The Agency proposes to update health care clinic rule to align with recently revised statutory changes per Chapter 2018-24, Laws of Florida. Section 400.9935, FS. was amended to specify that a certificate of exemption from health care clinic ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-33.006Certificates of Exemption and Exempt Status

PURPOSE AND EFFECT: The Agency proposes to update health care clinic rule to align with recently revised statutory changes per Chapter 2018-24, Laws of Florida. Section 400.9935, F.S. was amended to specify that a certificate of exemption from health care clinic licensure is valid for up to 2 years. Previously certificates of exemption from health care clinic licensure did not expire. The Agency proposes to modify this rule to revise the exemption application and add renewal policies and procedures.

SUMMARY: The renewal of health care clinic exemption certificates.

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 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: 400.9925 FS.

LAW IMPLEMENTED: 400.9905(4), 400.9925 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 13, 2019, 9:30 a.m. – 11:00 a.m.

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

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of Rule 59A-33.006 follows. See Florida Administrative Code for present text.)

59A-33.006 Certificates of Exemption and Exempt Status.

(1) Persons, facilities and entities, hereafter referred to as entities, exempt from health care clinic license requirements are set forth in Section 400.9905(4), F.S. An entity is not required to have, but may voluntarily apply for, a certificate of exemption.

(2) Entities that claim an exemption, either by filing an application for a certificate of exemption with the Agency and receiving a certificate of exemption, or self-determining, must maintain an exempt status at all times of operation.

(3) Entities requesting a certificate of exemption from the health care clinic license requirements shall make application to the Agency on the Application for Certificate of Exemption from Licensure as a Health Care Clinic, AHCA Form 3110-0014, July 2018, which is incorporated by reference, and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10284. The application form is also available at http://www.ahca.myflorida.com/HQAlicensureforms.

(4) The applicant for a certificate of exemption must affirm:

(a) The specific exemption sought pursuant to Section 400.9905(4), F.S.;

(b) The qualifying requirements for obtaining and maintaining an exempt status;

(c) The current existence of applicable exemption-qualifying health care practitioner licenses, qualified ownership, qualified certifications or registration of the entity or owners;

(d) The federal employer identification number;

(e) Proof of legal existence and fictitious name, when the entity and name are required to be filed with the Division of Corporations, Department of State; and

(f) Other satisfactory proof required by form adopted by this rule.

(5) The fee for issuance of a certificate of exemption is required to be submitted to the Agency with the application. 

(a) Applications received without the requisite fee shall be returned to the applicant unprocessed.

(b) When the payment of a certificate fee has been dishonored, the applicant has 10 days from the date of notification to remit to the Agency the certificate fee plus any applicable fees as provided by law in the form of a money order or cashier’s check. In the event that the certificate fee is not paid, the application may be subject to withdrawal or the certificate may be subject to revocation.

(6) Upon receipt of an application for a certificate of exemption, the Agency shall examine the application and, within 30 days after receipt, notify the applicant in writing of any apparent errors or omissions and request any additional information required.

(7) Requested information omitted from an application for a certificate of exemption must be filed with the Agency within 21 days after the Agency’s request for omitted information or the application shall be deemed incomplete and shall be withdrawn from further consideration and the fees shall be forfeited.

(8) An application for a certificate of exemption from health care clinic licensure shall be granted or denied by the Agency within 60 days of receipt of a completed application.

(9) A certificate of exemption, unless sooner surrendered or revoked, shall automatically expire two years from the date of issuance, and shall be renewable biennially, provided that the applicant and facility continues to meet the requirements established under Chapter 400, Part X, F.S., and Rule 59A-33.006, F.A.C.

(10) An application for renewal of the certificate of exemption should be submitted to the Agency 60 to 120 days prior to the date of expiration of the certificate of exemption.

(11) An application to change the name or address of the certificate of exemption should be submitted to the Agency 21 to 120 days in advance of the requested effective date.

(12) Whenever an entity discontinues operation, the entity shall notify the Agency in writing, prior to the discontinuance of operation, by submitting a letter to the Hospital and Outpatient Services Unit, 2727 Mahan Drive, Mail Stop #53, Tallahassee, Florida 32308 or via email at [e-mail], including the effective date of closure. The entity shall remain responsible for retaining and appropriately distributing all medical records.

(13) If the applicant is required to register or file with the Florida Secretary of State, Division of Corporations, the principal, fictitious name and mailing addresses submitted with the licensure application for the applicant must be the same as the information registered with the Division of Corporations.

(14) An entity becomes a “clinic” as defined in Section 400.9905(4), F.S., when it does not qualify for an exemption, provides health care services to individuals, and bills third-party payers for those services. A facility or entity’s exempt status expires when a change occurs that negates a facility or entity’s qualification for the exemption. In such a case, the health care clinic must file with the Agency a license application under Sections 400.900-400.995, F.S. and shall be subject to all provisions applicable to unlicensed health care clinics. Failure to timely file an application for licensure of becoming a health care clinic will render the health care clinic unlicensed and subject the owners, medical or clinic directors and the health care clinic to sanctions under Sections 400.900-400.995, F.S.

(15) The Agency may deny or revoke a certificate of exemption as a health care clinic for the following actions by the applicant or owner:

(a) False representation of a material fact in the application for a certificate of exemption or omission of any material fact from the application.

(b) A violation of section 400.9905, F.S.

(c) A violation of this rule.

(16) Certificates of exemption are not transferable, directly or indirectly. They are valid only for the entity, qualifying owners, licenses, registrations, certifications and services provided under specific statutory exemptions and are valid only for the specific exemption claimed and granted. In order for a certificate of exemption to be valid, the entity must apply for and receive an amended certificate of exemption for changes of name or location.

Rulemaking Authority 400.9925 FS. Law Implemented 400.9905(4), 400.9925 FS. History–New 8-28-06, Amended 2-12-15,_____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jessica Munn

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 12/03/2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 08/14/2018