J9381 — Injection, teplizumab-mzwv, 5 mcg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation confirming patient age (>= 8 years)
- Documentation confirming diagnosis of stage 2 type 1 diabetes, including:
- Laboratory evidence of at least two positive pancreatic islet autoantibodies (one or more of: Glutamic acid decarboxylase 65 (GAD) autoantibodies; Insulin autoantibody (IAA); Insulinoma-associated antigen 2 autoantibody (IA-2A); Zinc transporter 8 autoantibody (ZnT8A); Islet cell autoantibody (ICA))
- Evidence of dysglycemia without overt hyperglycemia as defined by one of: fasting plasma glucose ≥100 mg/dL and <126 mg/dL; or 2-hour post-prandial plasma glucose ≥140 mg/dL and <200 mg/dL; or A1C ≥5.7 and <6.5% or ≥10% increase in A1C
Key Coverage Criteria
- Authorization will be issued for no more than one treatment course (i.e., 14 doses) per lifetime
- Applicable HCPCS code for drug billing: J9381 Injection, teplizumab-mzwv, 5 mcg
- FDA indication (informational): "to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type diabetes."
- Applicable diagnosis codes listed for reference: E10.8 Type 1 diabetes mellitus with unspecified complications; E10.9 Type 1 diabetes mellitus without complications
- Tzield, administered as a one-time 14-day course of therapy, is proven to delay the onset of stage 3 type 1 diabetes in pediatric and adult patients that meet the following criteria:
- Patient is 8 years of age and older
8 Active Policies
UHC-POL-tzield — Tzield (Teplizumab-Mzwv)
UMR-POL-UMR-tzield — Tzield (Teplizumab-Mzwv)
SUREST-POL-SUREST-tzield — Tzield (Teplizumab-Mzwv)
BCBSIL-RX501.150 — Teplizumab-mzwv
BCBSMT-RX501.150 — Teplizumab-mzwv
Related Codes
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