Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsBaylor Scott & White Zevaskyn Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentBaylor Scott & White Health PlanPolicy 321

    Prademagene zamikeracel (Zevaskyn) coverage

    Customize your policy alerts

    Sign up for baylor_scott_and_white_health_plan Policy 321 alerts

    Get alerted when Policy 321 changes without checking for updates manually.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Prior authorization and medical-necessity coverage for prademagene zamikeracel (Zevaskyn) for wounds associated with recessive dystrophic epidermolysis bullosa.

    Policy Summary
    PayerBaylor Scott & White Health Plan
    PolicyPrademagene zamikeracel (Zevaskyn) coverage
    Policy CodePolicy 321
    Change TypeNo material change
    Effective DateOct 1, 2026
    Last ReviewSep 24, 2026
    Next Review DateSep 24, 2027
    Key ActionSubmit prior authorization for prademagene zamikeracel (Zevaskyn).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥6 yearsMinimum member age
    ≥20 cm²Minimum wound area
    ≥6 monthsMinimum wound duration
    2 lifetimeMaximum treatments
    1 yearAuthorization duration

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    12 sheetsDose per authorization

    Coverage Criteria

    Initial Therapy

    Prademagene zamikeracel (Zevaskyn®) is covered for initial therapy when ALL of the following criteria are met:

    ALL of the following

    • Member has a confirmed diagnosis of recessive dystrophic epidermolysis bullosa (RDEB), supported by skin biopsy immunohistochemistry with fluorescence-labelled secondary antibodies (immunofluorescence mapping) confirming positive expression of the non-collagenous region 1 of the type VII collagen protein (NC1+) in the skin, AND genetic testing confirming a COL7A1 mutation and collagen VII deficiency or absence with a recessive inheritance pattern.
    • Member has an appropriate clinical presentation, such as skin blistering, erosions, slow-healing chronic wounds, scarring, milia, or itchy, painful skin.
    • Provider has ruled out other related skin disorders with similar clinical presentations.
    • Member is 6 years of age or older.>= 6 years
    • Prademagene zamikeracel (Zevaskyn®) is prescribed by or in consultation with a dermatologist experienced in treating patients with RDEB.

    • At least one candidate wound has ALL of the following characteristics

      • Surface area of at least 20 cm².>= 20 cm²
      • Stage 2 chronic wound, defined as an open skin wound with partial-thickness loss of the dermis that has not extended through the dermis into subcutaneous tissue.
      • Present for at least 6 months.>= 6 months
    • Prademagene zamikeracel (Zevaskyn®) will be applied according to FDA-approved labeling.
    • Provider attests that the member will use an authorized treatment center.

    • Member does not have any of the following exclusionary conditions

      • Anti-type VII collagen (C7) antibodies.
      • Active systemic infection, including hepatitis B or C or human immunodeficiency virus (HIV), or infection at candidate wound sites.
      • Cardiac abnormalities that could complicate anesthesia, such as left ventricular dysfunction, congestive heart failure, or dilated cardiomyopathy.
      • Squamous cell carcinoma lesions at or near candidate wounds.
      • Vancomycin or amikacin hypersensitivity.
      • Use of beremagene geperpavec (Vyjuvek®), birch bark gel (Filsuvez®), or investigational gene or cell therapies on candidate wounds leading up to or after prademagene zamikeracel (Zevaskyn®) application.

    Continuation or Renewal Therapy

    Renewal or continuation therapy is covered when ALL of the following criteria are met:

    ALL of the following

    • Member meets all universal criteria for prademagene zamikeracel (Zevaskyn®) treatment.
    • Request is for new candidate wounds that were not previously treated with prademagene zamikeracel.
    • Member has manageable or no side effects from previous treatment.
    • Previously treated wounds show a positive clinical response, such as a reduction in wound area size, within 6 months of application.within 6 months
    • Member did not experience graft rejection from the previous application.

    Experimental and Investigational Use

    The following uses of prademagene zamikeracel (Zevaskyn®) are considered experimental and investigational and are not medically necessary:

    ANY of the following

    • More than two lifetime administrations of prademagene zamikeracel (Zevaskyn®).
    • Treatment of indications other than the supported RDEB wound indication.

    Prademagene zamikeracel (Zevaskyn®) is not medically necessary for a member with anti-type VII collagen (C7) antibodies, active systemic infection such as hepatitis B or C or HIV, infection at candidate wound sites, cardiac abnormalities that may complicate anesthesia, squamous cell carcinoma lesions at or near candidate wounds, or vancomycin or amikacin hypersensitivity. It is also not medically necessary when the member will apply beremagene geperpavec (Vyjuvek®), birch bark gel (Filsuvez®), or investigational gene or cell therapies to candidate wounds before or after treatment.

    BSWHP considers more than two lifetime treatments with prademagene zamikeracel (Zevaskyn®) experimental and investigational because the effectiveness of this strategy has not been established.

    BSWHP considers prademagene zamikeracel (Zevaskyn®) for indications other than the supported RDEB wound indication experimental and investigational because the effectiveness of this strategy has not been established.

    Coding and Eligibility Thresholds

    HCPCS CodesHCPCS
    J3389Topical administration, prademagene zamikeracel, per treatment
    Candidate wound surface area
    Minimum wound surface area≥20 cm²
    Wound requirementAt least one qualifying wound must meet the surface-area requirement.
    Coverage applicationThe wound surface-area threshold is part of the universal criteria for Zevaskyn treatment.
    Member age
    Minimum member age≥6 years
    Eligibility requirementThe member must be at least six years old for Zevaskyn treatment.
    Coverage application

    Provider Actions and Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for prademagene zamikeracel (Zevaskyn®). Submit clinical documentation demonstrating that all applicable plan criteria are met.

    Documentation Required

    Initial Clinical Documentation

    Document confirmed recessive dystrophic epidermolysis bullosa (RDEB), the applicable clinical presentation, exclusion of similar skin disorders, age, specialist involvement, and at least one qualifying chronic wound.

    • Confirmed RDEB: Skin biopsy with immunohistochemistry using fluorescence-labelled secondary antibodies (immunofluorescence mapping) confirming positive expression of the NC1 region of collagen VII, plus genetic confirmation of a COL7A1 mutation and collagen VII deficiency or absence with recessive inheritance.
    • Clinical presentation: Skin blistering, erosions, slow-healing chronic wounds, scarring, milia, and/or itchy, painful skin; the provider must rule out related skin disorders with similar presentation.

    Clinical Background

    Recessive dystrophic epidermolysis bullosa (RDEB) is a severe inherited skin-fragility disorder caused by mutations in the COL7A1 gene. These mutations result in absent or deficient type VII collagen, a protein needed to anchor skin layers together, leading to blistering, erosions, scarring, and chronic nonhealing wounds. Zevaskyn uses the member’s autologous keratinocytes, genetically modified to express a non-mutant COL7A1 gene, to create cellular sheets that are applied to wounds.

    Policy Definitions

    Stage 2 chronic wound
    Wound statusAn open skin wound.
    Dermal involvementThe wound has partial-thickness loss of the dermis.
    Depth limitationThe wound has not extended through the dermis into subcutaneous tissue.
    Confirmed RDEB
    DiagnosisRecessive dystrophic epidermolysis bullosa (RDEB).
    Skin testingSkin biopsy with immunohistochemistry and fluorescence-labelled secondary antibodies confirms positive expression of the NC1 region of the type VII collagen protein in the skin.
    Genetic confirmation

    Initial Therapy Criteria

    Initial Therapy Criteria

    Initial treatment requires ALL universal criteria.

    Diagnosis and laboratory confirmation: Member has confirmed recessive dystrophic epidermolysis bullosa with positive NC1 expression of type VII collagen on skin immunofluorescence mapping or immunohistochemistry and a recessive COL7A1 mutation with type VII collagen deficiency or absence confirmed by genetic testing.
    Clinical and wound eligibility: Member has an appropriate RDEB clinical presentation and at least one Stage 2 chronic wound measuring at least 20 cm² and present for at least six months.≥20 cm²; Stage 2; ≥6 months
    Treatment requirements: Member is at least six years old; a dermatologist experienced in treating patients with RDEB prescribes or provides consultation; treatment follows FDA-approved labeling; and an authorized treatment center will be used.≥6 years

    Continuation and Renewal Criteria

    Renewal Therapy

    Renewal requests require ALL of the following.

    Universal criteria remain met: Member meets all universal criteria.
    New candidate wounds: The request is for new candidate wounds that were not previously treated with prademagene zamikeracel (Zevaskyn).
    Manageable adverse effects: Member has manageable or no side effects from previous treatment.
    Positive clinical response: Previously treated wounds show a positive clinical response, such as reduction in wound area size, within six months of application.Within 6 months

    Quantity and Lifetime Limits

    Prademagene zamikeracel (Zevaskyn)
    DoseOne dose consists of 12 cellular sheets.
    Lifetime maximumNo more than two treatments per lifetime are medically necessary.
    Further administrationMore than two lifetime treatments are considered experimental and investigational because effectiveness has not been established.

    Site of Care Requirements

    Note

    Use an authorized treatment center

    Treatment must be provided through an authorized treatment center. The provider must attest that the member will use an authorized treatment center.

    Policy Summary
    PayerBaylor Scott & White Health Plan
    PolicyPrademagene zamikeracel (Zevaskyn) coverage
    Policy CodePolicy 321
    Change TypeNo material change
    Effective DateOct 1, 2026
    Last ReviewSep 24, 2026
    Next Review DateSep 24, 2027
    Key ActionSubmit prior authorization for prademagene zamikeracel (Zevaskyn).
    SourceLink
    On This Page
    Coverage CriteriaCoding and Eligibility ThresholdsProvider Actions and DocumentationClinical BackgroundPolicy DefinitionsInitial Therapy CriteriaContinuation and Renewal CriteriaQuantity and Lifetime LimitsSite of Care Requirements
    Age is included among the universal criteria applied to all requests.
    Chronic wound duration
    Minimum wound duration≥6 months
    Qualifying woundThe wound must have been present for at least six months.
    Coverage applicationChronic wound duration is part of the wound requirements for Zevaskyn treatment.
  1. Age and prescriber: Member is 6 years or older, and treatment is prescribed by or provided in consultation with a dermatologist experienced in treating RDEB.
  2. Candidate wound: At least one wound has a surface area of ≥20 cm², is a Stage 2 chronic wound with partial-thickness dermal loss that does not extend into subcutaneous tissue, and has been present for ≥6 months.
    3. Documentation Required

    Treatment Eligibility and Safety Documentation

    Document that treatment will follow FDA-approved labeling, occur at an authorized treatment center, and satisfy the required clinical safety conditions before application.

    • Application must be performed according to FDA-approved labeling.
    • Provider must attest that the member will use an authorized treatment center.
    • Document absence of anti-type VII collagen (C7) antibodies; active systemic infection, including hepatitis B, hepatitis C, or HIV, or infection at candidate wound sites; cardiac abnormalities that could complicate anesthesia; squamous cell carcinoma at or near candidate wounds; and vancomycin or amikacin hypersensitivity.
    • Document that the patient will not apply beremagene geperpavec (Vyjuvek®), birch bark gel (Filsuvez®), or investigational gene or cell therapies to candidate wounds before or after Zevaskyn® application.
    Documentation Required

    Renewal Documentation

    For renewal, submit documentation showing that universal criteria remain satisfied and that the requested treatment meets the plan’s continuation requirements.

    • The request is for new candidate wounds that were not previously treated with Zevaskyn®.
    • The member has manageable or no side effects from prior treatment.
    • Previously treated wounds demonstrated a positive clinical response, such as reduced wound area, within 6 months of application.
    • The member did not experience graft rejection from the prior application.
    • Authorization duration is 1 year for one dose (12 cellular sheets).
    Denial Risk

    Lifetime Treatment Limit

    BSWHP considers only two Zevaskyn® treatments per lifetime medically necessary. Further administration is experimental and investigational because the effectiveness of this strategy has not been established.

    • Lifetime limit: 2 treatments.
    Denial Risk

    Other Indications Not Covered

    Use of Zevaskyn® for indications other than RDEB is experimental and investigational because the effectiveness of this strategy has not been established.

    Denial Risk

    Exclusionary Clinical Conditions

    Coverage is not medically necessary when an exclusionary clinical condition is present or when required safety conditions are not met.

    • Anti-type VII collagen (C7) antibodies.
    • Active systemic infection, including hepatitis B, hepatitis C, or HIV, or infection at a candidate wound site.
    • Cardiac abnormalities that may complicate anesthesia, including left ventricular dysfunction, congestive heart failure, or dilated cardiomyopathy.
    • Squamous cell carcinoma lesions at or near candidate wounds.
    • Vancomycin or amikacin hypersensitivity.
    • Use of Vyjuvek, Filsuvez, or investigational gene or cell therapies on candidate wounds before or after Zevaskyn® application.
    Denial Risk

    Renewal Failure Criteria

    Renewal requests do not meet coverage criteria when they fail the continuation requirements, including requests for previously treated wounds, inadequate clinical response, unacceptable adverse effects, or graft rejection.

    • Requested wounds are not new candidate wounds.
    • Universal criteria are no longer met.
    • Prior treatment did not produce a positive clinical response within 6 months.
    • Side effects from previous treatment are not manageable or are unacceptable.
    • Graft rejection occurred after the previous application.
    Genetic testing confirms a COL7A1 mutation and type VII collagen deficiency or absence with a recessive inheritance pattern.
    Safety and exclusion criteria: Member has none of the policy-listed antibodies, infections, cardiac abnormalities, squamous cell carcinoma lesions, antibiotic hypersensitivities, or competing or investigational wound therapies.
    No graft rejection: Member did not experience graft rejection from the previous application.