Category: Government Enforcement

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 […]

Regulator Panel at FDLI’s Advertising & Promotion Conference

The Food and Drug Law Institute (FDLI) is hosting its annual Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologic & Veterinary Medicine Industries this week in Washington DC. The conference kicked off this morning with the highly anticipated Food and Drug Administration (FDA) regulator panel that included Thomas […]