Teplizumab-mzwv (Tzield) (CPB 1022, reviewed 2025-12-03)

IMMEDIATELY (Effective 2025-12-03): Billing team must establish precertification workflow for Tzield (J9381). (1) Update billing system to flag all J9381 claims as requiring prior authorization before submission to Aetna. (2) Create precertification protocol requiring providers to call (866) 752-7021 or fax (888) 267-3277 before patient treatment initiation. (3) Configure system to require Statement of Medical Necessity (SMN) documentation via Specialty Pharmacy Precertification portal. (4) Verify on encounter forms that prescriber is an endocrinologist or consulting with one. (5) Ensure claims include documented evidence of: patient age 8+, two or more pancreatic islet autoantibodies (GAD65, IAA, IA-2A, ZnT8A, or ICA) from samples within past 6 months, abnormal OGTT within past 2 months showing dysglycemia, absence of T1D symptoms, and single 14-day treatment course compliance. (6) Train billing and front-desk staff that claims submitted without precertification will be DENIED. (7) Ensure infusion administration codes (96365, 96413, 99601, 99602) are billed with appropriate supporting lab codes (80076, 82950-82952, 85027, 86337, 86341) for medical necessity documentation. NOTE: Medicare coverage differs—refer Medicare patients to Medicare Part B Criteria per policy.