The Agency is proposing to amend Rule 59C-1.002, F.A.C., to update language due to statutory changes.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Certificate of Need

RULE NO.:RULE TITLE:

59C-1.002Definitions

PURPOSE AND EFFECT: The Agency is proposing to amend Rule 59C-1.002, F.A.C., to update language due to statutory changes.

SUMMARY: Rule 59C-1.002, F.A.C., outlines general definitions utilized by the Certificate of Need Program. The Agency is proposing to amend the rule to update language due to statutory changes. The changes include removing the definition of a mobile unit, removing adult cardiovascular services from the list of tertiary services, and removing outdated citations and duplicative definitions which are already in statute.

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.

The Agency prepared a checklist for the 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: 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. 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(8) and 408.15 (8) FS.

LAW IMPLEMENTED: 408.033(1)(a), 408.036 (1)(2), 408.037 (1), 408.039 (1) and (2) 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: April 19, 2019, 8:30 a.m. – 10:00 a.m.

PLACE: Agency for Health Care Administration, Conference Room B, 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: Marisol Fitch, Bureau of Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [phone] or 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, [phone], email: [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

59C-1.002 Definitions.

(1) “Acute care bed” means a patient accommodation or space licensed by the Agency pursuant to Chapter 395, Part I, F.S., and regulated under Rule 59C-1.038, F.A.C. Acute care beds exclude neonatal intensive care beds, comprehensive medical rehabilitation beds, hospital inpatient psychiatric beds, hospital inpatient substance abuse beds, beds in distinct part skilled nursing units, and beds in long term care hospitals licensed pursuant to Chapter 395, Part I, F.S.

(2) through (27) No change.

(28) “Long term care hospital” means a hospital licensed under Chapter 395, Part I, F.S., which meets the requirements of Part 412, subpart B, paragraph 412.23(e), Code of Federal Regulations (1994), and seeks exclusion from the Medicare prospective payment system for inpatient hospital services.

(29) “Mental health services” means inpatient services provided in a hospital licensed under Chapter 395, F.S., and listed on the hospital license as psychiatric beds for adults; psychiatric beds for children and adolescents; intensive residential treatment beds for children and adolescents; substance abuse beds for adults; or substance abuse beds for children and adolescents.

(30) “Mobile unit” means an object with the ability by structure, function or design to move or be moved from one health care facility to another, such that upon arriving at a facility the object is not permanently fixed but is temporarily secured for the purpose of providing a health service to inpatients.

(28)(31) “Nongovernmental health care consumer” means an individual who is not a health care provider or a health care purchaser as defined in subsections (20) and (21) of this section. Nongovernmental health care consumers include but are not limited to elected government officials, members of the general public and representatives of consumer organizations.

(29)(32) “Nursing home” means a health care facility licensed under Chapter 400, Part I, F.S.

(30)(33) “Operate” means to have the legal responsibility, pursuant to the appropriate licensure statute where licensure is required, for the proper functioning of all aspects of a health care facility or service.

(31)(34) “Shared service” means a health service which is operated by or on behalf of two or more health care facilities or health care providers.

(32)(35) “Shared service project” means the act of two or more health care facilities or health care providers entering into an arrangement to jointly offer an existing, approved or proposed health service for a pre-determined period of time.

(33)(36) “Sheltered nursing home beds” means nursing home beds configured into a nursing home facility licensed pursuant to Chapter 400, Part I, F.S., which are located within a continuing care retirement community certified under Chapter 651, F.S., for which a Certificate of Need has been issued as sheltered beds, and which are regulated under Rule 59C-1.037, F.A.C.

(34)(37) “State Agency Action Report” means the single written document prepared by the Agency after reviewing a Certificate of Need application, or applications where more than one 1 Certificate of Need application is accepted by the Agency in the same batching cycle, which sets forth the evaluation of the Agency with respect to the application or applications.

(35)(38) “Subdistricts” mean a subdivision of a district designated by the local health council as established under Rules 59C-2.100 and 59C-2.200, F.A.C.

(36)(39) “Substantial change in health services” means:

(a) The offering by a health care facility, through conversion of beds or other means, of a new institutional health service or a health service which has not been offered on a continuing basis by or on behalf of the health care facility within the 12-month period prior to the time such service would be offered, excluding obstetrical services; or

(b) The designation of acute care beds in a health care facility as beds regulated under Rule 59C-1.036, F.A.C., or the redesignation of such beds returning back to acute care beds; or

(c) The conversion of a general acute care or specialty hospital licensed under Chapter 395, Part I, F.S., to a long term care hospital.

(37)(40) “Termination of an inpatient health service” means the cessation of a health service which currently requires a Certificate of Need. It does not include the temporary cessation of a service lasting 6 months or less.

(38)(41) “Tertiary health service” means a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost effectiveness of such service. Examples of such service include, but are not limited to, organ transplantation, specialty burn units, neonatal intensive care units, comprehensive rehabilitation, and medical or surgical services which are experimental or developmental in nature to the extent that the provision of such services is not yet contemplated within the commonly accepted course of diagnosis or treatment for the condition addressed by a given service. The types of tertiary services to be regulated under the Certificate of Need Program in addition to those listed in Florida Statutes include:

(a) Heart transplantation;

(b) Kidney transplantation;

(c) Liver transplantation;

(d) Bone marrow transplantation;

(e) Lung transplantation;

(f) Pancreas and islet cells transplantation;

(g) Heart/lung transplantation;

(h) Adult open heart surgery;

(h)(i) Neonatal and pediatric cardiac and vascular surgery; and,

(i)(j) Pediatric oncology and hematology.

In order to determine whether services should be added or deleted, the listing of tertiary services shall be reviewed annually by the Agency.

(39)(42) “Transfer of a Certificate of Need” means the conveyance of a Certificate of Need which has been issued and remains valid from one person to another person.

(40)(43) “Transfer costs” means any expense actually incurred by the transferor, and, as provided for in Section 408.04, F.S., the expense was incurred in obtaining the initial Certificate of Need which authorized the project. Costs incurred in implementing the Certificate of Need subsequent to its award are project costs, not transfer costs.

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 408.033(1)(a), 408.036(1), (2), 408.037(1), 408.039(1), (2), 651.118 FS. History–New 1-1-77, Joint Administrative Procedures Committee Objection Filed–See F.A.R. Volume 3, No. 10, March 11, 1977, Amended 11-1-77, 9-1-78, 6-5-79, 4-25-80, 2-1-81, 3-31-82, 7-29-82, 12-23-82, Formerly 10-5.02, Amended 11-24-86, 11-17-87, 12-5-90, 1-31-91, 1-1-92, Formerly 10-5.002, Amended 12-14-92, 2-27-94, 6-23-94, 10-18-95, 10-8-97, 12-12-00,______, Amendment resolved Joint Administrative Procedures Committee objection, 10-27-77, Florida Administrative Register Vol. 35, No. 27, July 10, 2009.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Marisol Fitch

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Mary C. Mayhew

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 14, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 19, 2018