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    v1.0.28
    OpenPayerPolicy UpdatesNeurology/NeurosurgeryHighmark Blueshield NENY Ocrevus Prior Auth | Open…
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    CurrentHighmark Blueshield NenyPolicy N/A

    Outpatient Ocrevus (ocrelizumab) Authorization — Coverage Criteria

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    This form governs prior authorization requests for outpatient administration of Ocrevus (ocrelizumab) for members covered by Highmark BlueShield entities; it is used by ordering providers/site of care to request authorization and document clinical information.

    Policy Summary
    PayerHighmark Blueshield Neny
    PolicyOutpatient Ocrevus (ocrelizumab) Authorization — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit a completed outpatient Ocrevus authorization form including HCPCS J2350, dose, diagnosis, site of care, and required clinical attachments.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    J2350drug and HCPCS code listed on form
    MS/MRI/HepBclinical checklist
    Location

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    site of care fields

    Coverage Criteria for Ocrevus (ocrelizumab)

    Initial or continuation therapy authorization criteria

    Covered when ALL of the following are documented on the authorization form

    Primary coverage criteria: 1) Diagnosis of relapsing forms of multiple sclerosis (including relapsing‑remitting, active secondary progressive disease, or clinically isolated syndrome) OR primary progressive multiple sclerosis based on McDonald criteria (see form); 2) Documentation of an MRI of the brain showing abnormalities consistent with multiple sclerosis; 3) Ocrevus is prescribed by or in consultation with a neurologist or a provider who specializes in treatment of multiple sclerosis; 4) No active Hepatitis B virus infection documented; 5) No live vaccines administered within 4 weeks prior to or during treatment; 6) Member is not receiving Ocrevus in combination with another disease‑modifying therapy for MS; 7) For continuation requests: documentation of a positive clinical response (e.g., reduction in relapse rate, delay or improvement in disability progression, or reduction in MRI lesion number/volume) is provided.

    All items are requested by the authorization form to support coverage.

    The authorization form asks whether the member is receiving Ocrevus in combination with another disease-modifying therapy for multiple sclerosis. Concurrent use is specifically queried because it may preclude coverage; if the member is receiving another disease-modifying therapy in combination with Ocrevus, this may be an exclusion to authorization and should be clearly documented and justified on the form.

    The form requires documentation that the member does not have an active Hepatitis B virus infection and asks whether the member will receive any live vaccines within 4 weeks prior to or during treatment. Use of Ocrevus in combination with another disease-modifying therapy, or administration despite active Hepatitis B infection or recent live vaccination, is specifically queried and may be considered not medically necessary or contraindicated.

    Coding (HCPCS / ICD-10)

    Covered HCPCS / drug code listedHCPCSCovered
    J2350OCREVUS (ocrelizumab) outpatient injectable code as listed on form
    Diagnosis codes (ICD-10) — provider suppliedICD-10
    ICD-10Diagnosis code field (specific codes not listed on form; provider to supply appropriate MS code)

    Provider Actions, Prior Authorization & Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for outpatient injectable Ocrevus (HCPCS J2350). Requests must be submitted using the Outpatient Medical Injectable Ocrevus Authorization Request Form and include the HCPCS code J2350, dose/strength, quantity, date of service, and site of care information. Fax completed forms to 833-581-1861. Verify member eligibility and benefits through the health plan prior to submission.

    • Form: Outpatient Medical Injectable Ocrevus Authorization Request Form
    • HCPCS: J2350 (OCREVUS)
    • Fax: 833-581-1861
    • Include: dose/strength, date of service, quantity (# of doses/visits), place of service, NPI, Tax ID, billing type (facility or professional)
    Documentation Required

    Required Documentation

    Completed authorization form must include member demographics and identifiers, provider and site-of-care details, drug name and HCPCS code (OCREVUS J2350) with strength/dose, directions, quantity (number of doses/visits), date of service, and diagnosis code (ICD-10). If supplied by a specialty pharmacy for home infusion, include pharmacy name and NPI. Attach all pertinent clinical documentation requested on the form.

    Background

    Ocrevus (ocrelizumab) is indicated for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. For primary progressive MS the form expects documentation consistent with diagnostic standards (e.g., McDonald criteria), and the authorization process requests supporting clinical information such as MRI findings, specialist involvement, and evidence of progressive neurologic worsening or other diagnostic data to support the diagnosis.

    Definitions

    McDonald criteria — primary progressive MS
    Required duration of progressive neurologic worseningOne or more years of neurologic symptoms typical of multiple sclerosis progressively worsening
    Brain lesion dissemination criterion≥1 T2 lesion in at least one characteristic brain area (periventricular, juxtacortical, or infratentorial); gadolinium enhancement not required
    Spinal cord lesion dissemination criterion≥2 T2 lesions in the spinal cord; gadolinium enhancement not required
    CSF criterionDocumented history or presence of elevated CSF IgG index or CSF oligoclonal bands
    McDonald criteria applicationPrimary progressive MS diagnosis must meet McDonald criteria (combination of progressive course ≥1 year plus at least two of the listed dissemination/CSF findings)
    Policy Summary
    PayerHighmark Blueshield Neny
    PolicyOutpatient Ocrevus (ocrelizumab) Authorization — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit a completed outpatient Ocrevus authorization form including HCPCS J2350, dose, diagnosis, site of care, and required clinical attachments.
    SourceLink
    On This Page
    Coverage Criteria for Ocrevus (ocrelizumab)Coding (HCPCS / ICD-10)Provider Actions, Prior Authorization & DocumentationBackgroundDefinitions
    • Member name, DOB, Member ID (UMI), address
    • Provider: place of service name, NPI, Tax ID, phone, fax
    • Site of care: Home Infusion / Office Professional / Ambulatory Infusion Suite / Outpatient Hospital; indicate if billed as facility
    • Drug: OCREVUS (J2350) — strength/dose, directions, quantity, date of service
    • Diagnosis code (ICD-10)
    • Specialty pharmacy info (if applicable): Pharmacy name, Pharmacy NPI
    • Attach: MRI reports, neurologist consultation notes, treatment response documentation, Hepatitis B testing/results, vaccination history
    Step Therapy

    Step / Continuation Therapy Checks

    The form asks whether Ocrevus is a new start or continuation of therapy and requires documentation of clinical response for continuation requests. For continuation, include evidence of a documented positive clinical response (for example: reduction in annualized relapse rate, confirmed delay or improvement of disability progression, or reduction in number/volume of MRI lesions). The form also asks whether Ocrevus is being given in combination with another disease-modifying therapy.

    • Indicate: New Start or Continuation of Therapy
    • For Continuation: provide documentation of positive clinical response (e.g., relapse reduction, disability improvement/delay, MRI lesion reduction)
    • State whether Ocrevus is being used in combination with another disease-modifying therapy for MS
    Denial Risk

    Triggers for Potential Denial

    Applications may be denied or delayed if required documentation is missing or if clinical exclusion criteria are present. Common triggers for potential denial include absence of MRI evidence consistent with multiple sclerosis, lack of neurologist involvement or specialist consultation, active Hepatitis B infection, planned receipt of live vaccines within 4 weeks prior to or during treatment, concurrent use with another disease-modifying therapy without justification, or failure to attach requested clinical records.

    • No MRI documentation consistent with MS
    • Prescribing provider is not a neurologist or treatment not in consultation with a neurologist/specialist
    • Active Hepatitis B infection present
    • Receipt or planned receipt of live vaccines within 4 weeks prior to or during Ocrevus treatment
    • Concurrent use of Ocrevus with another disease-modifying therapy without documentation
    • Required clinical attachments not provided (e.g., MRI reports, treatment response evidence)