SC vs. IV formulations — J2351 vs. J2350 FDA verified Aug 2025
The single most common biller error on this drug. Every billing axis differs.
Ocrevus has two FDA-approved formulations from Genentech: the original intravenous infusion (Ocrevus, J2350, approved 2017) and the newer subcutaneous injection (Ocrevus Zunovo, J2351, approved September 2024 with permanent J-code effective April 1, 2025). Both treat the same MS indications, but they are not interchangeable for billing.
| Ocrevus Zunovo (SC) | Ocrevus (IV) | |
|---|---|---|
| HCPCS | J2351 | J2350 |
| NDC | 50242-0554-01 | 50242-0150-01 |
| Vial size | 920 mg + 23,000 U / 23 mL | 300 mg / 10 mL |
| Maintenance dose | 920 mg q6mo | 600 mg q6mo |
| Initial dose | Same (no loading split) | 300 mg × 2, 14 days apart |
| Billable units | 920 | 600 |
| Administration CPT | 96401 / 96372 | 96413 / 96365 |
| Time to administer | ~10 minutes (SC, abdomen) | 2–3.5 hours (IV) |
| Premedication | Dexamethasone 20 mg PO + antihistamine | Methylprednisolone 100 mg IV + antihistamine |
| Wastage modifier (JZ) | Required | Required |
| Q2 2026 ASP+6% | $46.794/mg | $59.596/mg |
| FDA approval | September 2024 (BLA 761371) | March 2017 (BLA 761053) |
J2351. If it says "infusion," "IV," or runs 2+ hours,
bill J2350. The unit math is fundamentally different (920 vs 600); a wrong code produces a denial
or a 35% billing error.
This page covers the SC formulation (Zunovo, J2351). For the IV reference, see Ocrevus (J2350).
Dosing & unit math FDA label Aug 2025
From FDA prescribing information, label revised August 2025 (BLA 761371).
FDA-labeled dose schedule (verbatim):
"920 mg/23,000 units (920 mg ocrelizumab and 23,000 units of hyaluronidase) administered as a single 23 mL subcutaneous injection in the abdomen over approximately 10 minutes every 6 months."
- No split loading dose. Unlike IV Ocrevus, the very first Zunovo dose is the full 920 mg.
- Maintenance: single 920 mg SC injection every 6 months.
- Site: abdomen only (per FDA label).
- Time per dose: ~10 minutes.
- 1 mg = 1 unit: bill 920 units per dose.
Worked example — first-year billing for a new patient
Drug units billed: 920
HCPCS: J2351 · Modifier: JZ · Vials: 1 × 920 mg
# Month 6 — second 920 mg SC injection
Drug units billed: 920
HCPCS: J2351 · Modifier: JZ · Vials: 1 × 920 mg
# Total year-1 drug units billed: 1,840
# Year-1 dose count: 2 (vs. 4 for IV Ocrevus initial year)
Required premedication (label-mandated)
Premedications differ from IV Ocrevus — do not copy IV protocols:
- Dexamethasone 20 mg PO (or equivalent corticosteroid), at least 30 minutes prior
- Antihistamine (e.g., desloratadine), at least 30 minutes prior
- Antipyretic optional
Note: oral dexamethasone (PO), not IV methylprednisolone. The FDA label explicitly specifies dexamethasone for Zunovo. Bill the corticosteroid and antihistamine separately if the practice supplies them.
NDC reference FDA NDC Directory verified May 2026
| NDC (10-digit) | NDC (11-digit, claim form) | Package | Manufacturer |
|---|---|---|---|
50242-554-01 |
50242-0554-01 |
920 mg ocrelizumab + 23,000 U hyaluronidase in 23 mL (40 mg/mL + 1,000 U/mL), single-dose vial | Genentech, Inc. |
N4 qualifier in CMS-1500 Box 24A and UB-04 Box 43.
Canonical source: FDA National Drug Code Directory.
Administration codes CPT verified May 2026
The 96401 vs. 96372 fork is the most common payer denial trigger on this drug.
| Code | Description | When to use |
|---|---|---|
96401 |
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic | Manufacturer-recommended. Use for payers that recognize ocrelizumab/hyaluronidase as a "complex biologic" eligible for chemo administration. |
96372 |
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular | Fallback for payers that don't recognize ocrelizumab as chemo-eligible. Default for commercial home-infusion contracts. |
Practical workflow: maintain a per-payer crosswalk. Default to 96401; flip to 96372 for payers known to deny. The reimbursement difference is modest for SC (10-minute) administration but matters for high-volume practices. Codes 96369–96371 (SC infusion via pump) do NOT apply — Zunovo's ~10-minute single injection falls below the 96369 hour-based infusion threshold.
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 Zunovo is supplied in a 920 mg single-dose vial used in full per dose, with no remainder. JZ applies to every Zunovo claim.
JW — does NOT apply
JW is for documenting the discarded portion of a single-dose vial. Because each Zunovo dose uses the complete vial with zero remainder, there is no drug to discard and JW is not used. Per CMS, J2351 is not on the JW/JZ single-dose container list in the conventional sense — the entire vial is administered. Genentech does not provide JW guidance for Zunovo.
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 injection. Genentech's Zunovo billing guide lists modifier 25 explicitly, anticipating frequent same-day E/M billing for this drug.
340B modifiers (JG, TB)
For 340B-acquired Zunovo, follow your MAC's current 340B modifier policy. The manufacturer billing guide does not provide 340B-specific instructions.
ICD-10-CM diagnosis codes Effective Oct 1, 2025
Identical list to IV Ocrevus — no Zunovo-specific ICD-10. Many payers reject the parent code G35.
| 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
Because Zunovo is a 10-minute SC injection, it can be administered in any of the following with no infusion-suite requirement:
| 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 administration of Zunovo is a real option given the 10-minute SC injection. Billing differs sharply between Medicare and commercial payers — do not use the same code set for both.
Medicare home admin (Part B Home Infusion Therapy benefit)
| Code | Type | Description |
|---|---|---|
G0089 | HCPCS | Professional services, initial visit, SC immunotherapy or other SC infusion drug administration in patient's home, each 15 minutes |
G0069 | HCPCS | Same as above, subsequent visits, each 15 minutes |
Commercial home admin (most non-Medicare plans)
| Code | Type | Description |
|---|---|---|
S9329 | HCPCS | Home infusion therapy, chemotherapy infusion; per diem |
S9330 | HCPCS | Home infusion therapy, continuous chemotherapy; per diem |
S9331 | HCPCS | Home infusion therapy, intermittent anti-emetic; per diem |
96372 | CPT | Therapeutic SC/IM injection (the actual administration) |
Genentech does not maintain a Zunovo-exclusive home infusion network. Patients route through whatever specialty pharmacy or home-infusion vendor their plan dictates — commonly Option Care, Coram, Optum Specialty, Accredo, BriovaRx, or Vivo Infusion. Coordinate through Genentech Access Solutions (1-844-OCREVUS).
Claim form field mapping Genentech v6.0 / Sept 2025
From Genentech "Coding & Billing for Ocrevus & Ocrevus Zunovo" 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, amount, strength) | 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 |
Form references: NUCC (CMS-1500).
Payer policy snapshot Reviewed May 2026
All major payers cover Zunovo at parity with IV Ocrevus — usually under a single combined policy.
| Payer | PA? | IV-first step? | SoC steering | Pediatric | Re-auth |
|---|---|---|---|---|---|
| UnitedHealthcare Policy 2026D0056P (combined) |
Yes | No | Yes (separate policy) | No | 12 mo |
| Aetna CPB 0264 (combined) |
Yes | No | Yes (separate policy) | Case-by-case | Continuous w/ response |
| Cigna Policy IP0705 |
Yes | No | Standard SoC policy | No | w/ documented response |
| SC BCBS / Anthem-Carelon Combined policy |
Yes | No | Site-of-care UM applies | No | w/ response |
What's the same as IV Ocrevus
- Indications covered: RRMS, active SPMS, PPMS, CIS
- Combined PA criteria (one policy, both formulations)
- No commercial step therapy
- Site-of-care UM applied equally
- Same ICD-10 codes accepted
What's different from IV Ocrevus
- Pediatric: Zunovo is FDA adult-only (18+); IV Ocrevus is FDA-labeled for RMS ≥10. No payer extends pediatric off-label allowance to Zunovo.
- McDonald Criteria documentation: some payers (e.g., SC Blues) require lighter diagnostic documentation for Zunovo than for IV Ocrevus.
- Admin code denials: 96401 denials are more common for Zunovo than for IV (where 96413 denials drive the fork). Have 96372 ready as fallback.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J2351
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 at Novitas / First Coast). All MACs cover J2351 for FDA-approved on-label indications. Bill with a specific G35.x ICD-10.
Code history
- C9173 — temporary code, effective post-FDA approval (Q4 2024)
- J2351 — permanent code, effective April 1, 2025
Canonical code source: CMS HCPCS quarterly update file.
Patient assistance & copay support Genentech verified May 2026
- OCREVUS / OCREVUS ZUNOVO Co-pay Program — commercial patients only, single program covering both formulations
- 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
- Enrollment: genentech-access.com
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong J-code (J2350 instead of J2351) | SC dose billed under the IV J-code — or vice versa | Verify formulation in encounter notes. SC = J2351, 920 units. IV = J2350, 600 units. |
| Admin code denial (96401) | Payer doesn't recognize ocrelizumab/hyaluronidase as chemo-eligible | Resubmit with 96372. Maintain payer crosswalk. |
| Modifier denial (JW) | JW used instead of JZ on a single-dose vial claim | Resubmit with JZ. JW does not apply (no waste). |
| Home admin code mismatch | G0089/G0069 used on a commercial claim | Resubmit with S9329-S9331 + 96372 for commercial. G-codes are Medicare HIT-only. |
| 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). |
| PA not on file | Initial dose given before authorization confirmed | Submit with appeal + clinical documentation. Combined Ocrevus+Zunovo PA at most payers; check before each q6mo dose. |
| NDC format | 10-digit NDC submitted; payer requires 11-digit | Use 11-digit form: 50242-0554-01 with N4 qualifier. |
| Pediatric Zunovo denial | Patient under 18; Zunovo is FDA adult-only | Switch to IV Ocrevus (FDA-labeled for RMS ≥10) or seek separate appeal — no payer reviewed covers pediatric Zunovo. |
Frequently asked questions
What is the HCPCS code for Ocrevus Zunovo?
Ocrevus Zunovo (subcutaneous ocrelizumab + hyaluronidase-ocsq) is billed under HCPCS
J2351 — "Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq." Each milligram of
ocrelizumab equals one billable unit, so the standard 920 mg dose is billed as 920 units. The intravenous
formulation (Ocrevus) uses a separate code: J2350. J2351 became a permanent J-code effective
April 1, 2025.
How many units do I bill for a 920 mg dose of Ocrevus Zunovo?
Bill 920 units under J2351 for every Ocrevus Zunovo dose. 1 mg of
ocrelizumab = 1 unit. The dose is fixed: a single 920 mg subcutaneous injection every 6 months, with no
split loading dose (unlike the IV version).
What administration CPT do I use for Ocrevus Zunovo?
Genentech recommends 96401 (chemotherapy administration, subcutaneous or intramuscular,
non-hormonal anti-neoplastic). Some payers — especially regional BCBS plans, Cigna, and Oscar —
do not recognize ocrelizumab/hyaluronidase as chemo-administration eligible and require 96372
(therapeutic SC/IM injection) instead. Default to 96401 and maintain a per-payer crosswalk for plans that
deny.
Does the JW modifier apply to Ocrevus Zunovo?
No. Ocrevus Zunovo is supplied in a 920 mg single-dose vial used in full for each dose, with no remainder.
The JZ modifier (zero drug discarded) is required on every claim under CMS's July 2023
single-dose container policy. JW does not apply because there is no drug discarded.
Is Ocrevus Zunovo billed differently from Ocrevus IV?
Yes — every billing axis differs. J2351 vs J2350. NDC 50242-554-01 vs 50242-150-01. 920 units vs 600 units (per maintenance dose). Admin CPT 96401 (SC chemo) vs 96413/96365 (IV chemo or therapeutic). 10-minute SC injection vs 2–3.5 hour IV infusion. Wrong code = denial or 35% billing error. Confirm formulation in encounter notes before billing.
What is the Medicare reimbursement for J2351?
For Q2 2026, the Medicare Part B payment limit for J2351 is $46.794 per mg (ASP + 6%). A 920 mg dose is reimbursed at approximately $43,050.48 before sequestration. Sequestration (~2%) reduces the actual paid amount to roughly ASP + 4.3%. ASP is updated quarterly by CMS.
Does Ocrevus Zunovo have separate payer policies from IV Ocrevus?
Most major payers cover both formulations under a single combined policy with parity criteria. UnitedHealthcare (2026D0056P) and Aetna (CPB 0264) both list J2350 and J2351 in the same medical-drug policy with identical PA and continuation criteria. No payer reviewed requires a trial of IV Ocrevus before approving Zunovo.
Can Ocrevus Zunovo be administered at home?
Yes, but the home-administration billing differs from in-office. For Medicare patients, use G0089
(initial visit) and G0069 (subsequent) — these are the CMS Home Infusion Therapy benefit
codes. For commercial patients, home infusion vendors typically bill S9329–S9331
(per-diem home-infusion HCPCS) plus 96372 — not 96401, because most commercial home-infusion
contracts exclude chemo-administration codes.
Source documents
- Genentech — Tips and Considerations for Claims Submission: Ocrevus & Ocrevus Zunovo
- Genentech Access Solutions — Billing & Coding for MS (Ocrevus Zunovo)
- DailyMed — Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) Prescribing Information
- FDA approval letter — Ocrevus Zunovo (BLA 761371)
- Genentech press release — September 13, 2024 approval
- 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
- UnitedHealthcare Commercial Medical Benefit Drug Policy: Ocrevus / Ocrevus Zunovo
- Aetna Clinical Policy Bulletin 0264 — Multiple Sclerosis
- Cigna IP0705 — Multiple Sclerosis: Ocrevus & Zunovo
- 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, Cigna) | 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, Cigna IP0705, SC Blues / Anthem-Carelon (combined Ocrevus + Zunovo policies).
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. We do not paraphrase from billing-software vendor blogs. When manufacturer guidance and payer policy conflict (as happens with the 96401 vs. 96372 administration code question, and the Medicare-vs-commercial home-admin code split), we surface the conflict rather than picking a side.