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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsHighmark Blueshield Neny G-CSF Coverage Update | O…
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    CurrentHighmark Blueshield NenyPolicy N/A

    Outpatient Medical Injectable Granulocyte Colony-Stimulating Factors (G-CSF) — Coverage Criteria

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    Form and criteria for prior authorization of outpatient medical benefit injectable G-CSF products for members (prevention of chemotherapy-induced febrile neutropenia and related uses). Affects providers requesting coverage for listed G-CSF agents.

    Policy Summary
    PayerHighmark Blueshield Neny
    PolicyOutpatient Medical Injectable G-CSF — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit the outpatient medical injectable G-CSF request form by fax to 833-619-5745 with clinical justification and supporting attachments.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ≥1listed non-preferred G-CSF products
    833-619-5745fax number to submit request form

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    J2506, Q5111, Q5108, Q5120
    sample HCPCS-like codes

    Coverage Criteria for Outpatient G-CSF

    Coverage criteria for outpatient G-CSF

    Covered when ALL of the following are met

    Indication: Medication is being used to prevent chemo-induced febrile neutropenia (or other intended use is documented)

    If not for prevention of chemo-induced febrile neutropenia, provider must state intended use on the request form

    Clinical documentation: Submit cancer diagnosis and staging, the complete chemotherapy regimen, and risk stratification for febrile neutropenia (low/intermediate/high)

    Attach all pertinent clinical information (use outpatient medical injectable G-CSF request form and fax to 833-619-5745)

    Risk factors: Member has one or more risk factors such as persistent neutropenia (ANC ≤ 1500/mm3), history of febrile neutropenia, prior exposure to chemotherapy or radiation, bone marrow involvement by tumor, recent surgery/open wounds, liver or renal dysfunction, age >65 receiving full chemo dose intensity, or comorbidities that increase risk of serious infection≤ 1500/mm3

    Document which risk factors are present

    The form does not list any explicit exclusions for outpatient injectable granulocyte colony-stimulating factors (G-CSFs). Providers should follow the coverage criteria and submit required clinical documentation; absence of listed exclusions means coverage determinations rely on the stated medical necessity criteria and supporting information provided on the request form.

    Use of a non-preferred product is permitted only when the member has documented therapy failure after an adequate therapeutic trial of a preferred product, or when the preferred product is not tolerated or is contraindicated. Medicare members already established on a non-preferred therapy are exempt from this step requirement.

    Coding and Clinical Values

    Listed G-CSF products (non-preferred list context)HCPCS
    Q5111Udenyca
    J2506Neulasta
    Q5108Fulphila
    Q5120Ziextenzo
    Other listed non-preferred products (descriptions without HCPCS in source)mixed
    StimufendStimufend
    FylnetraFylnetra
    RolvedonRolvedon
    Absolute neutrophil count (ANC) — clinical threshold value
    ANC thresholdAbsolute neutrophil count (ANC) ≤ 1500/mm3
    Source contextANC threshold is listed as ‘Persistent neutropenia (ANC of 1500/mm3 or less)’ in the form
    Clinical relevancePersistent neutropenia (ANC ≤1500/mm3) is a documented risk factor considered when assessing need for prophylactic G-CSF

    Provider Actions & Submission Requirements

    Prior Authorization

    Prior Authorization Required

    Prior Authorization Required — Submit the Outpatient Medical Injectable Granulocyte Colony-Stimulating Factors Request Form with clinical justification and all supporting attachments. Fax the completed form to 833-619-5745 (medical benefit only). Include member demographics, benefit type (Medicare or Commercial), requesting physician and facility information, date of service, and diagnosis code(s).

    • Fax: 833-619-5745 (medical benefit only)
    • Include: member name, DOB, UMI, benefit type (Medicare or Commercial)
    • Include: requesting physician name, NPI, address, office contact, phone/fax
    • Include: facility name, facility NPI, facility address, date of service, diagnosis codes
    Step Therapy

    Step Therapy for Non-Preferred Products

    Step therapy applies: non-preferred products will be considered only after documented failure of an adequate therapeutic trial of a preferred product, or when the preferred product is not tolerated or is contraindicated. Medicare members already established on a non-preferred therapy are not required to trial a preferred option.

    Initial Therapy — Consideration Rules

    Consideration of non-preferred G-CSF

    Step requirement: A non-preferred G-CSF will be considered only after documented therapy failure after an adequate trial of a preferred product, or when the preferred product is not tolerated or is contraindicated

    Medicare members currently established on a non-preferred therapy are exempt from the trial requirement; provide documentation of failure, intolerance, or contraindication on the request form

    Step Therapy Requirements

    StepRequirementNotes
    1Try a preferred G-CSF agent first prior to use of a non-preferred product; a non-preferred product will be considered only after documented failure of an adequate therapeutic trial of a preferred product, or if the preferred product is not tolerated or is contraindicated.Medicare members currently established on a non-preferred therapy are exempt from the step requirement and are not required to try a preferred option.

    Site of Care / Benefit

    Note

    Infusion center — outpatient medical benefit only

    Requests for outpatient administration at an infusion center must be submitted under the outpatient medical benefit using the outpatient G-CSF request form.

    • Use the form designated 'Medical Benefit Only' and fax to 833-619-5745.

    Biosimilar / Non-preferred Notes

    Billing Rule

    Neulasta and non-preferred product policy for Medicare members

    Neulasta (J2506) and the other listed products are labeled non-preferred; however, Medicare members currently established on a non-preferred therapy are not required to try a preferred option.

    • Listed non-preferred products include Udenyca (Q5111), Fulphila (Q5108), Ziextenzo (Q5120), and Neulasta (J2506).

    Definitions and Risk Factors

    Risk factors for febrile neutropenia — categories and contributing factors
    Risk categoriesLow, Intermediate, High (risk of febrile neutropenia)
    Key hematologic risk factorPersistent neutropenia: ANC of 1500/mm3 or less
    Patient history factorsHistory of febrile neutropenia; prior exposure to chemotherapy or radiation
    Clinical and surgical contributorsBone marrow involvement by tumor; recent surgery and/or open wounds
    Physiologic and comorbidity factorsLiver or renal dysfunction; age >65 receiving full chemotherapy dose intensity; comorbidities that increase risk of serious infection

    Background

    Granulocyte colony-stimulating factors (G-CSFs) are indicated to prevent chemotherapy-induced febrile neutropenia by stimulating neutrophil production. Clinical decision-making should consider the patient’s cancer diagnosis and staging, the complete chemotherapy regimen, and individualized risk factors—such as persistent neutropenia (ANC ≤ 1500/mm3), prior febrile neutropenia, bone marrow involvement, recent surgery or open wounds, liver or renal dysfunction, age >65 receiving full chemotherapy intensity, and relevant comorbidities—when assessing the need for prophylactic G-CSF.

    Policy Summary
    PayerHighmark Blueshield Neny
    PolicyOutpatient Medical Injectable G-CSF — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit the outpatient medical injectable G-CSF request form by fax to 833-619-5745 with clinical justification and supporting attachments.
    SourceLink
    On This Page
    Coverage Criteria for Outpatient G-CSFCoding and Clinical ValuesProvider Actions & Submission RequirementsInitial Therapy — Consideration RulesStep Therapy RequirementsSite of Care / BenefitBiosimilar / Non-preferred NotesDefinitions and Risk FactorsBackground
    • Non-preferred examples: Udenyca (Q5111), Stimufend, Fylnetra, Neulasta (J2506), Rolvedon, Fulphila (Q5108), Ziextenzo (Q5120)
    • Non-preferred will be denied unless documentation shows prior failure/intolerance/contraindication to preferred product
    • Medicare members currently on non-preferred therapy are exempt from step therapy
    Documentation Required

    Required Submission Information

    Required submission information and documentation — verify member eligibility and benefits, and attach all pertinent clinical information. On the form, answer cancer diagnosis and staging, intended use (e.g., prevention of chemo-induced febrile neutropenia), complete chemotherapy regimen, FN risk level (low/intermediate/high), and any risk factors (bone marrow involvement, recent surgery/open wounds, liver/renal dysfunction, age >65 on full chemo dose intensity, relevant comorbidities). Indicate whether attachments are included.

    • Verify eligibility and benefits with the health plan before submission
    • Document cancer diagnosis and staging
    • State whether medication is for prevention of chemo-induced febrile neutropenia; if no, state intended use
    • Provide complete chemotherapy regimen
    • Assess and document FN risk level: Low / Intermediate / High
    • List specific FN risk factors and comorbidities; attach supporting clinical records
    • Indicate whether attachments are included (YES/NO)
    Denial Risk

    Denial Risk for Non-Preferred Product Usage

    Denial Risk — Use of a non-preferred product without documentation of prior failure, intolerance, or contraindication to a preferred product may result in denial. Ensure clinical justification explicitly addresses why a preferred agent is inappropriate when requesting a non-preferred product.

    • Requests for non-preferred agents require documentation of prior preferred product failure, intolerance, or contraindication
    • Medicare members already on non-preferred therapy are exempt from this requirement