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 ,
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
On September 23, 2024, the Criminal Division of the United States Department of Justice (“DOJ” or the “Department”) revised its Evaluation of Corporate Compliance Programs guidance (the “ECCP”)....more
In March 2024, at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (“DAG”) Lisa Monaco announced that the Department of Justice (“DOJ” or the “Department”) intended to...more
8/16/2024
/ American Bar Association (ABA) ,
Audits ,
Bribery ,
Corporate Misconduct ,
Corruption ,
Department of Justice (DOJ) ,
Financial Institutions ,
Forfeiture ,
Fraud ,
Incentives ,
Non-Prosecution Agreements ,
Pilot Programs ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblowers ,
White Collar Crimes
In early March 2024 at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (DAG) Lisa Monaco’s keynote remarks previewed the development of new and significant Department of...more
3/21/2024
/ American Bar Association (ABA) ,
CFTC ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Healthcare ,
Securities and Exchange Commission (SEC) ,
Self-Reporting ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
As part of the Biden administration’s State of the Union blitz, the Federal Trade Commission (FTC) convened a workshop on private equity (PE) investments in the health care industry on March 5, 2024. Immediately prior to the...more
2023 was a very active one for Department of Justice (DOJ or the “Department”) guidance, and that guidance had one clear theme: DOJ wants companies to voluntarily self-disclose their misconduct. To incentivize...more
2/15/2024
/ Compliance ,
Cooperation ,
Corporate Crimes ,
Corporate Misconduct ,
Corruption ,
Department of Justice (DOJ) ,
Due Diligence ,
Enforcement ,
False Claims Act (FCA) ,
Safe Harbors ,
Self-Disclosure Requirements ,
Settlement ,
Voluntary Disclosure ,
White Collar Crimes
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
Record Settlement in a Declined Case -
While defendants typically breathe a sigh of relief when the Department of Justice (DOJ) declines to intervene in a qui tam False Claims Act (FCA) case, a more favorable outcome is by...more
2/13/2023
/ Cyber Crimes ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Long-Term Care ,
Private Equity Firms ,
Qui Tam ,
Settlement
The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal...more
12/21/2022
/ Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Department of Veterans Affairs ,
Federal Health Care Programs (FHCP) ,
Healthcare ,
OIG ,
Payment Systems ,
Telehealth ,
TRICARE
Disclosing known or suspected fraud to regulators can have its benefits. As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA)...more
Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more
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
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more
11/11/2021
/ Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Violations ,
Healthcare Fraud ,
OIG ,
Provider Self-Disclosure Protocol ,
Reporting Requirements ,
Settlement ,
Whistleblowers
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
During a recent panel discussion hosted virtually by the American Bar Association, attorneys from the Department of Justice (DOJ) and certain U.S. Attorneys’ Offices known for health care fraud enforcement provided valuable...more
DOJ Continues Historic Level of Criminal and Civil Enforcement Against COVID-19 Fraud -
On Friday, March 26, 2021, the Department of Justice (DOJ) announced an update on its efforts to combat COVID-19 related fraud. ...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
Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating these risks....more
7/6/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Infectious Diseases ,
Natural Disasters ,
OIG ,
Paycheck Protection Program (PPP) ,
Qui Tam ,
Relators ,
Whistleblower Protection Policies ,
Whistleblowers
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
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
The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden...more
9/23/2019
/ Amended Complaints ,
Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Drug Compounding ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud and Abuse ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Portfolio Companies ,
Private Equity Firms ,
TRICARE