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. 49 No. 85, May 2, 2023 issue of the Florida Administrative Register.
The following sections of the proposed rule will be changed to read:
59B-12.001 Bone Marrow Transplantation.
As used in this rule, the term “appropriate oncological specialty” means that where a particular kind of tumor or disease is usually treated by a subspecialty group within the general discipline of oncology, those who practice within that subspecialty have had specific input into the decision making process. Cellular therapies include cellular immunotherapies, chimeric antigen receptor (CAR) T cells, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications. Human gene therapy refers to products that introduce genetic material into a person’s DNA to replace faulty or missing genetic material, thus treating a disease or abnormal medical condition.
(1) Upon the recommendation of the Bone Marrow Transplant Panel, each of the following procedures meets a minimum level of evidence based on high quality systematic reviews of case control or cohort studies, high quality case-control or cohort studies with a very low risk of confounding bias, or chance, and a high probability that the relationship is causal, and is considered accepted within the appropriate oncological specialty and not experimental for the purposes of Section 627.4236, F.S.
(a) Allogeneic bone marrow transplant for the following:
1. Acute myelogenous leukemia and myeloid sarcoma;
2. Acute lymphoblastic leukemia;
3. Chronic myelogenous leukemia;
4. Myelodysplastic syndromes;
5. Chronic myelomonocytic leukemia;
6. Myelofibrosis;
7. Non-Hodgkin lymphoma;
8. Hodgkin lymphoma after autologous stem cell collection failure or relapsed after autologous transplant but not progressing on salvage chemotherapy;
9. Chronic lymphocytic leukemia;
10. Severe or very severe aplastic anemia from HLA compatible siblings and any type of bone marrow transplant transplanat for acquired severe aplastic anemia unresponsive to immunosuppression or bone marrow failure syndromes;
11. Severe aplastic anemia and other bone marrow failure syndromes syndroms;
12. Thalassemia;
13. Inborn errors of immune system including severe combined immune deficiencies, primary immune deficiencies, and primary immune regulatory disorders;
14.Sickle cell disease.
(b) Autologous bone marrow transplant for the following:
1. Multiple myeloma (including double bone marrow transplant), Waldenstrom macroglobulinemia and primary amyloidosis;
2. Non-Hodgkin lymphoma;
3. Hodgkin lymphoma;
4. Acute myelogenous leukemia (stem cells collected in remission);
5. Neuroblastoma;
6. Germ cell tumor, after failure of first therapy but not progressing on salvage therapy;
7. Primitive neuroectodermal tumor (PNET), (including medulloblastoma and pinealoblastoma), chemotherapy sensitive after first relapse;
8. Medulloblastoma and other PNET tumors, metastatic, at diagnosis;
9. Ewing sarcoma, chemotherapy sensitive after first relapse.
(c) Gene and cellular therapy:.Tisagenlecleucel, a CD19-directed, genetically modified autologous T cell immunotherapy is medically necessary for the treatment of:
1.Tisagenlecleucel, a CD19-directed, genetically modified autologous T cell immunotherapy is medically necessary for the treatment of:
a.1. Adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including:
b. a. Diffuse large B-cell lymphoma not otherwise specified;
c. b. High grade B-cell lymphoma and diffuse large B-cell lymphoma arising from follicular lymphoma.
d. Pediatric patients up to 25 years old with B-cell precursor acute lymphoblastic leukemia that is relapsed or refractory.
2. through 10. No change
(2) through (7) No change
Rulemaking Authority 627.4236 FS. Law Implemented 627.4236 FS. History–New 11-9-95, Formerly 10D-127.001, Amended 9-26-00, 8-10-05, 7-7-13, 7-12-15, 2-4-19,_________.
