NCD 110.24: Chimeric Antigen Receptor (CAR) T-cell therapy

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Last Modified: 1/7/2022 Location: FL, PR, USVI Business: Part A, Part B

NCD 110.24: Chimeric Antigen Receptor (CAR) T-cell therapy

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 external pdf file

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 external pdf file

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.

Billing and coding CAR T-cell therapy for inpatient services

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	For dates of discharge prior to October 1, 2021
XW033H7 -- Yescarta: Introduction of axicabtagene ciloleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7	XW033C3 -- Yescarta, ABECMA, Kymriah: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3
XW043H7 -- Yescarta: Introduction of axicabtagene ciloleucel immunotherapy into central vein, percutaneous approach, new technology group 7	XW043C3 -- Yescarta, ABECMA, Kymriah: Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3
XW033J7 -- Kymriah: Introduction of tisagenlecleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7	XW23346 -- Tecartus: Transfusion of brexucabtagene autoleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6
XW043J7 -- Kymriah: Introduction of tisagenlecleucel immunotherapy into central vein, percutaneous approach, new technology group 7	XW24346 -- Tecartus: Transfusion of brexucabtagene autoleucel immunotherapy into central vein, percutaneous approach, new technology group 6
XW033K7 -- ABECMA: Introduction of idecabtagene vicleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7	XW23376 -- Breyanzi: Transfusion of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6
XW043K7 -- ABECMA: Introduction of idecabtagene vicleucel immunotherapy into central vein, percutaneous approach, new technology group 7	XW24376 -- Breyanzi: Transfusion of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group 6
XW033M7 -- Tecartus: Introduction of brexucabtagene autoleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7
XW043M7 -- Tecartus: Introduction of brexucabtagene autoleucel immunotherapy into central vein, percutaneous approach, new technology group 7
XW033N7 -- Breyanzi: Introduction of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7
XW043N7 -- Breyanzi: Introduction of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group 7
XW033C7 -- FDA approved products awaiting their own PCS code: Introduction of autologous engineered chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 7
XW043C7 -- FDA approved products awaiting their own PCS code: Introduction of autologous engineered chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 7

Note: Since allogenic T-cells are 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.

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

Billing and coding CAR T-cell therapy for outpatient 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 of the electronic claim. 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.

Procedure or drug	Applicable DOS	HCPCS	Payable/ Not payable	Rationale	Additional Notes
The administration*	On and after August 7, 2019-current	0540T KX	Payable in Part B* Payable in Part A outpatient**	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. *In Part A, the administration (HCPCS code 0540T) is payable with or without the KX modifier appended.	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.
Axicabtagene ciloleucel (Yescarta)	On and after August 7, 2019-current	Q2041	Not payable in Part B Payable in Part A outpatient	Providers will only be paid for the administration of the CAR T-cell products, not the CAR T-cell products themselves. HCPCS code is 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)	HCPCS code Q2041 has an ASC payment indicator "B5" (Alternative code may be available, no payment made).
Tisagenlecleucel (Kymriah)	On and after August 7, 2019-current	Q2042	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	HCPCS code Q2042 has an ASC payment indicator "B5" (Alternative code may be available, no payment made).
Brexucabtagene Autoleucel (Tecartus)	On and after April 1, 2021-current	Q2053	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	HCPCS code Q2053 is invalid code in the ASC setting.
Brexucabtagene Autoleucel (Tecartus)	Prior to April 1, 2021	J3490, J3590, or J9999	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	Code is used by Part B providers (not ASC) to report this product
Brexucabtagene Autoleucel (Tecartus)	On and after January 1-March 31, 2021	C9073	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	Code is used by ASCs (not Part B providers) to report this product. HCPCS code C9073 has an ASC payment indicator "B5" (Alternative code may be available, no payment made).
Brexucabtagene Autoleucel (Tecartus)	Prior to January 1, 2021	C9399	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	Code is used by ASCs (not Part B providers) to report this product
Lisocabtagene maraleucel (Breyanzi)	On and after October 1, 2021	Q2054	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	HCPCS code C9076 (replaced with Q2054 October 1, 2021) is an invalid code in the ASC setting.
Lisocabtagene maraleucel (Breyanzi)	Prior to October 1, 2021	J3490, J3590, or J9999)	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	Code is used by Part B providers (not ASC) to report this product
Lisocabtagene maraleucel (Breyanzi)	On and after July 1-September 30, 2021	C9076	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	Code is used by ASCs (not Part B providers) to report this product HCPCS code C9076 (replaced with Q2054 October 1, 2021) is an invalid code in the ASC setting.
Lisocabtagene maraleucel (Breyanzi)	Prior to July 1, 2021	C9399	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	Code is used by ASCs (not Part B providers) to report this product
Idecabtagene vicleucel (ABECMA)	On and after January 1, 2022	Q2055	Not payable in Part B Payable in Part A outpatient	HCPCS code is non-payable on Part B provider claims and will be denied as a Part A service.	HCPCS code Q2055 is an invalid code in the ASC setting.
Idecabtagene vicleucel (ABECMA)	Prior to January 1, 2022	J3490, J3590, or J9999	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	Code is used by Part B providers (not ASC) to report this product
Idecabtagene vicleucel (ABECMA)	On and after October 1-December 31, 2021	C9081	Not payable in Part B Payable in Part A outpatient	HCPCS code is non-payable on Part B provider claims and will be denied as a Part A service.	Code is used by ASCs (not Part B providers) to report this product HCPCS code C9081 has an ASC payment indicator "B5" (Alternative code may be available, no payment made).
Idecabtagene vicleucel (ABECMA)	Prior to October 1, 2021	C9399	Not payable in Part B Payable in Part A outpatient	HCPCS code is 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)	Code is used by ASCs (not Part B providers) to report this product
Collection/Handling**	On and after August 7, 2019-current	0537T	Not payable	** Tracking codes only. These steps are not paid separately.	** HCPCS codes represent steps required to collect and prepare the genetically modified T-cells.
Preparation for transport**	On and after August 7, 2019-current	0538T	Not payable	** Tracking codes only. These steps are not paid separately.	** HCPCS codes represent steps required to collect and prepare the genetically modified T-cells.
Receipt and preparation**	On and after August 7, 2019-current	0539T	Not payable	** Tracking codes only. These steps are not paid separately.	** HCPCS codes represent steps required to collect and prepare the genetically modified T-cells.

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), C9081 (replaced with Q2055 January 1, 2022) or C9399

Additional information

Information for the following products can be found at their respective websites

• Kymriah -- https://www.us.kymriah.com/treatment-center-locator external link

• Yescarta -- https://www.yescarta.com/find-a-treatment-center external link

• Tecartus -- https://www.tecartus.com/hcp/treatment-center-locator external link

• Breyanzi -- https://www.breyanzihcp.com/treatment-centers external link

• ABECMA -- https://www.abecmahcp.com/treatment-centers external link

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 MM12177 external pdf file

. Make sure your billing staff are aware of these changes if you bill for these services.

Medicare Advantage claims

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.

Source: MM12177 NCD 110.24: Chimeric Antigen Receptor (CAR) T-cell Therapy - This change request (CR) Rescinds and Fully Replaces CR 11783 external pdf file

; CR12245 October 2021 HCPCS Quarterly Update Reminder external pdf file

;
CR12432 October 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.3 external pdf file

;
CR12436 October 2021 Update of the Hospital OPPS external pdf file

; CR12480 ICD-10 and Other Coding Revisions to NCDs -- April Added to sources: 2022 (CR 1 of 2) external pdf file

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