The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the...more
In January 2023, the Criminal Division of the Department of Justice (DOJ) announced revisions to its Corporate Enforcement Policy (CEP), which we previously summarized here and discussed in further detail as part of...more
As discussed in EnforceMintz – Significant 2022 Regulatory and Policy Developments, the Department of Justice (DOJ) issued several memoranda in late 2022 and early 2023, reinforcing DOJ’s approach to individual accountability...more
2/14/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Crimes ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Individual Accountability ,
Policies and Procedures ,
Regulatory Agenda ,
Settlement
The Physician Self-Referral Law — known as the “Stark Law” — broadly prohibits physicians from profiting from self-referrals for “designated health services” (DHS) payable by Medicare or Medicaid. For example, the Stark Law...more
2/13/2024
/ Anti-Kickback Statute ,
Compensation ,
Department of Homeland Security (DHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Liability ,
Medicaid ,
Medicare ,
Physicians ,
Stark Law
In 2023, the Supreme Court and the United States Courts of Appeals published a number of significant decisions with implications for entities in the health care and life science industries facing False Claims Act (FCA)...more
2/12/2024
/ Anti-Kickback Statute ,
Appeals ,
Causation ,
False Claims Act (FCA) ,
Healthcare ,
Life Sciences ,
Scienter ,
SCOTUS ,
Teva Pharmaceuticals ,
United States ex rel Polansky v Executive Health Resources Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION -
FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
2/11/2022
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacies ,
Qui Tam ,
Telehealth