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

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?

With the release of the decision in Dobbs v. Jackson, questions regarding enforcement activity in states that restrict or ban abortion by statute have been raised and have remained mostly hypothetical. The frequency and scope of future enforcement activity remains unknown. Given the variety of laws now in effect in restricted and ban states, and that enforcement of such laws is subject to state prosecutorial discretion as well as the prevailing political climate, enforcement initiatives are expected to vary by state.

Continue Reading Post-Dobbs Abortion Enforcement: Nebraska Uses Facebook Messages as Evidence

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

On June 24, 2022, the U.S. Supreme Court released its opinion in Dobbs v. Jackson Women’s Health Organization, overturning Roe v. Wade—the 1973 landmark ruling that established the constitutional right to abortion. Now, companies that operate in states where abortions are banned or restricted are facing a quagmire of laws and risks regarding enforcement. Additionally, the risk landscape is not static, but rather in flux, as the federal government (agencies such as the U.S. Department of Justice and the U.S. Department of Health and Human Services) and a myriad of states introduce new legislation and issue guidance on a near-daily basis.

Continue Reading Warning Signs of a Criminal Investigation: Considerations for In-House Counsel and Corporate Executives in a Post-Roe World

Now that the Supreme Court of the United States has declared that authority to regulate abortion rests with the states, organizations operating across state lines face new and some unprecedented challenges created by the civil and criminal legal issues arising from risks of enforcement in any state where abortion is or will be banned (a “ban state”). Health care providers, employers, and other organizations with any nexus to such states will need to conduct careful analyses and may have to accept an unknown level of enforcement risk while various jurisdictions respond to their newfound power and determine if and how to wield it. The risks may extend to providers who deliver abortions, patients seeking abortions, companies who support their employees traveling to non-ban states to receive abortions, and their executives. The outer parameters of who is subject to enforcement risk are presently unknown but are likely to vary from jurisdiction to jurisdiction.

Continue Reading The Impact of Dobbs: Enforcement Risks to Expect and Monitor

The Judicial Conference of the United States’ Committee on Rules of Practice and Procedure seems poised to advance proposed amendments to Federal Rule of Evidence 702, after the Advisory Committee on Evidence unanimously voted to approve the proposed amendments and recommended that the Committee on Rules of Practice and Procedure refer the amendments to the Judicial Conference for a full vote.

Continue Reading One Step Closer to a Revised Standard for the Admissibility of Expert Testimony Under Rule 702