Chimeric Antigen Receptor (CAR) T-cell Therapy

Table of Contents

• NCD 110.24: Chimeric Antigen Receptor (CAR) T-cell therapy: Billing Instructions
  • Overview
  • Billing and coding CAR T-cell therapy for inpatient services
    • Clinical Trials
  • Billing and coding CAR T-cell therapy for outpatient services
    • Clinical Trials
  • Billing for Part B (Outpatient) Claims
  • When Dosage Exceeds Code Descriptor
  • Additional information
  • Medicare Advantage Claims
  • Related Content

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

Effective for DOS on or after 8/7/2019, Medicare will pay claims from approved providers for administration of autologous T-cells expressing at least one CAR for the treatment for cancer.

This article provides billing information and instructions to providers regarding CAR T-cell therapy. The article was updated on 1/19/2023, 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 DOS on and after 1/1/2022.

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Overview

Effective for DOS on or after 8/7/2019, CMS will cover the treatment for cancer with autologous T-cells expressing at least one CAR when administered at an FDA REMS approved facility. Coverage guidelines and limitations regarding the new NCD for CAR T-cell therapy are detailed in MLN Matters articles, M12177 and MM12928.

CMS established editing only allowing CAR T-cell therapy services to be submitted by or performed in an FDA REMS approved facility. 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 8/7/2019. 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.

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Billing and coding CAR T-cell therapy for inpatient services

Effective for claims with DOS on or after 8/7/2019, Medicare Contractors 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 the claim. Your claims may be delayed if this information is not included.

In addition to requiring specific diagnoses for each CAR T-cell product, CMS also created Part A editing for the following ICD-10-PCS codes that only allow CAR T-cell therapy services to be submitted by or performed in an FDA REMS approved facility.

Note: Since allogenic T-cells are not autologous CAR T-cells, it’s 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

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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 NCT number for the specific trial, CC 30, VC D4 and the ICD-10 code Z00.6 clinical trial diagnosis code effective for DOS on or after 10/1/2021.

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 10/1/2021.

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Billing and coding CAR T-cell therapy for outpatient services

Effective for DOS on or after 8/7/2019:

• 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, Medicare Contractors 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 OPPS and 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 1/1/2022:

• 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 claim(s) may be delayed if this information is not included.

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 4/1/2021), C9076 (replaced with Q2054 10/1/2021), C9081 (replaced with Q2055 1/1/2022) , C9098 (replaced with Q2056 10/1/2022) or C9399

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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 8/7/2019.

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 8/7/2019.

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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 1/1/2022, 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

Claim 2 Example (repeat process for claims 3-5)

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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
• Yescarta
• Tecartus
• Breyanzi
• ABECMA
• Carvykti

The necessary TOB, detailed diagnosis and payment requirements, and CARC and RARC are detailed within the CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 400. 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 1/1/2021, and beyond to the Medicare Advantage plan.

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Related Content

• CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 400
• CMS NCD 110.24 CAR T-Cell Therapy
• MLN Matters® MM12177 Revised: NCD 110.24: Chimeric Antigen Receptor (CAR) T-cell Therapy - This change request (CR) Rescinds and Fully Replaces CR 11783
• CR12245 October 2021 HCPCS Quarterly Update Reminder
• CR12432 October 2021 Integrated Outpatient Code Editor (I/OCE) Specifications Version 22.3
• CR12436 October 2021 Update of the Hospital OPPS
• MLN Matters® MM12480 Revised: ICD-10 and Other Coding Revisions to NCDs -- April Added to sources: 2022 (CR 1 of 2)
• MLN Matters® MM12928 Revised: National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy
• CMS IOM, Publication 100-04 Medicare Claims Processing Manual, Chapter 32, section 68-68.4

Reviewed 9/19/2024