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    v1.0.28
    OpenPayerPolicy UpdatesOrthopedics/MusculoskeletalHealth Choice Arizona Arthroplasty Policy | OpenPa…
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    CurrentHealth Choice ArizonaPolicy O926.6

    Individual-Specific Instrumentation (e.g., Cutting Guides) for Joint Arthroplasty

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    This policy governs coverage determinations for patient-specific instrumentation, such as custom cutting guides, used in joint arthroplasty. It identifies when the technology is considered experimental or investigational based on regulatory approval and available scientific evidence.

    Policy Summary
    PayerHealth Choice Arizona
    PolicyIndividual-Specific Instrumentation (e.g., Cutting Guides) for Joint Arthroplasty
    Policy CodePolicy O926.6
    Change TypeNo material change
    Effective DateSep 19, 2022
    Last ReviewAug 16, 2022
    Next Review Date3rd Qtr 2023
    Key ActionTreat individual-specific instrumentation as experimental or investigational when it lacks final regulatory approval or sufficient evidence of improved health outcomes outside an investigational setting.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3Experimental or investigational criteria

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    8
    FDA-approved knee systems listed
    2Arthroplasty indications
    38Literature resources
    2CPT codes
    33Document resources

    Experimental or Investigational Criteria

    Experimental or Investigational Individual-Specific Instrumentation

    Use of individual-specific instrumentation, including cutting guides, for joint arthroplasty is considered experimental or investigational when any ONE or more of the following criteria are met:

    Any one or more

    • The instrumentation lacks final approval from the appropriate governmental regulatory bodies, such as the Food and Drug Administration.
    • Scientific evidence is insufficient to permit conclusions concerning the effect on health outcomes.
    • Evidence is insufficient to support improvement outside the investigational setting.

    CPT Codes

    CPTCPT
    27299Unlisted procedure, pelvis or hip joint
    27599Unlisted procedure, knee

    Provider Impact

    Denial Risk

    Individual-specific instrumentation may be noncovered

    Use of individual-specific instrumentation, including cutting guides, for joint arthroplasty is considered experimental or investigational when any one or more of the following criteria are met: the device lacks final approval from the appropriate governmental regulatory bodies, scientific evidence is insufficient to permit conclusions concerning its effect on health outcomes, or evidence is insufficient to support improvement outside the investigational setting.

    • Lack of final approval from the appropriate governmental regulatory bodies, such as the Food and Drug Administration.
    • Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes.
    • Insufficient evidence to support improvement outside the investigational setting.

    Clinical Background

    Individual-specific instrumentation is an alternative to conventional cutting guides used in joint arthroplasty. Patient-specific cutting guides are developed from preoperative three-dimensional computed tomography or magnetic resonance imaging scans using proprietary planning software. The intended goals are to increase surgical efficiency and improve implant alignment and clinical outcomes. The clinical applications identified in this policy include total knee arthroplasty and unicompartmental knee arthroplasty.

    Policy Definitions

    Definitions
    PurposeAn alternative to conventional cutting guides for joint arthroplasty.
    Patient-specific constructionConstructed for an individual patient using preoperative three-dimensional computed tomography or magnetic resonance imaging scans.
    Planning methodDeveloped with proprietary planning software.
    Definitions
    Terminology“Experimental” and “investigational” are interchangeable terms.
    ApplicationThis terminology applies for purposes of this Evidence-Based Criteria.
    Policy context
    Policy Summary
    PayerHealth Choice Arizona
    PolicyIndividual-Specific Instrumentation (e.g., Cutting Guides) for Joint Arthroplasty
    Policy CodePolicy O926.6
    Change TypeNo material change
    Effective DateSep 19, 2022
    Last ReviewAug 16, 2022
    Next Review Date3rd Qtr 2023
    Key ActionTreat individual-specific instrumentation as experimental or investigational when it lacks final regulatory approval or sufficient evidence of improved health outcomes outside an investigational setting.
    SourceLink
    On This Page
    Experimental or Investigational CriteriaCPT CodesProvider ImpactClinical BackgroundPolicy Definitions
    The terms are used in the Evidence-Based Criteria to describe the applicable coverage determination standard.