CMS Pub. 100-04, ch. 32, § 400.1

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 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 (the 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. See Publication

100-03, National Coverage Determination (NCD) Manual 110.24 for complete coverage criteria. See the following

websites for specific REMS facility information:

Kymriah® https://www.us.kymriah.com/treatment-center-locator

Yescarta® https://www.yescarta.com/find-a-treatment-center

Tecartus™ https://www.tecartus.com/hcp/treatment-center-locator

Breyanzi® https://www.celltherapy360.com/locations

ABECMA® https://www.celltherapy360.com/locations

CARVYKTI™ https://www.carvyktihcp.com/treatment-centers

NOTE: The use of allogenic T-cells from healthy donors are not autologous CAR T-cell treatments and shall not be

billed as autologous CAR T-cell treatments.