CMS Pub. 100-04, ch. 32, § 400.2.5

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.