[Federal Register Volume 90, Number 242 (Friday, December 19, 2025)]
[Proposed Rules]
[Pages 59463-59478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-23465]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 482
[CMS-3481-P]
RIN 0938-AV87
Medicare and Medicaid Programs; Hospital Condition of
Participation: Prohibiting Sex-Rejecting Procedures for Children
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: 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.
DATES: 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.
ADDRESSES: In commenting, please refer to file code CMS-3481-P.
[[Page 59464]]
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. 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. By express or overnight mail. 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 SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
For press inquiries: CMS Office of Communications, Department of
Health and Human Services; email [email protected].
For technical inquiries: CMS Center for Clinical Standards and
Quality. Department of Health and Human Services.
[email protected].
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: 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: http://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov 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.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
plain language summary of this proposed rule may be found at https://www.regulations.gov/.
I. Background
On January 28, 2025, President Trump signed Executive Order (E.O.)
14187 ``Protecting Children from Chemical and Surgical Mutilation.''
\1\ 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 (Sec.
482.46(a)).
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\1\ ``Protecting Children from Chemical and Surgical
Mutilation.'' The White House, 28 Jan. 2025, https://www.whitehouse.gov/presidential-actions/2025/01/protecting-children-from-chemical-and-surgical-mutilation/.
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A. Statutory Authority
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 Sec. Sec. 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.
B. Sex-Rejecting Procedures for Children With Gender Dysphoria
1. The Rise of Chemical and Surgical Interventions for Children as Part
of Sex-Rejecting Procedures for Gender Dysphoria
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.'' 2 3
Over the past decade, increasing numbers of children have been
diagnosed with gender dysphoria and been treated with
SRPs.4 5 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
[[Page 59465]]
characteristics associated with the opposite biological sex, and
surgical procedures (such as chest/breast and genital
surgery).6 7
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\2\ Coleman, E., et al. ``Standards of Care for the Health of
Transgender and Gender Diverse People, Version 8.'' International
Journal of Transgender Health, vol. 23, suppl. 1, 2022, pp. S1-S259.
Taylor & Francis Online, doi:10.1080/26895269.2022.2100644.
\3\ American Psychiatric Association. Diagnostic and Statistical
Manual of Mental Disorders. 5th ed. Edition, Text Revision, American
Psychiatric Publishing,2022, https://doi.org/10.1176/appi.books.9780890425787.
\4\ Coleman Eli, et. al., ``Standards of Care for the Health of
Transgender and Gender Diverse People, Version 8.'' International
Journal of Transgender Health, vol. 23, suppl. 1, 2022 pp. S1-S259.
Taylor & Francis Online, https://www.tandfonline.com/doi/pdf/10.1080/26895269.2022.2100644.
\5\ Hembree, Wylie C., et al., ``Endocrine Treatment of Gender-
Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical
Practice Guideline.'' The Journal of Clinical Endocrinology &
Metabolism, vol. 102, no. 11 (13 September 2017, pp. 3869-3903,
https://academic.oup.com/jcem/article/102/11/3869/4157558.
\6\ Coleman, Eli, et al. ``Standards of Care for the Health of
Transgender and Gender Diverse People, Version 8.'' International
Journal of Transgender Health, vol. 23, suppl. 1, 2022, pp. S1-S259.
Taylor & Francis Online, https://doi.org/10.1080/26895269.2022.2100644.
\7\ Hembree, Wylie C., et. al. ``Endocrine Treatment of Gender-
Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical
Practice Guideline.'' The Journal of Clinical Endocrinology &
Metabolism. vol. 102, no. 11, 1 November 2017, https://academic.oup.com/jcem/article/102/11/3869/4157558.
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The recorded prevalence of SRPs for children with gender dysphoria
varies across sources. A study published in 2023 estimated that between
2016 and 2020, nearly 3,700 children aged 12 to 18 years old diagnosed
with gender dysphoria underwent SRPs (2.50 per 100,000),\8\ including
an estimated 3,200 chest/breast procedures (2.17 per 100,000) \9\ and
400 genital surgeries (0.27 per 100,000).10 11 Another study
documented that almost 0.2 percent (or almost 2 in every 1,000) of 17-
year-olds \12\ with private insurance received SRP hormone treatment
between 2018 through 2022.13 14
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\8\ CMS calculation: The annual number of overall SRPs (Breast/
chest surgery, genital surgery, and other cosmetic procedures) on
children aged 12 to 18 years is 740. The annual estimated number of
children aged 12 to 18 according to U.S, Census Bureau data is
29,600,770. This results in annual estimate of 2.17 chest/breast
procedures per 100,000 children aged 12 to 18 ((643/29,600,770) x
100,000 =2.50)). This calculation assumes 1 SRP per person.
\9\ CMS calculation: The annual number of breast/chest surgeries
on children aged 12 to 18 years is 643. The annual estimated number
of children aged 12 to 18 according to U.S, Census Bureau data is
29,600,770. This results in annual estimate of 2.17 breast/chest
surgeries per 100,000 children aged 12 to 18 ((643/29,600,770) x
100,000 =2.17)). This calculation assumes 1 breast/chest surgery per
person.
\10\ CMS calculation: The annual number of genital surgeries on
children aged 12 to 18 years is 81. The annual estimated number of
children aged 12 to 18 according to U.S. Census Bureau data is
29,600,770. This results in annual estimate of 0.27 genital
procedures per 100,000 children aged 12 to 18 ((81/29,600,770) x
100,000 =0.27)). This calculation assumes 1 genital surgery is done
per person.
\11\ Wright J. D., et al. ``National estimates of gender-
affirming surgery in the US.'' JAMA Network Open, vol. 6, no. 8,
e2330348, 23 Aug. 2023, http://jamanetwork.com/journals/jamanetworkopen/fullarticle/2808707.
\12\ CMS calculation: Per the article, the highest rate of
hormone treatment occurs at age 17 with 140 AFAB adolescents
(assigned female at birth) receiving testosterone (per 100,000 is
0.14% (140/100,000) x100=0.14%)) and 82 AMAB adolescents (assigned
male at birth) receiving estrogen (per 100,000 is 0.082% (82/
100,000) x100 =0.082%). This results in 222 (82+140= 222) per
100,000 or 0.222 (0.14% + 0.082% = 0.222). This calculation assumes
1 sex rejecting hormone treatment is done per person.
\13\ Hughes Landon D., et al., ``Gender-affirming medications
among transgender adolescents in the US.'' JAMA Pediatrics, 179,3
(2025): 342-344. doi:10.1001/jamapediatrics.2024.6081, https://pubmed.ncbi.nlm.nih.gov/39761053.
\14\ CMS calculation: 140 + 82 = 222. This results in an
estimate of 222 SRP hormone treatment per 100,000 children aged 17,
between 2018 through 2022. This calculation assumes 1 SRP hormone
treatment is done per person.
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While Medicare does not pay for a significant number of SRP
procedures for children, we conclude that, based on the previously
cited data, hospitals that participate in Medicare perform a
considerable number of these procedures every year. We further note
that the Medicare hospital CoPs apply to hospitals providing services
to patients receiving Medicaid covered services ((Sec. Sec.
440.10(a)(3)(iii) and 440.20(a)(3)(ii)). Approximately half of U.S.
children receive health care through Medicaid.
2. Medical Evidence Regarding Sex-Rejecting Procedures in Children
The rising numbers of children seeking and receiving SRPs in recent
years \15\ has spurred ongoing debates regarding the safety and
efficacy of these interventions.
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\15\ Wright, Jason D., et al.. ``National Estimates of Gender-
Affirming Surgery in the US.'' JAMA Network Open, vol. 6, no. 8, 23
Aug. 2023, doi:10.1001/jamanetworkopen.2023.30348, http://jamanetwork.com/journals/jamanetworkopen/fullarticle/2808707.
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a. The HHS Review
In compliance with Executive Order (E.O.) 14187, ``Protecting
Children from Chemical and Surgical Mutilation'' \16\ signed on January
28, 2025 (as discussed previously in this proposed rule), HHS released
a preliminary comprehensive review of the evidence and best practices
for treating pediatric gender dysphoria on May 1, 2025.\17\ On November
19, 2025, HHS published a final version following the conclusion of a
peer review process.\18\ the Review provides an overview of systematic
reviews--also known as an ``umbrella review''--to evaluate the evidence
of the benefits and harms of SRPs in children. Several existing
systematic reviews of evidence that have informed health authorities in
Europe were assessed for methodological quality.
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\16\ 90 FR 8771 (February 3, 2025).
\17\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office Of Population Affairs, 1 May 2025.
https://opa.hhs.gov/gender-dysphoria-report.
\18\ U.S. Department of Health and Human Services (HHS),
``Treatment for Pediatric Gender Dysphoria: Review of Evidence and
Best Practices.'' HHS Office of Population Affairs,19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report.
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The Review itself does not provide clinical or policy
recommendations. Instead, it analyzes evidence and best practices for
children experiencing gender dysphoria. The Review also contains an
ethics review that applies widely accepted principles of medical ethics
to the practice of SRPs in children.\19\ Accordingly, the Review
states:
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\19\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria: Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025,
https://opa.hhs.gov/gender-dysphoria-report, Pg. 218-246.
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``As demonstrated throughout this Review, the presuppositions that
guide [pediatric medical transition (PMT)] have not been shown to be
valid; the nature, probability and magnitude of risks associated with
PMT have not been distinguished with sufficient clarity; PMT
proponents' estimates of the probability of harm and benefit have not
been shown to be reasonable, as judged by known facts and available
studies; and the risks of serious impairment that PMT involves have not
been shown to be justified. For these reasons, administering PMT to
adolescents, even in a research context, is in tension with well-
established ethical norms for human subjects research.'' \20\
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\20\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria: Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025,
https://opa.hhs.gov/gender-dysphoria-report, Pg., 246.
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The Review (as further discussed in Section I.B.c. of this proposed
rule) provides evidence of the clinical realities of SRPs in the United
States, documenting the abandonment of medical guardrails. For example,
the Review highlights how a protocol establishing SRPs in minors
originated in the Netherlands and quickly spread to other Western
countries without rigorous testing, and was codified in medical
guidelines, which later did away with some of their already contested
safeguards.\21\ The Endocrine Society (ES) incorporated puberty
blockers and hormones into their 2009 and 2017 clinical practice
guidelines, recommending hormonal interventions for certain pediatric
patients with gender dysphoria while also acknowledging the lack of
reliable evidence for these treatments.\22\ ES justified this
recommendation in a ``values and preferences'' statement that places a
higher priority on ``avoiding a[n] unsatisfactory physical outcome when
secondary sex characteristics have
[[Page 59466]]
become manifest and irreversible'' than on ``avoiding potential harm
from early pubertal suppression.'' \23\
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\21\ Biggs, M. (2023b). The Dutch Protocol for juvenile
transsexuals: Origins and evidence. Journal of Sex & Marital
Therapy, 49(4), 348-368.
\22\ Hembree, Wylie C., et al. ``Endocrine treatment of
transsexual persons: An Endocrine Society clinical practice
guideline.'' Journal of Clinical Endocrinology & Metabolism, vol.
94, 9, 2009: 3132-52/doi:10.1210/jc.2009-0354.
\23\ Hembree, Wylie C., et al. ``Endocrine treatment of gender-
dysphoric/gender-incongruent persons: An Endocrine Society clinical
practice guideline. Endocrine Practice,'' 23(12), 2017: 1437-1437.
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The World Professional Association for Transgender Health (WPATH)
endorsed a similar approach and most recently recommend these in their
Standards of Care, Version 8 (SOC-8).\24\ However, as carefully
documented in the Review, the creation of SOC-8 marked ``a clear
departure from the principles of unbiased, evidence-driven clinical
guideline development.'' \25\ The HHS Review cites court documents
containing internal WPATH communications used when developing SOC-8
that show WPATH suppressed systematic reviews of evidence after
learning that these reviews would not support its preferred medical
approach. WPATH also failed to manage conflicts of interest and
eliminated age minimums for hormones and most surgeries due to
political pressures.\26\ A recent systematic review of international
guidelines did not recommend either the WPATH or ES guidelines for
clinical use after determining they ``lack developmental rigour and
transparency.'' \27\
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\24\ Coleman, Eli, et al. ``Standards of Care for the Health of
Transsexual, Transgender, and Gender-Nonconforming People, Version
7.'' International Journal of Transgenderism, 13(4), 165-232.
\25\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report,, p. 181.
\26\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, p. 157-186.
\27\ Taylor, Jo, et al. ``Interventions to suppress puberty in
adolescents experiencing gender dysphoria or incongruence: A
systematic review.'' Archives of Disease in Childhood, vol. 109,
Suppl. 2, s33-s47, 30 Oct. 2024, doi:10.1136/archdischild-2023-
326669.
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b. International Reviews of SRPs in Children
The Review also describes practice reversals in several European
countries (Norway, Finland, Sweden, Denmark, United Kingdom) following
systematic reviews of evidence.
In 2020, Finland's Council for Choices in Health Care, a monitoring
agency for the country's public health services, issued guidelines
stating that ``gender reassignment of minors is an experimental
practice.'' While not banning SRPs outright, the guidelines state
``based on studies examining gender identity in minors, hormonal
interventions [puberty blockers, hormone therapy] may be considered
before reaching adulthood in those with firmly established transgender
identities, but it must be done with a great deal of caution, and no
irreversible treatment should be initiated.'' \28\ For children with
gender dysphoria prior to and worsening at the onset of puberty, the
report recommends that ``puberty suppression treatment [that is,
puberty blockers] may be initiated on a case-by-case basis after
careful consideration and appropriate diagnostic examinations if the
medical indications for the treatment are present and there are no
contraindications.'' This is similar to past recommendations, and as
before, these treatments would be limited to research settings for
payment by the nation's health service. For children with gender
dysphoria that have undergone puberty, the guidelines recommend that
decisions regarding initiation of hormone treatment that alter sex
characteristics be ``based on thorough, case-by-case consideration, [.
. .] [and] only if it can be ascertained that their identity as the
other sex is of a permanent nature and causes severe dysphoria [. . .]
and that no contraindications [that is, mental health conditions] are
present.'' Previously, recommendations noted that hormone therapy
should not begin before age 16 in this group and that patients under 18
may receive 3 to 6 months of puberty blockers prior to beginning
hormone therapy. The current report mentions no age or month specific
treatment guidelines. The report continues to recommend that all such
interventions be done in a research setting. The report adds that
``[i]nformation about the potential harms of hormone therapies is
accumulating slowly and is not systematically reported'' and calls for
further rigorous research of the benefits and risks of these
treatments. Consistent with past recommendations, the report adds that
``surgical treatments are not part of the treatment methods for
dysphoria caused by gender-related conflicts in minors.'' \29\
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\28\ Council for Choices in Health Care Finland. ``Finnish 2020
COHERE Guidelines for Minors Finland)'' certified translation. IFTCC
Archives, 2020, https://archive.iftcc.org/finnish-2020-cohere-guidelines-minors-finland-certified-translation.
\29\ Council for Choices in Health Care Finland. ``Finnish 2020
COHERE Guidelines for Minors Finland)'' certified translation. IFTCC
Archives, 2020, https://archive.iftcc.org/finnish-2020-cohere-guidelines-minors-finland-certified-translation.
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In 2022, Sweden's National Board of Health and Welfare (NBHW)
reviewed and updated its guidelines for treatment of children with
gender dysphoria.30 31 At the population level, NBHW issued
``weak, negative recommendation as guidance to the healthcare system''
that the risks of hormone treatment (which included gonadotropin
releasing hormones (GnRH) also known as puberty blockers) and
mastectomy likely outweigh the expected benefits for most adolescents.
NBHW concludes that ``existing scientific evidence is insufficient for
assessing the effects of puberty suppressing and gender-affirming
hormone therapy on gender dysphoria, psychosocial health and quality of
life of adolescents with gender dysphoria.'' While not banning access
to SRPs, NBHW suggests restricting such treatments to exceptional
circumstances or research settings, and adhering to the original
``Dutch protocol'' criteria including ``existence of the incongruence
since childhood, the stability of gender identity over time, clear
distress caused by the onset of puberty, and the absence of factors
that complicate the diagnostic assessment.'' \32\ The report did not
discuss SRP surgeries aside from mastectomy.
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\30\ The National Board of Health and Welfare (Socialstyrelsen).
``Care of children and adolescents with gender dysphoria: Summary of
National Guidelines.'' Dec. 2022. https://www.socialstyrelsen.se/publikationer/care-of-children-and-adolescents-with-gender-dysphoria--summary-of-national-guidelines--december-2022-2023-1-8330.
\31\ The 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.'' 16 Dec. 2022. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/kunskapsstod/2022-12-8302.pdf.
\32\ The National Board of Health and Welfare (Socialstyrelsen).
``Care of children and adolescents with gender dysphoria-summary of
national guidelines.'' Dec 2022, https://www.socialstyrelsen.se/publikationer/care-of-children-and-adolescents-with-gender-dysphoria--summary-of-national-guidelines--december-2022-2023-1-8330/.
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In the United Kingdom, the National Health Service (NHS)
commissioned a comprehensive review of the existing literature on SRPs
and the prevailing service model. The 4-year independent evaluation of
pediatric gender medicine (PGM), known as the ``Cass Review,'' was
published by Dr. Hilary Cass in April 2024. The Cass review concluded
that the evidence base for SRPs in children is ``remarkably weak'' and
recommended restructuring of the service model towards prioritization
of psychotherapy.\33\
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\33\ Cass, Hilary ``Cass Review Final Report.'' The National
Archives, Apr. 2024, https://cass.independent-review.uk/home/publications/final-report.
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In terms of research quality, the Cass Review notes that the number
of studies on gender dysphoria treatment in children is very low, with
small study sizes that have inconsistent metrics, low
[[Page 59467]]
quality methods (uncontrolled observational studies), results of low
certainty, and lack of longitudinal data (that is, do not follow youth
into adulthood; average duration of hormone treatment is between 1 year
and 5.8 years). The Cass Review notes that this weak evidence base
makes conclusions regarding the benefits versus risk of gender
dysphoria treatment in children extremely difficult to assess. The Cass
Review also critiques WPATH guidelines, noting that WPATH's own
systemic review acknowledges a high risk of bias in study designs,
small sample sizes, and confounding variables.
Regarding guideline development, the Cass Review notes that most
current guidelines have not followed the international standards for
guideline development, including the WPATH guidelines. As such, the
Cass Review only recommends two guidelines: the Finnish guideline
(2020) and the Swedish guideline (2022) as discussed above. However,
the Cass Review notes that even these guidelines lack clear
recommendations regarding certain aspects of practice and ``would be of
benefit if they provided more detailed guidance on how to implement
recommendations.''
While not banning access to puberty blockers, Dr. Cass concluded in
a July 2023 letter that ``because of the potential risks to
neurocognitive development, psychosexual development and longer-term
bone health, [puberty blockers] should only be offered under a research
protocol [for treatment of pediatric gender dysphoria].'' NHS England
and National Institute for Health and Care Research (NIHR) have enacted
this recommendation as of December 2024. Exceptions are permitted for
non-gender dysphoria-related medical conditions (i.e. precocious
puberty) and for those patients already on treatment.\34\ For hormone
interventions, the Cass Review highlights a lack of high-quality
research assessing the (long-term) outcomes of hormone interventions in
children with gender dysphoria. Given this weak evidence base, Dr. Cass
notes that ``no conclusions can be drawn about the effect [of hormone
interventions] on gender dysphoria, body satisfaction, psychosocial
health, cognitive development, or fertility. Uncertainty remains about
the outcomes for height/growth, cardiometabolic and bone health.'' the
Cass Review ultimately calls for caution, better research (prospective
studies with long-term outcome data), honest communication with
patients about the limitations of current knowledge, and development of
evidence-based guidelines that acknowledge the limitations of current
evidence. Of note, in the United Kingdom, children have never received
gender dysphoria related surgery as paid by the NHS; Cass therefore did
not systemically review evidence for gender dysphoria related surgeries
in children.
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\34\ Department of Health and Social Care. ``Ban on puberty
blockers to be made indefinite on experts' advice.''GOV.UK, 11 Dec.
2024. https://www.gov.uk/government/news/ban-on-puberty-blockers-to-be-made-indefinite-on-experts-advice.
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Norway and Denmark are exploring or have enacted similar
restrictions, though neither have issued direct bans of SRPs. In 2023,
the Norwegian Commission for the Investigation of Health Care Services
(Ukom), an independent State-owned agency, made recommendations on the
treatment for youth with gender dysphoria.\35\ The recommendations
consisted of: defining SRPs (that is, puberty blockers, hormonal
therapies, and surgical treatment) as ``experimental treatment,''
revising national guidelines based on a systematic knowledge summary,
and consideration for a national registry to improve quality and reduce
variation in patient treatment.While not banning access to SRPs,
Norway's public health authorityhas signaled an intention torespond to
UKOM's concerns with an adjustment to the current treatment
guidelines.\36\ While also not banning access to SRPs, Denmark has also
taken a cautious approach to hormone interventions (that is, puberty
blockers and cross-sex hormones) pending more evidence of its
beneficial effects becoming available.\37\ Notably, Denmark does not
offer surgical treatment to children with gender dysphoria before age
18 as paid for by its national health service.\38\ Other countries that
have considered or restricted various gender dysphoria treatments for
children include Italy,\39\ Brazil,\40\ New Zealand,\41\ and
Australia.\42\
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\35\ 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.
\36\ Block, Jennifer. ``Norway's guidance on paediatric gender
treatment is unsafe, says review,'' BMJ (Clinical research ed.) vol.
380 697, 23 Mar. 2023, doi:10.1136/bmj. p697.
\37\ Hansen, Mette Vinther et al., ``Sundhedsfaglige tilbud til
b[oslash]rn og unge med k[oslash]nsubehag [Healthcare services for
children and adolescents with gender dysphoria],'' Ugeskrift for
Laeger [The Journal of the Danish Medical Association] 3 July 2023,
https://ugeskriftet.dk/videnskab/sundhedsfaglige-tilbud-til-born-og-unge-med-konsubehag.
\38\ Hansen, Mette Vinther et al., ``Sundhedsfaglige tilbud til
b[oslash]rn og unge med k[oslash]nsubehag [Healthcare services for
children and adolescents with gender dysphoria],'' Ugeskrift for
Laeger [The Journal of the Danish Medical Association] 3 July 2023,
https://ugeskriftet.dk/videnskab/sundhedsfaglige-tilbud-til-born-og-unge-med-konsubehag.
\39\ Armellini, Alvise. ``Italy moves to tighten controls on
gender-affirming medical care for minors.'' Reuters. 5 Aug. 2025.
https://www.reuters.com/business/healthcare-pharmaceuticals/italy-moves-tighten-controls-gender-affirming-medical-care-minors-2025-08-05.
\40\ AFP. ``Brazil prohibits hormone therapy for transgender
minors.'' MSN News. 17 Apr. 2025. https://www.msn.com/en-in/news/other/brazil-prohibits-hormone-therapyfor-transgender-minors/ar-AA1D66l7.
\41\ Corlett, Eva. ``New Zealand Bans Puberty Blockers for Young
Transgender People.'' The Guardian, Guardian News and Media, 19 Nov.
2025, https://www.theguardian.com/world/2025/nov/19/new-zealand-bans-new-prescriptions-of-puberty-blockers-for-young-transgender-people.
\42\ Australian Associated Press. ``Queensland halts
prescription of puberty blockers and hormones for children with
gender dysphoria.'' The Guardian, 28 Jan. 2025. https://www.theguardian.com/australia-news/2025/jan/28/queensland-halts-prescription-of-puberty-blockers-and-hormones-for-children-with-gender-dysphoria.
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c. Medical Professional Societies Supporting SRPs
We are aware that major medical organizations \43\ (including the
American Medical Association (AMA),\44\ the American Academy of
Pediatrics (AAP),\45\ and the American Psychological Association
46 47) have issued statements supporting access to SRPs,
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.\48\ We reviewed
[[Page 59468]]
each of these documents and agree with the HHS Review that discusses
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 are very low quality and
should not be implemented.\49\
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\43\ Advocates For Trans Equality. ``Medical Organization
Statements.'' A4TE's Trans Health Project, https://transhealthproject.org/resources/medical-organization-statements/.
\44\ ``Clarification of Evidence-Based Gender-Affirming Care H-
185.927,'' American Medical Association Policy Finder, American
Medical Association, 2024, https://policysearch.ama-assn.org/policyfinder/detail/%22Clarification%20of%20Evidence-Based%20Gender-Affirming%20Care%22?uri=%2FAMADoc%2FHOD-185.927.xml.
\45\ Alyson Sulaski Wyckoff, ``AAP continues to support care of
transgender youths as more states push restrictions,'' AAP News, 6
Jan. 2022, https://publications.aap.org/aapnews/news/19021/AAP-continues-to-support-care-of-transgender.
\46\ ``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.
\47\ ``Criminalizing Gender Affirmative Care with Minors,''
American Psychological Association, accessed September 2, 2025,
https://www.apa.org/topics/lgbtq/gender-affirmative-care.
\48\ The American Academy of Pediatrics' (AAP) 2018 Policy
Statement was reaffirmed in 2023 (Rafferty et al., 2018); the
Endocrine Society's (ES) published in 2017 represents the most
recent published version (Hembree et al., 2017); the World
Professional Association for Transgender Health's (WPATH) most
recent clinical practice guideline is Standards of Care, Version 8
(SOC-8) (Coleman et al., 2022).
\49\ HHS Review pg. 141.
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As the HHS Review notes 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. 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.'' \50\
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\50\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, pg. 15.
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The Endocrine Society (ES) issued clinical practice guidelines in
2017 entitled ``Endocrine Treatment of Gender-Dysphoric/Gender-
Incongruent Persons.'' \51\ As the HHS Review notes:
---------------------------------------------------------------------------
\51\ 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.
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``In WPATH and ES guidelines, the principal goal of CSH
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 argued that perceived
identity does not alter physiological processes and that such a belief
can result in inappropriate and potentially dangerous hormone dosing.''
\52\
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\52\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 124.
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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.'' \53\
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\53\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 147.
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As explained in Chapter 9 of HHS Review, the guidelines issued by
the World Professional Association for Transgender Health (WPATH)
``have been rated among the lowest in quality and have not been
recommended for implementation by systematic reviews (SRs) of
guidelines.'' \54\ 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.'' \55\ In 2022, WPATH issued guidelines entitled
``Standards of Care for the Health of Transgender and Gender Diverse
People, Version 8'' (SOC-8).\56\ These guidelines relaxed eligibility
criteria for children to access sex-rejecting procedures and ultimately
recommends 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, ``in 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.'' \57\ 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.\58\
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\54\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, pg. 157.
\55\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, pg. 157.
\56\ E. Coleman et al., ``Standards of Care for the Health of
Transgender and Gender Diverse People, Version 8.'' International
Journal of Transgender Health, vol. 23, suppl. 1, 2022, pp. S1-S259.
Taylor & Francis Online, https://doi.org/10.1080/26895269.2022.2100644.
\57\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 14.
\58\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 165.
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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.'' \59\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.'' \60\ Because
SOC-8 defines transgender in a similar way (``people whose gender
identities and/or gender expressions are not what is typically
[[Page 59469]]
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.'' \61\
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\59\ E. Coleman et al., ``Standards of Care for the Health of
Transgender and Gender Diverse People, Version 8.'' International
Journal of Transgender Health, vol. 23, suppl. 1, 2022, pp. S1-S259.
Taylor & Francis Online, https://doi.org/10.1080/26895269.2022.2100644.
\60\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 194.
\61\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 194-195.
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While AMA and the AAP have not issued their own treatment
guidelines, they support the ES and WPATH guidelines, as discussed
previously in this proposed rule. AAP issued a policy statement in 2018
supporting the use of puberty blockers, cross-sex hormones, and
surgeries for minors.\62\ In support of sex-rejecting surgeries, AAP
stated that while ``current protocols [(ES, WPATH)] 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.'' The AAP
reaffirmed its policy statement in 2023 but also stated that it was
conducting its own review of the evidence and guideline development--
which still has not been released.\63\
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\62\ Rafferty, Jason, et al. ``Ensuring Comprehensive Care and
Support for Transgender and Gender-Diverse Children and
Adolescents.'' Pediatrics, vol. 142, no. 4, 1 Oct. 2018,
doi:10.1542/peds.2018-2162.
\63\ Wyckoff, Alyson Sulaski. ``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.
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Regarding the AAP policy statement, the HHS Review states:
``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 [gender dysphoria].\64\ Because the document offers
extensive clinical recommendations regarding every step of PMT--from
social transition to PBs [puberty blockers], CSH [cross-sex hormones],
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 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.'' \65\
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\64\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 148.
\65\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 148, 149.
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We solicit comment of any published peer-reviewed findings that
measure the effects of restrictions similar to those in this proposed
rule on insurers, providers, and patients in international settings as
well as the U.S.
3. U.S. Legal Landscape Regarding Sex-Rejecting Procedures
The United States has seen a high level of activity both at the
State level and within the judicial system on this topic in recent
years.
a. U.S. State Laws
Several States and territories have adopted laws reflecting their
views of the evidence on SRPs for children with 28 restricting and 15
protecting this treatment. As of August 2025, 27 States and one
territory have laws limiting or prohibiting some or all SRPs for
children.\66\ 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. Of these, 2 States'
laws or policies (Montana and Arkansas) are pending resolution of
ongoing legal challenges (as of August 2025).
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\66\ Dawson, L., Kates, J. ``Policy Tracker: Youth Access to
Gender Affirming Care and State Policy Restrictions.'' KFF, 21 Aug.
2025 [24 Nov. 2025], https://www.kff.org/other/dashboard/gender-affirming-care-policy-tracker.
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States with such laws or policies apply them to varying age ranges.
Twenty-five States prohibit certain SRPs in individuals under the age
of 18. Two States (Nebraska and Alabama) prohibit them for those under
the age of 19. Puerto Rico prohibits such procedures for those under
the age of 21.
Which SRPs (that is puberty blockers, hormone therapy, and surgery)
are banned for children varies by State. As of August 2025, 25 States
have laws that prohibit access to puberty blockers, hormone therapies,
and gender dysphoria related surgeries for children. Two States (New
Hampshire and Arizona) have restrictions on surgery (but permit
endocrine SRPs) for this population. No State bans only medications
without also banning surgical procedures.\67\
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\67\ American Psychological Association. ``Navigating the legal
landscape: FAQs on gender affirming care for minors.'' American
Psychological Association, 28 Jun. 2024, https://www.apaservices.org/practice/legal/managed/legal-landscape-gender-care-minors.
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All the States and the territory with restrictions provide
exceptions to the law/policies. The most common exceptions include:
Children born with medically verifiable disorder of sex
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 factors that
can be medically verified.
Children who have been diagnosed with a disorder of sexual
development by a physician through genetic or biochemical testing.
Treatment for any infection, injury, disease, or disorder
that has been caused or exacerbated by the performance of SPRs.
Children suffering from physical disorders, physical
injuries, or physical illnesses that would otherwise place the children
in danger of death or impairment of bodily function.
We note that 12 States provide tapering off periods for patients
who started puberty blockers or hormones before enactment of the
restriction, with some specifying specific dates (for example, in South
Carolina services cannot go beyond January 31, 2025) and others
specifying a period of time from the date 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.
Conversely, 14 States and the District of Columbia have shield laws
protecting SRPs, and three other States have E.O.s protecting these
procedures.\68\ These
[[Page 59470]]
States are (not including the District of Columbia): Arizona,\69\
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 E.O.s
often describe SRPs broadly, including medications and procedures, and
include these under broader definitions of protected healthcare
activities. These laws often protect providers from adverse action by
medical malpractice insurers and licensure boards and allow for their
address to remain confidential. One State (Maine) has a shield law that
allows children 16 and over to receive hormone therapy when the
guardian has refused SRPs. Four States explicitly provide child abuse
and child custody protections for parents who supported their children
in receiving specified procedures. Four State shield laws and E.O.s
have requirements for SRPs to be covered under health plans. Arizona
requires coverage for State employee health plans. Illinois, Oregon,
and Vermont require some level of SRPs coverage by all health insurance
providers. Vermont includes an exception for services that do not
comply with Federal law.
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\68\ ``Equality Maps: Transgender Healthcare `Shield' Laws.''
Movement Advancement Project, n.d., accessed 11 August 2025, https://www.lgbtmap.org/equality-maps/healthcare/trans_shield_laws.
\69\ Arizona banned SRPs for transgender minors in 2022, but in
2023 the governor issued an executive order with ``shield'' style
protections for SRPs that are still legal in the State.
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b. United States Supreme Court
Recently, the Supreme Court in United States v. Skrmetti, 145 S.
Ct. 1816 (2025) upheld Tennessee's law (referred to as Senate Bill 1;
SB 1) banning certain surgical and chemical interventions for children
with gender dysphoria, 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 with
gender dysphoria incorporates classifications based on age and medical
use--not the child's sex. As a result of these classifications based on
age and medical use, the Court held that SB1 was not subject to
heightened scrutiny under the Equal Protection Clause of the Fourteenth
Amendment and the law satisfied so called ``rational basis'' review.
4. CMS Actions
The proposed rule is animated by significant child safety concerns
when SRPs 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 biological sex. CMS published a formal guidance letter to
State Medicaid Directors regarding SRPs on April 11, 2025, reminding
States of their responsibility to ensure that Medicaid payments are
consistent with quality of care and that covered services are provided
in a manner consistent with the best interest of recipients.\70\ In
addition, the Administrator of CMS sent a letter issued on May 28,
2025, to a number of hospitals addressing significant issues concerning
quality standards and specific procedures affecting children. The
letter requested that the recipient hospitals provide CMS with copies
of certain hospital policies and procedures on the adequacy for
informed consent protocols for children with gender dysphoria,
including how hospitals determine that children are capable of making
these potentially life changing decisions and when parental consent is
required; describe any 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; provide
CMS with medical evidence of any adverse events related to these
procedures, particularly in children who later sought to detransition;
and complete financial data for all pediatric SRPs performed at the
institution and paid, in whole or in part, by the Federal
Government.\71\
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\70\ Department of Health & Human Servies, Centers for Medicaid
& CHIP Services. ``Puberty blockers, cross-sex hormones, and surgery
related to gender dysphoria.'' Received by State Medicaid Director,
7500 Security Blvd. Mail Stop S2-26-12, 11 Apr. 2025, Baltimore,
Maryland, https://www.cms.gov/files/document/letter-stm.pdf.
\71\ Department of Health & Human Services, Centers for Medicare
and Medicaid Services. ``Urgent Review of Quality Standards and
Gender Transition Procedures.'' 28 May 2025, Washington, DC,
www.cms.gov/files/document/hospital-oversight-letter-generic.pdf.
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In addition, on May 28, 2025, Secretary Kennedy wrote to hospitals,
health care providers, health care risk managers, and State medical
boards across the nation, asking them to read the HHS Review, and to
make necessary updates to their ``treatment protocols and training for
care for children and adolescents with gender dysphoria to protect them
from these harmful interventions.'' \72\
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\72\ U.S. Department of Health & Human Services [@HHSGov]. X
(formerly Twitter), 28 May 2025, https://x.com/HHSGov/status/1927791449476567043.
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These letters reaffirmed CMS' and HHS' commitment to following the
highest standards of care and to adhering closely to the foundational
principles of medicine, especially relating to doing no harm to
America's children and in alignment with CMS's obligations to ensure
baseline quality standards at institutions participating in the
Medicare and Medicaid programs.
II. Provisions of the Proposed Regulations
We have undertaken a review of the current hospital health and
safety standards (known as the CoPs) as well as the latest information
regarding SRPs in children to ensure hospitals are best protecting the
health and safety of children. The evidence as presented in the Review
(see section I.B.2. of this proposed rule) indicates that SRPs lack the
necessary outcomes data on safety and long-term effectiveness. CMS
takes very seriously the absence of rigorous scientific data
demonstrating the safety and effectiveness of SRPs and the considerable
evidence regarding the risks. Based on this, we believe that certain
SRPs (namely pharmaceutical and surgical interventions) are not
consistent with the health and safety of children, given the risk of
significant (long term) harms, known complications, and weak and
uncertain evidence of benefits.
We therefore propose to add a new section to 42 CFR part 482,
subpart C that would prohibit Medicare and Medicaid-participating
hospitals from performing sex-rejecting procedures (SRPs) on any child
(Sec. 482.46(a)). As set out in proposed Sec. 482.46(a)(5), we
propose to define SRPs as any pharmaceutical or surgical intervention
that attempts to align an individual's physical appearance or body with
a stated identity that differs from the individual's sex by either (1)
intentionally disrupting or suppressing the development of biological
functions, including primary or secondary sex-based traits or (2)
intentionally altering an individual's physical appearance or body,
including removing, minimizing, or permanently impairing the function
of primary or secondary sex-based traits such as the sexual and
reproductive organs.
[[Page 59471]]
We propose at Sec. 482.46(a)(1) through (4) to include several
additional definitions critical to interpreting the proposal. We
propose that the term ``child'' be defined as any individual younger
than 18 years of age. We further propose that the term ``female'' be
defined as an individual of the sex characterized by a reproductive
system with the biological function of (at maturity, absent disruption
or congenital anomaly) producing eggs (ova). We propose that the term
``male'' be defined as an individual of the sex characterized by a
reproductive system with the biological function of (at maturity,
absent disruption or congenital anomaly) producing sperm. Finally, we
propose that the term ``sex'' is defined as an individual's immutable
biological classification as either male or female.
At Sec. 482.46(b), we are proposing exceptions to Sec. 482.46(a)
to protect the health and safety of children in certain rare and
exceptional circumstances. Proposed exceptions include:
Procedures to treat an individual with a
medically verifiable disorder of sexual development (Sec.
482.46(b)(1)). This allows treatment for children who are born with
certain 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 and documented. Examples include
a child with external biological sex characteristics that are
irresolvably ambiguous, such as those born with 46 XX chromosomes with
virilization, 46 XY chromosomes with under-virilization, or having both
ovarian and testicular tissue.
Procedures for purposes other than attempting to
align an individual's physical appearance or body with an asserted
identity that differs from the individual's sex (Sec. 482.46(b)(2)).
This permits procedures that are done for reasons entirely separate
from changing a child's physical appearance to match a gender identity
that differs from their biological sex, including procedures for
children with a physical disorder, injury, or physical illness. In
other words, the procedure must have a purpose separate from intending
to change the body to not correspond to one's biological sex.
Treating Complications (Sec. 482.46(b)(3)).
This exception allows treatment for any infections, injuries, diseases,
or other medical disorders that were caused by or made worse by
previous SRPs. This exception allows physicians or other licensed
practitioners to treat complications that arise from these procedures.
While we are proposing certain exceptions, any procedures or
treatments under these exceptions must still be performed with the
consent of the child's parent or legal guardian, as currently required
under the patient rights CoP at Sec. 482.13(b)(2), the medical records
CoP at Sec. 482.24 (c)(4)(v), the surgical services CoP at Sec.
482.51(b)(2), and in compliance with applicable State law(s).
Practice of Medicine
Under Section 1801 of the Act, CMS may not ``exercise any
supervision or control over the practice of medicine or the manner in
which medical services are provided, (42 U.S.C. 1395). However, we
believe that providing the SRPs for children is not healthcare and
hence are not subsumed under the term of ``the practice of medicine.''
Therefore, the proposed rule would not regulate the practice of
medicine. As the Review notes regarding SRPs, 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.'' \73\ As the Review
states, ``in the domain of pediatrics, these norms limit the authority
not only of patients (who in any case lack full decision-making
capacity) but of parents as well.'' \74\ The first obligation of the
physician, under the Hippocratic Oath, originating in the fourth
century BC, is to first do no harm, as the purpose of the practice of
medicine is to heal. SRPs introduce a unique set of iatrogenic harms,
especially, ``surgeries to remove healthy and functioning organs.''
\75\ The Review states: ``to discharge their duties of nonmaleficence
and beneficence, clinicians must ensure, insofar as reasonably
possible, that any interventions they offer to patients have clinically
favorable risk/benefit profiles relative to the set of available
alternatives, which includes doing nothing.'' \76\ As related
previously in this proposed rule, the risk-benefit profile of these
procedures for children is extremely poor. At the same time,'' the
Review notes, ``there is increasing recognition of the risk and harms
associated'' with pediatric sex-rejecting procedures, including
``possible outcomes, such as impaired cognitive function, greater
susceptibility to hormone-sensitive cancers, cardiac disease, reduced
bone density, sexual dysfunction, infection, and infertility [that] are
objectively detrimental to health'' The Review concludes that``[s]uch
medical harms, or plausible risks thereof, should not be imposed on
children or adolescents in the absence of a reasonable expectation of
proportionate medical benefit.'' \77\
---------------------------------------------------------------------------
\73\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov, 2025.
https://opa.hhs.gov/gender-dysphoria-report Pg. 15.
\74\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report Pg. 225.
\75\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025.
https://opa.hhs.gov/gender-dysphoria-report, Pg. 128.
\76\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025,
https://opa.hhs.gov/gender-dysphoria-report, Pg. 226.
\77\ U.S. Department of Health and Human Services (HHS)
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs, 19 Nov. 2025,
https://opa.hhs.gov/gender-dysphoria-report Pg. 227-228.
---------------------------------------------------------------------------
There are other considerations for why the regulations proposed in
this rule do not regulate the practice of medicine. A person's body
(including its organs, organ systems, and processes natural to human
development like puberty) are either healthy or unhealthy based on
whether they are operating according to their biological functions.
Organs or organ systems do not become unhealthy simply because the
individual may experience psychological distress relating to his or her
sexed body. For this reason, removing a patient's breasts as a
treatment for breast cancer is fundamentally different from performing
the same procedure solely to alleviate mental distress arising from
gender dysphoria. The former procedure aims to restore bodily health
and to remove cancerous tissue. In contrast, removing healthy breasts
or interrupting normally occurring puberty to ``affirm'' one's ``gender
identity'' involves the intentional destruction of healthy biological
functions. This is not health care and hence imposing restrictions as
this rule proposes does not limit the practice of medicine. The Review
further notes there is lack of clarity about what SRPs' fundamental
aims are, unlike the broad consensus about the purpose of medical
treatments for conditions like appendicitis, diabetes, or severe
depression.\78\ Rather as discussed above, these procedures lack strong
evidentiary foundations, and our
[[Page 59472]]
understanding of long-term health impacts is limited and needs to be
better understood. Nothing in this proposed rule prohibits or permits
the basic legality of SRPs. Rather, this proposed rule would ensure
patient safety and medical integrity. CMS would no longer directly or
indirectly support harm to children by allowing facilities that engage
in such harmful practices to receive Medicare and Medicaid funds.
---------------------------------------------------------------------------
\78\ U.S. Department of Health and Human Services (HHS).
``Treatment for Pediatric Gender Dysphoria, Review of Evidence and
Best Practices.'' HHS Office of Population Affairs,19 Nov. 2025,
https://opa.hhs.gov/gender-dysphoria-report, Pg. 24-26.
---------------------------------------------------------------------------
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. To
fairly evaluate whether an information collection should be approved by
OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995
requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following section of this document that contains information collection
requirements (ICRs).
A. Hospital Notifications to Patients
Proposed Sec. 482.46 would require that hospitals not perform sex-
rejecting procedures (SRPs) on children, barring certain exceptions. We
expect that hospitals that are currently performing these procedures on
children would need to inform the child and their parents or legal
guardian who are seeking such procedures that they no longer perform
such procedures. Based on our experience, we expect that the child's
physician or the licensed practitioner providing this care would spend
an average of 30 minutes writing each notification. In addition, they
would spend 30 minutes answering any questions from the child and their
parents or legal guardian. This leads to a total burden of 1 hour per
patient.
To calculate the total provider burden across all patients, we
first examined State laws and found that 25 States have active laws
restricting SRPs.\79\ Given these State laws that already prohibit
these procedures, we do not expect that physicians or licensed
practitioners in these States would be writing a significant number of
notifications. While acknowledging that some children living in these
States may be traveling to States that permit SRPs for children, we do
not expect that this is a large number of children for two reasons.
First, across States with these restrictions, nearly 45 percent of
children were enrolled in Medicaid or CHIP as of March 2025 and these
programs would not fund SRPs outside the State.\80\ Second, a recent
study showed that across States with restrictions on SRPs, the average
driving time to the nearest clinic in a State without restrictions was
5.3 hours, with the average time in Florida reaching 9 hours.\81\ As
such, we base our estimate on the number of children affected for
children in States that currently do not have restrictions but seek
comments on this assumption.
---------------------------------------------------------------------------
\79\ Dawson, L., Kates, J. ``KFF Analysis of State Laws and
Policies Restricting Minor Access to Gender Affirming Care.'' KFF,
24 Nov. 2025, https://www.kff.org/other/dashboard/gender-affirming-care-policy-tracker/.
\80\ Centers for Medicare & Medicaid Servies. ``State Medicaid
and CHIP Applications, Eligibility Determinations, and Enrollment
Data.'' Data.Medicaid.gov, https://data.medicaid.gov/dataset/6165f45b-ca93-5bb5-9d06-0db29c692a360/data. Accessed 6 Aug.2025.
\81\ Borah, Luca et. al. ``State Restrictions and Geographic
Access to Gender-Affirming Care for Transgender Youth.'' JAMA, vol.
330,4 (2023): 375-378. doi: 10.1001/jama.2023.11299.
---------------------------------------------------------------------------
The second step was to identify the number of individuals under the
age of 18 who live in States that allow SRPs. We combined information
on State restrictions with Census Bureau population estimates \82\ and
found that there are approximately 8,674,717 females and 9,165,563
males between the ages of 10 and 17 living in States that do not have
active laws restricting SRPs. While acknowledging that children younger
than 10 may be receiving SRPs, we believe this is a reasonable estimate
of the population affected by the proposed requirement.
---------------------------------------------------------------------------
\82\ U.S. Census Bureau, U.S. Department of Commerce. ``Age and
Sex.'' American Community Survey, ACS 1-Year Estimates Subject
Tables, Table S0101, https://data.census.gov/table/ACSST1Y2023.S0101?q=population+by+age+by+state. (Accessed 26 Jul.
2025).
---------------------------------------------------------------------------
The third step was to identify the number of individuals under 18
years of age who may be receiving SRPs. A recent study \83\ found that
among children between the ages of 8 and 17 covered by private
insurance, males received puberty blockers and hormones at a rate of
15.22 per 100,000 and 25.34 per 100,000, respectively. Meanwhile,
females received puberty blockers and hormones at a rate of 20.81 per
100,000 and 49.9 per 100,000, respectively. Applying these rates to the
number of males and females in States without active laws restricting
SRPs,\84\ we estimate that there are approximately 6,651 individuals
receiving hormones and 3,200 individuals receiving puberty blockers for
a total of 9,851 individuals. As the authors note, these rates are more
likely to be generalizable to patients with private insurance in large
care plans and they expect lower rates for those utilizing Medicaid and
in less comprehensive care plans. Another study \85\ used national data
to estimate the rate of sex rejecting surgical procedures and found
that in 2019, there were approximately 85 sex-rejecting surgical
procedures for children with a gender dysphoria diagnosis. The same as
our estimates for the number of children receiving puberty blockers and
hormones, this estimate is for insured patients and there may be lower
rates for those utilizing Medicaid and in less comprehensive care
plans. Given the overlap in treatment for some patients who may receive
both surgical procedures and hormones, we estimate that a maximum of
9,851 individuals under the age of 18 are receiving SRPs.
---------------------------------------------------------------------------
\83\ Hughes Landon D. et al. ``Gender-Affirming Medications
Among Transgender Adolescents in the US, 2018-2022.'' JAMA
Pediatrics, vol. 179, 3, (2025): p.342-344. doi:10.1001/
jamapediatrics.2024.6081.
\84\ Dawson, L., Kates, J. ``KFF Analysis of State Laws and
Policies Restricting Minor Access to Gender Affirming Care.'' KFF,
24 Nov. 2025, https://www.kff.org/other/dashboard/gender-affirming-care-policy-tracker/.
\85\ Dai Dannie, et al. ``Prevalence of Gender-Affirming
Surgical Procedures Among Minors and Adults in the US.'' JAMA
Network Open, vol. 7, 6, 27 Jun. 2024, doi:10.1001/
jamanetworkopen.2024.18814.
---------------------------------------------------------------------------
While hospitals often prescribed puberty blockers and hormone
replacement therapy as part of sex-rejecting procedures, primary care
providers and endocrinologists outside of hospitals, who would not be
affected by these requirements, can also prescribe these treatments. A
recent analysis found that approximately 52 percent of primary care
physicians were not affiliated with a hospital.\86\ We do not know the
share of children receiving puberty blockers or hormone replacement
therapy outside the hospital setting and, therefore, would not need to
receive notification that
[[Page 59473]]
SRPs were no longer offered. Assuming that 25 percent of children are
receiving care from primary care physicians or endocrinologists and
that 52 percent of these providers are outside the hospital system,
then 8,570 of the 9,851 children receiving treatment as identified
above would need to receive notices and have discussions with their
treating physician or licensed practitioner. We seek comments on data
sources on the number of children receiving puberty blockers or hormone
replacement therapy outside the hospital setting who would not be
affected by the proposed requirement.
---------------------------------------------------------------------------
\86\ Singh, Yashaswini et al. ``Growth of Private Equity and
Hospital Consolidation in Primary Care and Price Implications.''
JAMA Health Forum vol. 6,1 e244935. 3 Jan. 2025, doi:10.1001/
jamahealthforum.2024.4935.
---------------------------------------------------------------------------
To estimate the total cost for this requirement, we assumed that a
physician would write these notices. We calculated the physician's
hourly rate by doubling the national mean salary for physicians
(occupation code 29-1210) using the BLS' May 2024 National Occupational
Employment and Wage Estimates for hospitals (NAICS code 622000),\87\
leading to an hourly cost of $226.18 ($113.09 x 2). We doubled the mean
salary since the BLS data do not include overhead costs and fringe
benefits. The HHS wide guidance on preparation of regulatory and
paperwork burden estimates states that doubling salary costs is a good
approximation for including these overhead and fringe benefit costs.
Utilizing these data, in Table 1, we estimate that this requirement
would cost $1,938,363. We seek comments on the estimated time burden
for physicians to provide written notices to their patients that the
hospital is no longer providing SRPs.
---------------------------------------------------------------------------
\87\ U.S. Bureau of Labor Statistics. ``Occupational Employment
and Wage Statistics (OEWS) Tables.'' Occupational Employment and
Wage Statistics, BLS.gov, May 2024, https://www.bls.gov/oes/tables.htm. Accessed 23 Jul. 2025.
Table 1--Notification Letters to Patients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average hourly Hours per Number of Total hourly
Employee type rate patient patients Total cost cost
(a) (b) (c) (d = a x b x c) (e = b x c)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physician.......................................................... $226.18 1 8,570 $1,938,363 8,570
--------------------------------------------------------------------------------------------------------------------------------------------------------
B. Updating Hospital Policies and Procedures
In addition to sending out notices to patients that they are no
longer providing SRPs, hospitals will need to update their policies and
procedures to ensure that they align with the proposed requirements.
To estimate the cost for hospitals to update their policies and
procedures, we used data from the BLS' May 2024 National Occupational
Employment and Wage Estimates for hospitals (NAICS code 622000),\88\
and doubled the mean salary since the BLS data do not include overhead
costs and fringe benefits. Based on our experience, we estimate that
updating the hospital's policies and procedures related to SRPs for
children would take 3 hours of work from a physician (occupation code
29-1210) at $678.54 ($226.18 x 3 hours) and a member of the clerical
staff (occupation code 43-6010) at $143.40 ($47.80 x 3 hours), and 3
hours of work from a lawyer (occupation code 23-1010) at $650.16
($216.72 x 3 hours) to review the updated policies and procedures to
ensure that they meet the legal guidelines. This leads to a total per
facility cost of $1472.10.
---------------------------------------------------------------------------
\88\ U.S. Bureau of Labor Statistics. ``Occupational Employment
and Wage Statistics (OEWS) Tables.'' Occupational Employment and
Wage Statistics, BLS.gov, May 2024, https://www.bls.gov/oes/tables.htm. Accessed 23 Jul. 2025.
---------------------------------------------------------------------------
To estimate the number of hospitals that would need to update their
policies and procedures, we first used the CMS' Q2 2025 Provider of
Services File--Hospitals & Non-Hospital Facilities dataset and
identified a total of 4,832 Medicare/Medicaid certified hospitals.\89\
We expect that even in States that have active bans on SRPs, some
hospitals would still need to update their policies and procedures
since many of these States have exceptions that conflict with the
requirements in this proposed rule. We recognize, however, that not all
hospitals offer SRPs for children, and increasingly more hospitals
nationwide are ending these services.\90\ Given these uncertainties, we
assume that 75 percent, or 3,624 hospitals would need to update their
policies and procedures. Using this estimate, we expect that hospitals
would spend $5,334,890 updating their policies and procedures. We seek
comments on this estimate, specifically whether there are data sources
to more accurately estimate the number of hospitals nationwide that
currently offer SRPs for children.
---------------------------------------------------------------------------
\89\ Centers for Medicare and Medicaid Services. ``Provider of
Services File--Hospital & Non-Hospital Facilities, Q2 2025.''
Data.CMS.gov, https://data.cms.gov/provider-characteristics/hospitals-and-other-facilities/provider-of-services-file-hospital-non-hospital-facilities/data. Accessed 13 Aug. 2025.
\90\ Cowan, Jill Cowan. ``Hospitals Are Limiting Gender
Treatment for Trans Minors, Even in Blue States.'' The New York
Times, 22 Jul. 2025, https://www.nytimes.com/2025/07/22/us/trump-transgender-healthcare-california-hospitals.html. Accessed 6 Aug.
2025.
Table 2--Cost for Updating Facility Policies and Procedures
----------------------------------------------------------------------------------------------------------------
Per hospital Total hourly
Per hospital cost Hospitals hourly cost Total cost cost
(a) (b) (c) (a x b) (b x c)
----------------------------------------------------------------------------------------------------------------
$1,472.10................................... 3,624 9 $5,334,890 32,616
----------------------------------------------------------------------------------------------------------------
The information collections will be sent to OMB for approval under
the OMB Control number: 0938-NEW.
If you comment on this information collection, that is, reporting,
recordkeeping or third-party disclosure requirements, please submit
your comments electronically as specified in the ADDRESSES section of
this proposed rule.
Comments must be received by the date and time specified in the
DATES section of this proposed rule.
[[Page 59474]]
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Regulatory Impact Analysis
A. Statement of Need
Throughout the United States, thousands of children are receiving
sex-rejecting procedures (SRPs), specifically pharmacological and
surgical interventions, for gender dysphoria. As outlined in section I.
and II. of this proposed rule, however, recent HHS and international
analyses question the efficacy and safety of SRPs in children. To
protect children's health and safety, we are proposing to prohibit
hospitals subject to part 482 from performing SRPs on any child with
certain exceptions to best protect children's health and safety.
B. Overall Impact
We have examined the impacts of this proposed rule as required by
Executive Order 12866, ``Regulatory Planning and Review''; Executive
Order 13132, ``Federalism''; Executive Order 13563, ``Improving
Regulation and Regulatory Review''; Executive Order 14192, ``Unleashing
Prosperity Through Deregulation''; the Regulatory Flexibility Act (RFA)
(Pub. L. 96 354); section 1102(b) of the statute; and section 202 of
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select those regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Section 3(f) of Executive Order 12866 defines a
``significant regulatory action'' as any regulatory action that is
likely to result in a rule that may: (1) have an annual effect on the
economy of $100 million or more or adversely affect in a material way
the economy, a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or State, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise novel legal or policy issues arising out of legal
mandates, or the President's priorities. The Office of Management and
Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) has
determined this rulemaking is significant per section 3(f) of Executive
Order 12866.
As noted above in Table 1 and Table 2, estimated costs of
approximately $7.3 million are due to the time that a physician or
licensed practitioner would spend providing patients with notification
that the hospital no longer provides these procedures and for hospitals
to update their policies and procedures related to SRPs for children.
Below, we estimate additional impacts from the proposed requirement.
1. Costs and Transfers
We estimated the value of treatments in hospitals that would change
in response to the proposed requirements using data from a study
analyzing the per person cost of these treatments based on commercial
claims data from 1993 to 2019.\91\ This study estimated that for SRPs
that included testosterone, estrogens and anti-androgens, and GnRH,
there was an average combined cost to payors of $755 per person in 2019
dollars. Adjusting for inflation,\92\ this leads to an average cost of
approximately $909 per patient in 2024 dollars. For surgical
procedures, there was an average per procedure cost of $28,367 in 2019
dollars. Adjusting for inflation, this leads to an average cost of
approximately $34,165 in 2024 dollars. Utilizing our estimate in the
collection of information section that 8,570 children would be affected
by our rule and that there are 85 surgical SRPs on children annually,
we estimate an annual value of $7,790,130 (8,570 patients x $909) for
non-surgical SRPs and $2,904,025 (85 patients x $34,165) for surgical
SRPs, for a total annual value of $10,694,155.
---------------------------------------------------------------------------
\91\ Baker, Kellan, and Arjee Restar. ``Utilization and Costs of
Gender-Affirming Care in a Commercially Insured Transgender
Population.'' The Journal of Law, Medicine & Ethics, vol. 50,3
(2022): 456-470. doi:10.1017/jme.2022.87
\92\ Bureau of Economic Analysis. ``National Income and Product
Accounts.'' BEA Interactive Data Application, https://apps.bea.gov/iTable/?reqid=19&step=3&isuri=1&1921=survey&1903=13#eyJhcHBpZCI6MTksInN0ZXBzIjpbMSwyLDMsM10sImRhdGEiOltbIk5JUEFfVGFibGVfTGlzdCIsIjEzIl0sWyJDYXRlZ29yaWVzIiwiU3VydmV5Il0sWyJGaXJzdF9ZZWFyIiwiMjAyMSJdLFsiTGFzdF9ZZWFyIiwiMjAyNCJdLFsiU2NhbGUiLCIwIl0sWyJTZXJpZXMiLCJBIl1dfQ==. Accessed 3
Dec. 2025.
---------------------------------------------------------------------------
For children who are currently receiving SRPs at hospitals, there
is likely to be bifurcation in their response to the proposed
requirement. Some of these children may no longer receive SRPs at non-
hospital providers that are not covered by the proposed requirement due
to factors, such as difficulty in identifying in-network providers that
have available space and longer commute times to these
providers.93 94 The end of SRPs for these children would
result in a reduced payments from payors, including insurance companies
and private persons, to hospitals. Other children, however, are likely
to switch to other provider types that are not affected by this
proposed requirement. For these children, the proposed requirement
would result in a change in transfers from Medicare-certified hospitals
to other providers.
---------------------------------------------------------------------------
\93\ Borah, Luca et al. ``State Restrictions and Geographic
Access to Gender-Affirming Care for Transgender Youth.'' JAMA vol.
330,4 (2023): 375-378. doi:10.1001/jama.2023.11299.
\94\ Gridley, Samantha J et al. ``Youth and Caregiver
Perspectives on Barriers to Gender-Affirming Health Care for
Transgender Youth.'' The Journal of Adolescent Health, vol. 59,3
(2016): 254-261. doi:10.1016/j.jadohealth.2016.03.017.
---------------------------------------------------------------------------
In the absence of data showing the likely share of patients in each
category, we assumed that 50 percent of affected children would fall
into each of the categories described above. Using this percentage, we
estimate that the proposed requirements would result in $5,347,077 in
reduced costs for payors and a $5,347,077 change in transfers from
hospitals to other provider types annually. We seek comments on our
assumption regarding the share of patients in each group.
For children who continue receiving SRPs, there are the costs
associated with switching providers. Dahl and Forbes (2023) estimate
that 46-percent of individuals are willing to pay over $600 per person
(in 2011 dollars, or approximately $821 when updated for inflation) to
avoid switching medical providers.95 96 The full
willingness-to-pay (WTP) distribution is not reported, but for purposes
of this regulatory
[[Page 59475]]
impact analysis, it is assumed that $821 is a reasonable estimate of an
average that includes the 46-percent of WTP amounts above it and the
54-percent below. Applying this $821 amount to the above-estimated
8,570 affected patients (including 4,285 patients who would switch
providers and 4,285 patients for whom the switching-cost estimate is a
lower bound on the WTP to avoid the experience of being unable to
switch \97\ yields a cost estimate of $7,035,970 that declines over
several years to an annual $3,517,985. Because the Dahl and Forbes
estimate is derived from a choice between retaining or switching
primary-care physicians--where finding substitute providers may be
relatively easy as compared with finding, and maintaining patient-
provider relationship with facilities offering the specialized
treatment associated with adolescent gender dysphoria--this estimate
may have a tendency toward understatement of the proposed rule's cost
to patients for switching providers.
---------------------------------------------------------------------------
\95\ Bureau of Economic Analysis. ``National Income and Product
Accounts.'' BEA Interactive Data Application, https://apps.bea.gov/iTable/?reqid=19&step=3&isuri=1&1921=survey&1903=13#eyJhcHBpZCI6MTksInN0ZXBzIjpbMSwyLDMsM10sImRhdGEiOltbIk5JUEFfVGFibGVfTGlzdCIsIjEzIl0sWyJDYXRlZ29yaWVzIiwiU3VydmV5Il0sWyJGaXJzdF9ZZWFyIiwiMjAyMSJdLFsiTGFzdF9ZZWFyIiwiMjAyNCJdLFsiU2NhbGUiLCIwIl0sWyJTZXJpZXMiLCJBIl1dfQ==. Accessed 18
Aug. 2025.
\96\ Dahl, Gordon B., and Forbes, Silke J. ``Doctor switching
costs.'' Journal of Public Economics vol. 221, May (2023): pp.
104858.
\97\ The latter portion of the estimate persists in any year
when SRPs are estimated to occur at a reduced level due to the
proposed rule. By contrast, the former effect is assumed to decline
over the first several years of the analytic time horizon, as
provider-switching patients age out of childhood.
---------------------------------------------------------------------------
In Table 3, we estimate the costs and transfers associated with the
proposed requirement over 10 years. Overall, we expect that this
proposed rule would result in approximately $53.5 million in savings
for payors due to some patients ending SRPs, with a cost of $44 million
to patients who continue treatment at new providers for finding a new
provider and for patients who would have paid to avoid the experience
of being unable to switch providers. We also expect a change in
transfers of $53.5 million from hospitals to other provider types as
patients seek alternative sources of care. The effect attributable to
this proposed rule might be lower in magnitude than the aggregate
presented here if other actions, such as the HHS/CMS proposal titled
``Prohibition on Federal Medicaid and Children's Health Insurance
Program Funding for Sex-Rejecting Procedures Furnished to Children''
are finalized before finalization of this proposal.
Table 3--Costs and Transfers for Changing Patient Behavior Related to Sex-Rejecting Procedures
----------------------------------------------------------------------------------------------------------------
Costs
--------------------------------------
Switching
providers
Year Ending sex- (probably tending Transfers ($)
rejection toward cost
procedures ($) underestimation)
($)
----------------------------------------------------------------------------------------------------------------
1...................................................... -5,347,077 7,035,970 5,347,077
2...................................................... -5,347,077 6,156,474 5,347,077
3...................................................... -5,347,077 5,276,978 5,347,077
4...................................................... -5,347,077 4,397,481 5,347,077
5...................................................... -5,347,077 3,517,985 5,347,077
6...................................................... -5,347,077 3,517,985 5,347,077
7...................................................... -5,347,077 3,517,985 5,347,077
8...................................................... -5,347,077 3,517,985 5,347,077
9...................................................... -5,347,077 3,517,985 5,347,077
10..................................................... -5,347,077 3,517,985 5,347,077
--------------------------------------------------------
10 Year Total...................................... -53,470,770 43,974,813 53,470,770
----------------------------------------------------------------------------------------------------------------
In developing our estimate, we acknowledge that this quantitative
approach may fail to capture a societal cost pattern that may be
somewhat concentrated in upfront transition activity--for example, the
potential establishment of free-standing clinics to provide SRPs that
would newly be prohibited at hospitals participating in Medicare.\98\
There may also be costs for clinicians who provide SRPs for children at
hospitals who would incur costs to move to other provider types where
these procedures are allowed. We also acknowledge that some patients
may choose new forms of treatment such as psychotherapy. Given these
various uncertainties, we request comment on how to refine the
estimation of regulatory costs.
---------------------------------------------------------------------------
\98\ The cost of setting up separate specialty facilities (a
process encompassing managerial, legal, and physical tasks) would
exceed the cost of achieving only physical separation--estimated
previously by the Department to be at least $20,000 to $40,000 per
entity undertaking such actions. Please see Compliance With
Statutory Program Integrity Requirements, 84 FR 7714, https://www.federalregister.gov/d/2019-03461/ page-7782.
---------------------------------------------------------------------------
2. Benefits
As we have noted throughout the proposed rule in Sections I and II,
the proposed requirement is designed to ensure the health and safety of
children by limiting SRPs given recent research that questions its
efficacy and safety. Although we do not have quantitative financial
data on the impact of the proposed rule's provision, we estimate the
number of children who this proposed rule would positively affect using
the same strategy used when estimating the rule's collection of
information costs. Specifically, we expect that due to factors such as
difficulty in identifying in-network providers that have available
space and longer commute times to these providers 99 100,
half of the 8,570 (or 4,285) children who are receiving SRPs in
hospitals would stop receiving these procedures leading to the
avoidance of unnecessary health complications. As noted in the
collection of information section, we assumed this percentage in the
absence of quantitative data showing the number of children who will no
longer seek SRPs. We seek comments on additional benefits that could
emerge from these proposed requirements and sources of data to provide
a quantitative estimate of the proposed rule's benefits. We also seek
comments on sources of data to more accurately estimate the
[[Page 59476]]
number of children who will stop receiving SRPs.
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\99\ Borah, Luca et al. ``State Restrictions and Geographic
Access to Gender-Affirming Care for Transgender Youth.'' JAMA vol.
330,4 (2023): 375-378. doi:10.1001/jama.2023.11299.
\100\ Gridley, Samantha J et al. ``Youth and Caregiver
Perspectives on Barriers to Gender-Affirming Health Care for
Transgender Youth.'' The Journal of Adolescent Health, vol. 59,3
(2016): 254-261. doi: 10.1016/j.jadohealth.2016.03.017.
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C. Alternatives Considered
As we detailed earlier in this proposed rule, the growth in SRPs in
children is a growing concern given recent research that questions its
efficacy and safety. We believe that the changes we are proposing are
necessary to ensure the health and safety of children throughout the
United States and align with the best available scientific evidence. We
acknowledge, however, that there are different standards that we could
have used in developing these proposed requirements.
In developing this proposed rule, we considered aligning our
requirements with those States that already have restrictions on SRPs
but with a variety of exceptions they provide as outlined in Section
1.B of this proposed rule. For example, we could have allowed those
currently receiving these procedures to continue receiving them.
Ultimately, however, we have decided to adopt the proposed provisions
with fewer exceptions than are allowed in these States to maximize
health and safety for all children. We seek comments, however, on
whether we should adopt one or more of the additional State exceptions
related to SRPs.
D. Regulatory Review Cost Estimation
Due to the uncertainty involved with accurately quantifying the
number of entities that will review the proposed rule when finalized,
we assume that all hospitals will review this rule. We acknowledge that
this assumption may understate or overstate the costs of reviewing this
proposed rule. It is also possible that other individuals and providers
will review this proposed rule. For these reasons we thought that
doubling the number of Medicare or Medicaid certified hospitals (n =
4,832) would be a fair estimate of the number of reviewers of this
proposed rule. We welcome any comments on the approach in estimating
the number of entities which will review this proposed rule. We also
recognize that different types of entities are in many cases affected
by mutually exclusive sections of this proposed rule, and therefore,
for the purposes of our estimate, we assume that each reviewer reads
approximately 75 percent of the rule. We seek comments on this
assumption.
Using the wage information from the Bureau of Labor Statistics
(BLS) for medical and health service managers (Code 11-9111), we
estimate that the cost of reviewing this proposed rule is $132.44 per
hour, including overhead and fringe benefits (https://www.bls.gov/oes/current/oes_nat.htm). Assuming an average reading speed of 250 words
per minute, we estimate that it would take approximately ([9,500 words/
250 words per minute] x 75 percent) 28.5 minutes for the staff to
review 75 percent of this proposed rule. For each entity that reviews
the rule, the estimated cost is $62.91 (0.475 hours x $132.44).
Therefore, we estimate that the total cost of reviewing this regulation
is $607,962 ($[62.91] x [9,664]).
E. Accounting Statement
As required by OMB Circular A-4 (available online at https://www.whitehouse.gov/wp-content/uploads/2025/08/CircularA-4.pdf), we have
prepared an accounting statement in Table 4 showing classification of
the costs and benefits associated with the provisions of this proposed
rule. This includes the total costs for hospitals providing notices to
children and their parents that they are no longer providing SRPs as
identified in Table 1, the cost for hospitals to update their policies
and procedures in Table 2, the reduction in costs due to the ending of
SRPs for some patients as well as an increase in cost for patients who
seek new providers in Table 3, as well as the regulatory review costs.
There are also transfer costs for patients seeking care at other
providers as outlined in Table 3. There are $0 benefit estimates in the
statement. This statement provides our best estimate for the Medicare
and Medicaid provisions of this proposed rule.
Table 4--Accounting Statement
----------------------------------------------------------------------------------------------------------------
Units
-----------------------------------------------
Category Estimate Discount rate
Year dollar (%) Period covered
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Costs ($million/year)...... 0.32-0.04 2024 7 or 3 2026-2035
Annualized Monetized Transfers ($million/year).. 5.3 2024 7 or 3 2026-2035
----------------------------------------------------------------------------------------------------------------
F. Regulatory Flexibility Act (RFA)
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, we estimate that
most hospitals (NAICS 6221) are considered small businesses either by
the Small Business Administration's size standards with total revenues
of $47.0 million or less in any single year or by the hospital's not
for profit status. According to the 2022 Economic Census,\101\ general
medical and surgical hospitals (NAICS 6221) have revenues of $1.27
trillion.
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\101\ U.S. Census Bureau. ``All Sectors: Summary Statistics for
the U.S., States, and Selected Geographies: 2022.'' Economic Census,
United States Census Bureau, 2022, data.census.gov/table/EC2200BASIC?q=EC2200BASIC. Accessed 15 Dec. 2025.
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Individuals and States are not included in the definition of a
small entity. As its measure of significant economic impact on a
substantial number of small entities, HHS uses a change in revenue of
more than 3 to 5 percent. With estimated annual costs and reduction in
transfers resulting in the loss of approximately $11.4 million in
annual revenues for hospitals, which is approximately 0.0008 percent of
revenues, this proposed rule would not have a significant economic
impact as measured on a substantial number of small businesses or other
small entities as measured by a change in revenue of 3 to 5 percent.
Therefore, the Secretary has certified that this proposed rule will not
have a significant economic impact on a substantial number of small
entities.
In addition, section 1102(b) of the statute requires us to prepare
a regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the statute, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. With total requirement
costs and the loss of transfers reducing hospital revenues by
approximately $11.4 million annually for all 4,832 hospitals, or $2,194
per hospital, we expect that
[[Page 59477]]
this proposed rule would have a negligible impact on small rural
hospitals. Therefore, the Secretary has certified that this proposed
rule will not have a significant impact on the operations of a
substantial number of small rural hospitals.
G. Unfunded Mandates Reform Act (UMRA)
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2025, that
threshold is approximately $187 million. This proposed rule does not
mandate any spending requirements for State, local, or tribal
governments, or for the private sector.
H. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule (and subsequent final
rule) that imposes substantial direct requirement costs on State and
local governments, pre-empts State law, or otherwise has federalism
implications. This proposed rule would pre-empt State laws that
prohibit SRPs for children that include exceptions for reasons beyond
those exceptions provided in this proposed rule, including for children
who are already undergoing these procedures. It would also pre-empt
State laws requiring hospitals to provide SRPs.
Consistent with the Executive Order, we find that State and local
laws that provide exceptions from the prohibition beyond those listed
in this proposed rule, as well as State and local laws that require
hospitals to provide SRPs for children, directly conflict with this
exercise of CMS' statutory health and safety authority to prohibit
providers subject to this proposed rule from providing these
procedures.
Similarly, to the extent that State-run hospitals that receive
Medicare and Medicaid funding are required by State or local law to
provide SRPs for children except in those cases covered by our
exceptions, there is direct conflict between the provisions of this
proposed rule (prohibiting such procedures) and the State or local law
(allowing them).
As is relevant here, this proposed rule preempts the applicability
of any State or local law providing for SRPs to the extent such law
provides broader grounds for these procedures than provided for by
Federal law and are inconsistent with this proposed rule. In these
cases, consistent with the Supremacy Clause of the Constitution, the
agency intends that this proposed rule preempts State and local laws to
the extent the State and local laws conflict with this proposed rule.
The agency has considered other alternatives (for example, relying
entirely on State laws prohibiting SRPs) and has concluded that the
requirements established by this proposed rule are the minimum
regulatory action necessary to achieve the objectives of the statute.
Given the growth in SRPs among children in recent years, we believe
that the prohibition of these procedures for children is necessary to
promote and protect patient health and safety. The agency has examined
research on SRPs for children and concludes that it can cause permanent
harm with uncertain benefits. We are inviting State and local comments
on the substance as well as legal issues presented by this proposed
rule, and its impact on them.
I. E.O. 14192, ``Unleashing Prosperity Through Deregulation''
Executive Order 14192, entitled ``Unleashing Prosperity Through
Deregulation'' was issued on January 31, 2025, and requires that ``any
new incremental costs associated with new regulations shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least 10 prior regulations.'' We followed the
implementation guidance from OMB-M-25-20 (https://www.whitehouse.gov/wp-content/uploads/2025/02/M-25-20-Guidance-Implementing-Section-3-of-Executive-Order-14192-Titled-Unleashing-Prosperity-Through-Deregulation.pdf) when estimating the proposed rule's impact related to
the executive order. Specifically, we used a 7 percent discount rate
when estimating the cost for the purposes of Executive Order 14192. In
accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
Mehmet Oz, Administrator of the Centers for Medicare & Medicaid
Services, approved this document on December 17, 2025.
List of Subjects in 42 CFR Part 482
Grant programs health, Hospitals, Medicaid, Medicare, Reporting and
recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
1. The authority citation for part 482 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise
noted.
0
2. Section 482.46 is added to subpart C to read as follows:
Sec. 482.46 Condition of participation: Sex-rejecting procedures.
The hospital must not perform sex-rejecting procedures on any
child.
(a) Definitions. As used in this section:
(1) ``Child'' means any individual younger than 18 years of age.
(2) ``Female'' means an individual of the sex characterized by a
reproductive system with the biological function of (at maturity,
absent disruption or congenital anomaly) producing eggs (ova).
(3) ``Male'' means an individual of the sex characterized by a
reproductive system with the biological function of (at maturity,
absent disruption or congenital anomaly) producing sperm.
(4) ``Sex'' means an individual's immutable biological
classification as either male or female.
(5) ``Sex-rejecting procedure'' means any pharmaceutical or
surgical intervention that attempts to align an individual's physical
appearance or body with an asserted identity that differs from the
individual's sex either by:
(i) Intentionally disrupting or suppressing the development of
biological functions, including primary or secondary sex-based traits;
or
(ii) Intentionally altering an individual's physical appearance or
body, including removing, minimizing, or permanently impairing the
function of primary or secondary sex-based traits such as the sexual
and reproductive organs.
(b) Exceptions. The definition at paragraph (a)(5) of this section
does not include procedures:
(1) To treat an individual with a medically verifiable disorder of
sexual development;
(2) For purposes other than attempting to align an individual's
physical appearance or body with an asserted identity that differs from
the individual's sex; or
(3) To treat complications, including any infection, injury,
disease, or disorder that has been caused by or
[[Page 59478]]
exacerbated by the performance of a sex-rejecting procedure.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-23465 Filed 12-18-25; 8:45 am]
BILLING CODE 4120-01-P