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    v1.0.28
    OpenPayerPolicy UpdatesOrthopedics/Musculoskeletalmediviewcurative viscosupplementation Coverage Upd…
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    CurrentmediviewcurativePolicy MM-PNP-022

    Viscosupplementation for knee osteoarthritis (coverage criteria)

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    This policy governs prior-approval, medical necessity, and coverage criteria for intra-articular viscosupplementation (hyaluronates) for knee osteoarthritis for Curative Health Plan participating providers and members.

    Policy Summary
    Payermediviewcurative
    PolicyViscosupplementation for knee osteoarthritis (coverage criteria)
    Policy CodePolicy MM-PNP-022
    Change TypeNo material change
    Effective DateDec 1, 2023
    Next Review Date
    Key ActionObtain prior approval for viscosupplementation products for participating providers and members where required.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3Preferred viscosupplement products named
    10+Non-preferred viscosupplement examples listed
    6 monthsMinimum interval between completed series
    Prior approvalAdministrative requirement

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    Coverage Criteria

    Initial Approval

    Covered when ALL of the following are met:

    Initial approval criteria: Member has a diagnosis of knee osteoarthritis supported by radiographic evidence (e.g., joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts) OR the member has at least 5 of the specified signs/symptoms; member has knee pain that interferes with functional activities (e.g., ambulation, prolonged standing); member has experienced inadequate response or intolerance to non-pharmacologic treatments (e.g., physical therapy, exercise, insoles, knee bracing, weight reduction); member has experienced inadequate response, intolerance, or has a contraindication to a trial of analgesics (e.g., acetaminophen up to 3–4 g/day, NSAIDs, topical capsaicin) for at least 3 months; member has experienced inadequate response, intolerance, or has a contraindication to a trial of intra-articular corticosteroid injections for at least 3 months; member is not scheduled for total knee replacement within 6 months of starting treatment.

    Signs/symptoms list: bony enlargement; bony tenderness; crepitus on active motion; ESR < 40 mm/hr; < 30 minutes morning stiffness; no palpable synovial warmth; age > 50 years; rheumatoid factor < 1:40 (agglutination); synovial fluid clear with normal viscosity and WBC < 2000/mm3.

    Continuation of Therapy

    Covered when ALL of the following are met:

    Continuation criteria: Member meets all initial medical necessity criteria; member experienced improvement in pain and functional capacity after the previous injection series; at least 6 months have elapsed since the last injection in the prior completed series of injections.6 months

    This policy identifies a number of indications for which viscosupplementation is considered experimental and investigational because effectiveness has not been established. Examples include intra‑articular polynucleotides and the use of imaging guidance (ultrasound, fluoroscopy, or knee arthrography) for viscosupplement injections. The policy also considers viscosupplementation investigational when used in combination with anesthetics, corticosteroids, mannitol/sorbitol, mesenchymal stem cells, or platelet‑rich plasma, as well as several specific product/formulation‑indication combinations and a range of non‑knee joint or disorder indications (see policy for the full list).

    Curative explicitly lists numerous clinical scenarios as investigational for viscosupplementation, including use after ACL reconstruction or arthroscopic knee surgery, treatment of chondromalacia patellae, facet joint arthropathy, hemophilic arthropathy, patellofemoral syndrome, various peripheral nerve or plantar entrapment syndromes, psoriatic arthritis, and other conditions where benefit has not been established.

    For medically necessary indications, Curative designates certain higher‑cost viscosupplement brands as non‑preferred when lower‑cost alternatives are available that are at least as likely to produce equivalent results. Specifically, Gel‑One, Gelsyn‑3, GenVisc 850, Hyalgan, Hymovis, Synojoynt, Synvisc, Synvisc One, Triluron, and Trivisc are identified as more costly and lack reliable evidence of superiority compared with the lower‑cost products Durolane, Supartz FX, and Visco‑3. Use of these non‑preferred products for medically necessary indications is considered not medically necessary when a lower‑cost alternative producing equivalent therapeutic results is available.

    Coding and Product List

    Preferred viscosupplement productsmixed
    DurolanePreferred viscosupplement product
    Supartz FXPreferred viscosupplement product
    Visco-3Preferred viscosupplement product
    Non-preferred viscosupplement productsmixed
    Gel-OneNon-preferred viscosupplement product
    Gelsyn-3Non-preferred viscosupplement product
    GenVisc 850Non-preferred viscosupplement product
    HyalganNon-preferred viscosupplement product
    HymovisNon-preferred viscosupplement product
    SynojoyntNon-preferred viscosupplement product
    SynviscNon-preferred viscosupplement product
    Synvisc OneNon-preferred viscosupplement product
    TriluronNon-preferred viscosupplement product
    TriviscNon-preferred viscosupplement product
    Interval between completed series — continuation threshold
    Minimum intervalAt least 6 months must have elapsed since the last injection in the prior completed series
    Applies toContinuation of viscosupplementation therapy for knee osteoarthritis when initial criteria are met
    Requirement linkageMember must have experienced improvement in pain and functional capacity following the previous injections

    Provider Actions and Administrative Requirements

    Prior Authorization

    Prior approval required

    Prior Approval of viscosupplementation products is required for all Curative participating providers and members in applicable plan designs.

    Step Therapy

    Step therapy — failed conservative treatments required

    Members must have experienced inadequate response, intolerance, or contraindication to non‑pharmacologic treatments and to analgesics, and must also have inadequate response/intolerance/contraindication to intra‑articular steroid injections for the specified durations before initial approval.

    • Inadequate response or adverse effects with non‑pharmacologic options (e.g., physical therapy, exercise, insoles, knee bracing, weight reduction).
    • Inadequate response/intolerance/contraindication to an analgesic trial (e.g., acetaminophen up to 3–4 g/day, NSAIDs, topical capsaicin) for at least 3 months.
    • Inadequate response/intolerance/contraindication to intra‑articular steroid injections for at least 3 months.

    Background

    Viscosupplementation refers to intra‑articular injection of hyaluronate preparations as a treatment option for knee osteoarthritis. Curative recognizes these hyaluronate products as therapeutic options when coverage criteria are met and names Durolane, Supartz FX, and Visco‑3 as the preferred products based on cost‑effectiveness. The policy requires clinical and radiographic evidence of knee osteoarthritis and documentation of failed conservative therapies prior to approval, and it outlines specific clinical signs and symptoms that may support the diagnosis (for example, crepitus, limited morning stiffness duration, or radiographic findings such as joint space narrowing and osteophytes).

    Definitions

    Radiographic evidence of osteoarthritis of the knee — key findings
    DefinitionRadiographic evidence of knee osteoarthritis includes findings such as joint space narrowing, subchondral sclerosis, osteophytes, and subchondral cysts
    Alternative clinical supportDiagnosis may instead be supported by at least five specified signs/symptoms (e.g., bony enlargement, bony tenderness, crepitus, ESR < 40 mm/hr, <30 minutes morning stiffness)
    Synovial fluid criteriaSynovial fluid consistent with OA: clear fluid of normal viscosity and WBC < 2000/mm3
    Associated functional criterionMember has knee pain that interferes with functional activities (e.g., ambulation, prolonged standing)
    Policy Summary
    Payermediviewcurative
    PolicyViscosupplementation for knee osteoarthritis (coverage criteria)
    Policy CodePolicy MM-PNP-022
    Change TypeNo material change
    Effective DateDec 1, 2023
    Next Review Date
    Key ActionObtain prior approval for viscosupplementation products for participating providers and members where required.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Product ListProvider Actions and Administrative RequirementsBackgroundDefinitions
    Documentation Required

    Clinical support and prior treatment documentation required

    Documentation submitted with the request must support the diagnosis with either radiographic evidence of knee osteoarthritis or at least five of the specified clinical signs/symptoms, and must document prior nonpharmacologic and pharmacologic treatment attempts as described in the initial approval criteria.

    • Radiographic evidence examples: joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts.
    • Clinical signs/symptoms list (examples include bony enlargement, bony tenderness, crepitus, ESR < 40 mm/hr, < 30 minutes morning stiffness, no palpable warmth, age > 50, rheumatoid factor < 1:40, synovial fluid clear with WBC < 2000/mm3).
    Denial Risk

    Lack of prior approval may result in denial

    Services provided without prior approval may be denied.