Navigating Federal and State Oversight in Gender-Affirming Care

Davis Wright Tremaine LLP

On August 1, Washington D.C. and 16 states sued the Department of Justice, U.S. Attorney General Pamela Bondi, and President Donald Trump, alleging that the Trump Administration unlawfully prevented transgender minors from receiving necessary medical care. The provision of gender-affirming care for minors has become a focal point for the Trump Administration, and healthcare providers are increasingly caught between conflicting state directives, federal priorities, patient care decisions, and other considerations. Recent federal actions, including requests for information from the Centers for Medicare & Medicaid Services ("CMS"), Department of Justice ("DOJ") subpoenas, and Federal Trade Commission ("FTC") inquiries, have intensified scrutiny of gender-affirming care for minors.

This article provides a chronology of the key directives and guidance from the federal government regarding the provision of gender-affirming care services for minor patients, to assist healthcare providers in better understanding the current landscape.

Federal Enforcement Backdrop: Executive Order 14187 and DOJ Directives

On January 28, 2025, President Trump issued Executive Order 14187, titled "Protecting Children from Chemical and Surgical Mutilation." The Executive Order targets the provision of gender-affirming care to individuals under the age of 19.

The Executive Order directs federal agencies to take a series of regulatory and enforcement actions to fulfill the Executive Order's directives and curtail the provision of gender-affirming care for minors. Key directives include:

  • Ordering the Secretary of the Department of Health and Human Services ("HHS") to take "all appropriate actions" to end the provision of gender-affirming care for minors. This may involve addressing such gender-affirming care services in the Medicare Conditions of Participation and Conditions of Coverage; the civil rights protections under Section 1557 of the Affordable Care Act; CMS-issued patient quality, safety, and oversight memoranda; revisions to the International Classification of Diseases (ICD) diagnostic manual; and other related changes;
  • Ensuring that research and education grants are disbursed to medical institutions that do not provide or have ceased providing gender-affirming care for minors;
  • Ending reliance on the World Professional Association for Transgender Health ("WPATH") guidance in federal health policies; and
  • Instructing the DOJ to prioritize and coordinate with States' Attorneys General in enforcing protections against female genital mutilation and addressing the deception of consumers about long-term side effects of chemical and surgical mutilation under existing law.

This Executive Order has already been challenged in two federal district courts. Those courts granted preliminary injunctions in PFLAG v. Trump (nationwide injunction) and Washington v. Trump (limited to the plaintiff states of Washington, Minnesota, and Oregon) to block Section 4 of the Executive Order, which restricts federal grant funding to medical institutions providing gender-affirming care. However, multiple federal agencies have continued to pursue implementation of the Executive Order's directives, given the U.S. Supreme Court's decision in Trump v. CASA, Inc., which curtailed universal preliminary injunctions, and now requires injunctions to be tailored to parties involved (unless class certification is later pursued).

In furtherance of the Executive Order, on April 22, 2025, Attorney General Bondi issued a DOJ-wide memorandum (the "April Memorandum") outlining the agency's enforcement priorities regarding gender-affirming care. The memorandum focuses on five directives:

  1. "Enforcement of Laws Outlawing Female Genital Mutilation";
  2. "Investigation of Violations of the Food, Drug and Cosmetics Act and False Claims Act";
  3. "Ending Reliance on Junk Science by the Department";
  4. "Establish Federal and State Coalition Against Child Mutilation"; and
  5. "Promoting New Legislation Protecting Children."

The April Memorandum elucidates how the DOJ's recent issuance of the provider subpoenas, as discussed below, fits into the agency's overall objectives to halt gender-affirming care for minor patients, particularly through the second directive's focus on False Claims Act ("FCA") investigations. AG Bondi ordered the DOJ Civil Division's Fraud Section to "pursue investigations under the False Claims Act of false claims submitted to federal health care programs for any non-covered services related to radical gender experimentation." The April Memorandum then provides examples of potential false claims, which would be subject to treble damages and severe penalties: "Examples include but are not limited to physicians prescribing puberty blockers to a child for an illegitimate reason (e.g., gender dysphoria) but reporting a legitimate purpose (i.e., early onset puberty) to the Centers for Medicare & Medicaid Services, and hospitals performing surgical procedures to remove or modify a child's sex organs while billing Medicaid for an entirely different procedure." The April Memorandum also encourages and incentivizes qui tam whistleblower reporting related to the provision of gender-affirming care.

Moreover, on June 11, 2025, the DOJ Civil Division published a memorandum (the "June Memorandum") discussing its enforcement priorities. One of the five policy objectives discussed is "Protecting Women and Children," which encompasses enforcement of Executive Order 14187. Specifically, the June Memorandum states that "[t]he Civil Division will use all available resources to prioritize investigations of doctors, hospitals, pharmaceutical companies, and other appropriate entities consistent with these directives . . . In addition, the Civil Division will aggressively pursue claims under the False Claims Act against health care providers that bill the federal government for impermissible services."

In addition to Executive Order 14187 and the two DOJ memoranda discussed above, other key federal agency actions include those summarized in the following table:

Date

Agency

Description

Feb. 20, 2025

HHS

Rescinded Biden-era Office of Civil Rights guidance titled "HHS Notice and Guidance on Gender Affirming Care, Civil Rights and Privacy." That guidance had outlined confidentiality requirements and civil rights protections within Section 1557 and HIPAA for those seeking gender-affirming care.

March 5, 2025

CMS

Issued a Quality & Safety Special Alert Memorandum titled "Protecting Children from Chemical and Surgical Mutilation" that stated that CMS "may begin taking steps to update its policies to protect children from chemical and surgical mutilation."

March 6, 2025

Health Resources & Services Administration ("HRSA")

Warned institutions that, in response to the March 5 CMS memorandum on gender-affirming care for minors, the agency "may consider re-scoping, delaying, or potentially cancelling new grants in the future depending on the nature of the work and any future policy change(s)."

March 6, 2025

Substance Abuse and Mental Health Services Administration ("SAMHSA")

Same as the above row.

(The SAMHSA letter is unavailable publicly but is described in this PFLAG v. Trump court filing as having "almost identical wording" to the HRSA letter.)

April 11, 2025

CMS

Sent a letter to State Medicaid Directors discussing Medicaid payment obligations as applied to gender-affirming care for minors.

April 14, 2025

HHS

Launched an online whistleblower portal for tips and complaints regarding provision of gender-affirming care for minors (with information sent to the HHS Office of Inspector General).

May 1, 2025

HHS

Published a 409-page report on "Treatment for Pediatric Gender Dysphoria: Review of Evidence and Best Practices." This report advocated for a greater reliance on behavioral therapy rather than gender-affirming medical care for youths with gender dysphoria and questioned WPATH standards.

May 28, 2025

CMS

Sent a letter to certain hospitals titled "Urgent Review of Quality Standards and Gender Transition Procedures" that requested information regarding those hospitals' gender-affirming care policies and procedures for minors and related financial data about gender transition procedures and billing codes for patients under the age of 19. CMS requested a response within 30 days.

May 28, 2025

HHS

HHS Secretary Robert F. Kennedy Jr. shared a two-page open letter on social media that urged healthcare providers, risk managers, and state medical boards to read the HHS Gender Dysphoria Report from May 1, cease gender-affirming care for minors with gender dysphoria, and end overall reliance on WPATH standards.

June 25, 2025 CMS The ACA Marketplace Final Rule prohibits coverage of gender-affirming care (referred to as sex-trait modification) as an essential health benefit ("EHB") for all beneficiaries, not just minors, starting in Plan Year 2026. However, CMS noted that this would neither prohibit health plans from voluntarily covering such care as a non-EHB nor prevent states from requiring the coverage of such care.

DOJ Subpoenas: Scope and Implications

On July 9, 2025, the United States Department of Justice ("DOJ") issued a brief press release announcing that it had sent more than 20 subpoenas to doctors and clinics involved in performing what the DOJ termed transgender medical procedures on children. Although very few details were provided in the press release, including what the DOJ considers transgender medical procedures, the DOJ emphasized that the investigations relate to, among other things, healthcare fraud and false statements.

The DOJ's subpoenas signal heightened federal interest in the practices and protocols surrounding gender-affirming treatments for minor patients. While the stated purpose of these inquiries remains unclear, they appear to align with Executive Order 14187.

FTC Panel: Exploring Market and Regulatory Impacts

The FTC held a workshop on July 9, 2025, analyzing whether gender-affirming healthcare involves consumer deception or constitutes unfair trade practices. The FTC's press release stated that "Section 5 of the Federal Trade Commission Act gives the FTC broad authority to protect consumers from unfair or deceptive acts or practices. The workshop will help the FTC to understand whether consumers are being or have been exposed to false or unsupported claims about 'gender-affirming care' and to gauge the harms consumers may be experiencing." Given the Trump Administration's and FTC's priorities, providers of gender-affirming care should be aware that the FTC may conduct investigations related to claims about the benefits, effectiveness, and risks of gender-affirming care. In his opening remarks at the workshop, FTC Chairman Andrew Ferguson assured the public that the FTC's inquiry would remain non-political, focusing on investigating whether gender-affirming care is harmful to children. "I'm not charged with passing moral judgment on anyone's ideology, lifestyle, or medical choices. I am charged, however, with protecting my fellow citizens from unfair or deceptive trade practices." (A full transcript of the event and video can be found here.) Furthermore, on July 29, per an FTC press release, the FTC "launched a public inquiry to better understand how consumers may have been exposed to false or unsupported claims about 'gender-affirming care,' especially as it relates to minors, and to gauge the harms consumers may be experiencing." As part of this inquiry, the FTC issued a request for public comments.

Federal-State Tension

The federal government's actions under the Trump administration have created tension between federal and state policy that may be difficult for providers in some states to navigate. In New York, for instance, Attorney General Letitia James reaffirmed the state's commitment to protecting access to gender-affirming care for transgender youth. In a letter dated February 3, 2025, James emphasized providers' obligations to comply with New York State laws that prohibit discrimination against individuals based on their membership in a protected class, including but not limited to sex, gender identity or expression, or sexual orientation.

James stated, "Electing to refuse services to a class of individuals based on their protected status, such as withholding the availability of services from transgender individuals based on their gender identity or their diagnosis of gender dysphoria, while offering such services to cisgender individuals, is discrimination under New York law." Her statement underscores the difficulties that providers face as they reconcile their state law with the risks of federal scrutiny, all while trying to maintain federal program participation, reimbursement, and grant funding, often critical to the provider's survival.

On August 1, a coalition of 16 states and the District of Columbia filed suit in Massachusetts federal court against the Department of Justice, U.S. Attorney General Pamela Bondi, and President Donald Trump. The lawsuit challenges the Executive Order, the April Memorandum, and the June Memorandum by asking the court to declare unconstitutional the portion of the Executive Order that would bar federal funding from going to hospitals that provide gender-affirming care to individuals under 19 and prohibit the DOJ from enforcing the April Memorandum and June Memorandum.

Key Takeaways

Providers that offer gender-affirming care for minors are in a difficult position, navigating growing complexity of compliance in this area. Healthcare providers must stay current with federal and state policies and stay in touch with legal counsel for help reviewing policies, procedures, and service lines.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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