20882856, 59B-12.001 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 20882856

Notice of Proposed Rule

Department:

AGENCY FOR HEALTH CARE ADMINISTRATION

Division:

Cost Management and Control

Chapter:

BONE MARROW TRANSPLANTATION

Overview

RULE:

59B-12.001

Bone Marrow Transplantation

PURPOSE:

The Agency is proposing to amend Rule 59B-12.001, F.A.C., to update procedures based on recommendations from the Bone Marrow Transplant Advisory Panel.

SUMMARY:

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.  
New language adds to the specific conditions for which the use of cellular therapies is necessary.  The amendments also adjust the conditions in sections one through three to add or move conditions to the proper section.

RULEMAKING AUTHORITY:

627.4236 F.S.

LAW:

627.4236 F.S.

PRINT PUBLISH DATE:

9/21/2018 Vol. 44/185

COMMENTS:

From 9/21/2018 To 10/12/2018 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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