A recently unsealed action brought under the False Claims Act is one of the first to allege claims related to Medicare Part D. Medicare contracts with private entities known as Part D sponsors to administer prescription drug plans. A sponsor may use subcontractors to obtain and provide the medications. Medicare makes certain […]
Fifth Court Differentiates Whistleblower Protection If Whistleblower Reports to SEC or Internally to Company The Fifth Circuit ruled on June 17, 2013, that anti-retaliation provisions in Dodd-Frank only protect whistleblowers who disclose alleged fraud to the U.S. Securities and Exchange Commission (“SEC”) and not just internally to the company. The […]
1. Off-Label Marketing vs. Off-Label Prescribing The Food and Drug Administration (“FDA”) requires that drugs be proven to be safe and effective for a particular use before they can be marketed. The FDA’s approval is always limited to use or uses for which the manufacturer has submitted evidence of safety […]
Is there False Claims Act liability regarding fraudulent applications for federally guaranteed loans where: there are no defaults on those loans after the government guarantees them; the government is not required to expend any funds in support of those guarantees; or the government is otherwise not financially harmed? The question […]
What is the False Claims Act Alternative Remedy Provision? When a relator brings a false claims action in the name of the Government under the False Claims Act (“FCA”), the Government may elect to pursue its claim through any alternate remedy available to the Government, including any administrative proceeding, to determine a civil money […]