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Anti-Kickback Statute › Healthcare Fraud › Prescription Drugs

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 -
Cozen O'Connor

TX AG Prescribes Legal Action Against Eli Lilly for Alleged Kickbacks

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Texas AG Ken Paxton has sued pharmaceutical manufacturer Eli Lilly for allegedly bribing and illegally inducing medical providers to prescribe and continue prescribing several Lilly drugs—including GLP-1 medications Mounjaro...more

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

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On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

Quarles & Brady LLP

A Prescription for Caution: Senators Release Investigative Report on Direct-To-Consumer Telehealth Models

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On July 17, the offices of Senators Durbin (D. IL.), Warren (D. MA.), Sanders (I. VT.), and Welch (D. VT.) (collectively, “Senators”) released a report summarizing the results of a nine month investigation into...more

Cozen O'Connor

AGs Inject Accountability into Pharma Practices via $202M Gilead Settlement

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New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...more

Lowenstein Sandler LLP

Two False Claims Act Cases From SDNY Highlight Continuing Bite of Aggressive Healthcare Enforcement

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The U.S. Attorney’s Office for the Southern District of New York last week announced the resolution of two significant False Claims Act (FCA) cases—one from a large settlement and the other the result of a jury verdict after...more

ArentFox Schiff

Investigations Newsletter: Gilead to Pay $202 Million to Settle DOJ Claims Over Speaker Program Kickbacks

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Gilead to Pay $202 Million to Settle DOJ Claims Over Speaker Program Kickbacks - Gilead Sciences, Inc. has agreed to pay $202 million to resolve allegations brought by the US Department of Justice (DOJ) that it violated...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

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In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Perkins Coie

First Circuit Imposes Higher “But-for” Causation Standard for False Claims Act Liability Based on Alleged Anti-Kickback Statute...

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On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more

ArentFox Schiff

Investigations Newsletter: Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case

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Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case - A federal jury in Illinois recently found SuperValu not liable in a whistleblower lawsuit that accused the company of overcharging the...more

Morgan Lewis - As Prescribed

FCA Enforcement Risk Remains for Rare Disease Stakeholders

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In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Arnall Golden Gregory LLP

Lowering the Bar: Second Circuit Finds “At-Least-One-Purpose” Sufficient for Proving Anti-Kickback Statute Violation

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On December 27, 2024, the United States Court of Appeals for the Second Circuit joined other federal circuit courts in adopting the “at-least-one-purpose” rule (generally shortened to the “one purpose rule”)....more

Foley Hoag LLP - White Collar Law &...

False Claims Act in 2025: Looking Back and What’s Ahead

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This is the fifth in our 2025 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more

King & Spalding

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

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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

Polsinelli

Swing and a Miss: the Government Strikes Out in Pharmacy Executive Kickback Trial

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Last week, the government submitted its decision to the federal court not to retry partially-acquitted pharmacy executive, Chad Beene, for conspiracy and illegal kickback allegations. At the end of last year, a New Jersey...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

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

Pietragallo Gordon Alfano Bosick & Raspanti,... on

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

Farrell Fritz, P.C.

Second Circuit Adopts At-Least-One-Purpose Rule For Anti-Kickback Statute Violations

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At the end of December, the Second Circuit joined several other circuit courts in holding that a plaintiff adequately pleads an Anti-Kickback Statute (“AKS”) violation when she states with the requisite particularity that at...more

Benesch

Third-Party Co-Pay Assistance Program Kickback Scheme Results in $450 Million DOJ Settlement

Benesch on

Teva Pharmaceuticals, the largest generic drug manufacturer in the United States, has agreed to pay $450 million to resolve allegations of violating the False Claims Act and Anti-Kickback Statute arising from purported...more

The Volkov Law Group

DaVita Pays $34 Million to Settle Kickback Violations

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DaVita is a regular target of government enforcement actions involving fraud and illegal kickbacks.  It has an extensive history of violations and settlements....more

Lathrop GPM

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

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The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more

Dinsmore & Shohl LLP

First Circuit Poised to Consider Anti-Kickback Statute’s Causation Element in FCA Cases, Take a Position on Circuit Split

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Conflicting interpretations of the causation standard in two AKS-predicated False Claims Act cases in the District of Massachusetts, Teva and Regeneron, mirrored the circuit split on the issue and led to interlocutory appeals...more

Dorsey & Whitney LLP

Healthcare Fraud: A World Beyond the Anti-Kickback Statute

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Americans spend more than $3 trillion per-year on healthcare-related expenses. Of that, the National Health Care Anti-Fraud Association estimates that between $60-250 billion is lost to fraud every year....more

Polsinelli

Health Care Fraud and Abuse 2023 Year in Review

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Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Bass, Berry & Sims PLC

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

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We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Rivkin Radler LLP

Fraud Week: CT Behavioral Health Providers Sentenced

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We’ll wrap up this edition of Fraud Week with a look at two Connecticut behavioral health providers, one bad and one very, very bad. First, Alicia Thompkins, a social worker from Hartford, pleaded guilty on April 27 to...more

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