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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsGeorgia DCH injectable testosterone Prior Auth | O…
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    CurrentGeorgia Department of Community HealthPolicy N/A

    Georgia Medicaid Fee-for-Service Androgenic Agents, Injectable PA Summary

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    Defines prior authorization (PA) requirements and coverage criteria for injectable testosterone products (testosterone cypionate, testosterone enanthate, and Xyosted) under Georgia Medicaid outpatient pharmacy; applies to providers submitting PA requests for these agents.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyGeorgia Medicaid Fee-for-Service Androgenic Agents, Injectable PA Summary
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization for all preferred and non-preferred injectable androgenic agents by calling OptumRx at 1-866-525-5827 and include two morning serum testosterone results (separate days) showing < 300 ng/dL.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsLength of authorization
    ≥ 2Confirmatory tests required
    < 300 ng/dLTestosterone threshold
    All agents

    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.

    PA required

    Coverage Criteria for Injectable Testosterone Agents

    Testosterone cypionate or enanthate (generics)

    Covered when ALL of the following are met

    Eligibility and diagnosis: Member is male 12 years of age or older with primary hypogonadism, secondary hypogonadism, or delayed male puberty OR female with metastatic breast cancer.age/gender-specific
    Laboratory confirmation: Serum testosterone < 300 ng/dL confirmed by 2 morning blood levels on separate days.< 300 ng/dL, 2 tests
    Site of administration: Must be administered in the member's home or long-term care facility.

    Xyosted (testosterone enanthate subcutaneous autoinjector)

    Covered when ALL of the following are met

    Eligibility: Male member 18 years of age or older with primary or secondary hypogonadism.age >=18
    Laboratory confirmation: Serum testosterone < 300 ng/dL confirmed by 2 morning blood levels on separate days.< 300 ng/dL, 2 tests
    Prior treatment requirement: Member has tried and failed to achieve testosterone level goal with intramuscular testosterone OR is not a candidate for intramuscular testosterone.

    This functions as a step prior to Xyosted in most cases.

    If an injectable androgenic agent is administered in a physician's office or clinic, it must be billed through the DCH physician services program rather than the outpatient pharmacy program. The outpatient pharmacy prior authorization criteria and PA processes outlined in this policy do not apply to claims billed through the physician services program; providers should reference the physician services billing guidance at www.mmis.georgia.gov.

    Laboratory Thresholds & Confirmatory Testing

    inv-04: Serum testosterone level — threshold for approval
    Serum testosterone threshold< 300 ng/dL
    Applies toMale members (generics: >=12 years; Xyosted: >=18 years)
    Confirmation methodMeasured as morning serum testosterone
    inv-05: Confirmatory tests — number and timing of morning measurements required
    Number of measurements requiredTwo (2) morning blood levels
    Timing of measurementsEach measurement must be taken in the morning
    Separation requirement

    Provider Actions, Authorization & Documentation Requirements

    Prior Authorization

    Prior authorization required for all injectable androgenic agents

    Prior authorization is required for all preferred and non-preferred injectable androgenic agents. To initiate a PA request, contact OptumRx at 1-866-525-5827.

    Step Therapy

    Xyosted requires prior IM testosterone trial or documented non‑candidacy

    For Xyosted, the member must have tried and failed to achieve the testosterone level goal with intramuscular testosterone or be documented as not a candidate for intramuscular testosterone prior to approval.

    Documentation Required

    Provide two morning serum testosterone measurements and diagnosis documentation

    Background

    Hypogonadism is diagnosed when morning serum testosterone is persistently low and, when appropriate, patients receive replacement therapy to restore physiologic testosterone levels. For male hypogonadism and delayed puberty the policy requires objective laboratory confirmation with serum testosterone < 300 ng/dL confirmed by two morning blood levels on separate days before outpatient pharmacy coverage is approved for injectable testosterone products. Replacement therapy is indicated for documented primary or secondary hypogonadism (and for selected female indications such as metastatic breast cancer) when these diagnostic thresholds are met.

    This policy distinguishes product-specific requirements: generic intramuscular testosterone formulations (cypionate or enanthate) are covered when the diagnostic and site-of-care criteria are satisfied, while the subcutaneous autoinjector Xyosted requires the same laboratory confirmation plus evidence of prior failure of, or contraindication to, intramuscular testosterone before approval.

    Key Definitions

    inv-12: Confirmed low serum testosterone definition — < 300 ng/dL confirmed by two morning labs on separate days
    DefinitionSerum testosterone lower than 300 ng/dL confirmed by two laboratory blood levels
    Measurement specificsBoth labs must be conducted in the morning on separate days
    Context of useUsed to confirm low serum testosterone for male hypogonadism/delayed puberty and eligibility for generics

    Initial Therapy Criteria

    Initial therapy - generics

    Initial approval for generics: Male members >=12 years with confirmed low testosterone (<300 ng/dL by 2 morning tests) for primary hypogonadism, secondary hypogonadism, or delayed male puberty; female members with metastatic breast cancer indication are also approvable.

    Initial therapy - Xyosted

    Initial approval for Xyosted: Male members >=18 years with confirmed low testosterone (<300 ng/dL by 2 morning tests) who have tried and failed intramuscular testosterone or who are not candidates for intramuscular testosterone.

    Continuation Criteria & Authorization Duration

    Duration

    Authorization duration

    Authorization length: Approvals are issued for up to 6 months.6 months

    Reauthorization requirements not detailed in this summary.

    Step Therapy Requirements

    StepRequirement
    1Prior trial of intramuscular testosterone (treated and failed to achieve testosterone level goal) OR documented non‑candidacy for intramuscular testosterone is required prior to approval of Xyosted.

    Quantity Limits

    inv-17: See QLL list — refer to current Quantity Level Limits (QLL) list
    Quantity Level Limits (QLL)Refer to the current Quantity Level Limits (QLL) list
    Where to accessOnline at www.mmis.georgia.gov/portal → Pharmacy → Other Documents → select most recent quarter's QLL List
    ApplicabilityApplies to outpatient pharmacy quantity restrictions for injectable androgenic agents

    Site of Care and Billing

    Note

    Home or long-term care administration required for generics

    When covered under the outpatient pharmacy program, injectable generic testosterone (cypionate or enanthate) must be administered in the member's home or a long-term care facility.

    Billing Rule

    Office/clinic administrations billed via DCH physician services

    If the medication is administered in a physician's office or clinic, providers must bill through the DCH physician services program and not the outpatient pharmacy program.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyGeorgia Medicaid Fee-for-Service Androgenic Agents, Injectable PA Summary
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective Date
    Next Review Date
    Key ActionObtain prior authorization for all preferred and non-preferred injectable androgenic agents by calling OptumRx at 1-866-525-5827 and include two morning serum testosterone results (separate days) showing < 300 ng/dL.
    SourceLink
    On This Page
    Coverage Criteria for Injectable Testosterone AgentsLaboratory Thresholds & Confirmatory TestingProvider Actions, Authorization & Documentation RequirementsBackgroundKey DefinitionsInitial Therapy CriteriaContinuation Criteria & Authorization DurationStep Therapy RequirementsQuantity LimitsSite of Care and Billing
    Measurements must be conducted on separate days

    Documentation must include morning serum testosterone levels from two separate days showing levels < 300 ng/dL and clinical documentation of the hypogonadism diagnosis (primary or secondary) as applicable.

    • Two morning blood levels on separate days confirming serum testosterone < 300 ng/dL
    • Diagnosis documentation matching covered indications (e.g., primary or secondary hypogonadism, delayed male puberty, metastatic breast cancer where applicable)
    Billing Rule

    Use DCH physician services billing pathway for in‑office administration

    If the medication is administered in a physician’s office or clinic, bill the service through the DCH physician services program rather than the outpatient pharmacy program; see www.mmis.georgia.gov for physician services program information.

    Denial Risk

    Denial risk if prior authorization not obtained

    Failure to obtain prior authorization for preferred or non‑preferred injectable androgenic agents will result in denial of coverage.