Special thanks to summer associate Sheridan Organ for her contributions to this article.
On May 4, 2023, the Florida Senate passed SB 254 by a sweeping vote of 83 to 23. This law, which imposes restrictions on gender-affirming care in Florida, took effect immediately upon Governor Ron DeSantis signing on May 17, 2023. Please see our previous blog for a discussion of the statute.
Since May, the joint committee of the Board of Medicine and Board of Osteopathic Medicine (the Committee) has met several times to implement the law by developing and publishing emergency rules and informed consent forms. The most recent iteration of the emergency rules and informed consent forms were published by the Committee on August 22, 2023 for adults and July 5, 2023 for minors. As discussed below, the August 22, 2023 update removed the requirement for patients over the age of 18 to undergo a psychological evaluation from the informed consent forms for hormone replacement therapy (HRT).
Both payors and providers must understand the current requirements in Florida: (1) to ensure that no one is providing or paying for a prohibited items or services; and (2) to work together to find solutions for their patients and members who may experience a disruption in care during the implementation of the new law.
Emergency Rules
The statute requires the use of informed consent forms that the Committee had yet to issue. As a result, the Committee passed an emergency rule on June 2 allowing the renewal of previous prescriptions while the Committee finalized the consent form. Notably under the June 2 emergency rule, prescriptions could be renewed without using the informed consent forms for up to six months after the informed consent forms were issued. The Committee held several meetings to discuss and finalize the emergency rules and informed consent forms for both minors and adults. Subsequent emergency rules and the lengthy informed consent forms were issued on July 5, 2023, and again on August 22, 2023. The most recent iteration of the emergency rules merely updated the hyperlinks to the revised informed consent forms for adults.
Informed Consent Forms
In creating the informed consent forms, the Committee added in various requirements for issuing prescriptions to minors. These requirements include: x-rays of the hand each year to monitor and document the patient’s bone age progression, an annual bone density scan, and an annual mental health assessment by a Florida licensed psychiatrist or psychologist.
The Committee also added a requirement into the adult informed consent forms. Specifically, the original informed consent forms required a psychological assessment and supporting letter from a Florida-licensed psychiatrist or psychologist prior to beginning HRT and every two years thereafter.
After issuing emergency rules and informed consent forms, the Committee received notice from the Joint Administrative Procedures Committee (JAPC). JAPC is a joint standing committee of the Florida Legislature that is tasked with ensuring agency rules do not exceed the statutory authority upon which they are based. In its notice, JAPC stated that it suspected the Committee exceeded its authority in promulgating the above-mentioned practice standards for adults. JAPC explained that the statue only authorized the Board of Medicine and Board of Osteopathic Medicine to promulgate practice standards for gender affirming care provided to minors. During the last Committee meeting on August 3, the Committee acknowledged the notice and voted to remove the language requiring a visit with a psychologist or psychiatrist from informed consent process for adults. This was subsequently reflected in revised forms published on August 22, 2023. However, the Committee simultaneously noted that the requirement to see a psychologist or psychiatrist is consistent with the general standard of care for adult patients seeking gender affirming care.
Court Challenges
In addition to regulatory activity, this law has been challenged in a variety of different ways in court. In a recent lawsuit, Dekker v. Weida, 2023 WL 4102243 (N.D. Fla. 2023), Judge Robert Hinkle ruled that Florida’s prohibition on Medicaid coverage for treatment of gender dysphoria for transgender Floridians is unlawful and stated that the “State of Florida’s decision to ban payment for GnRH agonists and cross-sex hormones for transgender individuals is not rationally related to a legitimate state interest.” This final ruling ended a ban on using Medicaid funds that began in August 2022 and nullified the section of SB 254 that banned Medicaid coverage of gender-affirming care.
In addition to Dekker, another lawsuit, Doe v. Ladapo, 2023 WL 3833848 (N.D. Fla 2023), challenged the ban on puberty blocking prescriptions for minors. The court issued a preliminary injunction preventing the enforcement of Florida’s ban on minors being able to access puberty-blocking hormones. Specifically, the Court found that the minors risked irreparable injury through the “the unwanted and irreversible onset and progression of puberty in their natal sex” if the injunction was not issued. The complaint was later amended to include adults as plaintiffs and to seek class-wide relief for all trans minors and adults affected by the law. This case is ongoing and a hearing was recently scheduled related to the motion to certify a class on August 29.
Court challenges against SB254, including Doe v. Ladapo, will continue and impact the full scope and effect of this law on Floridians.
Looking Forward
In the last Committee meeting on August 3, the Committee assigned members from both the Medical Board and Osteopathic Board to consider ways the emergency rules should be updated when formulating the final, permanent rules. The Committee announced that it will solicit public comments on these permanent rules. The Committee set a tentative goal date for end of year to the issue the final rules.
Payor/Provider Convergence Blog Series
For additional resources on the intersection of payor/provider convergence and the issues that plague insurance and health companies, payors, and providers, click here to read the other articles in our series.
Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, our Payor/Provider Convergence Area of Focus, or to our Health Care Practice Group with any questions.
