Citing the need to strike a balance between “overbroad and unchecked corporate and white-collar enforcement [that] burdens U.S. businesses and harms U.S. interests” and “[u]nchecked fraud in U.S. markets and government...more
5/15/2025
/ Corporate Crimes ,
Corporate Misconduct ,
Criminal Prosecution ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Priorities ,
Non-Prosecution Agreements ,
Trump Administration ,
Voluntary Disclosure ,
Whistleblowers ,
White Collar Crimes
Welcome to the third issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more
2/28/2025
/ California ,
Centers for Medicare & Medicaid Services (CMS) ,
Corporate Practice of Medicine ,
Data Privacy ,
Medicaid ,
Medicare ,
New Legislation ,
Popular ,
Private Equity ,
Reproductive Healthcare Issues ,
Telehealth
In a unanimous panel opinion filed on February 18, 2025, the First Circuit held that False Claims Act cases predicated on violations of the Anti-Kickback Statute (“AKS”), require proof that alleged kickbacks were the...more
2/21/2025
/ Anti-Kickback Statute ,
Appeals ,
But For Causation ,
Causation ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Judicial Authority ,
Litigation Strategies ,
Medicare ,
Pharmaceutical Industry ,
Regeneron ,
Statutory Interpretation
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
Over the last few years, the U.S. Department of Justice (“DOJ”) has continuously announced significant policies and programs directed at encouraging and rewarding the timely reporting of corporate wrongdoing, incentivizing...more
3/18/2024
/ Artificial Intelligence ,
Compliance ,
Cooperation ,
Corporate Crimes ,
Corporate Misconduct ,
Cyber Threats ,
Department of Justice (DOJ) ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Investment ,
National Security ,
Pilot Programs ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblowers ,
White Collar Crimes
On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more
11/27/2023
/ Anti-Kickback Statute ,
Board of Directors ,
Compliance ,
Department of Health and Human Services (HHS) ,
Employee Training ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
New Guidance ,
OIG ,
Policies and Procedures ,
Stark Law ,
Voluntary Correction Program ,
Voluntary Participation
On October 4, 2023, the United States Department of Justice (DOJ) announced a “safe harbor” policy for companies that voluntary self-disclose violations identified during the M&A process.
US Deputy Attorney General Lisa...more
10/10/2023
/ Acquisitions ,
Compliance ,
Cooperation ,
Corporate Misconduct ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Due Diligence ,
Enforcement ,
Mergers ,
Safe Harbors ,
Voluntary Disclosure
On September 27, 2023, the Chief Judge of the District of Massachusetts decided that the standard in False Claims Act (“FCA”) cases premised on alleged violations of the Anti-Kickback Statute (“AKS”) is but-for causation....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
As part of a recent series of announcements regarding updates to its corporate compliance policies, the Department of Justice (DOJ) announced significant revisions to its evaluation criteria for corporate compliance programs,...more
3/8/2023
/ Chief Compliance Officers ,
Clawbacks ,
Compliance ,
Corporate Crimes ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Electronic Communications ,
Enforcement Priorities ,
Executive Compensation ,
Monaco Memo ,
White Collar Crimes
On February 22, 2023, the US Department of Justice (DOJ) announced a Voluntary Self-Disclosure Policy (VSD Policy) to formalize DOJ’s efforts to incentivize companies to voluntarily self-report criminal misconduct to the...more
3/1/2023
/ Chief Compliance Officers ,
Compliance ,
Cooperation ,
Corporate Crimes ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Federal Pilot Programs ,
Foreign Corrupt Practices Act (FCPA) ,
Monaco Memo ,
Self-Disclosure Requirements ,
Voluntary Disclosure ,
White Collar Crimes