End-of-year regulatory report
By Mary Thomas, Esq., FMA Assistant General Counsel | Dec. 7, 2023
As 2023 comes to an end, so does another eventful year in Florida’s healthcare regulatory landscape. The following summarizes some of the most notable discussions and decisions made by the state boards of medicine, osteopathic medicine, nursing, and pharmacy, and how the FMA represents you.

Board of Medicine and Board of Osteopathic Medicine
The Board of Medicine and Board of Osteopathic Medicine held several joint committee meetings throughout 2023, primarily focused on office surgery and implementing SB 254, Treatments for Sex Reassignment.

Office Surgery
The Joint Surgical Care & Quality Assurance Committee began the year with two major initiatives – to require the pre-registration of office surgery facilities and to implement the emergency rules passed in 2022 that temporarily amended the standards of care when performing gluteal fat grafting procedures, better known as Brazilian Butt Lifts (BBLs). Ultimately, the Florida Legislature picked up both of these issues during the 2023 Session with the passage of HB 1471. To thwart a potential rule challenge, HB 1471 codifies much of the BBL standard of care as developed by the medical boards, along with other general provisions of the office surgery rule.

This legislation sets forth the following requirements for physicians performing BBLs in an office surgery setting:

  • The surgeon must perform an in-person examination of the patient no later than the day before the procedure.
  • The surgeon may not delegate the fat extraction or gluteal fat injection portion of the procedure.
  • The patient must provide written informed consent for any other duties that may be delegated.
  • The surgeon must use ultrasound guidance when placing and navigating the canula and injecting fat into the subcutaneous space. This is to ensure that the fat is placed above the fascia overlying the gluteal muscle.
  • An office in which a physician performs BBLs must at all times maintain a ratio of one physician to one patient during all phases of the procedure. After a physician has commenced, and while he or she is engaged in, a BBL procedure, the physician may not commence or engage in another BBL procedure or any other procedure with another patient at the same time.

The Boards have withdrawn their proposed rules concerning BBLs while they monitor the effect of HB 1471 to determine whether it has a positive impact on the number of BBL-related adverse incidents.

In addition to codifying the standards of care for gluteal fat grafting procedures, HB 1471 requires the Department of Health to inspect an office surgery facility before issuing a registration. This change is due to the high volume of ambulatory surgical centers operating under the guise of an office surgery facility, particularly in south Florida. Under this law, if a registered office refuses an inspection, the Department must immediately suspend the registration for at least 14 days and the office may not reopen until the Department completes an inspection of the office.

Looking ahead, the Boards of Medicine and Osteopathic Medicine are set to amend the definition of office surgery in order to further clarify the difference between an office surgery facility and an ambulatory surgical center. The proposed language as agreed to at the December meeting will amend the definition as follows:


64B8-9.009 Standard of Care for Office Surgery.

(1) Definitions.
…

(d) Office surgery.
1. For the purpose of this rule, office surgery is defined as surgery which is performed in an office maintained by a physician for the practice of medicine where a surgeon performs procedures as permitted by this rule and which is governed pursuant to Rule 64B8-9.0091, F.A.C., and Section 458.328, F.S. The Physician’s office must be an office at which the surgeon regularly performs consultations with surgical patients, pre-surgical examinations, and post-surgical care related to the surgeries performed at the physician’s office, and where patient records are readily maintained and available. outside of any facility licensed under Chapter 390 or 395, F.S. Office surgical procedures shall not be of a type that generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures, except for laparoscopic procedures; involve major blood vessels performed with direct visualization by open exposure of the major vessel, except for percutaneous endovascular intervention; or are generally emergent or life threatening in nature.

2. A facility that meets the definition of an ambulatory surgical center as defined in Section 395.002(3), F.S., a hospital as defined in Section 395.002(12), F.S., or an abortion clinic as defined in Section 390.011(2), F.S., may not be registered as an office surgery facility under Rule 64B8-9.0091, F.A.C.


*The amended language is identical in the Osteopathic office surgery rule (Rule 64B15-14.007) except for the rule and statutory references, which are 64B15-14.0076, F.A.C., and 459.0138, F.S., respectively.

This language will be noticed as a proposed rule in the coming weeks, and the FMA will continue to provide updates to our members as this rule proceeds through the rulemaking process.

Treatments for Sex Reassignment
 The Boards and Joint Rules and Legislative Committee spent considerable time this year implementing SB 254, which prohibits physicians from providing gender clinical interventions to a minor. This legislation also requires physicians treating adult patients to be physically present in the room with the patient in order to obtain written informed consent from the patient each time the physician provides gender clinical interventions. The Boards of Medicine and Osteopathic Medicine were charged with promulgating the standards of practice for treating minors with gender dysphoria who were being treated with such therapies prior to May 17, 2023, and with creating the adult informed consent form.

The Boards issued several emergency rules that will remain in place until the formal rulemaking process is completed. The emergency rules are listed as follows:

  • 64B8ER23-7 and 64B15ER23-9 – Sex-reassignment Standards of Practice in Minors
  • 64B8ER23-11 and 64B15ER23-12 – Mandatory Standardized Informed Consent for Sex-reassignment Prescriptions or Procedures in Adults

The current informed consent forms can be found on the Board of Medicine’s Resources page under Forms & Requests and Informed Consent Forms.

Expert Witness
The Department needs quality medical experts to assist in reviewing cases, making recommendations to the Probable Cause Panel (PCP), and litigating cases at the Division of Administrative Hearings (DOAH). Expert consultants review medical records and other materials from the Department’s investigation and render written opinions for the benefit of the Department and the PCP. Such opinions from medical experts in the relevant field are crucial in assisting the Department to make an informed recommendation to the PCP and in helping the PCP decide whether it is appropriate to file an Administrative Complaint and pursue discipline against a licensee. Should a case require litigation at DOAH to resolve, experts testify on behalf of the Department. Most expert reviews involve determining whether a licensee met the standard of care in their treatment. Other issues that experts may address include whether a licensee practiced within the scope of their license or was competent to perform the services rendered, whether the licensee performed a wrong or medically unnecessary procedure, and whether a licensee’s crime relates to the practice of their profession.

The Department is always working to recruit quality experts from across the spectrum of medical practice; however, it has the most pressing need for experts in the following fields:

  • Neurosurgery
  • Psychiatry
  • Plastic Surgery (especially with expertise in BBLs)
  • Orthopedic Spine Surgeons
  • Cardio-Thoracic Surgeons
  • OB/GYN
  • Maternal Fetal Medicine
  • Gynecologic Oncology
  • ENT Facial Plastics (Otolaryngology Facial Plastics)
  • Oculoplastics
  • Pediatrics-Neonatology

Physicians who are interested in being experts for the Department can find additional information and apply here. Questions about the Department’s needs for experts or the process for becoming an expert can be directed to Florida Department of Health Chief Legal Counsel Andrew Pietrylo at Andrew.Pietrylo@flhealth.gov or (850) 558-9905.

Elections
The Board of Medicine held its annual election for Chair and Vice-Chair at the conclusion of December’s meeting. Congratulations to Nicholas Romanello, Esq., who was elevated from Vice-Chair to Chair, and to Amy Derick, MD, who was elected Vice-Chair. The FMA extends sincere gratitude to Scot Ackerman, MD, for his service and commitment to the citizens of Florida as Chair throughout 2023.

Board of Nursing
Petitions for Declaratory Statement
 The FMA continues to monitor activities at the Board of Nursing. Over the past few years there has been a significant increase in the number of registered nurses and advanced practice registered nurses attempting to expand their scope of practice through declaratory statements. The FMA frequently intervenes in these petitions when the intended conduct would violate that nurse’s scope of practice.

Of note, the FMA along with other interested specialty societies intervened in three petitions for declaratory statement. The first petition was by an RN attempting to perform a litany of aesthetic procedures with an undisclosed degree of supervision by a physician. The FMA was able to get this petition dismissed on technical grounds.

The second petition was filed by an Autonomous APRN seeking to employ and supervise non-autonomous APRNs. This is clearly in conflict with Florida law, which states that an APRN can only be supervised for directing the specific course of medical treatment by a practitioner licensed under Chapters 458, 459, or 466.

The third petition, filed by the same Autonomous APRN, petitioned the Board to allow all APRNs to certify medical marijuana for patients. While this conduct is both unconstitutional and against state law, what was most concerning about this petition was petitioner’s assertion that Autonomous APRNs currently have the ability to prescribe other Schedule I controlled substances such as LSD, Psilocybin, and MDMA. Upon receiving the FMA’s motions to intervene, the petitioner withdrew his petitions. While defeating these attempted scope-of-practice expansions may be comforting temporarily, it is alarming to see the lack of basic understanding of state and federal law by nurse practitioners who are allowed to practice without physician oversight.

Operation Nightingale
The U.S. Department of Health and Human Services Office of Inspector General conducted a multi-state investigation that uncovered and shut down a scheme to sell false and fraudulent nursing diplomas and degrees. The Florida Board of Nursing is currently working with the federal government and is in the process of revoking licenses obtained with fraudulent nursing degrees. As of this fall, 42 licenses were voluntarily relinquished, and 24 cases are currently proceeding through the full disciplinary process for license revocation. This is an ongoing investigation and the FMA will continue providing updates on the number of revoked licenses that were fraudulently obtained.

Board of Pharmacy
Collaborative Practice Agreement
Section 465.1865, F.S., allows for a collaborative practice agreement between a physician and pharmacist for the management of certain chronic conditions. These conditions include arthritis, asthma, COPD, Type 2 diabetes, HIV/AIDS, obesity or any other chronic condition adopted in rule by the Board of Pharmacy in consultation with the Boards of Medicine and Osteopathic Medicine. Rule 64B16-31.007, F.A.C., adds to the conditions provided in statute to include hyperlipidemia, hypertension, anti-coagulation management, nicotine dependence and opioid use disorder. Under a collaborative practice agreement, the physician may allow a pharmacist to modify or discontinue medications and order, perform, and interpret clinical and laboratory tests.

In May, the Board of Pharmacy sought to add hepatitis C, heart disease, and multiple sclerosis to this list. The FMA, along with other specialties, had serious concerns about the addition of heart disease and multiple sclerosis as conditions that can be collaboratively managed. As a result of FMA advocacy, the Board only moved forward with adding hepatitis C to this list. As of August, there are 37 pharmacists and 37 physicians actively engaged in collaborative practice, as defined in §465.1865, F.S. Of the enumerated conditions, HIV/AIDS is the most prevalent condition collaboratively managed.