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    v1.0.31
    OpenPayerPolicy UpdatesOphthalmology/OptometryRegence Iris Prosthesis Coverage Policy | OpenPaye…
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    CurrentRegencePolicy 246

    Iris Prosthesis

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    This policy governs coverage of artificial iris or iris prosthesis implantation, including devices such as the CustomFlex Artificial Iris, for treatment of partial or complete absence of the iris. The service is considered investigational for any indication.

    Policy Summary
    PayerRegence
    PolicyIris Prosthesis
    Policy CodePolicy 246
    Change TypeNo material change
    Effective DateJanuary 1, 2027
    Last ReviewAug 1, 2026
    Next Review DateAugust 1, 2027
    Key ActionTreat claims for iris prosthesis implantation, including the CustomFlex Artificial Iris, as investigational and subject to denial.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    InvestigationalCoverage status
    0Randomized controlled trials identified
    94%Symptom reduction reported
    27.6%Eyes developing secondary glaucoma
    2Cross-referenced policies

    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.

    Coverage Criteria

    Investigational for any indication

    The use of an iris prosthesis is considered investigational for any indication.

    Investigational service: Use of an iris prosthesis, including the CustomFlex Artificial Iris, is considered investigational for any indication.

    No covered indication is established by this policy.

    Coding

    CPTCPTNot Covered
    66683Implantation of iris prosthesis, including suture fixation and repair or removal of iris, when performed.
    HCPCSHCPCSNot Covered
    C1839Iris prosthesis

    Provider Actions

    Denial Risk

    Iris prosthesis claims may be denied as investigational

    Claims for use of an iris prosthesis, including implantation of an artificial iris such as the CustomFlex™ Artificial Iris, are subject to denial because the service is considered investigational for any indication.

    Clinical Background

    Aniridia is the partial or complete absence of the iris and may be congenital or acquired. Congenital aniridia is a rare condition that typically affects both eyes. Management may include refractive correction, amblyopia therapy, correction of squint, and tinted contact lenses or glasses to reduce photophobia and improve vision or appearance.

    Artificial iris implants, including the CustomFlex Artificial Iris, may reduce disabling glare and light sensitivity during the day or night and may enhance vision-related quality of life. However, reported risks include development or worsening of glaucoma, aniridia-associated keratopathy or limbal stem cell deficiency, prosthesis decentration, and endothelial cell loss.

    Definitions

    Aniridia
    DefinitionA partial or complete absence of the iris.
    CausesMay have either a congenital or acquired etiology.
    Congenital formA rare, typically autosomal dominant disease that affects both eyes.
    Artificial iris or iris prosthesis
    DefinitionAn artificial iris used to treat a partial or total absence of the iris, called aniridia.
    PurposeProvides an implant option for treatment of partial or total iris absence.
    Policy Summary
    PayerRegence
    PolicyIris Prosthesis
    Policy CodePolicy 246
    Change TypeNo material change
    Effective DateJanuary 1, 2027
    Last ReviewAug 1, 2026
    Next Review DateAugust 1, 2027
    Key ActionTreat claims for iris prosthesis implantation, including the CustomFlex Artificial Iris, as investigational and subject to denial.
    SourceLink
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    Coverage CriteriaCodingProvider ActionsClinical BackgroundDefinitions