (e.g., at least four weeks for DFU/VLU) before advanced product use.
Include clinical information relevant to the wound (infection status, offloading/compression used, comorbidities, glycemic control, smoking status and cessation efforts, and other modifiable risk‑factor management).
For requests beyond the initial four applications, include explanation of medical necessity for extended treatment, evidence of response to initial therapy, estimated additional applications, and plan if healing is not achieved.

Billing Rule

Coding and Billing Actions

Billing must reflect the specific HCPCS/CPT code(s) that correspond to the product applied. Some HCPCS codes do not support medical necessity and may be denied — verify applicable code lists before submission.

Use HCPCS codes listed in HCPCS Code Table 1 and HCPCS Code Table 2 when they correspond to the product applied (e.g., G0681–G0684 for nonsheet forms where applicable; Q41xx/C93xx/Q43xx codes for listed products).
Do not rely on HCPCS codes listed in HCPCS Code Table 3 (codes that do not support medical necessity) for coverage; such codes may be denied.
When applicable, include the specific product name and package/NDC information in the medical record to support coding and payment.
Requests that list products must include product identification to match to the appropriate HCPCS/CPT code(s).

Denial Risk

Application Limits and Denial Triggers

Limits on number and timing of applications will affect authorization and payment. Requests exceeding the plan-defined initial limits require additional justification.

Up to four initial applications may be authorized under primary criteria; payment and authorization beyond four applications require meeting the policy's continuation criteria.
Total applications per wound per 12‑week episode are limited (initial authorizations plus approved additional applications should not exceed eight applications per 12‑week episode unless otherwise specified by the Health Plan).
Requests for treatment longer than 12 weeks, repeat applications after unsuccessful initial treatment, retreatment of healed wounds, or retreatment within one year for the same wound are subject to non‑coverage per policy — verify plan‑specific limits.

inv-60: Skin substitute / cellular and tissue-based product (CTP) — Definition of products covered by this policy

DefinitionSkin substitute / CTP = products including acellular and cellular matrices, amnion/chorion allografts, and bioengineered skin substitutes used as grafts or biologic dressings to promote wound healing

Clinical useCTPs are used as grafts or biologic dressings to promote wound healing in chronic wounds, burns, and reconstructive applications

Reference guidancePolicy and definitions reference CMS local coverage determinations and technology assessments for context

inv-61: Skin and soft tissue substitutes — Biologic or acellular grafts including amnion/chorion membranes, acellular dermal matrices and other allografts

ScopeSkin and soft tissue substitutes include biologic or acellular grafts such as amnion/chorion membranes, acellular dermal matrices and other allografts used to facilitate wound healing, burn care, and reconstructive applications

Product heterogeneityProducts vary by composition (epidermal, dermal, composite) and origin (cellular vs acellular), which affects clinical function

Clinical implicationSelection should be guided by product-specific evidence, wound characteristics, and labeled indications