ICD-10-CM Codes

The ICD-10-CM codes listed below for the approved indications for Breyanzi are provided by Bristol Myers Squibb and should be verified with a patient’s payer. Some payers may specify which codes are covered under their policies. Please code to the level of specificity documented in the medical record.

_{*This code should be reported only for clinical trial cases. In the event that the CAR T product is purchased in the usual manner but is being used for a clinical trial involving a different product (ie, the clinical trial is for a non-CAR T cell therapy product), the provider may enter a Billing Note NTE02 (“Diff Prod Clin Trial”) on the electronic claim form (or a remark “Diff Prod Clin Trial” on a paper claim). To notify Medicare of expanded access use (EAU) of a CAR T product, the provider may enter a Billing Note NTE02 “Expand Acc Use” on the electronic claim 837I (or a remark “Expand Acc Use” on a paper CMS 1450 claim form).²}

HCPCS Level II Codes
Effective October 1, 2021, Breyanzi has been assigned a unique Q-code for use in all sites of care and by all payers.³

Effective July 1, 2021, Breyanzi has been assigned a transitional pass-through status under the Medicare FFS Outpatient Prospective Payment System (OPPS). Transitional pass-through status is typically granted for a period of at least 2 years, but not more than 3 years.⁵*

_{*Based on OPPS reporting requirements for drugs with a transitional pass-through status, -TB modifier should be reported for informational purposes when Breyanzi has been acquired under the 340B drug pricing program. Note that effective January 2025, the -TB modifier will be required for all OPPS claims for products acquired under the 340B Drug Pricing Program; the -JG modifier will remain effective only through December 2024. During the course of 2024, hospitals that currently report the -JG modifier may choose to continue to use it or choose to transition to the -TB modifier.⁵}

NDC Information
Breyanzi consists of genetically modified autologous T cells, supplied in vials as separate frozen suspensions of each CD8 component and CD4 component. A single dose of Breyanzi contains CAR-positive viable T cells that consist of CD8 and CD4 components, with each component supplied separately in 1 to 4 single-dose vials. For R/R LBCL after 1 line of therapy, a single dose contains 90 to 110 x 106 CAR-positive viable T cells. For R/R LBCL after ≥2 lines of therapy, a single dose contains 50 to 110 x 10⁶ CAR-positive viable T cells.⁶

Payers may require that the NDC number(s) is (are) documented on medical claims submitted for provider-administered therapies.

Specific requirements for NDC reporting may vary; however, the 11-digit format is generally preferred for medical claims. Some payers may require reporting the 11-digit NDC number, along with the NDC qualifier, basis of measure, and quantity.⁶ For example, the Breyanzi NDC number(s) reported in this format would include:

ICD-10-PCS Inpatient Procedure Codes
The following CAR T cell therapy-designated revenue codes may be reported with accompanying line items billed for services associated with Breyanzi.

_{*Site/setting-of-care decisions are at the sole discretion of the treating physician.
^†For Medicare Advantage patients, billing requirements and reimbursement methodology may vary by plan}.
_{^‡The estimated average does not include outlier, pass-through payments, or other applicable hospital-specific adjustments.}

Hospital Revenue Codes
The following CAR T cell therapy-designated revenue codes may be reported with accompanying line items billed for services associated with Breyanzi.

_{*For Medicare FFS patients, when the charges for collection and preparation of the CAR T cells are included with the charges for the CAR T product (as a single line item under 0891), the reported date of service must be based on the date of CAR T administration. When cell collection and/or cell processing/storage services are initiated and furnished in the hospital outpatient setting, but the CAR T cell therapy is administered in the inpatient setting, all related charges must be reported on the inpatient claim with the date of CAR T administration as the date of service (reported as separate line items for tracking purposes under 0871, 0872, and 0873 or as a single line item along with CAR T product charges under 0891). For more information, please see Chapter 32 of the Medicare Claims Processing Manual.^13
†For Medicare FFS patients, 3-day payment window policy applies to outpatient services furnished by a hospital or an entity wholly owned or wholly operated by the hospital. Note that for IPPS-exempt hospitals, 1-day payment window applies.¹⁴}

CPT^® Codes for Outpatient Hospital and Physician Services*
The following CAR T cell therapy-designated CPT Category III codes may be reported for outpatient hospital facility services or physician services associated with Breyanzi. Please note that only one of these CPT Category III codes (CPT code 0540T) is separately payable by Medicare under the Hospital OPPS.¹⁵
CMS has not assigned relative value units or APCs to these Category III CPT codes, with the exception of the CPT code 0540T under the OPPS.^14,15 As such, they may not be payable by non-Medicare payers.

CMS has instructed MACs that Medicare only covers CAR T therapy when administered in a REMS‑certified healthcare facility. When a facility submits a claim, in order to acknowledge that they are REMS‑certified, the claim must have the KX modifier appended to the CAR T administration code 0540T. In Transmittal 11179 (released in January 2022), CMS clarified that the KX modifier is required for CAR T claims submitted by outpatient hospital facilities (Part A outpatient claims) and physician practices (Part B professional claims).^13,17||

_{*Site/setting-of-care decisions are at the sole discretion of the treating physician.
^†See previous section for revenue code descriptions.
^‡For Medicare Advantage patients, billing requirements and reimbursement methodology may vary by plan.
^§CPT Category III codes 0537T, 0538T, and 0539T can be reported for tracking purposes only, as non-covered charges. For more information, please see Chapter 32 of the Medicare Claims Processing Manual.^13
||Once a hospital facility is identified by a MAC as an FDA REMS-approved facility for a particular CAR T cell therapy, the facility is added to a special edit that allows their inpatient and outpatient facility claims to process automatically regardless of whether the KX modifier is present on subsequent claims. This special Medicare edit is not applicable to professional claims billing 0540T. For all Medicare professional claims billing this code, the KX modifier must be present on each CAR T claim.¹⁵}