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DOJ Preserves Its Options in Cooperation Credit Guidance


By and on Jun 21, 2019
Posted In Compliance Developments

Last month, the Civil Division of the Department of Justice (DOJ) announced the release of formal guidance to DOJ civil attorneys on how to award “cooperation credit” to defendants who cooperate with the Department during a False Claims Act (FCA) investigation. The formal policy, added to the Justice Manual Section 4-4.112, identifies the type of...

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DOJ Guidance on Evaluation of Corporate Compliance Programs: Key Takeaways


By , , , , and on May 9, 2019
Posted In Compliance Developments, Government investigation

Boards and management should make use of recent expanded guidance from the US Department of Justice to ensure that their compliance programs are considered “effective” if and when an investigation arises. Companies should affirmatively answer three fundamental questions in evaluating a compliance program: Is the compliance program well designed? Is the program being implemented effectively...

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Health Care Enforcement Quarterly Roundup – Q1 2019


By , , , , , , , , , , , , and on Apr 26, 2019
Posted In Additional Compliance Resources, Other Notable Enforcement Actions, Pharmaceuticals

In this first installment of the Health Care Enforcement Quarterly Roundup for 2019, we continue to monitor trends we identified in 2018 and introduce new enforcement efforts that are expected to persist in the coming year. In this Roundup, we focus on increased enforcement activity against electronic health record (EHR) companies, enforcement against individuals (with an acute focus...

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Health Care Enforcement Quarterly Roundup | Q4 2018


By , , , , , , , , , , and on Jan 30, 2019
Posted In Compliance Developments, Other Notable Enforcement Actions, Yates Memorandum

This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of Justice’s (DOJ) December announcement of its fiscal year 2018 False Claims Act (FCA) recoveries, it remains clear that the...

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Updated Yates Memo Still Has Force In Civil Domain


By and on Jan 24, 2019
Posted In Government investigation, Yates Memorandum

In September 2015, Deputy Attorney General Sally Yates issued the Yates memo on individual accountability in the context of corporate investigations. It is no understatement to say that this memo created a near-cottage industry of articles and panels on the memo’s impact on government investigations and officer/director liability. After the change in administration, a favorite...

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Health Care Enforcement Quarterly Roundup | Q3 | September 2018


By , , , , , , , , , , , and on Oct 8, 2018
Posted In Compliance Developments, Other Notable Enforcement Actions

In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry that we have observed over the past few months. In this issue, we report on: Practical applications of recent guidance from the US Department of Justice (DOJ) A recent blow to DOJ’s effort to use...

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Health Care Enforcement Quarterly Roundup | Q2 | July 2018


By , , , , , , , , , , , , and on Jul 18, 2018
Posted In Compliance Developments, Other Notable Enforcement Actions

How will key trends and developments in health care policy and enforcement impact future litigants? In the latest Health Care Enforcement Quarterly Roundup, we address this question in the context of: Continued interpretations of the landmark Escobar case The latest guidance from US Department of Justice (DOJ) leadership regarding enforcement priorities The uptick in state...

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District Court Rejects FCA Claim Based on “Substandard” Product


By on Mar 26, 2018
Posted In Uncategorized

On March 13, 2018, the United States District Court for the Eastern District of Oklahoma dismissed U.S. ex rel. Montalvo v. Native American Servs. Corp. In this case, the relators alleged that the defendants performed substandard work at a US Army ammunition plant. Specifically, the relators alleged that the defendant oversaw a construction project in...

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Update: Judge Denies Relator’s Attempt to Freeze Nursing Home’s Assets Pending Appeal


By and on Jan 30, 2018
Posted In Damages and Penalties, Materiality, Sampling/Extrapolation

On January 23, 2018, the same judge who two weeks ago set aside a $350 million jury verdict against a nursing home operator denied a new emergency motion by relator to freeze the defendant’s assets pending the relator’s appeal of the court’s order granting judgment as a matter of law. The relator argued that the...

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DOJ Issues Memorandum Outlining Factors for Evaluating Dismissal of Qui Tam FCA Cases in Which the Government Has Declined to Intervene


By , and on Jan 29, 2018
Posted In Anti-Kickback Statute / Stark Law, Government investigation, Government Knowledge, Materiality, Other Notable Enforcement Actions, Pharmaceuticals, Public Disclosure Bar

As first reported in the National Law Journal, the US Department of Justice (DOJ), Civil Division, recently issued an important memorandum to its lawyers handling qui tam cases filed under the False Claims Act (FCA) outlining circumstances under which the United States should seek to dismiss a case where it has declined intervention and, therefore,...

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