Summary & Overview
HCPCS Level II J3380: Vedolizumab Injection, Intravenous, 1 mg
HCPCS Level II code J3380 designates vedolizumab supplied for intravenous injection, billed per 1 mg. As a biologic agent used in inflammatory bowel disease and related immune-mediated conditions, vedolizumab dosing and billing affect drug spend, infusion workflow, and payer coverage policies across the U.S. This code matters nationally because biologic drug costs drive significant outpatient specialty drug spending and require precise unit-based billing for claims processing and benefit management.
Key payers reviewed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of how the code is used in practice, typical sites of service, and the clinical context surrounding vedolizumab therapy. The publication summarizes common billing considerations for unit-based HCPCS reporting, typical payer coverage patterns, and operational implications for infusion centers.
The report delivers benchmarks for utilization and reimbursement where available, outlines relevant policy updates affecting specialty drug billing and reimbursement, and provides clinical context on vedolizumab as an IV-administered biologic. Data not available in the input is noted where applicable.
Billing Code Overview
HCPCS Level II code J3380 represents the medication vedolizumab supplied for intravenous injection, billed per 1 mg. This code denotes the drug component of an infused biologic therapy administered intravenously.
Service type: Intravenous drug administration (infusion drug) — drug component
Typical site of service: Hospital outpatient department or ambulatory infusion center
Clinical & Coding Specifications
Clinical Context
A 42-year-old patient with moderate-to-severe ulcerative colitis presents to an outpatient infusion center for maintenance therapy with vedolizumab. The patient was initially induced with weight-based intravenous doses and now receives a scheduled maintenance infusion of vedolizumab, billed as J3380 per mg. The clinical workflow includes pre-infusion nursing assessment (vital signs, review of allergies, medication reconciliation), verification of the ordered vedolizumab dose and lot number, IV access placement or assessment of existing port, medication preparation by pharmacy (reconstitution and verification), administration by an infusion nurse with appropriate monitoring for infusion-related reactions, and post-infusion observation for 30–60 minutes. Documentation includes indication, dose in mg, infusion start and stop times, lot number, site of service, any reactions and their management, and any applicable modifier(s) for billing. Typical sites of service are outpatient infusion centers, hospital outpatient departments, and ambulatory surgical centers when appropriate.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
JW | Drug amount discarded/not administered | When a portion of the vedolizumab vial is wasted and must be reported per payer requirements. |