Chimeric Antigen Receptor T-Cell Therapy Reminder

National Government Services is receiving certain CAR T-Cell therapy claims that are billed incorrectly resulting in claim rejection or erroneous claim adjudication. Please note that rejected claims do not have appeal rights.

Providers billing MACs for CAR T-Cell Therapy services provided to Medicare patients are reminded to follow the billing guidelines provided in MLN Matters Article SE19009 to prevent claim denials.

On 8/7/2019, CMS finalized the decision to cover FDA-approved CAR T-cell therapy, which is a form of cancer treatment that uses a patient’s own genetically-modified immune cells to fight disease. FDA-approved CAR T-cell therapies are approved to treat some people with specific types of cancer – certain types of non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.

• Refer to the Resources section at the end of this article for links to the CMS Decision Memo and National Coverage Analysis Tracking Sheet for additional information.

Medicare will cover CAR T-cell therapies when provided in health care facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies for FDA-approved indications (according to the FDA-approved label). In addition, Medicare will cover FDA-approved CAR T-cell therapies for off-label uses that are recommended by CMS-approved compendia.

Currently there are only two drugs approved by the FDA for use in this therapy for the following conditions and age limitations:

1. Tisagenlecleucel, received FDA approval on 8/30/2017 for the treatment of patients up to 25 years of age (age limitation) with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

A second FDA indication for tisagenlecleucel was granted on 5/1/2018 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Additional information about the FDA approval of tisagenlecleucel, including the Risk Evaluation Mitigation Strategy (REMS) program, is available on the FDA website.

2. Axicabtagene ciloleucel received FDA approval on 10/18/2017 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL, not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Additional information about the FDA approval of axicabtagene ciloleucel, including the REMS program, is available on the FDA website.

Hospital Outpatient

• Report CPT code 0540T with revenue code 0874 for the administration with:
• HCPCS Q2041 (Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose; registered name is Yescarta)

or

• Q2042 (Tisagenlecleucel, up to 600 million car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose; registered name is Kymriah) for the drug/biological with revenue code 0891.
• Report value code 86 (Invoice Cost)

Bundled Services: Medicare payment for the various steps required to collect and prepare CAR-T is included in payment for the biological. Providers should choose one method for including the charges for the various steps. Do not report the same charge(s) twice

• Either include the charges for these various steps in the charge submitted for the biological

or

• Report these charges separately, as noncovered services, for tracking purposes using the following as applicable:

• • • HCPCS 0537T with revenue code 0871
    • HCPCS 0538T with revenue code 0872
    • HCPCS 0539T with revenue code 0873
       
• Do not include charges for pre-infusion steps in both the drug revenue code (0891) and separately listed for the pre-infusion revenue codes (0871, 0872 and 0873).

Hospital Inpatient Billing

FDA approved indication: If the CAR-T service is for an FDA approved indication, no national clinical trial (NCT) number is included on the claim. Note that in addition to reimbursement for DRG 016, these claims, when properly coded and billed, will receive additional payment for the appropriate CAR-T drug.

Indication is not FDA approved: When the CAR-T service is not for an FDA approved indication, then the appropriate NCT number must be included on the claim along with all applicable clinical trial requirements. When properly coded and billed, these claims will receive reimbursement for DRG 016. However, the claim will not receive any additional payment for the CAR-T drug.

When CAR T-cell preparation services are initiated and furnished in the hospital outpatient setting, but the CAR T-cells are administered in the inpatient setting following an inpatient admission to the hospital more than three days after the related outpatient services are furnished, do not report the drug Q-code.

Note: When the cells are collected in the hospital outpatient 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.

Report the charge associated with the various steps to collect and prepare the CAR T-cells on the inpatient claim (Type of Bill 11x) in one of two ways:

• Report separately using revenue codes 0871, 0872 or 0873

or

• 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.

CAR T-Cell Therapy Codes

Related Content

• CMS Change Request 11216 “April 2019 Update of the Hospital Outpatient Prospective Payment System (OPPS)”
• CMS Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)
• National Coverage Analysis (NCA) Tracking Sheet for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Posted 11/20/2019