CAR-T: Is Risk Evaluation and Mitigation Strategy (REMS) verified by the facility’s site name or address?
The facility’s site name and address must be identified as an FDA-approved REMS facility.
Part A does not match site name and address exactly, but will look for other related campuses; e.g., if the REMS is for Hospital X in City, State and Hospital X has an oncological hospital 3 blocks down which is the billing hospital, then Hospital X may be considered as having a REMS. The REMS must also be for the specific drug being administered.
Part B claims processing does not review the facility site name and address, since the KX modifier attests to the facility’s REMS status.