News & Analysis as of November 15, 2024

Anti-Kickback Statute › Enforcement Actions › Life Sciences

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict

Husch Blackwell LLP on 7/29/2024

Host Jonathan Porter welcomes Tynan Kugler, Principal with PYA, P.C., and Mara Smith Kouba, legal and compliance counsel with Bristol Myers Squibb, to discuss a recent False Claims Act trial verdict from a New Jersey federal...more

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part II

Jones Day on 4/8/2024

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

Morrison & Foerster LLP on 1/10/2024

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

McDermott Will & Emery on 11/30/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

American Conference Institute (ACI) on 11/22/2023

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

[Hybrid Event] Healthcare Litigation, Compliance and Investigations Forum 2023 - November 1st, Chicago, IL

McDermott Will & Emery on 10/10/2023

McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most. Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more

Video: Record-Shattering Year for FCA Recoveries in Health Care - Thought Leaders in Health Law

Epstein Becker & Green on 3/10/2022

The U.S. Department of Justice (DOJ) collected $5.6 billion in False Claims Act recoveries in fiscal year (FY) 2021. That is over twice as much as 2020, and a record 90 percent of the total was collected from the health care...more

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

Goodwin on 3/8/2022

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

Taro, Sandoz and Apotex Pay $447.2 Million to Settle False Claims Act Liability for Price-Fixing of Generic Drugs

The Volkov Law Group on 10/7/2021

The healthcare industry faces cascading risks – one risk flows to another with compounding financial results. Three generic drug companies just experienced this cascading liability. ...more

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

McDermott Will & Emery on 3/18/2021

Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

Are Speaker Programs a Thing of the Past? OIG’s Fraud Alert Indicates It Thinks They Should Be

Mintz - Health Care Viewpoints on 11/30/2020

In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as...more

Skadden's 2020 Insights

Skadden, Arps, Slate, Meagher & Flom LLP on 1/30/2020

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 1/24/2020

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

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/2/2019

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/13/2018

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

OIG gives the green light to another innovative warranty

Hogan Lovells on 9/28/2018

Last week, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion No. 18-10, advising that the OIG would not pursue an enforcement action under the Anti-Kickback Statute (AKS)...more

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/5/2017

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

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