Summary & Overview
HCPCS Q2041: Axicabtagene ciloleucel CAR T-cell Therapy
HCPCS Level II code Q2041 denotes axicabtagene ciloleucel — an autologous anti-CD19 CAR T-cell therapeutic dose that includes leukapheresis and dose preparation. This specialty biologic therapy is used in oncology for patients requiring cellular immunotherapy and represents a high-cost, high-complexity service with implications for hospital and specialty clinic billing, coverage policy, and utilization management.
Key national payers in scope include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of what the code covers, how it is used in clinical and billing workflows, and common payer considerations. The publication outlines benchmark elements such as typical sites of service and service line classification, summarizes common modifier usage where available, and highlights policy-relevant points for coverage and reimbursement discussion.
This summary provides a clinical and billing context for Q2041, clarifying the bundled nature of the therapeutic dose (collection plus preparation) and what stakeholders should expect when encountering the code in claims and policy documents. Data not available in the input is explicitly identified elsewhere in the full publication.
Billing Code Overview
HCPCS Level II code Q2041 represents axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. This code covers a single therapeutic dose of an autologous CAR T-cell therapy directed against CD19, billed to include collection (leukapheresis) and preparation of the cellular product.
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Service type: Cellular therapy infusion and product preparation
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Typical site of service: Hospital inpatient or hospital outpatient infusion center, specialty cancer centers, and advanced infusion facilities
Clinical & Coding Specifications
Clinical Context
A 58-year-old patient with relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) who has failed at least two prior lines of systemic therapy undergoes autologous CD19-directed CAR T-cell therapy using Q2041 (axicabtagene ciloleucel, up to 200 million viable CAR-positive autologous T cells). The clinical workflow includes: leukapheresis to collect peripheral blood mononuclear cells; cellular processing and manufacture of the CAR T product at a specialty cellular therapy laboratory; preconditioning lymphodepleting chemotherapy (typically fludarabine and cyclophosphamide) administered in the inpatient or outpatient oncology infusion setting; administration of a single therapeutic dose of Q2041 with close monitoring for infusion reactions, cytokine release syndrome (CRS), and immune effector cell–associated neurotoxicity syndrome (ICANS); and post-infusion observation with daily assessments, supportive care, and potential admission to an inpatient unit with intensive care capabilities if severe CRS or neurotoxicity occurs. Typical sites of service include an academic medical center or certified cellular therapy program with capabilities for leukapheresis, cell processing coordination, and inpatient/observational monitoring.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier |