Photo of Madeline Townsley

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

During the first Trump administration, the Department of Education (the “Department”) focused intensely on universities’ compliance with foreign source gift and contracting under Section 117 of the Higher Education Act (HEA).[i] The Department undertook 19 investigations of major research institutions and interpreted Section 117 to significantly expand both reporting requirements and the diligence expected of universities. Although no new investigations were opened in the Biden administration, Congress and political advocacy organizations continued to collect information and issue reports criticizing universities’ Section 117 compliance. In 2025, the White House issued an Executive Order and Fact Sheet on Section 117 but, perhaps more importantly, commenced three new Section 117 investigations and re-opened a closed Section 117 investigation. These new or revised investigative letters contain requests for information which are much more extensive than prior letters and delve into areas well beyond Section 117 such as export controls, non-disclosure of foreign support in federal grant proposals, malign foreign talent recruitment program restrictions and research security generally. This article analyzes how the content of these new letters suggest areas of heightened risk, what universities might be prioritized for investigations based on these letters and reports by Congress and advocacy organizations, and what universities can do to prepare for and lower such risk.Continue Reading How Universities Can Prepare for the New Higher Education Act Section 117 Investigations

On July 16, 2025, President Trump signed into law the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl Act or the Act), which significantly reformed the 1970 Controlled Substances Act (CSA). The HALT Fentanyl Act permanently reclassifies “fentanyl-related substances” as Schedule I controlled substances. Moreover, the Act simplifies Drug Enforcement Administration (DEA) research registration requirements in several ways, including (1) streamlining research registration processes for Schedule I or II controlled substances registrants performing research involving Schedule I controlled substances under active investigational new drug applications (INDs) or conducted or funded by certain federal agencies, (2) allowing agents or employees of a research institution to conduct research with a controlled substance without separately registering if another agent or employee of that institution is registered to conduct research with a controlled substance in the same schedule, and (3) expanding the ability of persons registered to perform research on a controlled substance to perform certain manufacturing activities coincident to that research without needing to obtain a manufacturing registration.Continue Reading HALT Fentanyl Act: Clarification of the Campus DEA Research Registration

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