Back to Access & Reimbursement Support

This information is provided for educational purposes only. Bristol Myers Squibb cannot guarantee insurance coverage or reimbursement. Coverage and reimbursement may vary significantly by payer, plan, patient, and setting of care and may be subject to frequent change. It is the sole responsibility of the healthcare provider to select the proper codes and ensure the accuracy of all statements used in seeking coverage and reimbursement for an individual patient.

Breyanzi Billing and Coding Information

Breyanzi® (lisocabtagene maraleucel)

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.

ICD-10-CM Diagnosis Codes

ICD-10-CM Diagnosis Codes

The ICD-10-CM codes listed below for the approved indication 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.

ICD-10-CM Code1 Description
C82.40Follicular lymphoma grade IIIb, unspecified site
C82.41Follicular lymphoma grade IIIb, lymph nodes of head, face, and neck
C82.42Follicular lymphoma grade IIIb, intrathoracic lymph nodes
C82.43Follicular lymphoma grade IIIb, intra-abdominal lymph nodes
C82.44Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb
C82.45Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb
C82.46Follicular lymphoma grade IIIb, intrapelvic lymph nodes
C82.47Follicular lymphoma grade IIIb, spleen
C82.48Follicular lymphoma grade IIIb, lymph nodes of multiple sites
C82.49Follicular lymphoma grade IIIb, extranodal and solid organ sites
C83.30Diffuse large B-cell lymphoma, unspecified site
C83.31Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck
C83.32Diffuse large B-cell lymphoma, intrathoracic lymph nodes
C83.33Diffuse large B-cell lymphoma, intra-abdominal lymph nodes
C83.34Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb
C83.35Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb
C83.36Diffuse large B-cell lymphoma, intrapelvic lymph nodes
C83.37Diffuse large B-cell lymphoma, spleen
C83.38Diffuse large B-cell lymphoma, lymph nodes of multiple sites
C83.39Diffuse large B-cell lymphoma, extranodal and solid organ sites
C83.90Non-follicular (diffuse) lymphoma, unspecified, unspecified site
C83.91Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of head, face, and neck
C83.92Non-follicular (diffuse) lymphoma, unspecified, intrathoracic lymph nodes
C83.93Non-follicular (diffuse) lymphoma, unspecified, intra-abdominal lymph nodes
C83.94Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of axilla and upper limb
C83.95Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of inguinal region and lower limb
C83.96Non-follicular (diffuse) lymphoma, unspecified, intrapelvic lymph nodes
C83.97Non-follicular (diffuse) lymphoma, unspecified, spleen
C83.98Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of multiple sites
C83.99Non-follicular (diffuse) lymphoma, unspecified, extranodal and solid organ sites
C85.10Unspecified B-cell lymphoma, unspecified site
C85.11Unspecified B-cell lymphoma, lymph nodes of head, face, and neck
C85.12Unspecified B-cell lymphoma, intrathoracic lymph nodes
C85.13Unspecified B-cell lymphoma, intra-abdominal lymph nodes
C85.14Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb
C85.15Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb
C85.16Unspecified B-cell lymphoma, intrapelvic lymph nodes
C85.17Unspecified B-cell lymphoma, spleen
C85.18Unspecified B-cell lymphoma, lymph nodes of multiple sites
C85.19Unspecified B-cell lymphoma, extranodal and solid organ sites
C85.20Mediastinal (thymic) large B-cell lymphoma, unspecified site
C85.21Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face, and neck
C85.22Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes
C85.23Mediastinal (thymic) large B-cell lymphoma, intra-abdominal lymph nodes
C85.24Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb
C85.25Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb
C85.26Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes
C85.27Mediastinal (thymic) large B-cell lymphoma, spleen
C85.28Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites
C85.29Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites
C85.80Other specified types of non-Hodgkin lymphoma, unspecified site
C85.81Other specified types of non-Hodgkin lymphoma, lymph nodes of head, face, and neck
C85.82Other specified types of non-Hodgkin lymphoma, intrathoracic lymph nodes
C85.83Other specified types of non-Hodgkin lymphoma, intra-abdominal lymph nodes
C85.84Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb
C85.85Other specified types of non-Hodgkin lymphoma, lymph nodes of inguinal region and lower limb
C85.86Other specified types of non-Hodgkin lymphoma, intrapelvic lymph nodes
C85.87Other specified types of non-Hodgkin lymphoma, spleen
C85.88Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites
C85.89Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites
Z00.6*Encounter for examination for normal comparison and control in clinical research program
Z51.12Encounter for antineoplastic immunotherapy

*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 (i.e., 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 (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 (or a remark “Expand Acc Use" on a paper claim).

1-888-805-4555
Contact Cell Therapy 360® for 24/7 on-call assistance with billing and coding information.

HCPCS Level II Product Codes

HCPCS Level II Product Codes

Effective July 1, 2021, Breyanzi has been assigned a transitional pass-through status under the Medicare FFS Outpatient Prospective Payment System (OPPS).2 Products with a pass-through status are not subject to the payment adjustment for 340B-acquired drugs (status indicator G); reimbursement is based on ASP plus 6% (or WAC plus 3% when ASP is not available). Transitional pass-through status is typically granted for up to 3 years.3

Effective October 1, 2021, Breyanzi has been assigned a unique Q-code for use in all sites of care and by all payers.4

HCPCS Code
Description
Notes
For services before October 1, 20212:
C9076 Lisocabtagene maraleucel, up to 110 million autologous anti-CD 19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose FOR MEDICARE FFS*:
  • Required for claims billed by outpatient hospital facilities under the OPPS for services performed on or after July 1, 20215*
  • 1 billing unit
J3490 Unclassified drugs FOR OTHER PAYERS AND/OR SITES OF CARE:
  • Additional information is typically required, including:
    • Product name
    • Dosage
    • NDC number
    • Route of administration
  • Requirements may vary; refer to the specific payer policy
J3590 Unclassified biologics
For services on or after October 1, 20214‡:
Q2054 Lisocabtagene maraleucel, up to 110 million autologous anti-CD 19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose FOR ALL PAYERS AND SITES OF CARE:
  • 1 billing unit

*Some commercial and Medicare Advantage plans may also require C9076 for Breyanzi claims; refer to specific payer policies as billing requirements may vary.

For Medicare FFS claims billed by outpatient hospital facilities under the OPPS including those billed by off-campus provider-based departments (PBDs). TB modifier should be reported if Breyanzi has been acquired under the 340B drug pricing program.3,6

Medicare Administrative Contractors (MACs) are expected to implement Q2054 on October 1, 2021. Implementation by commercial and other payers may be delayed; refer to specific payer for billing requirements.

NDC Information

NDC Information

Breyanzi consists of genetically modified autologous T cells, supplied in vials as separate frozen suspensions of each CD8 component and CD4 component.7 A single dose of Breyanzi contains 50 to 110 × 106 CAR-positive viable T cells (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components), with each component supplied separately in one to four single-dose vials.7

10-digit Format7
11-digit Format
Description
73153-900-01 73153-0900-01 Outer carton containing:
  • Carton for CD8 component, with up to 4 single-dose vials
  • Carton for CD4 component, with up to 4 single-dose vials

Payers may require that the NDC number(s) is (are) documented on medical claims submitted for provider-administered therapies, including drugs and biologics billed with an unclassified/miscellaneous code or those with an assigned code.

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.8 For example, the Breyanzi NDC number(s) reported in this format would include:

NDC Qualifier
11-digit NDC
Quantity Qualifier
Quantity for a Single Dose
N4 73153-0900-01 UN 1

ICD-10-PCS Inpatient Procedure Codes

ICD-10-PCS Inpatient Procedure Codes*

For Medicare FFS, the following CAR T cell therapy-designated ICD-10-PCS codes may be reported for inpatient facility services associated with Breyanzi administration.

ICD-10-PCS Code9
Description
Notes for Medicare FFS
XW23376 Transfusion of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group6 Under the Inpatient Prospective Payment System (IPPS) for FY 2021, these codes are assigned to MS-DRG 018 (Chimeric Antigen Receptor [CAR] T-cell Immunotherapy), with the average national base payment rate of $239,928 (the exact rate may vary widely based on hospital-specific adjustments).10‡§
XW24376 Transfusion of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group6

For commercial plans and other payers, depending on specific policies, in addition to the codes listed above, the following ICD-10-PCS codes may apply.

ICD-10-PCS Code9
Description
Notes for Commercial Plans & Other Payers
6A550Z1 Pheresis of leukocytes, single Requirements may vary; refer to the specific payer policy.
6A551Z1 Pheresis of leukocytes, multiple

*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, new technology add-on payment (NTAP), pass-through payments, or other applicable hospital-specific adjustments.

§CAR T cell therapies are not eligible for NTAP in FY 202111; for FY 2022, NTAP eligibility decisions will be made on a case-by-case basis.

Hospital Revenue Codes

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.

Revenue Code12
Description
Notes for Medicare FFS*
0871 Cell/gene therapy—cell collection Charges for services associated with cell collection and cell processing/storage can be reported under 0871, 0872, and 0873, as separate line items for tracking purposes only. Alternatively, these charges can be reported with Breyanzi charges under 0891, as a single line item.13†‡
0872 Cell/gene therapy—specialized biologic processing and storage—prior to transport
0873 Cell/gene therapy—storage and processing after receipt of cells from manufacturer
0874 Cell/gene therapy—infusion of modified cells
0891 Pharmacy—specialized processed drugs—FDA approved cell therapy

*Site/setting of care decisions are at the sole discretion of the treating physician.

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 Medicare Transmittal 10796.14

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.15

CPT® Codes

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 Outpatient Prospective Payment System (OPPS) and the Physician Fee Schedule (PFS).3,16

CMS has not assigned relative value units to these Category III CPT codes, with the exception of the CPT code 0540T under the OPPS.16,17 As such, they may not be payable by non-Medicare payers.

CPT Category III Code3
Description
Corresponding Hospital Revenue Code
Medicare FFS Reimbursement Status in CY 2021
OPPS3,17 PFS16
Apheresis and Preparation
0537T Chimeric antigen receptor T cell (CAR T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR T cells, per day 0871 Not recognized by OPPS§ (status indicator B) Bundled code, not separately paid§ (status indicator B)
0538T Chimeric antigen receptor T cell (CAR T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage) 0872
0539T Chimeric antigen receptor T cell (CAR T) therapy; receipt and preparation of CAR T cells for administration 0873
Administration
0540T Chimeric antigen receptor T cell (CAR T) therapy; CAR T cell administration, autologous 0874 Paid under APC 5694 (status indicator S, CY 2021 national average payment rate is $310.75) Contractor-priced code (status indicator C)

*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 Medicare Transmittal 10796.14

Medicare Administrative Contractors typically require additional documentation for contractor-priced codes.

APC=Ambulatory Payment Classification; CAR=chimeric antigen receptor; CMS=Centers for Medicare and Medicaid Services; CPT=Current Procedural Terminology; CY=calendar year; FFS=fee-for-service; FY=fiscal year; HCPCS=Healthcare Common Procedure Coding System; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification; ICD-10-PCS=International Classification of Diseases, Tenth Revision, Procedure Coding System; IPPS=Inpatient Prospective Payment System; MAC=Medicare Administrative Contractor; MS-DRG=Medicare Severity Diagnosis Related Group; NDC=National Drug Code.

Online resources

Blank CMS 1450 and CMS 1500 claim forms can be found at CMS.gov.

Downloadable resources

Breyanzi PA submission tip sheet Breyanzi codes and sample claim forms

This information is provided for educational purposes only. Bristol Myers Squibb cannot guarantee insurance coverage or reimbursement. Coverage and reimbursement may vary significantly by payer, plan, patient, and setting of care and may be subject to frequent change. It is the sole responsibility of the healthcare provider to select the proper codes and ensure the accuracy of all statements used in seeking coverage and reimbursement for an individual patient.

References

  1. CMS. 2021 ICD-10-CM Tabular List of Diseases and Injuries. https://www.cms.gov/medicare/icd-10/2021-icd-10-cm. Accessed June 21, 2021.
  2. CMS. HCPCS Quarterly Update. July 2021. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update. Accessed June 21, 2021.
  3. CMS. Fed Regist. December 29, 2020;85(249): 85866-86305.
  4. CMS. HCPCS Application Summaries and Coding Decisions, Second Quarter 2021 Coding Cycle for Drugs and Biological Products. https://www.cms.gov/files/document/2021-hcpcs-application-summary-quarter-2-2021-drugs-and-biologics.pdf. Accessed July 26, 2021.
  5. CMS. HHS. Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures. https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/2018-11-30-HCPCS-Level2-Coding-Procedure.pdf. April 21, 2021. Accessed June 21, 2021.
  6. CMS. January 2019 Update of the Hospital Outpatient Prospective Payment System (OPPS). MLN Matters MM11099. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11099.pdf. Accessed June 21, 2021.
  7. Breyanzi® [prescribing information]. Bothell, WA; Juno Therapeutics, Inc. A Bristol‐Myers Squibb Company. 2021.
  8. CMS. Medicare Shared Systems Modifications Necessary to Capture and Crossover Medicaid Drug Rebate Data Submitted on Form UB 04 Paper Claims and Direct Data Entry (DDE) Claims. MLN Matters MM5950. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1496CP.pdf. Accessed January 6, 2021.
  9. Centers for Medicare & Medicaid Services (CMS). ICD-10 Procedure Coding System (ICD-10-PCS) 2021 Tables and Index. https://www.cms.gov/medicare/icd-10/2021-icd-10-pcs. Accessed September 11, 2020.
  10. CMS, FY 2021 IPPS Proposed Rule Tables. https://www.cms.gov/medicare/acute-inpatient-pps/fy-2021-ipps-proposed-rule-home-page#Tables. Accessed September 11, 2020.
  11. CMS. Fed Regist. September 18, 2020;85(104):32460-32975.
  12. NUBC. Summary of gene and cell therapy code changes. February 2020. https://www.nubc.org/system/files/media/ file/2020/02/Cell-Gene%20Therapy%20Code%20Changes.pdf. Accessed June 22, 2020.
  13. CMS. Chimeric Antigen Receptor (CAR) T-Cell Therapy Revenue Code and HCPCS Setup Revisions. MLN Matters SE19009. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE19009.pdf. Accessed June 22, 2020.
  14. CMS. Transmittal 10796, May 10, 2021. https://www.cms.gov/files/document/r10796ncd.pdf. Accessed June 21, 2021.
  15. CMS. Bundling of Payments for Services Provided to Outpatients Who Later Are Admitted as Inpatients: 3-Day Payment Window Policy and the Impact on Wholly Owned or Wholly Operated Physician Offices. MLN Matters MM7502. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2373CP.pdf. Accessed December 21, 2020.
  16. CMS. Revisions to Payment Policies under the Medicare Physician Fee Schedule, Quality Payment Program and Other Revisions to Part B for CY 2021. (Addenda A and B). https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1736-fc. Accessed December 21, 2020.
  17. CMS. Hospital Outpatient Prospective Payment-Notice of Final Rulemaking with comment for CY2021 (Addenda B). https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1736-fc. Accessed December 21, 2020.