IV vs. SC formulations — J2350 vs. J2351 FDA verified Aug 2025
Common biller mistake. The IV and SC versions of Ocrevus are billed entirely differently.
Ocrevus has two FDA-approved formulations from Genentech: the original intravenous infusion (Ocrevus, J2350, 2017) and the subcutaneous injection (Ocrevus Zunovo, J2351, effective April 1, 2025). They are not interchangeable for billing purposes — every code, NDC, dose, and admin CPT differs.
| Ocrevus (IV) | Ocrevus Zunovo (SC) | |
|---|---|---|
| HCPCS | J2350 | J2351 |
| NDC | 50242-0150-01 | 50242-0554-01 |
| Vial size | 300 mg / 10 mL | 920 mg + 23,000 U / 23 mL |
| Maintenance dose | 600 mg q6mo | 920 mg q6mo |
| Billable units | 600 | 920 |
| Administration CPT | 96413 / 96365 | 96401 |
| Time to administer | 2–3.5 hours (IV) | ~10 minutes (SC, abdomen) |
| Wastage modifier (JZ) | Required | Required |
| FDA approval | March 2017 (BLA 761053) | September 2024 (BLA 761371) |
J2350. If it says "subcutaneous," "SC injection," or "abdomen," bill
J2351. The unit math is fundamentally different (600 vs. 920); a wrong code
produces a denial or a 35% billing error.
This page covers the IV formulation (J2350). For the SC reference, see Ocrevus Zunovo (J2351).
Dosing & unit math FDA label Aug 2025
From FDA prescribing information, label revised August 2025.
FDA-labeled dose schedule:
- Initial: 300 mg IV infusion, followed two weeks later by a second 300 mg IV infusion (total 600 mg over the loading period).
- Maintenance: single 600 mg IV infusion every 6 months.
At 1 mg = 1 unit, every milligram administered is one billable unit on the claim. There is no weight-based dosing for ocrelizumab; the dose is fixed.
Worked example — first-year billing for a new patient
Drug units billed: 300
HCPCS: J2350 · Modifier: JZ · Vials: 1 × 300 mg
# Day 14 — second 300 mg infusion
Drug units billed: 300
HCPCS: J2350 · Modifier: JZ · Vials: 1 × 300 mg
# Month 6 — first 600 mg maintenance infusion
Drug units billed: 600
HCPCS: J2350 · Modifier: JZ · Vials: 2 × 300 mg
# Month 12 — second 600 mg maintenance infusion
Drug units billed: 600
HCPCS: J2350 · Modifier: JZ · Vials: 2 × 300 mg
# Total year-1 drug units billed: 1,800
Infusion rate schedule (admin claim line)
The administration CPT depends on infusion duration. From the FDA label:
- Infusions 1 & 2 (300 mg each): start at 30 mL/hr, increase by 30 mL/hr every 30 min, max 180 mL/hr — 2.5 hours or longer.
- Subsequent (600 mg) infusions, standard option: ~3.5 hours.
- Subsequent (600 mg) infusions, shorter option: 2 hours, only eligible if no prior serious infusion reaction.
Bill 96413 (or 96365) for the initial hour, plus 96415 (or 96366) for each additional hour. Document actual start and stop times; payers audit infusion duration.
Required premedication (label-mandated)
- Methylprednisolone 100 mg IV (or equivalent corticosteroid) ~30 min prior
- Antihistamine (e.g., diphenhydramine) 30–60 min prior
- Antipyretic (acetaminophen) optional, 30–60 min prior
Premedications are billed separately under their own J-codes / CPTs. The corticosteroid injection itself bills as J2920/J2930 (methylprednisolone) plus an admin code.
NDC reference FDA NDC Directory verified May 2026
| NDC (10-digit) | NDC (11-digit, claim form) | Package | Manufacturer |
|---|---|---|---|
50242-150-01 |
50242-0150-01 |
300 mg ocrelizumab in 10 mL (30 mg/mL), single-dose vial, 1 vial per carton | Genentech, Inc. |
N4 qualifier in CMS-1500
Box 24A and UB-04 Box 43 to indicate NDC format.
Canonical source: FDA National Drug Code Directory.
Administration codes CPT verified May 2026
The 96413/96365 fork is the single biggest source of payer denials. Get this right.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Manufacturer-recommended for initial hour. Use for payers that recognize ocrelizumab as a "complex biologic" eligible for chemo administration. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Pair with 96413. Bill once per additional hour beyond the first. |
96365 |
IV infusion, for therapy/prophylaxis/diagnosis; initial, up to 1 hour | Fallback for payers that don't recognize ocrelizumab as chemo-eligible. |
96366 |
IV infusion, for therapy/prophylaxis/diagnosis; each additional hour | Pair with 96365. |
Practical workflow: maintain a per-payer crosswalk. Default to 96413/96415; flip to 96365/96366 for payers known to deny. The reimbursement difference matters — chemo admin codes carry a higher RVU than therapeutic infusion codes. For NCCI procedure-to-procedure edits, see the CMS NCCI edit tables.
Modifiers CMS verified May 2026
JZ — required, every claim
Effective July 1, 2023, CMS requires the JZ modifier on all claims for single-dose container drugs when no drug is discarded. Ocrevus is supplied in a 300 mg single-dose vial; both the 300 mg and 600 mg doses use whole vials with no remainder. JZ applies to every Ocrevus claim.
JW — does NOT apply
JW is for documenting the discarded portion of a single-dose vial. Because Ocrevus doses use complete vials with zero remainder, there is no drug to discard and JW is not used.
Modifier 25 — situational
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion. Documentation must clearly support that the E/M service was distinct from the routine pre-infusion assessment.
340B modifiers (JG, TB)
For 340B-acquired Ocrevus, follow your MAC's current 340B modifier policy (JG for Medicare Advantage / outpatient claims at most rates, TB for the discounted ASP rate). The manufacturer billing guide does not provide 340B-specific instructions.
ICD-10-CM diagnosis codes Effective Oct 1, 2025
G35 family expanded effective October 1, 2025. Many payers reject the parent code.
| ICD-10 | Description | Use for |
|---|---|---|
G35 | Multiple sclerosis (parent) | Avoid — many payers reject |
G35.A | Relapsing-remitting multiple sclerosis | RRMS indication |
G35.B0 | Primary progressive MS, unspecified | PPMS, activity not characterized |
G35.B1 | Active primary progressive MS | PPMS with active disease |
G35.B2 | Non-active primary progressive MS | PPMS without active disease |
G35.C0 | Secondary progressive MS, unspecified | SPMS, activity not characterized |
G35.C1 | Active secondary progressive MS | SPMS with relapses (covered indication) |
G35.D | Multiple sclerosis, unspecified | Disseminated MS, NOS |
Site of care & place of service Verified May 2026
Ocrevus is most commonly administered in the physician office (POS 11) or ambulatory infusion suite (POS 49). Hospital outpatient (POS 19/22) is increasingly disfavored by commercial payers due to higher facility fees.
Both UnitedHealthcare and Aetna run separate site-of-care utilization-management policies that steer Ocrevus infusions away from hospital outpatient toward non-hospital sites or home infusion. If your practice operates under a hospital's billing TIN, expect a payer challenge.
| Setting | POS | Claim form | Electronic |
|---|---|---|---|
| Physician office | 11 | CMS-1500 | 837P |
| Ambulatory infusion suite | 49 | CMS-1500 | 837P |
| Hospital outpatient | 19 or 22 | UB-04 / CMS-1450 | 837I |
| Patient home | 12 | CMS-1500 (with home-infusion HCPCS) | 837P |
Home administration billing Verified May 2026
Home infusion of Ocrevus is supported by Genentech and reimbursed by an increasing number of commercial payers (Optum, Coram, Option Care). Home admin uses a different code set than in-office.
| Code | Type | Description |
|---|---|---|
99601 | CPT | Home infusion/specialty drug administration, per visit (up to 2 hours) |
99602 | CPT add-on | Home infusion administration, each additional hour |
S9329 | HCPCS | Home infusion therapy, chemotherapy infusion; per diem (do not bill with S9330/S9331) |
S9379 | HCPCS | Home infusion therapy, NOC; per diem |
Claim form field mapping Genentech v6.0 / Sept 2025
From Genentech "Coding & Billing for Ocrevus" v6.0 (September 2025).
CMS-1500 / 837P (physician office, POS 11/49)
| Information | CMS-1500 box | Electronic loop / segment |
|---|---|---|
| NPI | 17b | 2310A/2420E/2310D — NM109 |
| Drug info (name, dose, NDC, route) | 19 | 2300 NTE/PWK |
| ICD-10 | 21 | 2300 HI01-2 |
| PA number | 23 | 2300 REF02 |
| Dates of service | 24A | 2400 DTP03 |
| HCPCS + NDC (N4) + admin CPT + modifiers | 24D | 2400 SV101 (each on its own line) |
| Units | 24G | 2400 SV104 |
UB-04 / 837I (hospital outpatient, POS 19/22)
| Information | UB-04 box | Electronic loop / segment |
|---|---|---|
| Revenue code | 42 | 2400 SV201 |
| NDC w/ N4 qualifier | 43 | 2410 LIN03 |
| HCPCS / CPT admin + modifiers | 44 | 2400 SV202-2 (each on its own line) |
| Units | 46 | 2400 SV205 |
| NPI | 56 | 2010AA — MB1/85/09 |
| Treatment auth codes | 63 | 2300 REF/G1/02 |
| ICD-10 | 67 | 2300 HI01-2 |
Form references: NUCC (CMS-1500) · NUBC (UB-04).
Payer policy snapshot Reviewed May 2026
Verify policies directly with each payer before submission.
| Payer | PA? | Step therapy? | Site-of-care steering | Pediatric | Re-auth |
|---|---|---|---|---|---|
| UnitedHealthcare Policy 2026D0056P |
Yes | No | Yes (separate policy) | FDA label (RMS ≥10) | 12 mo |
| Aetna CPB 0264 |
Yes | No | Yes (separate policy) | Case-by-case | Continuous w/ response |
| Horizon BCBS-NJ Policy 150 |
Yes (MagellanRx) | No | Not in policy | No (18+ only) | 6 mo |
Strictest policy — Horizon BCBS-NJ
Horizon BCBS-NJ (Policy 150) imposes the most stringent initial criteria of the three:
- RMS: MRI of the brain showing abnormalities consistent with MS, AND at least 2 documented clinical relapses in the previous 2 years (or 1 in the past year)
- PPMS: Pyramidal Functional Systems Scale score ≥2, AND elevated IgG index OR ≥1 IgG oligoclonal band in CSF
- Both: Mandatory hepatitis B screening (negative HBsAg/anti-HBV); no live vaccines within 6 weeks; no active infection
- RMS only: Neurologic stability for 30 days prior to initiation
Common non-covered uses (all three payers)
Rheumatoid arthritis, systemic lupus erythematosus, lupus nephritis, autoimmune encephalitis, and combinations with other DMTs or B-cell-targeted therapies (rituximab, ofatumumab, ublituximab) are non-covered or "experimental" across UHC, Aetna, and BCBS.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J2350
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
Coverage
There is no NCD or LCD specific to ocrelizumab. Coverage falls under the generic drug-coverage LCD framework (e.g., LCD L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses at Novitas / First Coast). All MACs cover J2350 for FDA-approved on-label indications. Bill with a specific G35.x ICD-10.
Code history
- Q9010 — temporary code, effective Jan 1, 2017 (post-FDA approval)
- J2350 — permanent code, effective Jan 1, 2018
Canonical code source: CMS HCPCS quarterly update file.
Patient assistance & copay support Genentech verified May 2026
- OCREVUS Co-pay Program — commercial patients only. Up to annual program limits per Genentech terms.
- Genentech Patient Foundation — free drug for uninsured/underinsured eligible patients.
- Patient Navigator: 1-844-OCREVUS / 1-844-627-3887 (M–F 9 a.m.–8 p.m. ET).
- Genentech Spoilage Program: 1-800-551-2231 — replaces spoiled, damaged, or contaminated product.
- Enrollment: genentech-access.com
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong administration code | 96413 used with a payer that requires 96365 | Maintain payer crosswalk; resubmit with 96365/96366. |
| Modifier denial (JW) | JW used instead of JZ on a single-dose vial claim | Resubmit with JZ on every line. JW does not apply (no waste). |
| ICD-10 too broad | G35 (parent) used instead of a specific G35.x | Use G35.A (RRMS), G35.B0–B2 (PPMS), or G35.C1 (SPMS active). |
| Site of care | Hospital outpatient under a payer with site-of-care UM | Move to ambulatory infusion suite or home infusion. Submit medical necessity letter if hospital required. |
| PA not on file | Initial dose given before authorization confirmed | Submit with appeal + clinical documentation. Future doses: confirm PA letter before each infusion (re-auths required q12mo at UHC, q6mo at Horizon). |
| NDC format | 10-digit NDC submitted; payer requires 11-digit | Use 11-digit form: 50242-0150-01 with N4 qualifier. |
Frequently asked questions
What is the HCPCS code for Ocrevus?
Ocrevus (intravenous ocrelizumab) is billed under HCPCS J2350 — "Injection,
ocrelizumab, 1 mg." Each milligram equals one billable unit, so a 600 mg maintenance dose is
billed as 600 units. The subcutaneous formulation, Ocrevus Zunovo, uses a separate code:
J2351.
How many billing units are in a 600 mg dose of Ocrevus?
A 600 mg maintenance dose of Ocrevus is billed as 600 units under
J2350 (1 mg = 1 unit). The initial dose is split into two 300 mg infusions two
weeks apart, each billed as 300 units.
What administration CPT code do I use for Ocrevus?
Genentech recommends 96413 (chemotherapy IV infusion, initial hour) and
96415 (each additional hour). Some payers do not recognize ocrelizumab as a
chemotherapy administration drug; for those payers, use 96365 and
96366 (therapeutic IV infusion). Verify with each payer's policy.
Does the JW modifier apply to Ocrevus?
No. Ocrevus is supplied in a 300 mg single-dose vial; a 600 mg maintenance dose uses two
complete vials with no remainder. The JZ modifier (zero drug discarded) is
required on every Ocrevus claim under CMS's July 2023 single-dose container policy. JW does
not apply because there is no drug remaining to discard.
What is the Medicare reimbursement for J2350?
For Q2 2026, the Medicare Part B payment limit for J2350 is $59.596 per mg (ASP + 6%). A 600 mg maintenance dose is reimbursed at approximately $35,757.60 before sequestration. Sequestration (~2%) reduces the actual paid amount to roughly ASP + 4.3%. ASP is updated quarterly by CMS.
Do commercial payers require step therapy for Ocrevus?
No. UnitedHealthcare, Aetna, and major BCBS plans approve Ocrevus as a first-line disease-modifying therapy for relapsing MS, CIS, and PPMS. Prior authorization is required, but no trial of interferon, glatiramer, or other DMTs is required first. Site-of-care steering is the dominant utilization-management lever, not step therapy.
Is Ocrevus a medical benefit or pharmacy benefit drug?
Medical benefit. Ocrevus is provider-administered (buy-and-bill) and submitted by the
administering provider under J2350. It is not dispensed through specialty
pharmacy under the pharmacy benefit at any major commercial payer reviewed (UHC, Aetna,
Horizon BCBS).
Can the parent code G35 be used for the Ocrevus diagnosis?
Many payers will not accept the parent code G35 alone. Use a specific G35.x code:
G35.A for relapsing-remitting MS, G35.B0–B2 for primary progressive MS, G35.C0–C1
for secondary progressive MS, or G35.D for unspecified MS. The G35.A–G35.D codes were
effective October 1, 2025.
Source documents
- Genentech — Tips and Considerations for Claims Submission: Ocrevus & Ocrevus Zunovo
- DailyMed — Ocrevus (ocrelizumab) Prescribing Information
- Drugs@FDA — Ocrevus (BLA 761053) approval history
- FDA approval letter — Ocrevus Zunovo (BLA 761371)
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file (canonical J-code source)
- CMS LCD L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
- FDA National Drug Code Directory
- CMS NCCI — National Correct Coding Initiative edit tables
- UnitedHealthcare Commercial Medical Benefit Drug Policy: Ocrevus / Ocrevus Zunovo
- Aetna Clinical Policy Bulletin 0264 — Multiple Sclerosis
- Horizon BCBS New Jersey Policy 150 — Ocrelizumab (Ocrevus)
- Genentech Access Solutions
About this page
We maintain this page as a living reference. The drug fact card and Medicare ASP pricing are bound to our underlying CareCost data layer and refresh automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly update file and AMA CPT releases. |
| NDC, dosing, FDA label | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer source: v6.0 Sept 2025. FDA label: Aug 2025. Payer policies: UHC 2026D0056P, Aetna CPB 0264, Horizon BCBS-NJ Policy 150.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents on a quarterly cadence. We do not paraphrase from billing-software vendor blogs. When manufacturer guidance and payer policy conflict (as happens with the 96413 vs. 96365 administration code question), we surface the conflict rather than picking a side.