CAR T-cell Therapy: Coverage and Billing for Outpatients

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. A future newsletter will provide instructions when used for an inpatient.

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 five that are Car T-cell therapies:

ABECMA (idecabtagene vicleucel)

BREYANZI (lisocabtagene maraleucel)

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, including leukapheresis and dose preparation procedures, per therapeutic dose.

Breyanzi- (lisocabtagene maraleucel) received FDA approval on 2/5/2021 and Abecma (idecabtagene vicleucel) received FDA approval on 3/26/2021. CMS has not yet assigned a HCPCS code to these new products and we would recommend that these 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 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim.

CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples on these two options for CAR T-cell billing for ou