Podcast — UK FinReg Focus Areas in 2025: Wholesale Markets
On January 23, 2025, in Pharmaceutical Coalition for Patient Access v. United States, the Fourth Circuit held that a proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would...more
In this post, we summarize noteworthy False Claims Act (FCA) decisions so far from 2023. Each of the three circuit court opinions discussed here ruled in favor of the defendants on different aspects of the FCA: the Sixth...more
On March 28, 2023, the Sixth Circuit issued an important False Claims Act (“FCA”) decision in U.S. ex rel. Shannon Martin, et al. v. Darren Hathaway, et al., No. 22-1463, which (1) adopted a “but-for” causation standard for...more
In Short - The Situation: The Anti-Kickback Statute ("AKS") prohibits a defendant from willfully paying or receiving "remuneration" in exchange for referrals—and, in addition, also specifies that any claims "resulting...more
On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more
In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as...more
On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more