A defendant's mens rea, or intent, is almost always a contested element in a criminal prosecution, particularly in criminal healthcare fraud cases that frequently arise out of complex legal and regulatory regimes....more
The healthcare industry is one of the most heavily regulated industries in the United States. Healthcare companies and practitioners devote significant resources to complying with the complex and often changing legal and...more
In Ruan v. United States, the U.S. Supreme Court on June 27, 2022, dealt a blow to the U.S. Department of Justice by vacating convictions of two physicians convicted of violating 21 U.S.C. §841(a) of the Controlled Substances...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more
A recent U.S. Department of Justice (DOJ) settlement should serve as a reminder that pharmaceutical manufacturers are not the only entity in the drug supply chain that are susceptible to enforcement actions with respect to...more
U.S. District Court Judge Richard Stearns issued an order on May 6, 2020, finding that the two primary features of the Massachusetts Attorney General's COVID-19 debt collection regulation — a ban on debt collector initiated...more
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) provides for billions of dollars in relief funds to healthcare providers responding to the coronavirus (COVID-19) pandemic. In April 2020, the U.S. Department...more
ACA International (ACA), the Association of Credit and Collection Professionals, filed a complaint on April 20, 2020, in the U.S. District Court for the District of Massachusetts challenging the validity of the recently...more
While the COVID-19 pandemic has not yet peaked in the United States, federal and state prosecuting and regulatory agencies are already devoting resources to investigating and prosecuting fraud, waste and abuse associated with...more
A prominent professor at Harvard University, Charles Lieber, chair of the Harvard Chemistry Department, was arrested on Jan. 28, 2020, and charged with the federal crime of making a false statement to the government arising...more
On Feb. 8, 2018, the National Science Foundation (NSF) announced in its “Important Notice to Presidents of Universities and Colleges and Heads of Other National Science Foundation Grantee Organization” that it was taking...more
Corporate integrity agreements (CIAs) are a familiar feature of many civil False Claim Act and joint civil/criminal resolutions in healthcare fraud cases. These agreements are entered into between the defendant company and...more
The federal government has stepped-up its enforcement efforts in the areas of academic research and grant funding. Just this week, Northwestern University agreed to pay $2.93 million to settle a federal whistleblower suit...more
In the wake of a number of highly publicized corporate scandals, many of which involved both SEC enforcement and criminal prosecution (WorldCom, Adelphia, Tyco and Enron, among others), Congress enacted the Dodd-Frank Wall...more