The Agency is proposing to amend 59C-1.044 to align definitions and remove outdated language.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Certificate of Need

RULE NO.:RULE TITLE:

59C-1.044Organ Transplantation

PURPOSE AND EFFECT: The Agency is proposing to amend Rule 59C-1.044, F.A.C. to align definitions and remove outdated language.

SUMMARY: The proposed amendments to this rule update language to align the pediatric age requirement with Medicaid definitions for designated pediatric transplant programs and remove an outdated grandfathering provision.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 408.034 (3), (8); 408.15 (8), FS.

LAW IMPLEMENTED: 408.033 (1)(b)4., 408.034 (3), 408.035, 408.036 (1)(f), 408.032 (17), FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: February 23, 2018, 9:00 a.m. to 10:00 a.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room C, 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: Marisol Fitch, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone] or by email at [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 IS: Marisol Fitch at [phone] or email at: [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59C-1.044 Organ Transplantation.

(1) through (10) No change.

(11) Pediatric transplant programs with a valid CON at a Medicaid designated transplant center may perform transplants for patients under the age of 21.  In case of conflict between provisions in this rule, the provisions of this subsection shall prevail. Any health care facility which operated an organ transplantation program as of October 1, 1987, shall be given a reasonable time, not to exceed 1 year from the effective date of this rule, within which to comply with these rule standards. Health care facilities to be included under this provision shall include any health care facilities which performed one or more transplants prior to October 1, 1987, or facilities which provide documentation to the Agency which shall include but not be limited to:

(a) A written implementation plan for the establishment of specific organ transplantation services which was approved by the hospital board of trustees or other duly designated authority prior to October 1, 1987, the effective date of the Health Facility and Services Development Act;

(b) Written documentation that the hospital had hired and trained personnel in the specific organ transplantation program applied for; and,

(c) That money had been expended prior to October 1, 1987 in preparation of implementing the organ transplantation program.

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.034(3), 408.035, 408.036(1)(f), 408.032(17), 408.033(1)(b)4., 11. FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(x), 10-5.044, Amended 8-24-93, 12-13-94, 7-6-09,_____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Marisol Fitch

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Justin M. Senior

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 22, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 11/17/2017