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    v1.0.28
    OpenPayerPolicy UpdatesWound CareIndependent Health Skin Substitutes Coverage | Ope…
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    CurrentIndependent HealthPolicy M20211221065

    Skin Substitutes

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    Medical necessity criteria and coverage stance for bioengineered skin substitute products used as adjuncts to standard wound care across Independent Health lines of business (Commercial, Medicare Advantage, MediSource/Connect, Child Health Plus, Essential Plan).

    Policy Summary
    PayerIndependent Health
    PolicySkin Substitutes
    Policy CodePolicy M20211221065
    Change TypeNo material change
    Effective DateMar 1, 2022
    Last ReviewMar 1, 2022
    Next Review DateN/A
    Key ActionObtain preauthorization and submit photographic documentation showing failure of standard wound care and adequate arterial supply (ABI ≥ 0.65) before requesting a skin substitute.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    >1clinical indications listed
    <=12wapplication limit noted
    >=0.65ABI requirement
    >1cmulcer size range
    Requiredprior authorization
    Extensiveinvestigational products

    Medical Necessity & Coverage Criteria

    Diabetic foot ulcers

    Covered when ALL of the following are met for diabetic foot ulcers:

    Documentation: Photographic documentation is submitted of wound(s) prior to treatment

    Photographic documentation must be retained and may be subject to retrospective review

    Perfusion: Patient has adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in the limb being treated>= 0.65
    Support: Patient is competent and/or has support system required to participate in follow-up care associated with treatment with a bioengineered tissue product
    Policy Summary
    PayerIndependent Health
    PolicySkin Substitutes
    Policy CodePolicy M20211221065
    Change TypeNo material change
    Effective DateMar 1, 2022
    Last ReviewMar 1, 2022
    Next Review DateN/A
    Key ActionObtain preauthorization and submit photographic documentation showing failure of standard wound care and adequate arterial supply (ABI ≥ 0.65) before requesting a skin substitute.
    SourceLink
    On This Page
    Medical Necessity & Coverage CriteriaBilling Codes, Units, and Clinical ParametersAuthorization, Documentation & Operational RequirementsClinical DefinitionsClinical Background & Rationale
    Size:
    Ulcer size is >1 cm and <25 cm2
    >1 cm and <25 cm2
    Depth: Ulcers are full thickness, extend through the dermis but without tendon, muscle, capsule, or bone exposure
    Prior standard care failure: Documentation that the ulcer has failed to demonstrate measurable signs of healing after at least 4 weeks of standard wound care, including application of dressings to maintain a moist wound environment, debridement if indicated, and offloading>=4 weeks

    Measurable signs of healing defined as a wound diminishing in size with decreased exudate and necrotic tissue

    Underlying disease treatment: Patient has adequate treatment of underlying disease process(es) contributing to the ulcer
    Infection/exposure exclusion: Ulcers located on foot or toes and are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar, or necrotic material that would interfere with adherence of a bioengineered tissue product
    Glycemic control: Patient's current HbA1c does not exceed 12% within the last 60 days<=12%
    No malignancy: Patient does not have a known or suspected malignancy of the current ulcer being treated
    Product selection: One or more of the listed covered skin substitutes is being requested (see product codes)

    Examples: Allopatch HD, Apligraf, Dermagraft, Epifix, Grafix, Integra, Oasis Wound Matrix

    Venous ulcers

    Covered when ALL of the following are met for venous ulcers:

    Documentation: Photographic documentation is submitted of wound(s) prior to treatment

    Photographic documentation must be retained and may be subject to retrospective review

    Perfusion: Patient has adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in the limb being treated>= 0.65
    Support: Patient is competent and/or has support system required to participate in follow-up care associated with treatment with a bioengineered tissue product
    Size: Ulcer size is >1 cm and <25 cm2>1 cm and <25 cm2
    Depth and prior care failure: Ulcers are partial or full thickness and have failed to demonstrate measurable signs of healing of at least one month duration despite regular dressing changes, debridement of necrotic tissue, and standard therapeutic compression>=1 month

    Measurable signs of healing defined as a wound diminishing in size with decreased exudate and necrotic tissue

    Underlying disease treatment: Patient has adequate treatment of the underlying disease process(es) contributing to the ulcer
    Infection/exposure exclusion: Ulcers are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar, or necrotic material that would interfere with adherence of a bioengineered tissue product and wound healing
    Product selection: One or more of the listed covered skin substitutes is being requested (e.g., Apligraf, Oasis Wound Matrix)

    Burns

    Covered when ALL of the following apply for burns (product-specific):

    Integra (Omnigraft): Integra Dermal Regeneration Matrix (Omnigraft) is requested and ALL of the following are met: insufficient autograft is available at the time of burn excision or the member is too ill to have more donor sites created; and the burn site is free of residual eschar

    Code: Q4105 or procedure code 28899

    Biobrane is requested for superficial partial-thickness burns with limited dermal involvement (<=25% total body surface area); burn is clean, non-infected, and free of nonviable tissue and coagulation eschar<=25% TBSA

    Code: Q4100

    Epicel is requested for full-thickness burns over greater than 30% of the body when insufficient autograft is available; burn site is free of residual eschar>30% TBSA

    Breast reconstruction

    Covered when used following surgical mastectomy:

    Breast reconstruction products: Use of listed products following mastectomy (examples: Alloderm, Allomax, DermACELL AWM, DermaMatrix, FlexHD, GraftJacket, Surgimend)

    Codes include surgical codes listed with Alloderm (19357-19369) and product HCPCS/implant codes as applicable

    Medical necessity context

    Covered when medical necessity criteria are met (policy contains medical necessity criteria that apply for this service).

    General coverage context: Skin substitutes may be used to cover defects following burns or other injuries, or for reconstruction (e.g., release of severe post-burn contractures); measurable signs of healing are defined as a wound diminishing in size (surface or depth) with decreased exudate and necrotic tissue.

    Clinical definitions provided for diabetic foot ulcer, burns, venous stasis ulcer; payment is subject to eligibility, contract exclusions, and member contract limitations at time of service

    All bioengineered tissue products that are not specifically listed as covered in this policy are considered investigational or unproven due to insufficient evidence of clinical efficacy and are NOT COVERED for any indication.

    Payment for skin substitute services is subject to the member's eligibility and the terms of the member's contract. Coverage and reimbursement are determined by applicable benefit language, contract exclusions, and any limitations in the member's contract at the time services are rendered.

    Requests that exceed 10 applications for the treatment of a single wound within a 12-week period will be considered Not Reasonable and Necessary and are subject to review, except where product-specific limits apply (for example, EpiFix and Grafix are limited to one application per week for up to 12 weeks).

    This policy does not provide a separate, product-level list of items designated as not medically necessary within this section. Determinations regarding payment for unlisted products and any exclusions will be made in accordance with the member's contract and the policy's coverage stance.

    Billing Codes, Units, and Clinical Parameters

    Covered products (examples listed for diabetic foot ulcers)mixedCovered
    Q4128Allopatch HD
    15271-15278Apligraf
    Q4151Amnioband Membrance
    15275Dermagraft
    Q4187Epicord
    Q4186Epifix
    Q4132Grafix CORE / PL Core
    Q4133Grafix PRIME / PL Prime
    28899Integra (procedure code listed)
    Q4105Integra Dermal Regeneration Matrix (Omnigraft)
    1–10 of 12
    1/2
    Products considered investigational / not covered (partial list)HCPCSNot Covered
    Q4356Abiomed membrane and abioment hydromembrane per sq cm
    Q4355Abiomed XPlus membrane and Abiomed XPlus hydromembrane per sq cm
    Q4325ACApatch, per sq cm
    Q4395Acelagraft, per sq cm
    C9354Acellular pericardial tissue matrix of non-human origin (Veritas), per sq cm
    Q4311Acesso, per sq cm
    Q4312Acesso AC, per sq cm
    Q4293Acesso DL, per sq cm
    Q4300Acesso TL, per sq cm
    Q4386Acesso TrifACA, per sq cm
    1–10 of 12
    1/2
    Clinical indications (group 1)HCPCS
    Q4285NuDYN DL or NuDYN DL MESH, per sq cm
    Q4286NuDYN SL or NuDYN SLW, per sq cm
    Q4160NuShield, per sq cm
    Q4103Oasis burn matrix, per sq cm
    Q4124OASIS ultra tri-layer wound matrix, per sq cm
    A2014Omeza collagen matrix, per 100 mg
    Q4276ORION, per sq cm
    Q4354PalinGen dual-layer membrane, per sq cm
    Q4173PalinGen or PalinGen Xplus, per sq cm
    Q4174PalinGen or ProMatrX, 0.36 mg per 0.25 cc
    1–10 of 16
    1/2
    Clinical indications (group 2)HCPCS
    C9364Porcine implant, Permacol, per sq cm
    Q4110PriMatrix, per sq cm
    Q4244Procenta
    Q4310Procenta, per 100 mg
    Q4222ProgenaMatrix, per sq cm
    Q4195PuraPly, per sq cm
    Q4196PuraPly AM, per sq cm
    Q4197PuraPly XT, per sq cm
    Q4296Rebound Matrix, per sq cm
    Q4314Reeva FT, per sq cm
    1–10 of 36
    1/4
    Clinical indications (group 3)HCPCS
    Q4183Surgigraft, per sq cm
    Q4219SurgiGRAFT-DUAL, per sq cm
    Q4393SurGraft AC, per sq cm
    Q4394SurGraft ACA, per sq cm
    Q4268SurGraft FT, per sq cm
    Q4263SurGraft TL, per sq cm
    Q4269SurGraft XT, per sq cm
    Q4209SurGraft, per sq cm
    A2009Symphony, per sq cm
    Q4261TAG, per sq cm
    1–10 of 31
    1/4
    Clinical indications (group 4)HCPCS
    Q4280Xcell Amnio Matrix, per sq cm
    Q4234XCellerate, per sq cm
    A2004Xcellistem, 1 mg
    Q4142XCM biologic tissue matrix, per sq cm
    Q4204XWRAP, per sq cm
    Q4358XWRAP dual per sq cm
    Q4357XWRAP plus per sq cm
    Q4253Zenith Amniotic Membrane, per sq cm
    inv-16: Ankle-Brachial Index (ABI)
    Ankle-Brachial Index (ABI)ABI >= 0.65 in the limb being treated
    PurposeEvidence of adequate arterial blood supply required prior to skin substitute use
    Documentation timingABI value must be documented prior to application
    inv-17: Ulcer size
    Covered ulcer size range>1 cm and <25 cm2
    Applies toDiabetic foot ulcers and venous ulcers when other criteria are met
    Measurement requirementUlcer size must be documented (surface area) prior to treatment
    inv-18: Diabetic control (HbA1c)
    Glycemic control thresholdPatient's current HbA1c does not exceed 12% within the last 60 days
    Applies toDiabetic foot ulcer coverage criteria
    Documentation timingHbA1c must be from within the prior 60 days
    inv-19: unit measures
    Unit measures used for billing codesPer square centimeter (per sq cm)
    Other unit measuresPer 0.5 cc; per 100 mg; per 1 mg; or each as specified for individual HCPCS/CPT/other codes
    Example units in listItems include per sq cm, per 0.5 cc, per 100 mg, 1 mg, and each

    Authorization, Documentation & Operational Requirements

    Prior Authorization

    Preauthorization Required

    Preauthorization is required for all skin substitute services listed in this policy. Requests for services provided without prior authorization may be denied; payment is subject to member eligibility, contract exclusions, and limitations in the member's contract at the time of service.

    • Preauthorization required for all listed skin substitute services
    Documentation Required

    Required Documentation

    Photographic documentation of the wound must be submitted prior to treatment and obtained/retained with each skin substitute application; these photos may be subject to retrospective review. Documentation must support medical necessity, including evidence of adequate arterial blood supply, ulcer characteristics, prior standard wound care, and other criteria in this policy.

    • Photographic documentation prior to treatment and with each application
    • Documentation to support medical necessity and member eligibility per contract
    Documentation Required

    Failure of Standard Wound Care Required

    Ulcers must have failed to demonstrate measurable healing after a period of standard wound care before a skin substitute is considered. For diabetic foot ulcers this includes at least 4 weeks of standard wound care (dressings to maintain a moist environment, debridement if present, offloading). For other ulcer types this generally requires at least one month of conservative care including regular dressing changes, debridement, and, where applicable, compression.

    • Failure of measurable healing after ≥4 weeks (diabetic foot ulcers) or ≥1 month (other ulcers) of standard wound care
    • Standard wound care includes dressings, debridement, offloading, and compression as applicable
    Denial Risk

    Overuse and Unlisted Products May Trigger Denial

    Overuse or requests for unlisted products may trigger denial or be considered Not Reasonable and Necessary. Requests exceeding greater than 10 applications for a single wound within a 12‑week period will be subject to review and may be denied. Product-specific exceptions and limits noted in the policy (for example, EpiFix and Grafix limited to one application per week for up to 12 weeks) apply. If a requested skin substitute is not listed, an Independent Health Medical Director will determine clinical utility for the indication.

    • >10 applications for a single wound within 12 weeks may be considered Not Reasonable and Necessary
    • EpiFix and Grafix: limited to one application per week for up to 12 weeks
    • Unlisted products: adjudication by Independent Health Medical Director
    Step Therapy

    Step Therapy

    No explicit step therapy (step-wise trial of alternate therapies) or step-therapy requirements are specified in this policy. Providers should follow the medical necessity criteria and any payer-specific prior authorization or utilization management programs.

    • No step therapy requirements specified in this document
    Note

    Provider Operational Actions

    Providers must ensure preauthorization is obtained and documentation supports medical necessity and member eligibility. Services provided without prior authorization risk denial and payment is subject to eligibility, contract exclusions, and member contract limitations.

    • Obtain preauthorization before providing services
    • Maintain documentation of medical necessity and eligibility per contract

    Clinical Definitions

    inv-29: Skin substitutes
    DefinitionBioengineered tissue products used as adjuncts to standard wound care for uninfected wounds; classified into cellular (living cells) and acellular (synthetic or devitalized tissue) products
    Intended useProvide coverage or support for open skin wounds when wound bed prepared and criteria met
    Classification noteIncludes products that may be temporary or permanent and replicate properties of normal skin
    inv-30: Prepared wound bed
    Prepared wound bed definitionWound bed must be prepared prior to application, generally with sharp debridement and cleansing and free of infection, necrotic material, eschar, tunnels/tracts, or osteomyelitis that would interfere with adherence/healing
    Preparation elementsSharp debridement and cleansing; removal of necrotic tissue; wound free of infection and nonviable tissue
    DocumentationPrepared wound bed should be documented prior to skin substitute application
    inv-31: Diabetic foot ulcer
    DefinitionAn open break of the skin of the foot associated with neuropathy and/or peripheral arterial disease of the lower limb in a patient with diabetes
    Coverage contextSubject to diabetic foot ulcer criteria including size, perfusion (ABI >= 0.65), failure of standard care, and HbA1c <=12%
    ExclusionsUlcers with infection, drainage, osteomyelitis, surrounding cellulitis, tunnels/tracts, eschar, or necrotic material are excluded
    inv-32: Full-Thickness Thermal Burn (Third Degree Burn)
    DefinitionFull-Thickness Thermal Burn (Third Degree Burn): destruction of all layers of the skin, involving epidermal and dermal layers with varying subcutaneous involvement
    Clinical implicationMay require skin substitutes when insufficient autograft is available or patient not a candidate for further donor sites (product-specific criteria apply)
    Severity noteInvolves all epidermal and dermal layers; variable subcutaneous tissue involvement
    inv-33: Partial-Thickness Thermal Burn (Second Degree Burn)
    DefinitionPartial-Thickness Thermal Burn (Second Degree Burn): involves the epidermis and part of the dermis; deep partial-thickness involves most of the dermis with few intact skin appendages
    Clinical implicationSurface and depth involvement vary; some superficial partial-thickness burns may be appropriate for specific products (see product-specific criteria)
    Depth noteDeep partial-thickness burns leave few intact skin appendages and nerve endings
    inv-34: Measurable signs of healing
    DefinitionMeasurable signs of healing: a wound diminishing in size (surface or depth) with decreased amount of exudate and necrotic tissue
    Use in criteriaUsed to determine failure of standard wound care (e.g., lack of measurable healing after required period: >=4 weeks for DFU, >=1 month for venous ulcers)
    DocumentationPhotographic documentation demonstrating measurable healing (or lack thereof) is required and retained with each application
    inv-35: Skin substitutes
    Alternate definitionSkin substitutes are biologic, synthetic, or biosynthetic materials that provide temporary or permanent coverage of open skin wounds and replicate properties of normal skin
    ClassificationMay be cellular (living cells) or acellular (nonliving matrix) and used as adjuncts to standard wound care
    Clinical usesUsed for coverage after burns, for wound defects, or for reconstruction such as release of severe post-burn contractures
    inv-36: Venous stasis ulcer
    DefinitionVenous stasis ulcer: an open break of the skin in an area with sluggish circulation and poor venous return, commonly in the ankle
    Coverage contextVenous ulcers covered when criteria met, including ABI >= 0.65, size >1 cm and <25 cm2, and failure of standard therapeutic compression for at least one month
    Typical locationCommonly occurs around the ankle where venous return is poor

    Clinical Background & Rationale

    Chronic wounds (for example, diabetic foot ulcers and venous leg ulcers) frequently fail to progress through normal healing and may require adjunctive interventions to restart healing. Skin substitutes are bioengineered materials—cellular or acellular—used as adjuncts to standard wound care for uninfected, prepared wound beds. Independent Health's coverage requires that wounds be appropriately prepared (for example, sharp debridement and cleansing), free of infection or necrotic material, and meet specified clinical thresholds (such as adequate arterial perfusion and wound size) before a skin substitute will be considered medically necessary.