News & Analysis as of

Supreme Court of the United States Anti-Kickback Statute

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
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

Womble Bond Dickinson

For Whom the Bell Tolls? The Impact of Wisconsin Bell v. United States ex rel. Todd Heath and United States v. Regeneron...

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The Supreme Court’s decision in Wisconsin Bell v. United States ex rel. Todd Heath clarifies what constitutes a “claim” under the federal False Claims Act (FCA). ...more

King & Spalding

Recent Decisions and DOJ Policy Announcements Signal Key Changes to FCA Enforcement and Litigation Environment

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Recent legal and political False Claims Act (“FCA”) developments signal a potentially turbulent time for the defense of investigations and lawsuits brought under the FCA...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

Epstein Becker & Green

First Circuit Joins Sixth and Eighth Circuits in Adopting “But-For” Causation Standard Under the Federal Anti-Kickback Statute for...

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In 2010, as part of the Affordable Care Act, Congress resolved a highly litigated issue about whether a violation of the Anti-Kickback Statute (AKS) can serve as a basis for liability under the federal False Claims Act (FCA)....more

Lowenstein Sandler LLP

Circuit Split Deepens on Anti-Kickback Statute’s Causation Standard

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Introduction: In its recent decision in United States v. Regeneron Pharmaceuticals, Inc., the United States Court of Appeals for the First Circuit deepened an existing federal circuit court split regarding the causation...more

Goodwin

Health Headlines: January 2025

Goodwin on

Welcome to the second issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. In this issue, we cover expected changes under the new Trump administration, the Food and Drug Administration’s...more

ArentFox Schiff

Investigations Newsletter: Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case

ArentFox Schiff on

Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case - On January 6, a District Court of Massachusetts judge granted summary judgment for defendants on allegations of violating the...more

Mintz - Health Care Viewpoints

EnforceMintz — Scienter, Causation, and Constitutional Questions: 2024’s Three Key FCA Litigation Issues

In 2024, federal courts issued a number of important decisions in False Claims Act (FCA) cases that are particularly noteworthy for the health care and life sciences industries. We focus here on decisions that further develop...more

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

ArentFox Schiff on

Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more

Polsinelli

Supreme Court Declines to Hear “Willfulness” Case

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On Monday, October 7, 2024, the U.S. Supreme Court declined to consider a petition for certiorari in United States ex rel. Hart v. McKesson Corp., Case No. 23-1293, where relator, Adam Hart (“Relator”), sought review of a...more

ArentFox Schiff

Investigations Newsletter: US Supreme Court Declines to Consider AKS ‘Willfulness’ Question

ArentFox Schiff on

US Supreme Court Declines to Consider AKS ‘Willfulness’ Question - On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether a “willful” act under the federal...more

Stevens & Lee

Intent Required Under the Anti-Kickback Statute: Supreme Court Lets Stand Second Circuit’s Decision in the McKesson Case

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On Oct. 7, the U.S. Supreme Court denied a petition for review and let stand a widely watched Second Circuit Court of Appeals decision in which the court ruled that the term “willfully” as used in the Anti-Kickback Statute...more

Vinson & Elkins LLP

Supreme Court Declines to Revisit Limitations on Anti-Kickback Statute: What This Means for Enforcement of Corruption, Kickbacks...

Vinson & Elkins LLP on

On October 7, 2024, the U.S. Supreme Court declined to hear a case concerning the “willfulness” element of the Anti-Kickback Statute (the “AKS”). This decision leaves intact a recent Second Circuit holding, which established...more

ArentFox Schiff

Eleventh Circuit Makes Wide-Ranging Ruling on Application of Co-Conspirator Hearsay Exception

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Last week, the Eleventh Circuit held that a conspiracy need not be unlawful to introduce co-conspirator statements under Federal Rule of Evidence 801(d)(2)(E), reversing the district court’s exclusion of certain statements....more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

ArentFox Schiff

Relator Calls on Supreme Court to Define Standard for a ‘Willful’ Kickback under Federal Anti-Kickback Statute

ArentFox Schiff on

On June 7, Adam Hart, a former employee of McKesson Corporation, filed a petition for certiorari to the US Supreme Court asking the Court to define the “willfulness” element of the Anti-Kickback Statute (AKS). United States...more

NAVEX

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

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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

Bass, Berry & Sims PLC

Causation Split: First Circuit Pauses Teva Appeal; Regeneron Appeal Going Forward

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False Claims Act (FCA) practitioners have been closely watching cases in which courts address the causation requirement in FCA actions based on Anti-Kickback Statute (AKS) violations....more

Mintz

EnforceMintz — Practical Lessons Learned from FCA Litigation in 2023

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In 2023, the Supreme Court and the United States Courts of Appeals published a number of significant decisions with implications for entities in the health care and life science industries facing False Claims Act (FCA)...more

Foley & Lardner LLP

Health-Care Fraud Scrutiny Heats Up For Companies, Providers

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This year will see a continued proliferation of enforcement against health-care fraud, with old and new theories. Some hot spots for enforcement will involve cases about new technologies; data outliers; entities perceived as...more

Bradley Arant Boult Cummings LLP

District of Massachusetts Split on Causation Standard in Kickback FCA Cases

The District of Massachusetts has joined the growing chorus of courts that have applied a heightened causation standard in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS). U.S. District Judge F....more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

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Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Stevens & Lee

U.S. Supreme Court Declines to Clarify Key Provisions of the False Claims and Anti-kickback Statutes

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Last week, the U.S. Supreme Court denied the request of qui tam relators that it review the Sixth Circuit’s recent decision in United States of America ex rel. Martin v. Hathaway, No. 22-1463 (6th Cir.). In so doing, the...more

Bass, Berry & Sims PLC

District Courts Wrestle with Causation in Kickback Cases While Circuit Courts Remain Divided

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Two Massachusetts federal district courts recently addressed—and disagreed about—an important False Claims Act (FCA) issue that has also divided the federal circuit courts: when an alleged FCA violation is based on an...more

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