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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. Accurate billing for these products and the associated services is extremely important due to the cost and clinical resource intensity of administering the products.
We previously provided instructions for the billing of CAR T-cell therapies when provided to an outpatient. This newsletter provides billing and reimbursement information when these products are administered to hospital inpatients.
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 (current as of 09/09/2021):
KYMRIAH (tisagenlecleucel)
YESCARTA (axicabtagene ciloleucel)
BREYANZI (lisocabtagene maraleucel)
ABECMA (idecabtagene vicleucel)
TECARTUS (brexucabtagene autoleucel)
Coverage
CMS finalized a National Coverage Determination (NCD 110.24) on CAR T-cell therapies on 8/7/2019 and has published a revision scheduled to be implemented on 09/20/2021. The revisions include additional general information about the use of CAR T-cell therapies in cancer, and to add HCPCS code C9076 for Breyanzi to the list of covered products. This information is in CMS Transmittal 10891 issued on July 20, 2021.
The NCD details 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), and,
Used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) – i.e. is used for either an FDA-approved indication (according to 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
The use of non-FDA-approved autologous T-cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the requirements noted above are not met.
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.
NOTE: The use of allogenic T-cells from healthy donors are not autologous CAR T treatments and should not be billed as autologous CAR-T treatments.
NOTE: As specific codes are created for current and future FDA-approved CAR T-cell therapies, the MACs will update their local systems and websites accordingly.
Billing and Reimbursement
General Billing
All CAR T-cell products should be billed using revenue code 891- – Special Processed Drugs – FDA (U.S. Food and Drug Administration) Approved Cell Therapy – Charges for Modified cell therapy.
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 outpatients is available at CMS Transmittal #10454- (November 13, 2020) and MLN Matters Article SE19009 (May 28, 2019).
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.
Product Reimbursement
Kymriah and Yescarta
From October 1, 2018 until September 30, 2020, Kymriah and Yescarta received New Technology Add
