Trump Signs Executive Orders To Limit Use of Informal Guidance

On Wednesday, President Donald Trump signed two executive orders (titled Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication and Promoting the Rule of Law Through Improved Agency Guidance Documents) that require agencies to publish all informal guidance online and to limit its use in enforcement actions. In his Oval Office signing ceremony,… More

Watch: Cybersecurity Regulation and Enforcement

As data breaches are seemingly reported on a daily basis, cybersecurity has emerged as a top enforcement priority for federal and state regulators and a key concern for companies of all sizes in a diverse range of industries. For example, compliance with federal cybersecurity regulations is required by nearly every government contract and the New York Division of Financial Services adopted a vast set of regulations that is applicable to all entities operating under NYDFS licensure. In short, ensuring that a company has effective cybersecurity policies and procedures in place is essential to both protecting customer information and avoiding unwanted attention from federal and state regulators.

Foley Hoag presents a webinar offering guidance for in-house counsel, compliance officers and other professionals on the cybersecurity regulatory and enforcement landscape.

Speakers

DOJ Issues Guidance on Corporate Poverty Claims

This is a follow-up to our September 13, 2019 post discussing the DOJ guidance on corporate claims of inability to pay.

On Tuesday, October 8, 2019, the Department of Justice provided guidance on how its prosecutors should evaluate claims of corporate poverty.  This comes on the heels of Deputy Assistant Attorney General Matthew Miner’s comments last month suggesting that further guidance on corporate poverty claims was forthcoming. … More

Challenge to Attorneys’ Fees in False Claims Act Cases

Thanks to inexact language in a settlement agreement, a for-profit hospital chain can challenge whistleblowers’ eligibility for attorneys’ fees under the False Claims Act (“FCA”).  The single sentence that spawned nearly 5 years of litigation was: “All Parties agree that nothing in this Paragraph or this Agreement shall be construed in any way to release, waive or otherwise affect the ability of CHS to challenge or object to [whistleblower’s] claims for attorneys’ fees,… More

Life Sciences Investors Beware: Private Equity Firm Settles Federal False Claims Act Suit Regarding Compounding Pharmacy It Managed

On September 18, 2019, the Department of Justice announced a $21.36 million settlement to resolve a False Claims Act (“FCA”) lawsuit alleging a fraudulent kickback scheme through which a pharmaceutical company (Patient Care America, or “PCA”) induced doctors to write expensive and unnecessary prescriptions to military veterans. A False Claims Act settlement of this magnitude is not unusual, particularly in the healthcare industry (which accounted for $2.5 billion of the DOJ’s $2.8 billion in FCA settlements and judgments in 2018).… More

U.S. Senate Considering Update to Federal Anti-Money Laundering System

A bipartisan group of Senators, with the support of the American Bankers Association, recently introduced bill S.2563, known as the ILLICIT Cash Act.  The acronym “ILLICIT” stands for “Improving Laundering Laws and Increasing Comprehensive Information Tracking of Criminal Activity in Shell Holdings.”  As that name suggests, the bill’s primary purposes are to close loopholes involving shell companies, improve information collection, and encourage communication between financial institutions and law enforcement. … More

DOJ Takes Aim at Telehealth and Genetic Testing Markets

The U.S. Department of Justice (DOJ) continues to actively target the healthcare industry for False Claims Act (FCA) and other alleged violations, and it took significant steps to further its reach into the telehealth and genetic testing markets this week.  Prosecutors in the Southern District of Florida (SDFL) indicted the CEO of a genetic testing company in an alleged referral-source kickback scheme in which, according to the indictment,… More

DOJ Considers Guidance on Corporate Claims of Inability to Pay

Please see our follow-up concerning the DOJ’s October 8, 2019 guidance.

On September 12, 2019, Deputy Assistant Attorney General Matthew Miner signaled that the Department of Justice may provide further guidance to prosecutors—and companies—on how to evaluate claims of corporate poverty.  In a speech at the University of Texas School of Law’s 6th Annual Government Enforcement Institute,  Miner stated that the DOJ has been considering the issuance of “concrete guidance or factors to consider” to assist prosecutors in their evaluation of companies who claim that they are unable to pay DOJ-assessed fines and penalties for their misconduct. … More

Eleventh Circuit Holds Differences in Clinical Judgment Do Not Create FCA Liability for Hospice Provider

The Eleventh Circuit agreed with the trial court that the government must do more than present expert evidence that a physician’s clinical judgment was inaccurate to establish falsity under the False Claims Act.  Nonetheless, the appellate court remanded for the trial court to consider additional evidence that, the government contends, establish falsity even under the standard now set by the Eleventh Circuit.

At issue was whether AseraCare Inc.… More

No False Claim Where Relator Merely Analyzes or Interprets Publicly Available Data

The Massachusetts Superior Court recently held that a qui tam relator’s analysis of publicly available information was subject to the public disclosure bar and that, no matter how involved or expert that analysis was, the relator was not the original source of the information alleged in the complaint.  Thus, in Commonwealth ex rel. Johan Rosenberg v. JPMorgan Chase & Co., et al., SUCV2014-03323, Judge Kaplan,… More