The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims Act Working Group. The Working Group will be jointly led by Deputy Assistant Attorney General (DAAG) of the Commercial Litigation Branch Brenna Jenny, HHS Acting General Counsel Sean Keveney, and HHS Office of Inspector General Acting Chief Counsel Susan Edwards, and will include the Centers for Medicare & Medicaid Services (CMS) Center for Program Integrity and U.S. Attorneys’ Offices.

Read the full alert here.

For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance expert may become a reality. (We collectively refer to all of these individuals and entities as monitors throughout this update.) Hiring an independent monitor is a sensitive topic, as a company subject to a monitorship is required to open up its records and files, financial information, proprietary and confidential materials, IT assets, and employees to a third party — often at frequent and regular intervals, and often for a period of five years — not to mention the potential multimillion-dollar expense associated with the engagement.

Read the client alert here.