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DOJ Reinforces Emphasis on Voluntary Self-Disclosure With Latest Updates to the Evaluation of Corporate Compliance Programs Guidance
October 7, 2024 | | By Eoin Beirne, Nick A. LaPalme, Karen Lovitch
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”). This article focuses on significant revisions detailed in the most recent installment of the guidance.
Federal District Court Holds FCA’s Private Whistleblower Provisions Unconstitutional
October 4, 2024 | Blog | By Grady Campion, Jane Haviland, Karen Lovitch
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. Assocs., LLC, C.A. No. 8:19-cv-01236-KKM, 2024 U.S. Dist. LEXIS 176626 (M.D. Fla. Sept. 30, 2024) (“Zafirov”). While Zafirov’s holding is novel, the constitutional issue raised in that decision is not.
The New Private Equity Post-Acquisition Paradigm
October 1, 2024 | Alert | By Eoin Beirne
Read about DOJ recent scrutiny of private equity deals, its initiatives aimed at increasing acquirer oversight of M&A transactions, and best practices for private equity sponsors in the current enforcement landscape.
Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the Anti-Kickback Statute Requires Knowledge that the Conduct is Unlawful
July 8, 2024 | Blog | By Laurence Freedman, Laura E. Martin
The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the relator, Adam Hart, a former McKesson employee, filed a petition for certiorari seeking Supreme Court review of a Second Circuit decision that upheld the dismissal of relator’s complaint asserting claims under the civil False Claims Act (FCA) premised on alleged violations of the AKS. U.S. ex rel. Hart v. McKesson Corp., 96 F.4th 145 (2d Cir. 2024). A violation of the AKS requires as the scienter element that the defendant "knowingly and willfully" offered or paid remuneration to induce the recipient of the renumeration to purchase goods or items for which payment may be made under a federal health care program. 42 U.S.C. § 1320a-7b(b)(2). The Second Circuit held that a defendant does not act “willfully” within the meaning of the AKS unless that defendant “act[s] knowing that his conduct is unlawful.” United States ex rel. Hart, 96 F.4th at 154.
Acting U.S. Attorney Levy Forecasts False Claims Act COVID Cases Targeting Private Lenders Of CARES Act Loans That Failed In Their Obligation To Safeguard Government Funds
June 5, 2024 | Blog | By Eoin Beirne, Jane Haviland
Acting U.S. Attorney Joshua Levy discussed the enforcement priorities for the Massachusetts U.S. Attorney’s Office (USAO) during a Q&A session on May 29, 2024, and made clear that the historical focus of the office remains the top priority: detecting and combating health care fraud, waste, and abuse.
DOJ Releases COVID-19 Fraud Enforcement Task Force Report Touting Its Successes and Urging Lawmakers to Enact New Legislation
April 18, 2024 | Blog | By Jane Haviland, Abdie Santiago
The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task Force’s (CFETF) report released on April 9, 2024. The CFETF, which represents a concerted effort across numerous federal agencies to investigate pandemic-related fraud, has, according to its 2024 report, succeeded in prosecuting over 3,500 defendants in criminal enforcement matters, in bringing civil enforcement actions resulting in more than 400 civil settlements and judgments, and in securing more than $1.4 billion in seizures and forfeitures. The report itself is a showcase of the CFETF’s COVID-19 fraud enforcement efforts to date.
EnforceMintz — Health Care False Claims Act Statistical Year in Review
March 20, 2024 | Blog
Mintz’s annual report on False Claims Act case activity analyzes data from the DOJ and the firm’s Health Care Qui Tam Database, and explores the 2023 spike in FCA case activity, the ongoing moderate decline in health care–related activity, and continuing
DOJ Announces it is Designing a Whistleblower Rewards Program
March 18, 2024 | Blog | By Eoin Beirne, Karen Lovitch, Brian Dunphy, Nick A. LaPalme
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 Justice (DOJ or the Department) policy initiatives. Her speech reemphasized many of DOJ’s key themes throughout the current administration, including individual accountability, the importance of strong corporate compliance programs, incentivizing voluntary self-disclosure of misconduct, and adapting to keep up with disruptive technologies such as artificial intelligence.
Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs
March 7, 2024 | Podcast | By Bridgette Keller, Joanne Hawana, Benjamin Zegarelli
In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs).
FTC Hosts Panel and Launches Public Inquiry with DOJ and HHS on Private Equity and Health Care
March 6, 2024 | Advisory | By Karen Lovitch, Bruce Sokler, Joseph Miller, Raj Gambhir
Read about the FTC’s March 5, 2024 workshop on private equity (PE) investments in the health care industry and a joint request for information on the effects of PE transactions in the health care industry issued by the FTC, DOJ, and HHS.
EnforceMintz — Health Care Enforcement Trends & 2024 Outlook
February 12, 2024 | Blog
Keeping pace with the ever-evolving landscape of health care enforcement can prove challenging. In the latest EnforceMintz newsletter, Mintz’s Health Care Enforcement Defense practice group highlights emerging enforcement trends and developments in FCA investigations, and provides predictions for 2024, offering helpful guidance through the complexities of health care enforcement.
EnforceMintz — DOJ and OIG Guidance Emphasizes the Importance of a Robust and Dynamic Compliance Program
February 8, 2024 | Blog | By Cory S. Flashner, Samantha Kingsbury, Nick A. LaPalme
In 2023, the DOJ amplified compliance-related incentives for companies under criminal investigation (including health care companies), while the OIG has substantially revised and modernized previously issued compliance guidance and resources applicable to health care companies and providers.
EnforceMintz — DOJ’s Limited Use of NPAs and DPAs in Criminal Health Care Investigations
February 8, 2024 | Blog | By Grady Campion, Daniel Cody, Laurence Freedman, Laura E. Martin
Despite the DOJ Criminal Division’s January 2023 revisions to its Corporate Enforcement Policy defining the criteria for declining to prosecute a criminal case, based on the two case examples from this past year, it is unclear how often the DOJ will actually put that policy into practice and decline or defer prosecution.
EnforceMintz — Tech Corner: Q&A with Mintz’s E-Discovery Pro Regarding Artificial Intelligence
February 8, 2024 | Blog | By Samantha Kingsbury, John Koss, Trust D. Kupupika
This Q&A with John Koss, Managing Director of Mintz’s E-Data Consulting Group, delves into the work of the group along with the benefits, challenges, and emerging issues related to using AI in e-discovery.
EnforceMintz — Government Scrutiny of Medicare Advantage Organizations Expected to Continue in 2024
February 8, 2024 | Blog | By Brian Dunphy, Nicole Henry
Enforcement against Medicare Advantage Organizations continues to be a top priority for the DOJ and HHS’s Office of Inspector General as the number of Medicare Advantage enrollees continued to rise in 2023.
EnforceMintz — Tele-Fraud Enforcement in 2023 Remained Focused on Same Schemes as Years Past
February 8, 2024 | Blog | By Samantha Kingsbury
Government enforcement activities focused on tele-fraudsters remained active in 2023, with most enforcement actions focusing on fraud schemes involving medically unnecessary durable medical equipment or genetic testing, or both.
EnforceMintz — DOJ’s Efforts in 2023 to Incentivize Voluntary Self-Disclosure
February 8, 2024 | Blog | By Eoin Beirne, Nick A. LaPalme, Karen Lovitch
In 2023, DOJ announced significant updates to the Criminal Division’s Corporate Enforcement Policy, the agency’s Voluntary Self-Disclosure Policy for corporate criminal enforcement, and a new safe harbor for voluntary self-disclosures made in connection with M&A deals, all aimed at incentivizing companies to self-disclose their misconduct.
EnforceMintz — A 2023 Legislative Push to Address AI in Health Care Will Continue in 2024
February 8, 2024 | Blog | By Daniel Cody, Brian Dunphy, Samantha Kingsbury
Since May 2023, federal legislators have introduced more than 50 bills focused on issues related to AI technologies, with patient privacy, the role of clinicians, and health equity emerging as areas of focus. In addition, the Biden administration released an Executive Order focused on promoting AI safety in October 2023.
EnforceMintz — Some of 2023’s Largest FCA Resolutions Involved Stark Law Allegations
February 8, 2024 | Blog | By Grady Campion, Daniel Cody, Laurence Freedman, Laura E. Martin
In the past year, DOJ obtained some of its largest recoveries in cases where violations of the Stark Law, which bars physicians from profiting from self-referrals for certain services payable by Medicare or Medicaid, served as a predicate offense for FCA claims. These included cases against Community Health Network, Covenant Healthcare System, Cardiac Imaging, and Steward Health entities.
EnforceMintz — 2023 Brings Uptick in Cybersecurity Enforcement, Insight Into Potential Risks
February 8, 2024 | Blog | By Samantha Kingsbury
An uptick in DOJ cybersecurity enforcement in 2023, includes two FCA settlements, an unsealed qui tam complaint, and significant regulatory activity that could pose future enforcement risk.
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