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
On July 11, 2025, the Ninth Circuit Court of Appeals affirmed the criminal conviction of laboratory operator Mark Schena for violations of the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220 (EKRA) based on...more
Since April 2024, the California Department of Health Care Access and Information (HCAI), Office of Health Care Affordability (OHCA) has received twenty-six Material Change Transaction Notices (Notices) as part of its...more
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
California legislative activity focused upon private equity group and hedge fund health care transactions continues notwithstanding California Governor Gavin Newsom’s veto last fall of California Assembly Bill 3129 (AB-3129)....more
5/23/2025
/ California ,
Health Care Providers ,
Healthcare ,
Hedge Funds ,
Hospitals ,
New Legislation ,
Popular ,
Private Equity ,
Proposed Legislation ,
Regulatory Oversight ,
Regulatory Requirements
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
In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead.
Hear from a dynamic group of...more
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 the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead....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
Commencing October 2024, CMS will start off-cycle revalidations of all Skilled Nursing Facilities (SNFs). As part of the revalidation process, SNFs must disclose the additional information required under CMS’ final rule,...more
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
On September 30, 2024, a federal district court judge held that the qui tam provisions of the False Claims Act (FCA) violate the Appointments Clause of Article II of the Constitution. U.S. ex rel. Zafirov v. Fla. Med....more
On September 28, 2024, California Governor Gavin Newsom vetoed California Assembly Bill 3129 (AB-3129) originally introduced by California Attorney General Rob Bonta (AG) and Assembly Speaker pro Tempore Jim Wood and passed...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
States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care...more
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
California Attorney General Rob Bonta (AG) and Assembly Speaker pro Tempore Jim Wood recently introduced legislation (AB-3129) that would authorize the AG to review private equity group and hedge fund health care...more
California’s health omnibus trailer bill SB-184 and the final cost and market impact review (CMIR) regulations (CMIR Regulations), which went into effect on December 18, 2023, have ushered in a significant change in...more
In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more