Commercial Litigation Update

In an indictment announced on October 26, 2023 in Miami, the U.S. Department of Justice, Criminal Division’s Fraud Section, working with the FBI and HHS-OIG, brought what may be only the second federal criminal charges directly related to the Medicare Advantage (Medicare Part C) risk adjustment payment methodology.  DOJ enforcement in the Medicare Advantage risk adjustment space overwhelmingly has proceeded civilly under the False Claims Act. Although the allegations suggest conduct far more troubling than prior civil cases under risk adjustment, these criminal charges ...

Six months from the date of closing. That’s how long acquiring companies have under the newly announced Department of Justice (DOJ) Mergers and Acquisitions (M&A) Safe Harbor Policy to disclose misconduct discovered in the context of a merger or acquisition – whether discovered pre or post-acquisition.  And the acquiring company has one year from the date of closing to remediate, as well as provide restitution to any victims and disgorge  any profits.

Over the last two years, the DOJ has made clear its priority to encourage companies to self-disclose misconduct aiming to ...

On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a nationwide health care fraud enforcement action targeting a variety of alleged health care fraud schemes. As has been the case over the last few years, DOJ and HHS-OIG have moved away from categorizing the enforcement action as a “takedown”. The government has not explained the naming change, but one explanation is that it is no longer properly considered a true “takedown” because the enforcement activity (charges, arrests) occurs over many weeks leading up to the day it is announced.  

The U.S. Department of Justice (“DOJ”) remains busy updating its policies relating to corporate prosecutions, evaluations of compliance programs, and voluntary disclosures. In a pair of speeches at March’s ABA White Collar Conference in Miami, Deputy Attorney General Lisa Monaco and Assistant Attorney General Kenneth Polite, Jr. returned to the Department’s revision of its Evaluation of Corporate Compliance Program (“ECCP”) by unveiling several significant policies, including those relating to a corporation’s access to and retention of employee electronic communications as well as a company’s compensation structure for executives and employees.

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.

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.

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.

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:

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.

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.

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.

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.

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.

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.

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?

In many cases, the payment of restitution by a party in a lawsuit involving the government or a governmental entity creates a tax-deductible business expense under Title 26, United States Code, Section 162(f) (hereinafter, “Section 162”). When it comes to violations of the False Claims Act, the Anti-Kickback Statute, Stark Law, or even common law fraud claims and contract disputes, understanding how this statute operates can offer substantial short- and long-term tax-benefits to entities facing stiff financial recoupments.  While it is unlikely that the costs of an investigation or restitution order will ever generate a financial net-gain for the entity footing the bill, it is important to appreciate that restitution and proactive remediation costs are viewed differently by both government enforcers (i.e. prosecutors) and tax-collectors, compared with other types of remuneration. Recognizing that there is a difference can, in some cases, help mitigate significant financial burdens.

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 C-Suite and Boardroom” that DOJ “will not hesitate to take action when necessary to combat corporate wrongdoing.”

Monaco, DOJ’s second in command, is no stranger to prosecuting corporate crimes having ...

On June 30, 2021, the Financial Crimes Enforcement Network (“FinCEN”), issued the first government-wide Priorities for anti-money laundering (“AML”) and countering the financing of terrorism (“CFT”) policy (the “Priorities”). In accordance with the Anti-Money Laundering Act of 2020 (“AMLA 2020”), FinCEN established the Priorities, after consulting with the Attorney General, and various Federal regulators, to assist covered financial institutions, (which include, banks, brokers-dealers, mutual funds, insurance companies, commodities ...

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 enforcement action against 14 telehealth executives, physicians, marketers, and healthcare business owners for their alleged fraudulent COVID-19 related Medicare claims resulting in over $143 million in false billing.[1] This coordinated ...

Do plaintiffs’ attorneys smell blood in the water? A raft of class-action suits recently initiated against dietary supplement manufacturers, alleging deceptive practices in the sale of fish oil products, suggests that they might.

These suits, filed in California federal courts (a favorite jurisdiction for the plaintiffs’ bar), are nearly identical in that they allege that the manufacturers’ fish oil products do not actually contain fish oil. To date, plaintiffs’ class action lawyers have already targeted well-known dietary supplement products, such as Dr. Tobias ...

Most have heard the cliché “don’t do the crime, if you can’t do the time.” For many criminal defendants, however, a significant factor in the time served is not just the crime committed, but rather the so-called “trial penalty.”

A “trial penalty” describes situations where a defendant chooses to proceed to trial instead of accepting whatever plea deal the Government had offered and receives a significantly lengthier sentence than she would have received had she not gone to trial. Often the “trial penalty” results in a defendant receiving a much lengthier ...

EBG attorney Edward J. Loya, Jr. was recently named Chair of the Hispanic National Bar Association’s Criminal Law Section. I recently sat down with him for a Q&A regarding this honor, his work with the HNBA, and his white collar criminal practice at EBG.

Q: Most of our readers are probably familiar with the Hispanic National Bar Association, but for those who may not be, can you tell us a little about HNBA’s history and mission?