Fla. Admin. Code R. 64B15ER23-9

Current through Reg. 50, No. 235-239, December 10, 2024

Section 64B15ER23-9 - Sex-reassignment Standards of Practice in Minors

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.

Fla. Admin. Code Ann. R. 64B15ER23-9

Rulemaking Authority 456.52 FS. Law Implemented 456.52 FS.

Adopted by Florida Register Volume 49, Number 133, July 11, 2023 effective 7/5/2023 (EMERGENCY).