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A former federal prosecutor and current co-chair of the firm’s Compliance & Government Investigations Practice Group, Lisa Rivera’s practice focuses on advising healthcare providers, pharmaceutical manufacturers, medical device companies and other clients on matters related to civil and criminal healthcare fraud and abuse, as well as government investigations and enforcement.

I was recently interviewed on the Healthcare Strategies podcast about how the Department of Justice (DOJ) is enforcing the Civil Cyber-Fraud Initiative to hold healthcare organizations accountable for cybersecurity matters. The Initiative, launched by DOJ in October 2021, utilizes the False Claims Act (FCA) to take action against entities that knowingly provide insufficient data security measures.

Continue Reading DOJ’s Civil Cyber-Fraud Initiative Impact on Healthcare Organizations

Last week, the District Court for the Eastern District of California denied the defendant’s motion for summary judgment of a False Claims Act (FCA) count against Aerojet Rocketdyne (Aerojet) for allegedly fraudulently inducing the government to enter into federal contracts when the company knew it was not compliant with cybersecurity requirements.

Continue Reading Government Contractors Face False Claims Act Liability for Cybersecurity Non-Compliance

On December 2, the U.S. District Court for the Western District of Virginia granted a motion to dismiss a False Claims Act (FCA) lawsuit brought by the United States and the Commonwealth of Virginia, which alleged that a Walgreens clinical pharmacy manager falsified hepatitis C drug prior authorization submissions to Virginia Medicaid. See United States v. Walgreen Co., 2021 WL 5760307 (W.D. Va. Dec. 3, 2021).

Continue Reading FCA Lawsuit Against Walgreens Dismissed Because Government Fails to Plead Materiality

There is a new weapon in the Department of Justice’s (DOJ’s) already powerful False Claims Act (FCA) arsenal.  In October 2021, the DOJ announced a new Civil Cyber-Fraud Initiative, under which it will pursue FCA liability against government contractors in the cybersecurity space.  According to the announcement from Deputy Attorney General Lisa O. Monaco, the initiative seeks to “hold accountable entities or individuals that put U.S. information or systems at risk by knowingly providing deficient cybersecurity products or services, knowingly misrepresenting their cybersecurity protocols, or knowingly violating obligations to monitor and report cybersecurity incidents and breaches.”

Overview of the Civil Cyber-Fraud Initiative

The Civil Cyber-Fraud Initiative follows several significant cyberattacks, which are only becoming more prevalent. The new initiative is the first formal step DOJ has taken in combatting them by focusing on the preventative cybersecurity efforts of government contractors.

Continue Reading DOJ Expands False Claims Act Reach into Cybersecurity

To foster open and honest communications with counsel, it is critically important that those communications are protected from disclosure by the attorney-client privilege.  But, not every communication with counsel is privileged, and knowing when a communication with counsel is protected can sometimes prove difficult.  Given an increasingly complex regulatory landscape, more and more attorneys—particularly in-house attorneys—are wearing dual hats as both lawyers and business advisors.  As a lawyer, communications  may be privileged; but if acting as a business advisor, communications may be subject to disclosure.

Since the corporate setting doesn’t lend itself to bifurcating legal and business communications, what happens when the lines are blurred or when a communication serves both purposes?

The “Primary Purpose” Test

Many courts, like the U.S. Courts of Appeal for the Second, Fifth, Sixth, and D.C. Circuits, require that for a communication to be protected by the attorney-client privilege, the “primary purpose” of the communication must be to give or receive legal advice. Attorney-client privilege does not apply to business, commercial, or tax advice.  Under this method of analysis, courts look to the content of a communication to determine its predominant or primary purpose.

Continue Reading Reminder: When Are Communications with Corporate Counsel Privileged?

In our previous article, we outlined steps companies can take now to protect themselves during later government investigations and enforcement actions related to COVID-19 relief funding. These steps include: leverage compliance resources, document the application/funding process, document how money is used, schedule an interim internal review, and respond to employee complaints. In this article we focus specifically on the health care industry and how companies can protect against inevitable government scrutiny after receiving COVID-19 relief funding.

The health care industry must be particularly vigilant about protecting against future enforcement risks because it is a highly regulated industry facing an enforcement perfect storm—fast cash, poor guidance and retrospective review. Congress allocated $175 billion to the U.S. Department of Health and Human Services (HHS) through the Coronavirus Aid, Relief and Economic Security Act Provider Relief Fund (Relief Fund). To support an industry hurt by COVID-19-related patient surges, stay-at-home driven closures and elective procedure treatment delays, HHS adopted a strategy to release relief funds quickly and perform reconciliation on the back end. As a result, HHS released what it touted as “no strings attached” relief funds through a series of general and targeted allocations each with a list of somewhat vague terms and conditions. The only other guidance available were application instructions, where applicable, and a continuously evolving set of frequently asked questions.

Of course, no government funding comes with “no strings attached.” The government inevitably will review whether recipients of HHS relief funds met the eligibility requirements and complied with the terms and conditions for using relief funds. Given that any deliberate omission, misrepresentation or falsification of information related to the HHS relief funds comes with potentially severe consequences—including but not limited to revocation of Medicare billing privileges; exclusion from federal health care programs; and/or the imposition of fines, civil damages and/or imprisonment—health care companies should consider the following steps to support their acceptance and use of the funds:

Continue Reading How Health Care Companies Can Protect Against Government Scrutiny of COVID-19 Relief Funding

This article is the first in a series addressing what companies can do now to protect themselves during later government investigations and enforcement actions related to COVID-19 relief funding. In this article, we provide general practice tips applicable to all industries. Future articles will target compliance issues related to specific areas and industries—healthcare, finance, government contracting, and labor and employment—and what companies can do to reduce the risk when accepting government aid. Don’t miss the second article in this series that discusses what companies can do now to protect themselves during later government scrutiny related to COVID-19 relief funding.

Unprecedented Funding

The government has distributed an unprecedented amount of money in response to the COVID-19 pandemic. Under the Coronavirus Aid, Relief and Economic Security (CARES) Act, for example, the government is providing over $1 trillion through loans, grants and tax credits. Companies in the healthcare and financial industries, government contractors and many other businesses have all received government help.

The government, to its credit, has moved quickly to make funding available to companies in need. As a result, many government agencies have shifted their focus to responding to the pandemic and distributing allocated funds—with all requests and distributions of money completed as quickly as possible.

Continue Reading The Government Is Here to Help—For Now: What Your Company Should Be Doing Today to Protect Against Inevitable Government Scrutiny of COVID-19 Relief Funding

While the government is writing checks to companies to cope with recent pandemic losses, it simultaneously updated its internal guidance for scrutinizing a company’s corporate compliance program.  Earlier this week, the Department of Justice (DOJ) issued to prosecutors an update to its guidance document for the “Evaluation of Corporate Compliance Programs.”  DOJ counsel has long considered the existence and adequacy of a company’s corporate compliance program when determining whether, and to what extent, charges should be brought against that company, as well as how investigations should be resolved.

This guidance document, originally published in 2017, assists government counsel with that evaluation process.  While primarily intended for use in the criminal context, the same guidance could undoubtedly be considered during a civil investigation against a company, such as in a False Claims Act investigation.  The guidance document and its updates are excellent resources for a company to use in the company’s ongoing evaluation of its compliance program.

Purposefully tailoring the compliance program to your company.  Many DOJ updates reinforce the notion that a company should create a corporate compliance program that is tailored to that specific company, based upon its evaluation of its particular risks and anecdotes.  For instance, the update clarifies that government counsel should consider “the company’s size, industry, geographic footprint, regulatory landscape, and other factors, both internal and external to the company’s operations, that might impact its compliance program.”  And when evaluating whether the compliance program is well designed for a particular company, government counsel is directed “to understand why the company has chosen to set up the compliance program the way that it has, and why and how the company’s compliance program has evolved over time.”

Continue Reading DOJ Updates Guidance for Evaluating Corporate Compliance Programs as a Record Number of Companies are Receiving Federal Funding