Description
This policy addresses reimbursement for Chimeric Antigen Receptor T-cell (CAR-T) Gene Therapy.
Description
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CAR-T Therapy
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A cell-based gene therapy in which T-cells are collected and genetically engineered to express a chimeric antigen receptor that will bind to a certain protein on a patient’s cancerous cells. The CAR-T are then administered to the patient to attack certain cancerous cells and the individual is observed for potential serious side effects that would require medical intervention.
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Policy
The National Uniform Billing Committee (NUBC) created new Gene Therapy revenue codes and a value code for reporting on the UB-04 Claim Form that went into effective April 1, 2019. Blue Cross Blue Shield of North Dakota (BCBSND) will separately reimburse for the administration of CAR-T in the hospital outpatient setting for CPT code 0540T only.
Hospitals may report CPT codes 0537T, 0538T, and 0539T, as non-covered items/services to allow for tracking of CAR-T Gene Therapy services when furnished in the hospital outpatient setting. Hospitals may report the new CAR-T related revenue codes 087X (Cell/Gene Therapy) and 089X (Pharmacy) with the new value code 86 (Invoice Cost) established by the NUBC which are reportable on UB-04 Claim Form.
CPT codes 0537T, 0538T, and 0539T describe various steps required to collect and prepare the genetically modified T-cells, which are not paid separately for each step used to manufacture a drug or biological. Reporting of these codes will be used to track utilization and cost data from hospitals reporting these services.
Codes
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Description
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Value Code 86
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Cell/Gene Therapy Invoice Cost
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Revenue Code
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087X - Cell/Gene Therapy (structured sequentially to the Gene Therapy process)
- 0 – General Classification
- 1 – Cell Collection
- 2 – Specialized Biologic Processing and Storage – Prior to Transport
- 3 – Storage and Processing after receipt of cells from manufacturer
- 4 – Infusion of Modified Cells
- 5 – Injection of Modified Cells
089X – Pharmacy – Extension of 025X and 063X
- 1 – Special Processed Drugs – Food and Drug Administration (FDA) Approved Cell Therapy
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HCPCS Codes
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Q2041
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Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car positive viable T-cells, including leukapheresis and dose preparation procedures, per therapeutic dose
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Q2042
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Tisagenlecleucel, up to 600 million car-positive viable T-cells, including leukapheresis and dose preparation procedures, per therapeutic dose
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0537T
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Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day
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0538T
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Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage)
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0539T
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Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration
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0540T
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Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous
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