(Medicare Claims Processing Manual)

* Procedure represents the various steps required to collect and prepare the genetically modified T -cells, and these steps are not paid separately under the Outpatient Prospective Payment System (OPPS)/Medicare Physician Fee Schedule (MPFS).   400.2.3.1  A/B MAC (B) Places of Service (POS)  (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23)  The following places of service (POS) are covered for CAR T -cells product HCPCS codes (Q2041, Q2042, Q2053-Q2056, J3490, J3590, and J9999):   11 (Office)  49 (Independent clinic)   Professional claims for the procedure to administer CAR T -cells (0540T) may include (but are not necessarily limited to):  11 (Office)  19 (Off Campus -Outpatient Hospital)  21 (Inpatient Hospital)  22 (On Campus -Outpatient Hospital)  49 (Independent Clinic)   400.2.4 - A/B MAC Diagnosis and Procedure Code Requirements  (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23)  Please see NCD spreadsheet for the applicable International Classification of Disease (ICD) -10-CM diagnosis codes for CAR T -cell therapy coverage.   The following are the applicable ICD -10-PCS procedure codes for CAR T -cell therapy coverage for inpatient claims:    For dates of service on or after October 1, 2021:   CARVYKTI  - XW033A7: Introduction of Ciltacabtagene Autoleucel into Peripheral Vein, Percutaneous Approach, New Technology Group 7  CARVYKTI  - XW043A7: Introduction of Ciltacabtagene Autoleucel into Central Vein, Percutaneous Approach, New Technology Group 7   When other CAR T -cell therapy obtains FDA approval but has not yet received a specific PCS code, and for use in clinical trials FDA -approved under NCD 310.1  XW033C7: Introduction of Autologous Engineered Chimeric Antigen Receptor T -cell Immunotherapy int o Peripheral Vein, Percutaneous Approach, New Technology Group 7  When other CAR T -cell therapy obtains FDA approval but has not yet received a specific PCS code, and for use in clinical trials FDA -approved under NCD 310.1  XW043C7: Introduction of Autologous Engineered Chimeric Antigen Receptor T -cell Immunotherapy int o Central Vein, Percutaneous Approach, New Technology Group 7  Yescarta -  XW033H7: Introduction of Axicabtagene Ciloleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7   Yescarta -  XW043H7: Introduction of Axicabtagene Ciloleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7   Kymriah -  XW033J7: Introduction of Tisagenlecleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7   Kymriah -  XW043J7: Introduction of Tisagenlecleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7  ABECMA -  XW033K7: Introduction of Idecabtagene Vicleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7   ABECMA -  XW043K7: Introduction of Idecabtagene Vicleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7   Tecartus  - XW033M7: Introduction of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7   Tecartus  - XW043M7: Introduction of Brexucabtagene Autoleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7   Breyanzi -  XW033N7: Introduction of Lisocabtagene Maraleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7   Breyanzi -  XW043N7: Introduction of Lisocabtagene Maraleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7   For dates of service prior to October 1, 2021:   Yescarta, ABECMA, Kymriah -  XW033C3: Introduction of Engineered Autologous Chimeric Antigen  Receptor T -cell Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 3   Yescarta, ABECMA, Kymriah -  XW043C3: Introduction of Engineered Autologous Chimeric Antigen  Receptor T -cell Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 3   Tecartus  - XW23346 - Transfusion of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein,  Percutaneous Approach, New Technology Group 6   Tecartus  - XW24346 - Transfusion of Brexucabtagene Autoleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 6   Breyanzi -  XW23376   Transfusion of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6   Breyanzi - XW24376  Transfusion of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology 6   NOTE:  Since allogenic T -cells are by definition not autologous CAR T -cells, it is inappropriate to use any of the above autologous CAR T -cell ICD -10 PCS procedure codes for allogenic T -cell treatments.   For Part A Inpatient contractors shall not require NCD 110.24 REMS facility and diagnosis codes for autologous CAR T-cell therapy ICD -10-PCS codes XW033A7/XW043A7, XW033H7/XW043H7, XW033J7/XW043J7, XW033K7/XW043K7, XW033M7/XW043M7, and XW033N7/XW043N7 in c linical trials under NCD 310.1 billed with the NCT number for the specific trial, condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code effective for dates of service on or after August 7, 2019.  400.2.5  Billing Information for Professional Claims  (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23)  Professional claims for CAR T -cell therapy and related services are billed using the Form CMS -1500 or 837P following instructions in chapter 12 of this manual (www.cms.hhs.gov/manuals/104_claims/clm104index.asp).   Contractors shall pay professional claims for CAR T -cell therapy when the service is administered at a healthcare facility that is enrolled in the REMS program as a REMS participating site. Contractors shall use the CMS HCPCS Website for current HCPCS codes, https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS -Quarterly -Update, and the individual REMS facility websites noted at section 400.1.   Contractors shall create an edit that only allows CAR T -cell therapy services to be submitted by, or performed in, an FDA REMS approved facility when the line item has a - KX modifier appended. Note: When a provider submits a - KX modifier on CAR T -cell therapy services, they are acknowledging that the service is being submitted by or performed in an FDA REMS approved facility.   Contractors shall create an edit that only allows CAR T -cell therapy services when the line item has a - LU modifier appended in addition to a - KX modifier. Note: When a provider submits an    - LU modifier on a CAR T -cell claim, it informs the MAC that the service is fractionated. The total units shall not exceed 1 unit.   Contractors shall set up their systems to allow fractionated units on multiple claims for CAR T -cell products on the same DOS. These claims should suspend for proper adjudication of payment.   The total payment will be divided by 10 and the provider will need to bill in 0.1 unit fractions. The provider will need to bill a total of 10 fractional units to reach the total Medicare allowed payment amount.   Example: CAR T -cell product allowed payment $445,000:   0.2 units = $89,000.06 0.2 units = $89,000.00 0.2 units = $88,999.99  0.2 units = $88,999.98 0.2 units = $88,999.97  Note:  Contractors shall only pay up to 1 unit, anything exceeding 1 unit must be denied.    For CAR T -cell products when the dose exceeds the code descriptor, use HCPCS code J3490, J3590, or J9999 for the exceeded dosage. Include the CAR T -cell product name and the exceeded dosage in Block 19 of the 1500 claim form or its electronic equivalent.                            Example: CAR T -cell product with dose exceeded allowed payment $150,000:  0.5 units = $74,999.00 0.5 units = $75,001.00  For CAR T -cell products when the dose exceeds the code descriptor, the provider would bill a total of 1 unit of the Q code plus a total of 1 unit of the J code. For example, Q2041 Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive T- cells. If the provider gives 300 million cells, they will bill:   Q2041 for 0.1 fraction $42,294.00 x10 for 200 million cells (total $422,940.00) J9999 for 0.2 fractions $42,294.00 x5 for 100 million cells (total $211,470.00)  NOTE: The FDA labels for CAR T -cell products state the maximum number of cells that are to be infused. The HCPCS code descriptors for Q2041, Q2042, Q2053, Q2054, Q2055, and Q2056 all align with the FDA label maximum number of cells that are to be infused. If a provider exceeds the HCPCS code descriptor number of cells, this is off label use. This should be extremely rare.  Contractors shall allow a -76 modifier (repeat procedure or service by same physician or other qualified healthcare professional) on subsequent claims billed on the same date of service to assist with preventing duplicate denials.    400.3 - Payment Requirements (Rev. 10891, Issued: 07-20-21, Effective: 08-07-19, Implementation: 09-20-21)  Inpatient  The A/ B MAC billing requirements will allow for CAR T -cell therapy when the services are submitted on the following TOB: 11X. Type of facility and setting determines the basis of payment: For services performed in inpatient hospitals, TOB 11X, under the Inpatient PPS is based on the Medicare Severity -Diagnosis Related Group (MS- DRG).  For services performed in Critical Access Hospital (CAH) inpatient TOB 11X, payment is based on 101% of reasonable cost.  Outpatient  The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the TOBs: 13X and 85x. Type of facility and setting determines the basis of payment: For services performed in hospital outpatient departments (HOPDs), TOBs 13X, or inpatient ancillary TOB 12X, payment is based on OPPS. For services performed in CAH OPDs, TOB 85X, payment is based on reasonable cost.  For services performed in CAH Method II with revenue code 096X, 097X, and 098X, TOB 85X, payment is based on the lesser of the actual charge or the Medicare Physician Fee Schedule (115% of the lesser of the fee schedule amount and submitted charge).