On August 12, 2026, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. sent a letter (“Referral Letter”) to HHS Inspector General T. March Bell, targeting more than 250 health care entities providing gender-affirming care “for investigation into possible violation of federal statutes.”
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The seven-page Referral Letter names hospitals, health care systems and networks, specialty pharmacies and infusion services, medical clinics and practices, individual health care providers, university medical centers, and Planned Parenthood affiliates. The list originates from an August 13 report, “Wolves in White Coats: How Doctors and Hospitals Pushed and Profited from the Fraud of ‘Gender Medicine’” (“HHS Report”)—purporting to identify “an objectively defined cohort of claims that exhibit potentially anomalous billing patterns, which justifies further scrutiny by the HHS OIG,” the Referral Letter states.
“Given the seriousness of these potential violations, HHS requests that HHS OIG swiftly evaluate this referral,” Kennedy concludes.
In a separate letter dated August 13, Vice President J.D. Vance referred the HHS report and the allegations therein to Attorney General Todd Blanche, directing DOJ to determine “whether the providers identified have violated federal law, regulations, or policies including, but not limited to, the Federal Food, Drug, and Cosmetic Act [(“FD&C Act”)], the [civil] False Claims Act [(FCA)], 18 U.S.C. § 24, and federal fraud and conspiracy laws.” (“DOJ Letter”).
“When providers miscode treatment in order to secure insurance coverage for gender-transitioning interventions that insurance would not otherwise cover, they should be held accountable,” the DOJ Letter states. “If they have done so intentionally, thereby perpetrating a fraud on Medicaid or on private insurers, they should go to prison. Rather than allow the proliferation of harmful, sex-rejecting procedures on our children, we must send a clear message that any hospitals and providers that have participated in these practices will face justice.”
In a third development, the letters come just after CMS announced on August 11 that federal Medicaid and CHIP will end taxpayer-funded “child sex-change” procedures, including hormone therapy and surgeries (note that the federal government has also referred to gender-affirming care as “sex-trait modification procedures” or “sex-rejecting procedures”). The announcement was accompanied by the Final Rule noted above, scheduled to go into effect on October 13.
We discuss these developments and their implications in this Insight.
HHS: Swift Evaluation
The HHS Report presents commercial and government insurance claims data from 2015 through 2025, across chapters addressing hospital revenue incentives, diagnostic and procedural coding practices, first-hand patient and parent narratives, and more.
The HHS Report claims that during that 10-year time period, public and private insurance was billed nearly $50 million for puberty-blocking drugs in patients aged 9 to 17 with endocrine disorder diagnoses, demonstrating a “pattern of potentially fraudulent billing that relies on miscoding for endocrine disorders to justify the prescription of puberty blockers.”[1] The HHS Report also notes that more than 225 hospitals and health systems had pediatric gender programs by the early 2020s and points to prior settlements as examples of the kind of liability these billing patterns could trigger.
In addition, the HHS Report recommends that state Medicaid programs do “periodic reviews of claims associated with” ICD codes listed in its findings and ensure that states can justify, through claims and documentation, “that their providers are not submitting false claims.” Finally, the HHS Report calls for “similar internal controls” at managed care organizations.
Building on these findings, the seven-page Referral Letter sorts organizations slated for investigation into four “cohorts” based on claims data: (1) puberty-blocker claims billed with an endocrine-disorder code with no accompanying gender-dysphoria or precocious-puberty code, (2) puberty-blocker claims billed with a precocious-puberty diagnosis, (3) same-day claims for a gender-dysphoria diagnosis with a cross-sex-hormone prescription in states where such prescriptions were prohibited for minors, and (4) Planned Parenthood affiliates identified through prescriber billing affiliation matching rather than direct claims. Because the Referral Letter targets billing fraud, any investigations it generates will not be limited to the time frame encompassing the current administration’s executive orders (EOs) regarding gender-affirming care for minors but can look back six and possibly 10 years prior to commencement of the investigation.
DOJ: “Clear Message”
The August 13 DOJ letter—in which Vice President J.D. Vance refers the HHS Report and the allegations it contains to Attorney General Todd Blanche—is not the first time that agencies have threatened to use the FD&C Act and the FCA to target gender-affirming care.
FD&C Act. As we wrote in 2025, the threat posed by the FD&C Act reflects administration priorities outlined in EO 14187, “Protecting Children From Chemical and Surgical Mutilation.” EO 14187 stated, “[I]t is the policy of the United States that it will not fund, sponsor, promote, assist, or support the so-called ‘transition’ of a child from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”
EO 14187 therefore directed—among other things—the HHS secretary to “take all appropriate actions to end the chemical and surgical mutilation of children, including regulatory and subregulatory actions,” and the attorney general to “prioritize investigations and take appropriate action to end deception of consumers, fraud, and violations of the [FD&C Act] by any entity that may be misleading the public about long-term side effects of chemical and surgical mutilation.”
On April 22, 2025, Attorney General Pam Bondi issued a memorandum entitled “Preventing the Mutilation of American Children” (“Bondi Memo”). As Epstein Becker Green wrote, the Bondi Memo tasked DOJ’s Consumer Protection Branch with investigating violations of the FD&C Act by manufacturers and distributors for alleged misbranding of “puberty blockers, sex hormones, or any other drug used to facilitate a child’s so-called ‘gender transition.’”
FCA. The Bondi Memo further tasked DOJ’s Civil Division Fraud Section with conducting investigations under the FCA of “false claims submitted to health care programs for any non-covered services related to radical gender experimentation”:
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 [CMS], and hospitals performing surgical procedures to remove or modify a child’s sex organs while billing Medicaid for an entirely different procedure. Falsely billing the government for the chemical or surgical mutilation of a child is a violation of the [FCA] and is subject to treble damages and severe penalties.
Further, Bondi emphasized an intent to work with FCA qui tam whistleblowers by notifying the public that DOJ is “eager” to work with them. This was driven home again in a DOJ Civil Division Enforcement Priorities memorandum authored by Assistant Attorney General Brett A. Shumate, published on June 11, 2025 (see related Epstein Becker Green blog post here), which stated:
The Civil Division will use all available resources to prioritize investigations of doctors, hospitals, pharmaceutical companies, and other appropriate entities consistent with these directives. These efforts will include, but will not be limited to, possible violations of the [FD&C] Act and other laws by (1) pharmaceutical companies that manufacture drugs used in connection with so-called gender transition and (2) dealers such as online pharmacies suspected of illegally selling such drugs. 21 U.S.C. § 301 et seq. 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. This includes, for example, providers that attempt to evade state bans on gender dysphoria treatments by knowingly submitting claims to Medicaid with false diagnosis codes.
In these publications, the message was clear: “all available resources” and “aggressive” enforcement. These pronouncements further suggest that any investigations will not be limited to alleged billing fraud for gender-affirming care for minors but will include such treatment for adults as well.
The Final Rule
On August 11, 2026, CMS announced that federal Medicaid and CHIP will end taxpayer-funded “child sex-change” procedures, including hormone therapy and surgeries. To that end, the accompanying Final Rule was published in the Federal Register on August 13 and is scheduled to go into effect on October 13. The stated goal of the Final Rule is to protect both Medicaid and CHIP beneficiaries and ensure quality of care by prohibiting federal financial participation (FFP) in payments by states for sex-rejecting procedures for a child under 18 (Medicaid) and 19 (CHIP).
The Final Rule creates a new Subpart N to 42 C.F.R. Part 441 with respect to Medicaid, and a new 42 C.F.R. Part 457.476 with respect to CHIP: states must provide that the state Medicaid and CHIP agencies will not make payment under the plan for “sex-rejecting procedures” for children under 18 (Medicaid) and 19 (CHIP). Federal dollars are also prohibited for those purposes.
Tapering-off period: For Medicaid and CHIP beneficiaries who are actively receiving cross-sex hormone therapy, state Medicaid and CHIP agencies may continue to claim FFP for those hormone therapy medications for a period of up to six months from the date of the Final Rule (August 13 to February 13). Note that the tapering-off period does not apply to puberty blockers or surgeries, and it does not apply to those who initiate cross-sex hormone therapy following the effective date of the rule. The preamble to the Final Rule also notes that treating providers may find that a shorter timeline for tapering may be medically appropriate. Notably, the proposed rule, published in the Federal Register on December 19, 2025 (“Proposed Rule”),[2] contained no such tapering provision; the Final Rule’s tapering-off period was added in response to comments to the Proposed Rule.
Definitions. In keeping with administration goals set forth in EO 14168 of January 20, 2025, regarding gender, the Final Rule defines “sex” as “a person’s immutable biological classification as either male or female.” “Male” and “female” are also defined in the Final Rule in terms of biological function at maturity, “absent disruption or congenital anomaly.”
“Sex-rejecting procedure” is defined as “any pharmaceutical or surgical intervention that attempts to align an individual’s—replacing ‘child’s’ in the Proposed Rule—physical appearance or body with an asserted identity that differs from the individual’s sex by:
- intentionally disrupting or suppressing the normal development of natural biological functions, including primary or secondary sex-based traits; or
- intentionally altering an individual’s physical appearance or body, including amputating, minimizing, or destroying primary or secondary sex-based traits such as the sexual and reproductive organs.”
However, “sex-rejecting procedure” does not include procedures undertaken:
- to treat an individual with a medically verifiable disorder of sexual development;
- 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
- to treat complications, including any infection, injury, disease, or disorder that has been caused by or exacerbated by the performance of sex-rejecting procedures.
The Final Rule does not affect coverage of mental health services. Medicaid’s Early and Periodic Screening, Diagnostic, and Treatment provisions continue to ensure comprehensive coverage of mental health services for eligible children, and CHIP continues to require coverage of necessary mental health services in accordance with federal law.
The Final Rule is already facing legal challenge. On September 2, 21 states and the District of Columbia filed suit against HHS, CMS, and their respective leaders in federal court in Massachusetts, seeking declaratory and injunctive relief and alleging violations of the Administrative Procedure Act and the Spending Clause of the U.S. Constitution.
Recent DOJ Settlements
In addition to the actions noted above, the federal government has used civil and criminal investigations, notice-and-comment rulemaking, agency enforcement, and public pressure campaigns in order to advance its policy objectives with various providers.
Some are settling. On August 5, 2026, DOJ announced that Connecticut Children’s Medical Center agreed to end pediatric “gender-affirming care.” The hospital is to pay a monetary penalty and $500,000 in medical care “for individuals living with the harmful consequences of gender affirming care.”
Notably, DOJ “acknowledged that Connecticut Children’s took significant steps entitling it to credit for cooperation with the Department in its investigation, [remaining] cooperative, proactive, and solution-driven, as highlighted by its financial commitment to providing restorative care to the victims who desperately need it.”
On June 5, 2026, DOJ announced that it had secured a resolution with Cleveland Clinic to end pediatric gender-affirming care, with the Clinic agreeing to a 20-year moratorium across its network, a $308,000 payment to resolve allegations regarding false billings submitted to public and private payors and for billing code discrepancies, and a $2 million commitment “to provide restorative care for detransitioners.”
And on May 15, 2026, Texas Children’s Hospital (TCH) entered into the first settlement with DOJ to end pediatric gender-affirming care, including commitments not to administer puberty blockers and sex hormones, and to establish a clinic dedicated to “restorative care for transitioners.” TCH also agreed to pay $10 million to resolve allegations that it submitted false billings to public and private payors in violation of the FCA and FD&C Act, and federal fraud and conspiracy laws.
Recent DOJ Investigative Efforts
One tool that DOJ is using in connection with enforcement is the administrative subpoena, authorized under 18 U.S.C. § 3486 for a “federal health care offense.” In the summer of 2025, DOJ issued multiple administrative subpoenas to hospitals, doctors, and clinics—requesting highly sensitive patient health and procedure information related to gender-affirming care (see a related Epstein Becker Green blog post here). At the time, DOJ said only that its “investigations include healthcare fraud, false statements, and more.”
Yet some providers, patients, and hospitals are fighting back, and for the most part, courts have shown willingness to look beyond an agency’s formal legal justification to assess whether agency actions are motivated by improper political objectives. Significant cases include the following:
District of Massachusetts. On September 9, 2025, the U.S. District Court for the District of Massachusetts granted a motion to quash an administrative subpoena issued to a hospital in the state pursuant to 18 U.S.C. § 3486 for information regarding personnel, documents, and billing codes in connection with pediatric gender-affirming care.[3] The subpoena was purportedly issued to investigate whether the hospital was engaged in unlawful off-label promotion and/or unlawful dispensing of puberty blockers and cross-sex hormones in violation of the FD&C Act, and any potential false claims submitted to federal health care programs.
Judge Myong J. Joun concluded that the government failed to show that the subpoena was issued for a proper purpose and that it provided no information as to improper billing practices and unlawful off-label promotion.
Western District of Washington. On September 3, 2025, the U.S. District Court for the Western District of Washington granted a motion made by a hospital to quash a DOJ subpoena duces tecum seeking personnel files, patient information and medical records, and billing information related to gender-affirming care.[4] The subpoena also sought information regarding communications with pharmaceutical companies and government agencies regarding puberty blockers and hormones.
Judge John H. Chun found that the DOJ did not establish “that it has a realistic expectation of discovering something relevant to the investigation of a federal healthcare offense.” Even if it did establish a prima facie case, the hospital was able to show that the subpoena was issued for an improper purpose—“to further its broader goal of ending ‘gender-affirming treatment’ in Washington state”—and not issued to investigate a federal health care offense.
DOJ has appealed to the U.S. Court of Appeals for the Ninth Circuit; the docket is closed for administrative purposes until October 30, 2026.[5]
On October 27, 2025, the Western District of Washington granted a motion to quash another administrative DOJ subpoena duces tecum issued against a telehealth provider offering gender-affirming care in 10 states.[6] While the parties did not dispute that DOJ had statutory authority to issue the subpoena, the court found that DOJ issued the subpoena for the improper purpose of “eliminating gender affirming care.” The requests, the court found, “demand a staggering amount of personal health data” that “have little to do with investigating violations of [the FD&C] Act or the FCA.” DOJ appealed to the Ninth Circuit.
Ninth Circuit. In a 2-1 decision, the Ninth Circuit reversed and remanded on August 14, 2026, holding that the district court erred in quashing the subpoena on the basis that it was issued for an improper purpose.[7]
The majority held that DOJ issued the administrative subpoena pursuant to statutory authority because (1) the Health Insurance Portability and Accountability Act (HIPAA) permits investigations for potential violations of the FD&C Act’s misbranding prohibitions, (2) DOJ complied with HIPAA’s procedural requirements, and (3) the subpoena requests were relevant to an authorized investigation under HIPAA. Yet because the district court decided only that the subpoena was motivated by an improper purpose, and did not rule on the provider’s arguments that DOJ’s subpoena is overbroad and poses an undue burden, the court remanded for the district court to consider those issues in the first instance.
Judge Richard Paez dissented, asserting that the district court’s finding was not clearly erroneous. “DOJ submitted essentially nothing in opposition to the motion to quash the subpoena….” Paez wrote. “The record amply supports the district court’s finding that DOJ issued the subpoena as pretext for its real goal of eliminating gender-affirming care, not in good faith investigation of potential violations of the Federal Food, Drug, and Cosmetic Act[.]”
Northern District of California. On July 2, 2026, the U.S. District Court for the Northern District of California held, among other things, that minor patients and parents—who brought a putative class action against one children’s hospital, the DOJ and the attorney general—would suffer irreparable harm absent a preliminary injunction prohibiting DOJ and the hospital from taking further action to enforce or comply with an administrative subpoena relating to gender-affirming care. [8] The decision granted in part the plaintiffs’ motion for a preliminary injunction preventing DOJ from “requesting, receiving, producing, transmitting, disclosing, or otherwise obtaining any records, documents, or information” connected to four categories of information pertaining to gender-affirming care. The defendants appealed to the Ninth Circuit on July 10, 2026.[9]
Eastern District of Pennsylvania. On November 21, 2025, the U.S. District Court for the Eastern District of Pennsylvania granted in part a hospital’s motion to limit a DOJ subpoena.[10] The judge found that DOJ erred in seeking child-patient-specific files in its quest to find any “federal health care offense” under 18 U.S.C. § 3486 tied to misbranding by manufacturers and distributors promoting off-label uses under the FD&C Act. DOJ asserted that the files were relevant to a Section 331 investigation—in part because “[l]inking each patient’s clinical record to corresponding billing and insurance claims can demonstrate whether diagnoses were miscoded, which can prove fraudulent intent.” Those explanations, Judge Mark A. Kearney wrote, did not “withstand scrutiny”:
Congress, through the Act, regulates the introduction, labeling, and distribution of drugs in interstate commerce; it does not govern how physicians diagnose patients, obtain consent, document treatment, or communicate with them. The conduct [DOJ] describes—miscoded diagnoses, allegedly incomplete disclosures, or purportedly misleading consent forms—concerns how drugs are used in practice, not how they are labeled, promoted, or distributed in commerce. Alleged deficiencies in those areas may implicate state informed-consent or professional-discipline standards, but they do not establish a Section 331 violation “relating to” a health care benefit program within the meaning of Section 3486.
Linking individualized clinical narratives to billing data does not transform clinical narratives into statutorily relevant material. If coding accuracy or billing irregularities exist, the relevant evidence lies in the Hospital’s coding guidance, claim forms, insurer correspondence, and internal communications….
DOJ appealed to the Third Circuit but later requested a voluntary dismissal pursuant to Fed. R. App. P. 42(b).[11]
Northern District of Texas/District of Rhode Island. On May 1, 2026, DOJ and the U.S. Attorney’s Office for the Northern District of Texas announced that they were seeking to enforce an administrative subpoena duces tecum against a Rhode Island hospital as part of an investigation into the prescription of certain drugs to minors with gender dysphoria and related disorders, including puberty blockers and cross-sex hormones.
After Chief Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas issued an opinion and order on April 30, 2026, compelling the hospital to comply,[12] the Child Advocate for the State of Rhode Island, as well as the hospital, filed motions to quash in Rhode Island. On May 13, 2026, the U.S. District Court for the District of Rhode Island granted the motions, enjoining the DOJ from seeking or receiving any documents related to the subpoena, and issued an order regarding the government’s conduct relating to the Texas investigation.[13]
On the merits, Judge Mary S. McElroy—sitting in Rhode Island—concluded that (1) the government failed to show that the subpoena was issued for a congressionally authorized purpose, (2) that it was issued for an improper purpose in bad faith, and (3) that the enforcement of the subpoena would violate the Fourteenth Amendment right to informational privacy of the children that are the subject of the medical records at issue. Regarding the lack of a congressionally authorized purpose, Judge McElroy wrote:
The DOJ acknowledges that merely writing off-label prescriptions is not an [FD&C Act] offense but attempts to reach prescribing hospitals indirectly by characterizing their participation in a supply chain as causing the distribution of misbranded drugs. That reframing does not save the theory.
The government appealed to the U.S. Court of Appeals for the First Circuit. On May 19, 2026, a First Circuit panel (Judges Gustavo A. Gelpí, Lara E. Montecalvo, and Joshua E. Dunlap) denied the Child Advocate’s request for an injunction pending appeal that would have barred the hospital from producing any subpoena-related records while the Rhode Island order remained on appeal.[14] The panel found no irreparable harm, noting that the Texas court had directed the records be held in camera pending the outcome of both the Fifth and First Circuit appeals, rather than turned over to the DOJ.
While the above was happening, back in Texas, the hospital appealed Judge O’Connor’s April 30 order to the Fifth Circuit, which denied the hospital’s request for a stay pending appeal on May 12, 2026.[15] The Fifth Circuit case is ongoing.
FTC Involvement
In addition to DOJ, the Federal Trade Commission (FTC) has been targeting health care entities—including professional associations—for their communications, publications, guidelines, and advocacy respecting gender-affirming care. The Endocrine Society (or the “Society”) was among those nonprofits seeking declaratory and injunctive relief, alleging constitutional violations, after receiving Civil Investigative Demands (CIDs) from the FTC in January 2026.
On May 7, 2026, Judge James E. Boasberg of the U.S. District Court for the District of Columbia preliminarily enjoined the FTC from implementing or enforcing its CID against the Endocrine Society. [16] According to the opinion, the FTC CID required the Society to turn over “a wide range of materials,” including:
- any documents “relating to substantiation” for the proposition that pediatric-gender-dysphoria treatment is safe and effective;
- all “[c]ommunications … regarding the development and publication” of the Endocrine Society’s Guidelines (relating to treatment of gender-dysphoric/gender incongruent persons);
- any materials or information the Society uses in its educational and advocacy work; and
- the Society’s financial statements and records of payments between it and other medical companies or hospitals.
Judge Boasberg concluded that the Society was likely to demonstrate that the FTC CID violated its constitutional rights, showing that it (1) engaged in conduct protected under the First Amendment, (2) that the alleged retaliatory action was “sufficient to deter a person of ordinary firmness in plaintiff’s position from speaking again,” and (3) that there exists a causal link between the protected speech and the retaliatory action.
The WPATH Litigation. Judge Boasberg incorporated those conclusions in another Memorandum Opinion issued the same day, World Professional Association for Transgender Health v. Federal Trade Commission.[17]
FTC would later withdraw the CIDs but bring—along with several state attorneys general—a separate enforcement action against WPATH in the Northern District of Texas on June 17, 2026, alleging violations of the FTC Act and various state consumer protection laws.[18] The suit alleges that an association of clinicians that provides gender-affirming care promulgated deceptive standard-of-care recommendations, leading medical providers to make false and unsubstantiated claims to parents in order to promote gender transition services for minors. This compelled WPATH to seek relief from Judge Boasberg, in D.C., from the Texas litigation. On July 10, however, Judge Boasberg denied WPATH’s motion for a temporary restraining order to block the FTC’s enforcement action in the Texas case, which is ongoing.[19]
State Actions
As Epstein Becker Green has written, there is now a tension between laws in some states and the administration’s efforts to restrict or prevent medication and surgical gender-affirming care, especially for minors. In some states, gender identity is a protected class, and denial of care for that reason violates antidiscrimination laws. Some states require coverage of gender-affirming care in their health insurance markets. Licensing boards in certain states prohibit discrimination based on gender identity, sometimes without express exceptions for religious refusal. There are numerous state legal developments. Several states have adopted “shield” laws or policies designed to protect providers and patients seeking care that is legal under the law of that state; whether and how those states carry out the Final Rule and continue access remains to be seen.
In an unusual twist, the Colorado Supreme Court held on May 18, 2026, that a state trial court abused its discretion by denying a motion for preliminary injunction that would have required Children’s Hospital Colorado to repeal its recent suspension of gender-affirming care—“when that repeal might invite the wrath of the federal government.” There was sufficient evidence, the Colorado Supreme Court found, that a children’s hospital violated state antidiscrimination law when it suspended gender-affirming care in the face of federal threats; the trial court erred in its application of the relevant factors.[20] The Supreme Court reversed the trial court’s decision and ordered the latter to issue a preliminary injunction requiring the hospital to restore its offering of gender-affirming care, pending a decision on the merits. Two judges dissented.
On January 30, 2026, California Attorney General Rob Bonta filed a complaint in Superior Court of the State of California, County of San Diego, against a children’s hospital, for injunctive relief, penalties, and more after the hospital allegedly curtailed its gender-affirming care services.[21] This action, Bonta asserted, violates the hospital’s obligation to maintain these services as documented in an affiliation agreement effective January 1, 2025, as the merger between Rady and a number of entities (also named as defendants) was subject to attorney general review.
In addition to filing amicus briefs in federal cases, state attorneys general are also challenging the numerous government actions relating to gender-affirming care[22]—asserting claims including violation of the Tenth Amendment and the Administrative Procedure Act. The August 2025 complaint in Commonwealth of Massachusetts v. Trump, for example, argues among other things that the FD&C Act “does not regulate the physician-patient relationship, and does not make it unlawful for healthcare providers to provide medically necessary healthcare to treat gender dysphoria in adolescents, including providing or prescribing drugs off-label.” Also, the FCA “does not make it unlawful for healthcare providers to provide medically necessary healthcare to treat gender dysphoria in adolescents and to accurately bill for that treatment, nor does it deem such care inherently fraudulent.”
DOJ filed a motion for summary judgment on all claims and accompanying memorandum on August 14, 2026.
Of course, not all states are pushing back, and some continue to follow the federal government’s lead. On August 21, a Florida judge denied a motion to dismiss filed by defendants including WPATH and the Endocrine Society—in a lawsuit alleging that defendants “initiated a coordinated campaign to develop ‘clinical guidelines’ recommending interventions for pediatric gender dysphoria” in violation of federal law.[23] Judge Michael D. Porter agreed with the Florida attorney general that the claim at issue “targets alleged anticompetitive commercial conduct, as opposed to protected speech.” The case is ongoing.
Takeaways
The administration’s multi-agency strategy to combat gender-affirming care continues to escalate. The federal government has been clear that it intends to eradicate this type of care. Providers and health care entities need to pay attention to the various federal and state constraints.
Those operating in the gender-affirming care space should focus on rigorous compliance with all applicable federal and state laws, including those outlined above; audit to ensure accurate coding and billing; preserve billing records and clinical documentation for the relevant service dates; and continue to seek the advice of counsel.
In particular, hospitals, health care systems and networks, specialty pharmacies and infusion services, medical clinics and practices, individual health care providers, university medical centers, and Planned Parenthood affiliates should review the Referral Letter and seek counsel to evaluate their potential legal exposure and collateral issues.
Remember that the Final Rule presently is scheduled to go into effect on October 13 (though litigation, with a potential injunction, is a distinct possibility):
- States must provide that the state Medicaid and CHIP agencies will not make payment under the plan for “sex-rejecting procedures” for children under 18 (Medicaid) and 19 (CHIP).
- Federal dollars are prohibited for those purposes.
- For Medicaid and CHIP beneficiaries who are actively receiving cross-sex hormone therapy, state Medicaid and CHIP agencies may continue to claim FFP for those hormone therapy medications for a period of up to six months from the date of the Final Rule (August 13 to February 13).
Note that Epstein Becker Green’s “Gender-Affirming Care: What Health Care Providers Need to Know About Federal Enforcement” video series provides first-step analysis and takeaways:
- Coordinated Enforcement Tools: The federal government is employing EOs, civil and criminal investigations, notice-and-comment rulemaking, agency enforcement actions, and public pressure campaigns to limit gender-affirming care. Providers may face challenges from multiple federal agencies and branches at once.
- Judicial Scrutiny of Agency Motives: Courts are examining whether agency enforcement actions are grounded in legitimate regulatory authority or motivated by political objectives.
- Multi-Forum Defense Strategies: Health care providers defending against coordinated federal enforcement are engaging across multiple agencies and courts rather than pursuing a single legal strategy or forum.
- Collaborative Response Efforts: Health care organizations are coordinating with peer organizations and state attorneys general in response to federal enforcement efforts.
* * * *
For additional information about the issues discussed in this Insight or if you need assistance with an internal investigation or a response to an enforcement action, please contact the attorney(s) listed on this page or the Epstein Becker Green Health Care and Life Sciences attorney who regularly handles your legal matters.
Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this Insight.
ENDNOTES
[1] For reference, in 2024 alone, Peterson-KFF reports that private health insurers paid $1.645 billion on health consumption expenditures and the government paid $1.118 billion for Medicare. Total health care spending approached $5.3 trillion in 2024 alone. From 2015 through 2025, an estimated $46 trillion total (combined public and private) was spent on health care (CMS, National Health Expenditures by type of service and source of funds, CY 1060-2024).
[3] In Re: Administrative Subpoena No. 25-1431-019, 800 F. Supp. 3d 229 (D. Mass. 2025).
[4] In Re Subpoena Duces Tecum No. 25-1431-016, 2025 WL 3562151 (W.D. Wash. Sept. 3, 2025).
[5] Seattle Children’s Hospital v. DOJ-United States Department of Justice, No. 26-409 (9th Cir. Jun. 23, 2026).
[6] QueerDoc PLLC v. DOJ-United States Department of Justice, 807 F.Supp.3d 1295 (W.D. Wash. 2025).
[7] QueerDoc PLLC v. DOJ-United States Department of Justice, 2026 WL 2359440 (9th Cir. Aug. 14, 2026).
[8] Z.A. v. Blanche, 2026 WL 1907181 (N.D. Calif. Jul 2, 2026).
[9] Z.A. v. Blanche, No. 26-4388 (9th Cir. Jul 10, 2026).
[10] In re Subpoena No. 25-1431-014, 810 F.Supp.3d 555 (E.D. Pa. 2025).
[11] In Re Administrative Subpoena No. 25-1431-014, Docket No. 26-01134 (3d Cir. Jan. 26, 2026).
[12] In Re: Administrative Subpoena 25-1431-032, Docket No. 4:26-mc-00006-O (N.D. Tex. May 10, 2026).
[13] In Re: Motion to Quash Administrative Subpoena…, 2026 WL 1392565 (D.R.I. May 14, 2026).
[14] In re: Motion to Quash Administrative Subpoena…, Child Advocate for Rhode Island, et al., v. United States of America, 177 F. 4th 21 (1st Cir. May 19, 2026) (order denying injunction pending appeal).
[15] No. 26-10431 (5th Cir. May 7, 2026).
[16] Endocrine Society v. Federal Trade Commission, 832 F.Supp.3d 1 (D.D.C. May 7, 2026).
[17] World Professional Association for Transgender Health v. Federal Trade Commission, 2026 WL 1257321 (May 7, 2026).
[18] Federal Trade Commission et al. v. World Professional Association for Transgender Health, Inc. et al., No. 4:26-cv-00748 (N.D. Tex. Jun 17, 2026).
[19] World Professional Association for Transgender Health v. Federal Trade Commission, 2026 WL 1999008 (July 10, 2026).
[20] Boe v. Child.’s Hosp. Colo., 2026 CO 32.
[21] No. 26CU005360C (San Diego Super. Ct. 2026).
[22] Commonwealth of Massachusetts v. Trump, No. 1:25-cv-12162 (D. Mass. Aug. 1, 2025)
[23] Office of the Attorney General, State of Florida v. World Professional Association for Transgender Health, No. 56-20 25-CA-2660 (Fla. Cir. Ct. Aug. 21, 2026).