Subject


The Agency is rescheduling a rule hearing that was originally scheduled for October 16, 2018 due to Hurricane Michael. This hearing for Rule 59B-12.001, F.A.C., will address rule changes to update procedures based on recommendations from the Bone Marrow Transplant Advisory Panel. The proposed amendments include coverage for cellular therapies which include cellular immunotherapies, chimeric antigen receptor (CAR) T cells, cancer vaccines, and other types of autologous and allogeneic cells for certain therapeutic indications. The language mirrors that of the Food and Drug Administration’s language for approved cellular therapy.