Holly Drumheller Butler

Despite the numerous pivots in the Department of Justice's focus over the past year, one priority remains constant: identifying “waste, fraud, and abuse, including health care fraud and federal program and procurement fraud that harm the public fisc.” Indeed, the Criminal Division identified this as its No. 1 priority last year. Subsequently, DOJ announced the formation of a DOJ-HHS False Claims Act Working Group signaling a coordinated, cross-agency approach with the Department of Health and Human Services (HHS) to rooting

Some early actions by the Trump administration have led corporate legal departments to question the extent to which they need to invest in ethics and compliance at this time, based on a perceived reduction in enforcement risk: A presidential action issued in February paused enforcement of the Foreign Corrupt Practices Act, stating “overexpansive and unpredictable FCPA enforcement against American citizens and businesses . . . for routine business practices in other nations . . . wastes limited prosecutorial resources that could

Companies have always faced the potential for a visit from an agent from U.S. Immigration and Customs Enforcement (ICE) but President Donald Trump’s heightened focus on immigration increases the likelihood of that reality. Over the past month, the Trump administration has issued new policies that alter previous guidelines for how ICE agents may act in the line of duty. Of course, a visit from an ICE agent, like contact with any law enforcement officer, may prompt nervous or inappropriate reactions that

The Environmental Protection Agency (EPA) chooses criminal, civil or administrative enforcement based on its assessment of the severity of violations. A significant development in EPA’s enforcement strategy has been the increased integration and collaboration between its civil and criminal enforcement offices. To further its enforcement program, the EPA recently introduced the Strategic Civil-Criminal Enforcement Policy. This policy replaces previous guidelines, is effective immediately and according to the EPA aims to address modern environmental challenges more effectively. The key takeaways from this policy

U.S. Deputy Attorney General Lisa Monaco delivered keynote remarks March 7 at the American Bar Association’s 39th National Institute on White Collar Crime. In addition to unveiling a new whistleblower pilot program, she discussed the rise of artificial intelligence (AI) and DOJ’s continued effort to fight corruption at the hands of people using AI to further their illegal activities. Just because an unlawful activity is done by or orchestrated with AI does not mean it is not illegal. “Fraud using AI

U.S. Deputy Attorney General Lisa Monaco delivered keynote remarks March 7 at the American Bar Association’s 39th National Institute on White Collar Crime. Emphasizing the need for a culture of compliance, Monaco highlighted the continued importance of existing DOJ programs, including those related to corporate claw backs, acquisition-related disclosures and voluntary self-disclosure. Monaco also announced that the Department of Justice is designing a new whistleblower program that will use monetary rewards to strengthen corporate enforcement efforts and proactively incentivize individuals to

Deputy Attorney General Lisa Monaco announced a new safe harbor policy for voluntary self-disclosures made in connection with mergers and acquisitions on Wednesday. Pursuant to this new policy, the DOJ will not prosecute companies that self-report potential violations occurring within an acquisition target's business. Here are the key parameters of the M&A self-disclosure policy: The self-disclosure must be made within six months of a deal's closing. The six-month threshold applies whether the misconduct was discovered pre- or post-acquisition. The acquirer will have one

The U.S. Department of Justice (DOJ) announced Friday a three-year pilot program designed to promote compensation systems that “shift the burden of corporate financial penalties away from shareholders . . . on to those more directly responsible.” The Compensation Incentives and Clawbacks Pilot Program directs companies entering into criminal resolutions to implement  compliance-oriented compensation systems and provides incentives to companies that seek to recoup compensation from culpable employees. First, the DOJ directs companies entering into criminal resolutions to implement robust, compliance-related

The U.S. Department of Justice (DOJ) on Wednesday issued a new Voluntary Self-Disclosure (VSD) Policy for United States Attorney’s Offices, effective immediately. “The policy details circumstances under which a company will be considered to have proactively and voluntarily self-disclosed misconduct by employees or agents, as well as the incentives associated with making such a disclosure.” The policy aims to make the USAO’s definition of VSD uniform across offices and clarify the requirements needed to receive disclosure credit. The policy identifies three

It happens so often. An individual voluntarily talks with law enforcement agents in an effort to appear cooperative, but the prosecutor later labels the statements as incriminating “admissions.” Whether made before or after arrest, such statements prove compelling evidence. For example, during a recent trial, the prosecutor successfully argued to the jury that a Harvard professor unquestionably made false statements to government agencies because “the defendant himself has said that he did” during an interview. Example of the Harvard Professor Federal agents

The Department of Justice (DOJ) recently overturned the prior administration’s limitations on the use of regulatory guidance in False Claims Act (FCA) litigation. Now, DOJ attorneys may rely on guidance documents “in any appropriate and lawful circumstances.” How should compliance programs respond to the resurgence of the regulators in the ongoing FCA wars? Background Former Attorney General Jeff Sessions initiated the limitation on the use of regulatory guidance in the prior administration with his Memo dated November 16, 2017. His mandate prohibited “Improper Guidance

Whistleblowers who report perceived illegal activity by an individual, agency, or organization have long been heralded as heroes, serving both the public and private sectors by producing evidence of wrongdoing despite great personal risk. Accordingly, whistleblowers are afforded heightened protections that prohibit an employer from retaliating against an employee for reporting alleged wrongdoing. However, a recent decision from the D.C. Circuit demonstrates that whistleblowers are not shielded by a super power of invincibility.  Any adverse action taken by an employer against

It’s no secret that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) exists to protect the privacy of patients and their sensitive health information. However, understanding the importance of HIPAA compliance and the potential consequences of violations also can help protect the health care providers who care for them. With this in mind, we are pleased to share a recap of five key areas important for health care providers of all shapes and sizes. The HIPAA Security Rule places

China employs its Thousand Talents Program (“TTP”) to recruit overseas academic and scientific talent to work in China by promising research funding from the Chinese government and, occasionally, compensation. TTP has drawn increased scrutiny from the U.S. government, specifically the FBI and the Department of Justice, over purported concerns of intellectual property theft or espionage. However, a closer review of the actual charges brought to date by these government agencies reveals the crux of the matter has related to disclosures.

On January 1, 2021, the National Defense Authorization Act became law after Congress overrode the President’s veto. As highlighted below, Congress enacted a variety of key provisions that create significant and sweeping reforms to statutes and regulations designed to combat money laundering and terrorism financing. 1. Requiring Entities to Report “Beneficial Ownership” Congress determined that “malign actors” and “money launderers” conduct financial transactions through corporate structures that conceal their identities “much like Russian nesting ‘Matryoshka’ dolls.” In order to pierce these facades,

A medical device manufacturer learned what might seem an obvious lesson when it paid $18 million to settle a False Claims Act lawsuit brought by its former Compliance Officer: don’t ignore your compliance officer. The federal government received $15.21 million; state governments received $2.79 million; and the whistleblower received $2.65 million of the federal share. The company, Merit Medical Systems, Inc. (MMS), also must pay attorneys’ fees due to the whistleblower’s counsel and enter into a five-year Corporate Integrity Agreement with the

The Department of Justice recently announced the results of its 2020 National Health Care Fraud and Opioid Takedown. This annual DOJ tradition, aimed at targeting and arresting individuals for health care fraud abuse, resulted in the filing of criminal charges against more than 50 doctors and more than 20 health care executives. Prosecutions spanned the country, including more than 50 federal districts and 40 U.S. Attorney’s Offices. FY2020’s efforts represent “the largest amount of fraud ever charged by the department

The U.S. Department of Justice (“DOJ”) is scrutinizing borrowers who have applied for loans through the Small Business Administration’s Paycheck Protection Program (“PPP”), established by the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). To date, the DOJ has filed charges in seven separate cases against defendants accused of fraud in connection with PPP loans, and the number of charges continue to grow. These charges demonstrate the Government’s strong intent to claw back any loan proceeds which were obtained

On March 28, 2019, a federal grand jury indicted two executives for failing to timely report that the dehumidifiers their companies imported and distributed were known to catch fire. According to the U.S. Department of Justice, this is the “first-ever criminal prosecution for failure to report under the Consumer Product Safety Act.” Click here to read the full Law360 article written by Holly Drumheller Butler and Dwight Stone about a recent DOJ indictment for violating the CPSA through late reporting and misrepresentations - plus, how companies can avoid

On Friday, December 1, 2017, the U.S. Environmental Protection Agency (EPA) decided NOT to finalize rules to require hard rock mines and mineral processing operations to provide financial assurance to fund future cleanups of their properties under the federal Superfund law (Comprehensive Environmental Response, Compensation and Liability Act (CERCLA)). A link to EPA’s action can be found here. What a Difference a Year Can Make: Brief History of the Rule from Proposal to EPA’s Decision Not to Finalize Exactly a year before, EPA