CPT® Code 0538T

Code Deleted. See 38225, 38226, 38227, 38228.

Official Description

Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage)

Common Language Description

Chimeric antigen receptor T-cell (CAR-T) therapy represents a groundbreaking approach in the field of immunotherapy, utilizing the patient's own white blood cells, specifically lymphocytic T-cells, to combat cancer. This innovative treatment involves a sophisticated process where T-cells are extracted from the patient's blood, typically over a span of one or more days. The extracted T-lymphocytes are then subjected to genetic engineering in a controlled laboratory or manufacturing environment. This is achieved by introducing a disarmed virus that carries genetic material into the T-cells, prompting them to produce chimeric antigen receptors (CARs) on their surfaces. These CARs are crucial as they enable the T-cells to identify and bind to specific protein antigens present on the surface of cancer cells. Once the T-cells are genetically modified to express CARs, they undergo a significant expansion phase, multiplying to reach hundreds of millions of cells. During this manufacturing period, the patient typically receives lymphocytic cell-depleting chemotherapy to prepare their immune system for the subsequent infusion of the engineered T-cells. After the CAR-T cells are fully prepared and the patient is adequately primed, the modified T-cells are infused back into the patient's bloodstream. The CARs on the surface of these engineered T-cells facilitate their recognition and destruction of cancer cells, effectively targeting and eliminating malignant cells. Furthermore, the CAR-T cells are designed to persist in the patient's body for an extended duration, providing ongoing surveillance against potential cancer recurrence.

1. Indications

The indications for the preparation of blood-derived T lymphocytes for transportation in the context of CAR-T therapy include the following:

Cancer Treatment The procedure is indicated for patients diagnosed with certain types of cancers, particularly hematologic malignancies such as acute lymphoblastic leukemia (ALL) and certain types of lymphoma, where traditional treatment options have been exhausted or are not effective.

2. Procedure

The procedure for the preparation of blood-derived T lymphocytes for CAR-T therapy involves several critical steps:

Step 1: Blood Collection Blood is withdrawn from the patient, which may occur over one or more days. This step is essential to obtain a sufficient quantity of T-lymphocytes necessary for the subsequent processing and engineering.
Step 2: T-Lymphocyte Separation The collected blood undergoes a separation process to isolate the T-lymphocytes from other blood components. This is typically achieved through apheresis, a procedure that selectively extracts the desired cells while returning the remaining blood components to the patient.
Step 3: Genetic Engineering The isolated T-lymphocytes are then transported to a laboratory or manufacturing facility where they are genetically engineered. An inactive virus is introduced into the T-cells, which carries the genetic instructions for producing chimeric antigen receptors (CARs) on the T-cells' surfaces.
Step 4: Expansion of CAR-T Cells Following genetic modification, the T-cells are cultured and expanded in the laboratory. This process involves multiplying the CAR-T cells to reach a therapeutic dose, often numbering in the hundreds of millions.
Step 5: Patient Preparation While the CAR-T cells are being manufactured, the patient receives lymphocytic cell-depleting chemotherapy. This treatment is designed to reduce the number of existing lymphocytes in the patient’s body, creating an optimal environment for the newly infused CAR-T cells to thrive.
Step 6: Infusion of CAR-T Cells Once the CAR-T cells are adequately prepared and the patient is ready, the engineered T-cells are infused back into the patient’s bloodstream. This step marks the beginning of the therapeutic action, as the CAR-T cells seek out and destroy cancer cells.

3. Post-Procedure

After the infusion of CAR-T cells, patients are monitored for any immediate reactions and potential side effects. It is common for patients to experience symptoms related to the immune response, such as fever, fatigue, and flu-like symptoms. Ongoing follow-up care is essential to assess the effectiveness of the therapy and to manage any adverse effects. The persistence of CAR-T cells in the body is also monitored to ensure they remain active in targeting and eliminating cancer cells, thereby reducing the risk of cancer recurrence.

Short Descr	BLD DRV T LYMPHCYT PREP TRNS
Medium Descr	CAR-T THERAPY PREPJ BLD DRV T LMPHCYT F/TRNS
Long Descr	Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage)
Status Code	Bundled Code
Global Days	XXX - Global Concept Does Not Apply
PC/TC Indicator (26, TC)	9 - Not Applicable
Multiple Procedures (51)	9 - Concept does not apply.
Bilateral Surgery (50)	9 - Concept does not apply.
Physician Supervisions	09 - Concept does not apply.
Assistant Surgeon (80, 82)	9 - Concept does not apply.
Co-Surgeons (62)	9 - Concept does not apply.
Team Surgery (66)	9 - Concept does not apply.
Diagnostic Imaging Family	99 - Concept Does Not Apply
APC Status Indicator	Code Not Recognized by OPPS when submitted on Outpatient Hospital Part B Bill Type (12x/13x)
Berenson-Eggers TOS (BETOS)	none
MUE	Not applicable/unspecified.