AGENCY FOR HEALTH CARE ADMINISTRATION
RULE NO.:RULE TITLE:
59B-12.001Bone Marrow Transplantation
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 39, No. 31, February 14, 2013 issue of the Florida Administrative Register.
The following changes have been made to the proposed rule:
(4) Any bone marrow transplant performed outside of a clinical trial will be covered when all of the following criteria are met:
(a) The plan of care follows a clinical trial protocol that meets the requirements of subsection (5);
(b) Patient cannot be enrolled in the proposed clinical trial;
(c) Bone marrow transplant treatment is medically necessary;
(d) Patient is an appropriate candidate for bone marrow transplant; and
(e) Treatment center is part of the BMT CTN as a core or non-core center.
(6)(4) It should be noted that there are other non-malignant (not oncological) diseases that are genetic disorders, or that result in bone marrow failure or lead to immunodeficiency syndromes for which bone marrow transplantation may be appropriate. While these non-malignant diseases are not described in the preceding lists, there are generally accepted and appropriate indications for bone marrow transplantation in these cases. In addition, there are malignant diseases that are uncommon in their occurrence that also are not detailed in the above lists for which the appropriateness of bone marrow transplantation may be determined on a case by case basis.
