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Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to treat their cancer.
This newsletter details coverage and billing instructions when the products are used on an outpatient basis and has been updated to reflect HCPCS codes current as of April 1, 2022.
The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a list of approved cellular and gene therapies including six that are Car T-cell therapies:
ABECMA (idecabtagene vicleucel) BREYANZI (lisocabtagene maraleucel) CARVYKTI (ciltacabtagene autoleucel) KYMRIAH (tisagenlecleucel) TECARTUS (brexucabtagene autoleucel) YESCARTA (axicabtagene ciloleucel) Coverage
CMS finalized a National Coverage Determination (NCD 110.24) on Car T-cell therapies on 8/7/2019. The NCD detailed that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when:
Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS)
Used for a medically accepted indication, i.e. for either an FDA-approved indication as detailed in the FDA-approved label for the product, or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia
When the above requirements are not met, the CAR T-cell therapy is non-covered.
In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in NCD 310.1.
Billing and Reimbursement
HCPCS/CPT codes
Billing for CAR T-cell therapy on outpatients includes HCPCS codes for the therapies as well as the administration. All CAR T-cell products should be billed with revenue code 891.
Kymriah (tisagenlecleucel) is reported with HCPCS code Q2042- Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Yescarta (axicabtagene ciloleucel) is reported with HCPCS code Q2041- Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion.
Tecartus- (brexucabtagene autoleucel) is reported with HCPCS code Q2053- Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, includimg leukapheresis and dose preparation procedures, per therapeutic dose.
Breyanzi- (lisocabtagene maraleucel) is reported with HCPCS code Q2054- Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Abecma (idecabtagene vicleucel) is reported with HCPCS code Q2055- Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Carvykti (ciltacabtagene autoleucel) (received FDA approval on 2/28/2022, but CMS has not yet assigned a HCPCS code and we recommend that this product be reported with C9399- Unclassified drugs or biologicals. This HCPCS code is used to report newly approved products prior to HCPCS specific code assignment.
The administration of any CAR T-cell therapy should be reported with CPT code 0540T- Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous. This CPT code should be reported with revenue code 874 – Infusion of Modified Cells w/CPT 0540T.
Some payers also require that the claim include a new value code 86
