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 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 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
On 7 February 2023, the US Department of Justice (DOJ) publicly reported the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2022. While the DOJ emphasized in its accompanying press release that “the...more
In a significant departure from the general downward trend in False Claims Act (FCA) civil fraud recoveries over the past half-decade —and as predicted last year —recoveries in Fiscal Year (FY) 2021 drastically increased...more
False Claims Act (FCA) civil fraud recoveries in Fiscal Year (FY) 2020 dropped over US$850 million when compared to those in FY 2019. While the more than US$2.2 billion in recoveries in FY 2020 continued a general downward...more
This article analyzes emerging risks to PE firms that invest in the health care sector by examining the current enforcement landscape and significant FCA litigation; identifies key factors that increase FCA risk for PE firms...more
The U.S. Supreme Court’s 2019 decision in Azar v. Allina Health Services effectively curtailed the enforceability of certain Medicare policies established without notice-and-comment rulemaking. As a result, health care fraud...more
On 4 December 2020, the Department of Health and Human Services (HHS) announced the creation of a False Claims Act Working Group (Working Group), with the goal of enhancing HHS’s partnership with the Department of Justice...more
On this week’s episode, John Lawrence, Leah Richardson, and John Rothermich discuss compliance requirements associated with federal funding provided to health care providers through the CARES Act Provider Relief Fund, as well...more
This edition of the Qui Tam Quarterly focuses on the potential False Claims Act (FCA) risk areas faced by health care provider recipients of payments from the Provider Relief Fund (PRF) created by the CARES Act, as well as...more
On 19 June 2020, in a major reversal of the U.S. Department of the Treasury’s (Treasury) previous position, the U.S. Small Business Administration (SBA) and Treasury announced that they will publicize additional data...more
6/26/2020
/ Borrowers ,
CARES Act ,
Coronavirus/COVID-19 ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Investigations ,
Liability ,
Loans ,
Paycheck Protection Program (PPP) ,
Public Information ,
SBA
In response to the economic crisis caused by the spread of COVID-19, Congress passed the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) on March 27, 2020, which President Donald J. Trump subsequently signed...more
In 2019, the False Claims Act (“FCA”) remained the federal government’s (“Government”) primary method of civil fraud enforcement. While the more than $3 billion in civil fraud recoveries in Fiscal Year (“FY”) 2019 resulted...more
New frontiers are emerging in health care as burgeoning technologies merge with health care’s ever-evolving landscape. While these new frontiers provide seemingly endless possibilities and opportunities for improving the...more
In 2018, the False Claims Act (“FCA”) continued to be one of the federal government’s (“Government”) preferred civil fraud enforcement tools across a variety of industries. The healthcare industry, however, remained the...more
In Part 3 of our series on health care investigations, Mark Rush and John Lawrence discuss the process for external investigations conducted by federal and state governmental agencies, including in the context of qui tam...more
11/27/2018
/ Civil Investigation Demand ,
Dismissals ,
Employee Rights ,
False Claims Act (FCA) ,
Frivolous Lawsuits ,
Government Agencies ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Internal Investigations ,
Obstruction of Justice ,
Qui Tam ,
Search & Seizure ,
Search Warrant ,
Subpoenas ,
Whistleblowers
In this episode, Mark Rush and John Lawrence discuss the federal government’s expectations related to health care organizations conducting internal investigations and demonstrating a commitment to compliance. The episode also...more
10/30/2018
/ Anti-Kickback Statute ,
Civil Liability ,
Civil Monetary Penalty ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Internal Investigations ,
OIG ,
Qui Tam ,
Risk Mitigation ,
Stark Law
Recently, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced its largest ever national health care fraud takedown, resulting in charges against 601 diverse defendants including...more
7/19/2018
/ Anti-Fraud Provisions ,
Anti-Kickback Statute ,
Bribery ,
Corruption ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Distribution ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
FBI ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Medicare Fraud Strike Force ,
OIG ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
State Attorneys General ,
TRICARE