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Last Modified: 3/8/2023 Location: FL, PR, USVI Business: Part A, Part B

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

This article provides billing information and instructions to providers regarding CAR T-cell therapy. The article was updated on January 19, 2023, to add details regarding the new approved CAR T-cell product Carvykti as well as Part B (outpatient) billing instructions and pricing information effective for dates of service (DOS) on and after January 1, 2022.

Overview

Effective for DOS on or after August 7, 2019, CMS will cover the treatment for cancer with autologous T-cells expressing at least one CAR when administered at an FDA Risk Evaluation and Mitigation Strategies (REMS) approved facility. Coverage guidelines and limitations regarding the new national coverage determination (NCD) for CAR T-cell therapy are detailed in MLN Matters article MM12177 external pdf file and MM12928 external pdf file.
First Coast and other A/B MACs have editing only allowing CAR T-cell therapy services to be submitted by or performed in an FDA REMS approved facility. Prior to submitting Part A claims, inform First Coast when the REMS facility has been approved, along with the facility number. This will assist with the prevention of unnecessary claim denials. Providing this information prior to claim submission allows First Coast to update the Part A editing accordingly.
Additionally, routine costs in qualifying clinical trials using CAR T-cell therapy as an investigational agent meeting the requirements listed in NCD 310.1 will be covered effective August 7, 2019. MM12177 details situations in which T-cell therapy are 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.

Key topic links

list item Billing and coding CAR T-cell therapy for inpatient services
list item Billing and coding CAR T-cell therapy for outpatient services
list item Billing and pricing for Part B (outpatient) claims
list item Additional information
list item Medicare Advantage claims

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 also created 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.

Product name
For dates of discharge
Immunotherapy approach
ICD-10 PCS code
Carvykti
On and after February 28, 2022
Via peripheral vein
XW033A7 -- Carvykti: Introduction of ciltacabtagene autoleucel into peripheral vein, percutaneous approach, new technology group 7
Carvykti
On and after February 28, 2022
Through central vein
XW043A7 - Carvykti: Introduction of ciltacabtagene autoleucel into central vein, percutaneous approach, new technology group 7
Yescarta
On and after October 1, 2021
Via peripheral vein
XW033H7 -- Yescarta: Introduction of axicabtagene ciloleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7
Yescarta
On and after October 1, 2021
Through central vein
XW043H7 -- Yescarta: Introduction of axicabtagene ciloleucel immunotherapy into central vein, percutaneous approach, new technology group 7
Kymriah
On and after October 1, 2021
Via peripheral vein
XW033J7 -- Kymriah: Introduction of tisagenlecleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7
Kymriah
On and after October 1, 2021
Through central vein
XW043J7 -- Kymriah: Introduction of tisagenlecleucel immunotherapy into central vein, percutaneous approach, new technology group 7
ABECMA
On and after October 1, 2021
Via peripheral vein
XW033K7 -- ABECMA: Introduction of idecabtagene vicleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7
ABECMA
On and after October 1, 2021
Through central vein
XW043K7 -- ABECMA: Introduction of idecabtagene vicleucel immunotherapy into central vein, percutaneous approach, new technology group 7
Tecartus
On and after October 1, 2021
Via peripheral vein
XW033M7 -- Tecartus: Introduction of brexucabtagene autoleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7
Tecartus
On and after October 1, 2021
Through central vein
XW043M7 -- Tecartus: Introduction of brexucabtagene autoleucel immunotherapy into central vein, percutaneous approach, new technology group 7
Breyanzi
On and after October 1, 2021
Via peripheral vein
XW033N7 -- Breyanzi: Introduction of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7
Breyanzi
On and after October 1, 2021
Through central vein
XW043N7 -- Breyanzi: Introduction of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group 7
FDA approved products awaiting their own PCS code and products used in qualifying clinical trials
On and after October 1, 2021
Via peripheral vein
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
FDA approved products awaiting their own PCS code and products used in qualifying clinical trials
On and after October 1, 2021
Through central vein
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
Clinical trials
Medicare contractors will not require NCD 110.24 REMS facility and diagnosis codes for autologous CAR T-cell therapy ICD-10-PCS codes in the chart above in qualifying clinical trials under NCD 310.1 billed with the national clinical trial (NCT) number for the specific trial, condition code (CC) 30, value code (VC) D4, and the ICD-10 code Z00.6 clinical trial diagnosis code effective for DOS on or after October 1, 2021.
Medicare contractors will reject claims for allogeneic CAR T-cell therapy ICD-10-PCS codes XW033G7 and XW043G7, and autologous CAR T-cell therapy ICD-10-PCS codes XW033C7 and XW043C7, when not billed for qualifying clinical trials under NCD 310.1 with the NCT number for the specific trial, CC 30, VC D4, and ICD-10 code Z00.6 clinical trial diagnosis code effective for DOS on or after October 1, 2021.
list item Return to key topic links list list item

Billing and coding CAR T-cell therapy for outpatient services

Effective for DOS on or after August 7, 2019:
• Medicare will pay claims from approved providers for administration of autologous T-cells expressing at least one CAR for the treatment for cancer.
• In addition to requiring specific diagnoses for each CAR T-cell product and administration, First Coast and other A/B MACs will create editing for the HCPCS codes in the chart below that only allows CAR T-cell therapy services to be submitted by or performed in an FDA REMS approved facility.
• Medicare 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 in the chart below. Be sure to indicate the name of the CAR T-cell product the beneficiary receives on claim Page 7 of the electronic claim.
Effective for claims with DOS on or after January 1, 2022:
• Medicare Part B will recognize the following HCPCS codes in the chart below for CAR T-cell therapy for place of service (POS) 11 (office) or 49 (independent clinic) claims.
• 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 product
Applicable DOS
HCPCS
Payable or Not payable
Rationale
Additional Notes
The administration*
Effective August 7, 2019-current
0540T*
Payable in Part A and B outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
*Note: For Part B (outpatient claims), CPT code 0540T is only payable when the line item has a KX modifier appended.
Axicabtagene ciloleucel (Yescarta)*
Effective August 7, 2019-current
Q2041*
Payable in Part A and B outpatient.
Not payable in ASC.
HCPCS code Q2041 has an ASC payment indicator "B5" (Alternative code may be available, no payment made).
CAR T-cell therapy is not allowed in an ASC.
*Note: For Part B (outpatient claims), HCPCS code Q2041 is only payable when the line item has a KX modifier appended.
Tisagenlecleucel (Kymriah)*
Effective August 7, 2019-current
Q2042*
Payable in Part A and B outpatient.
Not payable in ASC.
HCPCS code Q2042 has an ASC payment indicator "B5" (Alternative code may be available, no payment made).
CAR T-cell therapy is not allowed in an ASC
Note: For Part B (outpatient claims), HCPCS code Q2042 is only payable when the line item has a KX modifier appended.
Brexucabtagene Autoleucel (Tecartus)*
Effective April 1, 2021-current
Q2053*
Payable in Part A and B outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code Q2053 is invalid in the ASC setting.
*Note: For Part B (outpatient claims), HCPCS code Q2053 is only payable when the line item has a KX modifier appended.
Brexucabtagene Autoleucel (Tecartus)*
Effective July 24, 2020-March 31, 2021
J3490, J3590, or J9999*
Payable in Part B.
Packaged in Part A outpatient.
Code should not be billed by ASCs.
  
Code is used by Part B providers (not ASC) to report this product.
*Note: For Part B (outpatient claims), HCPCS codes J3490, J3590 and J9999 are only payable when the line item has a KX modifier appended.
Brexucabtagene Autoleucel (Tecartus)
Effective January 1, 2021-March 31, 2021
C9073
Not payable in Part B.
Payable in Part A outpatient.
Not payable in ASC.
HCPCS code C9073 has an ASC payment indicator "B5" (Alternative code may be available, no payment made).
CAR T-cell therapy is not allowed in an ASC.
HCPCS code is non-payable on Part B provider claims.
Code is used by Part A outpatient and ASCs (not Part B providers) to report this product.
Brexucabtagene Autoleucel (Tecartus)
Effective July 24, 2020-December 31, 2020
C9399
Not payable in Part B.
Payable in Part A outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code is non-payable on Part B provider claims.
Code is used by Part A outpatient and ASCs (not Part B providers) to report this product.
Lisocabtagene maraleucel (Breyanzi)*
Effective October 1, 2021-current
Q2054*
Payable in Part A and B outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code Q2054 is invalid in the ASC setting.
*Note: For Part B (outpatient claims), HCPCS code Q2054 is only payable when the line item has a KX modifier appended.
Lisocabtagene maraleucel (Breyanzi)*
Effective February 5, 2021-September 30, 2021
J3490, J3590, or J9999*
Payable in Part B.
Packaged in Part A outpatient.
Code should not be billed by ASCs.
  
Code is used by Part B providers (not ASC) to report this product.
*Note: For Part B (outpatient claims), HCPCS codes J3490, J3590 and J9999 are only payable when the line item has a KX modifier appended.
Lisocabtagene maraleucel (Breyanzi)
Effective July 1, 2021-September 30, 2021
C9076
Not payable in Part B.
Payable in Part A outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code C9076 is invalid in the ASC setting.
HCPCS code is non-payable on Part B provider claims.
Code is used by Part A outpatient and ASCs (not Part B providers) to report this product.
Lisocabtagene maraleucel (Breyanzi)
Effective February 5, 2021-June 30, 2021
C9399
Not payable in Part B.
Payable in Part A outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code is non-payable on Part B provider claims.
Code is used by Part A outpatient and ASCs (not Part B providers) to report this product.
Idecabtagene vicleucel (Abecma)*
Effective January 1, 2022-current
Q2055*
Payable in Part A and B outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code Q2055 is invalid in the ASC setting.
*Note: For Part B (outpatient claims), HCPCS code Q2055 is only payable when the line item has a KX modifier appended.
Idecabtagene vicleucel (Abecma)*
Effective March 26, 2021-December 31, 2021
J3490, J3590, or J9999*
Payable in Part B.
Packaged in Part A outpatient.
Code should not be billed by ASCs.
Code is used by Part B providers (not ASC) to report this product.
*Note: For Part B (outpatient claims), HCPCS codes J3490, J3590 and J9999 are only payable when the line item has a KX modifier appended.
Idecabtagene vicleucel (Abecma)
Effective October 1, 2021-December 31, 2021
C9081
Not payable in Part B.
Payable in Part A outpatient.
Not payable in ASC.
HCPCS code C9081 has an ASC payment indicator "B5" (Alternative code may be available, no payment made)
CAR T-cell therapy is not allowed in an ASC.
HCPCS code is non-payable on Part B provider claims.
Code is used by Part A outpatient and ASCs (not Part B providers) to report this product.
Idecabtagene vicleucel (Abecma)
Effective March 21, 2021-September 30, 2021
C9399
Not payable in Part B.
Payable in Part A outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code is non-payable on Part B provider claims.
Code is used by Part A outpatient and ASCs (not Part B providers) to report this product.
Ciltacabtagene autoleucel (Carvykti)*
Effective October 1, 2022-current
Q2056*
Payable in Part A and B outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code Q2056 is invalid in the ASC setting.
*Note: For Part B (outpatient claims), HCPCS code Q2056 is only payable when the line item has a KX modifier appended.
Ciltacabtagene autoleucel (Carvykti)
Effective July 1, 2022-September 30, 2022
C9098
Not payable in Part B.
Payable in Part A outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code C9098 is invalid in the ASC setting.
HCPCS code is non-payable on Part B provider claims.
Code is used by Part A outpatient and ASCs (not Part B providers) to report this product.
Ciltacabtagene autoleucel (Carvykti)
Effective February 28, 2022- June 30, 2022
C9399
Not payable in Part B.
Payable in Part A outpatient.
Not payable in ASC.
CAR T-cell therapy is not allowed in an ASC.
HCPCS code is non-payable on Part B provider claims.
Code is used by Part A outpatient and ASCs (not Part B providers) to report this product.
Ciltacabtagene autoleucel (Carvykti)*
Effective February 28, 2022- September 30, 2022
J3490, J3590, or J9999*
Payable in Part B.
Packaged in Part A outpatient.
Code should not be billed by ASCs.
  
Code is used by Part B providers (not ASC) to report this product.
*Note: For Part B (outpatient claims), HCPCS codes J3490, J3590 and J9999 are only payable when the line item has a KX modifier appended.
Collection/Handling**
Effective August 7, 2019-current
0537T**
Not payable
**Tracking codes only. These steps are not paid separately.
**CPT code represents steps required to collect and prepare the genetically modified T-cells.
Preparation for transport**
Effective August 7, 2019-current
0538T**
Not payable
**Tracking codes only. These steps are not paid separately.
**CPT code represents steps required to collect and prepare the genetically modified T-cells.
Receipt and preparation**
Effective August 7, 2019-current
0539T**
Not payable
**Tracking codes only. These steps are not paid separately.
**CPT code represents steps required to collect and prepare the genetically modified T-cells.
Use the following revenue codes for billing Part A outpatient CAR T-cell therapy services:
• 0871 -- Cell Collection with CPT code 0537T
• 0872 -- Specialized Biologic Processing and Storage, Prior to Transport with CPT code 0538T
• 0873 -- Storage and Processing after Receipt of Cells from Manufacturer with CPT code 0539T
• 0874 -- Infusion of Modified Cells with CPT code 0540T
• 0891 -- Special Processed Drugs -- FDA Approved Cell Therapy with HCPCS codes Q2041, Q2042, C9073 (replaced with Q2053 April 1, 2021), C9076 (replaced with Q2054 October 1, 2021), C9081 (replaced with Q2055 January 1, 2022) , C9098 (replaced with Q2056 October 1, 2022) or C9399
Clinical trials
Part A outpatient (OPPS):
• Medicare contractors will not require NCD 110.24 REMS facility and diagnosis codes for CAR T-cell therapy CPT code 0540T in qualifying clinical trials under NCD 310.1 billed with the NCT number for the specific trial, the Q1 clinical trial modifier for routine clinical services, CC 30, VC D4, and ICD-10 code Z00.6 clinical trial diagnosis code effective for DOS on or after August 7, 2019.
Part B outpatient:
• Medicare contractors will not require the NCD 110.24 KX modifier and diagnosis codes for qualifying clinical trials under NCD 310.1.
• These claims must be billed with the NCT number for the specific trial, the Q1 clinical trial modifier for routine clinical services, and the ICD-10 code Z00.6 clinical trial diagnosis code on the CPT code 0540T claim line effective for DOS on or after August 7, 2019.
list item Return to key topic links list list item

Billing for Part B (outpatient) claims

Place of service
For Part B (outpatient claims), HCPCS codes Q2041, Q2042, Q2053, Q2054, Q2055, Q2056, J3490, J3590, and J9999 for CAR T-cell products will only be paid in POS 11 (office) or 49 (independent clinic). Any other place of service will be denied.
*Note: For Part B (outpatient claims), HCPCS codes Q2041, Q2042, Q2053, Q2054, Q2055, Q2056, J3490, J3590, and J9999 for CAR T-cell products are 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.
Number of units
Effective for DOS on and after January 1, 2022, when entering the dollar amount for the charge of a service, providers are limited to a maximum of $99,999.99 per claim because $100,000.00 would exceed the Part B MCS field size.
The total payment for the CAR T-cell products 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 or one (1) complete unit, except as follows:
• Providers billing $499,999.99 or less would submit five claims for 0.2 fractional units per claim, for one (1) complete unit.
• For claims priced over $500,000.00, providers would bill 10 claims for 0.1 fractional units per claim.
• The total units for fractions billed shall not exceed one (1) unit.
• All claims for fractional units shall be billed with modifier LU (fractionated payment CAR T-cell therapy).
• Modifier 76 (repeat service) should also be used to bill for all subsequent fractional units.
• Claims for fractional units billed without modifier LU will be denied.
Example:
CAR T-cell product allowed payment per one unit (1.0) is $445,000:
• Claim 1 -- 0.2 units = $89,000.06
• Claim 2 -- 0.2 units = $89,000.00
• Claim 3 -- 0.2 units = $88,999.99
• Claim 4 -- 0.2 units = $88,999.98
• Claim 5 -- 0.2 units = $88,999.97
Note: Each fractional unit would be billed on a separate claim (see below). Contractors shall only pay up to one (1.0) unit per HCPCS code. Anything above one (1.0) unit will be denied.
Claim 1 example
Claims example for Claim 1 -- 0.2 units = $89,000.06
Claim 2 example (repeat process for claims 3-5)
Claim example for Claim 2 -- 0.2 units = $89,000.00
When dosage exceeds code descriptor
When the dose exceeds the code descriptor for CAR T-cell products, use HCPCS code J3490, J3590, or J9999 for the exceeded dosage. The provider would bill a total of one (1.0) unit of the Q code plus a total of one (1.0) unit of the J code and include the CAR T-cell product name and the exceeded dosage in Block 19 of the 1500 claim form or its electronic equivalent.
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 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 to be infused. If a provider exceeds the HCPCS code descriptor number of cells, this is off label use. This should be extremely rare.
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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/lbcl/find-a-treatment-center/ external link
• Tecartus -- https://www.tecartus.com/hcp/treatment-center-locator external link
• Breyanzi -- https://www.celltherapy360.com/locations external link
• ABECMA -- https://www.celltherapy360.com/locations external link
• Carvykti -- https://www.carvyktihcp.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 the CMS IOM Pub. 100-04 Medicare Claims Processing Manual, Chapter 32, Section 400 external pdf file. Make sure your billing staff are aware of these changes if you bill for these services.
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Medicare Advantage claims

Medicare Advantage plans should have accounted for CAR T-cell therapy for cancer items and services in their contract year bids. Therefore, bill DOS January 1, 2021, and beyond to the Medicare Advantage plan.
Source: CMS IOM Pub. 100-04, Chapter 32, Section 400 external pdf file; CMS NCD 110.24 CAR T-cell Therapy external link; 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; MM12480 ICD-10 and Other Coding Revisions to NCDs -- April Added to sources: 2022 (CR 1 of 2) external pdf file;
MM12928 National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy ; CMS IOM Pub. 100-04 Medicare Claims Processing Manual, Chapter 32, section 68-68.4 external pdf file
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.