Knowledge Base Article

There has been a lot of talk lately about surprise medical bills.  These are usually that seemingly never-ending stream of bills people get after having a procedure or surgery from “other” physicians such as anesthesiologists, radiologists, pathologists, etc. But what if you were a Medicare Advantage (MA) insurer and that surprise bill was for $375,000 or more for an innovative therapy newly approved by Medicare? Luckily for the MA plans, Medicare fee-for-service (FFS) will be paying for CAR T-cell therapy for MA beneficiaries for two years – 2019 and 2020. CMS has instructed the MA plans to account for CAR T-cell therapy for cancer items and services in their contract year 2021 bids.

Chimeric Antigen Receptor (CAR) T-cell therapy is an immunotherapy where a patient’s lymphocyte T-cells are genetically altered to improve their ability to fight cancer. In a new National Coverage Determination, CMS approved coverage for CAR T-cell therapy:

Effective for services performed on or after August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T-cells expressing at least one Chimeric Antigen Receptor (CAR) when administered at healthcare facilities enrolled in the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) and used for a medically accepted indication as defined at Social Security Act Section 1861(t)(2) ‐i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.

On October 24, 2019, CMS released MLN Matters Article SE19024 concerning billing instructions for beneficiaries enrolled in MA plans for CAR T-cell therapy. As a result of the significant cost of this therapy, effective August 7, 2019, original fee-for-service Medicare will pay for CAR T-cell therapy for cancer obtained by beneficiaries enrolled in Medicare Advantage (MA) plans when the coverage criteria outlined in the decision memorandum is met. This applies for Calendar Years (CYs) 2019 and 2020 only.

The MLN article goes on to provide billing instructions for MA beneficiaries. The main issue with billing for CAR T-cell therapy is that providers can choose different methods of reporting charges for the various steps required to collect and prepare CAR T-cells. These costs can be included in the charge for the biological or they may be reported separately for tracking purposes. Medicare payment for the preparation services is included in the payment for the biological. HCPCS and revenue codes reported separately for the preparation services are not paid separately and will be rejected by Medicare. As stated above, this option is only for tracking purposes.

Do not report the same charge(s) twice. Providers should choose one option described below. You must 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).

When all services are provided on an outpatient basis:

• Report CPT code 0540T with Revenue Code 0874 for the administration of CAR T-cells
• Report HCPCS Q-code Q2041 or Q2042 for the drug/biological with Revenue Code 0891
• Option 1 for charges to collect and prepare CAR T-cells - report
• HCPCS 0537T with revenue code 0871
• HCPCS 0538T with revenue code 0872
• HCPCS 0539T with revenue code 0873
• Option 2 for charges to collect and prepare CAR T-cells - include the charges for these various steps in the charge submitted for the biological

When CAR-T dosing and preparation services are done in an outpatient setting, but the T-cells are administered in the hospital inpatient setting:

• Report the administration of the T-cells on the inpatient claim with revenue code 0874
• Report the drug/biological on the inpatient claim with revenue code 0891
• Option 1 for charges to collect and prepare CAR T-cells - report on inpatient claim under revenue codes 0871, 0872, and 0873 OR
• Option 2 for charges to collect and prepare CAR T-cells - include the charges for these various steps in the charge reported for the biological using revenue code 0891

If CAR-T dosing and preparation Services are performed in the hospital outpatient setting, but the viable T-cells are never administered back to the patient, report CPT codes 0537T, 0538T, and 0539T (as appropriate) and the charges associated with each code under the appropriate revenue code on the outpatient claim. Medicare will not pay for these services when the T-cells are not administered. They will reject these codes but reporting allows tracking of the services and inclusion of the associated costs in your charges.

For more details on billing CAR-T, refer to the MLN Matters Article referenced above or MLN Matters Article SE19009.