Category: Government Enforcement

HHS Office of Inspector General Releases 2014 Work Plan: New Items Relevant to Prescription Drugs

On February 6, 2014, the U.S. Department of Health & Human Services (“HHS”) Office of Inspector General (“OIG”) released its annual 2014 Work Plan.  In addition, the OIG has posted a 25-minute video vignette featuring senior OIG executives discussing the OIG’s top priorities for fiscal year 2014.  The OIG annually […]

LITIGATION ROUND-UP

Settlements The U.S. Department of Justice (DOJ) announced on Friday that it reached a nearly $5.5 million settlement with Abbott Laboratories to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products.  The alleged kickbacks […]

Update on HHS “Qualified Health Plans” Determination: Grassley Weighs in…

As we reported earlier this week, the U.S. Department of Health & Human Services (“HHS”) recently issued a letter concluding that HHS “does not consider [Qualified Health Plans (QHPs)], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to be federal […]

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 […]

HHS: Qualified Health Plans are NOT “Federal Health Care Programs” – Implications for Anti-Kickback, CMP, and Exclusion Analyses

In an October 30, 2013, letter to Representative Jim McDermott (D-WA), U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, stated that HHS “does not consider [Qualified Health Plans (QHPs)], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to […]

Resource Launch: Introducing Cooley’s Government Settlements Tracker

Cooley has added an exciting new resource to our blog: the Government Settlements Tracker.  This tracking chart provides an overview of select government settlements related to pharmaceutical, biotechnology and medical device manufacturers, including the settlement amount, whether the matter is civil and/or criminal, whether the matter resulted from a whistleblower action, resolution of the matter, and […]

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) […]

Equal Opportunity Exclusion from Federal Health Care Programs

On October 25, 2013, the U.S. Department of Health & Human Services Office of Inspector General (“OIG”) updated its “Frequently Asked Questions” webpage regarding exclusions from federal health care programs to address the implications of United States v. Windsor (570 U.S. __, 113 S. Ct. 2675 (2013)).  By way of background, on […]

LITIGATION ROUND-UP

Settlements On October 15th, Fougera Pharmaceuticals agreed to pay $22.75 million to resolve civil allegations related to Medicaid drug pricing claims.  The government alleged that between September 1995 and October 2013, Fougera knowingly set, reported and maintained fraudulent and/or inflated pricing information for certain drugs that resulted in overpayments by […]

Vermont AG Posts 25 Enforcement Actions Related to State Transparency Law

Last week, the Vermont Office of the Attorney General (“VT AG”) published 25 enforcement actions recently taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s Prescribed Products Disclosure Law, 18 V.S.A. §§ 4631, 4632.  These are the first enforcement actions that the VT AG has […]