On July 31, 2025, the United States Department of Justice (DOJ) announced a pair of settlements with companies accused of having violated the False Claims Act (FCA) by falsely representing their compliance with certain...more
8/5/2025
/ Compliance ,
Controlled Unclassified Information (CUI) ,
Corporate Counsel ,
Cybersecurity ,
Data Security ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Popular ,
Regulatory Requirements
In a brief press release published on July 9, 2025, the Department of Justice (DOJ) announced the issuance of more than 20 subpoenas to doctors and clinics as part of investigations into health care fraud, false statements,...more
This year’s National Health Care Fraud Takedown (Takedown) announced recently by the Department of Justice was touted by the Department of Justice (DOJ) as the largest to date, involving over $14.6 billion in “intended loss”...more
In May 2025 the Department of Justice (DOJ) Criminal Division published its enforcement priorities, and the Civil Division has now followed suit with a memorandum of its own (the “Civil Division Memo”)...more
Amid ongoing policy shifts in Washington, the federal government’s interest in pursuing civil cyber-fraud cases appears to be here to stay. In October 2021, the Department of Justice (DOJ) initiated its Civil Cyber-Fraud...more
4/3/2025
/ Corporate Counsel ,
Cybersecurity ,
Defense Contracts ,
Department of Justice (DOJ) ,
DFARS ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
NIST ,
Popular ,
Regulatory Requirements ,
Settlement ,
Whistleblowers
Health Care Cases Spur Largest FCA Recoveries -
Mintz’s annual report on False Claims Act case activity analyzes data from DOJ and the firm’s Health Care Qui Tam Database, and explores the 2024 record high in FCA case...more
In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and...more
Value-based care (VBC) is a health care delivery model that has grown increasingly common in recent years. Perhaps unsurprisingly, this growth seems to have attracted the attention of government enforcement agencies...more
1/17/2025
/ Anti-Kickback Statute ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
OIG ,
Settlement Agreements ,
Value-Based Care
Over the past two years, the Department of Justice (DOJ or the Department) has actively incentivized companies to voluntarily self-disclose potential civil and criminal violations. For example, in 2023, in the criminal...more
1/17/2025
/ Compliance ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Non-Prosecution Agreements ,
Self-Disclosure Requirements ,
Voluntary Disclosure ,
Whistleblowers ,
White Collar Crimes
Private equity (PE) investment in the health care industry has grown significantly over the last decade. This past year was no exception. While total deal volume lagged behind 2021 record highs, PE health care deal activity...more
2/9/2024
/ Antitrust Provisions ,
Compliance Manuals ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Investment ,
Investors ,
OIG ,
Private Equity Funds ,
Qui Tam
The Department of Justice and other federal enforcement agencies continued to hotly pursue individuals and entities involved in criminal telefraud schemes in 2022, as evidenced by the national coordinated law enforcement...more
2/13/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud ,
OIG ,
Public Health Emergency ,
Telemedicine
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
The U.S. Department of Justice (DOJ) recently announced its latest national enforcement action related to health care fraud (National Enforcement Action) in which DOJ filed criminal charges against 142 defendants. The...more
Comments made by Department of Justice (DOJ) attorneys during a recent webinar provided insight into the government’s civil enforcement priorities related to the coronavirus pandemic. In particular, government attorneys...more
8/19/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Government Investigations ,
Loan Forgiveness ,
Main Street Lending Programs ,
Paycheck Protection Program (PPP) ,
SBA ,
Telemedicine
The Department of Justice (DOJ) has announced its first criminal securities fraud prosecution related to COVID-19, and it involves health care fraud as well. Mark Schena, president of Arrayit Corporation, a publicly traded...more
6/12/2020
/ Bribery ,
Coronavirus/COVID-19 ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Guilty Pleas ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Public Health Emergency ,
Securities Fraud
Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more
As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care...more
Earlier this week the OIG took the somewhat unusual step of issuing a fraud alert directed to Medicare beneficiaries (rather than to Medicare providers) regarding “fraud schemes” that involve genetic testing. According to the...more
As in years past, the False Claims Act (FCA) remained a powerful health care enforcement tool in 2018, and FCA investigations and litigation persisted, fueled mainly by hundreds of lawsuits filed annually by relators,...more
1/16/2019
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Petition for Writ of Certiorari ,
Solicitor General ,
Universal Health Services Inc v United States ex rel Escobar
The Department of Justice (DOJ) recently intervened in a False Claims Act (FCA) case that raises a variety of interesting allegations, including payment of kickbacks by a compounding pharmacy to contracted marketing companies...more
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more
12/31/2015
/ Aetna ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CIGNA ,
CLIA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
OIG ,
PAMA ,
Stark Law
With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more
10/29/2015
/ 60-Day Rule ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Fair Market Value ,
False Claims Act (FCA) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Overpayment ,
Physician Compensation Arrangements ,
Qui Tam ,
Relators ,
Safe Harbors ,
Settlement ,
Stark Law ,
Suppliers ,
Third-Party ,
Training