On September 30, 2024, a federal judge for the Middle District of Florida issued a groundbreaking decision invalidating the qui tam provision of the False Claims Act (“FCA”) as unconstitutional because the relator (or...more
The Supreme Court recently issued a significant decision clarifying what it means to “knowingly” submit a false claim under the False Claims Act. At issue in United States ex rel. Schutte v. SuperValu Inc. were allegations...more
6/6/2023
/ Discount Pricing ,
Drug Pricing ,
False Claims Act (FCA) ,
Federal Contractors ,
Fraud ,
Medicaid ,
Medicare ,
Mens Rea ,
Objective Standard ,
Petition for Writ of Certiorari ,
Pharmacies ,
Prescription Drugs ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
Subjective Standard ,
US ex rel Tracy Schutte et al v SuperValu Inc et al ,
Willful Violations
Recent developments demonstrate that sponsor-backed companies in the healthcare and life sciences sectors, and in some instances private equity firms and professionals, have entered a new era of heightened regulatory scrutiny...more
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
3/8/2022
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Telehealth
On October 28, a majority of members on the Senate Judiciary Committee voted 15-7 to advance to the full Senate a bipartisan bill that would make a number of amendments to the False Claims Act (“FCA”), including one that...more
The federal False Claims Act (FCA) has long been a powerful tool for the U.S. Department of Justice (DOJ) — or private whistleblowers bringing suit on the DOJ’s behalf — to investigate and police activity financed with...more
7/2/2020
/ CARES Act ,
Colleges ,
Department of Justice (DOJ) ,
Educational Institutions ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Funding ,
Federal Grants ,
Financial Aid ,
Government Investigations ,
Research Funding ,
Risk Mitigation ,
Universities ,
Whistleblowers
The COVID-19 pandemic has created a seemingly constant state of concern and activity for companies in all sectors, with many businesses trying to launch new initiatives and find new financing to weather the storm and provide...more