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    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAmerihealth Caritas Zilretta Policy Update | OpenP…
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    ModifiedAmerihealth Caritas VIP CarePolicy MA08.097a

    Triamcinolone Acetonide Extended-Release Injectable (Zilretta)

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    This policy governs Medicare Advantage coverage and medical necessity requirements for intra-articular triamcinolone acetonide extended-release injectable (Zilretta) for adults with knee osteoarthritis. Coverage is subject to the member’s Evidence of Coverage and policy criteria; other uses, including repeat administration into the same knee, are generally experimental/investigational unless supported under the Company’s off-label coverage policy.

    Policy Summary
    PayerAmerihealth Caritas VIP Care
    PolicyTriamcinolone Acetonide Extended-Release Injectable (Zilretta)
    Policy CodePolicy MA08.097a
    Change TypeModified
    Effective DateMay 7, 2024
    Last ReviewSep 18, 2026
    Next Review DateN/A
    Key ActionDocument the individual’s age, knee osteoarthritis diagnosis, prior-treatment history, required therapy trials, treatment response, and planned dose.
    SourceLink
    POLICY UPDATE CHANGES

    The policy was reviewed and reissued to communicate the company’s continuing position on triamcinolone acetonide extended-release injectable (Zilretta).

    The policy history records addition of HCPCS code J3304 for preservative-free extended-release triamcinolone acetonide microsphere formulation, 1 mg.

    The policy history records removal of HCPCS code Q9993 for preservative-free extended-release triamcinolone acetonide microsphere formulation, 1 mg.

    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.

    18+ yearsMinimum age for covered therapy
    32 mgMaximum single knee injection dose
    11Listed knee osteoarthritis diagnosis codes
    Single injectionCovered treatment pattern
    1 addedHistorical HCPCS code added
    1 removedHistorical HCPCS code removed

    Coverage Criteria

    Medically necessary initial therapy

    Covered when ALL of the following are met:

    Initial Zilretta therapy requirements

    • Eligibility and diagnosis

      • The individual is 18 years of age or older and has a documented diagnosis of osteoarthritis of the knee.Age >= 18 years

    • No prior Zilretta treatment

      • The individual has not previously been treated with triamcinolone acetonide extended-release injectable (Zilretta).No previous Zilretta treatment

    • Conservative non-pharmacologic therapy

      • The individual has a documented inadequate response to conservative non-pharmacologic therapy, such as weight loss, strengthening, and range-of-motion exercises.Documented inadequate response

    • NSAID or tramadol therapy

      • The individual has a documented failure of, contraindication to, or inadequate response to at least a two-week trial of oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) or tramadol.Trial of at least 2 weeks

    • Prior intra-articular steroid injection

      • The individual has a documented inadequate response to previous treatment with an intra-articular steroid injection, including triamcinolone, methylprednisolone, betamethasone, or dexamethasone.Documented inadequate response

    • Dose

      • The dose does not exceed 32 mg as a single intra-articular injection to the knee.<= 32 mg per single knee injection

    All other uses of triamcinolone acetonide extended-release injectable (Zilretta), including repeat administration into the same knee, are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company's medical policy for off-label coverage of prescription drugs and biologics.

    Coding and Billing Information

    CPT Procedure Code Number(s)CPT
    N/AN/A
    ICD-10 Procedure Code Number(s)ICD-10
    N/AN/A
    ICD-10 Diagnosis Code Number(s)ICD-10Covered
    M17.0Bilateral primary osteoarthritis of knee
    M17.10Unilateral primary osteoarthritis, unspecified knee
    M17.11Unilateral primary osteoarthritis, right knee
    M17.12Unilateral primary osteoarthritis, left knee
    M17.2Bilateral post-traumatic osteoarthritis of knee
    M17.30Unilateral post-traumatic osteoarthritis, unspecified knee
    M17.31Unilateral post-traumatic osteoarthritis, right knee
    M17.32Unilateral post-traumatic osteoarthritis, left knee
    M17.4Other bilateral secondary osteoarthritis of knee
    M17.5Other unilateral secondary osteoarthritis of knee
    1–10 of 11
    1/2
    HCPCS Level II Code Number(s)HCPCSCovered
    J3304Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg
    Revenue Code Number(s)Revenue
    N/AN/A
    Historical HCPCS code addedHCPCS
    J3304Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg
    Historical HCPCS code removedHCPCSNot Covered
    Q9993Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg
    Age Requirement
    Minimum age18 years or older
    Prior NSAID or Tramadol Therapy
    Required trial durationAt least a two-week trial of oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) or tramadol
    Zilretta Dose Limit
    Maximum single doseDoes not exceed 32 mg as a single intra-articular injection to the knee

    Provider Documentation and Denial Risks

    Documentation Required

    Maintain Medical Necessity Records

    Maintain records demonstrating the medical necessity of the care provided. Records may include documentation from the professional provider’s office, hospital, nursing home, home health agency, therapy providers, and relevant test reports.

    • Make supporting medical records available to the Company upon request, including records from other treating providers and facilities when applicable.
    Documentation Required

    Document Required Clinical Criteria

    Document every required clinical criterion for triamcinolone acetonide extended-release injectable (Zilretta) coverage before administering the drug.

    • Individual is 18 years of age or older.
    • Documented diagnosis of osteoarthritis of the knee.
    • No prior treatment with triamcinolone acetonide ER injectable (Zilretta).
    • Documented inadequate response to conservative non-pharmacologic therapy, such as weight loss, strengthening, and range-of-motion exercises.

    Clinical Background

    Osteoarthritis involves cartilage degradation and bony hypertrophy and commonly causes knee pain, stiffness, reduced range of motion, and impaired mobility or activities of daily living. Zilretta is a microsphere formulation of triamcinolone acetonide administered by intra-articular injection for knee osteoarthritis and provides extended corticosteroid release in the synovium.

    Policy Definitions

    Product Definition
    ProductTriamcinolone acetonide extended-release injectable (Zilretta)
    FormulationMicrosphere corticosteroid formulation
    AdministrationIntra-articular injection
    IndicationManagement of osteoarthritis of the knee
    Experimental/Investigational Use
    DefinitionAll uses other than the covered indication for triamcinolone acetonide ER injectable (Zilretta), including repeat administration into the same knee, are considered experimental/investigational.
    Coverage status

    Initial Zilretta Therapy

    Initial Zilretta therapy

    Initial therapy is covered when all listed medical necessity criteria are met.

    Initial Zilretta therapy requirements

    • The individual is 18 years of age or older and has a documented diagnosis of osteoarthritis of the knee.Age >= 18 years
    • The individual has not previously been treated with triamcinolone acetonide extended-release injectable (Zilretta).No previous Zilretta treatment
    • The individual has a documented inadequate response to conservative non-pharmacologic therapy, such as weight loss, strengthening, and range-of-motion exercises.Documented inadequate response

    Required Prior Treatment

    StepRequired prior therapyCoverage requirement
    1Oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) or tramadolDocumented failure of, contraindication to, or inadequate response to a trial lasting at least 2 weeks before Zilretta
    StepRequired prior therapyCoverage requirement
    2Prior intra-articular steroid injection with triamcinolone, methylprednisolone, betamethasone, or dexamethasoneDocumented inadequate response to the prior injection

    Dose and Quantity Limits

    Quantity Limit
    ProductTriamcinolone acetonide ER injectable (Zilretta)
    Maximum quantity32 mg
    Administration limitPer single intra-articular injection to the knee
    Policy Summary
    PayerAmerihealth Caritas VIP Care
    PolicyTriamcinolone Acetonide Extended-Release Injectable (Zilretta)
    Policy CodePolicy MA08.097a
    Change TypeModified
    Effective DateMay 7, 2024
    Last ReviewSep 18, 2026
    Next Review DateN/A
    Key ActionDocument the individual’s age, knee osteoarthritis diagnosis, prior-treatment history, required therapy trials, treatment response, and planned dose.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Billing InformationProvider Documentation and Denial RisksClinical BackgroundPolicy DefinitionsInitial Zilretta TherapyRequired Prior TreatmentDose and Quantity Limits
  1. Documented failure of, contraindication to, or inadequate response to at least a two-week trial of oral or topical NSAIDs or tramadol.
  2. Documented inadequate response to prior intra-articular steroid injection, including triamcinolone, methylprednisolone, betamethasone, or dexamethasone.
  3. Dose does not exceed 32 mg as a single intra-articular injection to the knee.
    4. Denial Risk

    Avoid Unapproved or Repeat Same-Knee Use

    Do not use Zilretta for unapproved indications or repeat administration into the same knee. These uses are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company’s policy on off-label coverage for prescription drugs and biologics.

    • Repeat administration into the same knee is not covered absent qualifying accepted off-label support.
    • Other uses may be denied as experimental/investigational.
    Denial Risk

    Failure to Meet Medical Necessity Criteria

    Coverage requires that all medical-necessity criteria be met. If any required criterion is absent or cannot be substantiated in the medical record, the drug may be denied.

    • Confirm age, knee osteoarthritis diagnosis, treatment history, conservative-therapy response, NSAID or tramadol trial, prior intra-articular steroid response, and the 32 mg single-injection dose limit.
    • Do not administer when the individual has previously been treated with Zilretta or when the required documented treatment responses are not met.
    Denial Risk

    Provide Records When Requested

    The Company may review or audit services for members regardless of the provider’s participation status. Failure to produce requested supporting records may result in denial of the drug.

    • Ensure all documentation supporting medical necessity is complete, retained, and available to the Company upon request.
    • Records unavailable for review or not provided when requested create a denial risk.
    Not covered unless the indication is supported as an accepted off-label use under the Company medical policy on off-label coverage for prescription drugs and biologics.
  4. The individual has a documented failure of, contraindication to, or inadequate response to at least a two-week trial of oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) or tramadol.Trial of at least 2 weeks
  5. The individual has a documented inadequate response to previous treatment with an intra-articular steroid injection, including triamcinolone, methylprednisolone, betamethasone, or dexamethasone.Documented inadequate response
  6. The dose does not exceed 32 mg as a single intra-articular injection to the knee.<= 32 mg per single knee injection