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Showing 21 posts in Department of Justice.

New Formal Guidelines on "Cooperation Credit" for False Claims Act Defendants

The Department of Justice released formal guidelines on May 7, 2019 allowing False Claims Act defendants to receive "credit" by taking steps to cooperate with an ongoing government investigation. The goal of this guidance is to incentivize companies to provide meaningful assistance throughout a DOJ investigation, including voluntarily disclosing misconduct that may not be within the scope of any pending investigation. Although the impact of the formal guidance on False Claims Act cases is still unclear, there is some possibility that cases will resolve more quickly due to increased cooperation by defendants. More

Government Takes a Hard Line on Fraudulent Donations to Patient Assistance Programs

Last month, the Department of Justice ("DOJ") announced a settlement with two pharmaceutical companies – Astellas Pharma US, Inc. ("Astellas"), and Amgen Inc. ("Amgen") – resolving allegations that their "donations" to patient assistance programs violated the False Claims Act. The two companies agreed to pay a total of $124.75 million, and both entered into five-year corporate integrity agreements with the Office of Inspector General as part of their respective settlements. United States Attorney Andrew E. Lelling said that according to the allegations, the companies illegally subsidized the high costs of their own drugs at the expense of American taxpayers, and "[w]e will keep pursuing these cases until pharmaceutical companies stop engaging in this kind of behavior.” Multiple settlements related to similar investigations have already brought in hundreds of millions of dollars in only a few years' time. More

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Pharmaceutical Manufacturer US WorldMeds LLC Pays $17.5 Million to Settle False Claims Act Allegations

Pharmaceutical manufacturer US WorldMeds LLC (USWM), headquartered in Louisville, Kentucky, has agreed to pay $17.5 million to settle allegations that it violated the False Claims Act by paying kickbacks to both patients and physicians to induce prescriptions of its drugs Apokyn and Myobloc.  The Department of Justice (DOJ) announced the settlement on April 30, 2019. More

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Sutter Health Settles False Claims Act Allegations for $30 Million

Sutter Health, based in Sacramento, California, agreed to pay $30 million to settle allegations that the health system submitted inflated diagnosis codes to the Center for Medicaid Services (CMS) for Medicare Advantage beneficiaries.  The Department of Justice (DOJ) announced this in a press release on April 12, 2019.    More

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Duke University Pays U.S. Government $112.5 Million to Settle False Claims Act Allegations

Duke University, a private research university in Durham, North Carolina, recently paid the U.S. government $112.5 million to settle allegations that it submitted falsified data in order to win federal research grants.  The settlement was announced on Monday, March 25, 2019, by the Department of Justice.  More

Where Does Attorney General William Barr Stand on the False Claims Act?

William Barr was confirmed as Attorney General by the Senate a few months ago, after testifying before the Senate Judiciary Committee in a hearing on January 15, 2019. Immediately following the hearing, The National Whistleblower Center ("NWC") Whistleblower Protection Blog reported with a sigh of relief that Barr had committed to "diligently enforce" the False Claims Act. This post also included a statement from NWC Executive Director Stephen M. Kohn, calling this a "major victory for all whistleblowers," since Barr was historically opposed to the qui tam provision in the False Claims Act that enables whistleblowers to sue on behalf of the government if they have independent knowledge that fraud is taking place. More

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The Brand Memo – Everything You Need to Know

The Brand memo was issued in January 2018 by then-Associate Attorney General Rachel Brand, limiting the use of guidance documents in civil enforcement actions and preventing DOJ attorneys from using informal agency guidance as binding law.  To understand more, it is important to first understand the Sessions memo.  More

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Durable Medical Equipment Provider Agrees To Pay $1.6 Million To Resolve False Claims Allegations

U.S. Attorney for Utah, John W. Huber, announced on December 11, 2018, that the durable medical equipment ("DME") company Western Medical Group agreed to pay $1,634,844 million to settle False Claims Act allegations.  The settlement is the result of two qui tam actions filed by whistleblowers in December 2013 and February 2014.  More

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Drug Maker Actelion Agrees to Pay $360 Million to Settle False Claims Act Investigation Into Kickbacks

The pharmaceutical company Actelion Pharmaceuticals US, Inc. ("Actelion"), based in South San Francisco, California, has agreed to pay $360 million to resolve claims that it illegally funneled kickbacks through a patient-assistance charity.  Federal prosecutors allege in a press release on December 6, 2018 that Actelion "illegally used a foundation as a conduit to pay the copays of thousands of Medicare patients taking Actelion's pulmonary arterial hypertension drugs." These actions are in violation of the False Claims Act.  More

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Medicare Advantage Provider to Pay $270 Million to Settle False Claim Act Liabilities

HealthCare Partners Holdings LLC, doing business as Davita Medical Holdings LLC (DaVita), has agreed to settle a False Claims Act liability case and will pay $270 million to the United States Government.  DaVita, headquartered in El Segundo, California, did not admit fault.  Relators allege that DaVita was providing inaccurate information that caused Medicare Advantage Plans to receive inflated Medicare payments.  More

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