News & Analysis as of

Scienter False Claims Act (FCA)

Venable LLP

Defense-Friendly Anti-Kickback Statute and False Claims Act Marketing and Advertising Decisions

Venable LLP on

On April 14, 2025, the Seventh and Second Circuits each issued opinions narrowing the scope of advertising, marketing, and booking fee activities that run afoul of the federal Anti-Kickback Statute (AKS). See United States v....more

Sheppard Mullin Richter & Hampton LLP

SuperValu Wins False Claims Act Case with a “No Harm, No Foul” Jury Verdict

On March 5, 2025, SuperValu, Inc. (SuperValu), a grocery store chain that operates in-store pharmacies, was cleared of liability by a Central District of Illinois federal jury—finally quashing whistleblower claims that 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

Davis Wright Tremaine LLP

CMS Finalizes Changes to the Medicare Parts A and B Overpayment Rule

In the Calendar Year 2025 Medicare Physician Fee Schedule, the Centers for Medicare & Medicaid Services (CMS) finalized changes to the Medicare Parts A and B Overpayment Rule that were proposed in two prior rulemakings. This...more

Bass, Berry & Sims PLC

False Claims Act Decisions to Know from Q3 2024

Bass, Berry & Sims PLC on

Courts have addressed multiple False Claims Act (FCA) issues in the third quarter of this year. Below is a summary of top cases involving the constitutionality of the FCA’s qui tam provisions, the FCA’s scienter requirement,...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

Dentons

Ep. 24 – Implementing AI and Mitigating Compliance Risks – Part I

Dentons on

In the wake of the United States Supreme Court’s decision in U.S. ex rel. Schutte v. SuperValue, Inc., interpreting the False Claims Act’s scienter element – referring to the defendant’s knowledge and subjective beliefs –...more

Mintz - Health Care Viewpoints

Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the...

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the...more

Bass, Berry & Sims PLC

The California Insurance Frauds Prevention Act: Recent Developments Regarding California’s Powerful Commercial Health Insurance...

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We have previously discussed the California Insurance Frauds Prevention Act (IFPA)–a state antifraud statute that, while modeled on the False Claims Act (FCA), is unique in targeting fraud in the commercial health insurance...more

Health Care Compliance Association (HCCA)

The compliance lessons in the wake of the Supreme Court decision in U.S. ex rel Schutte v. SuperValu, Inc.

The False Claims Act (FCA) permits private individuals to bring lawsuits in the name of the United States—called qui tam—against those they believe have defrauded the federal government: 31 U.S.C. § 3730(b). The FCA thereby...more

Bass, Berry & Sims PLC

Second Circuit Clarifies Anti-Kickback Statute’s Scienter Requirement

Bass, Berry & Sims PLC on

On March 12, the U.S. Court of Appeals for the Second Circuit issued an important decision that sheds light on the test for determining scienter under the federal Anti-Kickback Statute (AKS). The Second Circuit reasoned that...more

Bradley Arant Boult Cummings LLP

False Claims Act - 2023 Year in Review

As we do every year, this issue revisits the key cases and other developments from the year gone by. And by most metrics, 2023 was a notable year for the False Claims Act (FCA). We start with the numbers: The Department...more

Mintz

EnforceMintz — Practical Lessons Learned from FCA Litigation in 2023

Mintz on

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

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

Paul Hastings LLP

SuperValu and Executive Health Resources: What to Know About the FCA Following the 2023 Term

Paul Hastings LLP on

As we take stock of the Supreme Court’s 2023 term, two landmark decisions shift our understanding of scienter and government intervention as it relates to the False Claims Act (“FCA”), 31 U.S.C. § 3729. First, on June 1,...more

Epstein Becker & Green

SuperValu’s Effect on the FCA Scienter Standard and Impact to Future Litigation

Epstein Becker & Green on

n June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is...more

Epstein Becker & Green

Supreme Court Holds the FCA Scienter Standard Is Subjective, but How Will This Impact Future FCA Litigation?

Epstein Becker & Green on

On June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief...more

Dorsey & Whitney LLP

Supreme Court’s Recent Decision on FCA’s Scienter Standard Potentially Raises Threshold for Government to Establish “Reckless...

Dorsey & Whitney LLP on

On June 1, 2023, a unanimous Supreme Court decision sought to clarify the meaning of “scienter” in the FCA context, which deals with the defendant’s knowledge (or lack thereof) that a claim for payment was false and intent to...more

Cozen O'Connor

Whistleblower Watch - A quarterly update on FCA Enforcement and Qui Tam Litigation

Cozen O'Connor on

Summer 2023- Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the...more

Dickinson Wright

False Claims Act “Knowledge” Is a Subjective Standard

Dickinson Wright on

The Federal False Claims Act (“FCA”) allows private parties to bring lawsuits in the name of the federal government against defendants who allegedly “knowingly” present a false claim to the government for payment. The...more

Dickinson Wright

Supreme Court Issues Ruling on the Requisite Intent for False Claims Act Defendants

Dickinson Wright on

A recent decision by the Supreme Court clarified the required intent for a defendant to be held liable under the False Claims Act. According to the Court, the FCA’s scienter requirement refers to a defendant’s knowledge and...more

Burr & Forman

Do I Believe You? Scienter Standard in a FCA Case

Burr & Forman on

Two False Claims Act (“FCA”) cases have recently been decided by the United State Supreme Court, further clarifying one aspect of the FCA. In the recent decisions in U.S. ex rel Proctor v. Safeway, Inc. and U.S. ex rel....more

Akin Gump Strauss Hauer & Feld LLP

False Claims Act Knowledge Element after Schutte: What Is Lost, What Remains, What Companies Should Do Next To Minimize Exposure...

Key Points - Supreme Court eliminates FCA scienter defense based solely upon an objectively reasonable interpretation of ambiguous law when defendant has subjective knowledge that claim is false. Supreme Court ruled that...more

Miller Canfield

Supreme Court Ruling Strengthens Government’s Ability to Voluntarily Dismiss Whistleblower Lawsuits

Miller Canfield on

The United States Supreme Court has ruled in an 8-1 decision that the U.S. government has broad authority to dismiss whistleblower actions over the individual whistleblower’s objections so long as the government intervenes...more

Jackson Lewis P.C.

U.S. Supreme Court: False Claims Act Liability Depends on Defendant’s Subjective Beliefs

Jackson Lewis P.C. on

Liability in False Claims Act (FCA) suits depends on whether a defendant subjectively believed its claims were false, not on whether it can offer an objectively reasonable basis for its claims, the U.S. Supreme Court has held...more

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