Summary & Overview
HCPCS J9345: Injection, retifanlimab-dlwr, 1 mg
HCPCS Level II code J9345 denotes the injectable oncology biologic retifanlimab-dlwr, reported per 1 mg. As a unit-based drug code for an infused monoclonal antibody, J9345 is relevant to hospital outpatient departments, infusion centers, and oncology clinics nationwide because it governs billing for a high-cost specialty therapy. Proper coding affects claim adjudication, patient cost-sharing, and utilization reporting.
Key payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication outlines payer coverage patterns and what organizations should track when managing billing for this agent.
Readers will find benchmarks and operational guidance on common billing practices for unit-based oncology drug coding, a synopsis of payer coverage considerations, and the clinical context for use as an infused systemic anticancer agent. The piece also highlights common modifiers and billing nuances encountered with unitized infusion drugs. Where specific input data were not provided, the publication notes that those elements are not available in the input. The focus is national in scope and aimed at billing managers, revenue cycle leaders, and oncology practice administrators needing clear, code-specific reference material.
Billing Code Overview
HCPCS Level II code J9345 represents an injection of retifanlimab-dlwr, billed per 1 mg unit. The service is an intravenous or injectable oncology/infusion medication administration intended for use where systemic anticancer biologic therapy is delivered.
Typical site of service: Hospital outpatient infusion center or physician office/oncology clinic.
Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.
Clinical & Coding Specifications
Clinical Context
A 68-year-old patient with recurrent or metastatic squamous cell carcinoma of the anal canal, previously treated with platinum-based chemotherapy, presents to the oncology infusion center for systemic immunotherapy. The clinician orders J9345 (retifanlimab-dlwr, 1 mg) as part of single-agent intravenous infusion per FDA-approved dosing. Pre-infusion evaluation includes vitals, review of prior imaging and labs (CBC, CMP, liver function tests), verification of allergies, and assessment for active autoimmune disease or infection. The pharmacy compounds the weight- or body-surface-area–based dose and documents lot, vial quantity, and expirations, applying JW or JZ modifiers as appropriate for discarded or single-use vial circumstances. Nursing completes infusion setup, places an appropriate IV or port access, and monitors for infusion-related reactions; management may include infusion rate modification or supportive meds (antipyretics, antihistamines, corticosteroids) per protocol. Post-infusion documentation includes medication administration record with J9345 dose, lot number, infusion start/stop times, and any immediate adverse events. Follow-up visits assess response with imaging and adverse event monitoring, and subsequent cycles are scheduled based on tolerance and oncologist orders.
Coding Specifications
| Modifier | Description | When to Use |
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