CAR-T Reimbursement Requirements Revamped Again
- By Stacy Chaplain
- In Billing
- February 1, 2022
- Comments Off on CAR-T Reimbursement Requirements Revamped Again
Learn the latest changes to reporting products and procedures related to Chimeric Antigen Receptor T-cell therapy to ensure proper coding.
Expensive cutting-edge cancer therapy is available to Medicare patients nationwide. Back in 2019, the Centers for Medicare & Medicaid Services (CMS) finalized the long-sought rules for coverage of chimeric antigen receptor (CAR) T-cell therapy, a novel, often curative, treatment that uses a patient’s own genetically modified immune cells to fight cancer. Since then, new products have come onto the market and reporting requirements have evolved. Medical coders and billers need to understand these potentially lifesaving CAR-T biologics and coverage stipulations for proper billing and reporting of CAR T-cell therapy.
Understand the Science Behind CAR-T
CAR T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer, where patients’ own immune cells are collected and used to treat their cancer. In this cell-based gene therapy, a patient’s white blood cells, T lymphocytes (T-cells), are extracted and chemically re-engineered in a laboratory to express CARs on their surface.
CARs enhance the ability of a T-cell to seek out and bind to a specific protein, called an antigen, on the surface of a cancer cell, readying it for destruction. 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. Ultimately, this therapy will not only kill existing tumors, but also provide an internal line of defense against future cancers.
These novel gene therapies are the first of their kind approved by the U.S. Food and Drug Administration (FDA). The first two CAR-T products granted coverage were Gilead Sciences’ Yescarta, approved for non-Hodgkin lymphoma, and Novartis’ Kymriah for acute lymphoblastic leukemia. Over the past couple of years, the list of FDA-approved cellular and gene treatments has expanded and now includes five of these innovative biologics. Excitingly, CAR-T therapies are expanding treatment options for certain cancer patients and are evidence of significant scientific advancements in the fight against cancer.
CAR T-cell Therapy Coverage Specifics
Despite being revolutionary for certain types of cancers, CAR-T biologics have experienced difficulty gaining traction. The reluctance has been, in part, tied to the exorbitant costs associated with CAR T-cell therapy, which run around $375,000 to $475,000, depending on the specific drug and indication. And if these patients end up requiring hospitalization, which is variable, it can cost hundreds of thousands of dollars more. Luckily, progress has been made to improve coverage and reimbursement for these transformative, lifesaving treatments.
Effective for claims with dates of service on or after Aug. 7, 2019, Medicare covers autologous treatment for cancer with T-cells expressing at least one CAR when administered in healthcare facilities that follow the FDA’s special safety rules, known as risk evaluation and mitigation strategies (REMS). Note that it’s only covered when used for a medically accepted indication — either an FDA-approved indication or for off-label uses that are recommended by CMS-approved compendia, which are used to determine medically accepted uses of drugs and biologics.
See What’s New in CAR-T Coding and Billing
Use the following HCPCS Level II codes for billing CAR T-cell therapy provided in a physician office or non-hospital clinic:
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
Breyanzi – 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 – Q2055 Idecabtagene vicleucel, up to 460 million autologous anti-bcma car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose *
Use C9399 Unclassified drugs or biologicals to bill newly approved products prior to assignment of a specific HCPCS Level II code or for the biologics when the dose of CAR T-cell therapy exceeds the code descriptor.
Report the appropriate CPT® Category III code for billing outpatient CAR T-cell therapy services:
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 Outpatient Prospective Payment System (OPPS).
Physicians and non-hospital clinics should use CPT® code 0540T to report the administration of any CAR T-cell immunotherapy and bill it with revenue code 0874. You must also report revenue code 0891 with all FDA-approved CAR T-cell products. Some payers also require that the claim include new value code 86 with the invoice/acquisition cost when revenue code 0891 is present on an outpatient claim.
The following revenue codes are used for billing all inpatient and outpatient CAR T-cell therapy services:
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 – Charges for Modified cell therapy
Append HCPCS Level II modifier KX Requirements specified in the medical policy have been met to indicate that your provider performed that service in an FDA REM-approved facility, when applicable. Always double-check that it’s been added to the claim, as your Medicare Administrative Contractor (MAC) will deny CAR T-cell therapy services when the line item doesn’t contain modifier KX.
Note Inpatient Requirements
Again, all CAR T-cell products should be billed using revenue code 0891. Medicare payment for the various steps required to collect and prepare the genetically modified CAR T-cells is included in the payment for the biologic. Per CMS’ instructions, hospitals may include the charges for the various steps in the charge submitted for the biologic using revenue code 0891. Alternatively, they may separately report cell collection, storage, and other preparatory activities separately via pre-infusion revenue codes (0871, 0872, 0873). However, CMS does not reimburse these codes separately; they are for data tracking purposes only.
CMS implemented several policy changes for fiscal year 2022 that went into effect last October. In cases where the CAR T-cell infusion is administered at an inpatient facility for dates of discharge on or after Oct. 1, 2021, assign the applicable ICD-10-PCS code:
XW033H7 Introduction of axicabtagene ciloleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7 (Yescarta)
XW043H7 Introduction of axicabtagene ciloleucel immunotherapy into central vein, percutaneous approach, new technology group 7 (Yescarta)
XW033J7 Introduction of tisagenlecleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7 (Kymriah)
XW043J7 Introduction of tisagenlecleucel immunotherapy into central vein, percutaneous approach, new technology group 7 (Kymriah)
XW033K7 Introduction of idecabtagene vicleucel into peripheral vein, percutaneous approach, new technology group 7 (ABECMA)
XW043K7 Introduction of idecabtagene vicleucel immunotherapy into central vein, percutaneous approach, new technology group 7 (ABECMA)
XW033M7 Introduction of brexucabtagene autoleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7 (Tecartus)
XW043M7 Introduction of idecabtagene vicleucel immunotherapy into central vein, percutaneous approach, new technology group 7 (Tecartus)
XW033N7 Introduction of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7 (Breyanzi)
XW043N7 Introduction of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, New Technology Group 7 (Breyanzi)
For dates of discharge prior to Oct. 1, 2021, assign the applicable ICD-10-PCS code:
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)
As always, check with your payer to verify coverage and billing requirements.
Familiarize Yourself With Applicable ICD-10-CM Codes
FDA-approved indications for each biologic include:
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: Acute lymphoblastic leukemia (C91.00, C91.02)
Yescarta: Follicular lymphoma grade I (82.01-C82.09), Follicular lymphoma grade II (C82.11-C82.19), Follicular lymphoma grade IIIa (C82.31-C82.39), Follicular lymphoma grade IIIb (C82.41-C82.49), Diffuse follicle center lymphoma (C82.51-C82.59), Cutaneous follicle center lymphoma (C82.61-C82.69), Other types of follicular lymphoma (C82.81-C82.89)
Breyanzi: Follicular lymphoma grade IIIb (C82.41-C82.49), as well as the diagnosis codes mentioned above for Yescarta and Kymriah.
Abecma: Multiple myeloma (C90.00, C90.02)
Tecartus: Mantle cell lymphoma (C83.11-C83.19), Acute lymphoblastic leukemia (C91.00, C91.02)
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 0874. And make sure to bill all FDA-approved CAR T-cell products with revenue code 0891.
Be careful not to report the same charges twice. Providers must choose one of the options listed above. You cannot include the charges for these various steps in both the drug revenue code (0891) and separately listed for the pre-infusion revenue codes (0871, 0872, 0873).
Inpatient coders need to be mindful of the date of service when reporting CAR-T services, as new ICD-10-PCS codes were introduced, effective Oct. 1, 2021. The list of applicable diagnosis codes was also modified, so double-check whether the patient’s condition is covered and include the appropriate diagnosis code(s) on the claim.
Hopefully, this overview has shed some light on the ever-evolving coverage and reporting requirements for these innovative therapies. Keep an eye out for future updates.
Resources:
National Coverage Determination (NCD 110.24)
CMS Transmittal 10891: www.cms.gov/files/document/R10891NCD.pdf
CMS Transmittal 11068: www.cms.gov/files/document/r11068otn.pdf
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