Category: Enforcement

OIG Creates New AKS Safe Harbors, Codifies Others

On January 6, 2017, two new safe harbors to the federal anti-kickback statute (the “AKS”) will become effective pursuant to a final rule published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) on December 7, 2016. The final rule also codifies safe harbors for certain AKS exceptions and makes a technical correction to the existing safe...

Jury Verdict in Declined Civil FCA Action Need Not Bar Criminal Prosecution for Same Conduct

The qui tam provisions of the False Claims Act allow private citizens to file FCA claims on behalf of the government.  The government may elect to intervene in the action—or it may not.  The United States District Court for the Western District of Virginia held earlier this month that when the government does not intervene, it is a party in interest, but not a party to...

Omnicare Inc. Settles Kickback Allegations for $28 Million

The United States Justice Department (DOJ) announced this week that Omnicare, Inc. (Omnicare), the largest nursing home pharmacy in the United States, will pay approximately $28 million dollars to resolve charges that it received kickbacks from Abbott Laboratories (Abbott) to promote Abbott’s anti-epileptic drug, Depakote, to nursing home patients. According to the press release, Omnicare, whose consultant pharmacists review nursing home resident’s medical charts and...

Nashville Pharmacy Services, LLC Settles FCA Allegations

Last week the Department Of Justice announced a settlement agreement with Nashville Pharmacy Services, LLC (“NPS”) and NPS majority owner Kevin Hartman.  Under the agreement, NPS and Mr. Hartman will pay up to $7.8 million to settle a lawsuit alleging violations of the False Claims Act.  The settlement agreement does not include any admission of liability on the part of NPS or Mr. Hartman. On...

Education Management Corporation Settles Significant FCA Claims

Education Management Corporation (EDMC), a Pittsburgh-based company that operates for-profit educational institutions, has agreed to pay $96 million in what attorneys involved in the case claim to be the largest settlement ever in a False Claims Act case involving the Department of Education.  The settlement was announced on November 16, 2015, and it resolved four cases spanning a period of eight years. The cases were...

Novartis Pharmaceuticals Settles $390MM FCA Allegations

Drugmaker Novartis Pharmaceuticals has agreed in principle to pay $390MM (including $20MM in civil forfeitures) to the Department of Justice.  This payment, in addition to modification and an extension of Novartis’s existing Corporate Integrity Agreement (“CIA”), settles claims that the company paid illegal kickbacks to specialty pharmacy companies in order to induce the pharmacies to recommend two drugs—Exjade and Myfortic—to their patients.  The Government sought...

New Justice Department Directive Underscores Focus on Individuals—and Importance of Cooperation—in False Claims Act Investigations

In a recent memorandum issued to Main Justice litigating components and United States Attorney’s offices nationwide, Deputy Attorney General Sally Quillan Yates emphasized that “fighting corporate fraud and other misconduct” remains a top priority for the Department and the Federal government’s vow to seek “individual accountability for corporate wrongdoing.” The memorandum, which appears to be designed to respond to criticism regarding the Department’s response to...