On 18 February 2025, the First Circuit Court of Appeals issued its decision in United States v. Regeneron Pharmaceuticals, Inc., determining that “but-for” causation is the proper standard for False Claims Act (FCA) actions...more
On 15 January 2025, the US Department of Justice (DOJ) published its report (Report) announcing civil recoveries under the False Claims Act (FCA) for Fiscal Year (FY) 2024. The recoveries for FY 2024 exceeded US$2.9 billion,...more
1/24/2025
/ Cybersecurity ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Healthcare Fraud ,
Medicare ,
Medicare Advantage ,
Opioid ,
Qui Tam ,
Settlement ,
Stark Law ,
Whistleblowers
In a first-of-its-kind ruling on 30 September 2024, Judge Kathryn Kimball Mizelle of the US District Court for the Middle District of Florida held in United States ex rel. Zafirov v. Florida Med. Assocs., LLC that the qui tam...more
On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more
On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more
6/25/2024
/ Anti-Kickback Statute ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Internal Investigations ,
Kickbacks ,
Pharmaceutical Industry ,
Settlement ,
White Collar Crimes
On 5 March 2024, in an issue of first impression in the District of South Carolina, a district court judge overseeing judicial review of a final agency decision in a Medicare claims appeal ordered the Government to complete...more
On 22 February 2024, the US Department of Justice (DOJ) published its report (Report) announcing civil recoveries under the False Claims Act (FCA) for Fiscal Year (FY) 2023. The recoveries for FY 2023 exceeded US$2.68...more
3/4/2024
/ Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Incentives ,
Paycheck Protection Program (PPP) ,
Physicians ,
Qui Tam ,
Whistleblowers ,
White Collar Crimes
On 16 June 2023, the United States Supreme Court issued a decision in the case of United States ex rel. Polansky v. Executive Health Resources1, holding that the federal government (Government) maintains the authority to...more
The United States Supreme Court recently held that a defendant’s subjective belief is always relevant to the False Claims Act’s scienter element, regardless of what an objectively reasonable person may have believed. This...more