Client Alerts 

CMS Joins Government Efforts to Combat Health Care Fraud
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
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5 Tips to Keep DOJ at Bay When DEI is in Play
Government contractors and grant recipients should heed the warning bell represented by the record haul of recoveries in 2025 under the federal False Claims Act (FCA). Although more than $6.8 billion was collected, according to the Department of Justice (DOJ), more troubling is the record number of 1,297 qui tam suits filed. This growth of whistleblower lawsuits comes just as DOJ has voiced its intent to use the FCA to combat diversity, equity and inclusion (DEI) initiatives. DOJ Investigations The DOJ is
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Federal Judge Rules Attorney-Client Privilege Does Not Cover AI Conversations
by Matthew T. Wagman on February 20, 2026
Many people use AI tools in their daily lives without a second thought. In fact, many of us have ChatGPT aiding our searches on our personal phones. But a federal judge in New York recently found during a criminal trial that conversations with AI tools were not protected by attorney-client privilege. This decision is believed to be a first-of-its-kind ruling that could have significant ramifications for potential waivers of attorney-client privilege. According to prosecutors’ filings, the defendant, charged with securities and
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DOJ Issues New Guidance on DEI and Federal Funding Compliance
by Tyler M. Duckett-Oliver on August 14, 2025
U.S. Attorney General Pam Bondi recently issued new guidance aimed at clarifying the current administration’s stance on the permissibility of diversity, equity and inclusion policies and procedures under federal anti-discrimination laws such as Title VII of the Civil Rights Act of 1964 and Title IX of the Education Amendments Act of 1972 – particularly among entities that receive federal funding, such as schools, universities, state and local governments, health care providers, nonprofits and other private employers. In its guidance, the Department
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DOJ Remains Focused on Domestic Health Care Providers
The Department of Justice (DOJ) recently issued its annual Health Care Fraud Takedown results, announcing a record-breaking 324 defendants, including 96 doctors and licensed professionals, as well as more than $14.6 billion in intended loss. While the large figures grab attention, an analysis of the DOJ’s statements offers important insight for American health care professionals and companies: Despite various executive orders and policy changes with the new administration, the DOJ and other government agencies continue to focus significant resources on
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Despite Reduced Enforcement Risks, Businesses Should Invest in Corporate Compliance
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
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What to Do If ICE Comes Knocking at Your Business
by Holly Drumheller Butler on March 11, 2025
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
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2 Changes Mean Contractors, Especially Small Businesses, Need to Prepare for AFCA
by Thomas E. Zeno, Kathryn J. Carlson on January 21, 2025
Government agencies may be eager to exercise their enhanced authority to investigate and pursue contractors under provisions in the newly enacted Administrative False Claims Act (AFCA). The two key changes discussed below could increase the number of claims that agencies may find appealing to investigate. Although these changes affect contractors of any size, small business contractors are likely to find investigations more disruptive if they lack a robust compliance program. But there are ways they can protect themselves by preparing for
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Navigating the New Waters of EPA Enforcement: A Deep Dive into the Strategic Civil-Criminal Enforcement Policy
by Holly Drumheller Butler on June 07, 2024
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
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Combatting Disruptive Technologies: DOJ Takes on 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. 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
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DOJ Provides a Contemporary Spin on ‘Wanted’ Posters: New Whistleblower Rewards Program Announced
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
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DOJ Announces New Voluntary Safe Harbor Policy for Mergers & Acquisitions
by Holly Drumheller Butler on October 05, 2023
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
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Individual Accountability Expanded: DOJ Launches Corporate Compliance Pilot Program Focused on Compensation System and Clawbacks
by Holly Drumheller Butler on March 06, 2023
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
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Forewarned is Forearmed: DOJ’s Corporate Voluntary Self-Disclosure Policy
by Holly Drumheller Butler on February 24, 2023
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
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Anesthesiologists Potentially “Pinged” for Checking Their Phones During Surgery
February 08, 2022
Medical professional holding a cellphone.
The federal False Claims Act results in a host of interesting relator claims. This one caught my eye. In United States of America v. Intermountain Healthcare, Inc., Case No. 2:20-cv-00372-TC-CMR (U.S. Dist. Ct. D. Utah 1/28/2022), the relator alleged that anesthesiologists participating in his medical group often spent time during surgeries playing on their phones or other personal electronic devices. Some allegedly watched football, others paid bills. Naturally, the relator alleged that the anesthesiologists were not paying attention to their
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The Fourth Circuit Grants Potential Relief from FCA Claims to Medical Providers Struggling to Decipher Medicare Requirements
February 04, 2022
A calculator and stethoscope on top financial papers.
Medical providers often are left confused by the incredibly complex statutory and regulatory body of law implemented by the Centers for Medicare and Medicaid Services (CMS). Without further administrative guidance, providers are left to their own conclusions with regard to what CMS intended. Unfortunately, sometimes these decisions lead to expensive and time-consuming False Claims Act litigation brought by relators, who disagree with the provider’s interpretation. In a recent decision, the Fourth Circuit offers some well-deserved protection from False Claims Act actions
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Yes, I Want a Lawyer
by Holly Drumheller Butler, Thomas E. Zeno on January 04, 2022
person sitting across the desk from two people who are looking at a piece of paper.
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
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The Regulators Strike Back: How Does Compliance Respond?
by Holly Drumheller Butler, Thomas E. Zeno on October 19, 2021
Person sitting at a desk typing on a computer with a medical needle and pill bottle in the fore ground.
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
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Whistleblowers Don’t Have Super Powers: Whistleblower Protections Don’t Equal Workplace Immunity
a person blowing a whistle and hold up a red card.
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
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Understanding HIPAA Compliance Can Help Protect Health Care Providers Too
by Holly Drumheller Butler on September 01, 2021
Person sitting at a desk typing on a computer with a medical needle and pill bottle in the fore ground.
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
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The Stark Law and Anti-Kickback Statute Final Rules: Value-Based Arrangements
by Lisa C. Keenan, Leslie M. Cumber on April 08, 2021
A medical professional holding a tablet, a medical professional holding a clipboard shaking hands with a professionally dressed person.
The Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) jointly published final rules that expand upon and modify regulatory safe harbors and exceptions to the Anti-Kickback Statute and the Ethics in Patient Referrals Act (the Stark law), respectively. This article will address each rule and focus on the exceptions and safe harbors applicable to value-based arrangements. Stark Law Final Rule: Value-Based Arrangements The Stark law prohibits physicians from referring patients to receive certain designated health services
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Disclosure Crucial to Thousand Talents Investigations
Chinese flag flying on a flagpole in the background and an American flag flying on a flagpole in the fore ground.
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.
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Top 5 Changes To Anti-Money Laundering Requirements
by Holly Drumheller Butler, Thomas E. Zeno on January 08, 2021
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,
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Disregard Compliance at Your Peril: Compliance Officer Paid As Whistleblower
by Thomas E. Zeno, Holly Drumheller Butler on October 16, 2020
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
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National Criminal Takedown of Health Care Professionals
by Thomas E. Zeno, Holly Drumheller Butler on October 07, 2020
Person sitting at a desk typing on a computer with a medical needle and pill bottle in the fore ground.
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
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Federal False Claims Act Wrap Up (September 2020)
September 14, 2020
This week we take look at two recent federal decisions concerning the False Claims Act (“FCA”). The first case, Ndoromo v. Barr, is interesting because of the billion dollars in alleged damages. In this case out of the U.S. District Court for the District of Columbia, the pro se plaintiff sued various government officials, including the United States Attorney General, for over $1 billion dollars in damages.  In separate, prior proceedings, the plaintiff was convicted of various criminal charges, including healthcare fraud.
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Federal False Claims Act Wrap-Up (August 2020)
September 04, 2020
A look at selected soon-to-be-reported decisions on various False Claims Act issues. This month we can glean three quick lessons: 1) A lesson for corporate executives: If you are the owner/CEO, don’t transfer company funds to your personal bank account, particularly if the funds represent Medicaid payments received from inappropriately submitted claims. A home health care company, with a single owner/CEO and six employees, allegedly submitted claims for reimbursement to the D.C. Medicaid program for services provided to patients without adequate documentation of
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