Current through Reg. 50, No. 187; September 24, 2024
The standards of practice in this rule do not supersede the
level of care, skill, and treatment recognized in general law related to
healthcare licensure.
(1) Pursuant to
Section 456.52, Florida Statutes,
sex-reassignment prescriptions and procedures are prohibited for patients
younger than 18 years of age, except that a physician may continue to treat
such patient with a prescription if such treatment for sex-reassignment was
commenced before, and is still active on, May 17, 2023. The physician is
required to obtain voluntary, informed consent while physically present in the
same room as the patient. Consent is not required for renewal of such
prescriptions if a physician and his or her patient have met the requirements
for consent for the initial prescription or renewal; however, a separate
consent is required for any new prescription for a pharmaceutical product not
previously prescribed to the patient.
(2) Informed Consent. The Board has approved
the following mandatory informed consent forms for the continued treatment of
minors with sex-reassignment prescriptions:
(a) For patients prescribed puberty blocking
medications, form DH5079-MQA, (06/23), entitled "Puberty Suppression Treatment
for Patients with Gender Dysphoria, Patient Information and Informed Parental
Consent and Assent for Minors," which is hereby incorporated by reference and
available from the Board's website at
https://flboardofmedicine.gov/forms/Puberty-Suppression-Treatment-for-Patients-with-Gender-Dysphoria-Patient-Information-and-Parental-Consent-and-Assent-for-Minors.pdf.
(b) For patients prescribed sex-reassignment
feminizing medications, form DH5080-MQA, (06/23), entitled "Feminizing
Medications for Patients with Gender Dysphoria, Patient Information and
Informed Parental Consent and Assent for Minors," which is hereby incorporated
by reference and available from the Board's website at
https://flboardofmedicine.gov/forms/Feminizing-Medications-for-Patients-with-Gender-Dysphoria-Patient-Information-and-Parental-Consent-and-Assent-for-Minors.pdf.
(c) For patients prescribed sex-reassignment
masculinizing medications, form DH5081-MQA, (06/23), entitled "Masculinizing
Medications for Patients with Gender Dysphoria, Patient Information and
Informed Parental Consent and Assent for Minors," which is hereby incorporated
by reference and available from the Board's website at
https://flboardofmedicine.gov/forms/Masculinizing-Medications-for-Patients-with-Gender-Dysphoria-Patient-Information-and-Parental-Consent-and-Assent-for-Minors.pdf.
(3) A Board-approved informed
consent form is not executed until:
(a) The
physician issuing the prescription, while physically present in the same room
as the patient, has informed the patient and the patient's parent or legal
guardian of the nature and risks of the prescription, and has provided and
received the written acknowledgement of the patient and the patient's legal
guardian before the prescription is prescribed or administered. The physician
is prohibited from delegating this responsibility to another person. The
physician is also required to sign the informed consent form.
(b) The patient's parent or legal guardian is
required to sign the informed consent form.
(c) The patient is required to assent to the
informed consent form.
(d) A
competent witness is also required to sign the informed consent form.
(4) Standards of Practice. The
nature and extent of the requirements set forth below will vary depending on
the practice setting and circumstances presented to the prescribing physician.
A prescribing physician who continues to treat a minor patient with
sex-reassignment prescriptions pursuant to section
456.52(1)(a),
Florida Statutes, shall comply with the following:
(a) Patient Evaluation. An in-person thorough
medical history and physical examination of the patient conducted by the
physician must be documented in the patient's medical record prior to
prescribing any new sex-reassignment prescription.
(b) Clinical Determinations. Based on the
patient evaluation, the following must be confirmed:
1. The patient has met the criteria for
gender dysphoria in the current Diagnostic and Statistical Manual of Mental
Disorders (DSM) or International Classification of Diseases (ICD);
2. The patient has pubertal changes resulting
in an increase in gender dysphoria;
3. The patient does not suffer from a
psychiatric comorbidity that interferes with the diagnostic work-up or
treatment;
4. The patient will have
psychological and social support during treatment;
5. The patient has experienced puberty to at
least Tanner Stage 2; and
6. The
patient demonstrates knowledge and understanding of the risks, benefits, and
expected outcomes of puberty suppression, future cross-sex hormone treatment,
as well as the medical and social risks and benefits of sex reassignment
surgery based on the patient's current treatment status.
(c) Patient Visit. The physician or their
designated covering physician must meet with the patient in-person every six
(6) months for the purpose of monitoring the patient and must document each
visit in the patient's medical records.
(d) Suicide Risk Assessment. A suicide risk
assessment by a licensed mental health care professional must be performed
every three (3) months.
(e)
Laboratory Testing. Relevant laboratory testing must be performed every four
(4) months.
(f) X-rays. X-rays of
the hand must be performed each year to monitor and document the patient's bone
age progression.
(g) Bone Density
Scan. An annual bone density (DEXA) scan must be performed to monitor the
patient's bone density during treatment.
(h) Mental Health Assessment. The physician
must have the patient undergo an annual mental health assessment to be
performed by a board-certified Florida licensed psychiatrist or
psychologist.
(i) Counseling. The
physician must refer the patient for counseling with a licensed mental health
care professional during the treatment period, with a frequency as recommended
by the licensed mental health care professional.
(j) Additional Consultations. The physician
must refer the patient as necessary for additional evaluation and treatment in
order to achieve treatment objectives.
Rulemaking Authority
456.52 FS. Law Implemented
456.52
FS.
