News & Analysis as of August 21, 2025

Anti-Kickback Statute › Pharmaceutical Industry › Bribery

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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 -

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

Greenbaum, Rowe, Smith & Davis LLP on 7/29/2025

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Fraud Week: Pharmacy Kickbacks, Fake Medical Directorships and More

Rivkin Radler LLP on 10/28/2022

Federal and state enforcement activity involving pharmacy fraud tops the list of categories in this edition of Rivkin Rounds’ Fraud Week. We’ll list just a sampling of cases....more

Investigations Newsletter: DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller

ArentFox Schiff on 11/15/2021

DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more

Report on Medicare Compliance Volume 30, Number 22. News Briefs: June 2021

Health Care Compliance Association (HCCA) on 6/17/2021

Report on Medicare Compliance 30, no. 22 (June 14, 2021) - CMS’ supplemental medical review contractor (SMRC) is now doing postpayment reviews of Medicare claims for electrodiagnostic (EDX) testing axial muscles and...more

NYC Pharmacy Owner Charged With Healthcare Fraud

Rivkin Radler LLP on 3/24/2021

The owner of Brooklyn Chemists in Gravesend, Brooklyn and Lucky Care Pharmacy in Flushing, Queens was recently indicted on charges of conspiracy to commit health care fraud, conspiracy to defraud the United States by paying...more

EpiPen RICO Ruling Opens Door for Private AKS Enforcement

Troutman Pepper Locke on 2/22/2021

A federal district court recently decided that private litigants may proceed in a Racketeer Influenced and Corrupt Organization Act (RICO) lawsuit predicated on violations of the Anti-Kickback Statute (AKS). The plaintiffs...more

Is Your Prior Authorization Program Demonstrably Compliant?

Stinson LLP on 9/23/2020

A recent settlement announced by DOJ serves as a good reminder of the need for device and pharmaceutical manufacturers to periodically revisit their prior authorization assistance programs, to assure that the programs are...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

White Collar Year in Preview: Healthcare Fraud Trends in 2020

Foley Hoag LLP - White Collar Law &... on 1/9/2020

Editors’ Note: This is the second in our start-of-year series examining important trends in white collar law and investigations in the coming year. Our previous entry discussed SEC enforcement in 2020. Up next: a look at...more

Walking the Line Between Marketing and Malfeasance

Butler Snow LLP on 10/7/2019

Opioid manufacturers, distributors, pharmacies and prescribers are facing a deluge of lawsuits that involve criminal and civil claims in both federal and state courts. On May 2, 2019, a federal jury in Boston, Massachusetts,...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

K&L Gates Triage: 2018 Health Care Fraud Takedown

K&L Gates LLP on 7/19/2018

Recently, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced its largest ever national health care fraud takedown, resulting in charges against 601 diverse defendants including...more

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

Bass, Berry & Sims PLC on 6/28/2017

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....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

Pharmaceutical And Medical Device Compliance: Domestic And Foreign Bribery

The Volkov Law Group on 6/3/2013

Pharmaceutical and medical device companies have a raw deal when it comes to domestic and foreign bribery. ...more

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