When the federal government reopens after a shutdown, the return to “business as usual” is rarely immediate. Agencies face backlogs, funding adjustments, and operational hurdles that can directly impact companies, contractors, and regulated entities. Below we outline several key issues businesses should anticipate in the days and weeks following a reopening of the federal government.Continue Reading What to Expect When the Government Reopens: Key Considerations for Businesses
Federal enforcement of the False Claims Act (FCA) against healthcare and pharmaceutical companies—especially based on alleged Anti-Kickback Statute (AKS) violations—continues to change, with the Regeneron Pharmaceuticals case at the forefront of recent developments. Recall that in Regeneron, the government alleges that the pharmaceutical company is illegally subsidizing copayments for Medicare beneficiaries by making large donations to third party foundations offering copay assistance to strategically steer patients to its high-cost specialty drug, Eylea, instead of lower-cost alternatives, resulting in alleged FCA liability based on an AKS violation. After the First Circuit held that a FCA plaintiff in an AKS-based FCA case must prove “actual causality, which in ordinary course takes the form of but-for causation,” United States v. Regeneron Pharms., Inc., 128 F.4th 324, 330 (1st Cir. 2025), the government is trying—again—to avoid having to prove a causal link between the alleged AKS violation and damages (i.e., financial harm to a government program). The government’s recent summary judgment brief in the United States District Court for the District of Massachusetts provides a detailed look at both its evolving legal theory and the practical compliance lessons for pharmaceutical manufacturers, providers, and health systems.Continue Reading Regeneron, the False Claims Act, and a New Era in Government Enforcement
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
In United States v. Chastain, No. 23-7038, 2025 WL 2165839 (2d Cir. July 31, 2025), the United States Court of Appeals for the Second Circuit vacated wire fraud and money laundering convictions in what the government described as its first crypto insider trading case. The case involves a former employee of OpenSea, an online non-fungible token (“NFT”) marketplace, who allegedly used confidential information about which NFTs would be featured on OpenSea’s homepage to purchase those NFTs before they were promoted, then sold them after a post-promotion price bump for a profit. At trial, the United States District Court for the Southern District of New York instructed the jury that property protected by the wire fraud statute need not have commercial value, and the defendant could be convicted of wire fraud by failing to abide by societal mores.Continue Reading Second Circuit Vacates Fraud Conviction in First Crypto “Insider Trading” Case
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
The U.S. Department of Justice (“DOJ”) Data Security Program (“DSP”) 90-day enforcement grace period ended as of July 8, 2025. While the program became effective April 8, 2025, DOJ implemented a 90-day enforcement grace period until July 8, 2025 for good-faith efforts towards compliance (see our previous blog here). With the expiration of the grace period, the majority of the DSP is now effective and will be enforced.Continue Reading DOJ’s 90-Day Data Security Compliance Grace Period is Over: Are You Compliant?
On Tuesday, July 8, the DOJ Antitrust Division announced a first-of-its-kind Antitrust Whistleblower Rewards Program (the “Program”). But the Program’s fine print suggests it may not be as lucrative for whistleblowers as it appears at first blush.Continue Reading New DOJ Antitrust Postal Whistleblower Rewards Program: A Look Under the Shiny Hood
On Monday June 9, 2025, the Deputy Attorney General Todd Blanche released “Guidelines for Investigations and Enforcement of the Foreign Corrupt Practices Act.” This much anticipated update directly responds to Executive Order 14209, signed by President Trump earlier this year, which temporarily paused Foreign Corrupt Practices Act (FCPA) enforcement. The new Guidelines focus FCPA enforcement going forward on protecting U.S. business interests, furthering the Administration’s efforts to stamp out cartels and transnational criminal organizations, and prioritizing prosecution of individuals rather than corporations. Conduct that can be described as “routine business practices” in foreign countries, under the Guidelines, will not be pursued.Continue Reading DOJ Releases Promised Guidelines for Investigation and Enforcement Under the FCPA
Recently, the Texas House of Representatives introduced HB 5007, along with its companion bill SB 2117. The legislation—“Relating to the establishment of the Texas Committee on Foreign Investment to review certain transactions involving certain foreign entities; creating a civil penalty”—is currently under committee review. If enacted, the Lone Star State would become the first state to establish its own interagency committee to screen foreign investments, modeled in part on the federal Committee on Foreign Investment in the United States (CFIUS).Continue Reading Big State, Big Scrutiny: Texas Steps into the Foreign Investment Review Arena
A serious step up in civil and criminal enforcement of customs laws, including tariff evasion, is imminent. In a May 12 memorandum, the Department of Justice’s new Chief of the Criminal Division, Matthew Galeotti, counted as one of the “most urgent” threats to the country “[t]rade and customs fraud, including tariff evasion.” Earlier in the Administration, in a February 2025 speech, Michael Granston, Deputy Assistant Attorney General for the DOJ’s Commercial Litigation Branch identified, as a key example of new enforcement activity, efforts to enforce payment of customs duties on imported goods and reiterated that enforcement against “illegal foreign trade practices” would be a priority for the Administration. Continue Reading Department of Justice Tariff Enforcement Likely to Surge After Tariff Increases and the Administration’s Increased Focus on Protecting Domestic Business