HCPCS
J1823
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the right diagnosis (AQP4-IgG+ NMOSD or IgG4-RD), the right loading vs maintenance phase, and the right vial-to-dose math.
Uplizna vs the NMOSD alternatives FDA verified May 2026
Three FDA-approved biologics for AQP4-IgG-seropositive NMOSD, three mechanisms, three dosing intervals. IgG4-RD: Uplizna is currently the only approved therapy.
Uplizna is the third FDA-approved biologic for AQP4-IgG-seropositive NMOSD (after Soliris in June 2019 and Ultomiris label expansion in 2024) and the only one targeting CD19 — depleting a broader B-cell range than anti-CD20 agents because CD19 persists on plasmablasts and some plasma-cell precursors that have downregulated CD20. The companion-diagnostic gate is the same across all three: AQP4-IgG seropositivity, ideally documented by cell-based assay (CBA). Off-label rituximab (anti-CD20) was the historical mainstay before approved therapies and remains in occasional use, but it carries no NMOSD label.
| Uplizna | Soliris | Ultomiris | Rituxan (off-label) | |
|---|---|---|---|---|
| HCPCS | J1823 | J1299 | J1303 | J9312 |
| Generic | inebilizumab-cdon | eculizumab | ravulizumab-cwvz | rituximab |
| Target | CD19 (B cells + plasmablasts) | C5 complement | C5 complement | CD20 (B cells) |
| Manufacturer | Amgen (ex-Horizon) | Alexion / AZ Rare Disease | Alexion / AZ Rare Disease | Genentech (+ biosimilars) |
| NMOSD FDA approval | June 11, 2020 | June 27, 2019 | April 2024 (label expansion) | Not FDA-approved for NMOSD |
| Pivotal NMOSD trial | N-MOmentum | PREVENT | CHAMPION-NMOSD | RIN-1, others (open-label) |
| Dose interval (maintenance) | q6 months (2 doses/year) | q2 weeks (26 doses/year) | q8 weeks (~6-7 doses/year) | Variable; ~q6mo typical |
| REMS | None (boxed warning only) | Soliris REMS (meningococcal) | Ultomiris REMS (meningococcal) | None |
| Vaccination requirement | Live vaccines avoided; HepB screen before first dose | MenACWY + MenB ≥2 wk pre-dose | MenACWY + MenB ≥2 wk pre-dose | HepB screen; live-vaccine avoidance |
| Pediatric NMOSD label | No (adults only) | No | No | No |
| IgG4-RD label | Yes (4/3/2025) | No | No | No |
Choosing among the three: the operational tradeoff is infusion burden vs mechanism preference.
Uplizna's q6mo cadence (just 2 infusions per maintenance year) is unmatched. Soliris and Ultomiris work
upstream on complement (potentially faster onset of attack prevention) but carry mandatory MenACWY+MenB
vaccination and active REMS programs. Many neurologists now favor Uplizna for naive patients without active
attacks who want minimal infusion burden, and favor C5 inhibitors when complement-driven inflammation is
prominent. Payer steering varies; expect plan-by-plan policy review at PA.
AQP4-IgG-seronegative NMOSD is NOT a covered indication. All three approved biologics
(Uplizna, Soliris, Ultomiris) carry FDA labels for the seropositive subtype only. Patients who meet 2015
IPND clinical criteria for NMOSD but test AQP4-IgG-negative (some of whom may have MOG-IgG-associated disease)
will trigger PA denials on all three drugs. Confirm AQP4-IgG positivity by cell-based assay before submitting.
IgG4-RD: first approved therapy. Uplizna's April 3, 2025 label expansion made it the first
FDA-approved therapy for IgG4-related disease. Pre-approval treatment was off-label glucocorticoids first
line, with off-label rituximab as a steroid-sparing second line; both remain common but neither carries a
label. For PA, document IgG4-RD per the 2019 ACR/EULAR classification criteria or the Revised International
Pathology Society (RIPS) histopathologic criteria. Serum IgG4 elevation supports but does not confirm
diagnosis (only ~70% of patients have elevated IgG4).
Dosing & unit math FDA label current (4/2025 IgG4-RD expansion)
Loading: Day 1 + Day 15. Maintenance: q6mo. Flat 300 mg (not weight-based). Same regimen for NMOSD and IgG4-RD.
Adult dose schedule (NMOSD + IgG4-RD)
| Phase | Timing | Dose | J1823 units | Vials (100 mg) |
|---|---|---|---|---|
| Loading dose 1 | Day 1 | 300 mg IV | 300 units | 3 vials (JZ) |
| Loading dose 2 | Day 15 (14 days after dose 1) | 300 mg IV | 300 units | 3 vials (JZ) |
| Maintenance | Month 6 (counted from dose 1) and every 6 months thereafter | 300 mg IV | 300 units | 3 vials (JZ) |
- 1 unit = 1 mg under J1823 (descriptor: "Injection, inebilizumab-cdon, 1 mg")
- Per dose: 300 mg = 3 vials (3 × 100 mg) — whole-vial multiple, no waste, JZ applies
- Dilution: withdraw 30 mL (3 vials × 10 mL) and add to a 250 mL bag of 0.9% NaCl; final volume 250 mL
- Infusion rate: per FDA label, minimum 90-minute infusion; stepped rate during the first 30 minutes, then increased per tolerance
- Premedication 30–60 min pre-infusion: methylprednisolone 80–125 mg IV (or equivalent oral) + antihistamine (e.g., diphenhydramine 25–50 mg) + antipyretic (acetaminophen 650–1,000 mg)
- Storage: refrigerate vials at 2°C–8°C (36°F–46°F) in the original carton; protect from light; do not freeze or shake
- No weight-based adjustment — flat 300 mg dose for all adult patients
Required pre-treatment workup
- HBV serology: HBsAg, anti-HBc total, anti-HBs — required before first dose per boxed warning
- Tuberculosis screen per local practice (e.g., IGRA or TST) when clinically indicated
- Quantitative immunoglobulins at baseline; consider periodic monitoring during therapy
- Live attenuated vaccines should be administered ≥4 weeks before first dose; non-live vaccines ≥2 weeks before first dose
- AQP4-IgG status (NMOSD indication) — CBA preferred over ELISA
- IgG4-RD diagnostic criteria documentation: 2019 ACR/EULAR classification or RIPS histopathologic criteria, with biopsy report and IgG4 staining when available
Worked example — first-year billing for new NMOSD start
# Year 1: loading + first maintenance dose
# Day 1 (loading dose 1): 300 mg
Drug units billed: 300 · HCPCS: J1823 · Vials: 3 × 100 mg
Modifier: JZ (3 full vials, no waste)
Admin: 96365 x1 + 96366 x1 (90+ min therapeutic IV) + premedications
# Day 15 (loading dose 2): 300 mg
Drug units billed: 300 · HCPCS: J1823 · Vials: 3 × 100 mg
Modifier: JZ · Admin: 96365 + 96366
# Month 6 (first maintenance): 300 mg
Drug units billed: 300 · HCPCS: J1823 · Vials: 3 × 100 mg
Modifier: JZ · Admin: 96365 + 96366
# Year 1 totals (3 infusions):
Total mg / units: 900 mg / 900 units
Total Medicare ASP+6% drug spend: $445,990.50 (3 × $148,663.50)
# Steady-state maintenance year (2 infusions):
Total mg / units: 600 mg / 600 units
Total Medicare ASP+6%: $297,327.00 (2 × $148,663.50)
# Day 1 (loading dose 1): 300 mg
Drug units billed: 300 · HCPCS: J1823 · Vials: 3 × 100 mg
Modifier: JZ (3 full vials, no waste)
Admin: 96365 x1 + 96366 x1 (90+ min therapeutic IV) + premedications
# Day 15 (loading dose 2): 300 mg
Drug units billed: 300 · HCPCS: J1823 · Vials: 3 × 100 mg
Modifier: JZ · Admin: 96365 + 96366
# Month 6 (first maintenance): 300 mg
Drug units billed: 300 · HCPCS: J1823 · Vials: 3 × 100 mg
Modifier: JZ · Admin: 96365 + 96366
# Year 1 totals (3 infusions):
Total mg / units: 900 mg / 900 units
Total Medicare ASP+6% drug spend: $445,990.50 (3 × $148,663.50)
# Steady-state maintenance year (2 infusions):
Total mg / units: 600 mg / 600 units
Total Medicare ASP+6%: $297,327.00 (2 × $148,663.50)
NDC reference FDA NDC Directory verified May 2026
| NDC (10-digit) | NDC (11-digit, claim form) | Strength | Package Size | Units / Vial (J1823) |
|---|---|---|---|---|
75987-140-01 |
75987-0140-01 |
100 mg / 10 mL (10 mg/mL) | Single-dose vial, carton of 1 | 100 units (1 mg = 1 unit) |
Manufacturer: Amgen Inc. (labeler code 75987). The Amgen labeler replaced the prior Horizon
Therapeutics labeler code following Amgen's October 2023 acquisition of Horizon. Older Horizon-labeled
inventory may carry a legacy labeler — confirm the vial carton label before billing.
11-digit NDC required on most claim forms. Pad the middle segment with a leading zero:
75987-0140-01. Use the
N4 qualifier in CMS-1500 Box 24A shaded area and UB-04
Box 43. Format: N475987014001ML30 (Uplizna, 3 vials = 30 mL).
Whole-vial multiples make this drug simple. The flat 300 mg dose paired with a 100 mg vial
yields exactly 3 vials per infusion with zero discard for every patient at every visit. JW (waste) modifier
is rarely if ever applicable on label-conformant Uplizna claims. JZ (no waste) is the universal modifier.
Phase 2
Code the claim
Build the line items: 96365 + 96366 admin pair, JZ modifier, diagnosis-specific ICD-10, and the right place of service.
Administration codes CPT verified May 2026
Uplizna is non-chemotherapeutic. Use therapeutic infusion codes; 90+ minute infusion typically triggers initial + each-additional-hour pairing.
| Code | Description | When to use |
|---|---|---|
96365 |
IV infusion, for therapy/prophylaxis/diagnosis; initial, up to 1 hour | Primary admin code for the first hour of the Uplizna infusion. |
+96366 |
IV infusion, for therapy/prophylaxis/diagnosis; each additional hour | Typically billed. The labeled minimum 90-minute infusion plus pre-infusion premedication time generally pushes total infusion past the first hour, supporting 1 unit of 96366. Document total infusion start/stop times. |
96367 |
Each additional sequential infusion of new drug, up to 1 hour | Use for premedications (steroid, antihistamine) administered as separate IV infusions, when given as additional sequential infusions rather than IV push. |
96375 |
Therapeutic, prophylactic, or diagnostic IV push; each additional sequential IV push of new substance | Use when premedications are given IV push during the same encounter. |
96413 / 96415 |
Chemotherapy IV administration codes | Not appropriate. Inebilizumab is a non-chemotherapeutic monoclonal antibody. Some payers historically allowed 96413 for biologics; current AMA/CMS guidance is to use 96365 for non-chemo IV infusions. |
Premedication billing: the methylprednisolone + antihistamine + antipyretic pre-infusion regimen
is separately billable. Bill the drugs (e.g., J2920/J2930 for methylprednisolone, J1200 for diphenhydramine)
plus their admin codes (96375 for sequential IV push, 96367 for sequential infusion). Acetaminophen oral is
not separately billable.
Document start/stop times. The 90-minute minimum infusion typically pushes total billable
infusion time past the first hour, supporting 96366 for the additional time. Without documented start/stop
times, MACs may deny the +96366 add-on as not supported.
Modifiers CMS JZ/JW policy verified May 2026
JZ — whole-vial use, universal for Uplizna
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container drug claims where no drug is discarded. Uplizna's flat 300 mg dose pairs with the 100 mg/10 mL single-dose vial to yield exactly 3 vials per infusion with zero waste for every adult patient at every visit. JZ is therefore the default and effectively universal modifier on Uplizna claims.
JW — vial wastage (essentially N/A for label-conformant dosing)
Because the 300 mg flat dose is a whole-vial multiple of the 100 mg single-dose vial, no drug is discarded on a normally executed Uplizna infusion. JW is therefore rarely applicable. Edge cases where JW could apply: partial-vial preparation due to a documented preparation error (still must be billed honestly per chart), or off-label dose modifications. Document any wasted volume in the medical record.
Worked JZ/JW example — standard 300 mg dose
# Standard adult 300 mg loading or maintenance dose
Vials drawn: 3 × 100 mg = 300 mg
Drug administered: 300 mg
Drug discarded: 0 mg
Line 1: J1823 units = 300, modifier = JZ
Line 2 (JW): not applicable — no waste on label-conformant dosing
# Compare: a hypothetical 250 mg dose (off-label) would create waste
Vials drawn: 3 × 100 mg = 300 mg · Drug administered: 250 mg · Drug discarded: 50 mg
Line 1: J1823 = 250, no JW · Line 2: J1823 = 50, modifier JW
(Off-label scenario shown for illustration; the FDA-approved dose is 300 mg flat.)
Vials drawn: 3 × 100 mg = 300 mg
Drug administered: 300 mg
Drug discarded: 0 mg
Line 1: J1823 units = 300, modifier = JZ
Line 2 (JW): not applicable — no waste on label-conformant dosing
# Compare: a hypothetical 250 mg dose (off-label) would create waste
Vials drawn: 3 × 100 mg = 300 mg · Drug administered: 250 mg · Drug discarded: 50 mg
Line 1: J1823 = 250, no JW · Line 2: J1823 = 50, modifier JW
(Off-label scenario shown for illustration; the FDA-approved dose is 300 mg flat.)
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 vital signs and protocol-driven assessment are bundled into the infusion service.
340B modifiers (JG, TB)
For 340B-acquired Uplizna, follow your MAC's current 340B modifier policy. CY 2026 OPPS continued post-American Hospital Association v. Becerra remediation; verify current MAC instructions and apply JG / TB per local guidance.
ICD-10-CM diagnosis codes FY2026 verified May 2026
NMOSD (G36.0) and IgG4-related disease (various, by organ involvement).
| ICD-10 | Description | Indication | Notes |
|---|---|---|---|
G36.0 | Neuromyelitis optica (Devic's disease) | NMOSD (AQP4-IgG+) | Primary NMOSD code; requires documented AQP4-IgG seropositivity |
H46.10 / H46.11 / H46.12 | Optic neuritis, unspecified / right / left eye | Secondary NMOSD code | Use as secondary when active optic neuritis attack documented |
G37.3 | Acute transverse myelitis in demyelinating disease of central nervous system | Secondary NMOSD code | Use as secondary when transverse myelitis attack documented |
M35.81 | Multifocal fibrosclerosis | IgG4-RD (multi-organ) | Best-fit code for multi-organ IgG4-RD; some payers prefer organ-specific codes below |
K86.1 | Other chronic pancreatitis (incl. autoimmune pancreatitis, type 1) | IgG4-RD (pancreas) | Type 1 autoimmune pancreatitis is the prototypical IgG4-RD presentation |
K83.01 | Primary sclerosing cholangitis | IgG4-RD differential | IgG4-related sclerosing cholangitis often miscoded as PSC; histology distinguishes |
K11.20 | Sialoadenitis, unspecified | IgG4-RD (salivary, Mikulicz disease) | Use when IgG4-related sialadenitis (Mikulicz / Kuttner tumor) documented |
N13.5 / K68.12 | Hydronephrosis with obstruction (RPF) / retroperitoneal fibrosis | IgG4-RD (retroperitoneum) | Use for IgG4-related retroperitoneal fibrosis (Ormond disease) presentation |
N16 (sequence with underlying) | Renal tubulo-interstitial disorders in diseases classified elsewhere | IgG4-RD (kidney) | For IgG4-related tubulointerstitial nephritis; sequence after the underlying classification |
H05.119 | Idiopathic orbital inflammation, unspecified orbit | IgG4-RD (orbital) | For IgG4-related orbital disease; document histology if biopsied |
AQP4-IgG seronegative NMOSD is NOT a covered Uplizna indication. The N-MOmentum pivotal trial
and the FDA label both restrict the NMOSD indication to AQP4-IgG-seropositive disease. Coding G36.0 without
documented AQP4-IgG positivity is the single most common payer denial reason. Cell-based assay (CBA) is the
preferred testing method; ELISA is acceptable but less specific. Submit the lab report with date and method
in the PA packet.
IgG4-RD coding is organ-dependent. ICD-10 has no single "IgG4-related disease" code. Payers
accept M35.81 (multifocal fibrosclerosis) as the best-fit code for multi-organ presentations; many also accept
organ-specific codes (K86.1 pancreas, K11.20 salivary, etc.). When in doubt, code the dominant organ
presentation primary and supporting organs secondary. Reference the 2019 ACR/EULAR classification criteria
in the PA letter for diagnostic justification.
Site of care & place of service Verified May 2026
Uplizna's 90+ minute infusion plus pre-medication and post-infusion observation fits ambulatory infusion settings cleanly. UHC, Aetna, Cigna, and most BCBS plans run site-of-care utilization management programs that steer Uplizna away from hospital outpatient (HOPD) toward office-based infusion (POS 11), ambulatory infusion centers (POS 49), or home infusion (POS 12) with appropriate vendor capability. The q6mo cadence makes home infusion attractive for stable patients.
| Setting | POS | Claim form | Electronic |
|---|---|---|---|
| Neurology / rheumatology office | 11 | CMS-1500 | 837P |
| Ambulatory / freestanding infusion suite | 49 | CMS-1500 | 837P |
| Hospital outpatient department | 19 or 22 | UB-04 / CMS-1450 | 837I |
| Patient home (qualified infusion vendor) | 12 | CMS-1500 (with home-infusion HCPCS) | 837P |
HOPD steering is now standard. At UHC, Aetna, Cigna, Carelon, and most BCBS plans, HOPD-administered
Uplizna is approved only when a clinically appropriate office, AIC, or home infusion option is unavailable.
Continuing a stable maintenance patient at HOPD without site-of-care justification frequently triggers
redirection at re-authorization. Specialty pharmacy + AIC pairing is the most common cost-efficient setup.
Home infusion considerations. The first dose is typically administered in a monitored
ambulatory setting because of infusion-reaction risk; subsequent doses may move to home if the patient
tolerated the first dose without significant reaction. Confirm home-infusion vendor capability for ≥90-minute
biologic infusions with full premedication regimen and post-infusion observation.
Claim form field mapping Verified May 2026
CMS-1500 / 837P (physician office, AIC, home; POS 11 / 49 / 12).
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b (referring) / 24J (rendering) | Rendering provider in 24J unshaded |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N475987014001ML30 (3 vials × 10 mL = 30 mL) |
| HCPCS J1823 + admin CPT (96365 + 96366) | 24D | Each on its own line; J1823 carries the unit count, admin codes carry start/stop time |
| Drug units | 24G | 300 for a single 300 mg dose (1 mg = 1 unit basis) |
| Modifier JZ on J1823 | 24D modifier slot | Whole-vial use, no waste — universal for label-conformant dosing |
| ICD-10 | 21 (up to 12) | G36.0 (NMOSD) + secondary attack codes, or IgG4-RD organ-specific codes |
| PA number | 23 | Required by virtually all payers; AQP4-IgG lab report or IgG4-RD criteria documentation referenced |
| HepB serology dates | Documented in chart | HBsAg, anti-HBc, anti-HBs; commonly requested at PA + audit |
| Infusion start/stop times | Documented in chart + 24G time fields if MAC requires | Supports 96365 + 96366 admin time billing |
Form references: NUCC (CMS-1500).
Phase 3
Get paid
Strict PA universal; AQP4-IgG documentation is the gate; site-of-care steering increasingly enforced.
Payer policy snapshot Reviewed May 2026
Strict PA universal. AQP4-IgG seropositivity gate for NMOSD. IgG4-RD coverage is plan-by-plan as labels are operationalized.
| Payer | PA? | AQP4-IgG documentation | IgG4-RD coverage | Re-auth |
|---|---|---|---|---|
| UnitedHealthcare Medical Benefit Drug Policy: Uplizna |
Yes | Required (CBA preferred) | Yes, per 4/2025 label expansion — expect operationalization in 2026 | 12 mo w/ documented attack-free interval (NMOSD) or response (IgG4-RD) |
| Aetna CPB on NMOSD biologics |
Yes | Required | Coverage updated post-FDA expansion; verify current CPB | 12 mo w/ response criteria |
| Anthem / Carelon CG-DRUG NMOSD biologics |
Yes | Required | Plan-specific; some plans require failed steroid + rituximab off-label first for IgG4-RD | w/ disease stability |
| Cigna Coverage policy: NMOSD biologics |
Yes | Required (CBA preferred) | Coverage expanded per FDA label; documentation per ACR/EULAR or RIPS | w/ documented response |
| Most Medicare Advantage | Yes | Required | Plan-specific; following CMS NCD/LCD framework as it develops | Annual |
Key payer trend: AQP4-IgG documentation is the universal gate for the NMOSD indication.
Test method (cell-based assay preferred over ELISA), titer when reported, and lab date should all appear in
the PA packet — not just "AQP4+ per chart." For IgG4-RD, payer policies are still operationalizing the
April 2025 label expansion; expect variability through 2026 as plans publish updated medical-benefit drug
policies. Many plans will likely require documented failure of glucocorticoids (and possibly off-label
rituximab) before approving Uplizna for IgG4-RD.
What to document for approval
- NMOSD: AQP4-IgG seropositivity confirmed (preferably by CBA), with lab report + date + method in PA
- NMOSD: 2015 IPND clinical criteria for NMOSD met; clinical attack history with imaging
- IgG4-RD: diagnosis per 2019 ACR/EULAR classification or RIPS histopathologic criteria; biopsy report with IgG4+ plasma cell count and IgG4/IgG ratio if available; serum IgG4 level (elevated in ~70%)
- Baseline HBV serology (HBsAg, anti-HBc total, anti-HBs) per boxed warning
- Baseline immunoglobulins; PML monitoring plan documented
- Live-vaccine status — deferred during therapy; documentation of vaccinations completed pre-treatment
- Site-of-care justification if HOPD requested over office/AIC
- For IgG4-RD: prior treatment history (typically corticosteroid course) and rationale for B-cell depletion
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J1823 (Uplizna)
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$495.545
per 1 mg unit
300 mg dose
$148,663.50
300 units × ASP+6%
Maintenance year
$297,327.00
2 doses/yr (q6mo)
Per-dose and per-year reimbursement math
| Phase | Doses | Total mg | Total units | Total ASP+6% |
|---|---|---|---|---|
| Loading (Day 1 + Day 15) | 2 | 600 | 600 | $297,327.00 |
| Year 1 (loading + first maintenance) | 3 | 900 | 900 | $445,990.50 |
| Maintenance year (steady state) | 2 | 600 | 600 | $297,327.00 |
Figures shown are Medicare Part B payment limits at ASP+6% before the ~2% sequestration adjustment, before any coinsurance, and before site-of-care payment differentials (HOPD payment via OPPS may differ from physician-office/AIC payment). ASP is updated quarterly by CMS — next update July 1, 2026 for Q3.
Coverage
No NCD specific to inebilizumab. Coverage falls under the generic drug-coverage LCD framework for each MAC. All MACs cover J1823 for FDA-approved on-label indications when standard PA criteria are met (AQP4-IgG documentation for NMOSD; ACR/EULAR or RIPS criteria for IgG4-RD).
Code history
- June 11, 2020 — FDA approval (NMOSD); initially billed under unclassified code J3490 / J3590 pending HCPCS assignment
- 2021 —
J1823assigned, "Injection, inebilizumab-cdon, 1 mg" (1 mg = 1 unit basis) - April 3, 2025 — FDA label expansion to IgG4-related disease (no HCPCS change)
Patient assistance — Amgen By Your Side / Amgen Assist 360 Amgen verified May 2026
Following Amgen's October 2023 acquisition of Horizon Therapeutics, Uplizna patient support transitioned from Horizon By Your Side to the Amgen support hubs (Amgen By Your Side for Uplizna; Amgen Assist 360 portfolio coordination).
- Amgen By Your Side — Uplizna: 1-833-UPLIZNA (1-833-875-4962), M–F
- Web: uplizna.com (patient + HCP resources, enrollment forms)
- Benefits investigation + prior authorization assistance (commercial, Medicare, Medicaid)
- Uplizna Co-Pay Program: commercial copay assistance for eligible patients (income/insurance criteria; excludes Medicare, Medicaid, TRICARE, VA, and other federal program patients per federal anti-kickback law)
- Independent foundation referral for Medicare and Medicaid patients (Amgen does not provide a manufacturer-funded copay program for federal-program patients; routes via independent charitable foundations)
- Bridge program / quick-start supply while coverage is being established
- Free-product Patient Assistance Program (PAP) for uninsured or underinsured patients meeting financial criteria
- Specialty pharmacy + AIC coordination through Amgen contracted distribution network
Independent foundations (for Medicare / Medicaid / uninsured)
- NORD (National Organization for Rare Disorders) — NMOSD fund opens intermittently; check status at enrollment
- Sumaira Foundation for NMO — patient advocacy + limited financial support for NMOSD patients
- PAN Foundation — NMOSD fund opens as funding allows
- HealthWell Foundation — periodic disease-specific funds for NMOSD and rare autoimmune diseases
- Patient Advocate Foundation (PAF) Co-Pay Relief — intermittent NMOSD and rare-disease funds
Foundation funds open and close fast. Uplizna's annual cost (~$300K maintenance year, higher
in loading year) means foundation co-pay funds for NMOSD are typically depleted within weeks of opening. Set
up alerts with NORD, Sumaira Foundation, PAN, and HealthWell; enroll patients at the moment a fund opens.
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J1823 pre-loaded.
Phase 4
Fix problems
Missing AQP4-IgG documentation, missing HepB serology, and IgG4-RD diagnostic gaps are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| #1: AQP4-IgG documentation missing | NMOSD diagnosis (G36.0) submitted without lab report demonstrating AQP4-IgG seropositivity by validated assay | Submit the lab report itself (date, method — ideally cell-based assay over ELISA, result, and titer if reported). If the patient was tested years ago, repeat testing may be requested. AQP4-IgG-seronegative patients are NOT label-eligible. |
| HepB serology baseline missing | PA submitted without HBsAg / anti-HBc total / anti-HBs results before first dose | Submit the three-test HBV panel results in the PA. Patients with positive HBsAg or anti-HBc require hepatology consultation and may need antiviral prophylaxis — document the plan. Boxed warning requires screening. |
| PML monitoring plan not documented | PA / chart lacks plan for monitoring new neurological symptoms suggesting PML | Document baseline neurological exam and patient education on PML warning signs (cognitive/personality changes, motor weakness, vision changes). Plan for evaluation (MRI brain, CSF JCV PCR) if new neurological symptoms emerge. |
| Prior immunosuppressant documentation gap | Plans requiring step therapy through prior immunosuppressants (azathioprine, mycophenolate, off-label rituximab) for NMOSD — documentation of trial/failure/contraindication not submitted | Submit trial documentation (drug, dose, duration, outcome — attack, intolerance, contraindication). Some plans accept "naive patient with high attack risk" justification with neurology specialty review. |
| IgG4-RD diagnostic criteria missing | IgG4-RD PA without explicit reference to 2019 ACR/EULAR classification criteria OR RIPS histopathologic criteria | Submit diagnostic packet: biopsy report (with IgG4+ plasma cell count and IgG4/IgG ratio when available), serum IgG4 level, organ involvement documentation, imaging. Reference the specific classification criteria met in the PA letter. |
| Pediatric patient denied | Patient under 18 (Uplizna labeled for adults only in both indications) | Uplizna is NOT FDA-approved for pediatric patients. Off-label use will trigger label-mismatch denial. Consider age-appropriate alternatives or specialty pediatric NMOSD/IgG4-RD center referral. |
| AQP4-IgG-seronegative NMOSD | Patient meets clinical NMOSD criteria but AQP4-IgG-negative | Seronegative NMOSD is NOT label-eligible for Uplizna, Soliris, or Ultomiris. Some seronegative patients have MOG-IgG-associated disease (MOGAD); test MOG-IgG and treat per MOGAD guidelines. Off-label rituximab is the historical option but carries no NMOSD label. |
| Site of care denial (HOPD) | HOPD administration on a commercial plan with site-of-care UM | Move to office (POS 11), AIC (POS 49), or home (POS 12) infusion. If HOPD required, submit medical-necessity justification (e.g., first dose monitoring requirement, no nearby AIC). |
| Wrong unit count | Submitted with vial count (3) instead of mg count (300) | J1823 is 1 mg = 1 unit. A 300 mg dose is 300 units, not 3. Resubmit corrected. |
| NDC format | 10-digit NDC submitted; payer requires 11-digit | Use 11-digit form: 75987-0140-01 with N4 qualifier (NDC qualifier). |
| Missing 96366 add-on | Only 96365 billed; 96366 not supported by chart documentation | Document infusion start/stop times. The labeled minimum 90-minute infusion plus premedication time generally supports at least one 96366 unit. Resubmit with corrected chart documentation. |
| Live-vaccine timing gap | Live vaccine given within 4 weeks of first dose (or planned during therapy) | Defer live vaccines during therapy. Vaccinate ≥4 weeks before first dose (live) or ≥2 weeks (non-live). Document timing in chart. |
Frequently asked questions
What is the HCPCS code for Uplizna?
Uplizna (inebilizumab-cdon) bills under HCPCS J1823 — "Injection, inebilizumab-cdon, 1 mg"
— at 1 mg per billable unit. A single 300 mg infusion is therefore 300 units of J1823. The drug comes
in 100 mg/10 mL single-dose vials, so 300 mg = 3 vials with no waste (modifier JZ exact). J1823 covers both
FDA-approved indications: AQP4-IgG-seropositive NMOSD and IgG4-related disease (IgG4-RD).
How is Uplizna dosed?
Uplizna uses a two-dose loading regimen followed by every-six-month maintenance. Loading: 300 mg IV on Day 1 and 300 mg IV on Day 15 (separated by 14 days). Maintenance: 300 mg IV every 6 months starting 6 months after the first infusion. Each infusion is 300 mg regardless of body weight (no weight-based dosing). The infusion runs at least 90 minutes per the FDA label, with premedication (methylprednisolone, antihistamine, antipyretic) 30-60 minutes prior to reduce infusion reactions.
How does Uplizna compare to Soliris and Ultomiris for NMOSD?
All three are approved for AQP4-IgG-seropositive NMOSD but work through different mechanisms. Uplizna (anti-CD19, J1823) depletes B cells and dosing is every 6 months after loading — the lowest infusion burden. Soliris (eculizumab, anti-C5, J1299) requires infusion every 2 weeks and mandates Soliris REMS with MenACWY/MenB vaccination. Ultomiris (ravulizumab, anti-C5, J1303) requires infusion every 8 weeks and shares the same meningococcal REMS framework. Uplizna has no REMS for meningococcal infection but carries its own boxed warning for serious infections and HepB reactivation, plus PML risk monitoring.
Is AQP4-IgG testing required before starting Uplizna for NMOSD?
Yes — AQP4-IgG seropositivity is the companion diagnostic for the NMOSD indication and the most common reason payers deny PA when documentation is absent. The N-MOmentum pivotal trial enrolled only AQP4-IgG-seropositive patients; the FDA label restricts Uplizna to that population for NMOSD. Cell-based assay (CBA) is preferred over ELISA because of higher sensitivity and specificity. Submit the lab report with date, method (CBA vs ELISA), and titer in the PA packet. AQP4-IgG-seronegative NMOSD patients are NOT FDA-approved candidates for Uplizna.
Does Uplizna cover IgG4-related disease?
Yes — the FDA approved Uplizna for IgG4-related disease (IgG4-RD) in adults on April 3, 2025, making it the first approved therapy for the condition. Same J1823 HCPCS, same 300 mg loading (D1 + D15) and q6mo maintenance dosing as NMOSD. IgG4-RD is a heterogeneous fibroinflammatory disease that can affect the pancreas, biliary tree, salivary glands, kidneys, retroperitoneum, and other organs. PA packets should document diagnosis per the 2019 ACR/EULAR classification criteria or the Revised International Pathology Society (RIPS) histopathologic criteria, plus serum IgG4 elevation when present.
Is HepB screening required before the first Uplizna dose?
Yes. Uplizna's boxed warning includes hepatitis B virus reactivation, so the FDA label requires HBV screening (HBsAg, anti-HBc total, and anti-HBs) before the first infusion. Patients with positive HBsAg or anti-HBc require hepatology consultation and may need antiviral prophylaxis throughout B-cell depletion. Skipping the HepB serology workup is a top-three PA-and-claims documentation gap; most payers require lab results in the chart and increasingly in the PA packet itself.
What administration codes apply to Uplizna?
CPT 96365 (IV infusion, therapy/prophylaxis/diagnosis; initial, up to 1 hour) plus
96366 (each additional hour) for the typical 90-minute or longer infusion. A standard 300 mg
infusion at the labeled rate runs at least 90 minutes (often 90-180 minutes total when premedication and
observation are factored in), so 96365 + one unit of 96366 is the most common admin pairing. Inebilizumab
is non-chemotherapeutic, so 96413 (chemo administration) is NOT appropriate.
Is Uplizna approved for pediatric patients?
No. Uplizna is FDA-approved only for adults (≥18 years) for both NMOSD and IgG4-RD. Pediatric NMOSD remains off-label for inebilizumab; eculizumab and ravulizumab have been studied in selected pediatric NMOSD populations, but the C5 inhibitors are also generally limited to adults under their respective labels. Off-label pediatric Uplizna will trigger a label-mismatch denial at most payers.
What is the Medicare reimbursement for J1823?
For Q2 2026, the Medicare Part B payment limit for J1823 is $495.545 per 1 mg unit (ASP + 6%). A single 300 mg infusion reimburses at approximately $148,663.50 (300 units × $495.545), before sequestration (~2%). The full loading regimen (Day 1 + Day 15, 600 mg total) reimburses approximately $297,327.00, and a maintenance year (two 300 mg infusions) reimburses approximately $297,327.00. ASP is updated quarterly by CMS.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- FDA — Uplizna (inebilizumab-cdon) Prescribing Information, 2025 (post-IgG4-RD expansion)
- DailyMed — UPLIZNA (inebilizumab-cdon) Prescribing Information
- FDA — Uplizna NMOSD approval announcement, June 11, 2020
- Amgen — Uplizna IgG4-RD FDA approval announcement, April 3, 2025
- Cree BAC et al. — N-MOmentum trial (Lancet 2019)
- Stone JH et al. — MITIGATE trial (IgG4-RD), NEJM 2025
- HCPCSdata — J1823 reference page
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file (canonical J-code source)
- FDA National Drug Code Directory
- NORD — Neuromyelitis Optica Spectrum Disorder
- Amgen By Your Side — Uplizna patient support hub
- Wallace ZS et al. — 2019 ACR/EULAR Classification Criteria for IgG4-Related Disease
- AAPC — HCPCS J1823
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 (J1823) | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, Carelon, Cigna) | Semi-annual | Manual review against published payer policy documents; IgG4-RD policies still operationalizing post-4/2025 label. |
| HCPCS / CPT / modifier rules | Annual | Stable since J1823 assignment in 2021. |
| NDC, dosing, FDA label | Event-driven | Tied to FDA label revision and manufacturer carton labeler changes (Horizon → Amgen post-10/2023 acquisition). |
| NMOSD competitive landscape (Soliris / Ultomiris) | Annual | Cross-checked against Alexion / AZ Rare Disease label updates and CMS code changes. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, manufacturer,
payer documents, peer-reviewed pivotal trials — all linked above). Editorial review in progress. Until
that review is complete, treat this as a draft reference and verify each cited source for high-stakes claims,
especially the AQP4-IgG companion-diagnostic requirement and the HepB serology requirement.
Change log
- — Initial publication. ASP data: Q2 2026 (J1823 = $495.545 per 1 mg unit). FDA label: post-IgG4-RD expansion (April 3, 2025). Manufacturer: Amgen (Horizon acquired October 2023; patient hub transitioned from Horizon By Your Side to Amgen By Your Side). Pivotal trials: N-MOmentum (NMOSD) and MITIGATE (IgG4-RD).
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. Clinical content is sourced from the FDA-approved label, the N-MOmentum (NMOSD) and MITIGATE (IgG4-RD) pivotal trial publications, the 2019 ACR/EULAR IgG4-RD classification criteria, and the 2015 IPND NMOSD diagnostic criteria. When operational details vary by payer (e.g., IgG4-RD coverage as policies operationalize the April 2025 label expansion), we surface the variability rather than assert a definitive answer.