Mid-year regulatory update
By Mary Thomas, Esq., FMA Assistant General Counsel
With an early legislative session this year, regulatory activity was off to a slow start as agencies waited to see which bills would make it across the finish line. With the passage of the Live Healthy Package, SB 7016, the Department of Health and Agency for Health Care Administration will have an incredibly busy year ahead as the agencies work to finalize implementation that arose from 2023 legislation, in addition to working on the many issues delegated by the 2024 Legislature. The following is a summary of the latest actions by the Board of Medicine and Board of Osteopathic Medicine, the Board of Nursing, and the Agency for Health Care Administration.
Board of Medicine and Board of Osteopathic Medicine
Office surgery
The past two years have created a slight timing problem for the Joint Surgical Care & Quality Assurance Committee in moving forward with amending the office surgery rule. Last year, the Committee aimed to require the pre-registration of office surgery facilities and to implement the emergency rules 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.
In the 2023 FMA End-of-Year Regulatory Report, we discussed that the Committee preliminarily agreed to draft language to amend the definition of office surgery. During the 2024 Legislative Session, legislation pertaining to office surgery was introduced that changed dramatically over the course of session – effectively delaying regulatory action until potentially new parameters were known. In the end, a narrower version of the bill passed (HB 1561), allowing the Committee to progress in the rulemaking process. On April 30, 2024, the boards published a notice of proposed rule to clarify the definition of office surgery as follows:
64B8-9.009 Standard of Care for Office Surgery.
(1) Definitions.
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(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 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 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. 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.
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(7) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.
*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.
It is anticipated that a rule hearing will be requested on this language and could be held as early as June. The FMA will continue to monitor this issue as it moves through the rulemaking process.
As a reminder, HB 1561, which will become law on May 10 if not vetoed by the Governor, requires an office in which a BBL is performed to establish financial responsibility by obtaining and maintaining professional liability coverage or an irrevocable letter of credit in an amount not less than $250,000 per claim, with a minimum annual aggregate of not less than $750,000 as provided by Sections
458.320(2)(b) or (c) and
459.0085(2)(b) or (c), F.S., as applicable. Because the Department has not been able to provide clear guidance on when this requirement will be enforced, we recommend that registered offices in which BBLs are performed secure this coverage as soon as possible to avoid any potential adverse action.
Implementation of Live Healthy
In addition to office surgery, the boards will have a busy year implementing provisions of the Live Healthy Package, signed by the Governor on March 21. At the upcoming June meeting, the boards will begin to create frameworks for new licensure pathways for graduate assistant physicians, certain foreign-trained physicians, and for physicians looking to join the Interstate Medical Licensure Compact. The rulemaking process for any one of these issues could easily take anywhere from six months to two years to fully implement. For a full summary of the Live Healthy Package, read the FMA’s
2024 Legislative Report.
Board of Nursing
Petition 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 a petition for declaratory statement filed by an autonomous advanced practice registered nurse (APRN). The petitioner sought clarification from the board to determine whether she could hire registered nurses to work in her aesthetic practice. The petitioner makes clear in her request that she is practicing aesthetic medicine without a medical director or any supervisory relationship with a physician. What the petitioner was ignorant of, whether willfully or otherwise, is that Florida law is clear that APRNs may only practice autonomously in areas of primary care. The FMA and other intervenors argued that the board need not address the question of whether she can hire RNs — as she has openly admitted to violating Florida Statute §464.0123 for the previous two years — and urged the board to instead refer the petitioner to the Department of Health’s investigative services unit. In a major win for patients, the board denied the petitioner’s request for a declaratory statement and requested the Department to open an investigation into the petitioner’s conduct.
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 degree diplomas and degrees. The Florida Board of Nursing is working with the federal government and is in the process of revoking licenses obtained with fraudulent nursing degrees. As of May 1, 54 licenses have been voluntarily relinquished, and 114 cases are 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.
Agency for Health Care Administration
Abortion – Emergency Rule Relating to Premature Rupture of Membranes and other Life-Threatening Conditions
After the Florida Supreme Court upheld Florida’s ban on abortions after 15 weeks, Florida’s six-week ban went into effect on May 1, 2024. Senate Bill 300 (2023) prohibits a physician from knowingly performing an abortion after six weeks of pregnancy unless one of the following is met:
a) Two physicians certify in writing that, in reasonable medical judgment, the termination of the pregnancy is necessary to save the pregnant woman’s life or avert a serious risk of substantial and irreversible physical impairment of a major bodily function of the pregnant woman other than a psychological condition.
b) The physician certifies in writing that, in reasonable medical judgment, there is a medical necessity for legitimate emergency medical procedures for termination of the pregnancy to save the pregnant woman’s life or avert a serious risk of imminent substantial and irreversible physical impairment of a major bodily function of the pregnant woman other than a psychological condition, and another physician is not available for consultation.
c) The pregnancy has not progressed to the third trimester and two physicians certify in writing that, in reasonable medical judgment, the fetus has a fatal fetal abnormality.
d) The pregnancy is the result of rape, incest, or human trafficking and the gestational age of the fetus is not more than 15 weeks, so long as the woman is able to provide proof that she is a victim of one of the enumerated crimes.
There was considerable concern amongst physicians and other healthcare practitioners regarding the parameters of the emergency exception and how to comply without risking criminal penalty, especially in situations where two physicians are not readily available. In response to these concerns, the Agency for Health Care Administration published two emergency rules clarifying the procedures for treating life-threatening conditions that are frequent and known complications of pregnancy.
Rule 59AER24-1, F.A.C., Medical Records Procedure for Treatment of Premature Rupture of Membranes and Other Life-Threatening Conditions, reads as follows:
Each hospital shall maintain written policies and procedures governing the maintenance of medical records for the treatment of premature rupture of membranes, ectopic pregnancies, trophoblastic tumors, and other life-threatening conditions. The policies and procedures shall be reviewed at least annually, dated to indicate time of last review, and revised as necessary. At a minimum, the policies and procedures shall address the following:
(1) When a patient receives a diagnosis of premature rupture of membranes, the patient shall be admitted for observation unless the treating physician determines that another course of action is more medically appropriate under the circumstances to ensure the health of the mother and the unborn baby. When the treating physician determines that another course of action is more medically appropriate, the physician shall document the reasons why the alternate course of action is more appropriate.
(2) When a physician attempts to induce the live birth of an unborn baby, regardless of gestational age, to treat the premature rupture of membranes, and the unborn baby does not survive, the incident does not constitute an abortion and shall not be reported pursuant to Rule 59A-9.034. The treating physician shall document the treatment in the patient’s medical record.
(3) The treatment of an ectopic pregnancy is not an abortion and shall not be reported pursuant to Rule 59A-9.034. The treating physician shall document the treatment in the patient’s medical record.
(4) The treatment of a trophoblastic tumor is not an abortion and shall not be reported pursuant to Rule 59A-9.034. The treating physician shall document the treatment in the patient’s medical record.
In addition to clarifying these treatment procedures provided within a hospital setting, the Agency released Emergency Rule 59AER24-2, F.A.C., amending Rule 59A-9.034, F.A.C., in relation to monthly reporting for abortion clinics and other facilities.
Rule 59AER24-2 (59A-9.034), F.A.C., Reports, reads as follows:
(1) Pursuant to Section 390.0112, F.S., an abortion clinic and any medical facility in which abortions are performed, including a physician’s office, must submit a report each month to the Agency, regardless of the number of terminations of pregnancy abortions, and regardless of method used. Monthly reports must be received by the Agency within 30 days following the preceding month. Failure to submit this report so that it is timely received by the Agency will result in an administrative fine being imposed pursuant to Section 390.0112, F.S.
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(3) Each clinic shall maintain a log of all terminations of pregnancy abortions, recording the date of the procedure and period of gestation.
(4) When a physician attempts to induce the live birth of an unborn baby, regardless of gestational age, to treat the premature rupture of membranes, and the unborn baby does not survive, the incident does not constitute an abortion and shall not be reported pursuant to this rule.
(5) The treatment of an ectopic pregnancy shall not be considered an abortion and shall not be reported pursuant to this rule.
(6) The treatment of a trophoblastic tumor shall not be considered an abortion and shall not be reported pursuant to this rule.
The FMA will continue to monitor the impact of SB 300 (2023) and provide information to our members to ensure compliance with applicable laws and rules.
Facial Coverings
In another matter related to 2023 legislation, the Agency held a rule hearing on May 7 to gather public comment on
Proposed Rule 59A-35.125, F.A.C, Standards for the Appropriate Use of Facial Coverings for Infection Control. A priority of the Governor, the Legislature passed SB 252 (2023) to expand protections against various COVID-19 mandates and discrimination. One of those mandates included facial covering requirements for healthcare practitioners.
Section 408.824, F.S., prohibits healthcare practitioners from requiring any person, including patients and employees, to wear a facial covering unless the requirement conforms with standards developed by the Agency for Health Care Administration and Department of Health. If a healthcare practitioner requires any person to wear a mask for any reason, the practitioner must also establish a written masking policy that is posted on their website or prominently in the lobby.
Concerns raised at the rule hearing were primarily geared toward the breadth of opt-out provisions and the risk of allowing unmasked visitors in common areas of certain units where vulnerable patients with compromised immune systems may be inpatient for weeks or months at a time. The FMA will continue to monitor whether the Agency incorporates any of the provided suggestions and share that information once finalized.