Ocrevus (ocrelizumab) (Intravenous) — Coverage Criteria
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Clinical prior authorization and medical necessity criteria for ocrelizumab (Ocrevus) intravenous administration for multiple sclerosis including dosing, renewal, and monitoring requirements for providers requesting coverage.
No material clinical or coverage changes in this revision.
Coverage Criteria for Ocrevus (ocrelizumab)
Initial Approval Criteria
Prior authorization validity is provided when ALL of the following universal and indication-specific criteria are met:
Renewal Criteria
Prior authorization may be renewed when ALL of the following are met:
Covered Diagnoses
Covered when the member has one of the following ICD-10 diagnoses:
These diagnoses are enumerated as covered in Appendix 1 of the policy.
Use of ocrelizumab with live or live-attenuated vaccines is prohibited during therapy and if administered within 4 weeks prior to initiation of treatment. Providers must confirm vaccines will not be given in these timeframes before approval.
This extract does not list specific Medicare Part B covered diagnosis codes for ocrelizumab (marked as N/A). Providers should consult applicable NCDs/LCDs/LCAs and the Medicare Coverage Database for Medicare coverage determinations and any jurisdictional guidance before submitting claims.
Requests will not be supported if baseline HBV screening was not performed prior to initiation or if the member has active hepatitis B infection. Additionally, requests are ineligible when an FDA-labeled contraindication to ocrelizumab is present (for example, a prior life‑threatening infusion reaction).
This extract does not enumerate explicit not medically necessary conditions beyond the requirements noted elsewhere. Medicare NCDs/LCDs may impose additional restrictions or indications; providers should review those documents where applicable for Medicare members.
Coding (HCPCS, NDC, ICD-10) and Dosing
| J2350 | Injection, ocrelizumab, 1 mg; 1 billable unit = 1 mg |
| 50242-0150-xx | Ocrevus 300 mg/10 mL single-dose vial |
| G35.A | Relapsing-remitting multiple sclerosis. |
| G35.B0 | Primary progressive multiple sclerosis, unspecified. |
| G35.B1 | Active primary progressive multiple sclerosis. |
| G35.B2 | Non-active primary progressive multiple sclerosis. |
| G35.C0 | Secondary progressive multiple sclerosis, unspecified. |
| G35.C1 | Active secondary progressive multiple sclerosis. |
| G35.C2 | Non-active secondary progressive multiple sclerosis. |
| G35.D | Multiple sclerosis, unspecified. |
| Medicare Part B Covered Diagnosis Codes | N/A (policy notes applicability to existing NCD/LCD/LCA) |
Provider Actions, Documentation, and Prior Authorization
Prior authorization required; 12‑month validity and baseline screening/documentation
Prior authorization is required for ocrelizumab and is valid for 12 months (365 days) for initial approval. Providers must document baseline HBV screening with no active disease (i.e., negative HBsAg and anti-HBV as applicable), baseline serum immunoglobulins, confirmation of no FDA‑labeled contraindications, confirmation that live or live‑attenuated vaccines will not be given while on therapy or within 4 weeks prior to initiation, absence of active infection, baseline and periodic liver function tests (ALT, AST), alkaline phosphatase and bilirubin, and that the member has not received ocrelizumab or ublituximab within the past 5 months.
- Initial PA validity: 12 months (365 days).
- Document HBV screening prior to initiation and confirm no active disease (positive HBsAg/anti‑HBV results indicate active disease).
- Obtain baseline serum immunoglobulins.
- Confirm no FDA‑labeled contraindications (e.g., prior life‑threatening infusion reaction).
- Confirm avoidance of live or live‑attenuated vaccines while on therapy or within 4 weeks prior to initiation.
- Confirm no active infection and obtain baseline and periodic LFTs (ALT, AST), alkaline phosphatase, and bilirubin.
- Confirm member has not received ocrelizumab or ublituximab within the past 5 months.
Submit PA with covered ICD‑10 diagnosis codes from Appendix 1
Submit prior authorization requests using one of the covered ICD‑10 diagnosis codes listed in Appendix 1 and include documentation supporting the indicated diagnosis and clinical rationale; PA consideration is applied per the NQTL factors (indication and drug cost noted).
- Use Appendix 1 covered ICD‑10 codes (e.g., G35.A, G35.B0, G35.B1, G35.B2, G35.C0, G35.C1, G35.C2, G35.D) on the PA request.
- Include documentation supporting the indication as appropriate given utilization management considerations in the NQTL checklist.
Document failure/inadequate response to at least one specified DMT for relapsing MS
For relapsing forms of MS, PA requires documentation of inadequate response to an adequate trial of at least one specified disease‑modifying therapy unless contraindicated or not tolerated.
- Required prior agent trial(s) include one of: dimethyl fumarate, fingolimod, teriflunomide, glatiramer acetate (Glatopa), or cladribine, unless contraindicated or not tolerated.
No additional explicit step therapy rules specified in this extract
The extracted policy sections do not specify explicit step therapy sequencing beyond the requirement for prior inadequate response in relapsing MS; no additional step therapy rules are listed in these sections.
Include documented diagnosis and age/weight for pediatric dosing
Provide documented evidence of the MS diagnosis (for example, MRI report) and the patient’s age; for pediatric dosing include the patient’s weight to support weight‑based dose selection.
- Documentation of confirmed MS diagnosis (e.g., MRI report).
- Document patient age to verify adult vs pediatric eligibility.
- For pediatric patients (10–17 years), document weight (e.g., ≥25 kg) to determine dosing schedule.
Use Appendix 1 ICD‑10 diagnosis codes on PA requests
When submitting requests for ocrelizumab, use the ICD‑10 codes listed in Appendix 1 (e.g., G35.A; G35.B0, G35.B1, G35.B2; G35.C0, G35.C1, G35.C2; G35.D) to indicate the covered MS diagnosis.
Denial risk if baseline HBV screening missing, active infection, recent dosing, or contraindication present
Requests lacking required baseline HBV screening, showing active hepatitis B infection, showing recent receipt of ocrelizumab or ublituximab within the past 5 months, or indicating FDA‑labeled contraindications (e.g., prior life‑threatening infusion reaction) may be denied.
- Absence of baseline HBV screening or evidence of active HBV infection may trigger denial.
- Receipt of ocrelizumab or ublituximab within the past 5 months is a denial risk.
- Presence of FDA‑labeled contraindications (e.g., prior life‑threatening infusion reaction) or active infection may result in denial.
PA may be considered based on NQTL factors (indication and cost)
Prior authorization may be applied due to indication and drug cost as noted in the NQTL checklist; utilize PA documentation to address utilization management factors.
- NQTL checklist identifies 'Indication' and 'Cost of drug' as factors considered for requiring PA.
Background and Indication Summary
Ocrelizumab is a humanized anti‑CD20 monoclonal antibody indicated for treatment of relapsing forms of multiple sclerosis (including relapsing‑remitting MS and active secondary progressive MS) and primary progressive MS (PPMS). Adult dosing usually 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 thereafter. Pediatric dosing varies by weight and indication. The agent depletes CD20‑positive B cells, requiring monitoring for infections, hepatitis B status, serum immunoglobulins, and liver function tests per the policy before and during therapy.
Definitions and Eligibility
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