Summary & Overview
HCPCS J3392: Injection of Exagamglogene Autotemcel, Per Treatment
HCPCS Level II code J3392 denotes the per-treatment injection of exagamglogene autotemcel, a gene therapy product administered by parenteral injection. As a high-cost, specialty drug treatment, accurate coding with J3392 is necessary for claims processing, payment determination, and care coordination at facilities that provide complex infusible or injectable gene therapies. Nationally, consistent use of this HCPCS Level II code supports standardized billing and enables payer review of utilization for novel gene therapies.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an explanation of what the code represents, expected sites of service, and an outline of common payer coverage considerations. The publication also summarizes available benchmarks and policy topics relevant to specialty injectable gene therapies, including billing practice implications, reimbursement pathways, and documentation elements typically required for high-cost biologic and gene therapy claims.
This overview is intended for billing managers, revenue cycle leaders, and clinical administrators seeking clarity on coding and payer coverage contexts for J3392. Data not available in the input is noted where applicable in detailed sections.
Billing Code Overview
HCPCS Level II code J3392 represents an injection of exagamglogene autotemcel, per treatment. This code describes a single administration of a gene therapy product delivered by injection.
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Service type: Drug administration (gene therapy injection)
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Typical site of service: Hospital outpatient department, ambulatory infusion center, or other facility capable of delivering parenteral gene therapy treatments
Clinical & Coding Specifications
Clinical Context
A 6‑ to 12‑year‑old child with transfusion‑dependent beta thalassemia or severe sickle cell disease is evaluated in a pediatric hematology center for gene‑modified autologous hematopoietic stem cell therapy using exagamglogene autotemcel. The workflow begins with pre‑treatment evaluation including genetic confirmation, organ function testing, infectious disease screening, and counseling. Mobilization of hematopoietic stem cells and collection via apheresis occur in an outpatient infusion center or hospital apheresis unit. The patient then undergoes myeloablative conditioning chemotherapy in an inpatient or outpatient oncology infusion suite, followed by reinfusion of the engineered cell product (exagamglogene autotemcel) administered as an intravenous injection/infusion per treatment. Post‑infusion monitoring occurs in an inpatient setting or specialized outpatient clinic for cytokine release syndrome, infection, engraftment, and graft‑related complications, with scheduled laboratory monitoring and supportive transfusions as needed. Documentation should include diagnosis, product lot and identifier, date and time of administration, infusion site, consent, and contemporaneous notes of monitoring and any adverse events.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Use when no special circumstances apply and no other modifier is appropriate |