Reimbursements

Category:

CAR T-Cell Gene Therapy

Reimbursement Policy NDRP-GC-016
Topic Gene Therapy Revenue Codes, HCPCS, and Value Codes 
Effective Date
April 1, 2019
Last Updated
June 19, 2019

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Description:

This policy provides direction on reporting Chimeric Antigen Receptor (CAR) T-cell (CAR-T) Gene Therapy revenue codes, HCPCS, and value codes.

Definitions:

CAR-T Therapy is 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. Effective April 1, 2019, the National Uniform Billing Committee (NUBC) created new Gene Therapy revenue codes and a value code for reporting on the UB-04.

New Value Code

  • Value Code 86 – Cell/Gene Therapy Invoice Cost

New Revenue Codes

  • 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

Policy:

Effective April 1, 2019, separate payment will be allowed 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 claims.

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.

HCPCS Codes

  • Q2041 – Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car positive viable T-cells, including leukapheresis and dose preparation procedures, per therapeutic dose
  • Q2042 – Tisagenlecleucel, up to 600 million car-positive viable T-cells, including leukapheresis and dose preparation procedures, per therapeutic dose
  • 0537T – 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
  • 0538T – Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage)
  • 0539T – Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration
  • 0540T – Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

Cross Reference:

Centers for Medicare & Medicaid Services (CMS) Change Request 11216