27463918, 64B15ER23-12 - Florida Administrative Rules, Law, Code, Register

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Notice: 27463918

Notice of Emergency Rule

Department:

DEPARTMENT OF HEALTH

Division:

Board of Osteopathic Medicine

Overview

RULE:

64B15ER23-12

Mandatory Standardized Informed Consent for Sex-reassignment Prescriptions or Procedures in Adults

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE:

On May 17, 2023, Florida Governor, Ronald DeSantis, signed CSSB 254 into law creating Ch. 2023-90, Laws of Florida and section 456.52, Florida Statutes. Pursuant to section 456.52(2), F.S., if sex reassignment prescriptions or procedures are prescribed for or administered to patients 18 years of age or older, consent must be voluntary, informed, and in writing on forms adopted in rule by the Board of Osteopathic Medicine. Pursuant to section 456.52(4), F.S., the consent required for sex-reassignment prescriptions does not apply to renewals of sex-reassignment prescriptions if a physician and his or her patient have met the requirements for consent for the initial prescription. Section 456.52(6)(a), F.S., states “[t]he Board of Medicine and the Board of Osteopathic Medicine shall adopt emergency rules to implement this section.”
Accordingly, the Board of Osteopathic Medicine, by emergency rule, hereby adopts the incorporated mandated consent forms for the treatment of gender dysphoria with hormone replacement therapy and surgical treatment for patients 18 years of age or older.  
*** This emergency rule does not apply to Susan Doe, Gavin Goe, or Lisa Loe, or their parents or healthcare providers  (see Jane Doe et al., v. Joseph A. Ladapo, et al, Preliminary Injunction, Filed June 6, 2023, Case No. 4:23cv114-RH-MAF, United States District Court for the Northern District of Florida). ***

REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES:

The procedure used for the promulgation of this emergency rule is fair under the circumstances. CSSB 254 was signed into law on May 17, 2023. The Board of Osteopathic Medicine was contacted by multiple licensed physicians and physician groups seeking clarification regarding the exception contained in section 465.52(4), F.S., and a timeframe for the required emergency rules shortly thereafter. In response, the Board of Medicine and the Board of Osteopathic Medicine held a Joint Rules/Legislative Committee (Joint Committee) meeting on June 1, 2023, to discuss the emergency rule.  On May 19, 2023, the Board of Medicine published notice of the Joint Committee’s June meeting both on its website and in the Florida Administrative Register.  On June 20, 2023, the Board of Osteopathic Medicine discussed the report of the Joint Committee and voted upon emergency rule language that would allow for the renewal of previous prescriptions while the Board worked on consent forms.  The Board of Osteopathic Medicine published notice of its June 20, 2023, meeting in the Florida Administrative Register on May 5, 2023, and on its website on May 12, 2023.
The Joint Committee held another meeting on June 23, 2023, to discuss an emergency rule adopting draft consent forms that were under consideration. On June 6, 2023, the Board of Osteopathic Medicine published notice of the Joint Committee’s June 23, 2023, meeting to its website and in the Florida Administrative Register. On June 30, 2023, the Boards of Medicine and Osteopathic Medicine held a Joint Board meeting (Joint Board Meeting) to discuss the draft consent forms that were approved by the Joint Committee on June 23, 2023. The Joint Board meeting was held via Microsoft Teams and notice of the same was published to the Board of Medicine’s website and in the Florida Administrative Register on June 22, 2023. During the June 30, 2023, Joint Board Meeting, the Boards voted to approve consent forms and adopted them via emergency rule filed on July 5, 2023.
On July 21, 2023, the Board received correspondence from the Joint Administrative Procedures Committee (JAPC) questioning the Board’s statutory authority for requiring adult patients “undergo a thorough psychological and social evaluation performed by a Florida licensed board-certified psychiatrist or a Florida licensed psychologist” before beginning hormone replacement therapy and every two years thereafter. Accordingly, the Florida Board of Medicine and Osteopathic Medicine’s Joint Rules/Legislative Committee held a public meeting on August 3, 2023, and voted to remove the provision addressed by JAPC. The Board of Osteopathic Medicine discussed the Joint Committee’s report and affirmed the decision at its August 11, 2023, Board meeting. 
The August 3, 2023, Joint Committee meeting was held in person in a public forum and was able to be attended by any interested parties. Notice of the Joint Committee meeting was published to the Board of Osteopathic Medicine’s website on July 19, 2023, and in the Florida Administrative Register on July 13, 2023. The August 11, 2023, Board Meeting was also held in person in a public forum and was able to be attended by any interested parties. Notice for the August 11, 2023, Board Meeting was published to the Board of Osteopathic Medicine’s website on June 1, 2023, and in the Florida Administrative Register on May 24, 2023.
Public comment was accepted at all of the aforementioned board and committee meetings. Further, the Boards accepted written public comment on the initial proposed rules up and until 24 hours prior to the Joint Board Meeting. The Board also accepted written comments up and until 24 hours prior to the August 3, 2023, Joint Rules/Legislative Committee meeting as well. Accordingly, all notice requirements contained in Rule 28-102.001, F.A.C., were properly complied with at all points during the rulemaking process and interested parties were given ample opportunity to participate at all points during this rulemaking process.

SUMMARY:

The proposed emergency rule formally adopts the required consent forms for an adult patient to receive sex-reassignment prescriptions and/or procedures per section 456.52(2), Florida Statutes.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS:

:  Danielle Terrell, Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256, or by email at Danielle.Terrell@flhealth.gov.

PRINT PUBLISH DATE:

8/22/2023 Vol. 49/163

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://flrules.org/gateway/ruleno.asp?id=64B15ER23-12&PDate=8/22/2023&Section=4

REFERENCE MATERIALS:

No reference(s).

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