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Madeline Townsley

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Madeline Townsley is an associate in the Business Trial Practice Group in the firm's New York office.

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On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to investigations into healthcare fraud, false statements and other misconduct.[i] DOJ’s recent announcement, combined with the other actions described below, signal the government’s interest in pursuing action against providers that bill federal healthcare programs for gender-affirming care for minors, including puberty blockers, hormone therapy and surgeries. Specifically, these actions strongly suggest that the government will investigate not only criminal claims but also civil claims under the False Claims Act[ii] (“FCA”) against gender-affirming care providers that bill federal healthcare programs for services provided to minors, relying on bases related to miscoding/misbilling, lack of informed consent and lack of medical necessity. The FCA provides for treble damages and penalties of up to $28,619 per claim. We discuss each of these theories below and what providers can do to reduce potential exposure under these theories.Continue Reading Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

Earlier this month, the Eleventh Circuit (the “Court”) issued a decision in a False Claims Act (“FCA”) case against a medical supplier that offers welcome clarity for companies facing whistleblower allegations. In Vargas ex rel. Alvarez v. Lincare, Inc., 2025 U.S. App. LEXIS 9084 (11th Cir.), the Court emphasized high pleading requirements FCA plaintiffs must satisfy to survive a motion to dismiss. Specifically, the court held that it is not enough to allege a general scheme; the FCA plaintiff must also plead, with detail, how the scheme caused the actual submission of false claims to the government. The decision is especially significant in the healthcare context with respect to Anti-Kickback Statute (“AKS”) based FCA cases. The court made clear that the plaintiff must do more than include conclusory allegations that one purpose of the payment was to induce referrals—it must include details as to the defendant’s intent.Continue Reading Inferential Leaps and Conclusory Kickback Allegations Remain Verboten in False Claims Act Complaints

On January 28, 2025, President Trump signed Executive Order 14187 (the “EO”), which directed the federal government to take steps to ensure that the federal government does not “sponsor, promote, assist, or support” the “‘transition’ of a child from one sex to another,” including the provision of gender-affirming care to individuals under the age of nineteen. Specific provisions of the EO directed, among other things, that: (1) all federal agencies rescind or amend all policies relying on guidance issued by the World Professional Association for Transgender Health; (2) federal agencies that provide research or education grants to hospitals and medical schools take “appropriate steps” to ensure that institutions receiving federal research or education grants end gender-affirming care to individuals under the age of nineteen; (3) the Secretary of the Department of Health and Human Services (“HHS”) take all appropriate regulatory and legal action to end gender-affirming care for individuals under the age of nineteen—such as through Medicare or Medicaid conditions of participation or conditions for coverage, clinical-abuse or inappropriate-use assessments relevant to State Medicaid programs; (4) the U.S. Attorney General to enforce an existing federal law against “genital mutilation” (18 U.S.C. § 116), and coordinate with state attorneys general to enforce state laws against gender-affirming care; and (5) the Director of the Office of Personnel Management include provisions in the Federal Employee Health Benefits and Postal Service Health Benefits programs call letter for the 2026 plan year specifying that eligible carriers exclude coverage for pediatric transgender surgeries or hormone treatments.Continue Reading Recent Legal and Regulatory Developments Involving Gender-Affirming Care