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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsViva Health Epioxa Prior Auth Coverage | OpenPayer
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    CurrentViva Health PlanPolicy IC-0635

    Epioxa and Epioxa HD (riboflavin 5'-phosphate) for corneal cross-linking

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    This policy governs prior authorization and coverage of Epioxa and Epioxa HD for epithelium-on corneal collagen cross-linking in members with keratoconus, including one treatment dose for each affected eye.

    Policy Summary
    PayerViva Health Plan
    PolicyEpioxa and Epioxa HD (riboflavin 5'-phosphate) for corneal cross-linking
    Policy CodePolicy IC-0635
    Change TypeNo material change
    Effective DateN/A
    Last ReviewOct 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for one dose in each eye only when the member is at least 13 years old and meets all keratoconus coverage criteria.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    13 yearsMinimum member age for initial approval
    1 dose per eyeInitial authorization duration
    4 unitsMaximum units per 180 days for both eyes
    No renewalRenewal authorization availability

    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.

    J2789
    Covered HCPCS billing code
    9Covered keratoconus diagnosis codes

    Coverage Criteria

    Initial Therapy

    Initial therapy for keratoconus is covered when ALL applicable criteria are met:

    ALL of the following

    • Member is at least 13 years of age.
    • Member has a confirmed diagnosis of keratoconus evidenced by compatible topographical findings, such as axial topography consistent with keratoconus, maximum corneal curvature (Kmax) of ≥ 47.00 D, or central or inferior steepening on the Pentacam topography map, and clinical examination findings, such as a Fleischer ring, Vogt striae, corneal thinning, corneal scarring, or scissoring of the retinoscopic reflex.
    • Member does not have any FDA-labeled contraindications to the requested agent, including hypersensitivity or aphakia/pseudophakia without a UV-blocking intraocular lens.
    • Member has not had prior corneal cross-linking treatment in the affected eye.
    • Member will use therapy for epithelium-on corneal collagen cross-linking in the treatment of keratoconus.
    • The O2n System and Boost Goggles will be used.
    • Member has progressive disease despite avoidance of eye rubbing and use of topical antiallergy medications, as applicable. Progression is evidenced by one or more of the following: increased maximum keratometry; steepening or changes in curvature of the anterior or posterior corneal surface; thinning and/or an increased rate of corneal thickness change from the periphery to the thinnest point; or refractive changes, including increasing myopia and astigmatism. Progression is not required in pediatric members.

    Renewal Therapy

    Renewal therapy is not available.

    Renewal criteria

    • Duration of authorization has not been exceeded; refer to Section I.

    The requested agent must not have any FDA-labeled contraindications, including hypersensitivity or aphakia/pseudophakia without a UV-blocking intraocular lens.

    The member must not have had prior corneal cross-linking treatment in the affected eye.

    Treatment must be epithelium-on corneal collagen cross-linking using the O2n System and Boost Goggles.

    Billing and Coding

    Covered HCPCS CodeHCPCSCovered
    J2789Riboflavin 5'-phosphate, ophthalmic solution (Epioxa HD/Epioxa), up to 2 mL; 1 billable unit = 2 mL
    Covered NDCNDCCovered
    25357-0024-xxEpioxa HD 0.239% or Epioxa 0.177%, one single-dose glass syringe containing 2 mL packaged in a foil pouch
    Covered Diagnosis CodesICD-10Covered
    H18.601Keratoconus, unspecified, right eye
    H18.602Keratoconus, unspecified, left eye
    H18.603Keratoconus, unspecified, bilateral
    H18.611Keratoconus, stable, right eye
    H18.612Keratoconus, stable, left eye
    H18.613Keratoconus, stable, bilateral
    H18.621Keratoconus, unstable, right eye
    H18.622Keratoconus, unstable, left eye
    H18.623Keratoconus, unstable, bilateral
    Minimum age13 years
    Maximum corneal curvature (Kmax)≥ 47.00 D
    Minimum corneal thickness before irradiation325 microns; do not irradiate below this threshold
    Maximum dosing4 billable units per 180 days

    Provider Requirements and Denial Risks

    Prior Authorization

    Submit prior authorization for initial treatment

    Prior authorization is required. Initial approval is provided for one dose for each eye when the member is at least 13 years old, has no FDA-labeled contraindication, has not had prior corneal cross-linking in the affected eye, and meets the keratoconus-specific criteria.

    Documentation Required

    Provide keratoconus clinical evidence

    Document a confirmed diagnosis of keratoconus using compatible topographical and clinical examination findings. Include evidence such as Kmax ≥ 47.00 D or central/inferior steepening when applicable, and describe disease progression when required; progression is not required in pediatric members.

    Clinical Background

    Keratoconus is a corneal ectatic disorder characterized by abnormal corneal steepening, thinning, and irregular curvature. This policy addresses epithelium-on corneal collagen cross-linking with topical riboflavin, oxygen supplementation, and UV-A irradiation for keratoconus. Coverage criteria require a confirmed diagnosis supported by compatible corneal topography and clinical examination findings; documented progression is not required for pediatric members.

    Initial Epioxa Therapy

    Initial Epioxa Therapy

    Initial approval requires ALL criteria below.

    Initial Epioxa therapy: Member is at least 13 years old; has no FDA-labeled contraindication; has no prior corneal cross-linking treatment in the affected eye; has confirmed keratoconus; will receive epithelium-on corneal collagen cross-linking using the O2n System and Boost Goggles; and meets the disease activity requirement unless pediatric.Age ≥ 13 years; Kmax ≥ 47.00 D may support the diagnosis

    Progression may be demonstrated by changes in keratometry, anterior or posterior corneal curvature, corneal thinning or thickness-change rate, increasing myopia, or increasing astigmatism. Progression is not required for pediatric members.

    Continuation and Renewal

    No Continuation Therapy

    Renewal is not permitted.

    Continuation limitation: Prior authorization validity may not be renewed; authorization is limited to one dose for each eye.One dose per eye

    No continuation therapy is authorized.

    Quantity and Dose Limits

    Quantity Limits
    ProductsEpioxa and Epioxa HD
    Maximum quantity4 billable units
    Time periodPer 180 days
    Unit basisHCPCS unit, based on administration to both eyes
    Policy Summary
    PayerViva Health Plan
    PolicyEpioxa and Epioxa HD (riboflavin 5'-phosphate) for corneal cross-linking
    Policy CodePolicy IC-0635
    Change TypeNo material change
    Effective DateN/A
    Last ReviewOct 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for one dose in each eye only when the member is at least 13 years old and meets all keratoconus coverage criteria.
    SourceLink
    On This Page
    Coverage CriteriaBilling and CodingProvider Requirements and Denial RisksClinical BackgroundInitial Epioxa TherapyContinuation and RenewalQuantity and Dose Limits
    Denial Risk

    Check FDA-labeled contraindications

    Coverage may be denied when the member has an FDA-labeled contraindication to the requested agent, including hypersensitivity or aphakia/pseudophakia without a UV-blocking intraocular lens.

    Denial Risk

    Verify no prior corneal cross-linking

    Coverage may be denied when the affected eye has previously received corneal cross-linking treatment.

    Denial Risk

    Use the required treatment system

    The requested treatment must be epithelium-on corneal collagen cross-linking using the O2n System and Boost Goggles. Requests that do not meet these treatment requirements are at risk for denial.

    Billing Rule

    Stay within the dosing limit

    Requests exceeding 4 billable units per 180 days, based on administration to both eyes, are at risk for denial.

    Denial Risk

    Do not submit renewal requests

    Renewal requests are not authorized because the policy provides an initial authorization for one dose per eye and does not permit renewal.