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
2023 was another record year for False Claims Act enforcement. On February 22, 2024, the U.S. Department of Justice (DOJ) announced that the federal government and whistleblowers were party to a record number of FCA...more
2/27/2024
/ Artificial Intelligence ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Due Diligence ,
Enforcement Actions ,
Enforcement Priorities ,
Enforcement Statistics ,
False Claims Act (FCA) ,
Health Care Providers ,
Investors ,
Life Sciences ,
Medicare ,
Medicare Advantage ,
Medicare Part C ,
Portfolio Companies ,
Private Equity ,
Private Equity Firms ,
Self-Disclosure Requirements ,
Voluntary Disclosure ,
Whistleblowers
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
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
The July 20, 2022 Special Fraud Alert describes findings from what OIG describes as “dozens of investigations of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services”...more
7/29/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Liability ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Durable Medical Equipment ,
Enforcement Actions ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Risk Alert ,
Telehealth ,
Telemedicine