Infusion coding can be complex, challenging coders and compliance professionals alike. There is an important and confusing newer service for 2023 that requires comprehensive knowledge in order to report and bill accurately. Our insight aims to breakdown the obstacles while exploring some of the intricacies of cellular and gene therapies, with a specific focus on chimeric antigen receptor therapy (CAR-T), which uses genetically modified T cells, to clarify reporting in this area. With some of this fundamental knowledge, we can help calm the confusion and shape your success with this service in 2023 and beyond.
Identifying the Intended Use of CAR-T
First, it is important to note that Medicare pays for the administration of CAR T-cells in the hospital outpatient setting separately under CPT® code 0540T with revenue Code 0874. Code 0540T continues to be assigned to status indicator “S” (Procedure or Service, Not Discounted When Multiple) under the OPPS.
|0540T||Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous
Revenue Code: 874
So, what does CAR-T encompass? The treatments involve the following elements:
- Collection of cells and tissues
- processing and handling of cells or other tissues
- genetic modification of those cells or tissues
- and administration of the genetically modified cells or tissues with the intent to treat
- and modify, reverse, or cure a serious or life-threatening disease or condition
Codes 0537T, 0538T, 0539T, 0540T establish the various steps required to collect, prepare, transport, receive, and administer genetically modified T cells. Note that the collection and handling code (0537T) may be reported only once per day, regardless of the number of collections or quantity of cells collected. Similarly, the administration code (0540T) may only be reported once per day, regardless of the number of units administered. Coders should be cautious and understand that the development of genetically modified cells is not reported with this family of codes.
The specialized services outlined in codes 0537T, 0538T, and 0539T are not conducted within hospital premises. Instead, these essential steps in cellular and gene therapies are carried out by dedicated specialty labs or contracted manufacturers. These experts play a crucial role, ensuring the highest standards of care and precision are performed.
Cell Collection and Processing
The CAR-T therapy journey commences with the collection of cells from the patient through peripheral blood leukocyte cell harvesting. These cells, essential for the therapy’s success, are carefully obtained to ensure their optimal quality. After collection, the cells are prepared for processing or shipping to a specialized manufacturing or cell processing facility, if required. This preparation may involve cryopreservation or other techniques to maintain the cells’ integrity during transportation.
The procedure to administer CAR-T cells includes the following components:
- physician monitoring of multiple physiologic parameters,
- physician verification of cell processing,
- evaluation of the patient during, as well as immediately before and after the administration of the CAR-T cells,
- physician presence during the administration and direct supervision of clinical staff,
- and management of any adverse events during the administration.
Coders may be wondering how the term “care” on the same date of service that is not directly related to the service of administration of the CAR-T cells is defined and how it may be reported. This type of care is essentially defined as care provided after the administration is complete, care for the patient’s underlying condition, or for other medical problems. Under these circumstances, this service may be separately reported using the appropriate evaluation and management code with modifier 25. However, coders should make special note that management of uncomplicated adverse events (e.g., nausea, urticaria) during the infusion is not reported separately.
Separate reporting is a common area of confusion for many coders time and time again. Like with other services, CAR-T has some critical points worth noting in this area. First, the fluid used to administer the cells and other infusions for incidental hydration (e.g., 96360, 96361) are not reported separately. Similarly, infusion(s) of any supportive medication(s) (e.g., steroids) concurrently with the CAR-T cell administration are not reported separately. However, one key exception is hydration or administration of medications (e.g., antibiotics, opioids) unrelated to the CAR-T administration. When these are administered, they may be reported separately with modifier 59. It is also common for lymphodepleting (LD) chemotherapy (e.g., Bendamustine, Fludarabine and Cyclophosphamide) to be added to the patient’s treatment plan. This form of chemotherapy is usually performed days before infusion of the CAR-T cells. Our experts note that chemotherapy drugs administered may be reported with applicable chemotherapy drug administration codes on the date they were performed.
Analyzing CAR-T Cell Administration
The physician or other qualified health care professional evaluates the patient immediately before the autologous CAR-T infusion and monitors multiple physiologic parameters, including frequent monitoring of vital signs and clinical status. The physician or other qualified health care professional, nurse, and cell-processing technologist hold multiple responsibilities in ensuring the success of the process These include reviewing:
- the cell-product label,
- patient identification,
- sterility testing,
- and product characteristics.
During the infusion process, the physician or qualified healthcare professional must be present for 15 to 30 minutes (possibly longer depending on the infusion rate). Their presence ensures the proper initiation of the product infusion and allows for immediate response in managing any potential toxicities or complications that may arise during or immediately after the infusion.
To ensure accurate billing and coding for CAR-T therapy, it’s essential to refer to CMS MLN Matters Number: MM11216, which provides valuable guidance on billing scenarios specific to various healthcare settings. Particularly in the hospital outpatient setting, it’s important to use the appropriate codes for reporting. CPT code 0540T should be used to report the administration of the CAR-T drug, while HCPCS Q-codes, specifically Q2041 or Q2042, should be utilized to report the drug/biological.
It’s worth noting that the procedures described by CPT codes 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and preparation) represent the various steps required to collect the cells and prepare the genetically modified T-cells, are not separately payable. However, these services may be reported as non-covered charges on the outpatient claim. This is noted in the CY 2019 OPPS/ASC final rule.
By focusing on accurate billing and proper reimbursement, healthcare professionals should stay updated on the latest coding guidelines and regulations. By following the appropriate coding practices and referencing official resources, you can ensure accurate documentation and streamline the billing process for CAR-T therapy and related services.
These are not all the necessary coding tips and rationale essential for CAR-T therapy and infusion therapy coding. As service volumes rebound and every dollar counts more than ever, it is imperative to make sure your CPT® coding is correct and compliant. Master more topics in our Coding Essentials for Infusion & Injection Therapy Services resource, fully equipped with expert-infused guidance tailored to your needs.