Administration & modifiers
| Code | When |
|---|
96365 | Therapeutic IV, initial up to 1 hr (primary) — non-chemo |
96366 | Each additional hour — rare for 30-min infusion |
96413 | Not appropriate — teplizumab is non-chemo mAb |
| Modifiers: JW (typical, BSA waste) or JZ (no waste, rare). Mod 25 on same-day E/M. |
JW expected on most days. 400-unit vial vs ~351-unit dose = ~50 units waste. Bill on separate JW line, same DOS.
ICD-10 documentation
| Code | For |
|---|
R73.03 | Prediabetes (most common; pair w/ clinical narrative) |
R73.01 | Impaired fasting glucose (supports R73.03) |
R73.02 | Impaired glucose tolerance (oral) |
Z83.3 | FHx of diabetes (supportive only) |
E10.x | NOT — overt T1D, contraindicated |
No perfect ICD-10 for stage 2 T1D. Submit clinical narrative attesting stage 2 with PA: autoantibodies + OGTT/HbA1c + no overt T1D + endo sign-off.
Premedication (first 5 doses)
- NSAID: ibuprofen (adult ~600 mg PO)
- Antihistamine: diphenhydramine (25–50 mg PO/IV)
- Antipyretic: acetaminophen (650–1,000 mg PO)
- Give 30–60 min before each Day 1–5 infusion
- Doses 6–14: not required unless CRS develops
CRS warning: cytokine release syndrome is the most common AE and peaks during first 5 doses. Monitor CBC weekly during course (lymphopenia can be severe and prolonged).
Payer requirements (May 2026)
| Payer | PA | Specialist |
|---|
| UnitedHealthcare | Yes | Endocrinology + autoantibody + OGTT/HbA1c |
| Aetna | Yes | Endocrinology + stage 2 documentation |
| BCBS plans | Yes | Plan-specific; mostly endocrinology |
| Medicare (LCD) | Variable | MAC LCDs evolving — verify active LCD |
Step therapy: NOT required. No class peer — Tzield is the only FDA-approved therapy to delay clinical T1D.
Medicare reimbursement (Q4 2026)
| Field | Value |
|---|
| ASP + 6% | $39.274 / 5 mcg unit (4/1–6/30/2026) |
| Per mcg | $7.679 |
| Per mg | $7,854.80 |
| Per vial (2 mg / 400 units) | $15,709.60 |
| Day 14 (1.7 m², ~351 units) | $13,785.17 |
| Full course (1.7 m², ~3,822 units) | ~$146,742 |
Site of care
| Setting | POS | Notes |
|---|
| Hospital outpatient (on-campus) | 22 | Common for endo infusion programs |
| HOPD off-campus PBD | 19 | Common |
| Ambulatory infusion suite | 49 | OK; CRS monitoring required |
| Physician office (endo) | 11 | If infusion + CRS capacity |
| Pediatric infusion center | 11/49 | For ≥8 yr peds patients |
| Patient home | 12 | Rare — CRS monitoring concerns first 5 doses |
Patient assistance — Sanofi
- Tzield Patient Support: 1-833-205-3220
- Sanofi Patient Connection: sanofipatientconnection.com (PAP for uninsured/underinsured)
- Tzield Co-Pay Card: commercial copay as low as $0/course (excludes Medicare, Medicaid, federal)
- Foundations: PAN, HealthWell, JDRF (T1D Fund) for Medicare patients
- Web: tzield.com
VACCINATION CONTRAINDICATION: Live vaccines (and most others) contraindicated 6 weeks
before, during, and 6 weeks after the 14-day Tzield course. Confirm vaccination history before Day 1.
First-in-class: Tzield is the only FDA-approved drug to delay clinical T1D (approved
Nov 2022; peds ≥8 yr added 2024). Reviewed by Erin Rose — verify high-stakes claims.