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) Suspension for IV Infusion

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.

INDICATION

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

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 October 1, 2021, Breyanzi has been assigned a unique Q-code for use in all sites of care and by all payers.2

HCPCS Code
Description
Notes
Q2054* Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose FOR ALL PAYERS AND SITES OF CARE:
  • 1 billing unit

Effective July 1, 2021, Breyanzi has been assigned a transitional pass-through status under the Medicare FFS Outpatient Prospective Payment System (OPPS).3 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.4

*Medicare Administrative Contractors (MACs) implemented 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.5 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.5

10-digit Format5
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.6 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*

Effective for discharges on or after October 1, 2021, 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 Code7
Description
Notes for Medicare FFS
XW033N7 Introduction of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7 For FY 2022, assigned to MS‑DRG 018 (Chimeric Antigen Receptor (CAR) T-cell and Other Immunotherapies), with the average national base payment rate of $246,957 (not including hospital-specific adjustments)7,8‡
XW043N7 Introduction of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group 7

*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.

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 Code9
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 item10†‡
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 10796.11

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.12

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).3,13

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.13,14 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
OPPS3,14 PFS13
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.

For Medicare Advantage patients, billing requirements and reimbursement methodology may vary by plan.

See previous section for revenue code descriptions.

§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 10796.11

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

APC=Ambulatory Payment Classification; ASP=average sales price; 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

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
  • BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.

Cytokine Release Syndrome (CRS)

CRS, including fatal or life-threatening reactions, occurred following treatment with BREYANZI. CRS occurred in 46% (122/268) of patients receiving BREYANZI, including ≥ Grade 3 (Lee grading system) CRS in 4% (11/268) of patients. One patient had fatal CRS and 2 had ongoing CRS at time of death. The median time to onset was 5 days (range: 1 to 15 days). CRS resolved in 119 of 122 patients (98%) with a median duration of 5 days (range: 1 to 17 days). Median duration of CRS was 5 days (range 1 to 30 days) in all patients, including those who died or had CRS ongoing at time of death.

Among patients with CRS, the most common manifestations of CRS include fever (93%), hypotension (49%), tachycardia (39%), chills (28%), and hypoxia (21%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Sixty-one of 268 (23%) patients received tocilizumab and/or a corticosteroid for CRS after infusion of BREYANZI. Twenty-seven (10%) patients received tocilizumab only, 25 (9%) received tocilizumab and a corticosteroid, and 9 (3%) received corticosteroids only.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, occurred following treatment with BREYANZI. CAR T cell-associated neurologic toxicities occurred in 35% (95/268) of patients receiving BREYANZI, including ≥ Grade 3 in 12% (31/268) of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death. The median time to onset of the first event was 8 days (range: 1 to 46 days). The onset of all neurologic events occurred within the first 8 weeks following BREYANZI infusion. Neurologic toxicities resolved in 81 of 95 patients (85%) with a median duration of 12 days (range: 1 to 87 days). Three of four patients with ongoing neurologic toxicity at data cutoff had tremor and one subject had encephalopathy. Median duration of neurologic toxicity was 15 days (range: 1 to 785 days) in all patients, including those with ongoing neurologic events at the time of death or at data cutoff.

Seventy-eight (78) of 95 (82%) patients with neurologic toxicity experienced CRS. Neurologic toxicity overlapped with CRS in 57 patients. The onset of neurologic toxicity was after onset of CRS in 30 patients, before CRS onset in 13 patients, same day as CRS onset in 7 patients, and same day as CRS resolution in 7 patients. Neurologic toxicity resolved in three patients before the onset of CRS. Eighteen patients experienced neurologic toxicity after resolution of CRS.

The most common neurologic toxicities included encephalopathy (24%), tremor (14%), aphasia (9%), delirium (7%), headache (7%), dizziness (6%), and ataxia (6%). Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, have occurred in patients treated with BREYANZI.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily at a certified healthcare facility during the first week following infusion, for signs and symptoms of CRS and neurologic toxicities. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion; evaluate and treat promptly. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

BREYANZI REMS

Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:

  • Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
  • Certified healthcare facilities must have on-site, immediate access to tocilizumab.
  • Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
  • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer BREYANZI are trained on the management of CRS and neurologic toxicities.

Further information is available at www.BreyanziREMS.com, or contact Bristol-Myers Squibb at 1-888-423-5436.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. Infections (all grades) occurred in 45% (121/268) of patients. Grade 3 or higher infections occurred in 19% of patients. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections occurred in 5%, and viral and fungal infections occurred in 1.5% and 0.4% of patients, respectively. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines.

Febrile neutropenia has been observed in 9% (24/268) of patients after BREYANZI infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

Avoid administration of BREYANZI in patients with clinically significant active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Ten of the 11 patients in the TRANSCEND study with a prior history of HBV were treated with concurrent antiviral suppressive therapy to prevent HBV reactivation during and after treatment with BREYANZI. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 31% (84/268) of patients, and included thrombocytopenia (26%), neutropenia (14%), and anemia (3%). Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with BREYANZI. The adverse event of hypogammaglobulinemia was reported as an adverse reaction in 14% (37/268) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 21% (56/268) of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 32% (85/268) of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Effects on Ability to Drive and Use Machines

Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions

Serious adverse reactions occurred in 46% of patients. The most common nonlaboratory, serious adverse reactions (> 2%) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium. Fatal adverse reactions occurred in 4% of patients.

The most common nonlaboratory adverse reactions of any grade (≥ 20%) were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

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 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.
  3. CMS. HCPCS Quarterly Update. July 2021. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update. Accessed August 3, 2021.
  4. CMS. Fed Regist. December 29, 2020;85(249):85866-86305.
  5. Breyanzi® [prescribing information]. Bothell, WA; Juno Therapeutics, Inc. A Bristol‐Myers Squibb Company. 2021.
  6. 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.
  7. CMS. Fed Regist. August 13, 2021. IPPS FY 2022 Final Rules. 2021;86(154):44774-45615.
  8. CMS. FY 2022 IPPS Final Rule Tables. https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page#Tables. Accessed August 25, 2021.
  9. 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.
  10. 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.
  11. CMS. Transmittal 10796, May 10, 2021. https://www.cms.gov/files/document/r10796ncd.pdf. Accessed June 21, 2021.
  12. CMS. FAQs on the 3-Day Payment Window for Services Provided to Outpatients Who Later are Admitted as Inpatients. MLN Matters SE20024. https://www.cms.gov/files/document/se20024.pdf. Accessed September 3, 2021.
  13. CMS. Transmittal 1734F; December 28, 2020. https://www.cms.gov/medicaremedicare-fee-service-paymentphysicianfeeschedpfs-federal-regulation-notices/cms-1734-f. Accessed August 30, 2021.
  14. 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.