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NCD 110.24: Chimeric Antigen Receptor (CAR) T-cell therapy
Last Modified: 10/5/2021
Location: FL, PR, USVI
Business: Part A, Part B
Effective for dates of service (DOS) on or after August 7, 2019, CMS will cover the treatment for cancer with autologous T-cells expressing at least one Chimeric Antigen Receptor (CAR) when administered at a Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) approved facility. This new NCD for CAR T-cell therapy is detailed in MLN Matters article
MM12177 
, which provides the instruction to be implemented September 20, rescinding, and replacing MM11783.
First Coast and other A/B MACs will create editing that only allows CAR T-cell therapy services to be submitted by or performed in an FDA REMS approved facility.
Additionally, routine costs in clinical trials using CAR T-cell therapy as an investigational agent meeting the requirements listed in NCD 310.1 will be covered as well effective August 7, 2019.
MM12177 also details situations in which T-cell therapy is not covered.
Note: The use of allogenic T-cells from healthy donors are not autologous CAR T-cell treatments and should not be billed as autologous CAR T-cell treatments.
Effective for claims with DOS on or after August 7, 2019, First Coast will recognize for inpatient claims the following ICD-10-PCS codes for CAR T-cell therapy.
Be sure to indicate the name of the CAR T-cell product the beneficiary receives on claim Page 7. Your claims could be delayed if this information is not included.
In addition to requiring specific diagnoses for each CAR T-cell product, First Coast and other A/B MACs will also create Part A editing for the following ICD-10-PCS codes that only allows CAR T-cell therapy services to be submitted by or performed in an FDA REMS approved facility.
For dates of discharge on and after October 1, 2021:
• XW033H7 -- Yescarta: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3
• XW043H7 -- Yescarta: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3
• XW033K7 -- ABECMA: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3
• XW043K7 -- ABECMA: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3
• XW033J7 -- Kymriah: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3
• XW043J7 -- Kymriah: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3
• XW033M7 -- Tecartus: Transfusion of brexucabtagene autoleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6
• XW043M7 -- Tecartus: Transfusion of brexucabtagene autoleucel immunotherapy into central vein, percutaneous approach, new technology group 6
• XW033N7 -- Breyanzi: Transfusion of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6
• XW043N7 -- Breyanzi: Transfusion of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group 6
For dates of discharge prior to October 1, 2021:
• XW033C3 -- Yescarta, ABECMA, Kymriah: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3
• XW043C3 -- Yescarta, ABECMA, Kymriah: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3
• XW23346 -- Tecartus: Transfusion of brexucabtagene autoleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6
• XW24346 -- Tecartus: Transfusion of brexucabtagene autoleucel immunotherapy into central vein, percutaneous approach, new technology group 6
• XW23376 -- Breyanzi: Transfusion of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6
• XW24376 -- Breyanzi: Transfusion of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group 6
Note: Since allogenic T-cells are not autologous CAR T-cell, it is inappropriate to use any of the above autologous CAR T-cell ICD-10- PCS procedure codes for allogenic T-cell treatments.
Information for the following products can be found at their respective websites
Use the following revenue codes for billing inpatient CAR T-cell therapy services:
• 0871 -- Cell Collection
• 0872 -- Specialized Biologic Processing and Storage, Prior to Transport
• 0873 -- Storage and Processing after Receipt of Cells from Manufacturer
• 0874 -- Infusion of Modified Cells
• 0891 -- Special Processed Drugs -- FDA Approved Cell Therapy
The necessary types of bill (TOB), detailed diagnosis and payment requirements, and claim adjustment reason code (CARC) and remittance advice remark codes (RARC) are detailed within the MM article. Make sure your billing staff are aware of these changes if you bill for these services.
In addition to specific diagnosis requirements, First Coast and other A/B MACs will create a Part B edit for HCPCS code 0540T 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. Claims billed without the KX modifier will be denied. Note: When a Part B provider submits a KX modifier on CAR T-cell therapy services, they are acknowledging the service is being submitted by or performed in an FDA REMS approved facility.
In addition to requiring specific diagnoses for each CAR T-cell product/administration, First Coast and other A/B MACs will also create Part A editing for the HCPCS codes below that only allows CAR T-cell therapy services to be submitted by or performed in an FDA REMS approved facility.
Effective for claims with DOS on or after August 7, 2019, First Coast Part A will recognize, for outpatient prospective payment system (OPPS) and critical access hospital (CAH) claims, the following HCPCS codes for CAR T-cell therapy. Be sure to indicate the name of the CAR T-cell product the beneficiary receives on claim Page 7. For Part B unclassified drugs or biologicals, be sure to indicate the name of the CAR T-cell product the beneficiary receives in Item 19 of the CMS-1500 (or the electronic equivalent). Your claims could be delayed if this information is not included.
• Q2041 -- Axicabtagene ciloleucel (Yescarta)
• Q2042 -- Tisagenlecleucel (Kymriah)
• Q2053 -- Brexucabtagene Autoleucel (Tecartus) (effective for DOS April 1, 2021)
• C9073 -- Brexucabtagene Autoleucel (Tecartus) (prior to DOS April 1, 2021)
• Q2054 -- Lisocabtagene maraleucel (Breyanzi) (effective for DOS October 1, 2021)
• C9076 -- Lisocabtagene maraleucel (Breyanzi) (effective for DOS July 1-September 30, 2021)
• C9081 -- Idecabtagene Vicleucel (ABECMA) (effective for DOS October 1, 2021)
• C9399 (or J3490, J3590, or J9999) -- Unclassified drugs or biologicals when dose of CAR T-cell therapy exceeds code descriptor or when a more specific code is unavailable (e.g., Idecabtagene Vicleucel [ABECMA], Lisocabtagene maraleucel [Breyanzi])
• 0540T -- The administration*
*In Part B, the administration (HCPCS code 0540T) is only payable when the line item has a KX modifier appended. When a provider submits a KX modifier on CAR T-cell therapy services, they are acknowledging the service is being submitted by or performed in an FDA REMS approved facility. Claims billed without the KX modifier will be denied.
Note: HCPCS codes Q2053 and C9076 (replaced with Q2054 October 1, 2021) are invalid codes in the ASC setting. HCPCS codes Q2041, Q2042, and C9073 have an ASC payment indicator "B5" (Alternative code may be available, no payment made).
Note: In Part B, providers will only be paid for the administration of the CAR T-cell products, not the CAR T-cell products themselves. The HCPCS codes Q2041, Q2042, Q2053, C9073, C9076 (replaced with Q2054 October 1, 2021), C9081 and the unclassified drugs and biologicals C9399 (or J3490, J3590, or J9999) are non-payable on Part B provider claims and will be denied as a Part A service. (See
Business Requirement 12177-04.4 for specifics on billing this service)
The following procedures (**) represent steps required to collect and prepare the genetically modified T-cells. These steps are not paid separately; these are tracking codes only.
• 0537T -- Collection/Handling**
• 0538T -- Preparation for transport**
• 0539T -- Receipt and preparation**
Use the following revenue codes for billing outpatient CAR T-cell therapy services:
• 0871 -- Cell Collection with CPT code 0537T
• 0872 -- Specialized Biologic Processing and Storage, Prior to Transport with CPT 0538T
• 0873 -- Storage and Processing after Receipt of Cells from Manufacturer with CPT 0539T
• 0874 -- Infusion of Modified Cells with CPT 0540T
• 0891 -- Special Processed Drugs -- FDA Approved Cell Therapy with HCPCS Q2041, Q2042, C9073 (replaced with Q2053 April 1, 2021), C9076 (replaced with Q2054 October 1, 2021) or C9399
Information for the following products can be found at their respective websites
The necessary TOBs, detailed diagnosis and payment requirements, and CARC and RARC are detailed within the MM article. Make sure your billing staff are aware of these changes if you bill for these services.
As this NCD is a significant cost under the law, for DOS from August 7, 2019 and through December 31, 2020 only, original fee-for-service Medicare will pay for CAR T-cell therapy for cancer obtained by beneficiaries enrolled in Medicare Advantage plans when the coverage criteria outlined in the NCD are met. Bill claims for Medicare Advantage beneficiaries to First Coast for CAR T-cell therapy services for DOS from August 7, 2019 through December 31, 2020.
Medicare Advantage plans should have accounted for CAR T-cell therapy for cancer items and services in their contract year 2021 bids. Therefore, bill DOS January 1, 2021, and beyond to the Medicare Advantage plan.
First Coast Service Options (First Coast) strives to ensure that the information available on our provider website is accurate, detailed, and current. Therefore, this is a dynamic site and its content changes daily. It is best to access the site to ensure you have the most current information rather than printing articles or forms that may become obsolete without notice.
