In response to a recent Department of Justice (DOJ) request that all DOJ components write voluntary self-disclosure policies and “clarify the benefits of promptly coming forward to self-report [as] a good business decision,” on January 17, 2023, Assistant Attorney General (AAG) Kenneth Polite, Jr. announced updates to the DOJ Criminal Division’s Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP). The updated CEP, policy 9-47.120, which was previously known as the Foreign Corrupt Practices Act (FCPA) Corporate Enforcement Policy, expands the applicability of the CEP to now apply to all corporate criminal matters handled by the DOJ’s Criminal Division. The updated CEP, which is effective prospectively only, offers new, significant, and concrete incentives to corporations to have effective compliance programs, to voluntarily disclose allegations of criminal misconduct (including that of its officers, directors and employees), to fully cooperate with the government’s investigation of alleged misconduct, and to timely and appropriately remediate the misconduct. In announcing the updated policy, AAG Polite stated, “Our number one goal in this area – as we have repeatedly emphasized – is individual accountability. And we can hold accountable those who are criminally culpable—no matter their seniority—when companies come forward and cooperate with our investigation.”

Continue Reading To Disclose or Not to Disclose: DOJ Revises Its Policy on How Corporate Criminal Matters Are Handled in an Attempt to Further Incentivize Voluntary Disclosure and Cooperation

Given the volume of funds that were quickly dispersed during the COVID-19 pandemic, there were plenty of new areas for fraud and abuse. The Department of Justice (“DOJ”) initially set its sights on targeting the borrowers of such funds. Now, the DOJ is ramping up enforcement with the first ever False Claims Act (“FCA”) settlement with a lender of Paycheck Protection Programs (“PPP”) funds.

Continue Reading DOJ Settles False Claims Allegations with the Paycheck Protection Program (“PPP”) Loan Lender for the First Time

It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.

Continue Reading Four Years After Enactment – Clinical Laboratories Should Not Forget About EKRA

In a rebuke of the Department of Justice, the Third Circuit recently overturned money laundering conspiracy convictions for a reverse distributor pharmaceutical company, Devos Ltd., and two of its former executives, CEO Dean Volkes and CFO Donna Fallon. The Third Circuit’s opinion, United States v. Fallon, affirmed other convictions against the company and individuals but ordered a resentencing and a recalculation of the sums subject to forfeiture.

Continue Reading Third Circuit Rejects DOJ’s Broad “Commingling” Theory of Money Laundering Concealment

Building on attempts in recent years to strengthen the Department of Justice’s (DOJ’s) white collar criminal enforcement, on September 15, 2022, Deputy Attorney General Lisa Monaco announced revisions to DOJ’s corporate criminal enforcement policies. The new policies, and those that are in development, further attempt to put pressure on companies to implement effective compliance policies and to self-report if there are problems. Notably, the new DOJ policies set forth changes to existing DOJ policies through a “combination of carrots and sticks – with a mix of incentives and deterrence,” with the goal of “giving general counsels and chief compliance officers the tools they need to make a business case for responsible corporate behavior” through seven key areas:

Continue Reading DOJ’s Corporate Criminal Enforcement Policies Are Revised: Individual Accountability, Corporate Responsibility, Additional Demands on Chief Compliance Officers

The Supreme Court recently granted certiorari in In re Grand Jury to resolve a circuit split regarding what standard governs the application of the attorney-client privilege to dual-purpose communications, that is communications which contain both legal and non-legal advice. The petition was filed on behalf of an unnamed law firm which asserted the privilege in response to a federal grand jury subpoena.

Continue Reading Supreme Court to Review Scope of Attorney-Client Privilege for “Dual Purpose” Communications

In a brush-back pitch to DOJ opioid initiatives, the U.S. Supreme Court this past June issued an important decision clarifying the mental state the government must establish to convict a licensed medical professional of illegal drug distribution under the federal Controlled Substances Act (“CSA”). No longer can a doctor be convicted of such a crime based on objectively unreasonable prescribing practices alone. The government now must show that the medical professional subjectively, knowingly, and intentionally prescribed a controlled substance with no legitimate medical purpose. While unlikely to materially impact the number of DOJ opioid prosecutions, the case will no doubt inform charging decisions in marginal cases and will support important defense arguments at trial.

Continue Reading Will the Supreme Court’s Latest Decision on Mens Rea Leave Medical Professional Prosecutions Ruan-ing on Empty?

On April 20, 2022, the U.S. Department of Justice (“DOJ”) announced a nationwide coordinated law enforcement action to combat health care-related COVID-19 fraud. In line with the announcement, the federal government has continued throughout this year to focus its enforcement on fraud in the COVID-19 space, particularly on misuse of Provider Relief funds and COVID-19 testing fraud.

Continue Reading The Department of Justice Continues to Target COVID-19-Related Fraud

Last week, the U.S. Department of Justice’s Deputy Attorney General Lisa Monaco announced plans to increase its enforcement of white collar crimes against individuals and corporations. Monaco made the announcement speaking at the American Bar Association’s While Collar Crime Conference. She made clear to “those of you who are counselors and voices in the

Our colleague Lauren Petrin of Epstein Becker Green has a new post on Health Law Advisor that will be of interest to our readers:  “DOJ’s Recent Telehealth Enforcement Action Highlights Increased Abuse of COVID-19 Waivers.

The following is an excerpt:

On May 26, 2021, the Department of Justice (“DOJ”) announced a coordinated law