Tag: Office of Inspector General

OIG Solicits Input for Anti-Kickback Statute Safe Harbor Regulations and Special Fraud Alerts

The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Federal Register notice last week soliciting proposals and recommendations for developing new and/or modifying existing safe harbor provisions for the federal Anti-Kickback Statute (AKS) in accordance with section 14 of the Medicare and Medicaid Patient and Program Protection […]

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 […]

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) […]

LITIGATION ROUND-UP

Settlements On July 24, 2013, GlaxoSmithKline (GSK) announced a settlement in principle with the Attorneys General of eight states related to the development and marketing of Avandia and a separate settlement with the Attorney General of Louisiana totaling $229 million.  GSK previously paid $3 billion to settle civil and criminal allegations related to the marketing of Avandia and […]

Electronic Submissions Now Available for OIG Voluntary Disclosures

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released an on-line Provider Self-Disclosure Protocol (“Protocol”) submission form for individuals and entities that seek to disclose to the OIG potential violations of criminal, civil, or administrative law governing health care programs for which exclusion or […]