CAR-T Therapy Coding and Billing Guide
Chimeric Antigen Receptor T-cell therapy (CAR-T) is a type of immune effector cell therapy which represents an advancement in the treatment of certain hematologic malignancies. The currently approved CAR-T therapy products are personalized, autologous therapies, which involve steps of cell collection, processing, and administration to a patient. This guide helps providers answer questions about appropriate coding and billing for hospital inpatients and outpatients surrounding CAR-T therapy and its related ancillary services for hospitals, regardless of the product used.
This guide addresses:
- US Food and Drug Administration (FDA)-approved commercial products
- Products administered as part of a clinical trial or expanded access program
- Clarifies the major billing differences and considerations between government and private payers
ASTCT’s Chimeric Antigen Receptor T-cell (CAR-T) Therapy Coding and Billing Guide is updated regularly to ensure it remains a relevant and current resource for CAR-T providers.
June 2023 Updates
ASTCT's Chimeric Antigen Receptor T-cell (CAR-T) Therapy Coding and Billing Guide is updated regularly to ensure it remains a relevant and current resource for CAR-T providers. For June 2023, updates include:
- Minor updates to the format, making it easier to read
- Minor text updates to improve clarity
January 2023 Updates
- Updates to the product coding section to include details from Medicare’s recent transmittals and final rules, including:
- HCPCS code billing when dose administered exceeds the HCPCS code description
- Modifiers on CAR-T therapy product code HCPCS codes
- Minor updates to links in references to current Medicare coverage articles
WHERE DO I START?
Confirm the status of the patient at each step of CAR-T care.
Understand the different payer types and impacts on billing.
|Coverage for Medicare Fee-For-Services (FFS) Beneficiaries
||The Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Decision (NCD) memorandum for autologous CAR T-cell therapy, which applies to Medicare beneficiaries. The NCD ensures consistent national coverage of CAR-T for Medicare beneficiaries as all A/B Medicare Administrative Contractors (MAC) are required to follow the decision.
|Coverage for Medicare Advantage (Part C) Beneficiaries
||CMS requires Medicare Advantage (MA) plans to provide the same coverage to their enrollees as exists for Medicare FFS beneficiaries. While the terms of the CAR-T NCD should apply to beneficiaries enrolled in MA plans, those plans may administer the NCD with additional requirements—such as prior authorization.
|Coverage for Commercial Plan Beneficiaries
||Non-governmental payers are often referred to as “commercial” payers. CAR-T is covered by many, if not most, commercial payers. The medical policies that determine patient eligibility are based on the FDA’s label, but often have additional requirements for treatment qualification.
|Coverage for Medicaid Patients
||Coverage of CAR-T therapy for Medicaid beneficiaries varies significantly by product and by state due to limited Federal coverage requirements. Therefore, it is important for providers who serve Medicaid beneficiaries to research the Medicaid state benefit documents and Medicaid Managed Care medical policies (if applicable) to determine eligibility and coverage.
Learn more about each payer type and coverage available.
What Codes Should I Be Using?
It is important to code the diagnosis being treated by the CAR-T product, any complications related to the CAR-T therapy administration, and any relevant co-morbid conditions impacting medical decision-making and/or the patient’s care.
Indications Complications of
HCPCS Level II product codes have been created to describe different FDA-approved CAR-T products.
CAR-T HCPCS Product Codes
Delivering a CAR-T episode of care requires many services across several departments and procedures, such as cell collection, cell processing, and the infusion/administration of the cells. These services need to be ordered, documented, and coded correctly in order for the facility to receive reimbursement.
Understand the reimbursement methodologies that apply to all services that comprise the CAR-T episode of care, including MS-DRG grouping logic for inpatient stays, negotiated contract terms, and how clinical trials may impact reimbursement as well as requirements for billing.
How Do We Bill for a clinical trial case?
The development of CAR-T products is on-going, with multiple clinical trials underway at any given time. Some products in clinical trial are seeking initial FDA approval; some are pursuing expansion to new indications; and others are individual cases where an FDA-approved product did not meet manufacturing release specifications, necessitating administration to a patient under an expanded access program or protocol. Billing for clinical trials is, therefore, likely be a constant in this field, and to present billing challenges for providers.
How Can I Maintain Revenue Integrity in the Billing and Coding Process?
The goal of revenue integrity, according to the National Association of Healthcare Revenue Integrity (NAHRI), “is to prevent recurrence of issues that can cause revenue leakage and/or compliance risks through effective, efficient, replicable processes and internal controls across the continuum of patient care, supported by the appropriate documentation and the application of sound financial practices that are able to withstand audits at any point in time.” Consider incorporating these steps into your revenue integrity process.
The American Society for Transplantation and Cellular Therapy (ASTCT) Government Relations Committee has made this guide available to provide a comprehensive review of accurate and complete coding and billing for CAR-T cell therapy and its related ancillary services for hospitals, regardless of the product used.