News & Analysis as of September 19, 2024

Anti-Kickback Statute › Foreign Corrupt Practices Act (FCPA)

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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 -

The Supreme Court Made Its Rulings; Corporate Compliance Needs March On

NAVEX on 7/3/2024

At the end of June, the U.S. Supreme Court issued major decisions on the enforcement power of the Securities and Exchange Commission, what does or doesn’t qualify as a bribe of government officials, and on federal judges’...more

No Free Tickets! Tackling Conflicts of Interest in Corporate Hospitality

NAVEX on 6/18/2024

The roar of the crowd, clinking champagne flutes, and gourmet cuisine… it’s the Big Game, and the season of extravagant corporate hospitality packages is in full swing. Welcome to the high-stakes minefield of conflicts of...more

Recent Fraud Settlements: DOJ Values Voluntary Self-Disclosure and Corporate Cooperation

Troutman Pepper on 2/7/2024

The Department of Justice’s (DOJ) conduct since announcing its February 22, 2023, Voluntary Self Disclosure (VSD) policy, demonstrates that the government continues to place a premium on corporate cooperation in both criminal...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

[Event] 2023 Board & Audit Committee Compliance Conference - October 23rd - 24th, Fort Lauderdale, FL

Health Care Compliance Association (HCCA) on 6/30/2023

Discover today's best practices for your role in healthcare compliance oversight - The Office of Inspector General of Health and Human Services expects healthcare board members, board audit/compliance committee members,...more

Biotronik Anti-Kickback Enforcement Action: Bribery Schemes and Lessons Learned

Thomas Fox - Compliance Evangelist on 7/27/2022

Today we conclude our series on a Federal Anti-Kickback enforcement action which was announced last week, involving the Oregon based medical device manufacturer Biotronik Inc. (Biotronik). Today, I want to consider the...more

The Wreck of the Andrea Doria and the Biotronik Anti-Kickback Enforcement Action

Thomas Fox - Compliance Evangelist on 7/26/2022

We have not had a This Day in History opening for the FCPA Compliance and Ethics Blog for some time. So not only is one long overdue but a shipwreck which occurred some 66 years ago makes a great opening for today’s start of...more

Investigations Newsletter: Four Convicted of Scheme to Fraudulently Obtain Millions in COVID-19 Relief Programs

ArentFox Schiff on 7/2/2021

After an eight-day trial, a federal jury convicted four California residents for their scheme to submit fraudulent loan applications seeking millions of dollars in the Paycheck Protection Program (PPP) and Economic Injury...more

AGG Food & Drug Newsletter - January 2021

Arnall Golden Gregory LLP on 1/26/2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

2020 Government Investigations Team Insights - September 2020

Arnall Golden Gregory LLP on 9/10/2020

AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors, SEC enforcement attorneys, and federal agency attorneys, has...more

Novartis US Corruption Settlements: Part 6 – Final Thoughts

Thomas Fox - Compliance Evangelist on 7/27/2020

We are nearing the end of this exploration of two major corruption enforcement actions involving the pharmaceutical giant Novartis. One in the US and one for the rest of the world....more

Novartis’ Simultaneous Settlements Break Records

Akerman LLP - Health Law Rx on 7/22/2020

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more

Novartis US Corruption Settlements: Part 3 – Compliance Failures

Thomas Fox - Compliance Evangelist on 7/22/2020

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Novartis Settles False Claims Act Cases and Pays $729 Million for Domestic Bribery Schemes

The Volkov Law Group on 7/8/2020

We have a new poster-child for a defective corporate culture of wrongdoing. Novartis has joined the exclusive club, along with Siemens, General Motors, Wells Fargo, and others in the misconduct Hall of Fame. ...more

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

Bass, Berry & Sims PLC on 2/4/2020

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

[Event] Board & Audit Committee Compliance Conference - February 24th - 25th, Fort Lauderdale, FL

Health Care Compliance Association (HCCA) on 11/21/2019

The Office of Inspector General of Health and Human Services expects board members, board audit/compliance committee members, and senior level leaders of organizations to be experienced in compliance oversight. The Board &...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

DOJ Offers Big Incentive to Healthcare Industry to Self-Disclose Criminal Conduct

Perkins Coie on 10/10/2018

The U.S. Department of Justice (DOJ) announced a “road map” for the healthcare industry last month to guide voluntary self-disclosures and cooperation with government investigations. Speaking at the annual American Health...more

Top Ten International Anti-Corruption Developments for December 2017

Morrison & Foerster LLP on 1/30/2018

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Health Care Fraud Institute Held at Georgia Bar Headquarters

Arnall Golden Gregory LLP on 12/14/2017

On December 7, 2017, the Institute for Continuing Legal Education (ICLE) of the State Bar of Georgia held its annual Health Care Fraud Institute. Topics discussed at the Institute included recent federal and state fraud and...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

Health Update - November 2017

Manatt, Phelps & Phillips, LLP on 11/27/2017

Fraud and Abuse 2017: Understanding Trends and Avoiding Actions - Editor’s Note: In a recent webinar for Bloomberg BNA, Manatt examined game-changing fraud and abuse trends and cases—and revealed strategies for avoiding...more

Corporate Investigations and White Collar Defense - October 2016

Manatt, Phelps & Phillips, LLP on 11/1/2016

Supreme Court: What Constitutes an Insider Trading “Personal Benefit” - Why it matters: On October 5, 2016, the Supreme Court heard oral argument in Salman v. United States, where the central issue was what the...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

Thomas Fox - Compliance Evangelist on 9/6/2016

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

The Volkov Law Group on 9/6/2016

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

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