Akron General Health Systems, a regional hospital system based in Akron, Ohio agreed to pay $21.25 million to resolve allegations under the False Claims Act that it maintained improper relationships with referring physicians, resulting in the submission of false claims to the Medicare program.  Akron General was acquired in late 2015 by the Cleveland Clinic Foundation.  The timing of the case and the investigation raise...

St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities.  St. Jude was acquired by Abbott Laboratories in early 2017. St. Jude failed to disclose serious health events caused by the early depletion of the battery in certain models of its Fortify, Fortify Assura, Quadra and Unify devices which...

Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. Alere sold diagnostic devices knowing that the devices had a materially defective algorithm.  During the period 2008 to 2016, Alere sold defective INRatio-blood coagulation monitors used by Medicare patients taking anticoagulant drugs (e.g., warfarin).  Blood coagulation...

The False Claims Act is a powerful enforcement tool.  The Justice Department with its partner agencies are ramping up enforcement efforts.  The Biden DOJ is preparing to implement an aggressive FCA program across healthcare, defense industries and other government contractors.  Combined with this initiative, DOJ recently implemented an antitrust enforcement task force relating to government procurement.  In this environment, companies have to address these risks...

The False Claims Act is a powerful enforcement tool.  The Justice Department with its partner agencies are ramping up enforcement efforts.  The Biden DOJ is preparing to implement an aggressive FCA program across healthcare, defense industries and other government contractors.     The False Claims Act stands as a major risk – businesses that depend on government business, including healthcare, defense and other contractors, have to address...

I am excited to welcome Clausematch, as a new sponsor of Corruption Crime and Compliance. The Volkov Law Team has been impressed with Clausematch’s unique compliance policy management product offerings. Clausematch provides effective and efficient policy management, regulatory change management and contract management. Clausematch brings digital transformation to governance, risk and compliance. POLICY MANAGEMENTClausematch brings digitalized workflows to policies and procedures, which can be linked,...

The Directive’s robust prohibitions against retaliation for covered persons—including both attempts and threats— is meticulously outlined in Article 19. Among other things, Article 19 broadly prohibits retaliation in the following forms: Suspension, lay-off, dismissal or equivalent measures Demotion or withholding of promotion Transfer of duties, change of location of place of work, reduction in wages or change in working hours Withholding of training Negative performance...

Hope everyone had wonderful Fourth of July holiday. Alex Cotoia, Regulatory Manager, at the Volkov Law Group rejoins us for Parts III and IV of his series on the EU Whistleblower Directive. If you want to reach Alex, his email is [email protected]. Article 17 of the Directive explicitly incorporates the provisions of Regulation 2016/679 on the protection of natural persons with regard to the processing...

The Justice Department and the Securities Exchange Commission are back in business.  The first corporate FCPA enforcement action in 2021 came after a six-month hiatus in 2021. The first case against a corporate entity in 2021 is an interesting one because it reflects a coordinated settlement not only between DOJ and the SEC but the U.K.’s Serious Fraud Office and Brazil’s Ministério Público Federal (MPF),...

To all our clients, colleagues, friends and family, Happy 4th of July. Here’s to the great future ahead. Happy 4th!!