The US Department of Health and Human Services (HHS) has advised health care providers to revise treatment protocols for pediatric gender dysphoria following publication of a May 1, 2025, evidence review. The review identified “weak evidence and growing international retreat” from medical interventions including puberty blockers, cross-sex hormones, and surgeries for minors and documented a “risk of significant harm” associated with such treatments.
In a May 28, 2025, letter distributed via electronic mail to health care providers, health care risk managers, and state medical boards, HHS referenced its publication Treatment for Pediatric Gender Dysphoria: Review of Evidence and Best Practices and called for immediate protocol modifications based on the review’s findings regarding intervention risks and limited efficacy data.
Evidence Review Findings
The HHS review documented what the agency characterized as a “risk of significant harm” associated with current treatment approaches. According to the letter, the review explains that “many treatments (e.g., surgery, hormone therapy) can lead to relatively common and potentially serious long-term adverse effects.”
The department’s analysis included a “methodologically rigorous assessment of evidence underpinning the use of surgical or endocrine interventions, including puberty blockers and cross-sex hormones, within the so-called ‘gender-affirming’ model of care,” while incorporating international practice evaluations, including the United Kingdom’s Cass Review published in April 2024.
HHS documented “serious concerns regarding the lack of reliable evidence of benefits and risks of significant harms for this model of care that have mounted in recent years.” The review included an “umbrella review” of systematic reviews, which found that “the overall quality of evidence concerning the effects of these interventions on psychological outcomes, quality of life, regret, or long-term health, is very low.” HHS emphasized risks such as “infertility/sterility, sexual dysfunction, impaired bone density accrual, adverse cognitive impacts, cardiovascular disease and metabolic disorders, psychiatric disorders, surgical complications, and regret.”
The review highlighted psychotherapy as a recommended alternative approach, noting that Sweden’s national health authority has advised that “psychosocial support that helps adolescents deal with natal puberty without medication needs to be the first option when choosing care measures.”
International Guidelines Criticized
The HHS letter advised providers to “avoid relying on” the World Professional Association for Transgender Health’s Standards of Care for the Health of Transgender and Gender Diverse People, Version 8 (SOC-8). According to the review, “the creation of SOC-8 was fraudulent and marked ‘a clear departure from the principles of unbiased, evidence-driven clinical guideline development.’” HHS stated that WPATH “suppressed systematic reviews of evidence, failed to manage conflicts of interest, and relied on legal and political considerations rather than clinical ones.”
The letter noted that “a recent systematic review of international guideline quality did not recommend either the WPATH or the Endocrine Society guidelines for clinical use after determining they ‘lack developmental rigour and transparency.’” The review concluded that guidelines based on the so-called “gender-affirming” model of care “should not be relied upon to harm children any further.”
Risk Management Implications
Addressing health care risk managers, the letter underscored providers’ “obligation to avoid serious harm” and emphasized that HHS “expects you promptly to make the necessary updates to your treatment protocols and training for care for children and adolescents with gender dysphoria to protect them from these harmful interventions.”
HHS reiterated guidance issued by the Centers for Medicare and Medicaid Services in a March 5, 2025, Quality & Safety Special Alert, which stated that “it is of utmost importance that all providers follow the highest standards of care and adhere closely to the foundational principles of medicine, especially as it comes to America’s children.”
International Context
The HHS position aligns with recent policy shifts in European countries. Sweden, Finland, and England have “sharply restricted” access to medical interventions for minors with gender dysphoria. The letter noted that these restrictions followed assessments by public health authorities concluding that “the risks outweighed the benefits.”
The review cited findings from the Cass Review, which conducted an independent assessment of gender identity services for children and young people in the United Kingdom and contributed to the international evidence base cited by HHS in its recommendations.
Clinical Implications
For practicing physicians, the HHS guidance reflects a shift away from medical interventions toward psychological support as first-line treatment for pediatric patients presenting with gender dysphoria. The letter emphasized that “when medical interventions pose unnecessary, disproportionate risks of harm, health care providers should refuse to offer them even when they are preferred, requested, or demanded by patients.”
The review reaffirmed the foundational medical commitment to “first, do no harm,” stating that “the evidence for benefit of pediatric medical transition is very uncertain, while the evidence for harm is less uncertain.”
Health care institutions and individual practitioners are advised to review current treatment protocols and implement modifications consistent with HHS recommendations.
Whistleblower Protections
To support oversight and accountability, HHS has launched a portal for reporting harmful interventions involving minors, including concerns about waste, fraud, and abuse in HHS-funded programs. The portal is available at www.hhs.gov/protect-kids. HHS stated it is committed to protecting whistleblowers and may take new policy actions to hold providers accountable.
Source: HHS Social Media
