HCPCS
J2329
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the right code, dose, and NDC before building the claim.
Anti-CD20 MS DMT comparison FDA verified Feb 2026
All three drugs target CD20 to deplete B-cells, but every billing axis differs.
Briumvi competes directly with Ocrevus (IV) and Kesimpta (SC) in the anti-CD20 MS DMT space. They share a mechanism but differ on indication breadth, infusion time, and benefit channel.
| Briumvi | Ocrevus (IV) | Kesimpta | |
|---|---|---|---|
| Generic | ublituximab-xiiy | ocrelizumab | ofatumumab |
| HCPCS | J2329 | J2350 | J3490/J3590 (unclassified) |
| Manufacturer | TG Therapeutics | Genentech / Roche | Novartis |
| FDA approval | Dec 2022 | Mar 2017 | Aug 2020 |
| Route | IV infusion | IV infusion | SC self-injection |
| Maintenance dose | 450 mg q24wk | 600 mg q24wk | 20 mg q4wk |
| Maintenance time | ~1 hour | 2–3.5 hours | n/a (SC) |
| First-dose time | 4 hours | 2.5 hours (split 300 mg) | n/a (SC) |
| Approved for PPMS? | No | Yes | No |
| Maintenance billable units | 450 | 600 | n/a |
| Benefit channel | Medical (buy-and-bill) | Medical (buy-and-bill) | Pharmacy (specialty) |
Key billing differentiator: Briumvi's 1-hour maintenance infusion (vs Ocrevus's 2–3.5 hours)
collapses chair time and reduces 96415/96366 add-on hours, but Day 1 (4 hours) requires more chair time than
Ocrevus's first dose. Net facility economics depend on chair turnover. Briumvi maintenance reimburses
approximately 75% of Ocrevus's mg load (450 vs 600).
Indication mismatch: Briumvi is NOT FDA-approved for primary progressive MS (PPMS). If your
patient has PPMS, bill Ocrevus (J2350), not Briumvi. Do not bill J2329 with G35.B0/B1/B2 (PPMS) ICD-10
codes — will deny.
Dosing & unit math FDA label Feb 2026
From FDA prescribing information, label revised February 19, 2026 (BLA 761238).
FDA-labeled dose schedule (verbatim):
- Day 1: 150 mg IV infusion over 4 hours
- Day 15: 450 mg IV infusion over 1 hour
- Subsequent infusions: 450 mg IV every 24 weeks (every 6 months) over 1 hour
At 1 mg = 1 unit, every milligram administered is one billable unit. The loading regimen creates two distinct claim events with different unit counts; this is unique to Briumvi among the major MS DMTs.
Worked example — first-year billing for a new patient
# Day 1 — 150 mg infusion (4 hours)
Drug units billed: 150
HCPCS: J2329 · Modifier: JZ · Vials: 1 × 150 mg
Admin: 96413 (initial hr) + 96415 × 3 (3 add'l hrs) or 96365 + 96366 × 3
# Day 15 — 450 mg infusion (1 hour)
Drug units billed: 450
HCPCS: J2329 · Modifier: JZ · Vials: 3 × 150 mg
Admin: 96413 alone or 96365 alone (1 hour, no add-on)
# Month 6 — first 450 mg maintenance (1 hour)
Drug units billed: 450
# Month 12 — second 450 mg maintenance (1 hour)
Drug units billed: 450
# Total year-1 drug units billed: 1,500
Drug units billed: 150
HCPCS: J2329 · Modifier: JZ · Vials: 1 × 150 mg
Admin: 96413 (initial hr) + 96415 × 3 (3 add'l hrs) or 96365 + 96366 × 3
# Day 15 — 450 mg infusion (1 hour)
Drug units billed: 450
HCPCS: J2329 · Modifier: JZ · Vials: 3 × 150 mg
Admin: 96413 alone or 96365 alone (1 hour, no add-on)
# Month 6 — first 450 mg maintenance (1 hour)
Drug units billed: 450
# Month 12 — second 450 mg maintenance (1 hour)
Drug units billed: 450
# Total year-1 drug units billed: 1,500
Required premedication (label-mandated)
- Methylprednisolone 100 mg IV (or equivalent corticosteroid) ~30 min prior to each Briumvi infusion
- Antihistamine (e.g., diphenhydramine) PO or IV 30–60 min prior
- Antipyretic (acetaminophen) optional
Same premed regimen as Ocrevus IV. Bill the corticosteroid separately under J2920/J2930 + admin code.
Post-infusion observation
FDA label requires 1-hour monitoring after the Day 1 and Day 15 infusions. Subsequent infusions follow clinician discretion (typically waived absent prior reactions). Observation does not bill separately beyond the infusion code itself.
NDC reference FDA NDC Directory verified May 2026
| NDC (10-digit) | NDC (11-digit, claim form) | Package | Manufacturer |
|---|---|---|---|
73150-150-06 |
73150-0150-06 |
150 mg ublituximab-xiiy in 6 mL (25 mg/mL), single-dose vial — only SKU | TG Therapeutics, Inc. |
11-digit NDC required on most claim forms. Pad the middle segment with a leading zero:
73150-0150-06. Use the
N4 qualifier in CMS-1500 Box 24A and UB-04 Box 43.
Canonical source: FDA National Drug Code Directory.
Phase 2
Code the claim
Build the line items: admin code, modifiers, ICD-10, site of care.
Administration codes CPT verified May 2026
TG Therapeutics lists chemo and therapeutic infusion codes as parallel options — no stated preference.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Use for payers that recognize ublituximab as a "complex biologic" eligible for chemo administration. Defensible as ublituximab is a cytolytic CD20 mAb. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Day 1 only (4-hour infusion): pair 96413 + 96415 × 3. |
96365 |
IV infusion, for therapy/prophylaxis/diagnosis; initial, up to 1 hour | Fallback for payers that don't recognize ublituximab as chemo-eligible. |
96366 |
IV infusion, for therapy/prophylaxis/diagnosis; each additional hour | Day 1 only: pair 96365 + 96366 × 3. |
99601 / 99602 |
Home infusion administration, per visit (up to 2 hr) / each addl hr | Per TG manufacturer materials; home infusion supported. |
S9329 / S9379 |
Home infusion therapy per-diem HCPCS | Commercial home infusion vendors (Option Care, Coram, etc.). |
TG's stance: the manufacturer's billing guide (US-UBL-2200093v7, Sept 2025) lists 96413/96415
and 96365/96366 in parallel without expressing a preference. Most practices default to 96413/96415 because
the chemo admin codes pay materially more. Some commercial payers explicitly require 96365 for non-oncology
biologics — verify per payer.
Day 1 (4 hours) bills the 1st hour code + 3 add-on hours. Day 15 and maintenance (1 hour) bill the 1st hour code alone. 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 single-dose container claims when no drug is discarded. Briumvi's 150 mg/6 mL single-dose vial is used in whole-vial multiples (1 vial for the 150 mg dose, 3 vials for the 450 mg dose), so wastage is typically zero. JZ applies to every Briumvi claim.
JW — rarely applies
Use JW only if ≥1 mg is actually discarded. Because doses are exact whole-vial multiples, this is uncommon. TG's billing guide does not provide JW examples for Briumvi.
⚠️ Common error: Using JW (instead of JZ) on Briumvi claims. JW with 0 units
in the discarded field is a known denial trigger at several MACs. Use JZ, not JW.
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. Routine pre-infusion assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Briumvi, follow your MAC's current 340B modifier policy (JG for Medicare Advantage / outpatient claims; TB for the discounted ASP rate). TG's billing guide does not provide 340B-specific instructions.
ICD-10-CM diagnosis codes G35.x family eff. Oct 1, 2025
Briumvi covers relapsing forms of MS only — do NOT use PPMS codes (G35.B0/B1/B2).
| ICD-10 | Description | Use for Briumvi? |
|---|---|---|
G35 | Multiple sclerosis (parent) | Avoid — many payers reject parent code |
G35.A | Relapsing-remitting multiple sclerosis | Primary indication |
G35.B0–B2 | Primary progressive MS family | NO — Briumvi not FDA-approved for PPMS |
G35.C0 | Secondary progressive MS, unspecified | Use if active relapses |
G35.C1 | Active secondary progressive MS | Yes — covered indication (active SPMS) |
G35.D | Multiple sclerosis, unspecified | Acceptable when specific subtype not documented |
G37.9 | Demyelinating disease of CNS, unspecified | TG's guide uses for clinically isolated syndrome (CIS) |
PPMS denial risk: Briumvi billed with G35.B0/B1/B2 will deny because the FDA label does
not include PPMS. Carelon/Anthem CC-0227 explicitly excludes "primary progressive multiple sclerosis" from
coverage. If the patient has PPMS, switch to Ocrevus (J2350) which is FDA-approved for PPMS.
Site of care & place of service Verified May 2026
Briumvi's dosing creates two different site-of-care considerations. Day 1 (4-hour infusion) requires a setting with capacity for prolonged monitoring — typically hospital outpatient (POS 19/22) or a high-capacity ambulatory infusion center. Day 15 and maintenance (1-hour infusions) fit cleanly in physician office (POS 11) or ambulatory infusion suite (POS 49) — this is Briumvi's operational advantage over Ocrevus's longer maintenance.
| Setting | POS | Day 1 (4 hr) | Day 15 / Maintenance (1 hr) |
|---|---|---|---|
| Physician office | 11 | Tight on chair time | Ideal |
| Ambulatory infusion suite | 49 | Workable | Ideal |
| Hospital outpatient (on-campus) | 22 | Common for Day 1 | Disfavored by commercial UM |
| Hospital outpatient (off-campus) | 19 | Common for Day 1 | Disfavored by commercial UM |
| Patient home | 12 | Not recommended (4-hr observation needed) | Supported via S9329 + 99601/99602 |
Site-of-care opportunity: Briumvi's 1-hour maintenance fits a non-hospital infusion model
cleanly. Practices can use Day 1 hospital capacity, then transition the patient to office or AIC for all
subsequent doses. UHC and Aetna's site-of-care UM policies favor this transition.
Claim form field mapping TG v7 / Sept 2025
From TG Therapeutics "Briumvi Billing and Coding Guide" v7 (US-UBL-2200093v7, September 2025).
CMS-1500 / 837P (physician office, AIC; POS 11/49)
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| Drug info (name, dose, NDC, route) | 19 | 2300 NTE/PWK |
| ICD-10 | 21 | G35.A / G35.C1 / G35.D / G37.9 (no PPMS codes) |
| PA number | 23 | Required by UHC, Carelon, most BCBS |
| Dates of service | 24A | Day 1 + Day 15 + maintenance = separate claims |
| HCPCS J2329 + JZ + admin CPT | 24D | Each on its own line |
| Drug units | 24G | 150 (Day 1) or 450 (Day 15 + maintenance) |
UB-04 / 837I (hospital outpatient, POS 19/22)
For Day 1 hospital outpatient billing, use UB-04 with revenue code 0636 (drugs requiring detailed coding) for the J2329 line, plus the appropriate admin code in field 44. The 4-hour Day 1 infusion benefits from the institutional billing structure.
Form references: NUCC (CMS-1500) · NUBC (UB-04).
Phase 3
Get paid
Step therapy is the dominant denial driver. Plan ahead.
Payer policy snapshot Reviewed May 2026
Major payers gate Briumvi behind step therapy or non-preferred status. Aetna's January 2026 step removal is the exception.
| Payer | PA? | Step therapy / Preference | Quantity limit | Re-auth |
|---|---|---|---|---|
| UnitedHealthcare MA Part B Step Therapy IAP.001.29 (eff. 5/1/2026) |
Yes | NON-PREFERRED — Ocrevus / Ocrevus Zunovo are preferred | FDA-label dosing | 12 mo |
| Carelon / Anthem CC-0227 (rev 11/14/2025) |
Yes | Step therapy required: dimethyl fumarate (commercial) or Kesimpta (Medicaid) trial first | 450 mg q24wk; loading 150 + 450 | w/ disease stability |
| Aetna CPB 0264 + MedB 5738-A (eff. 1/1/2026) |
Yes | Step edits removed for majority of commercial patients (Jan 2026) | FDA-label dosing | w/ documented response |
Existing-utilizer exemption (UHC): Patients with a paid claim for Briumvi within the
prior 365 days are exempt from the step-therapy requirement. Pull claim history before submitting a new
Briumvi PA — an existing-utilizer status materially changes the approval pathway.
Carelon/Anthem coverage criteria (verbatim summary)
Per CC-0227 effective Nov 14, 2025, Briumvi approval requires:
- Diagnosis of relapsing forms of MS (RRMS, active SPMS, or CIS)
- Ambulation ≥100 m without aid
- Either ≥2 relapses in past 2 years, ≥1 relapse in past year, OR ≥1 T1 Gd-enhancing lesion in past year
- Commercial: documented inadequate response or intolerance to a "preferred fumaric acid derivative" (generic dimethyl fumarate), OR documented high disease activity on another DMT
- Medicaid: trial of preferred agent AND trial of Kesimpta required
Common non-covered uses (all payers)
Primary progressive MS, non-active secondary progressive MS, and combination with other DMTs (Ocrevus, Kesimpta, Tysabri, Lemtrada, etc.) are non-covered or "experimental" across UHC, Aetna, and BCBS.
What to document for approval
- Date(s) and outcomes of any prior DMT trial (dimethyl fumarate, glatiramer, etc.)
- EDSS score at baseline
- Recent MRI showing disease activity (T1 Gd-enhancing or new T2 lesion)
- Documentation of relapses with dates
- Hepatitis B screening (negative HBsAg, anti-HBc) — required by FDA label
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J2329
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$68.747
per mg / per unit
150 mg dose (Day 1)
$10,312.05
150 units × ASP+6%
450 mg dose (Day 15 + maint.)
$30,936.15
450 units × ASP+6%
Coverage
There is no NCD or LCD specific to ublituximab. Coverage falls under the generic drug-coverage LCD framework (e.g., LCD L33394 at Novitas / First Coast). All MACs cover J2329 for FDA-approved on-label indications. Bill with G35.A, G35.C1, G35.D, or G37.9 ICD-10. Do not bill with G35.B0/B1/B2 (PPMS) — will deny.
Code history
- Pre-July 2023 — billed under unclassified codes J3490 / J3590
- J2329 — permanent J-code, effective July 1, 2023
Canonical code source: CMS HCPCS quarterly update file.
Patient assistance — BRIUMVI Patient Support TG verified May 2026
- BRIUMVI Patient Support: 1-833-BRIUMVI / 1-833-274-8684, M–F
- Copay Assistance: commercially insured patients — $0 copay up to $20,000/year; up to $550 first-infusion / $350 subsequent-infusion administration cost coverage
- Quick Start program: free drug during coverage delays / prior auth pending
- Interim Dose program: bridges patients between commercial coverage transitions
- Patient Assistance Program (PAP): free drug for uninsured/underinsured at income thresholds ($100k/1, $125k/2, $150k/3, $175k/4 household)
- Foundations: for Medicare patients, refer to PAN, HealthWell, GoodDays — verify open funds quarterly
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J2329 pre-loaded.
Phase 4
Fix problems
Step-therapy denials, PPMS-coding mismatches, and unit-count errors are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Step therapy not met (UHC) | Briumvi billed first-line on UHC Medicare Advantage | Confirm existing-utilizer status (claim within prior 365 days). If not, document Ocrevus contraindication or initiate via Ocrevus first. |
| Step therapy not met (Carelon) | No documented dimethyl fumarate trial (commercial) or Kesimpta trial (Medicaid) | Submit DMF/Kesimpta trial documentation, OR document intolerance / contraindication. |
| Wrong Day 1 unit count | 450 units billed for Day 1 (which is 150 mg, not 450 mg) | Resubmit with 150 units. Day 1 = 150 mg/150 units; Day 15 + maintenance = 450 mg/450 units. |
| Wrong ICD-10 (PPMS) | G35.B0/B1/B2 used — Briumvi is not FDA-approved for PPMS | If patient has PPMS, switch to Ocrevus (J2350). Briumvi cannot be approved for PPMS regardless of payer. |
| Modifier denial (JW) | JW used instead of JZ on a single-dose vial claim | Resubmit with JZ. JW does not apply unless ≥1 mg actually wasted (rare). |
| ICD-10 too broad | G35 (parent) used instead of G35.x sub-code | Use G35.A (RRMS), G35.C1 (active SPMS), G35.D (unspecified), or G37.9 (CIS). |
| Admin code denial (96413) | Payer doesn't recognize ublituximab as chemo-eligible | Resubmit with 96365/96366. Maintain payer crosswalk. |
| NDC format | 10-digit NDC submitted; payer requires 11-digit | Use 11-digit form: 73150-0150-06 with N4 qualifier. |
| Site of care (Day 15 + maintenance) | Hospital outpatient billing on UHC/Aetna w/ site-of-care UM | Move maintenance to office or AIC. Day 1 hospital billing typically accepted. |
Frequently asked questions
What is the HCPCS code for Briumvi?
Briumvi (ublituximab-xiiy) is billed under HCPCS J2329 — "Injection, ublituximab-xiiy,
1 mg." Each milligram equals one billable unit. The standard 450 mg maintenance dose is billed as 450 units.
J2329 became a permanent J-code effective July 1, 2023; before that Briumvi was billed under unclassified
J3490 / J3590.
How is Briumvi dosed for MS?
Three-step regimen: Day 1 — 150 mg IV over 4 hours; Day 15 — 450 mg IV over 1 hour; then 450 mg IV every 24 weeks (every 6 months) over 1 hour. The loading regimen creates two separate claim events with different unit counts (150 then 450); maintenance is 450 units twice per year.
What administration CPT do I use for Briumvi?
TG Therapeutics' billing guide lists 96413/96415 (chemotherapy IV infusion) and
96365/96366 (therapeutic IV infusion) as parallel options without stated
preference. Most practices default to 96413/96415 because ublituximab is a CD20-directed cytolytic mAb.
Some commercial payers require 96365 for non-oncology biologics — verify per payer. Day 1 (4-hour
infusion) bills 96413 + 96415 × 3 (or 96365 + 96366 × 3); maintenance (1-hour) bills 96413
alone (or 96365 alone).
Is Briumvi step-therapy gated at major payers?
Often, yes. UnitedHealthcare's Medicare Advantage Part B Step Therapy program (effective May 1, 2026) explicitly classifies Briumvi as NON-PREFERRED, with Ocrevus and Ocrevus Zunovo preferred. Carelon/Anthem CC-0227 requires trial of dimethyl fumarate (commercial) or Kesimpta (Medicaid) before approving Briumvi. Aetna removed step edits for the majority of commercial patients effective January 2026 — a competitive shift worth noting.
Is Briumvi FDA-approved for primary progressive MS (PPMS)?
No. Briumvi is approved only for relapsing forms of MS in adults — clinically isolated syndrome (CIS), relapsing-remitting MS, and active secondary progressive MS. Unlike Ocrevus, Briumvi is NOT approved for primary progressive MS. Do not bill J2329 with G35.B0, G35.B1, or G35.B2 (PPMS) ICD-10 codes.
Does the JW modifier apply to Briumvi?
Rarely. Briumvi comes in 150 mg/6 mL single-dose vials. The 150 mg loading dose uses one vial; the 450 mg
dose uses three vials. Both doses are even multiples of the vial size, so wastage is typically zero. The
JZ modifier (zero drug discarded) is required on every claim under CMS's July 2023 single-dose
container policy. JW only applies if a partial vial is discarded — uncommon for Briumvi.
What is the Medicare reimbursement for J2329?
For Q2 2026, the Medicare Part B payment limit for J2329 is $68.747 per mg (ASP + 6%). The 150 mg Day 1 dose reimburses at approximately $10,312.05; the 450 mg Day 15 and maintenance doses at approximately $30,936.15 — before sequestration. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS.
How does Briumvi compare to Ocrevus and Kesimpta?
All three are anti-CD20 MS DMTs. Briumvi maintenance infuses in 1 hour vs Ocrevus's 2–3.5 hours, but Day 1 of Briumvi is 4 hours vs Ocrevus's 2.5 hours. Per-dose drug cost (mg × ASP) is lower for Briumvi (450 mg × $68.747) than Ocrevus IV (600 mg × $59.596) at Q2 2026 rates. Kesimpta (ofatumumab) is a self-administered SC injection (not IV) and is typically pharmacy benefit, not buy-and-bill. Briumvi is NOT approved for PPMS; Ocrevus IS approved for PPMS.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- TG Therapeutics — BRIUMVI Billing and Coding Guide
- DailyMed — BRIUMVI (ublituximab-xiiy) Prescribing Information
- BRIUMVI HCP — Dosing & Administration
- CMS — Medicare Part B Drug ASP Pricing File
- TG Therapeutics — Permanent J-code press release (July 2023)
- CMS — HCPCS quarterly update file (canonical J-code source)
- CMS LCD L33394 — Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
- UnitedHealthcare — Medicare Part B Step Therapy Programs IAP.001.29
- Carelon / Anthem — Medical Drug Clinical Criteria CC-0227 (Briumvi)
- Aetna Clinical Policy Bulletin 0264 — Multiple Sclerosis
- Aetna Medicare Part B Briumvi criteria (5738-A)
- FDA National Drug Code Directory
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes 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, Carelon, Aetna) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, payer documents — all linked above). Final review by our SME, Catherine Rose (CPC),
is in progress. Until that review is complete, treat this as a draft reference and verify each cited
source for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer source: TG v7 / Sept 2025. FDA label: Feb 2026 (BLA 761238). Payer policies: UHC IAP.001.29, Carelon CC-0227, Aetna CPB 0264 + MedB 5738-A.
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 admin codes 96413 vs 96365, and step-therapy requirements), we surface the conflict rather than picking a side.