PURPOSE: The attorney general administers and enforces the provisions of the Merchandising Practices Act, Chapter 407, RSMo. The attorney general may make rules necessary to the administration and enforcement of the provisions of Chapter 407, RSMo, and, in order to provide notice to the public, may specify the meaning of terms whether or not used in the Act. This rule specifies the meanings of certain terms used in the enforcement of the Act and provides notice to the public of their application. This rule does not contain an exhaustive list of practices that violate the Act. Instead, this rule identifies certain specific practices that violate section 407.020, RSMo.
EMERGENCY STATEMENT: Individuals of any age experiencing gender dysphoria or related conditions should be able to and are able to obtain care in Missouri. Often this care takes the form of psychotherapy, also known as talk therapy, rather than any chemical or surgical intervention. As the World Professional Association for Transgender Health has previously put it, this therapy often involves exploring the many influences on a person's gender identity, including "peer and other social relationships," and ensuring that "gender dysphoria is not secondary to, or better accounted for, by other diagnoses." WPATH, which describes itself as an organization "committed to advocacy" for certain "changes in public policies," has been criticized as an organization far too quick to recommend chemical or surgical intervention. Even still, the organization has "highly recommended" psychotherapy because psychotherapy can "greatly facilitate the resolution of gender dysphoria" and because, through this therapy, many "individuals integrate their trans- or cross-gender feelings into the gender role they were assigned at birth and do not feel the need to feminize or masculinize their body."
But in recent years, the use of other forms of interventions, often without any talk therapy at all, has accelerated exponentially. These include life-altering pubertal suppression, cross-sex hormone therapy, and gender transition surgery-all of which pose very serious side effects.
Many medical organizations have determined that these interventions-as currently practiced-lack solid evidentiary support. For example, Sweden's National Board of Health and Welfare recently declared that there is a "lack of reliable scientific evidence concerning the efficacy and the safety" of pubertal suppression and cross-sex hormone therapy and that "the risks" of these interventions "currently outweigh the possible benefits." Similarly, the U.S. Agency for Healthcare Research and Quality recently determined that "here is a lack of current evidence-based guidance for the care of children and adolescents who identify as transgender, particularly regarding the benefits and harms of pubertal suppression, medical affirmation with hormone therapy, and surgical affirmation." And Finland has openly declared these interventions to be "an experimental practice." Because these gender transition interventions lack a solid evidentiary foundation and pose very serious side effects, they are unlawful under Missouri law absent sufficiently protective guardrails.
Part of the reason for the growing awareness of the lack of solid evidence is that many clinics have adopted practices that deviate substantially from the studies on which they say they rely. For example, although many clinics say that they rely on two Dutch studies to justify their practices, participants in those studies all received psychotherapy, and the studies excluded individuals with mental health comorbidities. Despite these and other limitations of the Dutch studies, some clinics have begun offering interventions to persons who would have been excluded from the Dutch protocol-such as persons experiencing significant mental health comorbidities-all without a comprehensive individualized assessment and often without any therapy at all directed at the patient's comorbidities. Even WPATH acknowledges the problem. Although WPATH is "committed to advocacy" of the "least restrictive" policies and "hope that future research will explore the effectiveness of this model," it admits that "here are no studies of the long-term outcomes of gender-related medical treatments for youth who have not undergone a comprehensive assessment."
This emergency rule is necessary to protect the public health, safety, and welfare, and also to protect a compelling governmental interest as the attorney general is charged with protecting consumers, including minors, from harm and investigating fraud and abuse in the state's health care payment system. Among other reasons, the recent immense increase in the use of these life-altering interventions, which have serious side effects, as well as the recent acknowledgment that these interventions are used in circumstances not supported by solid evidence, makes this issue time sensitive. Further, and independently, a whistle blower has issued a sworn affidavit, alleging that a prominent provider of these interventions in Missouri is systemically failing to comply with the medical standard of care, and an investigation has revealed that some providers in Missouri prescribe gender transition interventions without any individualized assessment, contrary to safeguards established in scientific literature and by medical organizations.
As a result, the attorney general finds that this emergency action is needed because of a compelling governmental interest and a need to protect the public health, safety, and welfare. The scope of this emergency rule is limited to the circumstances creating the emergency and complies with the protections extended in the Missouri and United States Constitutions. The Attorney General believes this emergency rule is fair to all interested persons and parties under the circumstances. This emergency rule was filed April 13, 2023, becomes effective April 27, 2023, and expires February 6, 2024.
(1) "Covered Gender Transition Intervention" or "Intervention" means the provision or prescription of any puberty-blocking drugs, cross-sex hormones, or surgery, for the purpose of transitioning gender, decreasing gender incongruence, or treating gender dysphoria, and does not include:(A) Treatment for a genetically or biochemically verifiable disorder of sex development such as 46, XX DSD; 46, XY DSD; sex chromosome DSDs; XX or XY sex reversal; or Ovotesticular disorder;(B) Treatment for precocious puberty; or(C) For subparagraphs (2)(C)-(K), continuing prescription or provision of a specific intervention that has already begun, so long as the person or health organization promptly seeks to initiate the treatments and assessments called for by these subparagraphs.(2) It is an unfair, deceptive, fraudulent, or otherwise unlawful practice for any person or health organization to provide a covered gender transition intervention to a patient (or refer a patient for such an intervention) if the person or health organization: (A) Fails to assess (at least annually) whether the patient continues to have gender dysphoria;(B) Fails to obtain informed consent by disclosing conspicuously-on its website, physically in writing, and orally in person by the prescribing provider-to the patient and (if the patient is a minor) to the patient's parents or legal guardians, by means of information that includes language materially identical to each point below, that: 1. The use of puberty blocker drugs or cross-sex hormones to treat gender dysphoria has been described as experimental by researchers and is not approved by the Food and Drug Administration (FDA);2. The use of puberty blocker drugs or cross-sex hormones to treat gender dysphoria has been recognized by medical authorities in Europe, after independent reviews, to be experimental or lacking sufficient evidence and has been substantially restricted in countries such as Sweden, Finland, Norway, and the United Kingdom;3. The U.S. Agency for Healthcare Research and Quality has determined, "There is a lack of current evidence-based guidance for the care of children and adolescents who identify as transgender, particularly regarding the benefits and harms of pubertal suppression, medical affirmation with hormone therapy, and surgical affirmation";4. A study spanning five (5) decades of almost five thousand (5,000) transgender people who had received crosssex hormones, regardless of treatment type, nevertheless showed a "two-fold increased mortality risk," which "did not decrease over time";5. An article in the International Review of Psychiatry found that, according to ten different studies, the vast majority of children, 85.2%, experiencing gender dysphoria grew to become comfortable with their natal sex, and the Endocrine Society found that "the large majority (about 85%) of prepubertal children with a childhood diagnosis did not remain GD/gender incongruent in adolescence";6. A scientific article in the Journal of Infant, Child, and Adolescent Psychotherapy concluded that "encouraging mastectomy, ovariectomy, uterine extirpation, penile disablement, tracheal shave, the prescription of hormones which are out of line with the genetic make-up of the child, or puberty blockers, are all clinical practices which run an unacceptably high risk of doing harm";7. Sweden's National Board of Health and Welfare ("NBHW") recently declared that, at least for minors, "the risks of puberty suppressing treatment with GnRH-analogues and gender-affirming hormonal treatment currently outweigh the possible benefits";8. A systematic review of the evidence by researchers in Europe regarding natal boys concluded that there is "insufficient evidence to determine the efficacy or safety of hormonal treatment" and that certain hormonal interventions can potentially cause or worsen depression;9. One scientific study noted that an individual whose friend identifies as transgender is "more than 70 times" as likely to similarly identify as transgender, suggesting that many individuals may "incorrectly believe themselves to be transgender and in need of transition" because of social factors";10. A follow-up study recently determined, "Youths with a history of mental health issues were especially likely to have taken steps to socially and medically transition";11. A study of one thousand six hundred fifty-five (1,655) parental reports found that "parents tended to rate their children as worse off after transition" and "that parents believed gender clinicians and clinics pressured the families toward transition";12. The FDA has issued a warning that puberty blockers can lead to brain swelling and blindness;13. Puberty is associated with profound developmental maturation of the brain, and researchers have expressed concern that interruption of normally timed puberty may therefore be harmful to the brain;14. Multiple observational studies conclude that nearly all children prescribed puberty blockers for gender dysphoria have later been prescribed cross-sex hormones. For example, an independent review of gender transition interventions based on data from multiple countries determined that "almost all children and young people who are put on puberty blockers go on to sex hormone treatment";15. After performing a systematic review, the Endocrine Society was unable to draw any conclusions on whether hormone therapy reduces death by suicide among individuals identifying as transgender;16. A summary of available evidence written by medical societies "from around the globe" found that "there are no proven methods to preserve fertility in early pubertal transgender adolescents";17. Researchers have suggested that allowing a child to go through puberty without medical intervention may resolve gender dysphoria, whereas puberty suppression may improperly influence and worsen gender dysphoria;18. Puberty suppression presents a risk of stunted growth and failure to attain normal peak bone density;19. There is a lack of understanding in the medical community of the causes of gender dysphoria, as well as an admission that more research is needed to fully understand the effects, especially long-term effects, of puberty suppression and cross-sex hormone treatment;20. A significant number of children and adolescents who begin gender transition interventions desist in their desire to transition, although the actual number is unknown because of low rates of follow up;21. The Endocrine Society has acknowledged that children experiencing gender dysphoria are more likely to identify with their natal sex if they do not socially transition;22. The World Professional Association for Transgender Health ("WPATH") has acknowledged, "In most children, gender dysphoria will disappear before, or early in, puberty"; and23. Many medical, hormonal, or surgical transition interventions are irreversible.(C) Fails to ensure that, for at least the 3 most recent consecutive years, the patient has exhibited a medically documented, long-lasting, persistent and intense pattern of gender dysphoria;(D) Fails to ensure that the patient has received a full psychological or psychiatric assessment, consisting of not fewer than 15 separate, hourly sessions (at least ten (10) of which must be with the same therapist) over the course of not fewer than 18 months to explore the developmental influences on the patient's current gender identity and to determine, among other things, whether the person has any mental health comorbidities;(E) Fails to ensure that any psychiatric symptoms from existing mental health comorbidities of the patient have been treated and resolved;(F) Fails to ensure that the patient has received a comprehensive screening to determine whether the patient has autism;(G) Fails, with respect to a patient who is a minor, to ensure that the patient has received a comprehensive screening (at least annually) for social media addiction or compulsion and has not, for at least the six months prior to beginning any intervention, suffered from social media addiction or compulsion;(H) Fails to ensure (at least annually) that the patient is not experiencing social contagion with respect to the patient's gender identity;(I) Fails to adopt and follow a procedure to track all adverse effects (both expected and unexpected) that arise from any course of covered gender transition intervention for all patients beginning the first day of intervention and continuing for a period of not fewer than fifteen (15) years;(J) Fails to maintain data about adverse effects in a form that can be accessed readily for systematic study; or(K) Fails to obtain and keep on file informed written consent from the patient and (if the patient is a minor) from all parents or guardians who have authority to consent to medical intervention, as to each requirement of this section. Such written consent shall be obtained for each intervention after the disclosures required by subsection (2)(B) and renewed not less than quarterly for the first three (3) years of such intervention (or until the age of majority for a patient less than fifteen (15) years old when such intervention begins), and not less than twice a year thereafter.(3) Any person or health organization providing a covered gender transition intervention to a patient (or referring a patient for such an intervention) shall document and retain in such patient's records a detailed description of compliance with the provisions of section (2).(4) If any application of any provision, word, or clause to any person or circumstances is found by a court to be invalid, that application alone shall be severed and the remaining possible applications of every provision, word, and clause to all other persons and circumstances shall remain in force.Adopted by Missouri Register May 15, 2023/Volume 48, Number 10, effective 4/27/2023