Tag: OIG

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 […]

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 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 […]

OIG Blesses Tiered Rebate Arrangement

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently determined that a proposed tiered rebate program would not constitute grounds for sanctions under the federal health care program anti-kickback statute (42 U.S.C. § 1320a-7b(b)(7)), or the civil monetary penalty provision of the Social Security Act […]

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 […]