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.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Cost Management and Control

RULE NO.:RULE TITLE:

59B-12.001Bone Marrow Transplantation

PURPOSE AND EFFECT: 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 AREA TO BE ADDRESSED: 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 IMPLEMENTED: 627.4236 FS.

IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: July 6, 2018, 9:00 a.m. – 10:00 a.m.

PLACE: Agency for Health Care Administration, Conference Room C, 2727 Mahan Drive, Building #3, Tallahassee, FL 32308.

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 3 days before the workshop/meeting by contacting: Dana Watson, Bureau of the Florida Center Health Information Exchange and Transparency, 2727 Mahan Drive, Tallahassee, Florida, Phone: [phone], E-mail: [e-mail] If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Dana Watson, Bureau of the Florida Center Health Information Exchange and Transparency, 2727 Mahan Drive, Tallahassee, Florida, Phone: [phone], E-mail: [e-mail]

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS AVAILABLE AT NO CHARGE FROM THE CONTACT PERSON LISTED ABOVE.