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THE LATEST ON GOVERNMENT INQUIRIES AND ENFORCEMENT ACTIONS

Government Investigations and White Collar Litigation Group

Michael J. Podberesky

Photo of Michael J. Podberesky Michael Podberesky, a former federal prosecutor in the U.S. Department of Justice’s Civil Fraud Section, is a partner in the firm’s nationally recognized Government Investigations and White Collar Litigation Department and co-chair of the False Claims Act Investigations, Litigation and Enforcement team. Employing his extensive experience with False Claims Act cases in the healthcare and defense sectors, Michael represents clients confronting high-stakes government investigations and litigation arising from allegations of healthcare and procurement fraud and also counsels clients regarding compliance issues.

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Key Takeaways From McGuireWoods’ Webinar on Enforcement Against PE Funds in Healthcare

Compliance, Fraud, Deception and False Claims
McGuireWoods partners Brett Barnett, Mindy Sauter, Mike Elliott, and Michael Podberesky recently conducted a solution-oriented discussion of key enforcement and compliance developments that impact private equity (PE) funds in healthcare. They also highlighted relevant cases regarding the government’s increased interest in compliance diligence in the PE space. Read on to learn about the eight key… Continue Reading

Federal District Court Finds Private-Insurer Relator Can Proceed with False Claims Action

Fraud, Deception and False Claims
Last month, the U.S. District Court for the District of New Jersey held that a private company could proceed with its whistleblower action against a clinical laboratory that allegedly submitted false claims to the federal government for medically unnecessary urine drug tests (UDTs). The lawsuit is part of a growing trend of nontraditional whistleblower-like insurance… Continue Reading

1st Circuit Rejects Convicted Former Medical Device Executives’ Off-Label “Free Speech” Theory

Fraud, Deception and False Claims
A federal appeals court recently upheld misdemeanor convictions of two former Acclarent Inc. executives for commercially distributing an adulterated and misbranded medical device by misleading the U.S. Food and Drug Administration regarding the device’s intended use. Read on for details about the decision, which rejected claims that their off-label promotion amounted to constitutionally protected commercial… Continue Reading

Eleventh Circuit Affirms Order for $1.195 Million in Restitution and 48 Month Sentence in Commercial Insurance Healthcare Fraud Case

Fraud, Deception and False Claims
Last month, the Eleventh Circuit upheld a $1.195 million restitution order and 48-month sentence against Carlos Verdeza for three counts of healthcare fraud. See United States v. Verdeza, No. 21-10461, 2023 WL 3728960 (11th Cir. 2023). Verdeza was a case brought by the United States against a physician assistant who produced fraudulent patient files and sought reimbursement from Blue Cross Blue… Continue Reading

U.S. Supreme Court Clarifies DOJ’s Authority to Dismiss Whistleblowers’ False Claims Act Suits, Questions Constitutionality of Qui Tam Provisions

Fraud, Deception and False Claims
The U.S. Supreme Court recently resolved a circuit split by holding that, in a False Claims Act action, (1) the government may seek dismissal of a qui tam case in which the government initially declined to intervene over the relator’s objection so long as it later intervened in the litigation, and (2) district courts should… Continue Reading

Supreme Court Clarifies the False Claims Act’s Knowledge Requirement, Eliminating a Potential Defense for Government Contractors and Healthcare Providers Accused of Fraud

Fraud, Deception and False Claims, Government Contracts
On June 1, 2023, the Supreme Court unanimously ruled in favor of whistleblower plaintiffs (referred to as “relators”) in consolidated False Claims Act (“FCA”) cases in a decision that clarified the application of the FCA’s knowledge requirement.  In United States ex rel. Schutte v. SuperValu Inc., the Court held that the FCA reaches defendants who… Continue Reading

7th Circuit Sides With Insured Party Seeking Coverage for False Claims Act Settlement

Fraud, Deception and False Claims
On May 3, the 7th U.S. Circuit Court of Appeals sided with the policyholder, resolving an insurance coverage dispute over a $100 million settlement related to claims under the federal Anti-Kickback Statute and the federal False Claims Act. Read on for analysis of this decision, which tries to clarify the difference between compensatory damages, which… Continue Reading

Ophthalmic Distributor May Face $848M in Penalties for Kickbacks, False Claims Act Violations

Fraud, Deception and False Claims
On Feb. 28, a federal jury in the District of Minnesota found the Cameron-Ehlen Group, d/b/a Precision Lens, and its founder and owner guilty of paying kickbacks to ophthalmic surgeons in violation of the False Claims Act and Federal Anti-Kickback Statute between 2006 and 2015. Read on for details about this case, which illustrates the… Continue Reading

Analysis of DOJ’s FY 2022 FCA Statistics and the Mixed Signals Therein

Fraud, Deception and False Claims
Earlier this month, the U.S. Department of Justice (DOJ) announced that it recovered over $2.2 billion under the False Claims Act (FCA) in Fiscal Year 2022.[1] That is a steep drop from last year’s near-record $5.7 billion haul and the lowest annual recovery since 2008. That year-over-year decline, though, was exacerbated by a $3 billion… Continue Reading

Supreme Court to Determine Whether False Claims Act Liability Is Precluded Where Defendants Proffer an Objectively Reasonable Interpretation of an Ambiguous Legal Requirement

Fraud, Deception and False Claims
On January 13, 2023, the Supreme Court granted a writ of certiorari to petitioners in two False Claims Act cases to determine whether the False Claims Act’s knowledge requirement reaches defendants who can offer an “objectively reasonable” interpretation of an ambiguous legal or contractual requirement material to government payment. The Court’s decision will likely be… Continue Reading

Pharmaceutical Manufacturer Agrees to $900 Million Dollar False Claims Act Settlement to Resolve Kickback Claims

Fraud, Deception and False Claims
On July 20th, on the eve of trial, Biogen Inc. agreed to pay $900 million dollars to settle claims that the company violated the False Claims Act (FCA) by allegedly paying improper consulting and speaker fees and providing lavish meals and entertainment (in violation of the Federal Anti-Kickback Statute (AKS)) to medical providers to induce… Continue Reading

Supreme Court Signals Interest in Clarifying Pleading Requirements in False Claims Act Suits

Fraud, Deception and False Claims
The U.S. Supreme Court soon will decide whether to tackle a longstanding question regarding the applicability of Federal Rule of Civil Procedure 9(b) pleading standards in False Claims Act suits. To satisfy the rule’s particularity requirement, plaintiffs generally have needed to detail specific false claims submitted by defendants. The question is whether plaintiffs instead may… Continue Reading

Largest-Ever Small-Business Contracting Fraud Settlement Related to Pass-Through Subcontracting

Enforcement and Prosecution Policy and Trends, Government Contracts
Federal contractors should take note of a $48.5 million False Claims Act settlement between the Department of Justice and TriMark USA LLC — the largest-ever FCA settlement based on allegations of small-business set-aside contracting fraud. DOJ alleged that TriMark had a plan to circumvent specific small-business contracting requirements by providing significant assistance to three small… Continue Reading

DOJ Settles First False Claims Act Enforcement Action Since Launch of Civil Cyber-Fraud Initiative

Fraud, Deception and False Claims
On March 8, 2022, the U.S. Department of Justice (DOJ) announced a $930,000 settlement with Comprehensive Health Services, LLC (CHS) for alleged violations of the False Claims Act (FCA). This settlement marks DOJ’s first resolution of an FCA enforcement action involving cyber fraud after launching its Civil Cyber-Fraud Initiative in October 2021, signaling DOJ’s eagerness to combat cybersecurity violations… Continue Reading

Analysis of DOJ’s 2021 FCA Statistics and the Trends Therein

Fraud, Deception and False Claims
Last week, the U.S. Department of Justice (DOJ or Department) announced that it recovered over $5.6 billion under the False Claims Act (FCA) in Fiscal Year 2021.[1] That is a massive headline haul that is second only to the roughly $6 billion recovered under the FCA in FY 2014, when there were $3.1 billion in… Continue Reading

Elizabeth Holmes of Theranos Found Guilty of Making False Representations to Investors

Fraud, Deception and False Claims
Elizabeth Holmes, founder of Theranos, was convicted of three counts of wire fraud and one count of conspiracy to commit wire fraud. The verdict follows a high-profile, fifteen-week trial in federal court in San Francisco.  Holmes was alleged to have defrauded investors, medical professionals, patients, and the public by exaggerating and making false statements about… Continue Reading

Another Circuit Weighs in on the Standard for Evaluating Government Motions to Dismiss False Claims Act Actions

Fraud, Deception and False Claims
In a recent opinion, the U.S. Court of Appeals for the Third Circuit weighed in on what standard to apply in reviewing government motions to dismiss False Claims Act actions. Read a new “FCA Insider” blog post for analysis of this decision and its implications for future cases after this summer’s three-way circuit split on… Continue Reading

Department of Justice Announces Increased FCA Enforcement Through New Civil Cyber-Fraud Initiative

Enforcement and Prosecution Policy and Trends, Fraud, Deception and False Claims
On October 6, 2021, the Department of Justice (DOJ) announced a new Civil Fraud Cyber Initiative to “combine the department’s expertise in civil fraud enforcement, government procurement and cybersecurity to combat new and emerging cyber threats to the security of sensitive information and critical systems.”… Continue Reading

Gleanings From DOJ’s 2021 Healthcare Takedown Announcement

Compliance
On Sept. 17, the U.S. Department of Justice released the results of its 2021 Healthcare Takedown — an annual announcement aggregating months of investigations and indictments across the country involving fraud in the healthcare and life sciences industries. Read on for details and analysis of criminal charges against 138 defendants, including 42 medical professionals, related… Continue Reading

Tide Is Turning Against FCA Case Dismissals

Enforcement and Prosecution Policy and Trends, Fraud, Deception and False Claims
According to a July 28 article in Law360 by McGuireWoods lawyers Michael J. Podberesky, John S. Moran, Todd R. Steggerda, David Pivnick and Cassandra M. Burns, the U.S. Supreme Court’s recent decision declining to review an appeal of a Seventh Circuit case that could have resolved a three-way circuit split regarding the proper standard for… Continue Reading

The Perils of Pleading the Fifth in the Corporate Fraud Context

Fraud, Deception and False Claims
“Pleading the Fifth” is one of the most commonly known phrases in our legal system, and the right against self-incrimination is one of the Constitution’s most meaningful protections. That said, in the corporate fraud context, exercising that right often entails risks and costs that may outweigh the potential benefits. As such, companies—particularly those that contract… Continue Reading

U.S. Attorney’s Office Settles with Urgent Care Providers to Resolve False Claims Act Allegations Related to Credentialing Issues

Fraud, Deception and False Claims
On April 8, 2021, the U.S. Attorney’s Office for the District of South Carolina announced a $22.5 million settlement with a network of urgent care providers, Doctors Care, P.A. (Doctors Care), and its management company, UCI Medical Affiliates of South Carolina, Inc. (UCI), for alleged False Claims Act (FCA) violations.… Continue Reading

DOJ Announces Plan for Coordinated Civil Rights Response to COVID-19

Compliance
On April 2, 2021, Pamela S. Karlan, the Principal Deputy Assistant Attorney General for Civil Rights at the U.S. Department of Justice Civil Rights Division (DOJ), issued a public statement regarding the Division’s intent to lead a coordinated civil rights response to the Coronavirus (COVID-19) pandemic. The statement, which attached a resource guide, is intended… Continue Reading

COVID-19 Fraud Surge: Criminal Enforcement of Pandemic-Related Fraud Reaches “Unprecedented Pace,” DOJ Warns

Enforcement and Prosecution Policy and Trends, Fraud, Deception and False Claims
While the spread of COVID-19 may finally be slowing, government enforcement of pandemic-related fraud is not. It is surging. And that may explain why you are hearing from the government more than usual, or will soon. The U.S. Department of Justice (DOJ) announced last week that it has now charged nearly 500 defendants with crimes… Continue Reading

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