Tag: corporate integrity agreement

GAO Releases Report Analyzing HHS-OIG Integrity Agreements Since 2005

The U.S. Government Accountability Office (GAO) released a report on May 10th characterizing over 10 years of corporate integrity agreements and integrity agreements (collectively, “Agreements”) entered into by the U.S. Department of Health and Human Services Office of Inspector General (“HHS-OIG”) with entities subject to HHS-OIG’s permissive exclusion authority. The […]

OIG Releases Criteria for Implementing Exclusion Authority

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. This guidance replaces guidance previously released by the OIG in 1997. All of […]

Court Holds Corporate Integrity Agreement May Be Basis for Reverse False Claim Liability

This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon, Inc. The motion to dismiss relates to claims made by the whistleblowers under 31 U.S.C.§ […]

LITIGATION ROUND-UP: SOME RECENT DRUG & DEVICE SETTLEMENTS, INVESTIGATIONS, INQUIRIES

Settlements Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies, promoted its antidepressants for unapproved uses, and misrepresented its drug prices to state Medicaid programs.  The settlement resolved two False Claims Act […]

Johnson & Johnson Finalizes $2.2 Billion Government Settlement

Earlier this week, the U.S. Department of Justice (DOJ) announced that it reached a settlement with Johnson & Johnson (J&J) and two of its subsidiaries — Janssen Pharmaceuticals and Scios Inc. — to resolve civil and criminal health care fraud allegations. The settlement in principle was first announced by J&J […]

Government Enforcement Presentations at Pharmaceutical Industry Conference

The government enforcement presentations are highly anticipated events by industry attendees at the Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (PCF).  This year’s agenda included a presentation by Mary Riordan of the U.S. Department of Health and Human Services Office of Inspector General (“OIG”), followed by an assistant U.S. Attorney (AUSA) […]