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
C83.30 Diffuse large B-cell lymphoma, unspecified site
C83.31 Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck
C83.32 Diffuse large B-cell lymphoma, intrathoracic lymph nodes
C83.33 Diffuse large B-cell lymphoma, intra-abdominal lymph nodes
C83.34 Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb
C83.35 Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb
C83.36 Diffuse large B-cell lymphoma, intrapelvic lymph nodes
C83.37 Diffuse large B-cell lymphoma, spleen
C83.38 Diffuse large B-cell lymphoma, lymph nodes of multiple sites
C83.39 Diffuse large B-cell lymphoma, extranodal and solid organ sites
C83.90 Non-follicular (diffuse) lymphoma, unspecified, unspecified site
C83.91 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of head, face, and neck
C83.92 Non-follicular (diffuse) lymphoma, unspecified, intrathoracic lymph nodes
C83.93 Non-follicular (diffuse) lymphoma, unspecified, intra-abdominal lymph nodes
C83.94 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of axilla and upper limb
C83.95 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of inguinal region and lower limb
C83.96 Non-follicular (diffuse) lymphoma, unspecified, intrapelvic lymph nodes
C83.97 Non-follicular (diffuse) lymphoma, unspecified, spleen
C83.98 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of multiple sites
C83.99 Non-follicular (diffuse) lymphoma, unspecified, extranodal and solid organ sites
C82.40 Follicular lymphoma grade IIIb, unspecified site
C82.41 Follicular lymphoma grade IIIb, lymph nodes of head, face, and neck
C82.42 Follicular lymphoma grade IIIb, intrathoracic lymph nodes
C82.43 Follicular lymphoma grade IIIb, intra-abdominal lymph nodes
C82.44 Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb
C82.45 Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb
C82.46 Follicular lymphoma grade IIIb, intrapelvic lymph nodes
C82.47 Follicular lymphoma grade IIIb, spleen
C82.48 Follicular lymphoma grade IIIb, lymph nodes of multiple sites
C82.49 Follicular lymphoma grade IIIb, extranodal and solid organ sites
C82.50 Diffuse follicle center lymphoma, unspecified site
C82.51 Diffuse follicle center lymphoma, lymph nodes of head, face, and neck
C82.52 Diffuse follicle center lymphoma, intrathoracic lymph nodes
C82.53 Diffuse follicle center lymphoma, intra-abdominal lymph nodes
C82.54 Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb
C82.55 Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb
C82.56 Diffuse follicle center lymphoma, intrapelvic lymph nodes
C82.57 Diffuse follicle center lymphoma, spleen
C82.58 Diffuse follicle center lymphoma, lymph nodes of multiple sites
C82.59 Diffuse follicle center lymphoma, extranodal and solid organ sites
C85.20 Mediastinal (thymic) large B-cell lymphoma, unspecified site
C85.21 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face, and neck
C85.22 Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes
C85.23 Mediastinal (thymic) large B-cell lymphoma, intra-abdominal lymph nodes
C85.24 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb
C85.25 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb
C85.26 Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes
C85.27 Mediastinal (thymic) large B-cell lymphoma, spleen
C85.28 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites
C85.29 Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites
Z51.12 Encounter for antineoplastic immunotherapy

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

As a newly approved biologic, Breyanzi does not have a unique HCPCS code at this time. Until a unique HCPCS code is assigned by CMS, Breyanzi may be reported using one of the following unclassified/miscellaneous HCPCS codes per payer requirements.

HCPCS Code2
Description
Notes
C9399 Unclassified drugs or biologicals Medicare FFS*:
  • Required for claims billed by outpatient hospital facilities under the Outpatient Prospective Payment System (OPPS)3†
J3490 Unclassified drugs All payers:
  • Requirements may vary; refer to the specific payer policy
J3590 Unclassified biologics

Although specific payer requirements may vary, additional information is typically required for claims with unclassified/miscellaneous HCPCS codes, including:

  • Product name
  • Dosage
  • NDC number(s)
  • Route of administration

*For Medicare Advantage patients, billing requirements may vary by plan.

For Medicare FFS claims billed by outpatient hospital facilities under the OPPS or those billed by off-campus provider-based departments (PBDs) under the Physician Fee Schedule, an appropriate modifier should be reported if Breyanzi has been acquired under the 340B drug pricing program. JG modifier is required if a provider is subject to the 340B payment adjustment; a TB modifier is required if a provider is exempted from the 340B payment adjustment (eg, IPPS-exempt hospital).4,5

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.6 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.6

10-digit Format6
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.7 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 Code8
Description
Notes for Medicare FFS
XW23376 Transfusion of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6 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). 9‡§
XW24376 Transfusion of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group 6

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 Code8
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/institution.

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 202110; for FY 2022, NTAP eligibility decisions will be made on a case-by-case basis.

Hospital Revenue Codes

Hospital Revenue Codes

For Medicare FFS,* the following CAR T cell therapy-designated revenue codes may be reported with accompanying line items billed for services associated with Breyanzi.

Revenue Code11
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.12†‡
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

For commercial plans and other payers, depending on specific policies, the following revenue codes may be reported, as an alternative to the codes listed above.

Revenue Code13
Description
Notes for Commercial Plans & Other Payers
0300 Laboratory—general classification Requirements may vary; refer to the specific payer policy.
0305 Laboratory—hematology
0310 Laboratory pathology—general classification
0260 IV therapy—general classification
0510 Clinic—general classification
0250 Pharmacy—general classification
0258 Pharmacy—IV solutions
0636 Pharmacy—drugs requiring detailed coding

*For Medicare Advantage patients, billing requirements may vary by plan.

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 cell therapy product (as a single line item under 0891), the reported date of service must be based on the date of CAR T cell therapy 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 cell therapy 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 cell therapy product charges under 0891). For more information, please see Medicare Learning Network Matters Article SE19009.12

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

CPT® Category III Codes for Outpatient Hospital and Physician Services*

For Medicare FFS, 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).4,15

CPT Category III Code4
Description
Corresponding Hospital Revenue Code
Medicare FFS Reimbursement Status in CY 2021
OPPS4,16 PFS15
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)

For commercial plans and other payers, depending on specific policies, the above listed codes may be reported. CMS has not assigned relative value units to these Category III CPT codes, with the exception of the CPT code 0540T under the OPPS.15,16 As such, they may not be payable by non-Medicare payers.

*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 III codes 0537T, 0538T, and 0539T can be reported for tracking purposes only, as non-covered charges. For more information, please see Medicare Learning Network Matters Article SE19009.12

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


CPT® Category I Codes for Outpatient Hospital and Physician Services*

For commercial plans and other payers, depending on specific policies, the following CPT Category I codes may be reported for apheresis and intravenous administration services associated with Breyanzi, as an alternative to the CPT Category III codes codes listed in the previous section.

CPT Category I Code17
Description
Notes for Commercial Plans & Other Payers
Apheresis Requirements may vary; refer to the specific payer policy.
36511 Therapeutic apheresis; for white blood cells
IV administration*
96409 Chemotherapy administration; intravenous, push technique, single or initial substance/drug
96413 Chemotherapy administration; intravenous infusion technique; up to 1 hour, single or initial substance/drug

Breyanzi is for autologous use only and is administered intravenously, as a one-time treatment.6 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. This is part of a larger CAR T cell therapy process that includes apheresis, manufacturing, administration, and monitoring. The CD8 and CD4 components are administered separately; the CD8 component is administered first, immediately followed by the CD4 component.6 The time for infusion will vary, but will usually be less than 15 minutes for each component.6

Please see section 2.2 of the full Prescribing Information for complete administration instructions.6

*These codes refer to intravenous infusion of chemotherapy and other highly complex drugs or highly complex biologic agents.

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 January 6, 2021.
  2. CMS. January 2021 Alpha-Numeric HCPCS File.  https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update Accessed January 6, 2021.
  3. CMS. Medicare Claims Processing Manual, Chapter 17. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf . Accessed June 22, 2020.
  4. CMS. Fed Regist. December 29, 2020;85(249):85866-86305.
  5. 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 22, 2020.
  6. Breyanzi [prescribing information]. Bothell, WA; Juno Therapeutics, Inc. A Bristol-Myers Squibb Company. 2021.
  7. 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/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM5950.pdf . Accessed June 22, 2020.
  8. CMS. ICD-10 Procedure Coding System (ICD-10-PCS) 2021 Tables and Index. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-PCS. Accessed September 11, 2020.
  9. CMS. FY 2021 IPPS Final Rule Tables. https://www.cms.gov/medicare/acute-inpatient-pps/fy-2021-ipps-final-rule-home-page . Accessed September 11, 2020.
  10. CMS. Fed Regist. September 18, 2020;85(104):32460-32975.
  11. 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.
  12. CMS. Chimeric antigen receptor (CAR) T-cell therapy revenue code and HCPCS setup revisions. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE19009.pdf . Accessed June 22, 2020.
  13. Noridian. Revenue codes. https://med.noridianmedicare.com/web/jea/topics/claim-submission/revenue-codes . Accessed June 22, 2020.
  14. 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/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM7502.pdf . Accessed June 22, 2020.
  15. 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.
  16. CMS. Hospital Outpatient Prospective Payment-Notice of Final Rulemaking with comment for CY2021 (Addendum B). https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1736-fc. Accessed December 21, 2020.
  17. American Medical Association. Current Procedural Terminology (CPT®). 2019.