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The U.S. Supreme Court resolved a split among federal circuits in its May 16 ruling that the public disclosure bar of the federal False Claims Act (FCA) precludes plaintiffs from bringing claims under the FCA based on information obtained through Freedom of Information Act (FOIA) requests for public documents. Schindler Elevator Corp. v. United States ex rel. Kirk, No. 10-188, 563 U.S. ___ (May 16, 2011).[1] The FCA's public disclosure bar generally forecloses qui tam suits that are "based upon the public disclosure of allegations or transactions . . . in a congressional, administrative, or Government Accounting Office report, hearing, audit, or investigation." Id. The Court found that a federal agency's written response to a FOIA request for records constitutes a "report" within the meaning of the FCA's public disclosure bar and, as such, cannot form an independent basis for an FCA claim. See 31 U.S.C. § 3730(e)(4)(A).Relator Daniel Kirk worked for petitioner Schindler Elevator … [Read more...] about U.S. Supreme Court Resolves Circuit Split: FCA Relators Cannot Base Claims on Information Received Through FOIA Request

On June 16, 2016, the Supreme Court issued its opinion (“Op.”) in Universal Health Services v. U.S. ex rel. Escobar (“Escobar”), a case testing the viability and scope of the implied certification theory of False Claims Act (“FCA”) liability.  Under the implied certification theory, a defendant may be liable under the FCA based on the its failure to comply with certain statutory, regulatory, or contractual provisions, even if the defendant did not expressly certify compliance..  The circuits have split, both on whether an implied certification theory is viable at all and, if so, when non-compliance can trigger FCA liability.Writing for a unanimous Court, Justice Thomas held the implied false certification theory can be a basis for liability when: (1) a defendant submits a claim that does not merely request payment, but also makes specific representations about the goods or services provided, and (2) knowingly fails to disclose the … [Read more...] about Supreme Court Preserves But Significantly Changes “Implied Certification” Theory of False Claims Act Liability

In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it finds similar to the claims at issue in Mayo. It also underscores the need for Congressional action to incentivize and protect investments in this important frontier of health care.The Personalized Medicine Treatment ClaimsThe decision was rendered in U.S. patent application 13/269,365, assigned to SureGene LLC. According to the background section of the application, in the treatment of psychotic disorders, “there are individual differences in response to specific drugs based on differences in drug pharmacology and metabolism, combined with genetic differences between patients.” Also according to the application, “[t]here are currently no proven ways to identify which antipsychotic drug is optimal for a given … [Read more...] about USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

In 2010, the Affordable Care Act (“ACA”) enacted new rules governing overpayments made by the Medicare and Medicaid programs. Under these rules, providers have 60 days from the date that the overpayment has been identified to return the overpayment or face penalties and treble damages under the False Claims Act (“FCA”).  As described below, recent regulations have clarified some of the issues surrounding the ACA obligation to refund overpayments, at least for overpayments under Medicare Parts A and B.  But, determining whether a provider has “identified” an overpayment – and thus started the 60 day countdown – can still be nuanced and complex.  Diligent providers that have proactive and robust compliance and audit functions in place may find some comfort, since such providers are presumably able to respond quickly to credible information that there has been a potential overpayment, as required by the new regulations, and … [Read more...] about Overpayment Rule and Implied False Claims Theory: “What You Don’t Know Can Still Hurt You”

Sommaruga (third from right) joins leaders in Sunday's march. Photo: AFP Swiss President Simonetta Sommaruga joined 59 world leaders at a march on Sunday in solidarity with victims of terror attacks in Paris that attracted an estimated crowd of more than one million people. Sommaruga participated in a who’s who cast of politicians from Europe and around the world who came to pay their respects at the request of French President François Hollande after a week of bloodshed that left 17 dead. “It was very impressive,” said Sommaruga, who told Swiss media she was “personally touched” by the historic march led by relatives of the victims of attacks last week at the Charlie Hebdo magazine and a kosher supermarket. She chatted with Italian Prime Minister Matteo Renzi, among other leaders, including German Chancellor Angela Merkel, UK Prime Minister David Cameron, Israel PM Benjamin Netanyahu and Palestinian leader Mahmoud Abbas, who walked arm in … [Read more...] about ‘Don’t succumb to fear’: President Sommaruga