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?

The Court has started the week with three decisions emphasizing textual readings, two of them unanimous and a third drawing Justice Kagan into the majority with the Court’s six nominal jurisprudential conservatives.

Continue Reading A Peaceful Resolution of Cases Concerning Arbitration, Medicaid, and Bankruptcy—All Involving Textual Analysis: SCOTUS Today

Imagine you’re a longtime employee of a company that operates in a highly regulated industry. Your employment has seen its ups and downs throughout the years, and you have witnessed many transitions: new policies and procedures implemented, new leadership appointed, and new rules and regulations with which your company must comply to remain in lawful standing with regulators. Occasionally, you’ve observed activity that might be questionable but you never thought much about it. That is, until you’re called into a meeting with your company’s lawyers who inform you that “the U.S. Attorney’s Office wants to meet with you.” What do you do next?

Continue Reading “Queen for a Day” or Risk of Peril? Considerations for Proffering with the Government

On March 15, 2022, President Biden signed into law the 2022 Consolidated Appropriations Act containing the Cyber Incident Reporting for Critical Infrastructure Act of 2022 (the “Cyber Incident Reporting Act”). While President Biden’s remarks highlighted the $13.6 billion in funding “to address Russia’s invasion of Ukraine and the impact on surrounding countries,” the 2022 Consolidated Appropriations Act contained numerous other laws, including the Cyber Incident Reporting Act, which should not be overlooked. The Cyber Incident Reporting Act puts in motion important new cybersecurity reporting requirements that will likely apply to businesses in almost every major sector of the economy, including health care, financial services, energy, transportation and commercial facilities. Critical infrastructure entities should monitor the upcoming rule-making by the Cybersecurity and Infrastructure Security Agency (“CISA”), as the final regulations will clarify the scope and application of the new law.

Continue Reading President Biden Signs into Law Federal Reporting Requirements for Cyber Incidents and Ransomware Payments

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