Cuvitru (immune globulin SC, 20%) — HCPCS J1555
CareCost Estimate · SCIG Billing Cheat Sheet
Takeda Pharmaceuticals
1 g / 2 g / 4 g / 8 g / 16 g single-dose vials (200 mg/mL = 20%)
SC pump infusion 60–90 min
Primary humoral immunodeficiency (PI) only
Reviewed: May 2, 2026
ASP: Q2 2026
HCPCS unit basis
100 mg
NOT 500 mg (IVIG basis)
10 g weekly dose
100 units
10,000 mg ÷ 100
SC Admin CPT
96369
+ 96370 / 96371 (NOT 96365)
Modifier
JZ
JW for partial-vial waste
Medicare ASP+6%
$17.580
/100 mg · ~$176/g · $1,758/10g
UNIT-BASIS TRAP: J1555 = 100 mg per unit, NOT 500 mg/unit (IVIG: J1459/J1568/J1569/J1561) and NOT 1 mg/unit. A 10 g (10,000 mg) weekly dose = 100 units. Bill it as 20 units (IVIG math) and underpaid 5x; bill it as 10,000 (per-mg math) and instant denial.
SC PUMP CODES ONLY: Use 96369 + 96370 + 96371. NOT 96365/96366 (IV). NOT 96372 (single-shot SC).
Codes & NDC
| HCPCS | J1555 — "Inj, immune globulin (Cuvitru), 100 mg" (1 unit = 100 mg) |
|---|
| NDCs | 0944-2856-01 1g/5mL · -02 2g/10mL · -04 4g/20mL · -08 8g/40mL · -16 16g/80mL |
|---|
| Vials | 1, 2, 4, 8, 16 g single-dose (200 mg/mL = 20%). 16g/80mL is largest in SCIG class. |
|---|
| Stabilizer | Glycine (vs L-proline in Hizentra; vs maltose in Cutaquig) |
|---|
| Benefit | Medical (Part B / commercial medical, home-infusion provider) OR specialty pharmacy — verify per payer |
|---|
Dosing & conversion (PI only)
- IVIG → Cuvitru: weekly = (monthly IVIG × 1.30) ÷ 4 (Hizentra is 1.37 — verify which product)
- Maintenance: 100–200 mg/kg per week SC
- Frequency: weekly (most common), biweekly, or rapid push
- Initiate 1 week after last IVIG dose
- 30 g/mo IVIG → (30 × 1.30) ÷ 4 = 9.75 g → round to 10 g/wk
CIDP NOT FDA-approved for Cuvitru. Use Hizentra (J1559) or HyQvia (J1575) for CIDP maintenance. G61.81 on a J1555 claim = denial.
Administration & modifiers
| Code | When |
|---|
96369 | SC infusion, initial up to 1 hr + pump set-up + first SC site |
96370 | Each additional hour (typical Cuvitru > 60 min) |
96371 | Additional pump set-up + new SC site (multi-site infusion) |
96365/96366 | WRONG — IV codes; Cuvitru is SC |
96372 | WRONG — single-shot SC (Cosentyx, B12); not pump infusion |
| Home self-admin: S9338 (per-diem) + 99601/99602 (RN visits if used). Drug + per-diem must both appear on claim. |
JZ on every claim with no waste (single-dose vials, all sizes). JW for partial-vial discard — especially when 16 g vial used for sub-16 g dose.
SCIG vs IVIG (foundational)
| Cuvitru (SCIG) | IVIG class |
|---|
| HCPCS | J1555 | J1459/J1568/J1569/J1561 |
| Unit | 100 mg | 500 mg |
| Route | SC pump | IV |
| Admin | 96369/70/71 | 96365/66 |
| Frequency | Weekly | Every 3–4 wk |
| Site | Home (POS 12) | AIC / HOPD |
| Per-gram | ~$176 | ~$60–$85 |
SCIG brand interchangeability (verify payer preference!)
| HCPCS | Brand | Mfr | Conc | Stabilizer | CIDP? |
|---|
J1555 | Cuvitru | Takeda | 20% | Glycine | NO |
J1559 | Hizentra | CSL Behring | 20% | L-proline | YES (2018) |
J1558 | Xembify | Grifols | 20% | Glycine | NO |
J1551 | Cutaquig | Octapharma | 16.5% | Maltose | NO |
J1575 | HyQvia | Takeda | 10%+rHuPH20 | Glycine | YES (2024) |
J1561 | Gamunex-C | Grifols | 10% IV/SC | Glycine | YES (IV only) |
Gamunex-C SC trap: Even when given SC, J1561 still uses 500 mg/unit (the IV basis). Do NOT apply 100 mg/unit math.
ICD-10 (PI family)
| Code | For |
|---|
D80.0 | X-linked agammaglobulinemia (Bruton) |
D80.1 | Hypogammaglobulinemia, unspecified |
D80.3 | Selective IgG subclass deficiency |
D80.8 / D80.9 | Other immunodeficiency w/ antibody defects |
D81.x | Combined immunodeficiency (SCID variants) |
D82.x | Wiskott-Aldrich, DiGeorge, etc. |
D83.0–D83.9 | Common variable immunodeficiency (CVID) |
G61.81 | NO — CIDP, not Cuvitru-approved |
PI documentation = LCD-required: IgG level + vaccine-challenge antibody response + recurrent infection history.
Payer requirements (May 2026)
| Payer | PA | Position |
|---|
| UnitedHealthcare | Yes | SCIG-preferred for stable PI; Cuvitru/Hizentra/Xembify per contracting |
| Aetna | Yes | Clinician choice; some plans steer to SCIG |
| Cigna | Yes | SCIG / IVIG parity (Policy 1006) |
| BCBS plans | Yes | Plan-specific; SCIG-preferred increasingly common |
| Medicare Part B | Often (DME) | PI well-covered under SCIG demo / HIT framework |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $17.580 / 100 mg unit (~$0.176/mg) |
| Per gram | ~$175.80 (10 units) |
| 10 g weekly dose | $1,758.00 (100 units) |
| Annual (52 wk × 10 g) | ~$91,416 (before sequestration) |
| Hizentra J1559 ASP+6% | ~$14.515/100 mg (~$145/g) for comparison |
Site of care
| Setting | POS | Notes |
|---|
| Patient home (self-infusion) | 12 | Dominant after training (80%+) |
| Patient home (RN) | 12 | + 99601 / 99602 nursing visits |
| Ambulatory infusion | 49 | Initial training (1–3 sessions) |
| Physician office | 11 | Training; same-day E/M |
| Hospital outpatient | 19/22 | Rarely justified — common denial |
Patient assistance — Takeda OnePath
- Phone: 1-866-861-1750 (Takeda OnePath)
- Commercial copay: Cuvitru Co-Pay Assistance Program (excludes Medicare/Medicaid/federal)
- PAP: free product for uninsured/underinsured (income-tested)
- Medicare patients: PAN Foundation, HealthWell, PAF (immunodeficiency funds)
- IDF: primaryimmune.org — education + nurse advocate program
- Web: cuvitru.com / takedaonepath.com
Pending SME review. Verify each cited source for high-stakes claims, especially the unit-basis math, SC vs IV admin code selection, and the PI-only indication scope (no CIDP coverage under J1555).