News & Analysis as of

Anti-Kickback Statute Prescription Drugs Compliance

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 -
Mintz - Health Care Viewpoints

OIG Favorable Advisory Opinion on Physician Practice’s Arrangement with Telehealth Platform and Recent Corporate Practice of...

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services...more

Polsinelli

A Deepened Divide: Appellate Court Joins False Claims Act Circuit Split in Favor of Health Care Defendants

Polsinelli on

On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must...more

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

King & Spalding on

On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

Bass, Berry & Sims PLC

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

Bass, Berry & Sims PLC on

Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

Akerman LLP - Health Law Rx

Novartis’ Simultaneous Settlements Break Records

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

Foley Hoag LLP - White Collar Law &...

White Collar Year in Preview: Healthcare Fraud Trends in 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

The Volkov Law Group

Two Charitable Foundations Pay $6 Million for Anti-Kickback Violations

The Volkov Law Group on

Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million.  The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

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