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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAmeriHealth Caritas Ocrevus Update | OpenPayer
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    ModifiedAmeriHealth Caritas VIP CarePolicy MA08.088e

    Ocrelizumab (Ocrevus) and Ocrelizumab and Hyaluronidase-ocsq (Ocrevus Zunovo)

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    Part B medical-benefit coverage of intravenous Ocrevus and subcutaneous Ocrevus Zunovo for adults with specified forms of multiple sclerosis, subject to medical necessity criteria including negative hepatitis B testing; Part D pharmacy-benefit coverage is not addressed.

    Policy Summary
    PayerAmeriHealth Caritas VIP Care
    PolicyOcrelizumab (Ocrevus) and Ocrelizumab and Hyaluronidase-ocsq (Ocrevus Zunovo)
    Policy CodePolicy MA08.088e
    Change TypeModified
    Effective DateDecember 15, 2025
    Last ReviewSep 18, 2026
    Next Review DateN/A
    Key ActionDocument the patient's adult status, qualifying multiple sclerosis diagnosis, and negative hepatitis B surface antigen and anti-hepatitis B virus test results.
    SourceLink
    POLICY UPDATE CHANGES

    The ICD-10 diagnosis codes G35.A, G35.B1, G35.C1, and G35.D were added to the policy.

    The ICD-10 diagnosis code G35 (Multiple sclerosis) was removed from the policy.

    Ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo) and HCPCS code J2351 were added to the policy effective June 13, 2025.

    The medical necessity criteria were revised in 2019 to reflect updated FDA labeling for relapsing forms of multiple sclerosis.

    HCPCS code J2350 was added and HCPCS codes C9494 and J3590 were removed in the 2018 code update.

    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.

    Adults with RMS or PPMSCovered disease populations
    HBsAg and anti-HBV negativeRequired hepatitis B status
    2Products addressed
    4ICD-10 codes added
    1ICD-10 code removed

    Medical Necessity and Coverage Criteria

    Medically Necessary Covered Indications

    Covered when ALL of the following criteria are met:

    ALL of the following

    • The individual is an adult.

    • ONE of the following covered indications

      • Relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome (CIS).
      • Relapsing-remitting multiple sclerosis.
      • Active secondary progressive multiple sclerosis.
      • Primary progressive multiple sclerosis (PPMS).

    • ONE of the following covered products and administration routes

      • Ocrelizumab (Ocrevus) administered as an intravenous (IV) infusion.
      • Ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo) administered as a subcutaneous (SC) injection.
    • The individual is hepatitis B negative, with negative results for hepatitis B surface antigen (HBsAg) and anti-hepatitis B virus tests.

    All other uses of ocrelizumab (Ocrevus) or ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo), including nonrelapsing secondary progressive multiple sclerosis, are considered experimental/investigational and therefore are not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

    Coding 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-10
    G35.ARelapsing-remitting multiple sclerosis
    G35.B1Active primary progressive multiple sclerosis
    G35.C1Active secondary progressive multiple sclerosis
    G35.DMultiple sclerosis, unspecified
    The following code is used to represent ocrelizumab (Ocrevus)HCPCS
    J2350Injection, ocrelizumab, 1 mg
    The following codes are used to represent ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo)HCPCS
    J2351Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq
    Revenue Code Number(s)Revenue
    N/AN/A
    ICD-10 codes addedICD-10
    G35.ARelapsing-remitting multiple sclerosis
    G35.B1Active primary progressive multiple sclerosis
    G35.C1Active secondary progressive multiple sclerosis
    G35.DMultiple sclerosis, unspecified
    ICD-10 code removedICD-10Not Covered
    G35Multiple sclerosis
    HCPCS code added for Ocrevus ZunovoHCPCS
    J2351Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq
    HCPCS code addedHCPCS
    J2350Injection, ocrelizumab, 1 mg
    HCPCS codes removedHCPCSNot Covered
    C9494Injection, ocrelizumab, 1 mg
    J3590Unclassified biologics

    Documentation and Denial Risk

    Documentation Required

    Medical Necessity Records

    The individual's medical record must reflect the medical necessity for the care provided. Supporting documentation may include records from the professional provider's office, hospital, nursing home, home health agency, therapy providers, and test reports.

    • Make medical records and supporting provider, hospital, facility, home health, therapy, and test reports available to the Company upon request.
    Documentation Required

    Clinical Eligibility Documentation

    Document that the individual is an adult with a covered multiple sclerosis indication and is hepatitis B negative. Coverage applies to relapsing forms of MS—including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease—or primary progressive MS when hepatitis B surface antigen and anti-hepatitis B virus tests are negative.

    • Adult status
    • Qualifying relapsing or primary progressive multiple sclerosis
    • Negative hepatitis B surface antigen (HBsAg) and anti-hepatitis B virus tests

    Multiple Sclerosis and Treatment Context

    Multiple sclerosis is an inflammatory disease of the central nervous system in which immune-mediated injury to myelin and axons produces neurologic symptoms and disability.

    Clinical and Laboratory Definitions

    Clinically isolated syndrome (CIS)
    EventFirst episode of a neurologic event
    Underlying processAssociated with inflammation and demyelination involving the central nervous system
    DurationLasts at least 24 hours
    Relapsing-remitting multiple sclerosis (RRMS)
    Disease formMost common form of multiple sclerosis
    Clinical patternRecurrent attacks to the nervous system followed by complete or partial recovery
    Remission

    Initial Dosing Criteria

    Ocrevus Initial Dosing

    For an eligible adult with a covered multiple sclerosis indication and negative hepatitis B testing:

    Initial Ocrevus therapy: Administer an initial 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion.300 mg IV, followed 2 weeks later by 300 mg IV

    Ocrevus Zunovo Dosing

    For an eligible adult with a covered multiple sclerosis indication and negative hepatitis B testing:

    Initial Ocrevus Zunovo therapy: Administer ocrelizumab and hyaluronidase-ocsq as a subcutaneous injection every six months.920 mg ocrelizumab plus 23,000 units of hyaluronidase every 6 months

    Maintenance Dose and Frequency Limits

    Ocrevus
    Maintenance dose600 mg intravenously
    FrequencyOne infusion every six months
    Initial regimenApplies after the initial two-dose regimen of 300 mg IV followed two weeks later by a second 300 mg IV infusion
    Ocrevus Zunovo
    Ocrelizumab dose920 mg
    Hyaluronidase dose23,000 units
    Frequency and routeAdministered as a subcutaneous injection every six months
    Policy Summary
    PayerAmeriHealth Caritas VIP Care
    PolicyOcrelizumab (Ocrevus) and Ocrelizumab and Hyaluronidase-ocsq (Ocrevus Zunovo)
    Policy CodePolicy MA08.088e
    Change TypeModified
    Effective DateDecember 15, 2025
    Last ReviewSep 18, 2026
    Next Review DateN/A
    Key ActionDocument the patient's adult status, qualifying multiple sclerosis diagnosis, and negative hepatitis B surface antigen and anti-hepatitis B virus test results.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaCoding InformationDocumentation and Denial RiskMultiple Sclerosis and Treatment ContextClinical and Laboratory DefinitionsInitial Dosing CriteriaMaintenance Dose and Frequency Limits
    Denial Risk

    Unsupported or Nonrelapsing MS Indication

    Ocrelizumab and ocrelizumab with hyaluronidase-ocsq are not covered for uses outside the covered adult relapsing or primary progressive MS indications, including nonrelapsing secondary progressive MS, 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.

    • Nonrelapsing secondary progressive MS is considered experimental/investigational and is not covered absent qualifying accepted off-label support.
    Denial Risk

    Missing Medical Records

    The Company may review or audit services regardless of the provider's participation status. Failure to provide requested medical records or other documentation supporting medical necessity may result in a denial for the drug.

    • Respond to Company requests with complete medical records and supporting documentation.
    • Missing requested records creates denial risk.
    No or minimal disease progression during remission; some symptoms may become permanent after partial recovery
    Primary progressive multiple sclerosis (PPMS)
    Disease courseGradual disease progression from symptom onset
    Disease activityMay include periods of active disease
    Clinical patternMay include occasional plateaus and temporary minor improvement of symptoms, but no distinct relapses or remissions
    Secondary progressive multiple sclerosis (SPMS)
    Initial presentationInitially presents as relapsing-remitting multiple sclerosis
    Later courseLater transitions to a condition similar to primary progressive multiple sclerosis
    RelapsesProgressive disease that may or may not have relapses
    Hepatitis B surface antigen (HBsAg)
    DefinitionProtein on the surface of the hepatitis B virus
    Clinical interpretationIts presence indicates that the person is infectious
    DetectionMay be detected at high levels in serum during acute or chronic hepatitis B virus infection
    Hepatitis B surface antibody (anti-HBs)
    DefinitionAntibody directed against hepatitis B surface antigen
    Clinical interpretationIts presence is generally interpreted as indicating recovery and immunity from hepatitis B infection
    VaccinationMay also develop after successful hepatitis B vaccination