On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services, Office of Inspector General (“OIG”). The case, Pharmaceutical Coalition for Patient Access v. United States, centered on whether the Advisory Opinion was appropriate when it found a proposed patient assistance program for Medicare Part D beneficiaries by the Pharmaceutical Coalition for Patient Access (the “Coalition”) could violate the Anti-Kickback Statute (“AKS”). In rejecting this challenge to the Advisory Opinion, the Fourth Circuit signaled the judiciary’s continued respect afforded to government agencies, including OIG’s issuing of advisory opinions, even in a post-Chevron world.

On February 20, 2025, during a speech to the Federal Bar Association’s annual qui tam conference, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice (DOJ), said that the Trump Administration will seek to “aggressively” enforce the False Claims Act (FCA). In particular, Granston stated that active FCA enforcement is consistent with the Trump Administration’s priorities of increasing government efficiency and “rooting out waste, fraud and abuse.”  

In United States ex rel. Feliciano v. Ardoin, the D.C. Circuit joined every other circuit to consider the issue, holding that a pro se litigant cannot bring a False Claims Act (FCA) case. The court’s reasoning was straightforward: FCA claims belong to the government, not the relator. While individuals may represent themselves in legal matters, they cannot represent another party—including the United States—without being a licensed attorney. The FCA does not provide an exception to this rule, leading the court to affirm the district court’s dismissal as pro se FCA cases cannot proceed.

In our last update, we reported that despite the Supreme Court staying the nationwide injunction against FinCEN’s enforcement of the CTA in one Texas case, a nationwide stay of the Reporting Rule granted by a federal judge in the Eastern District in Smith v. United States Department of Treasury (6:24-cv-00336) remained in effect. 

Court Square Capital Partners and WindRose Health Investors have completed a jointly controlled investment in Soleo Health, according to a news release.

Soleo, founded in 2014 and based in in Frisco, Texas, is a national provider of specialty pharmacy and infusion services.

Court Square, based in New York, is a middle market private equity…

Since the President signed the February 10, 2025 Executive Order (Order) pausing enforcement of the Foreign Corrupt Practices Act (FCPA) (Client Alert: President Trump issues Executive Order “Pausing Foreign Corrupt Practices Act Enforcement to Further American Economic and National Security”), companies with cross-border business operations have likely faced questions from both internal and external stakeholders regarding what the Order means from a practical, day-to-day perspective. In some cases, this may include questions as to whether companies need to continue maintaining anti-bribery and anti-corruption compliance programs and related controls. The short answer is “yes.” Read on to learn why and for practical advice for internal legal teams addressing the current landscape.