Medicare and Medicaid Programs; Hospital Condition of Participation: Prohibiting Sex-Rejecting Procedures for Children

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Part 482</CFR> <DEPDOC>[CMS-3481-P]</DEPDOC> <RIN>RIN 0938-AV87</RIN> <SUBJECT>Medicare and Medicaid Programs; Hospital Condition of Participation: Prohibiting Sex-Rejecting Procedures for Children</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This proposed rule would revise the requirements that Medicare and Medicaid certified hospitals must meet to participate in the Medicare and Medicaid programs. These changes are necessary to protect the health and safety of children and reflect HHS' review of recent information on the safety and efficacy of sex-rejecting procedures (SRPs) on children. The revisions to the requirements would prohibit hospitals from performing sex-rejecting procedures on children. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on February 17, 2026. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code CMS-3481-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. <E T="03">Electronically.</E> You may submit electronic comments on this regulation to <E T="03">http://www.regulations.gov.</E> Follow the “Submit a comment” instructions. 2. <E T="03">By regular mail.</E> You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3481-P, P.O. Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. <E T="03">By express or overnight mail.</E> You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3481-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. For information on viewing public comments, see the beginning of the <E T="02">SUPPLEMENTARY INFORMATION</E> section. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">For press inquiries:</E> CMS Office of Communications, Department of Health and Human Services; email <E T="03">press@cms.hhs.gov.</E> <E T="03">For technical inquiries:</E> CMS Center for Clinical Standards and Quality. Department of Health and Human Services. <E T="03">HospitalSRPInquiries@cms.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Inspection of Public Comments:</E> All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: <E T="03">http://www.regulations.gov.</E> Follow the search instructions on that website to view public comments. CMS will not post on <E T="03">Regulations.gov</E> public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments. <E T="03">Plain Language Summary:</E> In accordance with 5 U.S.C. 553(b)(4), a plain language summary of this proposed rule may be found at <E T="03">https://www.regulations.gov/.</E> <HD SOURCE="HD1">I. Background</HD> On January 28, 2025, President Trump signed Executive Order (E.O.) 14187 “Protecting Children from Chemical and Surgical Mutilation.”  <SU>1</SU> <FTREF/> In particular, Section 5(a) of the order directs the Secretary of HHS consistent with applicable law to “take all appropriate actions to end the chemical and surgical mutilation of children, including regulatory and subregulatory actions, which may involve [. . .]: Medicare or Medicaid conditions of participation or conditions for coverage.” CMS has developed this proposed rule in compliance with this E.O. As further discussed in this proposed rule, we describe CMS' statutory authority related to patient health and safety standards (known as Medicare “Conditions of Participation” (CoPs), “Conditions for Coverage” (CfCs), or simply “Requirements”), summarize data on the rise of sex-rejecting procedures (SRPs) on children, review the latest information on SRPs in children as described in the HHS Review (the Review), provide an overview of State laws, as well as prior CMS actions on this topic. We propose to add a new section to 42 CFR part 482, subpart C that would prohibit Medicare-participating hospitals from performing sex-rejecting procedures (SRPs) on any child (§ 482.46(a)). <FTNT> <SU>1</SU>  “Protecting Children from Chemical and Surgical Mutilation.” <E T="03">The White House,</E> 28 Jan. 2025, <E T="03">https://www.whitehouse.gov/presidential-actions/2025/01/protecting-children-from-chemical-and-surgical-mutilation/.</E> </FTNT> <HD SOURCE="HD2">A. Statutory Authority</HD> CMS has broad statutory authority under the Social Security Act (the Act) to establish health and safety regulations, which includes the authority to establish requirements that protect the health and safety of children. Section 1861(e)(9) of the Act, applicable to hospitals that participate in the Medicare program, explicitly gives CMS the authority to enact regulations that the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in a hospital, while section 1871 of the Act gives CMS the authority to prescribe regulations as necessary to carry out the administration of the program. Under this authority, the Secretary has established regulatory requirements that a hospital must meet to participate in Medicare at 42 CFR part 482, entitled “Conditions of Participation” for Hospitals. Section 1905(a) of the statute provides that Medicaid payments from States may be applied to hospital services. Under regulations at §§ 440.10(a)(3)(iii) and 440.20(a)(3)(ii), hospitals that provide inpatient and outpatient services, respectively, to Medicaid enrollees are required to meet the Medicare CoPs to also participate in Medicaid. In this way, the CoPs regulate the safety of all patients in a facility that is subject to 42 CFR part 482, regardless of payor (for example, Medicare, Medicaid, private insurance, and self-pay). The CoPs for hospitals include specific, process-oriented requirements for certain hospital services or departments. The purposes of these conditions are to protect patient health and safety and to ensure that quality care is furnished to all patients in Medicare-participating hospitals. <HD SOURCE="HD2">B. Sex-Rejecting Procedures for Children With Gender Dysphoria</HD> <HD SOURCE="HD3">1. The Rise of Chemical and Surgical Interventions for Children as Part of Sex-Rejecting Procedures for Gender Dysphoria</HD> Gender dysphoria is a condition defined by the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) as a “marked incongruence between one's experienced/expressed gender and assigned gender” that “must also be associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning.”  <E T="51">2 3</E> <FTREF/> Over the past decade, increasing numbers of children have been diagnosed with gender dysphoria and been treated with SRPs. <E T="51">4 5</E> <FTREF/> SRPs can encompass a range of hormonal and surgical interventions: pharmacological interventions including puberty blocking medications to delay the onset of puberty, cross-sex hormone therapy to promote secondary sexual characteristics associated with the opposite biological sex, and surgical procedures (such as chest/breast and genital surgery). <E T="51">6 7</E> <FTREF/> <FTNT> <SU>2</SU>  Coleman, E., et al. “Standards of Care for the Health of Transgender and Gender Diverse People, Version 8.” <E T="03">International Journal of Transgender Health,</E> vol. 23, suppl. 1, 2022, pp. S1-S259. <E T="03">Taylor & Francis Online,</E> doi:10.1080/26895269.2022.2100644. <SU>3</SU>  American Psychiatric Association. <E T="03">Diagnostic and Statistical Manual of Mental Disorders.</E> 5th ed. Edition, Text Revision, American Psychiatric Publishing,2022, <E T="03">https://doi.org/10.1176/appi.books.9780890425787.</E> </FTNT> <FTNT> <SU>4</SU>  Coleman Eli, et. al., “Standards of Care for the Health of Transgender and Gender Diverse People, Version 8.” <E T="03">International Journal of Transgender Health,</E> vol. 23, suppl. 1, 2022 pp. S1-S259. <E T="03">Taylor & Francis Online, https://www.tandfonline.com/doi/pdf/10.1080/26895269.2022.2100644.</E> <SU>5</SU>  Hembree, Wylie C., et al., “Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline.” <E T="03">The Journal of Clinical Endocrinology &amp; Metabolism,</E> <E T="03">https://academic.oup.com/jcem/article/102/11/3869/4157558.</E> </FTNT> <FTNT> <SU>6</SU>  Coleman, Eli, et al. “Standards of Care for the Health of Transgender and Gender Diverse People, Version 8.” <E T="03">International Journal of Transgender Health,</E> vol. 23, suppl. 1, 2022, pp. S1-S259. <E T="03">Taylor & ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 115k characters. 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