CMS Pub. 100-04, ch. 32, § 400.3

Inpatient

The A/ B MAC billing requirements will allow for CAR T-cell therapy when the services are submitted on the

following TOB: 11X. Type of facility and setting determines the basis of payment:

For services performed in inpatient hospitals, TOB 11X, under the Inpatient PPS is based on the Medicare

Severity-Diagnosis Related Group (MS-DRG).

For services performed in Critical Access Hospital (CAH) inpatient TOB 11X, payment is based on 101% of

reasonable cost.

Outpatient

The A/B MAC billing requirements will pay for CAR T-cell therapy when the services are submitted on the TOBs:

13X and 85x. Type of facility and setting determines the basis of payment:

For services performed in hospital outpatient departments (HOPDs), TOBs 13X, or inpatient ancillary TOB 12X,

payment is based on OPPS.

For services performed in CAH OPDs, TOB 85X, payment is based on reasonable cost.

For services performed in CAH Method II with revenue code 096X, 097X, and 098X, TOB 85X, payment is based

on the lesser of the actual charge or the Medicare Physician Fee Schedule (115% of the lesser of the fee schedule

amount and submitted charge).

HOPDs may report CPT codes 0537T, 0538T, and 0539T (end date 12/31/24 replaced with 38225, 38226, and 38227

effective 01/01/25) to allow tracking of these services when furnished in the outpatient setting. Medicare will reject these

lines as Medicare does not separately pay for these services under the OPPS.

These following scenarios present further clarification on how to report items and services related to CAR-T in various

clinical scenarios.

Scenario 1: CAR-T Dosing and Preparation Services and Viable T-cells Administered in HOPDs:

In instances when you administer the CAR-T drug in the HOPD setting, report CPT code 0540T (end date 12/31/24 and

replaced with 38228 effective 01/01/25) for the administration and HCPCS Q2041, Q2042, Q2053 (effective April 1,

2021), C9073 (prior to April 1, 2021), C9076, or, if a more specific code is unavailable, the most appropriate

unclassified drug code (e.g., C9399 for unclassified drugs or biologicals). NOTE: the drug codes will be denied as a Part

A service even if billed with the administration.) For specific instructions on billing unclassified drug codes, refer to

Chapter 26, Section 10.4 of the “Medicare Claims Processing Manual” on the CMS website at: Regulations-and-Guidance.Ch26. As discussed in the Calendar Year (CY) 2019 OPPS/Ambulatory Surgery Center final rule (83 FR

58904), the procedures described by CPT *0537T (collection/handling), 0538T (preparation for transport), and 0539T

(receipt and preparation) (*0537T, 0538T, and 0539T end date 12/31/24 and replaced with 38225, 38226, and 38227

effective 01/01/25) represent the various steps required to collect and prepare the genetically modified T-cells, and these

steps are not paid separately under the OPPS. However, you may report the charges for these various steps to collect and

prepare the CAR T-cells separately and Medicare will reject them on the HOPD claim, or they may be included in the

charge reported for the biological.

Note: When including the charges for collection and preparation of the CAR-T cells in the charge for the CAR-T

product, outpatient providers should code the CAR-T product service on the date that the CAR-T administration took

place and not on the date when the cells were collected.

Scenario 2: CAR-T Dosing and Preparation Services Administered in HOPD Setting, but Viable T-cells Not

Administered:

In instances when the CAR-T drug is not ultimately administered to the beneficiary, but the CAR-T preparation services

are initiated or performed in the HOPD facility, the hospital may not report the drug Q code (which only applies when

the T-cells are administered in the HOPD setting). HOPDs may report CPT *0537T, 0538T, and 0539T (as appropriate)

and (*0537T, 0538T, and 0539T end date 12/31/24 and replaced with 38225, 38226, and 38227 effective 01/01/25) the

charges associated with each code under the appropriate revenue code on the HOPD claim. Medicare will reject these

codes.

Scenario 3: CAR-T Dosing and Preparation Services Administered in HOPD Setting, but Viable T-cells

Administered in the Hospital Inpatient Setting:

When CAR T-cell preparation services are initiated and furnished in the HOPD setting, but the CAR T-cells are

administered in the inpatient setting, the hospital may not report the drug Q code (which only applies when the T-cells

are administered in the HOPD setting). Report the charge associated with the various steps to collect and prepare the

CAR T-cells on the inpatient claim (TOB 11x) separately using revenue codes 0871, 0872, or 0873. Alternatively, the

hospital may include the charges for these various steps in the charge reported for the biological using revenue code

0891 – Special Processed Drugs – FDA (U.S. Food and Drug Administration) Approved Cell Therapy – Charges for

Modified cell therapy.

Note: When the cells are collected in the HOPD setting and the CAR-T is administered in the hospital inpatient

setting, inpatient providers should report the date that the CAR-T administration took place and not the date the cells

were collected.

Physician Office or Non-Hospital Clinic

The A/B MAC billing requirements will pay for CAR T-cell therapy when the services are submitted on the Form

CMS-1500 or electronic 837P.

Scenario 1: CAR-T Dosing and Preparation Services and Viable T-cells Administered in Physician Office or Non-Hospital Clinic:

In instances when you administer the CAR-T drug in the physician office setting or other non-hospital clinic setting

that is enrolled in the REMS program as a REMS participating site, report CPT code 0540T (end date 12/31/24 and

replaced with 38228 effective 01/01/25) for the administration and HCPCS Q2041, Q2042, Q2053 (effective April 1,

2021), C9073 (prior to April 1, 2021), C9076, or, if a more specific code is unavailable, the most appropriate

unclassified drug code (e.g., J3590 for unclassified biologics). For specific instructions on billing unclassified drug

codes, refer to Chapter 26, Section 10.4 of the “Medicare Claims Processing Manual” on the CMS website at:

https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c26pdf.pdf

The procedures described by CPT *0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt

and preparation) represent the various steps required to collect and prepare the genetically modified T-cells, and these

steps are not paid separately under the MPFS. However, you may report them separately, and Medicare will reject them

on the professional claim. (*0537T, 0538T, and 0539T end date 12/31/24 and replaced with 38225,38226, and 38227

effective 01/01/25.)

Note: Practitioners should code the CAR-T product service on the date that the CAR-T administration took place and not

on the date when the cells were collected.

Scenario 2: CAR-T Dosing and Preparation Services Administered in Physician Office or Non-Hospital Clinic,

but Viable T-cells Not Administered:

In instances when the CAR-T drug is not ultimately administered to the beneficiary, but the CAR-T preparation services

are initiated or performed in the physician office or other non-hospital clinic facility, the practitioner may not report the

drug HCPCS code (which only applies when the T-cells are administered in the setting). The practitioner may report

CPT 0537T, 0538T, and 0539T. (0537T, 0538T, and 0539T end date 12/31/24 and replaced with 38225, 38226, and

38227 effective 01/01/25.)

Scenario 3: CAR T-cells Dosing and Preparation Services in Physician Office or Non-Hospital Clinic, but Viable

T-cells Administered in the Hospital Inpatient Setting:

When CAR T-cell preparation services are initiated and furnished in the physician office or other non-hospital clinic

setting, but the CAR T cells are administered in the hospital inpatient setting, the practitioner may not report the drug

HCPCS code (which only applies when viable T-cells are administered in the setting). The hospital that administers the

T-cells will report the charge associated with the various steps to collect and prepare the CAR T-cells on the inpatient

claim (TOB 11x) separately using revenue codes 0871, 0872, or 0873. Alternatively, the hospital may include the

charges for these various steps in the charge reported for the biological using revenue code 0891 – Special Processed

Drugs – FDA (U.S. Food and Drug Administration) Approved Cell Therapy – Charges for Modified cell therapy.

Note: When the cells are collected in the physician office setting and the CAR T-cell is administered in the hospital

inpatient setting, inpatient providers shall report the date that the CAR T-cell administration took place and not the date

the cells were collected.