C9076 is the newest addition to the list of HCPCS Level II codes for CAR-T therapies, effective July 1.
Learn the latest changes to reporting products and procedures related to Chimeric Antigen Receptor (CAR) T-cell therapy to ensure proper medical coding and billing of CAR-T services furnished to Medicare patients.
Review the Basics
CAR-T is a cell-based gene therapy where a patient’s own T lymphocytes (T-cells) are extracted and chemically reengineered in a laboratory to express chimeric antigen receptors (CARs) on their surface, which can enhance the ability of the T-cell to recognize and attach to a specific protein, called an antigen, on the surface of a cancer cell. The genetically modified CAR T-cells are then infused back into the patient, now able to recognize and kill cancer cells that have the targeted antigen on their surface.
Since the publication of my last article on this innovative cancer treatment, the Food and Drug Administration (FDA) has approved three additional biologics. The expanded list of FDA-approved cellular and gene treatments now includes the following five CAR T-cell therapies:
Kymriah (tisagenlecleucel)
Yescarta (axicabtagene ciloleucel)
Tecartus (brexucabtagene autoleucel)
Breyanzi (lisocabtagene maraleucel)
Abecma (idecabtagene vicleucel)
Unchanged, Medicare will cover autologous treatment for cancer with T-cells expressing at least one CAR when provided at healthcare facilities enrolled in the FDA’s risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication — either an FDA-approved indication, or for off-label uses that are recommended by the Centers for Medicare & Medicaid Services (CMS)-approved compendia.
See What’s New in CAR-T Coding and Billing
Outpatient Coding
Use the following HCPCS Level II codes for billing outpatient CAR T-cell therapy:
Yescarta – Q2041 Axicabtagene ciloleucel, up to 200 million autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion.
Kymriah – Q2042 Tisagenlecleucel, up to 600 million car-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Tecartus – Q2053 Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose. (HCPCS Level II code Q2053 replaced C9073, effective April 1, 2021.)
Breyanzi – C9076 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) received FDA approval on March 26, 2021. CMS has not yet assigned a HCPCS Level II code to this product. Until that time, report this biological with C9399 Unclassified drugs or biologicals. This code is used to bill newly approved products prior to assignment of a specific HCPCS Level II code.
Use the following CPT® codes for billing outpatient CAR T-cell therapy services:
CPT® Code Descriptor
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 (eg, 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
*Procedure represents the various steps required to collect and prepare the genetically modified T-cells; these steps aren’t paid separately under the OPPS
Inpatient Coding
In cases where the CAR T-cell infusion is administered at an inpatient facility, assign one of the following ICD-10-PCS codes:
XW033C3 Introduction of Engineered Autologous Chimeric Antigen Receptor T-cell Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 3 (Yescarta, ABECMA, Kymriah)
XW043C3 Introduction of Engineered Autologous Chimeric Antigen Receptor T-cell Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 3 (Yescarta, ABECMA, Kymriah)
XW23346 Transfusion of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 6 (Tecartus)
XW24346 Transfusion of Brexucabtagene Autoleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 6 (Tecartus)
XW23376 Transfusion of Lisocabtagene Maraleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 6 (Breyanzi)
XW24376 Transfusion of Lisocabtagene Maraleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 6 (Breyanzi)
Don’t Forget Revenue Codes
CMS has also provided instructions for specific revenue codes to report all inpatient and outpatient services associated with CAR T-cell therapy. When billing CAR-T, use the following revenue codes:
0871 – Cell Collection w/ CPT code 0537T
0872 – Specialized Biologic Processing and Storage – Prior to Transport w/CPT 0538T
0873 – Storage and Processing after Receipt of Cells from Manufacturer w/CPT 0539T
0874 – Infusion of Modified Cells w/CPT 0540T
0891 – Special Processed Drugs – FDA Approved Cell Therapy w/HCPCS Q2041, Q2042, C9073 (replaced with Q2053 April 1, 2021), C9076, or C9399
Take Note of Applicable ICD-10-CM Codes
FDA approved indications for each biological are as follows:
Tecartus: Mantle cell lymphoma (C83.11- C83.19)
Yescarta and Kymriah: Diffuse large B-cell lymphoma (C83.31- C83.39), Unspecified B-cell lymphoma (C85.11- C85.19), Mediastinal (thymic) large B-cell lymphoma (C85.21-C85.29), Other specified types of non-Hodgkin lymphoma (C85.81- C85.80)
Kymriah: C91.00 Acute lymphoblastic leukemia, not having achieved remission, C91.02 Acute lymphoblastic leukemia, in relapse
Breyanzi: Follicular lymphoma grade IIIb (C82.41- C82.49), as well as the diagnosis codes mentioned above for Yescarta/Kymriah.
Abecma: C90.00 Multiple myeloma not having achieved remission, C90.02 Multiple myeloma in relapse
See Attachment 1 of Transmittal R10796CP for the full list of primary ICD-10 diagnosis codes.
Put It All Together
Medicare pays for the administration of CAR T-cells in both inpatient and outpatient settings. Billing for outpatient CAR T-cell therapy includes HCPCS Level II codes for the therapies as well as coding for the administration. Physicians and non-hospital clinics should use CPT® code 0540T Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous to report the administration of any CAR T-cell immunotherapy and bill it with revenue code 874. And make sure to bill all FDA-approved CAR T-cell products with revenue code 891.
CMS includes the payment for the various steps required to collect and prepare the genetically modified T-cells in the payment for the biological. Providers may choose to include all costs and charges for these various steps and report them under revenue code 891; or separately report cell collection, storage, and other preparatory activities. However, Medicare does not reimburse these codes separately; they are for tracking purposes only.
Do not report the same charges twice. Providers must choose one of the options listed above. You may not include charges for pre-infusion steps in both the drug revenue code (0891) and separately listed for the pre-infusion revenue codes (0871, 0872, and 0873).
For More Information: https://www.aapc.com/blog/81163-car-t-coding-update/
