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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.

Last update took place in January 2024.

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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.

Payer Type	Coverage
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?

Diagnosis Coding

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.

CAR-T Product
Indications Complications of
CAR-T Therapy

Product Coding

HCPCS Level II product codes have been created to describe different FDA-approved CAR-T products.

CAR-T HCPCS Product Codes

Procedure 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.

Cell Collection and
Cell Processing Services

Administration of CAR-T

Reimbursement Methodologies

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.

Methodologies

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.

Medicare Guidance

Other Payer Guidance

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.

Prior to Service Delivery
	Eligibility, Coverage, and Prior Authorization Checklist
Concurrent with Service Delivery
	Change Capture and Documentation

After Service Provision
	Claim Submission Checklist
	Tracking After Submission & Resolving Denials
	Expected Reimbursement

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.