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    v1.0.31
    OpenPayerPolicy UpdatesOphthalmology/OptometryHealthy Blue Louisiana KPro Coverage | OpenPayer
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    ModifiedHealthy Blue LouisianaPolicy CG-SURG-94

    Keratoprosthesis

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    This policy governs coverage of permanent keratoprosthesis procedures, particularly the Dohlman-Doane Boston KPro, for individuals with corneal blindness or severe corneal disease who are poor candidates for conventional corneal transplantation. It applies to Healthy Blue Louisiana standard Medicaid benefit-plan coverage determinations.

    Policy Summary
    PayerHealthy Blue Louisiana
    PolicyKeratoprosthesis
    Policy CodePolicy N/A
    Change TypeModified
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument at least one prior failed corneal transplant when qualifying under the prior-transplant pathway.
    SourceLink
    POLICY UPDATE CHANGES

    The medical necessity criteria were revised regarding the number of previous failed corneal transplants.

    New medical necessity criteria were added for situations in which a corneal transplant is likely to fail.

    Additional ICD-10-CM diagnosis codes were added to the Coding section.

    The Coding section was revised to correct ICD-10-CM diagnosis codes, including the T86.8401-T86.8499 range.

    The Discussion, References, Websites, and Coding sections were updated or reformatted.

    Boston KProDevice considered medically necessary when criteria are met
    2 pathwaysAlternative clinical-indication pathways
    10 conditionsConditions predisposing to corneal transplant failure

    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.

    Other devicesNon-Boston KPro devices are not medically necessary
    CPT 65770Primary listed procedure code

    Medical Necessity and Noncovered Circumstances

    Medically Necessary Boston KPro

    Keratoprosthesis using the Dohlman Doane Boston KPro device is considered medically necessary for the treatment of corneal blindness when <strong>either</strong> qualifying pathway below is met.

    ONE of the following pathways

    • A. Prior corneal transplant

      • The cornea is severely opaque and vascularized.
      • There is documentation of at least one prior failed corneal transplant procedure.

    • B. High likelihood of corneal transplant failure

      • There is documentation of a condition predisposing the individual to a high likelihood of corneal transplant failure.

      • The predisposing condition is one or more of the following

        • Autoimmune condition with ocular involvement.
        • Heavily vascularized corneal scars.
        • Limbal stem cell compromise.
        • Mucus membrane pemphigoid.
        • Neuropathic keratopathy.
        • Ocular chemical burns.
        • Ocular cicatricial pemphigoid.
        • Postherpetic anesthesia.

    Not Medically Necessary

    The following circumstances are considered not medically necessary:

    ANY of the following

    • Keratoprosthesis using an artificial cornea device other than the Boston KPro.
    • Keratoprosthesis for an indication not listed above as medically necessary.
    • The procedure or diagnosis code describes a service for which the medical-necessity criteria are not met.
    • The diagnosis is not listed as a covered indication.
    • The code describes a procedure or situation designated as not medically necessary in the clinical indications.

    Selected Use After Failed or High-Risk Corneal Transplantation

    Boston KPro procedures are intended for selected individuals with severe corneal visual loss when conventional corneal transplantation has failed or is unlikely to succeed.

    ALL of the following

    • The individual has lost vision due to severe corneal opacification or corneal blindness.

    • The individual has one of the following transplantation circumstances

      • A conventional corneal transplant has not been successful.
      • A conventional corneal transplant is not feasible or has a high likelihood of failure, such that the condition is not amenable to human cadaveric keratoplasty techniques.

    Artificial cornea devices other than the Boston KPro are not medically necessary.

    Indications not listed as medically necessary above are not medically necessary.

    The procedure and diagnosis codes listed in this policy are not medically necessary when the applicable criteria are not met, when the diagnosis is not listed, or when the code describes a procedure or situation designated as not medically necessary in the clinical indications.

    Procedure and Diagnosis Codes

    Covered CPT CodesCPTCovered
    65770Keratoprosthesis
    Covered HCPCS CodesHCPCSCovered
    C1818Integrated keratoprosthesis
    L8609Integrated keratoprosthesis Artificial cornea
    ICD-10 Procedure CodesICD-10
    08R83JZReplacement of right cornea with synthetic substitute, percutaneous approach
    08R8XJZReplacement of right cornea with synthetic substitute, external approach
    08R93JZReplacement of left cornea with synthetic substitute, percutaneous approach
    08R9XJZReplacement of left cornea with synthetic substitute, external approach
    08U80JZSupplement right cornea with synthetic substitute, open approach
    08U83JZSupplement right cornea with synthetic substitute, percutaneous approach
    08U8XJZSupplement right cornea with synthetic substitute, external approach
    08U90JZSupplement left cornea with synthetic substitute, open approach
    08U93JZSupplement left cornea with synthetic substitute, percutaneous approach
    08U9XJZSupplement left cornea with synthetic substitute, external approach
    ICD-10 Diagnosis CodesICD-10
    B02.23Postherpetic polyneuropathy
    B02.29Other postherpetic nervous system involvement
    H04.121-H04.129Dry eye syndrome
    H16.441-H16.449Deep vascularization of cornea
    H17.10-H17.13Central corneal opacity
    H18.40-H18.49Corneal degeneration
    H18.811-H18.819Anesthesia and hypoesthesia of cornea
    H18.891-H18.9Other specified and unspecified disorders of cornea
    H54.0X33-H54.8Blindness and low vision
    L12.1Cicatricial pemphigoid
    ICD-10 Diagnosis CodesICD-10
    L51.1Stevens-Johnson syndrome
    M30.0-M36.8Systemic connective tissue disorders
    Q13.1Absence of iris
    T26.00XA-T26.92XSBurn and corrosion confined to eye and adnexa
    T86.8401-T86.8499Complications of corneal transplant
    ICD-10-CM Diagnosis Codes Referenced in Policy HistoryICD-10
    T86.8401-T86.8499ICD-10-CM diagnosis code range referenced in the policy history

    Documentation and Coverage Risk

    Documentation Required

    Document Prior Transplant Failure

    For individuals with a prior corneal transplant, document that the cornea is severely opaque and vascularized and provide documentation of at least one prior failed corneal transplant procedure for this qualifying pathway.

    • Severe corneal opacity and vascularization
    • At least one prior failed corneal transplant procedure
    Documentation Required

    Document High-Risk Transplant-Failure Condition

    Document the condition predisposing the individual to a high likelihood of corneal transplant failure when qualifying under the high-risk pathway.

    • Autoimmune conditions with ocular involvement
    • Heavily vascularized corneal scars
    • Limbal stem cell compromise
    • Mucus membrane pemphigoid
    • Neuropathic keratopathy

    Clinical Background

    A permanent keratoprosthesis is an implanted artificial cornea that provides a transparent optical pathway through an opaque cornea. It is intended to restore useful vision for individuals with severe corneal disease who are not reasonable candidates for conventional corneal transplantation. The policy identifies the Dohlman-Doane Boston KPro as the medically necessary device when specified clinical criteria are met.

    Terminology

    Permanent keratoprosthesis
    TermPermanent keratoprosthesis
    DefinitionAn implanted artificial cornea intended to restore useful vision in individuals with severe corneal disease that is not amenable to conventional corneal transplantation.
    Optical functionProvides a transparent optical pathway through an opacified cornea.
    Temporary keratoprosthesis
    TermTemporary keratoprosthesis
    UseA keratoprosthetic device used intraoperatively to aid visualization of ocular structures.
    Disposition
    Policy Summary
    PayerHealthy Blue Louisiana
    PolicyKeratoprosthesis
    Policy CodePolicy N/A
    Change TypeModified
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument at least one prior failed corneal transplant when qualifying under the prior-transplant pathway.
    SourceLink
    On This Page
    Medical Necessity and Noncovered CircumstancesProcedure and Diagnosis CodesDocumentation and Coverage RiskClinical BackgroundTerminology
  1. Severe dry eye.
  2. Stevens-Johnson Syndrome.
  3. Ocular chemical burns
  4. Ocular cicatricial pemphigoid
  5. Postherpetic anesthesia
  6. Severe dry eye
  7. Stevens-Johnson Syndrome
    8. Denial Risk

    Watch for Noncovered Devices and Unmet Criteria

    Coverage is limited to keratoprosthesis using the Dohlman Doane Boston KPro device for the listed medically necessary indications. Services are not medically necessary when another artificial cornea device is used, for an unlisted indication or diagnosis, or when the required criteria are not met.

    • Artificial cornea devices other than the Boston KPro are not medically necessary.
    • Indications not listed as medically necessary are not covered.
    • Denial risk applies when required criteria are not met or the diagnosis is not listed.
    The temporary device is removed following surgery.
    Boston KPro
    TermBoston KPro
    DeviceThe Dohlman-Doane Boston KPro is an artificial cornea with a rigid plastic optic positioned between a front and back plate in the shape of a collar button.
    IndicationProvides a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
    Anatomical failure
    TermAnatomical failure
    Study definitionKeratoprosthesis extrusion during the follow-up period.
    Reported exampleIn the cited study, extrusion occurred in 3 eyes in the high-risk group and none in the non-high-risk group.
    Functional failure
    TermFunctional failure
    Study definitionLoss of useful visual function associated with prior ocular disease or postoperative complications.
    Reported causesThe cited study associated functional failure with endophthalmitis, previous age-related macular degeneration, glaucoma, and secondary glaucoma.