ICD-10-CM Codes

The ICD-10-CM codes listed below 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.

FDA-Approved Indications

Adult Patients With R/R CLL or SLL After ≥2 Prior Lines of Therapy, Including a BTKi and BCL2i^‡

Adult Patients With R/R FL After ≥2 Prior Lines of Systemic Therapy^‡

Adult Patients With R/R MCL After ≥2 Prior Lines of Systemic Therapy, Including a BTKi

_{*Including DLBCL, PMBCL, HGBCL, FL3B, and DLBCL transformed from indolent lymphomas including FL, MCL, and RT CLL. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma. Please see full Prescribing Information for the complete FDA-approved indications.
^†C83.39 end date is effective September 30, 2024 and C83.390 is not applicable.^2
‡This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).}

Encounter Type

Medicare requires all clinical trial claims to report Z00.6 diagnosis code, condition code 30, value code D4 with the 8-digit National Clinical Trial number.^3†‡ For inpatient and outpatient claims with expanded access use (EAU) of a CAR T product, providers may enter condition code 90. Use of the code will apply a payment adjustment for inpatient claims only.^4,5 Note that MACs will pay for covered clinical trial services furnished to Medicare Advantage beneficiaries.^3§

_{*This code should be reported only for clinical trial cases.
^†For outpatient claims, Medicare also requires reporting HCPCS modifier Q0 for all lines containing an investigational item/service and Q1 for all lines containing a routine service.^3
‡If a 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 product), the provider may enter a Billing Note NTE02 (“Diff Prod Clin Trial”) on the electronic claim form 837I (or a remark “Diff Prod Clin Trial” on a paper CMS-1450 claim form).^3,4
§For Medicare Advantage patients, providers should not bill outpatient clinical trial services and non-clinical trial services on the same claim. Only covered clinical trial services should be submitted to Part A/B MACs; any outpatient services unrelated to the clinical trial should be billed to the patient’s Medicare Advantage plan.³}

CAR T Complications

To properly report CRS and ICANS conditions due to CAR T infusions, coders will have to use at least 2 codes–the code for the underlying condition, represented by a complication “T” code, in addition to a code from the CRS or ICANS code range based on the grade (if documented) or the selection of unspecified (if the grade is not documented).⁶

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.⁷

Since the MCS restricts the total billed amount to $99,999.99 on a single claim, CMS requires providers to submit multiple claims for the same date of service reporting fractional units (where the total adds up to 1 billing unit).^3,8 Specific instructions on the number of fractional units may vary by MAC.
When a physician practice submits multiple claims for a Medicare patient for the same date of service^3,8:

• The first claim must have -KX and -LU modifiers appended to the CAR T Q-code
• Subsequent claims must have -KX, -LU, and -76 modifiers appended to the CAR T Q-code

Medicare FFS requirement to report the -JZ modifier aligns with the -JW modifier policy for documenting the discarded amount for drugs from single-dose containers, when eligible for payment under the discarded drug policy.⁹
NOTE: Specific billing instructions for reporting the -JZ modifier in CAR T claims submitted by physician practices may vary by MAC.

The accurate completion of reimbursement or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol Myers Squibb makes no guarantee regarding reimbursement for any service or item.

_{*Note that as of January 1, 2025, the -TB modifier is required for all OPPS claims for products acquired under the 340B Drug Pricing Program.¹⁰}

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.¹¹

• For R/R LBCL after 1 line of therapy, CLL or SLL, FL, or MCL, 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

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.¹² For example, the Breyanzi NDC number reported in this format would include:

ICD-10-PCS Inpatient Procedure Codes*
Effective for discharges on or after October 1, 2021, the following CAR T-designated ICD-10-PCS codes may be reported for inpatient facility services associated with Breyanzi administration.

_{*Site/setting-of-care decisions are at the sole discretion of the treating physician/institution.
^†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.
^§MS-DRG 018 rate adjustment will not be applied for cases when a CAR T product is purchased in the usual manner but is being used for a clinical trial involving a different product as reported with a Billing Note NTE02 (“Diff Prod Clin Trial”) on the electronic claim form 837I (or a remark “Diff Prod Clin Trial” on a paper CMS-1450 claim form).^3,4,15}

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.

_{*Site/setting-of-care decisions are at the sole discretion of the treating physician/institution.
^†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.^3
‡For Medicare FFS patients, a 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, a 1-day payment window applies.¹⁸}

CPT^® Codes for Outpatient Hospital and Physician Services*

The following CAR T-designated CPT Category I codes may be reported for outpatient hospital facility services or physician services associated with Breyanzi. Please note that only one of these CPT Category I codes (CPT code 38228) is separately payable by Medicare under the Hospital OPPS.¹⁹

CPT Category III codes were in effect through December 31, 2024. New CPT Category I codes are effective as of January 1, 2025.¹⁹
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 38228. 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).^3,20,21¶

Caregiver Training

As of January 1, 2024, Medicare FFS pays for the following caregiver training services under the PFS. CPT codes for caregiver training can be used to report the total duration of face-to-face time spent by the physician or health professional providing individual or group training to caregivers of patients.^22,23

_{*Site/setting-of-care decisions are at the sole discretion of the treating physician/institution.
^†See previous section for revenue code descriptions.
^‡For Medicare Advantage patients, billing requirements and reimbursement methodology may vary by plan.
^§CPT Category I codes 38225, 38226, and 38227 can be reported for tracking purposes only, as non-covered charges. For more information, please see Chapter 32 of the Medicare Claims Processing Manual.^3,20
¶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 38228. For all Medicare professional claims billing this code, the -KX modifier must be present on each CAR T claim.²¹}