Medicaid Program; Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children

Over the past decade, increasing numbers of children and adolescents have been diagnosed with gender dysphoria. In light of this trend, in November 2025, the Office of Population Affairs (OPA) within the Department of Health and Human Services undertook a review of evidence and best practices regarding medical treatment for gender dysphoria (hereinafter “the HHS Review”). OPA advances “adolescent health and wellbeing by supporting high-quality clinical services, evidence-based and innovative programs, rigorous research and evaluation and the engagement of communities and partners to inform

policy.” \4\ This review sought to provide the most accurate and current information available regarding the evidence base for the treatment of gender dysphoria, the state of the relevant medical field in the United States, and relevant ethical considerations.\5\ This HHS Review was intended to serve as an objective umbrella review of the current status of the literature; \6\ although similar reviews had been undertaken in other countries, HHS wanted to conduct a survey relevant within the United States, while being informed by research conducted in other countries. As discussed below, for example, the most influential international effort to date has been the United Kingdom's Cass Review--a 4-year independent evaluation of pediatric gender medicine that was published in April 2024. In many respects, the Cass Review identified many of the same issues and concerns that are highlighted in the HHS Review.

\4\ See United States Department of Health and Human Services, Office of Population Affairs, available at https://opa.hhs.gov/about/mission (describing OPA Mission).

\5\ Department of Health and Human Services, “Treatment for Pediatric Gender Dysphoria Review of Evidence and Best Practices,” (November 19, 2025): 10-11, https://opa.hhs.gov/sites/default/files/2025-11/gender-dysphoria-report.pdf [hereinafter “HHS Review”].

\6\ An “umbrella review” has been defined as a high-level research synthesis that evaluates and compiles findings from multiple sources on a shared topic. Umbrella reviews are among the highest levels of evidence currently available in medicine. See Paolo Fusar-Poli and Joaquim Radua, “Ten simple rules for conducting umbrella reviews,” Evidence-Based Mental Health 21, no. 3 (2018): 95-100, doi:10.1136/ebmental-2018-300014.

In developing this rule, we relied on the research identified in the HHS Review, the Cass Review, and multiple other research initiatives on the current state of medicine in this field. As the agency charged with administering the Medicaid and CHIP programs, which together provide comprehensive health insurance coverage to 35.5 million children in the United States, CMS has a responsibility to ensure that our State partners are complying with their obligations under the program, including sections 1902(a)(19), 1902(a)(30)(A), 2101(a) and 2102(a)(7)(A) of the Act. The HHS Review and the Cass Review, as well as other research initiatives cited in this rule, helped to inform us of the current state of medicine to assist us in developing standards for our State partners.

In the United Kingdom, the recorded prevalence of gender dysphoria/ incongruence increased substantially in children and young people between 2011 and 2021, particularly in recorded females. “Levels of anxiety, depression and self-harm were high, indicating an urgent need for better prevention and treatment of mental health difficulties in these patients” with gender dysphoria.\7\

\7\ Stuart William Jarvis et al., “Epidemiology of gender dysphoria and gender incongruence in children and young people attending primary care practices in England: retrospective cohort study,” Archives of Disease in Childhood 110 (2025): 612, doi:10.1136/archdischild-2024-327992.

Similar research in Germany showed increasing rates in the diagnosis of gender incongruence.\8\ Additionally, research in England explained that “[r]ecent increases in incidence of gender dysphoria/ incongruence have a range of potential explanations, including social factors . . .; increasing rates of emotional distress and poor mental health in this age group, particularly for females; and changes in supply and delivery of healthcare.” \9\ The number of children receiving medical interventions for gender dysphoria rose significantly following the publication of the “Dutch Protocol” in an article in the European Journal of Endocrinology in 2006.\10\

\8\ Christian J. Bachmann et al., “Gender identity disorders among young people in Germany: Prevalence and trends, 2013-2022. An analysis of nationwide routine insurance data,” Deutsches [Auml]rzteblatt International 121 (2024): 370-371, doi:10.3238/ arztebl.m2024.0098. “Gender incongruence” as defined by ICD-11 is “characterized by a marked and persistent incongruence between an individual's experienced gender and the assigned sex.” See “International Classification of Diseases 11th Revision (ICD-11),” World Health Organization, accessed September 9, 2025, https://icd.who.int/en/.

\9\ Jarvis et al., “Epidemiology of gender dysphoria,” 619.

\10\ HHS Review, 59. See Henriette A. Delemarre-van de Waal and Peggy T. Cohen-Kettenis, “Clinical management of gender identity disorder in adolescents: A protocol on psychological and pediatric endocrinology aspects,” European Journal of Endocrinology 155, Supp 1 (2006): S131-S137, https://doi.org/10.1530/eje.1.02231.

Over the past decade, increasing numbers of children have received diagnoses of gender dysphoria and received sex-rejecting procedures as recommended by the World Professional Association for Transgender Health (WPATH) and the Endocrine Society (ES).11 12 The WPATH Standards of Care for the Health of Transgender and Gender Diverse People, Version 8 (SOC-8) noted that the creation of a chapter on adolescents was due in part to the “exponential growth in adolescent referral rates.” \13\ Surveys measuring “transgender” identity find prevalence of 1.2 percent among adolescents and “gender diverse” identities as high as 8.4 percent.\14\ WPATH also noted that female adolescents were seeking such procedures at twice to seven times the rate of males.\15\

\11\ E. Coleman et al., “Standards of Care for the Health of Transgender and Gender Diverse People, Version 8,” International Journal of Transgender Health 23, Supp 1 (2022): S1-S258, https://doi.org/10.1080/26895269.2022.2100644.

\12\ Wylie C. Hembree et al., “Endocrine Treatment of Gender- Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline,” The Journal of Clinical Endocrinology & Metabolism 102, no. 11 (2017): 3869-3903, https://doi.org/10.1210/jc.2017-01658.

\13\ E. Coleman et al., “Standards of Care,” S43.

\14\ E. Coleman et al., “Standards of Care,” S25, S43.

\15\ E. Coleman et al., “Standards of Care,” S43.

Included in SOC-8 is the recommendation that care providers “undertake a comprehensive biopsychosocial assessment of adolescents” who seek medical transition \16\ and “involve relevant disciplines, including mental health and medical professionals,” as well as parents, “unless their involvement is determined to be harmful.” \17\

\16\ Medical transition refers to the provision of hormonal or surgical interventions, as adapted from the HHS Review, 29.

\17\ Jennifer Block, “US transgender health guidelines leave age of treatment initiation open to clinical judgment,” BMJ 378 (2022), https://doi.org/10.1136/bmj.o2303. See also E. Coleman et al., “Standards of Care,” S50, S56, S58.

In recent years, “the U.S.--characterized by its decentralized and privatized healthcare system--saw the emergence of many new specialty gender clinics, along with a proliferation of independently practicing clinicians. According to a recent conservative estimate, as of March 2023 there were 271 clinics offering [pediatric medical transition] in the U.S., though 70 were inactive due to legislative restrictions.” \18\

\18\ HHS Review, 57-58. See Luca Borah et al., “State restrictions and geographic access to gender-affirming care for transgender youth,” JAMA 330, no. 4 (2023): 375-378, doi:10.1001/ jama.2023.11299.

An approach for gender dysphoria treatment, referred to in this final rule as sex-rejecting procedures,\19\ can involve the use of puberty-suppressing drugs to prevent the onset of puberty; cross-sex hormones to spur the secondary sex characteristics of the opposite sex; and surgeries including mastectomy and (in rare cases) vaginoplasty. “Over the past decade . . . [t]housands of American children and adolescents have received these interventions.” \20\

\19\ In this final rule, we have sought to use the term “sex- rejecting procedures” to refer to the set of procedures encompassed in the definition for that term.

\20\ HHS Review, 9.

A study published in 2023 estimated that between 2016 and 2020, nearly 3,700 children between the ages of 12 and 18 diagnosed with gender dysphoria underwent surgical

procedures, including over 3,200 children who had breast or chest surgery, and over 400 children who had genital surgery.\21\ Another analysis found that between 2017 and 2021, more than 120,000 children ages 6 to 17 were diagnosed with gender dysphoria and, of that group, more than 4,700 started taking puberty blockers and more than 14,000 started hormonal therapy.\22\ However, as discussed later in this final rule, current medical evidence does not support a favorable risk/ benefit profile for the use of chemical or surgical procedures in children to treat gender dysphoria.

\21\ Jason D. Wright et al., “National Estimates of Gender- Affirming Surgery in the US,” Jama Network Open 6, no. 8 (2023), doi:10.1001/jamanetworkopen.2023.30348.

\22\ Robin Respaut and Chad Terhune, “Putting numbers on the rise in children seeking gender care,” Reuters, October 6, 2022, https://www.reuters.com/investigates/special-report/usa-transyouth-data/.

The existing guidelines to support the care of children and adolescents experiencing gender dysphoria around the world vary in their methodological rigor and quality.

As mentioned above, on May 1, 2025, the HHS released the HHS Review, which is a comprehensive review of the evidence and best practices for promoting the health of children and adolescents diagnosed with gender dysphoria.\23\ On November 19, 2025, HHS published a final version of the HHS review following conclusion of the peer review process.\24\ Specifically, the HHS Review conducted an overview of systematic reviews--also known as an “umbrella review”-- to evaluate the evidence regarding the benefits and harms of hormonal and surgical interventions for children and adolescents diagnosed with gender dysphoria. Existing systematic reviews of evidence, including several that have informed health authorities in Europe, were assessed for methodological quality.

\23\ “HHS Releases Comprehensive Review of Medical Interventions for Children and Adolescents with Gender Dysphoria,” U.S. Department of Health and Human Services, released May 1, 2025, https://www.hhs.gov/press-room/gender-dysphoria-report-release.html.

\24\ HHS Review, 1. “HHS Releases Peer-Reviewed Report Discrediting Pediatric Sex-Rejecting Procedures,” U.S. Department of Health and Human Services, released November 19, 2025, https://www.hhs.gov/press-room/hhs-releases-peer-reviewed-report-discrediting-pediatric-sex-rejecting-procedures.html.

The HHS Review, informed by an evidence-based medicine approach, indicated serious concerns about outcomes associated with certain medical interventions, such as puberty blockers, cross-sex hormones, and surgeries, that attempt to transition children and adolescents away from their sex.\25\ The HHS Review includes a methodologically rigorous assessment of evidence underpinning the use of surgical or endocrine interventions, including puberty blockers and cross-sex hormones, while also drawing on international practice evaluations such as the United Kingdom's Cass Review, described in more detail below. The HHS Review documents serious concerns regarding the lack of reliable evidence of benefits, describes the plausible risks of significant harms for this model of care that have mounted in recent years, and points to psychotherapy (talk therapy) as one noninvasive alternative. The HHS Review makes clear that “[t]he evidence for benefit of pediatric medical transition is very uncertain, while the evidence for harm is less uncertain.” \26\ The HHS Review cites widely accepted principles of medical ethics to conclude that when “medical interventions pose unnecessary, disproportionate risks of harm, healthcare providers should refuse to offer them even when they are preferred, requested, or demanded by patients.” \27\

\25\ See “Information Quality Guidelines,” Office of the Assistant Secretary for Planning and Evaluation (ASPE), accessed August 11, 2025, https://aspe.hhs.gov/topics/data/information-quality-guidelines; “HHS Information Quality Peer Review,” ASPE, accessed August 11, 2025, https://aspe.hhs.gov/hhs-information-quality-peer-review.

\26\ HHS Review, 15, 95-96.

\27\ HHS Review, 15.

Further, the HHS Review highlights evidence pointing to significant risks associated with the use of puberty blockers, cross-sex hormones, and surgeries, including potentially irreversible harms such as infertility, and finds extremely weak evidence of benefit. Significantly, the HHS Review finds that the evidence base does not support conclusions about the effectiveness of medical and surgical interventions in improving mental health or reducing gender dysphoria symptoms, stating that “[a]nalysis of the biological plausibility of harms is necessary, and suggests that some short- and long-term harms are likely (in some cases expected) sequalae of treatment.” \28\ Likewise, the data considered in the HHS Review indicate that the risk/ benefit profile of medical and surgical interventions for children and adolescents diagnosed with gender dysphoria is unfavorable. While the HHS Review itself does not make clinical, policy, or legislative recommendations, it provides critical insights that should inform policymakers as they make decisions to promote health and safety, especially for vulnerable populations such as children.

\28\ HHS Review, 134.

Although the HHS Review acknowledges that systematic reviews offer limited evidence regarding the harms of sex-rejecting procedures in children, it also provides plausible explanations for why evidence of harms may not have been sought, detected or reported. This may be due to several factors: the relatively recent adoption of hormonal and surgical treatment approaches, shortcomings in existing studies in consistently monitoring and reporting adverse effects, and publication bias. Even in the absence of evidence from large-scale population studies, the HHS Review noted, based on what is known about human physiology and the effects and mechanisms of the pharmacological agents used, there are known and plausible risks of significant harms from puberty blockers, cross-sex hormones, and surgeries. These include “infertility/sterility, sexual dysfunction, impaired bone density accrual, adverse cognitive impacts, cardiovascular disease and metabolic disorders, psychiatric disorders, surgical complications, and regret.” \29\

\29\ HHS Review, 14, 117-123, 125-133.

The HHS Review documents the weak evidence and growing international retreat from the use of puberty blockers, cross-sex hormones, and surgeries to treat gender dysphoria in children \30\ and the “risk of significant harms.” \31\ The HHS Review explains that “many treatments (for example, surgery, hormone therapy) can lead to relatively common and potentially serious long-term adverse effects.” \32\

\30\ HHS Review, 63-65.

\31\ HHS Review, 10, 117-123, 125-133.

\32\ HHS Review, 230.

We were aware that approximately 17 State Medicaid programs cover one or more forms of sex-rejecting procedures for children, citing guidelines from several major U.S. medical professional associations (American Medical Association, the American Academy of Pediatrics, and the American Psychological Association) who have issued prior statements deeming sex-rejecting procedures, which they refer to as “gender-affirming care,” safe and effective.33 34 35 36 We note, on the

contrary, that in early 2026, the American Society of Plastic Surgeons (ASPS) formally updated its position \37\ to recommend against “gender-related surgeries” for children. These medical society endorsements were cited to support adoption of sex-rejecting procedures by clinicians across the U.S. The HHS Review explains why such guidelines, including SOC-8, are not trustworthy according to accepted standards for evaluating the quality of guidelines. As the HHS Review documents in detail, the creation of SOC-8 marked a “clear departure from the principles of unbiased, evidence-driven clinical guideline development.” \38\ In the context of developing its recommendations, WPATH suppressed systematic reviews of evidence, failed to manage conflicts of interest, and relied on legal and political considerations rather than clinical ones.\39\ A recent systematic review of international guideline quality concluded that “[h]ealthcare professionals should consider the lack of quality and independence of available guidance when utilizing this [WPATH and Endocrine Society international guidelines] for practice.” \40\

\33\ Stacy Weiner, “States are banning gender-affirming care for minors. What does that mean for patients and providers?,” AAMCNews, February 20, 2024, https://www.aamc.org/news/states-are-banning-gender-affirming-care-minors-what-does-mean-patients-and-providers.

\34\ “APA adopts groundbreaking policy supporting transgender, gender diverse, nonbinary individuals,” American Psychological Association, released February 28, 2024, https://www.apa.org/news/press/releases/2024/02/policy-supporting-transgender-nonbinary.

\35\ Alyson Sulaski Wyckoff, “AAP continues to support care of transgender youths as more states push restrictions,” AAP News, January 6, 2022, https://publications.aap.org/aapnews/news/19021/AAP-continues-to-support-care-of-transgender.

\36\ “Criminalizing Gender Affirmative Care with Minors,” American Psychological Association, accessed September 2, 2025, https://www.apa.org/topics/lgbtq/gender-affirmative-care.

\37\ “Position Statement on Gender Surgery for Children and Adolescents,” American Society of Plastic Surgeons, issued February 3, 2026, https://www.plasticsurgery.org/documents/health-policy/positions/2026-gender-surgery-children-adolescents.pdf.

\38\ HHS Review, 181.

\39\ HHS Review, 182.

\40\ Jo Taylor et al., “Clinical guidelines for children and adolescents experiencing gender dysphoria or incongruence: a systematic review of guideline quality (part 1),” Archives of Disease in Childhood 109, Supp. 2 (2024): s65-s72, doi:10.1136/ archdischild-2023-326499.

The HHS Review's current findings are aligned with conclusions reached by multiple European countries. Sweden, Finland, and the United Kingdom conducted independent systematic reviews of evidence commissioned by their public health authorities. “All three concluded that the risks of medicalization \41\ may outweigh the benefits for children and adolescents with gender dysphoria at the population level, and subsequently sharply restricted access to medical gender transition interventions for minors.” \42\ These three countries now recommend exploratory psychotherapy as the first line of treatment. Sweden and Finland reserve hormonal interventions only for exceptional cases, recognizing their experimental status.43 44 45

\41\ The authors of the study did not otherwise supply a specific definition for the term “medicalization,” but it generally means “the act of considering something to be a medical problem, or representing it as a medical problem.” Cambridge Dictionary, accessed August 8, 2025, https://dictionary.cambridge.org/us/dictionary/english/medicalization.

\42\ HHS Review, 255. See Jonas F. Ludvigsson et al., “A systematic review of hormone treatment for children with gender dysphoria and recommendations for research,” Acta Paediatrica 112, no. 11 (2023): 2279-2292, https://doi.org/10.1111/apa.16791; National Institute for Health and Care Excellence (NICE), “Evidence Review: Gender Affirming Hormones for Children and Adolescents with Gender Dysphoria,” (2020), https://cass.independent-review.uk/wp-content/uploads/2022/09/20220726_Evidence-review_Gender-affirming-hormones_For-upload_Final.pdf; National Institute for Health and Care Excellence (NICE), “Evidence Review: Gonadotrophin Releasing Hormone Analogues for Children and Adolescents with Gender Dysphoria,” (2020), https://cass.independent-review.uk/wp-content/uploads/2022/09/20220726_Evidence-review_GnRH-analogues_For-upload_Final.pdf; I. Pasternack et al., “L[auml][auml]ketieteelliset menetelm[auml]t sukupuolivariaatioihin liittyv[auml]n dysforian hoidossa: Systemaattinen katsaus [Medical approaches to treating gender dysphoria: A systematic review],” Summary Oy (2019); Jo Taylor et al., “Interventions to suppress puberty in adolescents experiencing gender dysphoria or incongruence: A systematic review,” Archives of Disease in Childhood 109, Supp 2 (2024): s33-s47, doi:10.1136/archdischild- 2023-326669; Jo Taylor et al., “Masculinising and feminising hormone interventions for adolescents experiencing gender dysphoria or incongruence: A systematic review,” Archives of Disease in Childhood 109, Supp 2 (2024): s48-s56, doi:10.1136/archdischild- 2023-326670.

\43\ “Children and young people's gender services: implementing the Cass Review recommendations,” NHS England, last updated August 29, 2024, https://www.england.nhs.uk/long-read/children-and-young-peoples-gender-services-implementing-the-cass-review-recommendations/.

\44\ “Care of children and adolescents with gender dysphoria- summary of national guidelines,” The Swedish National Board of Health and Welfare (Socialstyrelsen), December 2022, https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/kunskapsstod/2023-1-8330.pdf.

\45\ “One Year Since Finland Broke with WPATH `Standards of Care',” Society for Evidence Based Gender Medicine, July 2, 2021, https://segm.org/Finland_deviates_from_WPATH_prioritizing_psychotherapy_no_surgery_for_minors.

In particular, the most influential effort to date has been the United Kingdom's Cass Review--a 4-year independent evaluation of pediatric gender medicine that was published in April 2024.\46\ The findings of the Cass Review led to the closure of the United Kingdom's Gender Identity Development Service (GIDS), which had been given a rating of “inadequate” by the Care Quality Commission in 2021. The Cass Review recommended a restructuring of the care delivery model-- away from the centralized “gender clinic” model of care toward a more holistic framework centering on psychosocial support, to be delivered through regional hubs. The Cass Review's findings also led the United Kingdom to ban the use of puberty blockers outside of clinical trials, and to significantly restrict cross-sex hormones. In the United Kingdom, children have never received gender dysphoria-related surgery through the National Health Service (NHS). Additionally, on March 9, 2026, the NHS England proposed no longer recommending cross sex hormones to be available as a routine commissioning option through the NHS Children and Young People's Gender Service.\47\ They cited the reasons for this proposal include the “. . . limited evidence about safety, risks, benefits and outcomes.” \48\

\46\ Hilary Cass, “Independent review of gender identity services for children and young people: Final report,” (2024), https://cass.independent-review.uk/home/publications/final-report/ [hereinafter “Cass Review”].

\47\ “Clinical policy: Prescribing of masculinising and feminising hormones for children and adolescents who have gender incongruence or dysphoria--public consultation guide,” NHS England, published March 9, 2026, https://www.england.nhs.uk/long-read/clinical-policy-prescribing-of-masculinising-and-feminising-hormones-for-children-and-adolescents-who-have-gender-incongruence-or-dysphoria-public-consultation-guide/.

\48\ “Clinical policy: Prescribing of masculinising and feminising hormones for children and adolescents who have gender incongruence or dysphoria--public consultation guide,” NHS England, published March 9, 2026, https://www.england.nhs.uk/long-read/clinical-policy-prescribing-of-masculinising-and-feminising-hormones-for-children-and-adolescents-who-have-gender-incongruence-or-dysphoria-public-consultation-guide/.

In 2022, Sweden's National Board of Health and Welfare (NBHW) reviewed and updated its guidelines for children under the age of 18. Sweden's NBHW determined that the risks of puberty suppressing treatment with GnRH-analogues (injectable drugs that prevent the ovaries and testicles from producing sex hormones) and gender-affirming hormonal treatment likely outweigh the possible benefits.\49\ Specifically,

Sweden's NBHW outlined that the first line of treatment should be mental health support and exploratory psychological care. Hormonal interventions can be a last resort measure for some youth. Sweden has made the decision to no longer offer sex-rejecting procedures to children outside of research settings, and restricted eligibility to the early childhood-onset of gender dysphoria.

\49\ “Care of children and adolescents with gender dysphoria- summary of national guidelines,” The Swedish National Board of Health and Welfare (Socialstyrelsen), December 2022, https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/kunskapsstod/2023-1-8330.pdf. See also the Swedish National Board of Health and Welfare (Socialstyrelsen), “Care of children and young people with gender Dysphoria--national knowledge support with recommendations for the profession and decision makers,” (2022), https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/kunskapsstod/2022-12-8302.pdf.

In 2020, Finland's Council for Choices in Health Care, a monitoring agency for the country's public health services, issued guidelines that called for psychosocial support as the first line treatment, hormone therapy on a case-by-case basis after careful consideration, and no surgical treatment for children. Finland has restricted eligibility for hormone therapy to children with early childhood-onset of gender dysphoria and no mental health comorbidities.\50\

\50\ Council for Choices in Healthcare in Finland, “Summary of a recommendation by COHERE Finland,” June 16, 2020, https://palveluvalikoima.fi/documents/1237350/22895008/Summary_minors_en+(1).pdf/fa2054c5-8c35-8492-59d6-b3de1c00de49/ Summary_minors_en+(1).pdf?t=1631773838474.

In Denmark, more than 1,300 children with gender incongruence were “referred to the national service between 2016 and 2022 with increasing referral numbers over time,” of which females constituted 70 percent.\51\ The increase in the number of referrals for these procedures and reports of regret or reversal of hormone-induced changes to the body led Denmark to take an approach that focuses on assessment and psychosocial support for children, and postpones decisions on hormone therapy, including puberty blockers and cross-sex hormones, in circumstances “when gender incongruence has been brief,” such as “when there are concerns about the stability of the experienced gender identity.” \52\

\51\ Nanna Ravnborg et al., “Gender Incongruence in Danish Youth (GenDa): A Protocol for a Retrospective Cohort Study of Danish Children and Adolescents Referred to a National Gender Identity Service,” Journal of Clinical Medicine 13 (2024), https://doi.org/10.3390/jcm13226658.

\52\ Ravnborg et al., “Gender Incongruence in Danish Youth (GenDa).”

In Norway, the Norwegian Commission for the Investigation of Health Care Services (UKOM), an independent State-owned agency, made recommendations in 2023 on the treatment offered to children and young people with gender incongruence.\53\ The recommendations consisted of: defining puberty blockers and surgical treatment for children as experimental, revising national guidelines based on a systematic knowledge summary, and consideration for a national registry to improve quality and reduce variation in patient treatment. Norway's public health authority has signaled an intention to respond to UKOM's concerns by considering whether the current treatment guidelines need to be adjusted.\54\

\53\ Norwegian Healthcare Investigation Board (Ukom), “Pasientsikkerhet for barn og unge med kj[oslash]nnsinkongruens [Patient safety for children and adolescents with gender incongruence],” March 2023, https://ukom.no/rapporter/pasientsikkerhet-for-barn-og-unge-med-kjonnsinkongruens/sammendrag.

\54\ Jennifer Block, “Norway's guidance on paediatric gender treatment is unsafe, says review,” BMJ 380 (2023), doi:10.1136/ bmj.p697.

Other countries which have restricted various approaches to treatment for children (or have contemplated restrictions) include: New Zealand,\55\ Italy,\56\ Brazil,\57\ and Australia.\58\

\55\ Eva Corlett, “New Zealand bans puberty blockers for young transgender people,” The Guardian, November 19, 2025, https://www.theguardian.com/world/2025/nov/19/new-zealand-bans-new-prescriptions-of-puberty-blockers-for-young-transgender-people.

\56\ Alvise Armellini, “Italy moves to tighten controls on gender-affirming medical care for minors,” Reuters, August 5, 2025, https://www.reuters.com/business/healthcare-pharmaceuticals/italy-moves-tighten-controls-gender-affirming-medical-care-minors-2025-08-05/.

\57\ “Brazil prohibits hormone therapy for transgender minors,” Buenos Aires Times, April 16, 2025, https://www.batimes.com.ar/news/latin-america/brazil-prohibits-hormone-therapy-for-transgender-minors.phtml.

\58\ Australian Associated Press, “Queensland halts prescription of puberty blockers and hormones for children with gender dysphoria,” The Guardian, January 28, 2025, https://www.theguardian.com/australia-news/2025/jan/28/queensland-halts-prescription-of-puberty-blockers-and-hormones-for-children-with-gender-dysphoria.

In sum, there has been growing international concern about the use of hormonal and surgical interventions for pediatric gender dysphoria. 2. Medical Professional Societies Supporting Sex-Rejecting Procedures

Some professional organizations \59\ (including the American Medical Association (AMA),\60\ the American Academy of Pediatrics (AAP),\61\ and the American Psychological Association 62 63) have issued statements supporting access to sex-rejecting procedures, including for children. The most influential sources of clinical guidance for treating pediatric gender dysphoria in the U.S. are the WPATH and the ES clinical practice guidelines and the AAP guidance document.\64\ We reviewed each of these documents and agree with the conclusions of a recent systematic review of international guideline quality by researchers at the University of York (the York appraisal) that found all three documents to be of very low quality and concluded that the recommendations they contained should not be implemented.\65\

\59\ “Medical Organization Statements,” Advocates For Trans Equality's Trans Health Project, accessed November 20, 2025, https://transhealthproject.org/resources/medical-organization-statements/.

\60\ “Clarification of Evidence-Based Gender-Affirming Care H- 185.927,” American Medical Association, last modified 2024, https://policysearch.ama-assn.org/policyfinder/detail/%22Clarification%20of%20Evidence-Based%20Gender-Affirming%20Care%22?uri=%2FAMADoc%2FHOD-185.927.xml.

\61\ Alyson Sulaski Wyckoff, “AAP continues to support care of transgender youths as more states push restrictions,” AAP News, January 6, 2022, https://publications.aap.org/aapnews/news/19021/AAP-continues-to-support-care-of-transgender.

\62\ “APA adopts groundbreaking policy supporting transgender, gender diverse, nonbinary individuals,” American Psychological Association, released February 28, 2024, https://www.apa.org/news/press/releases/2024/02/policy-supporting-transgender-nonbinary.

\63\ “Criminalizing Gender Affirmative Care with Minors,” American Psychological Association, accessed September 2, 2025, https://www.apa.org/topics/lgbtq/gender-affirmative-care.

\64\ HHS Review, 146.

\65\ HHS Review, 141.

As the HHS Review noted regarding the role of medical organizations in the treatment of pediatric gender medicine:

U.S. medical associations played a key role in creating a perception that there is professional consensus in support of pediatric medical transition [PMT]. This apparent consensus, however, is driven primarily by a small number of specialized committees, influenced by WPATH. It is not clear that the official views of these associations are shared by the wider medical community, or even by most of their members. There is evidence that some medical and mental health associations have suppressed dissent and stifled debate about this issue among their members.\66\

\66\ HHS Review, 15.

The ES issued clinical practice guidelines in 2017 entitled “Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons.” \67\ As the HHS Review noted:

\67\ Wylie C. Hembree et al., “Endocrine Treatment of Gender- Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline,” The Journal of Clinical Endocrinology & Metabolism 102, no. 11 (2017): 3869-3903, https://doi.org/10.1210/jc.2017-01658.

In WPATH and ES guidelines, the principal goal of CSH [cross sex hormone] administration is to induce physical characteristics typical of the opposite sex. When hormone levels rise beyond the typical reference range for a person's sex, they are considered supraphysiologic. ES guidelines suggest that the sex an individual identifies as--as opposed to their biological sex--should determine the target reference range for hormonal concentrations. Critics have noted that perceived identity does not alter

physiological processes and that such a belief can result in inappropriate and potentially dangerous hormone dosing.\68\

\68\ HHS Review, 124.

The HHS Review states:

The ES 2017 guideline, which used the GRADE [Grading of Recommendations Assessment, Development and Evaluation] framework, has been criticized for making strong recommendations for hormonal interventions in the setting of a weak evidence base. Notably, none of the systematic reviews that supported the ES guidelines were based on outcomes for children or adolescents. The ES recommendation to initiate puberty blockade using gonadotropin-releasing hormone agonists was derived by putting a higher value on achieving a “satisfactory physical appearance” while putting the lowest value on avoiding physical harms. The ES recommendation for the initiation of cross-sex hormones no earlier than age 16 was justified by placing a higher value on adolescent's purported ability to meaningfully consent to cross-sex hormones (CSH) and placing a lower value on avoiding harm from potentially prolonged pubertal suppression.\69\

\69\ HHS Review, 147.

As explained in Chapter 9 of HHS Review, the guidelines issued by WPATH “have been rated among the lowest in quality and have not been recommended for implementation by systematic reviews (SRs) of guidelines.” \70\ As the HHS Review points out: “Despite their lack of trustworthiness, for more than a decade WPATH guidelines have served as the foundation of the healthcare infrastructure for gender dysphoric (GD) youth in the United States. The WPATH Standards of Care guidelines are embedded in nearly all aspects of healthcare including clinical education, delivery of care, and reimbursement decisions by private and public insurers.” \71\ In 2022, WPATH issued the SOC-8 guidelines.\72\ These guidelines relaxed eligibility criteria for children to access sex-rejecting procedures, and ultimately recommend that adolescents wishing to undergo sex-rejecting procedures receive them. Besides the problems identified in systematic reviews of international guidelines, as the HHS Review states, “[i]n the process of developing SOC-8, WPATH suppressed systematic reviews its leaders believed would undermine its favored treatment approach. SOC-8 developers also violated conflict of interest management requirements and eliminated nearly all recommended age minimums for medical and surgical interventions in response to political pressures.” \73\

\70\ HHS Review, 157.

\71\ HHS Review, 157.

\72\ E. Coleman et al., “Standards of Care.”

\73\ HHS Review, 14.

The HHS Review goes on to explain: “The recommendations are couched in cautious-sounding language, stating that GD should be `sustained over time,' particularly before administering CSH. However, no clear standard is set; the only guidance offered is the vague and clinically meaningless phrase `several years, leaving critical decisions open to broad and subjective interpretation.' ” \74\

\74\ HHS Review, 165.

Regarding the WPATH guidelines, the HHS review states:

On the surface, WPATH SOC-8 might appear to recommend a cautious approach toward assessment. Mental health providers are to conduct a “comprehensive biopsychosocial assessment” prior to initiating medical interventions in order “to understand the adolescent's strengths, vulnerabilities, diagnostic profile, and unique needs to individualize their care.” At the same time, however, WPATH recommends that clinicians use the International Classification of Diseases (ICD-11) diagnosis of “Gender Incongruence of Adolescence and Adulthood,” which, unlike the DSM-5 diagnosis of “Gender Dysphoria,” requires only “marked and persistent incongruence between an individual's experienced gender and the assigned sex.” Because SOC-8 defines transgender in a similar way (“people whose gender identities and/or gender expressions are not what is typically expected for the sex to which they were assigned at birth”) and provides no meaningful distinction between this meaning of transgender and gender non-conformity, SOC-8 effectively recognizes transgender identification as a medical condition justifying medical interventions.\75\

\75\ HHS Review, 194-195.

The HHS Review also states: “Although WPATH's guidelines do not necessarily discourage mental healthcare, they likewise do not require it as a precondition for PMT [pediatric medical transition]. Some guideline authors opposed even minimal requirements for mental health support, arguing that such provisions were analogous to “conversion therapy.” \76\ SOC-8's only formal recommendation is for a “comprehensive biopsychosocial assessment,” although WPATH emphasizes that its guideline is “flexible,” thereby leaving room for considerable variation in clinical practice.” \77\

\76\ “Conversion therapy”--sometimes called “reparative therapy”--originally referred to efforts to change the sexual orientation of gay and lesbian people. See HHS Review, 261.

\77\ HHS Review, 196.

While AMA and the AAP have not issued their own treatment guidelines, they support the ES and WPATH guidelines, as discussed previously in this final rule. AAP issued a policy statement in 2018 supporting the use of puberty blockers, cross-sex hormones, and surgeries for children.\78\ In support of sex-rejecting surgeries, AAP stated that while “current protocols typically reserve surgical interventions for adults, they are occasionally pursued during adolescence on a case-by-case basis, considering the necessity and benefit to the adolescent's overall health and often including multidisciplinary input from medical, mental health, and surgical providers as well as from the adolescent and family.” In 2023, the AAP reaffirmed its policy statement, but also stated that it was conducting its own review of the evidence and developing expanded guidance--which still have not been released as of July 2026.\79\ Regarding the AAP policy statement, the HHS Review states:

\78\ Jason Rafferty, AAP Committee on Psychosocial Aspects of Child and Family Health, AAP Committee on Adolescence, AAP Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness, “Ensuring Comprehensive Care and Support for Transgender and Gender Diverse Children and Adolescents,” Pediatrics 142, no. 4 (2018), doi.org/10.1542/peds.2018-2162.

\79\ Alyson Sulaski Wyckoff, “AAP reaffirms gender-affirming care policy, authorizes systematic review of evidence to guide update,” AAP News, August 4, 2023, https://publications.aap.org/aapnews/news/25340/AAP-reaffirms-gender-affirming-care-policy.

The AAP 2018 policy statement is not technically a CPG [clinical practice guideline] but has been widely cited in the U.S. as influential in establishing how pediatricians respond to children and adolescents with GD. Because the document offers extensive clinical recommendations regarding every step of PMT--from social transition to PBs [puberty blockers], CSH, and surgery--the York team assessed the trustworthiness of the AAP guidance using the same criteria they applied to CPGs. Using the AGREE II criteria, the AAP policy statement received the second-lowest average score among all international guidelines: 2 out of 7. As noted in Chapter 2, the AAP's policy statement's use of “gender diverse” casts a very wide net regarding which patients the organization considers eligible for medical intervention. The statement has been heavily criticized in peer-reviewed articles, which have pointed out that it is rife with referencing errors and inaccurate citations. Despite persistent advocacy among its members, who have petitioned the organization to release updated, evidence-based guidance for treating pediatric GD, the organization chose to reaffirm their policy statement in 2023.\80\

\80\ HHS Review, 148-149.

In addition to other issues, we solicited comment identifying any published peer-reviewed findings that measure the effects of restrictions similar to those in the proposed rule on insurers, providers, and patients in international settings as well as the U.S.

In response, we received numerous comments about the conclusions reached by a study commissioned by the Utah State legislature to inform future legislative restrictions on sex-rejecting procedures for children. This study (known as the Utah Review) was conducted by the University of Utah College of Pharmacy Drug Regimen Review Center and publicly released in 2025.\81\ However, the HHS review noted a variety of issues such that the Utah study “lacks a methodologically valid evidence appraisal”.\82\ The Utah Review's review of primary studies did not properly define the research question, conduct a comprehensive literature search, or critically appraise all included studies. Most critically, it failed to perform two key aspects of a systematic review, a formal evidence synthesis and an assessment of evidence certainty, and therefore does not qualify as a systematic evidence review. It concluded, without sound methodological basis, that “the consensus of the evidence supports that the treatments are effective.” \83\

\81\ University of Utah College of Pharmacy, Drug Regimen Review Center, “Gender-Affirming Medical Treatments for Pediatric Patients with Gender Dysphoria,” (August 6, 2024), https://le.utah.gov/AgencyRP/reportingDetail.jsp?rid=636.

\82\ HHS Review, 83.

\83\ HHS Review, 96-97.

We also received several comments regarding the conclusions reached by a study published in the New England Journal of Medicine in 2023 titled “Psychosocial functioning in transgender youth after 2 years of hormones.” \84\ The HHS review found that “[t]he study's observational, uncontrolled methodology does not justify the authors' use of explicitly casual language when reporting their results (CSH [cross sex hormone therapy] `improved appearance congruence and psychosocial functioning')” \85\ and cited a lack of a parallel control group as the study's biggest limitation. The HHS review concluded that:

\84\ Diane Chen et al., “Psychosocial Functioning in Transgender Youth after 2 Years of Hormones,” New England Journal of Medicine 388 (2023), https://www.nejm.org/doi/full/10.1056/NEJMoa2206297.

\85\ HHS Review, 107.

Although a recent systematic review was able to capture issues like study attrition in its risk of bias assessment for Chen et al., such reviews are unable to capture serious concerns that may be more related to research ethics than to methodology (for example, the altering of hypotheses between the protocol and the published article raises the possibility of “HARKing” [hypothesizing after the results are known]). Peer-reviewed critiques addressing the issues with Chen et al. were eventually published in NEJM, but not until nearly a year after the article first appeared.\86\

\86\ HHS Review, 109.

State lawmakers have adopted varying policy positions reflecting the emerging evidence regarding sex-rejecting procedures administered to youth. There are 27 States and one Territory that have enacted laws restricting sex-rejecting procedures.\87\ These include Alabama, Arkansas, Arizona, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Missouri, Mississippi, Montana, North Carolina, New Hampshire, North Dakota, Nebraska, Ohio, Oklahoma, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, and Wyoming. Some of these States have had ongoing litigation proceedings resulting in the State laws being partially or fully enjoined by a court.\88\

\87\ See “Policy Tracker: Youth Access to Gender Affirming Care and State Policy Restrictions,” KFF, last updated May 19, 2026, https://www.kff.org/other/dashboard/gender-affirming-care-policy-tracker; “Equality Maps: Bans on Best Practice Medical Care for Transgender Youth,” Movement Advancement Project, accessed May 19, 2026, https://www.lgbtmap.org/equality-maps/healthcare/youth_medical_care_bans.

\88\ On May 13, 2025, the Missoula County District Court issued an order permanently enjoining Montana's law (SB 99), which law restricted access to sex-rejecting procedures for minors. Cross v. State of Montana, No. DV-23-541 (Mont. Dist. Ct. May 13, 2025).

There are a mix of age ranges for these bans. Of the 27 States and one Territory with enacted laws/policies (in effect or not), 25 States prohibited some sex-rejecting procedures to young people under the age of 18, two States prohibited them for those under the age of 19, and Puerto Rico prohibited them for those under the age of 21.

Of the 27 States and one Territory with enacted laws/policies (in effect or not), 25 States and one Territory prohibited both the prescribing of at least one type of sex-rejecting medication and surgeries.\89\ No State bans only medications without also banning surgeries. However, all the States and the Territory with restrictions provide exceptions to the law/policies. The most common exceptions include procedures to treat:

\89\ Arizona currently does not prohibit sex-rejecting procedures using medications. Nebraska currently restricts, but does not fully ban, access to sex-rejecting procedures using medications, so it was not included in this count.

A medically verifiable disorder of sexual development. This allows treatment for children who are born with medical conditions that affect their sexual development. These are rare conditions where a child's reproductive or sexual anatomy does not develop in typical ways due to genetic, hormonal, or other medical factors that can be medically verified.

Any infection, injury, disease, or disorder that has been caused or exacerbated by the performance of sex-rejecting procedures.

A physical disorder, physical injury, or physical illness that would otherwise place the child in danger of death or impairment of bodily function.

We noted that 12 States provide tapering off periods for patients who started puberty blockers or hormones before enactment of the State restriction, with some specifying specific dates (for example, in South Carolina services could not go beyond January 31, 2025) and others specifying a period of time from the time of enactment (ranging between 6 months and 1 year). Ten States have grandfather clauses primarily allowing children who were already receiving treatment to continue receiving it indefinitely. However, we noted that many of these States do not provide such exceptions or grandfather clauses for purposes of prohibitions on State funding, including for State funding under the Medicaid program and CHIP, for sex-rejecting procedures.

Conversely, 14 States and the District of Columbia have shield laws that cover some or all sex-rejecting procedures, and three States have Executive Orders (State EOs) also covering these procedures. These States are Arizona,\90\ California, Colorado, Connecticut, Delaware, Illinois, Maine, Maryland, Massachusetts, Minnesota, New Jersey, New Mexico, New York, Oregon, Rhode Island, Vermont, and Washington. Shield laws and State EOs often describe various types of sex-rejecting procedures broadly, including medications and surgeries, and include these under broader definitions of covered health care activities. These laws and State EOs generally attempt to shield providers and recipients (of all ages) against laws in other States that restrict these services. They also often shield providers from adverse action by medical malpractice insurers and licensure boards and allow for their addresses to remain confidential. One State, Maine, has a shield law specific

to children that allows minors 16 and over to receive hormone therapy when the guardian has refused sex-rejecting procedures. Four States explicitly provide child abuse and child custody protections for parents who allowed their children to undergo sex-rejecting procedures. Four States have requirements for sex-rejecting procedures to be covered under health plans. Arizona requires coverage for State employee health plans. Illinois, Oregon, and Vermont require some level of coverage of sex-rejecting procedures by all health insurance providers. Vermont includes an exception for services that do not comply with Federal law.

\90\ Arizona banned pediatric sex-rejecting surgeries in 2022. However, in 2023 the governor issued an executive order which removes the exclusion of coverage for sex-rejecting surgery under the state's healthcare plan for state employees and prohibits investigative assistance to impose criminal or civil liability or professional sanctions on persons or entities for providing, assisting, seeking, or obtaining “gender affirming care.”

Some States may experience negative financial impacts as a result of having built their Medicaid programs and CHIPs, including policies and operations, on the understanding that CMS will make Federal Medicaid and CHIP payments to States for services that this final rule will define as sex-rejecting procedures. We believe protecting children enrolled in Medicaid and CHIP from the potential harms of sex-rejecting procedures, including possible long-term and irreversible harms, outweighs the possible financial costs some States may experience if they choose to begin to pay with State funds the full cost of sex- rejecting procedures for children enrolled in Medicaid and CHIP.

Providers in these States may be concerned that this final regulation will interfere with the physician-patient relationship. This final regulation will only prohibit Federal Medicaid and CHIP payment for certain services and does not require providers to communicate certain advice or information to patients, or cease care. Federal Medicaid and CHIP payments will still be available for other treatments, such as psychotherapy, for gender dysphoria. We believe a prohibition on Federal Medicaid and CHIP payments for sex-rejecting procedures is needed to reduce the possibility of children receiving irreversible or risky pharmaceutical or surgical interventions, particularly in circumstances where the child may be of an age to not have the capacity to understand the irreversible or long-term risks of these procedures or have the capacity to continue to communicate with providers their preferences regarding treatment after treatment has already begun.

Certain medical providers may also be relying on continued Federal funding for sex-rejecting procedures. These providers may face financial harm by the loss of the revenue from the limitations on Federal payment for these procedures; however, these providers have other avenues to continue to receive compensation for providing medical interventions. Providers that continue to provide sex-rejecting procedures on children may receive payment from sources other than Medicaid or CHIP. Providers may also receive payment for these services when providing these procedures for the exempted purposes as outlined in this final rule. Lastly, providers may be paid through Medicaid and CHIP for providing other types of care for individuals diagnosed with gender dysphoria, such as psychotherapy.

We also recognize that Medicaid and CHIP beneficiaries and their families will be impacted by this final rule. Families of these beneficiaries may look to obtain other health insurance, privately pay for these services, or seek State-sponsored funding. Medicaid beneficiaries under age 18 and CHIP beneficiaries under age 19 who are unable to find alternative means to pay for these services may either have to rely on other methods of treatment such as psychotherapy or mental health counseling or elect to not receive these services because of the rule.

This final rule will help to protect these children from the risks of adverse effects of sex-rejecting procedures. CMS carefully considered the scope of its limitation on Federal Medicaid and CHIP payments and permits coverage of other procedures, such as psychotherapy, which do not carry the same concerns of pharmaceutical or surgical interventions included in the definition of sex-rejecting procedures. Moreover, CMS does not believe Federal Medicaid and CHIP payment for these sex-rejecting procedures is consistent with quality of care given the state of the research into the effectiveness of these procedures for the purposes included in our definition of this term, namely as treatments for gender dysphoria. In light of the HHS Review, CMS continues to believe State reliance on certain medical organizations and the SOC-8 to justify covering sex-rejecting procedures is misplaced.

Recently, the U.S. Supreme Court in United States v. Skrmetti, 605 U.S. 495 (2025), upheld Tennessee's law restricting certain surgical and chemical interventions for children diagnosed with gender dysphoria (and similar conditions), referred to as Senate Bill 1 or “SB1” in litigation challenging that law under the Equal Protection Clause of the U.S. Constitution. SB1 prohibits a healthcare provider from performing medical procedures, including surgery, and prescribing puberty blockers, for a child for the purpose of enabling the child to identify with a purported identity inconsistent with the child's sex. At the same time, SB1 allows healthcare providers to perform medical procedures for children if the procedure is to treat a child's congenital defect, precocious puberty, disease, or physical injury. On June 18, 2025, the Court found that SB1's prohibition of certain medical procedures for children diagnosed with gender dysphoria incorporates classifications based on age and medical use--not the child's sex. Because the classifications turned on age and medical use rather than sex, the Court held that SB1 was not subject to heightened scrutiny under the Equal Protection Clause of the Fourteenth Amendment and went on to find the law satisfied rational basis review. As discussed in more detail later in this final rule, like the law at issue in Skrmetti, this final rule will not discriminate on the basis of sex. This rule is not based on an invidious discriminatory purpose, and it is not motivated by animus toward any group; rather, it is focused on preventing Federal payment for procedures that involve risks of significant and potentially irreversible harms, without sufficient evidence of benefit. The final rule is animated by significant child safety concerns when sex-rejecting procedures are used for certain medical uses--that is to align a child's physical appearance or body with an asserted identity that differs from the child's sex.

Since 2010, there has been a significant increase in mental health conditions among teens and young adults.\91\ Current research has not revealed a simple explanation for this rise in the need for youth mental health services. The etiology of gender dysphoria remains understudied.\92\ However, patients presenting to pediatric gender medicine clinics have a high rate of comorbid mental health conditions.\93\

\91\ Patrick McGorry et al., “The Lancet Psychiatry Commission on youth mental health,” Lancet Psychiatry 11, no. 9 (September 2024): 731-774, doi:10.1016/S2215-0366(24)00163-9.

\92\ HHS Review, 257.

\93\ HHS Review, 68.

When we issued the proposed rule, we believed interested parties supporting the use of sex-rejecting procedures to treat gender dysphoria in children would state that prohibiting Federal Medicaid and CHIP funding for sex-rejecting procedures would ultimately limit children's ability to

access such procedures and that this could exacerbate these comorbidities and lead to adverse mental health outcomes and increase suicide risks. As noted previously, the Cass Review emphasized the lack of robust evidence regarding the effectiveness of interventions such as puberty blockers and cross-sex hormones to treat gender dysphoria and incongruence in children and adolescents.\94\ Taylor et al. recently conducted a review of 23 international, national, and regional clinical guidelines that contained recommendations about the management of children/adolescents experiencing gender dysphoria. They found that the majority of these guidelines were developed without an independent or evidence-based approach and raised questions about the credibility of available guidance.\95\ As Sweden's national health authority has recommended, “[p]sychosocial support that helps adolescents deal with natal puberty without medication needs to be the first option when choosing care measures.” \96\

\94\ Cass, “Cass Review.”

\95\ Jo Taylor et al., “Clinical guidelines for children and adolescents experiencing gender dysphoria or incongruence: a systematic review of guideline quality (part 1),” Archives of Disease in Childhood 109, Supp. 2 (2024): s65-s72, doi:10.1136/ archdischild-2023-326499.

\96\ HHS Review, 256.

While evidence on the benefits of medical and surgical interventions to improve mental health or reduce symptoms of gender dysphoria is lacking, psychotherapy has been proven to be an effective intervention for many of the neurodevelopmental disorders and mental health conditions that are highly prevalent in children and adolescents, including those frequently co-occurring in patients diagnosed with gender dysphoria.\97\ Psychotherapy and mental health counseling are non-invasive interventions that will remain available to youth under Medicaid's mandatory Early and Periodic Screening, Diagnostic and Treatment (EPSDT) provisions in section 1905(r) of the Act. EPSDT requires the provision of screening, vision, dental, and hearing services, and such other necessary health care, diagnostic services, treatment, and other measures described in section 1905(a) of the Act to correct or ameliorate defects and physical and mental illness and conditions discovered by the screening services, whether or not such services are covered under the State plan. Nevertheless, these services are subject to the overarching requirements of section 1902(a)(19) and 1902(a)(30)(A) of the Act that States ensure that these services be provided in a manner consistent with the best interests of patients and payments be consistent with quality of care. Most children enrolled in Medicaid are entitled to coverage of robust and comprehensive psychotherapy services under EPSDT. We note that, under a State's EPSDT program, States may only include tentative limits on services and must take into account the individual needs of the child. Thus, EPSDT is key to ensuring that children receive appropriate mental health screenings and treatments. Furthermore, we developed numerous resources to provide information regarding services and good practices for children and youth with mental health conditions.\98\ While EPSDT is not a required CHIP benefit for States that have separate CHIPs, many States with such programs have opted to provide EPSDT services that mirror the Medicaid standards set out at section 1905(r) of the Act to children enrolled in CHIP. In addition, section 2103(c)(7) of the Act requires States to provide mental health services in CHIP that are applied in the same manner as required under section 2726(a) of the Public Health Service Act (42 U.S.C. 300gg-26(a)) for group health plans under such section.

\97\ HHS Review, 257-260.

\98\ “Children and Youth,” Medicaid, accessed June 12, 2025, https://www.medicaid.gov/medicaid/benefits/behavioral-health-services/children-and-youth.

Under section 1902(a)(19) of the Act, State Medicaid agencies are required to ensure that Medicaid-covered services are provided in a manner consistent with the best interests of beneficiaries; as relevant to this final rule, children under age 18. Additionally, States are required, under section 1902(a)(30)(A) of the Act, to ensure that Medicaid payments for Medicaid covered services are consistent, in relevant part, with quality of care. Under section 2101(a) of the Act, CHIP programs are required to provide health care services to uninsured, low-income children in an effective and efficient manner that is coordinated with other sources of health benefits coverage for children, including State Medicaid programs. The research described previously in this final rule indicates that sex-rejecting procedures lack the necessary outcomes data on evidence of long-term effectiveness for State Medicaid programs and CHIPs to determine that payment for such procedures is, for Medicaid purposes, consistent with quality of care or the best interests of beneficiaries or, for CHIP purposes, consistent with the effective and efficient standard under section 2101(a) of the Act.

On April 11, 2025, we issued a letter to State Medicaid Directors to ensure Medicaid agencies were aware of growing utilization of certain interventions offered to children to treat gender dysphoria, and to remind States of their statutory responsibilities to ensure that Medicaid payments are consistent with quality of care and that covered services are provided in a manner consistent with the best interests of recipients.\99\ In the letter, we also stated that due to the underdeveloped body of evidence, the use of sex-rejecting procedures to treat gender dysphoria lacks reliable evidence of long-term benefits for children and are now known to cause long-term and irreparable harm for some children.\100\ A second letter, issued on May 28, 2025, was sent to a number of hospitals to address significant issues concerning quality standards and specific procedures affecting children diagnosed with gender dysphoria. The letter requested hospitals to provide information on their policies and procedures related to the adequacy of informed consent protocols for children diagnosed with gender dysphoria, including how children are deemed capable of making these potentially life changing decisions and when parental consent is required; changes to clinical practice guidelines and protocols that the institution plans to enact in light of the recent comprehensive review and guidance released by the Department; medical evidence and any adverse events related to these procedures, particularly children who later looked to detransition; and complete financial data for all pediatric sex-rejecting procedures performed at the institution and paid, in whole or in part, by the Federal Government.\101\

\99\ Centers for Medicare and Medicaid Services, “Puberty blockers, cross-sex hormones, and surgery related to gender dysphoria,” April 11, 2025, https://www.cms.gov/files/document/letter-stm.pdf.

\100\ Centers for Medicare and Medicaid Services, “Puberty blockers.”

\101\ Department of Health & Human Services, Centers for Medicare and Medicaid Services, “Urgent Review of Quality Standards and Gender Transition Procedures,” May 28, 2025, www.cms.gov/files/document/hospital-oversight-letter-generic.pdf.

As outlined previously in this final rule, we take very seriously the absence of rigorous scientific data demonstrating the effectiveness of sex-rejecting procedures and the considerable evidence regarding the risks. Given the potential risks and lack of clear benefits

associated with sex-rejecting procedures, we believe that covering these procedures with Federal Medicaid or CHIP funding would be, for Medicaid beneficiaries, inconsistent with their best interests and with quality of care; and, for CHIP beneficiaries, inconsistent with the provision of health care services to uninsured, low-income children in an effective and efficient manner that is coordinated with other sources of health benefits coverage.

We do note that, after careful analysis of comments received and the concerns raised regarding sex-rejecting procedures on children, we are finalizing the allowance of FFP for a limited tapering period for a discrete category of affected beneficiaries. Specifically, for current Medicaid and CHIP beneficiaries who are receiving cross-sex hormone therapy as part of sex-rejecting procedures as of the effective date of this final rule, State Medicaid and CHIP Agencies may continue to claim FFP for those cross-sex hormone therapy medications for a tapering period of up to 6 months from the effective date of this final rule. This tapering period is intended to provide beneficiaries and their treating providers a reasonable opportunity to phase off these medications in a manner that allows for clinical discretion, if desired. This has been added to regulation text.

Importantly, the 6-month tapering period is not intended to serve as a clinical guideline. Treating providers may find a shorter timeline for tapering off cross-sex hormones to be medically appropriate.

The administration of puberty blockers is not eligible for this tapering provision, because upon stopping puberty blockers, pubertal manifestations generally reappear within months.\102\ Puberty blockers have been primarily studied in children affected by precocious puberty. When these medications are discontinued, the process of puberty tends to return to its normal course within a relatively short period. Research indicates that after ceasing puberty blocker therapy, females generally resume puberty within 6 to 18 months. This timeline reflects a typical pattern observed in clinical studies, suggesting that the hormonal development and physical changes characteristic of puberty restart within this timeframe.\103\ For males, the resumption of puberty following the discontinuation of puberty blockers usually occurs within a year. This period marks the typical return to the progression of puberty consistent with clinical findings.\104\

\102\ Jean-Claude Carel, M.D. and Juliane L[eacute]ger, M.D., “Precocious puberty,” N Engl J Med 358, no. 22 (2008): 2366-77, https://www.nejm.org/doi/full/10.1056/NEJMcp0800459.

\103\ Vickie Wu et al., “Clinical findings influencing time to menarche post gonadotropin-releasing hormone agonist therapy in central precocious puberty,” Annals of Pediatric Endocrinology & Metabolism 26 (2021): 185-191, https://doi.org/10.6065/apem.2040220.110.

\104\ Marisa M. Fisher et al., “Resumption of puberty in girls and boys following removal of the histrelin implant,” The Journal of Pediatrics 164 (2014): 912-916.e1, doi:10.1016/ j.jpeds.2013.12.009.

Several important limitations apply to this tapering provision. First, it applies only to children enrolled in Medicaid or CHIP who are receiving cross-sex hormone therapy as part of sex-rejecting procedures as of the effective date of this final rule. It does not apply to children who initiate cross-sex hormone therapy after the effective date, and FFP will not be available for any new initiations of these medications for children for sex-rejecting procedures following the effective date. Second, this tapering period applies only to cross-sex hormone therapy medications; it does not extend FFP for surgical sex- rejecting procedures or puberty blocking medications. FFP for such procedures (puberty blockers and surgeries) in Medicaid and CHIP will cease as of the effective date of the final rule. We also note that Federal Medicaid and CHIP funding remains available for mental health counseling and psychotherapy for individuals with gender dysphoria, and State Medicaid and CHIP agencies are encouraged to ensure that beneficiaries transitioning from cross-sex hormone therapy have access to these services throughout and after the tapering off period.

We have considered whether a longer transition period, such as the 12 months recommended by some commenters, would be appropriate. We conclude that a 6-month period strikes the appropriate balance between providing a reasonable period for individuals to consider discontinuing cross-sex hormones and avoiding unnecessarily prolonging the availability of Federal funding for procedures that raise the child safety concerns animating this rule. This timeframe is consistent with approaches taken by several States that have enacted restrictions on sex-rejecting procedures and is sufficient to allow a beneficiary to work with their treating provider to safely taper off of cross-sex hormones. A longer period would be inconsistent with our determination, grounded in the HHS Review and the broader body of evidence discussed in this final rule, that the risk/benefit profile of sex-rejecting procedures for children does not support continued Federal funding, and would unreasonably extend the period during which Federal funds are used to support procedures that we have concluded are not in the best interests of beneficiaries and not consistent with quality of care or with the provision of health care services to uninsured, low-income children in an effective and efficient manner that is coordinated with other sources of health benefits coverage for children.

In the following section, we describe how this final rule will intersect with existing statutory and regulatory provisions. 1. Intersection With Federal Cross-Cutting Nondiscrimination Laws

This final rule is consistent with crosscutting Federal nondiscrimination laws, such as Section 1557 of the Patient Protection and Affordable Care Act (Affordable Care Act),\105\ Section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975.

\105\ The Patient Protection and Affordable Care Act (Pub. L. 111-148, 124 Stat. 119) was enacted on March 23, 2010. The Healthcare and Education Reconciliation Act of 2010 (Pub. L. 111- 152, 124 Stat. 1049), which amended and revised several provisions of the Patient Protection and Affordable Care Act, was enacted on March 30, 2010. In this rulemaking, the two statutes are referred to collectively as the “Patient Protection and Affordable Care Act,” “Affordable Care Act,” or “ACA”.

Section 1557 of the Affordable Care Act prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs or activities, any part of which is receiving Federal financial assistance. A Federal court has considered whether the prohibition on sex discrimination found in section 1557 of the Affordable Care Act includes discrimination on the basis of gender identity. On October 22, 2025, in State of Tennessee v. Kennedy, 807 F. Supp. 3d 613, 629-30 (S.D. Miss. 2025), the district court found that “HHS exceeded its statutory authority when (1) it interpreted Title IX, as incorporated into Section 1557, to prohibit discrimination on the basis of gender identity, and (2) when it implemented Section 1557 regulations concerning gender identity and `gender affirming care.”' Accordingly, the Court vacated the following regulations to the extent that they expand Title IX's definition of sex discrimination to include gender-identity discrimination: 42 CFR 438.3(d)(4), 438.206(c)(2), 440.262, 460.98(b)(3), and 460.112(a), and 45 CFR 92.101(a)(2)(iv), 92.206(b)(1)-(4), 92.207(b)(3) through (5), 92.8(b)(1), 92.10(a)(1)(i), and

92.208.\106\ HHS subsequently issued a public notice that it cannot and will not investigate or enforce compliance with the vacated gender- identity provisions of section 1557.\107\

\106\ As part of a 2024 rulemaking implementing section 1557 of the Affordable Care Act, HHS amended 42 CFR 440.262, 438.3(d) and 438.206(c)(2) to specifically include discrimination based on “gender identity” as a form of “sex discrimination,” and amended 42 CFR 457.495 to cross-reference amended 440.262. The amendments to sections 438.3(d) and 438.206(c)(2) also apply to CHIP managed care through cross references in sections 457.1201(d) and 457.1230(a) that predated the section 1557 rulemaking. These amendments to the Medicaid and CHIP rules were based on sections 1902(a)(4), 1902(a)(19), and 2101(a) of the Act. See Nondiscrimination in Health Programs and Activities, 89 FR 37522 (May 6, 2024). In Tennessee v. Kennedy, 807 F. Supp. 3d 613, 629-630 (S.D. Miss. 2025), the court vacated 42 CFR 440.262, 438.3(d)(4), and 438.206(c)(2) (among others) “to the extent that they expand Title IX's definition of sex discrimination to include gender identity discrimination” and granted the plaintiffs a declaratory judgment that HHS had “exceeded its statutory authority when (1) it interpreted Title IX, as incorporated into Section 1557, to prohibit discrimination on the basis of gender identity, and (2) when it implemented Section 1557 regulations concerning gender identity and `gender affirming care.' ” See also Texas v. Becerra, No. 6:24-CV-211-JDK (E.D. Tex. Aug. 30, 2024), (entering a nationwide stay of certain regulations of the final rule, including 42 CFR 440.262, 438.3(d)(4), and 438.206(c)(2)). Given Skrmetti's holding, we believe that the outcome of this litigation will not affect the final rule. As a result, CMS does not further discuss 42 CFR 440.262, 438.3, and 438.206 in this final rule.

\107\ Notice of Vacatur Regarding Certain Provisions of the 2024 Nondiscrimination in Health Programs and Activities Final Rule, 91 FR 32887 (June 2, 2026) (affecting 45 CFR pts 80, 84, 92, 147, 155 and 156).

In addition, HHS has taken the position, based on the U.S. Supreme Court's holding in Skrmetti, that “regulating medical procedures on the basis of diagnosis does not automatically amount to discrimination on the basis of sex.” \108\ Consistent with that position, as well as the analysis previously set forth in this final rule and expounded upon below, it HHS's view is that this final rule will not discriminate on the basis of sex. As discussed above, in 2023, Tennessee enacted a State law,\109\ SB1, which, in relevant part, prohibits a healthcare provider from performing certain medical procedures, including surgery, and from prescribing puberty blockers, for a child for the purpose of enabling the child to identify with a purported identity inconsistent with the child's sex.\110\ SB1 does not prohibit healthcare providers from providing those procedures if done to treat a child's congenital defect, precocious puberty, disease, or physical injury. In Skrmetti, the U.S. Supreme Court analyzed SB1 under the Equal Protection Clause of the Fourteenth Amendment and held that SB1 did not turn on sex-based classifications and therefore did not warrant heightened scrutiny. In other words, the law did not discriminate on the basis of a protected class. In reaching this conclusion, the Court noted that “the law does not prohibit conduct for one sex that it permits for another.” \111\

\108\ Brief for the United States As Amicus Curiae In Support Of Appellant/Cross-Appellee, L.B. v. Premera Blue Cross, Nos. 25-5803, 25-6143 (9th Cir., filed July 13, 2026).

\109\ Tenn. Code Ann. Sec. 68-33-101 et seq.

\110\ As defined by SB1, “minor” means an individual under eighteen (18) years of age. Tenn. Code Ann. Sec. 68-33-102.

\111\ United States v. Skrmetti, 605 U.S. 495, 514-15 (2025).

Similarly, this final rule will apply uniformly to all children enrolled in Medicaid under age 18 and enrolled in CHIP under age 19 regardless of the child's sex. This final rule will treat all children the same and will prohibit a State Medicaid or CHIP agency from covering, as part of its Federally funded Medicaid program and CHIP, the procedures that the final rule defines as sex-rejecting procedures. At the same time, this final rule will permit State Medicaid and CHIP agencies to continue to cover procedures when the child has a medically verifiable disorder of sexual development, needs the procedure for a purpose other than attempting to align the child's physical appearance or body with an asserted identity that differs from the child's sex, or has complications, including any infection, injury, disease, or disorder that has been caused by or exacerbated by the performance of sex-rejecting procedures. In addition, the rule will continue to provide Federal matching funds for mental health treatment for gender dysphoria, and it does not prohibit States from providing coverage of sex-rejecting procedures using State-only funds.

Further, this final rule is neither arbitrary nor based on an invidious discriminatory purpose. Rather, based on the review of current research and the reasoning for similar conclusions reached and actions taken by multiple European countries discussed previously in this final rule, we continue to believe that Medicaid and CHIP payment of sex-rejecting procedures is not in the best interests of beneficiaries under section 1902(a)(19) of the Act and not consistent with quality of care under section 1902(a)(30)(A) of the Act, the effective and efficient standard under section 2101(a) of the Act, and not appropriate for inclusion in the State's assurance of quality and appropriateness of care under its plan as required under 2102(a)(7)(A) of the Act. We proposed to prohibit Federal funding for these procedures in Medicaid and CHIP. That proposal was based on careful consideration of the facts as described in detail in section I.B. of this final rule and on our determination that the risks of sex- rejecting procedures for children outweigh the benefits based on available evidence. We continue to support Medicaid and CHIP payment for services for children that research shows may be helpful for treating gender dysphoria in children that do not include the risks of harm associated with sex-rejecting procedures, including psychotherapy, for example. Further, while State laws may differ, State Medicaid agencies are not currently specifically prohibited under Federal law from covering sex-rejecting procedures for Medicaid beneficiaries who are 18 years of age and older or for CHIP beneficiaries who are 19 years of age or older, as applicable.

We note that HHS has separately proposed to amend its Section 504 regulations to clarify that gender dysphoria not resulting from physical impairments does not constitute a covered disability.\112\ Regardless of the resolution of that separate rulemaking, this Medicaid and CHIP rule does not categorically exclude care for individuals with gender dysphoria; it limits FFP for specific pharmaceutical and surgical interventions for a specific population while preserving FFP for mental health services, psychotherapy, and other care. A targeted limitation on a specific set of treatments does not constitute discrimination on the basis of disability.

\112\ Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance, 90 FR 59478 (December 19, 2025).

Finally, this final rule is consistent with the Age Discrimination Act of 1975 and section 1557, which prohibits discrimination on the basis of age, among other bases.\113\ The Age Discrimination Act prohibits discrimination based on age in programs receiving Federal financial assistance but explicitly excepts an otherwise prohibited action if it “reasonably takes into account age as a factor necessary to the normal operation or the achievement of any statutory objective of [a] program or activity.” 42 U.S.C. 6103(b)(1)(A). Indeed, each version of HHS's regulations implementing Section 1557 (2016, 2020, and 2024 versions) acknowledge the permissibility of certain age-related

distinctions.\114\ The age distinctions in this rule--limiting FFP for sex-rejecting procedures with respect to children under the applicable age thresholds--are necessary to achieve the statutory objective of protecting Medicaid and CHIP beneficiaries from the risks of irreversible interventions during childhood. These distinctions therefore do not violate the Age Discrimination Act or section 1557's prohibition of discrimination on the basis of age, to the extent that statute applies in this context.

\113\ 42 U.S.C. 18116 (incorporating the grounds prohibited by, and the enforcement mechanisms provided under, 42 U.S.C. 6101 et seq.)

\114\ See 89 FR 37522, 37604-37605 (May 6, 2024); 85 FR 37160, 37177 (June 19, 2020); 81 FR 31375, 31408 (May 18, 2016).

Section 1554 of the Affordable Care Act generally restricts HHS from issuing regulations that hinder access to medical care. In relevant part, section 1554 prohibits rules that create unreasonable barriers to the ability of individuals to obtain appropriate medical care, impede timely access to health care services, violate the ethical standards of health care professionals, or limit the availability of medical treatment throughout the course of a patient's care.\115\ The court in California v. Azar, 950 F.3d 1067, 1094 (9th Cir. 2020) (en banc), explained that section “1554 is meant to prevent direct government interference with health care, not to affect . . . funding decisions.” This holding affirms that the Affordable Care Act's prohibition on creating unreasonable barriers to care is best understood as restricting the Federal Government from affirmatively and unreasonably blocking access to appropriate medical services--not as requiring the Federal Government to fund every type of medical procedure.

\115\ Section 1554(3) to (5) also prohibits rules that interfere with communication regarding a full range of treatment options between patients and providers, limit providers' ability to fully inform patients, or violate principles of informed consent. Because this Rule imposes no limits on communications between health care providers and patients, the limits in these provisions do not apply.

This final rule comports with section 1554. As discussed above, the HHS Review surveyed multiple studies and sources of guidance assessing the risk profile of sex-rejecting procedures; that Review found that certain of these procedures, when performed on children, lack sufficient evidentiary support to conclude that the risks of sex- rejecting procedures for children outweigh the benefits based on available evidence. Given this evidentiary record, the final rule prohibits FFP for sex-rejecting procedures for children. However, the final rule does not place any substantive barrier on individuals' ability to access sex-rejecting procedures with non-Federal funding or on doctors' ability to carry out the same activities with non-Federal funds, if permitted by State law. Moreover, while the limited tapering provision in this rule imposes a 6-month Federal funding limit for certain eligible beneficiaries, those beneficiaries may continue to receive sex-rejecting procedures beyond 6 months with non-Federal funding. Further, this rule does not purport to regulate ethical standards that apply to health care professionals.

Section 1554 of the Affordable Care Act does not prohibit the Federal Government from withholding Federal funding for procedures for which there is insufficient evidence that the risk profile of the procedures meets the statutory requirements for payment (namely that they meet the best interests, quality of care, and effective and efficient standards in sections 1902(a)(19), 1902(a)(30)(A), and 2101(a) of the Act). See California v. Azar, 950 F.3d at 1093 (rejecting section 1554 argument and holding that the Government's funding restrictions on certain activities in the Title X context did not “interfere with appropriate medical care”); see also Fam. Plan. Ass'n of Maine v. U.S. Dep't of Health & Hum. Servs., 466 F. Supp. 3d 259, 270-71 (D. Me. 2020) (Family Planning Association) (rejecting section 1554 challenge to an HHS funding limitation, noting that this provision “does not prevent [HHS] from administering its own health services grant program”). Similar to the funding prohibitions that the courts in California v. Azar and Family Planning Association found were not impermissible under section 1554, this rule establishes no obstacle to the continued availability of relevant services beyond the withdrawal of Federal funding that patients remain free to replace through means other than with Federal funding and outside of the Federal Medicaid program and CHIP. Because the rule does not restrict providers' conduct or patients' ability to access care, this rule falls outside the scope of section 1554's prohibitions. 3. Intersection With Sufficiency of Amount, Duration, and Scope (Sec. 440.230)

This final rule will also be consistent with section 1902(a)(10)(B) and (C)(ii) of the Act and implementing regulations at 42 CFR 440.230, which provides that a Medicaid State plan must specify the amount, duration, and scope of covered services. CMS has long afforded State Medicaid agencies considerable flexibility under 42 CFR 440.230 to establish the amount, duration, and scope of covered Medicaid services under their State plans, and to develop State-specific medical necessity criteria and utilization control procedures for covered services. State-specific limits on amount, duration, and scope are frequently applied based on an assessment of a beneficiary's specific circumstances, rather than being blanket limitations. In addition to specifying the amount, duration, and scope of covered services, historically, States have determined whether, and how, to cover services and CMS has made Federal Medicaid payments to States if the services otherwise complied with Federal law and regulation. Within CHIP, under 42 CFR 457.402(x), States have the ability to pay for additional services if recognized by State law (subject to state licensing and practice supervision requirements).

However, this flexibility under 42 CFR 440.230 is not absolute. &),Regulations at 42 CFR 440.230 require State Medicaid agencies to comply with certain guidelines when determining the amount, duration, and scope of covered services. While States may not arbitrarily deny or reduce the amount, duration, or scope of a required service, they may place limits on services based on criteria related to medical necessity, per 42 CFR 440.230(c) and (d). While medical necessity is not reviewed under a state plan amendment submission, States must detail their proposed coverage of services (such as service definitions, provider types, provider qualifications and limitations) in a State plan amendment and submit the State plan amendment to CMS for approval. We review the State plan amendment to ensure that States meet these guidelines. For example, under 42 CFR 440.230(b), State Medicaid agencies must ensure that any covered service is sufficient in amount, duration, and scope to reasonably achieve its purpose. If a state limits the amount, duration, or scope of a service without exception for medical necessity, the State must explain to us the reasoning and evidence to support the limitation prior to CMS approving the State's submission. The flexibility in CHIP under 42 CFR 457.402(x) is also not absolute. CHIP regulations at 42 CFR 457.60 also require States to submit a State plan amendment when a State is adding or deleting specific categories of benefits under the State plan.

For this final rule, we considered the risk/benefit profile of sex- rejecting procedures for the purposes included in our definition and the alternative

treatments available, before determining that a national response prohibiting Federal Medicaid funding for sex-rejecting procedures for children under age 18 enrolled in Medicaid and under age 19 enrolled in CHIP is warranted. This prohibition applies even when a provider determines that a sex-rejecting procedure is medically necessary for treatment of gender dysphoria.

Lastly, this final rule is consistent with Sec. 440.230(c), which prohibits State Medicaid agencies from arbitrarily denying or reducing the amount, duration, or scope of a covered service to an otherwise eligible beneficiary solely because of the diagnosis, type of illness, or condition. This final rule reflects the agency's efforts to address significant concerns about the risk/benefit profile of sex-rejecting procedures for the uses included in our definition of that term, due to the safety concerns, risks of irreversible harm, long-term health outcomes, and unestablished effectiveness associated with those uses, as explained previously. Our definition of sex-rejecting procedures will exclude from the definition certain uses of these procedures for which the risk/benefit profile creates less significant concerns. Additionally, other treatments, such as mental health treatment, will remain Federally funded for children diagnosed with gender dysphoria.

As discussed previously in this final rule, we considered the concerns of States, providers, and beneficiaries who have relied on CMS making Federal Medicaid and CHIP payment for these services. Notwithstanding the potential financial burden to States, providers, and individuals, and the psychological and physical impact on beneficiaries who wish to receive these services, a nationwide prohibition on Federal Medicaid and CHIP payments for these services for children is warranted based upon the findings of the HHS Review, which revealed a lack of evidentiary support, such that continued Federal payments for the relevant procedures would not be consistent with the statutory standards in sections 1902(a)(19), 1902(a)(30)(A), and 2101(a) of the Act. We believe that the concerns of States, providers and beneficiaries described previously in this final rule are outweighed by the potential harm of sex-rejecting procedures for children, including potential long-term harm, especially when the possible benefits of these services are unproven and the procedures are potentially irreversible. More data is needed on how the procedures that the final rule defines as sex-rejecting procedures in children under age 18 in Medicaid and under age 19 in CHIP affect the long-term health of such individuals, including any impact on fertility, and whether these procedures result in, or increase the risk of, sexual dysfunction, impaired bone density, adverse cognitive impacts and other health deviations, as mentioned previously. 4. Intersection With Early and Periodic Screening, Diagnostic and Treatment (EPSDT)

This final rule is also consistent with States' obligations under the EPSDT requirement. Under EPSDT, States must cover medically necessary services described in section 1905(a) of the Act for most Medicaid eligible children under the age of 21, even if those services are not otherwise available under the State plan. Children eligible for EPSDT generally include beneficiaries under the age of 21 enrolled: in Medicaid through a categorically needy group; in Medicaid through a medically needy group in a State that has elected to include EPSDT in the medically needy benefit package; in a Medicaid-expansion CHIP program; or in a separate CHIP program that has elected to cover EPSDT. This includes beneficiaries with an institutional level of care who are eligible for Medicaid by virtue of their enrollment in a home and community-based services (HCBS) waiver under section 1915(c) of the Act. EPSDT is not available to beneficiaries without satisfactory immigration status who are eligible only for treatment of an emergency medical condition and other groups of individuals under age 21 who are eligible only for limited services as part of their Medicaid eligibility, such as, for example, family planning services.

Under this final rule, sex-rejecting procedures for the uses included in our definition will no longer be Federally funded as Medicaid-covered services for individuals under the age of 18 or as CHIP-covered services for individuals under the age of 19, because, as determined in the HHS Review, such services lack medical necessity and may pose a risk of harm to children, including long-term irreversible harm, and may result in adverse outcomes on their health including infertility/sterility, sexual dysfunction, impaired bone density accrual, adverse cognitive impacts, cardiovascular disease and metabolic disorders, and psychiatric disorders. Notwithstanding the broad mandate of coverage under the EPSDT benefit, States still are required to ensure that any service covered under EPSDT meets medical necessity criteria. See Garrido v. Dudek, 731 F.3d 1152, 1161 (11th Cir. 2013) (concluding that, even though services may be otherwise covered under the EPSDT benefit, a State Medicaid plan still has authority “to make individual medical necessity determinations, in accordance with governing law and regulations”). Under this regulation, States would be required to make medical necessity determinations in the context of the EPSDT benefit consistently with its terms. Subject to very limited exceptions, sex-rejecting procedures as defined in this regulation lack a sufficient evidentiary basis to support individualized medical necessity determinations.

In our EPSDT guidance,116 117 we discussed how States should approach their determination of whether a service is medically necessary. In this guidance, we emphasized that States (or their delegated entity) must take into account the particular needs of the child. We explained that States should consider the child's long-term needs, not just what is required to address the immediate situation. Accordingly, while sex-rejecting procedures have been covered by some State Medicaid programs to address gender dysphoria to alleviate its symptoms, these procedures can involve use of puberty suppressing drugs to prevent the onset of puberty and cross-sex hormones to spur the development of the secondary opposite sex characteristics. For children under 18 (or under 19 in CHIP) who have undergone the suppression of puberty, these procedures may pose a significant risk of harm, including possible long-term harm to a child's health, including the risk of infertility and bone density loss, as discussed previously.

\116\ CMS, “Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Guide for States: Coverage in the Medicaid Benefit for Children,” May 2026, https://www.medicaid.gov/medicaid/benefits/downloads/epsdt-coverage-guide.pdf.

\117\ CMS, State Health Official Letter #24-005, “Best Practices for Adhering to Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Requirements,” September 26, 2024, https://www.medicaid.gov/federal-policy-guidance/downloads/sho24005.pdf.

As discussed previously in this final rule, some State Medicaid programs and CHIPs have relied upon clinical guidelines that have failed to meet the principles of unbiased, evidence-driven clinical guideline development. As a result of this reliance, State Medicaid programs and CHIPs have developed coverage criteria which may not have considered the full effects of all aspects of a child's needs (including long-term needs) as required under EPSDT and as required under other provisions governing Medicaid and CHIP,

including sections 1902(a)(19), 1902(a)(30)(A), and 2101(a) of the Act.

Title XXI of the Act allows States to implement CHIP as a separate CHIP, a Medicaid-expansion program, or a combination of the two. Title XXI-funded Medicaid expansion programs generally follow Medicaid rules. This section relates to separate CHIPs.

States with separate CHIPs receive Federal funding from the title XXI allotment to provide child health assistance through obtaining coverage that meets the requirements of section 2103 of the Act and regulations at Sec. 457.402. Section 2101(a) of the Act calls for the provision of CHIP in a manner that is effective and efficient and coordinated with other sources of health benefits coverage for children. Section 2110(a)(24) of the Act allows States to cover any additional services that are recognized by State law, and section 2110(a)(28) of the Act allows the coverage of additional services specified by HHS, if not otherwise excluded by the CHIP statute. Nothing in section 2103(c) of the Act prevents a State child health plan from covering benefits outside the categories of services described in section 2103(c)(1) and (2) of the Act. Nevertheless, sections 2103(c)(3), 2110(a)(24) and (a)(28) all must be read in the context of section 2102(a)(7)(A) of the Act, which requires that CHIP plans must describe the methods that it will use “to assure the quality and appropriateness of care.” CMS has concluded that it is in the best interest of beneficiaries under age 19 enrolled in CHIP to no longer permit Federal funding when utilized for purposes of sex- rejecting procedures because such services may result in adverse outcomes including infertility/sterility, sexual dysfunction, impaired bone density accrual, diverse cognitive, cardiovascular disease and metabolic disorders, and psychiatric disorders. Therefore, CMS has concluded it is most efficient and effective, and in the best interests of beneficiaries, for CHIP to align and coordinate with the Medicaid program. A State child health plan would therefore not meet the requirements of section 2102(a)(7)(A) of the Act if it provided payment for these procedures because it would not be possible for the State to assure the quality and appropriateness of care under its plan if it provided payment for these services.

Section 2103 of the Act and Sec. 457.410 allow States to choose any of the following four types of health benefits coverage for separate CHIPs: (1) Benchmark coverage in accordance with Sec. 457.420; (2) Benchmark-equivalent coverage in accordance with Sec. 457.430; (3) Existing comprehensive State-based coverage in accordance with Sec. 457.440; and (4) Secretary-approved coverage in accordance with Sec. 457.450. Regardless of the type of health coverage selected by a State, States are required to provide all services identified at Sec. 457.410(b) to children enrolled in CHIP. In addition to these services, States have the flexibility to cover additional services at Sec. 457.402, which lists the services included in “child health assistance.” In addition to the specified services, Sec. 457.402(x) permits states to select additional services and treatments that it will cover, tracking the statutory language of section 2110(a)(24) of the Act. The majority of separate CHIP States have elected Secretary- approved coverage. Under Secretary-approved coverage at Sec. 457.450, the Secretary currently has the discretion to determine whether the coverage provided by a State is appropriate coverage for the population of targeted low-income children covered under the program. Recently, there have also been changes to allowable procedures under the benchmark coverage options for CHIP under Sec. 457.420 as described later in this final rule.

On June 20, 2025, we issued the “Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability,” final rule (90 FR 27074) (referred to hereafter as the “2025 Marketplace final rule”), which prohibits issuers of non-grandfathered individual and small group market health insurance coverage--that is, issuers of coverage subject to the essential health benefit (EHB) requirements--from providing coverage for “specified sex-trait modification procedures” as an EHB beginning with Plan Year 2026. This prohibition was proposed and finalized because section 1302(b)(2)(A) of the Affordable Care Act requires that the scope of the EHB be equal to the scope of benefits provided under a typical employer plan, and coverage of such procedures is not typically included in employer-sponsored plans.\118\ In addition, on January 31, 2025, the U.S. Office of Personnel Management issued letter 2025-01A, which prohibited coverage of certain surgeries and hormone treatments for covered individuals under age 19 in Federal Employees Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) Programs. That letter was amended by letter 2015-01B, issued on August 15, 2025, which eliminated the age limit and advised that for Plan Year 2026, chemical and surgical modification of an individual's sex traits through medical interventions (to include “gender transition” services) will no longer be covered under the FEHB or PSHB Programs. Specifically, it excludes hormone treatments that pertain to chemical and surgical modification of an individual's sex traits (including as part of “gender transition” services) and clarifies that carriers should not exclude coverage for entire classes of pharmaceuticals. For example, “GnRH agonists may be prescribed during [in vitro fertilization], for reduction of endometriosis or fibroids, and for cancer treatment or prostate cancer/tumor growth prevention.” \119\

\118\ 2025 Marketplace Final Rule, 90 FR 27152 (June 25, 2025). While portions of the 2025 Marketplace Final Rule have been challenged, the prohibition on issuers of non-grandfathered individual and small group market health insurance coverage from providing coverage for “specified sex-trait modifications” as an EHB took effect beginning with Plan Year 2026.

\119\ U.S. Office of Personnel Management (OPM) FEHB Program Carrier Letter, Letter Number 2025-01A, “Addendum to Call Letter for Plan Year 2026,” January 31, 2025, https://www.opm.gov/healthcare-insurance/carriers/fehb/2025/2025-1a.pdf. Amended by OPM FEHB Programs Carrier Letter, Letter Number 2025-01B, “Subject: Chemical and Surgical Sex-Trait Modification Services for Plan Year 2026 Proposals,” August 15, 2025, https://www.opm.gov/healthcare-insurance/carriers/fehb/2025/2025-01b.pdf.

As previously noted, section 2101(a) of the Act provides funds to States to enable them to initiate and expand the provision of child health assistance to uninsured, low-income children in an effective and efficient manner that is coordinated with other sources of health benefits coverage for children. As outlined previously in this final rule, while the prohibitions on FFP are not identical, they will effectively result in prohibition of payment of sex-rejecting procedures in both the FEHB Program and as an EHB beginning with Plan Year 2026. Therefore, consistently with these programs, we proposed to add a new section Sec. 457.476 to prohibit Federal financial participation for sex-rejecting procedures under CHIP, to align CHIP with Medicaid, the FEHB Program, and EHBs. Although title XXI of the Act does not apply EHB rules under a separate CHIP, the services which must be covered under title XXI also are EHBs. We noted that similar to Medicaid, this proposed change in CHIP will not prohibit Federal payment for procedures undertaken to treat a child with a medically verifiable disorder of sexual development; for purposes other than attempting to align a child's physical appearance or body with an

asserted identity that differs from the child's sex; or to treat complications, including any infection, injury, disease, or disorder that has been caused by or exacerbated by the performance of sex- rejecting procedures.

We take very seriously the weak evidence base supporting the safety or effectiveness of sex-rejecting procedures in children, and the plausible evidence of the risks of harm, for the purposes included in our definition. Based on these factors, we proposed to prohibit Federal CHIP funds for sex-rejecting procedures for the purposes included in our definition. It is also important to reiterate that these regulatory changes will not prohibit the use of Federal CHIP dollars for mental health treatments for conditions such as gender dysphoria.