Summary & Overview
HCPCS Level II Q2040: Tisagenlecleucel CAR T-Cell Infusion, Up to 250M
HCPCS Level II code Q2040 identifies tisagenlecleucel therapy—an autologous chimeric antigen receptor (CAR) T-cell product—delivered as a single infusion of up to 250 million CAR-positive viable T cells, and includes leukapheresis and dose preparation procedures. This code captures a high-cost, clinically complex cellular therapy used for specific hematologic malignancies and is nationally significant due to its clinical impact, resource intensity, and payer coverage challenges.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of what the code represents, typical sites of service, and the service components bundled under the code. The publication summarizes national benchmarking context for utilization and allowed amounts where available, notes common billing and coverage considerations for high-cost cellular therapies, and outlines relevant policy and coding updates affecting reimbursement and billing workflows for CAR T-cell products. Clinical context around administration setting, care coordination needs, and the role of leukapheresis and dose preparation is provided to help billing and clinical teams align coding with service delivery.
Billing Code Overview
HCPCS Level II code Q2040 represents tisagenlecleucel, up to 250 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per infusion. The service type is cellular gene therapy infusion with associated leukapheresis and product preparation. The typical site of service is hospital inpatient or outpatient specialty infusion center where advanced cellular therapies are administered and prepared for infusion.
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Clinical & Coding Specifications
Clinical Context
A 24-year-old patient with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who has exhausted conventional chemotherapy and is eligible for autologous cellular therapy presents for administration of Q2040 (tisagenlecleucel, up to 250 million CAR-positive viable T cells). The clinical workflow includes: pre-treatment evaluation by hematology/oncology and a CAR-T cell program team; leukapheresis to collect the patient’s peripheral blood mononuclear cells; manufacturing and quality testing of the CAR-T product; lymphodepleting chemotherapy (typically fludarabine and cyclophosphamide) to prepare the patient for infusion; pre-infusion verification and dose preparation in the cellular therapy pharmacy; inpatient or outpatient infusion of Q2040 with monitoring for acute infusion reactions; and post-infusion monitoring for cytokine release syndrome and neurotoxicity in an appropriate monitored setting. Typical multidisciplinary staff involved include medical oncologists/hematologists, apheresis nurses/technicians, cellular therapy pharmacists, infusion nurses, critical care consultants, and case management. The typical site of service is an academic or tertiary care center with a licensed cellular therapy program and accredited apheresis and inpatient infusion capabilities.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
59 |