DOJ and GSK Enter Into Record-Setting $3 Billion Settlement, Expansive CIA

The Department of Justice today announced the largest-ever health care fraud settlement and largest-ever payment by a drug company.  Global pharmaceutical giant GlaxoSmithKline LLC (GSK) agreed to pay $3 billion to resolve criminal and civil liability in connection with its drug sale and promotion practices, …

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The Wrinkle In Dinkel: The Departmental Appeals Board (Re)Defines the “Should Have Known” Standard for Exclusion Actions Under 1128(b)(7)

In a recent application of the Exclusion Statute, Social Security Act § 1128 et seq., the Department of Health & Human Services Departmental Appeals Board (Board) clarified that providers have an affirmative obligation to understand and correctly apply Medicare billing rules.  In doing so, the Board arguably …

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OIG Issues Report on Pharma Compliance Roundtable

On March 26, the Office of Inspector General (OIG) issued a paper entitled:  Report From February 23, 2012, Pharmaceutical Compliance Conference (Report).  The Report summarized discussions at a roundtable discussion convened by OIG for the 23 pharmaceutical industry manufacturers currently operating under a …

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OIG Approves Subsidiaries’ Participation in Novel Ascension Health Alliance GPO

Yesterday, the Department of Health and Human Services Office of Inspector General (OIG) published its first Advisory Opinion of 2012.  Advisory Opinion 12-01 sanctioned a novel group purchasing organization (GPO) arrangement.  The proposed arrangement was not merely hypothetical.  Today, Ascension Health …

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District Court Decisions Help Refine Heightened Pleading Standard For False Claims Act Cases

Two decisions were issued this past week in a district that handles a large number of qui tam actions.  The United States District Court in Boston issued decisions that will help demarcate the point where conduct is too attenuated from the submission of a claim to form a potential basis for False Claims Act …

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Caught by the CIA: Corporate Integrity Agreement Violation is Grounds for False Claims Act Liability

In a decision with potentially significant implications, the U.S. Court of Appeals for the Eleventh Circuit ruled on February 22, 2012, that the failure to satisfy reporting and monitoring obligations under a Corporate Integrity Agreement can form the basis for False Claims Act (FCA) liability. A Novel …

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