On May 26, the U.S. Supreme Court issued its ruling in Kellogg Brown & Root Services, Inc. v. United States ex rel Carter, No. 12-1497, __ S. Ct. __ (2015), in which a relator brought civil False Claims Act (FCA) claims against government contractors. The relator alleged that the contractors had made fraudulent payment claims … Continue Reading
Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading
Earlier this week, the Court of Appeals for the Federal Circuit reversed and remanded the Court of Federal Claims’ August 2014 decision in CGI Federal Inc. v. The United States, in which the Court of Federal Claims ruled that the Centers for Medicare and Medicaid Services (CMS) could include contract clauses that deviated from federal … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services identifies the underlying purpose of its exclusion authority as to protect federal health care programs and their beneficiaries from "untrustworthy health care providers, i.e., individuals and entities who pose a risk to program beneficiaries or the integrity of these programs." The OIG now has published a new proposed rule that would greatly expand the bases upon which it could affirmatively exclude an individual or entity from participation in federal health care programs.
Reed Smith has prepared a Client Alert that provides an overview of the Proposed Rule, including: proposed revisions to definitions; new grounds for exclusion; clarifications to existing regulations to add mitigating and aggravating factors; early reinstatement procedures; and proposed procedural changes in the OIG's exclusion authorities.… Continue Reading
In yet another reminder about the importance of maintaining evidence on company-issued laptops, blackberries, or other electronic devices; the United States District Court for the Northern District of California recently sanctioned a qui tam relator for destroying more than 10,000 documents on his company-issued laptop. Moore v. Gilead Sciences, Inc., No. C 07-03850 SI, 2012 WL 669531 (N.D. Cal. Feb. 29, 2012).… Continue Reading
The Supreme Court’s new Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., et al., 563 U.S. ___ (2011) decision has significant implications for federally-funded inventions and any patents that may result. As Christopher Rissetto, Louis DePaul, and Stephanie Giese explain in this new alert, each federal government contractor and grantee … Continue Reading
Recent posts on www.lifescienceslegalupdate.com include:
"New HHS Regulations Impose Federal Security Breach Notification Requirements" outlines a covered entity's obligation to notify individuals when their unsecured personal health information ("PHI") is breached.
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"U.S. Department of Homeland Security Mandates Use of E-Verify for All Employees Performing Work on Government Contracts" discusses the impact of new regulations mandating use of E-Verify to verify the employment eligibility of new hires on health care providers and pharmaceutical and medical device manufacturers who have a Federal government contract containing the E-Verify clause.… Continue Reading
On December 12, 2008 the Federal Acquisition Regulation ("FAR") Council's Final Rule - which applies to all federal government contracts in amounts greater than $5 million and more than 120 days in duration, including small business and commercial item contracts -- went into effect, requiring all federal contractors to disclose wrongdoing to the federal government, including certain violations of federal law, and violations of the False Claims Act. Specifically, contractors must "timely" disclose, in writing and to the Inspector General and the contracting officer (in that order), whenever, in connection with the award, performance, or closeout of a contract, the contractor has "credible evidence" that a principal, employee, agent, or subcontractor has committed a violation of federal criminal law involving fraud, conflict of interest, bribery or gratuity violations under Title 18 of the U.S. Code, or a violation of the False Claims Act.
In addition, the rule requires contractors to establish a "business ethics awareness and compliance program," as well as an "internal control system" with certain attributes. In addition, significant overpayments by the government must be disclosed to the contracting officer. Failure to disclose violations of federal criminal law or violations of the False Claims Act may lead to criminal sanctions, civil penalties, suspension, or debarment.… Continue Reading
This post was written by Lorraine M. Campos, Gregory S. Jacobs and Brett D. Gerson. On November 12, 2008, the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council issued an amendment to the Federal Acquisition Regulation (“FAR”) to establish: (1) mandatory disclosure requirements for certain violations of federal criminal law and the False … Continue Reading