In a brief press release published on July 9, 2025, the Department of Justice (DOJ) announced the issuance of more than 20 subpoenas to doctors and clinics as part of investigations into health care fraud, false statements, and related federal violations. The actions specifically target health care providers involved in transgender medical procedures for minors, representing a significant enforcement response that warrants careful analysis.

Understanding the Legal Landscape

Any health care provider facing a federal subpoena regarding this issue should understand the likely legal theories the DOJ will pursue and the defensive strategies available. Based on the announcement’s emphasis on “health care fraud” and a recent memorandum published by the DOJ’s Civil Division, several federal statutes appear relevant, including the False Claims Act (FCA), the Food, Drug & Cosmetic Act (FD&C Act), and the criminal health care fraud statute.

The government is likely to allege that providers submitted false claims to federal health care programs, such as Medicaid or TRICARE. The FCA targets anyone who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval.” Claims can be considered factually false (billing for services not rendered) or legally false (failing to comply with material requirements). The DOJ could also attempt to apply FD&C Act misbranding provisions to physicians prescribing Food & Drug Administration (FDA)-approved medications for off-label uses, although such claims would be relatively novel and would represent a potentially problematic expansion of traditional enforcement. More significantly, under the criminal health care fraud statute, criminal charges may be pursued for schemes to defraud health care benefit programs (which include commercial health plans), requiring proof of willful intent beyond a reasonable doubt.

Defensive Strategies

Health care providers may have several strong defenses against these potential claims. For example, if faced with FCA or criminal fraud claims, a provider might argue that care was medically necessary and demonstrate that treatments followed established standards of care recognized by major medical associations. If coding is an issue, a provider could try to show that their coding was accurate based on diagnosed conditions and services rendered. In any case, the provider could argue good faith and the absence of intent to defraud the government, as required by the FCA’s “knowingly” standard. Defenses to misbranding allegations due to off-label prescribing of FDA-approved medications could be that such activity falls within accepted medical practice and professional judgment, or that private physician communications with individual patients about the risks and benefits of an off-label treatment do not cause drug products to be misbranded under the FD&C Act.

Challenging Federal Subpoenas

A provider may have several grounds for filing a motion to quash under Federal Rule of Criminal Procedure 17(c)(2), including that the subpoena is unduly burdensome in proportion to any legitimate need or that it constitutes a “fishing expedition” rather than a targeted investigation of specific misconduct. Constitutional privacy protections also could be raised by arguing that the sensitive medical information of minors outweighs investigative interests. A provider also could argue that the subpoena violates the patient-provider privilege or that it otherwise encroaches on the practice of medicine. However, during a recent Federal Trade Commission (FTC) workshop entitled “The Dangers of ‘Gender-Affirming’ Care for Minors,” the FTC Chairman asserted that government enforcement actions of this nature do not interfere with the practice of medicine.

Strategic Considerations for Providers

A provider who receives a subpoena related to gender-affirming care should take immediate action in light of the complexities of federal investigations. For example, an internal audit of billing and clinical documentation practices under the protection of attorney-client privilege should be considered.

Broader coordinated defense strategies may be warranted, including joint defense groups with other targeted providers, to facilitate information sharing, coordinated legal strategy, and the pooling of resources. For example, engaging shared medical experts to establish standard of care evidence may effectively counter government narratives. Also, seeking support from medical associations and professional organizations through amicus curiae briefs can provide additional credibility and educational value for courts unfamiliar with the medical standards at issue.

The Broader Context

The DOJ’s announcement represents a significant development in federal health care fraud enforcement. The scope and coordination of subpoenas suggest a comprehensive investigation that may set precedents for future enforcement actions in contested areas of medical practice. Health care providers should recognize that federal investigations of this magnitude typically involve substantial resources and extended timelines, so early preparation and strategic legal counsel are essential for protecting both professional interests and patient care obligations.

The next targets are likely to be pharmaceutical manufacturers and distributors as well as online pharmacies. As discussed in a recent post, the Civil Division has announced its intent to use the FD&C Act and other laws to pursue manufacturers and distributors for making false representations about the use of FDA-approved products to facilitate a minor’s so-called “gender transition,” as well as “dealers” suspected of illegally selling such products (e.g., pharmacies).

Conclusion

While the legal theories that may underlie these investigations face significant challenges, the federal government’s enforcement capabilities require serious attention from targeted providers. The intersection of health care fraud law, constitutional privacy rights, and professional medical practice creates a complex legal environment that demands experienced counsel.

Providers facing federal subpoenas should act promptly to protect their interests while maintaining their commitment to patient care. As the legal landscape in this area continues to evolve, staying informed about developments is crucial for health care professionals operating in this regulatory environment.