Codes & vials
| HCPCS | J1569 — "Inj, immune globulin (Gammagard Liquid), non-lyophilized, 500 mg" |
|---|
| Vials | 1 g/10 mL, 2.5 g/25 mL, 5 g/50 mL, 10 g/100 mL, 20 g/200 mL, 30 g/300 mL single-dose |
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| Concentration | 10% (100 mg/mL) |
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| NDC family | 0944-2700-xx (Takeda IG family) — pull exact 11-digit NDC from carton |
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| NDC qualifier | N4 + 11-digit NDC + ML + total mL administered |
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NOT Gammagard S/D (J1566). S/D is the lyophilized product (different code, different ASP). Verify NDC + product on dispense record.
Dosing by indication
| Indication | Dose | Frequency |
|---|
| PI (D80.x, D81.x, D82.x) | 300–600 mg/kg | q3–4 wk |
| MMN (G61.82) | Load 2.0 g/kg over 2–5 d; maint 0.5–2.4 g/kg/mo | Monthly maint |
| CIDP (off-label) (G61.81) | Load 2.0 g/kg; maint 1.0 g/kg q3w | q3 wk |
| SID (off-label) (D83.x / D84.x) | 300–500 mg/kg | q3–4 wk |
| ITP (off-label) (D69.3) | 1.0 g/kg/d × 1–2 d OR 0.4 g/kg/d × 5 d | Single course |
On-label Gammagard Liquid: PI (≥2 yr) + MMN. Off-label CIDP / SID / ITP are common but require payer medical necessity — payers may steer to on-label products (Privigen for CIDP/ITP).
Infusion rate titration
| Step | mg/kg/min | Hold |
|---|
| Initial | 0.5 | 30 min |
| Step 2 | 1.0 | 30 min |
| Step 3 | 2.0 | 30 min |
| Step 4 | 4.0 | 30 min |
| Max maint. | 8.0 | To end |
Real-world: 35 g dose = 3–4 hr infusion (titration + max). Bill 96365 × 1 + 96366 × 2–3. Slow rates (≤3.3 mg/kg/min) for ≥65 yr, diabetes, renal disease, paraproteinemia per boxed warning.
Administration & modifiers
| Code | When |
|---|
96365 | Initial up-to-1-hr therapeutic IV (primary) |
96366 | Each additional hour (1 unit per add'l hr, ≥31 min) |
96413 | WRONG — chemo code; IVIG is non-chemo |
Home infusion (POS 12): add S9338 per diem for commercial; Medicare home IVIG benefit (now permanent for PI) |
JZ/JW required since 7/1/2023. JZ when full vial(s) administered; JW on separate line for waste. Waste mg ÷ 500 = JW units (e.g., 4 g waste = 8 units).
Site of care matrix
| Setting | POS | Payer steering |
|---|
| Patient home (specialty vendor) | 12 | Most preferred |
| Ambulatory infusion suite | 49 | Preferred if home not feasible |
| Physician office | 11 | Acceptable |
| Hospital outpatient (on-campus) | 22 | Disfavored after first 3 mo |
| Hospital outpatient (off-campus PBD) | 19 | Disfavored same as on-campus |
| Inpatient (acute) | 21 | OK when part of admission |
UHC / Aetna / Cigna run aggressive IVIG site-of-care UM. HOPD continuation requires specific documentation (vascular access, prior reaction, acute medical complexity).
Brand interchangeability (payer call)
| Product | HCPCS | Notes |
|---|
| Gammagard Liquid | J1569 | Takeda 10% IV (this page) |
| Privigen | J1459 | CSL 10% — PI / CIDP / ITP on-label |
| Octagam | J1568 | Octapharma 5% / 10% — PI / ITP / DM |
| Gamunex-C | J1561 | Grifols 10% IV/SC — PI / ITP / CIDP |
| Hizentra (SC) | J1559 | CSL 20% SC — PI / CIDP |
| Cuvitru (SC) Takeda sister | J1555 | 20% SC — PI |
| HyQvia (fSC) Takeda sister | J1575 | 10% facilitated SC — PI |
| Gammagard S/D Takeda | J1566 | Lyophilized — legacy use only |
Switching products = new PA. Each IVIG/IGSC product is its own formulary item. Re-titrate on new product.
Payer requirements (May 2026)
| Payer | PA | Site-of-care UM |
|---|
| UnitedHealthcare | Yes | Aggressive (Optum home steerage) |
| Aetna (CPB 0206) | Yes | Yes (out of HOPD after 3 mo) |
| Cigna (CP 1218) | Yes | Yes (Accredo home) |
| BCBS (Carelon / AIM) | Yes | Plan-specific |
| Medicare Part B | No PA | Home IVIG benefit (permanent for PI) |
PA docs: PI — dx + IgG <500 + functional antibody response + infection history. MMN — EMG/NCS conduction block.
Medicare reimbursement (Q4 2026)
| Field | Value |
|---|
| ASP + 6% | $49.495 / 500 mg unit (eff. 7/1 – 9/30/2026) |
| Per mg equivalent | $0.098 / mg |
| 35 g (70 unit) PI dose | $3,464.65 |
| 25 g (50 unit) dose | $2,474.75 |
| Annual PI maint. (12 × 35 g) | ~$41,228 |
Patient assistance — Takeda OnePath
- Phone: 1-866-861-1750 (Takeda OnePath)
- Benefits investigation, PA assistance, appeals
- Commercial copay: OnePath Co-Pay Assistance (excludes Medicare/Medicaid/federal)
- PAP: free product for uninsured / underinsured
- Medicare patients: refer to PAN, HealthWell, PAF, TAF foundations — verify open IVIG / immunodeficiency funds quarterly
- OnePath also covers Cuvitru, HyQvia, Gammagard S/D
BOXED WARNING — thrombosis / renal: thrombosis, renal dysfunction, acute renal failure. Risk highest in age ≥65, diabetes, dehydration, sepsis, paraproteinemia, prior renal disease. Maintain hydration; minimum effective dose / rate.