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Fraud and Abuse Drug Pricing Anti-Kickback Statute

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

The Volkov Law Group

Teva Pharmaceuticals Pays $450 Million to Resolve Anti-Kickback and False Claims Act Violations

The Volkov Law Group on

Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...more

ArentFox Schiff

Investigations Newsletter: OIG Warns That Proposed Drug Discounts May Warrant Sanctions

ArentFox Schiff on

OIG Warns That Proposed Drug Discounts May Warrant Sanctions - On October 5, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued an advisory opinion assessing a proposal that involved...more

Goodwin

Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance

Goodwin on

In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more

Hogan Lovells

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

Hogan Lovells on

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more

Mintz - Health Care Viewpoints

Recap of Our Health Law and Policy Year-in-Review Posts for 2019

Over the past month or so, our Health Care Team has published a number of posts examining important developments and trends in health law and policy during 2019, as well as providing some thoughts on what we expect to see in...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

K&L Gates LLP

Triage in 2020: Health Care Topics to Watch in the New Year

K&L Gates LLP on

In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year. Among these issues, Ms. Rogers-Seitz discusses the...more

Holland & Knight LLP

OIG Considers Drug Pricing History in an Unfavorable Advisory Opinion on Free Drugs

Holland & Knight LLP on

• The OIG issued an unfavorable advisory opinion on a proposed program by which a marketer would provide free drugs to hospitals to utilize in an inpatient setting to treat infantile epilepsy. • Contrary to the typical...more

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