Chimeric Antigen Receptor (CAR) T-cell Therapy

CMS National Coverage Determination | ncd_id=374 | manual_section=110.24 | coverage_level_code=1 | national_coverage_type=True | under_review=True | lab_ncd=False

B. Nationally Covered Indications 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 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. C. Nationally Non-Covered Effective for services performed on or after August 7, 2019, the use of non-FDA-approved autologous T-cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the requirements in Section A are not met. D. Other Effective for services performed on or after August 7, 2019, routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1 will be covered. (This NCD last reviewed August 2019.)