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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsViva Health Ocrevus Prior Auth & Coverage | OpenPa…
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    CurrentViva HealthPolicy IC-0298

    Ocrevus (ocrelizumab) prior authorization and coverage for multiple sclerosis

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    This policy governs prior authorization, dosing limits, coverage criteria, renewal requirements, and billing/coding for ocrelizumab (Ocrevus) intravenous therapy for members receiving MS treatment under Viva Health.

    Policy Summary
    PayerViva Health
    PolicyOcrevus (ocrelizumab) prior authorization and coverage for multiple sclerosis
    Policy CodePolicy IC-0298
    Change TypeNo material changes
    Effective DateJun 2, 2026
    Last ReviewJun 2, 2026
    Next Review DateJun 2, 2026
    Key ActionObtain prior authorization (valid 12 months) and document trial, intolerance, or contraindication to one generic disease‑modifying agent plus required baseline testing.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    600 mgsubsequent dose
    12 moPA validity
    J2350HCPCS
    50242-0150-xxNDC

    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.

    7
    ICD-10 codes
    4appendices

    Coverage Criteria for Ocrevus (ocrelizumab)

    Initial Approval Criteria

    Covered when ALL of the following are met:

    Initial approval requirements: Patient must have a contraindication, intolerance, or failure to ONE generic disease-modifying agent prior to consideration of ocrelizumab; patient screened for Hepatitis B prior to initiation and does not have active infection; baseline serum immunoglobulins assessed; no FDA-labeled contraindications to ocrelizumab (e.g., history of life‑threatening infusion reaction); will not receive live or live-attenuated vaccines while on therapy or within 4 weeks prior to initiation; no active infection; baseline and periodic liver tests (ALT, AST), alkaline phosphatase, and bilirubin will be measured; used as single-agent therapy; has not received ocrelizumab or ublituximab within the past 5 months.

    Indication-specific: Multiple Sclerosis (Adults and Pediatrics)

    Covered when ALL of the following indication-specific criteria are met:

    Age/diagnosis groups: Either: (1) Adult ≥18 years with confirmed diagnosis of multiple sclerosis documented (e.g., MRI) AND diagnosis of a relapsing form of MS (RRMS, active SPMS, or CIS) OR primary progressive MS (PPMS) AND member is <65 years of age AND EDSS ≤ 6.5; OR (2) Pediatric patient ≥10 years of age and weighing ≥25 kg with a diagnosis of RRMS.

    Members with FDA-labeled contraindications to ocrelizumab are excluded from coverage. Examples include a documented history of a life‑threatening infusion reaction to ocrelizumab. Prior to approval, providers must confirm absence of these contraindications as part of the universal safety criteria.

    For Medicare beneficiaries, Medicare-specific requirements (including National Coverage Determinations, Local Coverage Determinations, and Local Coverage Articles) may apply and take precedence over this policy. Providers and reviewers should consult the CMS Medicare Coverage Database and applicable MAC jurisdiction documents when evaluating Part B outpatient coverage and billing for ocrelizumab.

    For members receiving ocrelizumab for primary progressive MS (PPMS), renewal is contingent on continued ambulatory status. Specifically, renewal is not medically necessary if the member is no longer ambulatory, defined as an Expanded Disability Status Scale (EDSS) score ≥7.5.

    Billing, Codes, and Dosing

    HCPCS Covered CodesHCPCSCovered
    J2350Injection, ocrelizumab, 1 mg; 1 billable unit = 1 mg
    NDCNDCCovered
    50242-0150-xxOcrevus 300 mg/10 mL single-dose vial
    Covered ICD-10 CodesICD-10Covered
    G35.ARelapsing-remitting multiple sclerosis
    G35.B0Primary progressive multiple sclerosis, unspecified
    G35.B1Active primary progressive multiple sclerosis
    G35.B2Non-active primary progressive multiple sclerosis
    G35.C0Secondary progressive multiple sclerosis, unspecified
    G35.C1Active secondary progressive multiple sclerosis
    G35.C2Non-active secondary progressive multiple sclerosis
    G35.DMultiple sclerosis, unspecified
    inv-09: Dose amounts — initial and subsequent dosing (adult standard subsequent dose every 6 months)
    Initial dosing (adult)300 mg IV on day 1 and 300 mg IV on day 15 (two-dose initial regimen)
    Subsequent dosing (adult standard)600 mg IV every 6 months (first subsequent dose given 6 months after initial infusion)
    Pediatric dosing (≥25 kg to <35 kg)Initial: 150 mg IV x2 (day 1 and day 15); Subsequent: 300 mg IV every 6 months
    Pediatric dosing (≥35 kg)Initial: 300 mg IV x2 (day 1 and day 15); Subsequent: 600 mg IV every 6 months

    Prior Authorization, Documentation, and Step Therapy

    Prior Authorization

    Prior authorization required; 12‑month initial and renewal validity

    Prior authorization is required for Ocrevus. Initial authorization is valid for 12 months (365 days) and may be renewed every 12 months (365 days). Authorization requires meeting the policy's prior authorization conditions (including required trials, screening, and baseline testing).

    • Initial PA validity: 12 months (365 days).
    • Renewals: may be renewed every 12 months (365 days).
    Note

    PA considered due to indication and drug cost (NQTL checklist)

    Prior authorization was applied after consideration of the drug indication and drug cost as NQTL factors; the NQTL checklist indicates 'Indication' and 'Cost of drug' as reasons to consider PA.

    • NQTL factor: Indication = Consider for PA.
    • NQTL factor: Cost of drug = Consider for PA.

    Initial Dosing and Eligibility

    Initial dosing

    Initial dosing regimens by age/weight:

    Adult initial dosing: Initial dose: 300 mg IV on day 1 and 300 mg IV on day 15; subsequent dose: 600 mg IV every 6 months (first subsequent dose 6 months after Infusion 1 of the initial dose).
    Pediatric dosing: Pediatric RRMS weighing 25 kg to <35 kg: initial 150 mg IV on day 1 and 150 mg IV on day 15; subsequent 300 mg IV every 6 months. Pediatric RRMS weighing ≥35 kg: initial 300 mg IV on day 1 and 300 mg IV on day 15; subsequent 600 mg IV every 6 months.

    Renewal and Continued Therapy Criteria

    Continuation / Renewal

    Renewal is permitted when criteria show continued benefit and acceptable safety:

    Renewal criteria: Member continues to meet the universal and indication-specific criteria; absence of unacceptable toxicity from the drug (examples: severe infusion reactions, severe infections, PML, malignancy, hypogammaglobulinemia, immune-mediated colitis, clinically significant liver injury); and continuous monitoring indicates beneficial response. Note: inadequate response, in those adherent and on therapy long enough to realize effect, is defined as ≥1 relapse, ≥2 new MRI-detected lesions, or increased disability over a one-year period. For PPMS, member must continue to be ambulatory (EDSS <7.5) for renewal.

    Step Therapy Requirements

    StepRequirementNotes
    1Trial of ONE generic disease-modifying agent prior to Ocrevus (ocrelizumab)Trial may be bypassed if there is documented contraindication, intolerance, or failure to a generic disease-modifying agent. Documentation of prior use or reason for bypass is required for prior authorization.

    Quantity and Administration Limits

    inv-25: Ocrevus (ocrelizumab) — initial and subsequent quantity limits (initial: 300 mg x2; subsequent: 600 mg q6 months)
    Initial quantity limit300 mg per dose x2 (administered on day 1 and day 15)
    Subsequent quantity limit600 mg every 6 months (administered as a single 600 mg IV infusion)
    Per unit billing guidanceHCPCS billing uses J2350 (1 billable unit = 1 mg) — report units consistent with mg administered

    Administration Setting and Site-of-Care Guidance

    Note

    Infusion center directions: IV administration; next dose 6 months after initial infusion

    Ocrevus is administered by intravenous infusion. After the initial two 300 mg infusions (day 1 and day 15), the first subsequent dose should be administered 6 months after the first infusion of the initial dose.

    • Initial dosing: 300 mg IV on day 1 and 300 mg IV on day 15.
    • First subsequent dose: 600 mg IV given 6 months after Infusion 1 of the initial dose.
    Billing Rule

    Medicare site‑of‑care note: Part B infusion billing subject to CMS and MAC rules

    Medicare Part B outpatient infusion billing for Ocrevus may be subject to CMS policies and the applicable Medicare Administrative Contractor (MAC) jurisdiction rules; verify Part B coverage/payment rules when billing Medicare.

    • Medicare Part B outpatient infusions governed by Medicare Benefit Policy Manual and any applicable NCD/LCD/LCA.

    Background

    Ocrelizumab (Ocrevus) is an intravenous anti‑CD20 monoclonal antibody indicated for treatment of relapsing forms of multiple sclerosis (including relapsing‑remitting MS, active secondary progressive MS, and clinically isolated syndrome) and primary progressive MS (PPMS). Adult dosing begins with an initial course of 300 mg IV on day 1 and 300 mg IV on day 15, followed by 600 mg IV every 6 months for subsequent maintenance doses. Therapy requires baseline screening and monitoring for infection (including Hepatitis B), baseline immunoglobulins, and periodic liver function testing; live or live‑attenuated vaccines should not be given within 4 weeks prior to or during treatment. Use is as a single‑agent therapy and prior exposure to ocrelizumab or ublituximab within the previous 5 months contraindicates initiation.

    Definitions and Key Terms

    inv-19: RMS / RRMS / PPMS definitions — relapsing forms and primary progressive MS definitions
    Relapsing forms of MS (RMS)Includes relapsing‑remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS); covered indication for ocrelizumab.
    Primary progressive MS (PPMS)PPMS is a covered indication for ocrelizumab for adults meeting age and EDSS criteria.
    Age groupsAdults: ≥18 years with RMS or PPMS (and other criteria); Pediatrics: ≥10 years with RRMS and ≥25 kg for pediatric dosing rules.
    inv-20: Ambulatory for PPMS — ambulatory definition (EDSS <7.5) for renewal
    Ambulatory definition for PPMS renewalMember continues to be ambulatory defined as an EDSS score of <7.5 for renewal determination.
    Adult PPMS eligibility limits
    Policy Summary
    PayerViva Health
    PolicyOcrevus (ocrelizumab) prior authorization and coverage for multiple sclerosis
    Policy CodePolicy IC-0298
    Change TypeNo material changes
    Effective DateJun 2, 2026
    Last ReviewJun 2, 2026
    Next Review DateJun 2, 2026
    Key ActionObtain prior authorization (valid 12 months) and document trial, intolerance, or contraindication to one generic disease‑modifying agent plus required baseline testing.
    SourceLink
    On This Page
    Coverage Criteria for Ocrevus (ocrelizumab)Billing, Codes, and DosingPrior Authorization, Documentation, and Step TherapyInitial Dosing and EligibilityRenewal and Continued Therapy CriteriaStep Therapy RequirementsQuantity and Administration LimitsAdministration Setting and Site-of-Care GuidanceBackgroundDefinitions and Key Terms
    Step Therapy

    Step requirement: trial or documented contraindication/intolerance/failure to one generic DMT

    A trial of, or documented contraindication/intolerance/failure to, ONE generic disease‑modifying agent is required before Ocrevus will be considered.

    • Provider must document prior use of a generic disease‑modifying agent or document contraindication/intolerance/failure to one agent.
    Step Therapy

    No specific step sequence defined in appendices

    The policy notes that no specific step therapy sequence is defined in the appended sections; only the requirement for trial/contraindication/intolerance/failure to one generic agent is specified.

    • No ordered sequence of agents is specified in the appendices.
    Documentation Required

    Document confirmed MS diagnosis; bill J2350 and NDC 50242-0150-xx

    Providers must document a confirmed MS diagnosis (for example, MRI report) and bill using HCPCS and NDC codes specified by the policy; HCPCS J2350 is the procedure code and the NDC for the 300 mg vial is 50242-0150-xx.

    • Confirm MS diagnosis with documentation (e.g., MRI).
    • HCPCS for billing: J2350 - Injection, ocrelizumab, 1 mg.
    • NDC for 300 mg/10 mL vial: 50242-0150-xx.
    Note

    Consult NCDs/LCDs/LCAs and CMS rules for Medicare Part B

    For Medicare beneficiaries, consult applicable CMS guidance and any relevant NCDs, LCDs, or LCAs because Medicare Part B coverage and payment rules apply and may supersede the non‑Medicare policy language.

    • Search CMS Medicare Coverage Database for NCDs/LCDs/LCAs as applicable.
    • CMS rules and applicable MAC jurisdiction determinations take precedence for Medicare Part B outpatient drugs.
    Denial Risk

    Denial risk if prior agent use or contraindication/intolerance/failure not documented

    Failure to document prior use of a generic disease‑modifying agent or to document a contraindication, intolerance, or treatment failure may result in denial of the PA request.

    • Include records showing prior agent use or explicit documentation of contraindication/intolerance/failure.
    Prior Authorization

    PA rationale: indication and cost identified in NQTL checklist

    The policy explicitly states PA may be used because the indication and drug cost were identified as considerations on the NQTL factor checklist.

    • NQTL checklist identifies indication and cost as reasons to consider PA.
  1. Payment and coverage may vary by MAC jurisdiction.
    2. For initial coverage adults must be <65 years of age with EDSS ≤6.5 (separate initial criteria).
    Renewal implicationLoss of ambulatory status (EDSS ≥7.5) makes PPMS renewal not medically necessary per policy.
    inv-21: NQTL definition — Non-quantitative treatment limitations explanatory note
    NQTL definitionNon-quantitative treatment limitations (NQTLs) are methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan.
    ExamplesMay include utilization review or prior authorization and other utilization management practices.
    Parity noteThe utilization management NQTL applies comparably, and not more stringently, to MH/SUD and M/S medical benefit prescription drugs.