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    v1.0.30
    OpenPayerPolicy UpdatesOrthopedics/MusculoskeletalPremera Cartilage Implant Coverage Update | OpenPa…
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    ModifiedPremera Blue Cross of WashingtonPolicy 7.01.160

    Cartilage Implants for Joint Pain

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    This policy governs coverage of cartilage implants used to treat articular cartilage damage, including AGILI-C and Cartiva. These implants are classified as investigational because evidence is insufficient to demonstrate improved net health outcomes.

    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyCartilage Implants for Joint Pain
    Policy CodePolicy 7.01.160
    Change TypeModified
    Effective DateNovember 6, 2026
    Last ReviewAug 1, 2026
    Next Review DateN/A
    Key ActionExpect claims for AGILI-C and Cartiva to be denied because these implants are considered investigational.
    SourceLink
    POLICY UPDATE CHANGES

    The policy scope was expanded from synthetic cartilage implants to include cartilage implants more broadly.

    CPT code 28291 was removed from the policy.

    InvestigationalCoverage status
    3HCPCS codes listed

    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.

    2016FDA approval year: Cartiva
    2022FDA approval year: Agili-C
    1–7 cm²Agili-C treatable lesion area
    >10 mmCartiva contraindication threshold

    Coverage Criteria

    Cartilage Implants

    Cartilage implants are considered investigational.

    Investigational cartilage implants: Cartilage implants, including AGILI-C and Cartiva, are considered investigational for the treatment of articular cartilage damage.

    Available evidence is insufficient to show that these implants are effective.

    Investigational Cartilage Implants

    Synthetic cartilage implants are considered investigational for the treatment of articular cartilage damage.

    Investigational treatment: Synthetic cartilage implants are considered investigational for the treatment of articular cartilage damage.

    Investigational services are generally not eligible for coverage under the policy unless the member benefit plan provides otherwise.

    For Cartiva, lesions greater than 10 mm and insufficient bone quality or quantity are identified as contraindications.

    Cartilage implants, including AGILI-C and Cartiva, are considered investigational for treatment of articular cartilage damage because available evidence is insufficient to demonstrate effectiveness.

    Evidence is insufficient to determine that synthetic cartilage implants improve net health outcomes for early-stage or advanced first MTP osteoarthritis. Evidence is also insufficient for cartilage repair implants used for knee cartilage or osteochondral defects.

    Synthetic cartilage implants used to treat articular cartilage damage are considered investigational.

    Coding and Product Information

    HCPCSHCPCS
    L8641Metatarsal joint implant
    L8642Hallux implant
    L8699Prosthetic Implant, not otherwise specified
    FDA Product Codesmixed
    PNWFDA product code for the Cartiva Synthetic Cartilage Implant
    QRUFDA product code for Agili-C
    Historical Codes AddedHCPCS
    L8641Code added when the policy was created; description not provided in this window
    L8642Code added when the policy was created; description not provided in this window
    Removed CPT CodeCPT
    28291CPT code removed in the 2026 annual review; description not provided in this window
    Agili-C Treatable Knee Lesion Area
    Treatable lesion area1 to 7 cm²
    DeviceAgili-C
    FDA-approved indicationKnee-joint surface lesions without severe osteoarthritis
    Cartiva Lesion Size Contraindication
    Lesion-size contraindicationGreater than 10 mm
    DeviceCartiva Synthetic Cartilage Implant

    Provider and Claims Actions

    Denial Risk

    Investigational cartilage implants

    Claims for cartilage implants, including AGILI-C and Cartiva, may be denied because these devices are considered investigational for the treatment of articular cartilage damage.

    Denial Risk

    Investigational cartilage implant treatment

    Synthetic cartilage implants are considered investigational for the treatment of articular cartilage damage.

    Clinical Background

    Articular cartilage is the smooth, rubbery tissue covering the ends of bones in a joint, helping the joint move easily and without pain. Damage may result in focal cartilage or osteochondral lesions or diffuse osteoarthritis and may cause pain, swelling, impaired movement, loss of function, and disability. Cartilage implants are intended to replace or repair damaged tissue; examples include Cartiva for the first metatarsophalangeal joint and Agili-C for knee cartilage or osteochondral defects. The evidence reviewed for these applications was insufficient to establish improved net health outcomes.

    Definitions

    Articular Cartilage
    TissueSmooth, rubbery tissue
    LocationCovers the ends of bones in a joint
    FunctionHelps the joint move easily and without pain
    Cartilage Implant
    TypeDevice
    PlacementPlaced into a joint
    PurposeReplaces or repairs damaged cartilage
    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyCartilage Implants for Joint Pain
    Policy CodePolicy 7.01.160
    Change TypeModified
    Effective DateNovember 6, 2026
    Last ReviewAug 1, 2026
    Next Review DateN/A
    Key ActionExpect claims for AGILI-C and Cartiva to be denied because these implants are considered investigational.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Product InformationProvider and Claims ActionsClinical BackgroundDefinitions
    Additional contraindication
    Insufficient quality or quantity of bone
    Agili-C
    CompositionCell-free, biocompatible, and biodegradable
    DesignTapered-shape implant
    FunctionActs as a three-dimensional scaffold in a prepared osteochondral defect
    Potential effectMay support and promote regeneration of articular cartilage and underlying subchondral bone
    Coughlin Clinical-Radiographic System
    System typeClinical-radiographic grading system
    Condition assessedHallux rigidus
    Assessment factorsDorsiflexion, radiographic findings, and clinical findings
    Grade rangeGrades 0 through 4
    ROM
    AbbreviationROM
    MeaningRange of motion
    Table usageUsed to describe clinical findings at the extremes or middle range of motion