20571001, 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: 20571001

Notice of Development of Rulemaking

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.

SUBJECT:

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.

RULEMAKING AUTHORITY:

627.4236 FS

LAW:

627.4236 FS

PRINT PUBLISH DATE:

6/21/2018 Vol. 44/121

RELATED STATUTES
AND LAWS:

627.4236 FS, 627.4236 FS

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://www.flrules.org/gateway/ruleno.asp?id=59B-12.001&PDate=6/21/2018&Section=1

REFERENCE MATERIALS:

No reference(s).

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