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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsSelectHealth viscosupplementation Coverage Update …
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    CurrentSelectHealthPolicy N/A

    SelectHealth coverage policies for compounded medications; diagnostic testing for CFS; estradiol pellets; IV antibiotics for Lyme disease; viscosupplementation

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    Contains SelectHealth coverage criteria, exclusions, plan-specific guidance (Commercial, Medicare/CMS, Community Care/Medicaid), coding references, and clinical rationale for compounded medications, CFS diagnostic testing, estradiol pellets, IV antibiotics for Lyme disease, and viscosupplementation.

    Policy Summary
    PayerSelectHealth
    PolicyCompounded medications; CFS diagnostic testing; Estradiol pellets; IV antibiotics for Lyme disease; Viscosupplementation
    Policy CodePolicy N/A
    Change TypeMultiple (additions, removals, product list updates)
    Effective Date
    Last ReviewFeb 13, 2025
    Next Review Date
    Key ActionWhen a compound parallels a commercial product, obtain and document prescriber justification supporting medical necessity.
    SourceLink
    POLICY UPDATE CHANGES

    For Policy #288 (CFS), four diagnostic tests were added to the list of exclusions: RNAse L enzymatic activity assay or RNase L protein quantification; Gene expression profiling; Evaluation of mitochondrial disorders; Evaluation of enteric dysbiosis.

    10/12/23 - For Commercial Plan removed previous criterion #5, which required only certain providers administer this treatment.

    2/8/24 - For Commercial Plan added new coverage criteria #5: Failure of one preferred viscosupplement: Synvisc, Synvisc-One, or Euflexxa; preferred agents do not require prior authorization when administered preferred.

    2/4/25 - For Commercial Plan added SynoJoynt as an eligible viscosupplementation treatment option when criteria are met.

    4
    Policies contained in this part
    Up to 4 weeksAllowed IV antibiotic duration when criteria met
    >4 weeksRepeat/prolonged IV antibiotic courses
    3Preferred viscosupplements without PA
    6Reauthorization interval for repeat viscosupplementation (months)

    Coverage Summary (policies contained)

    This document contains four SelectHealth coverage policies: Compounded medications (Policy #325), Diagnostic testing for Chronic Fatigue Syndrome (CFS) (Policy #288), Estradiol pellets for estrogen replacement (Policy #256), and IV antibiotic therapy for Lyme disease (Policy #576).

    Coverage stance across these policies is mixed: each policy defines specific medically necessary criteria and explicit investigational/not-covered exclusions. High-level rules include: IV antibiotic therapy for Lyme disease is covered in limited indications for up to 4 weeks when criteria are met; compounded BHRT is not covered as a labeled category (coverage determined by submitted drug NDC and standard compounded medication rules); viscosupplementation policy designates preferred agents (Synvisc, Synvisc-One, Euflexxa) and notes those agents do not require prior authorization when administered for knee OA; and compounded medications must include at least one legend drug in therapeutic amounts with literature support.

    Quick counts/statistics from the policy part: 4 policies in this section; Up to 4 weeks allowed IV antibiotic duration when criteria are met; 3 preferred viscosupplements without prior authorization; and viscosupplement repeat reauthorization interval is 6 months.

    Key thresholds / facts
    Allowed IV antibiotic durationUp to 4 weeks
    Preferred viscosupplements without PA3 (Synvisc, Synvisc-One, Euflexxa)
    Reauthorization interval for viscosupplementationEvery 6 months
    Viscosupplementation age range40-65 years
    CFS diagnostic symptom duration threshold>= 6 months
    PCR consideration for Lyme diseaseConsider if neurologic symptoms < 14 days

    Medical-Necessity Criteria (grouped by policy area)

    Compounded Medications - Commercial Plan Policy (Medically necessary criteria)

    Compounded Medications — Commercial Plan & CHIP: A compounded prescription is considered medically necessary when ALL of the following are met:

    ALL of the following

    • The active ingredient(s) in the compounded product contains at least one federal legend medication component (a prescription drug).
    • The legend medication is FDA-approved for medical use in the United States.
    • The active medication component is present in therapeutic amounts, supported by scientific literature or national compendia.
    • The safety and effectiveness for the compounded medication and its route of administration (including the delivery system) is supported by scientific literature or national compendia.

    Coding (grouped by code_groups and coverage status)

    Compounded drug HCPCSHCPCSCovered
    J7999Compounded drug, not otherwise classified
    CPT codes referenced for CFS diagnostic testing (covered tests)CPTCovered
    70551MRI brain without contrast
    70552MRI brain with contrast
    70553MRI brain without and with contrast
    80048Basic metabolic panel
    80050General health panel
    80051Electrolytes panel
    81000Urinalysis with microscopy (non-automated)
    81001Urinalysis automated with microscopy
    81002Urinalysis without microscopy (non-automated)
    81003Urinalysis automated without microscopy
    1–10 of 41
    1/5
    CPT codes referenced for estradiol pellet proceduresCPTNot Covered
    11980Subcutaneous hormone pellet implantation
    11982Removal, non-biodegradable delivery implant
    11983Removal with reinsertion, non-biodegradable drug delivery implant
    IV infusion/professional administration CPT codesCPT
    96365Intravenous infusion; for therapy, prophylaxis, or diagnosis (specify substance or hour)
    96366Each additional hour (List separately in addition to code for primary procedure)
    96367Additional sequential infusion of a new drug/substance, up to 1 hour (List separately in addition to code for primary procedure)
    96368Concurrent infusion (List separately in addition to code for primary procedure)
    96372Therapeutic, prophylactic or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
    IV antibiotic and related HCPCS/J-codes (listed/informational)HCPCS
    J0456Azithromycin injection, 500 mg
    J0696Injection; ceftriaxone sodium, per 250 mg
    J0698Injection; cefotaxime sodium, per gm
    J2540Penicillin G potassium, up to 600,000 units (IV)
    S9494Home infusion therapy, antibiotic... per diem
    S9497Home infusion therapy, once every 3 hours; per diem
    S9500Home infusion once every 24 hours
    S9501Home infusion once every 12 hours
    S9502Home infusion once every 8 hours
    S9503Home infusion once every 6 hours
    1–10 of 22
    1/3
    CPT codes (arthrocentesis)CPT
    20610Arthrocentesis, aspiration and/or injection, major joint or bursa; without ultrasound guidance
    20611Arthrocentesis, aspiration and/or injection, major joint or bursa; with ultrasound guidance, with permanent recording and reporting
    HCPCS / J-codes (viscosupplementation products)HCPCS
    J3490Unclassified drug
    J7318Hyaluronan or derivative, Durolane, for intra-articular injection, mg
    J7320Hyaluronan or derivative, GenVisc 850, for intra-articular injection, mg
    J7321Hyaluronan or derivative, Hymovis, for intra-articular injection, mg
    J7322Hyaluronan or derivative, (unnamed in text) for intra-articular injection, mg
    J7323Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose
    J7324Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose
    J7325Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular injection, mg
    J7326Hyaluronan or derivative, gel-one, for intra-articular injection, per dose
    J7327Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose
    1–10 of 14
    1/2

    Provider Actions (authorization, documentation, billing/denial risks)

    Documentation Required

    Prescriber clinical justification for compounds similar to commercial products

    If a compound is similar to a commercially available product but differs, clinical documentation from the prescriber supporting the clinical need for the compound is required.

    Prior Authorization

    Compounded BHRT reimbursement determined by NDC

    Compounded 'bio-identical' hormone replacement therapy (BHRT) reimbursement and coverage are determined by the drug NDC code submitted; benefits follow standard coverage for compounded medications.

    Documentation Required

    CFS diagnostic evaluation

    Background & Evidence

    Compounding is defined by the FDA as combining, mixing, or altering ingredients to create a medication tailored to an individual patient's needs; to be covered a compounded prescription must contain at least one federal legend drug and the active medication component must be in therapeutic amounts with safety and effectiveness supported by scientific literature or national compendia.

    The CFS diagnostic policy aligns with the 2015 IOM (IOM) diagnostic criteria and NIH consensus recommendations: exclusionary screening laboratory and imaging tests (e.g., ANA, CBC, chemistries, thyroid tests, Lyme serology, MRI when indicated, polysomnography) are covered, while many specialized/investigational tests (eg, gene expression profiling, evaluation of mitochondrial disorders, enteric dysbiosis, RNase L assays) are not covered.

    Estradiol pellet implantation is not covered: there are no FDA-approved commercially available implantable estradiol pellet formulations in the US, published data show unpredictable and fluctuating serum concentrations and concerns about release rates, reversibility, bleeding, infection, and limited safety evidence.

    IV antibiotic therapy for Lyme disease is appropriate only in limited, specific circumstances (for example Lyme arthritis after oral antibiotic failure, cardiac conduction disease with PR prolongation, or objective neurologic complications) and evidence does not support prolonged or repeat IV courses; prolonged or repeat courses (>4 weeks) are considered not medically necessary based on RCTs and guideline statements.

    EvidenceSummary
    CFS diagnostic guideline referenced
    IOM 2015 diagnostic criteria for ME/CFS (requires specific symptom set and >=6 months duration); policy cites IOM 2015 as the diagnostic standard
    Lyme disease antibiotic evidence
    Randomized controlled trials and reviews show no sustained benefit for prolonged (>4 weeks) or repeat courses of antibiotics; multiple RCTs (Klempner 2001, Krupp 2003, Fallon 2008) found little sustained benefit and notable adverse events
    Professional guidelines consensus
    IDSA, AAN, EFNS and other professional societies recommend limited use of IV antibiotics for specific neurologic/cardiac indications and discourage prolonged or repeated long-term antibiotic courses due to lack of benefit and risk of harm
    Cochrane / meta-analyses on HA
    Systematic reviews and meta-analyses (eg, Bellamy/Cochrane, Lo et al, Wang et al, Medina et al) conclude hyaluronan (HA) injections provide a modest, short-term benefit versus placebo with heterogeneity across products limiting definitive conclusions
    Product-specific duration
    Pivotal trials/package-insert data: Supartz/Hyalgan (5 injections), Orthovisc (4 injections), Synvisc (3 injections) shown to provide pain relief up to ~6 months in responders; Euflexxa trials report relief up to ~3 months

    Federal legend drug: A medication product that by Federal law bears the statement "Caution Federal (U.S.A.) law prohibits dispensing without a prescription" or words of similar meaning.

    Bio-identical hormone replacement therapy (BHRT): Term commonly used for compounded hormones; the policy states this is not a defined medical term and that safety/efficacy for compounded BHRT is not documented in clinical studies—coverage for BHRT is determined by the drug NDC submitted.

    Revision History

    2023-02-21material addition

    For Policy #288 (CFS) added four diagnostic tests to the list of investigational/excluded tests: RNAse L enzymatic activity assay or RNase L protein quantification; gene expression profiling; evaluation of mitochondrial disorders; and evaluation of enteric dysbiosis.

    2023-10-12material revision

    Commercial Plan policy removal of prior provider-type restriction: previous criterion #5 requiring only certain providers to administer viscosupplementation was removed.

    2024-02-08material addition
    Policy Summary
    PayerSelectHealth
    PolicyCompounded medications; CFS diagnostic testing; Estradiol pellets; IV antibiotics for Lyme disease; Viscosupplementation
    Policy CodePolicy N/A
    Change TypeMultiple (additions, removals, product list updates)
    Effective Date
    Last ReviewFeb 13, 2025
    Next Review Date
    Key ActionWhen a compound parallels a commercial product, obtain and document prescriber justification supporting medical necessity.
    SourceLink
    On This Page
    Coverage Summary (policies contained)Medical-Necessity Criteria (grouped by policy area)Coding (grouped by code_groups and coverage status)Provider Actions (authorization, documentation, billing/denial risks)Background & EvidenceRevision History

    If a compound is similar to a commercially available product

    • Clinical documentation from the prescriber is provided that supports the specific clinical need for the compounded product (i.e., why the commercially available product is not appropriate).
  1. Exclusions / Not covered

    • Compounded 'bio-identical' hormone replacement therapy (BHRT) is not covered as a distinct clinical category; coverage will be determined based on the drug NDC submitted and standard coverage rules for compounded medications; pharmacy benefit limitations and exclusions apply.
  2. Compounded Medications - Medicare (Select Health Medicare / CMS) guidance

    Select Health Medicare (CMS) guidance:

    ALL of the following

    • Coverage is determined by the Centers for Medicare & Medicaid Services (CMS) when a CMS determination exists.
    • If a CMS coverage determination has not been adopted and InterQual criteria are not available, the Select Health Commercial policy applies as a fallback.
    • For the most up-to-date Medicare policies and coverage, refer to the CMS coverage database and applicable Medicare manuals.

    Compounded Medications - Community Care (Medicaid) guidance

    Select Health Community Care (Medicaid) guidance:

    ALL of the following

    • Select Health Community Care policies typically align with the State of Utah Medicaid policy, including use of InterQual when applicable.
    • In situations where NCD/LCD criteria exist or InterQual is used, those criteria take precedence; otherwise, Select Health commercial policy may be applied.
    • Drug compounding may be covered when clinically necessary (e.g., commercially unavailable strength or formulation, allergies to excipients, inability to swallow standard dosage forms), but compounding for convenience is not considered medically necessary.

    Diagnostic Testing for Chronic Fatigue Syndrome (CFS) - Covered diagnostic tests (Commercial Plan Policy & CHIP)

    Covered diagnostic tests for Chronic Fatigue Syndrome (CFS) — Commercial Plan Policy & CHIP: The following tests are covered when clinically indicated as part of the diagnostic evaluation:

    ALL of the following

    • Complete blood count (CBC) with differential.
    • Comprehensive metabolic panel (CMP).
    • Thyroid function tests (TSH, free T4 as indicated).
    • Inflammatory markers as clinically indicated (e.g., ESR, CRP).
    • Testing for other conditions to exclude alternative diagnoses as clinically indicated (e.g., sleep disorders, psychiatric evaluation, infectious disease testing based on history).

    Diagnostic Testing for Chronic Fatigue Syndrome (CFS) - Not covered / Investigational tests

    Not covered / Investigational tests for CFS: The following are considered investigational or not covered for routine diagnosis of CFS:

    ANY of the following

    • Unvalidated specialty tests marketed specifically for CFS/ME (e.g., proprietary panels without accepted clinical validation).
    • Routine use of broad antibody/biomarker panels lacking evidence of diagnostic validity for CFS.
    • Other laboratory or commercial tests identified in policy as investigational for CFS diagnosis.

    Diagnostic Testing for CFS - Medicare / Community Care guidance

    Medicare / Community Care guidance for CFS diagnostic testing:

    ALL of the following

    • Follow CMS coverage determinations where applicable.
    • Select Health Community Care aligns with Utah Medicaid and may use InterQual; if local Medicaid or CMS criteria apply, those take precedence over commercial policy.

    Estradiol Pellets for Estrogen Replacement - Commercial Plan Policy

    Estradiol pellets for estrogen replacement — Commercial Plan Policy:

    ANY of the following

    • Estradiol pellets for estrogen replacement are not covered (commercial plan policy — not a covered benefit).

    Estradiol Pellets - CMS/Community Care guidance

    Estradiol pellets — Medicare / Community Care guidance:

    ALL of the following

    • Follow CMS and state Medicaid guidance where applicable; if no CMS/Medicaid-specific coverage exists, Select Health commercial policy applies as a fallback.

    IV Antibiotic Therapy for Lyme Disease - Commercial Plan Policy

    IV antibiotic therapy for Lyme disease — Commercial Plan Policy (summary):

    ALL of the following

    • IV antibiotics may be covered for appropriate, documented manifestations of Lyme disease when medically necessary and supported by specialty evaluation.
    • Prolonged or repeated courses of parenteral antibiotics for chronic, non-specific, or subjective Lyme-related symptoms are considered not medically necessary.
    • PCR testing branch

      • Polymerase chain reaction (PCR) testing may be used when clinically indicated for objective evidence of infection in specific presentations (e.g., synovial fluid for Lyme arthritis).
    • Other diagnostic tests

      • Other diagnostic studies should be performed as clinically appropriate to confirm objective disease manifestations before prolonged IV therapy is considered.

    IV antibiotic therapy for Lyme disease - Medically necessary criteria

    Medically necessary criteria — IV antibiotic therapy for Lyme disease: Up to 4 weeks of IV antibiotics may be considered medically necessary when ALL of the following are met and the diagnosis is established by a board-certified infectious disease specialist:

    ALL of the following

    • A formal consultation and documented diagnosis by a board-certified infectious disease (ID) specialist with documentation of assessment and treatment plan.
    • Objective clinical manifestations (ONE of)

      • Lyme arthritis confirmed by synovial fluid analysis and appropriate testing for Borrelia burgdorferi.
      • Lyme carditis with objective cardiac conduction abnormalities attributable to Borrelia burgdorferi.
      • Discrete neurologic Lyme disease manifestations (e.g., confirmed meningitis, radiculoneuritis) with laboratory or CSF support as appropriate.
    • Supportive diagnostic testing consistent with presentation (e.g., serology, PCR from appropriate tissue/fluids) confirming active Borrelia burgdorferi infection when indicated.
    • Clinical documentation of prior appropriate oral antibiotic therapy when standard guidelines recommend oral therapy first, unless contraindicated or not feasible.
    • Antibiotic agent selection is consistent with accepted infectious disease practice; parenteral agents used include (but are not limited to) ceftriaxone, penicillin G, cefotaxime, or other recommended IV agents based on susceptibility and clinical scenario.
    • Duration generally limited to up to 4 weeks for the specified objective indications; longer or repeated courses require clear, objective documentation and specialist justification.

    IV antibiotic therapy for Lyme disease - Not medically necessary / Investigational exclusions

    Not medically necessary / Investigational exclusions for IV antibiotic therapy in Lyme disease:

    ALL of the following

    • Excluded agents and therapies

      • Prolonged IV antibiotic regimens beyond established guideline-recommended durations without objective evidence of active infection.
      • Use of parenteral agents not supported by infectious disease guidance for Lyme disease management when used solely for subjective chronic Lyme symptoms.
    • Not covered indications

      • Chronic, non-specific fatigue, diffuse pain, or cognitive complaints attributed to 'chronic Lyme' without objective infectious disease evidence — IV antibiotics are not covered for these indications.
    • Other investigational tests/uses

      • Unvalidated laboratory tests or testing panels for Lyme disease with insufficient clinical validation are considered investigational and not covered.

    Viscosupplementation of the knee - Medically necessary criteria

    Viscosupplementation of the knee — Medically necessary criteria: Coverage is provided when ALL of the following are met: (reauthorization may be considered every 6 months when criteria continue to be met)

    ALL of the following

    • Patient is 18 years of age or older.
    • Radiographic confirmation of symptomatic osteoarthritis of the knee consistent with clinical findings (e.g., x-ray evidence).
    • Functional impairment attributable to knee osteoarthritis (affecting activities of daily living or ambulation).
    • Documentation of failed conservative therapies (ALL of)

      • At least one trial of optimized oral analgesics or anti-inflammatory therapy (unless contraindicated).
      • At least one trial of physical therapy or structured exercise program appropriate for knee osteoarthritis (unless contraindicated).
      • At least one trial of assistive measures or activity modification (e.g., weight loss if applicable, bracing, assistive devices) unless contraindicated.
      • Failure of one preferred viscosupplement agent (per policy update effective 02/08/2024) prior to use of alternative agents, unless contraindicated or not tolerated.
    • The specific viscosupplement product is FDA-approved for intra-articular knee use.
    • Reauthorization: clinical reassessment and documentation required every 6 months to continue coverage; duration/number of courses per benefit may vary by plan.

    Viscosupplementation - Not covered

    Viscosupplementation — Not covered:

    ANY of the following

    • Viscosupplementation for non-knee joints (e.g., hip, shoulder, ankle) is not covered.

    Commercial Plan coverage criteria (revisions noted)

    Commercial Plan coverage criteria — revisions summary and operational notes:

    ALL of the following

    • NOTES on recent revisions

      • Provider-type restriction language removed from policy (operational change).
      • Policy now requires failure of one preferred viscosupplement agent (effective 02/08/2024) prior to use of alternative viscosupplement products, unless contraindicated or not tolerated.
    • ONE of (documentation required)

      • Clinical documentation demonstrating failure of conservative therapies and prior preferred agent trial as specified in the viscosupplementation medically necessary criteria.
    • Ensure supporting documentation (radiographs, therapy notes, medication trials, specialist notes) is included at time of prior authorization or claim review to demonstrate criteria have been met.
    • Operational reminder: follow plan benefit limits and prior authorization processes; coding: HCPCS J7999 may be used for compounded drugs where applicable — check member benefits for coverage.

    Perform a thorough history and physical examination and order only the covered exclusionary diagnostic tests as clinically indicated. Avoid ordering investigational tests listed as not covered.

    • Order only covered exclusionary tests (e.g., ANA, CBC, ESR, CRP, thyroid tests, Lyme serology, MRI head, polysomnography) as indicated.
    • Do not order investigational tests (e.g., gene expression profiling, evaluation of mitochondrial disorders, enteric dysbiosis, RNAse L assays).
    Prior Authorization

    IV antibiotics for Lyme disease - limited coverage

    IV antibiotics for Lyme disease are covered only in limited circumstances (e.g., Lyme arthritis after failed oral therapy, cardiac involvement with prolonged PR interval, or objective neurologic complications) and when criteria are met; when covered, IV antibiotic courses are limited to up to 4 weeks.

    • Coverage limited to specific indications such as persistent arthritis after 1-month oral trial, myocarditis with high-degree AV block or PR ≥ 300 ms, or neurologic disease as specified.
    • Maximum covered IV duration when criteria met: up to 4 weeks.
    Billing Rule

    Use of CMS/Medicaid guidance

    Follow CMS determinations when Medicare coverage applies. For Community Care (Medicaid), align with state Medicaid policy and InterQual where applicable.

    Prior Authorization

    IV antibiotics - Specialist diagnosis requirement

    A diagnosis for IV antibiotic therapy must be established by a board-certified infectious disease specialist and be laboratory-confirmed for medically necessary IV therapy (up to 4 weeks).

    Documentation Required

    Document prior treatment failures for Lyme disease

    Document prior treatment failures when requesting IV antibiotics: include a trial of oral antibiotics (typically 1 month for arthritis), objective CSF findings for neurologic indications, and the PR interval for cardiac cases.

    • Document 1-month trial of oral antibiotics for Lyme arthritis before IV therapy.
    • For neurologic indications, document objective CSF findings when required.
    • For cardiac indications, document PR interval when first-degree block is claimed (PR ≥ 300 ms criterion).
    Denial Risk

    Not covered uses of IV antibiotics

    Claims for IV antibiotics using listed agents considered investigational or for investigational indications will be denied as not medically necessary; avoid billing for excluded agents and noncovered uses.

    • Excluded IV agents include first-generation cephalosporins (e.g., cefazolin), carbapenems (doripenem, ertapenem, imipenem, meropenem), fluconazole, and fluoroquinolones (levofloxacin, moxifloxacin).
    • Do not bill IV antibiotics for investigational indications such as prophylaxis after tick bite without symptoms, treatment of chronic fatigue/fibromyalgia attributed to Lyme, repeat/prolonged courses >4 weeks, or initial treatment of Lyme arthritis without neurologic symptoms.
    Prior Authorization

    Viscosupplementation reauthorization & documentation

    Subsequent viscosupplementation injections require reauthorization every 6 months and must include chart notes documenting the patient's response to the previous treatment.

    • Reauthorization interval: every 6 months.
    • Attach chart notes documenting objective response (pain reduction/function improvement) to prior injection course.
    Billing Rule

    Preferred viscosupplements without prior authorization

    Synvisc, Synvisc-One, and Euflexxa are listed as preferred viscosupplements and do not require prior authorization when administered for osteoarthritis of the knee.

    Denial Risk

    Viscosupplementation not covered for non-knee joints

    Viscosupplementation is not covered for any joint other than the knee (for example TMJ, shoulder, hip, ankle); billing for non-knee joints will be considered investigational/not covered.

    Documentation Required

    Document prior conservative therapy and response

    Document failure of conservative therapies and the patient's response when requesting viscosupplementation or repeat treatment; include details of prior conservative measures and objective treatment response.

    • Document trials of weight reduction, activity modification/physical therapy, OTC analgesics, a ≥1-month NSAID trial within past 3 months, and at least one intra-articular steroid trial within past 6 months.
    • Document pain reduction and functional improvement after initial viscosupplementation when seeking repeat injections.
    Prior Authorization

    Commercial Plan prior authorization implications for preferred agents

    Per the 2/8/24 revision, failure of one preferred viscosupplement (Synvisc, Synvisc-One, or Euflexxa) was added as a coverage criterion; preferred agents (examples J7323, J7325) do not require prior authorization when administered for knee osteoarthritis.

    • Examples of J-codes: J7323 (Euflexxa), J7325 (Synvisc/Synvisc-One).
    Denial Risk

    Risk of adverse event with repeat Synvisc

    Repeat courses of cross-linked high‑molecular-weight Synvisc may be associated with increased local inflammatory reactions; document rationale and informed discussion of risk when requesting repeat Synvisc courses.

    • Be aware of increased frequency of acute local reaction with more than one course of Synvisc; document risk discussion and clinical justification for repeats.
    Billing Rule

    Use appropriate HCPCS/J-code per product

    Report the specific HCPCS/J-code corresponding to the hyaluronan product administered; if the product does not have a specific J-code, report J3490 (unclassified drug) as appropriate.

    • Use product-specific J-codes (e.g., J7323, J7325, J7331) when available.
    • Use J3490 for unclassified or otherwise unspecified viscosupplementation products.

    Post-Lyme syndrome (PLS) / Post-Lyme disease syndrome (PLDS): Persistent subjective symptoms lasting > 6 months after receiving recommended treatment regimens for documented Lyme disease.

    Viscosupplementation: Intra-articular injection of sodium hyaluronate (hyaluronan or derivatives) intended to restore synovial fluid viscoelasticity for osteoarthritis of the knee; policy notes product-specific courses and typical durations of effect up to 2–6 months depending on product.

    Commercial Plan added new coverage criterion for viscosupplementation requiring failure of one preferred viscosupplement (Synvisc, Synvisc-One, or Euflexxa); noted that these preferred agents do not require prior authorization when administered.

    2025-02-04material additionLatest

    Commercial Plan added SYNOJOYNT (HCPCS/J-code J7331) to the list of eligible viscosupplementation treatment options when criteria are met.