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Relators Scienter

Benesch

Seventh Circuit Holds Drug Manufacturer’s AMP Reporting Violated False Claims Act by Excluding Post-Sale Price Increases

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Relator Ronald Streck filed suit under the False Claims Act (FCA) asserting that Eli Lilly falsely under-reported its Average Manufacturer Price (AMP) for Medicaid by excluding “price increase values” (sometimes called...more

Bass, Berry & Sims PLC

False Claims Act Decisions to Know from Q3 2024

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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

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

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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

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

Miller Canfield

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

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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

Sheppard Mullin Richter & Hampton LLP

Supreme Court Hears Arguments on False Claims Act Scienter Standard

Companies regularly are required to interpret ambiguous and vague regulatory provisions. Today, the United States Supreme Court heard oral arguments in a pair of consolidated cases to determine whether a defendant’s...more

Venable LLP

Is 2023 the "Year" of the False Claims Act? For the Courts, Congress, and Contractors, It Just Might Be

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One hundred sixty years ago, Congress passed the False Claims Act (FCA) in response to widespread fraud committed against the United States government during the Civil War. Known as the "Lincoln Law," the FCA was originally...more

Akerman LLP - Health Law Rx

Mind Games: SCOTUS to Rule on what “Knowing” Means under the False Claims Act

What does it mean to “knowingly” or “recklessly” violate the law when that law consists of highly complex and ever-changing regulations, which may be open to interpretation? The U.S. Supreme Court recently agreed to review...more

Bass, Berry & Sims PLC

False Claims Act Fundamentals: Scienter

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Scienter is an element that the government or relator must prove to demonstrate a violation of the False Claims Act, 31 U.S.C. § 3729, et seq. Under the False Claims Act, the required scienter, or state of mind, is...more

Jones Day

Fourth Circuit Limits Who Can Act "Knowingly" Under False Claims Act

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Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more

Hogan Lovells

Fourth Circuit: Safeco Defense Applies to FCA Claims and Dooms Medicaid Best Price Qui Tam

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In a split decision issued January 25, 2022, the Fourth Circuit strongly endorsed a defense to False Claims Act liability for entities that submit claims to the government in today’s complex regulatory environment, finding:...more

Jones Day

Fourth Circuit Rejects FCA Claims on Scienter Grounds Based on Ambiguous Regulations

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The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more

Dorsey & Whitney LLP

In the First FCA Appellate Case of 2021, the Fourth Circuit Affirms the Dismissal of Relators’ Claims for Lack of Scienter and...

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On January 8, 2021, in the first appellate decision of the year addressing a False Claims Act case, the Fourth Circuit affirmed the summary judgment dismissal of relators’ claims that a manufacturer of allergenic extracts...more

Mintz - Health Care Viewpoints

Third Circuit Rejects AseraCare’s “Objective Falsity” Requirement, Allows Scrutiny of Medical Opinions in Hospice False Claims Act...

Last week, the Third Circuit joined several other appellate courts in finding that medical opinions related to medical necessity of hospice services can be subject to scrutiny and found to be “false” for purposes of proving a...more

Foley & Lardner LLP

Third Circuit Creates Budding Circuit Split in United States v. Care Alternatives, Ruling That “Objective Falsity” Is Not Required...

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The United States Court of Appeals for the Third Circuit ruled last week that whistleblower relators need not show “objective falsity” to prove their claims, and that a dispute among physician experts about a clinical...more

Akin Gump Strauss Hauer & Feld LLP

11th Circuit’s Decision in AseraCare: Important in Determining When Clinical Judgment Regarding Medical Necessity Can Result in an...

• Reasonable disagreement among clinicians, by itself, does not result in a false claim. • Clinical judgment must be objectively false to constitute an FCA violation. • A clinical judgment may only be objectively false...more

Sheppard Mullin Richter & Hampton LLP

Escobar’s Demanding Materiality Standard Nixes $350 Million Verdict Against Florida Nursing Facility

A Florida federal court threw out a $350 million jury verdict against a nursing facility, citing the Supreme Court’s landmark decision in Universal Health Services, Inc. v. United States ex rel. Escobar. The court explained...more

Bass, Berry & Sims PLC

Eleventh Circuit Affirms Two Grants of Summary Judgment in Favor of Diabetic Experts

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A unanimous panel of the U.S. Court of Appeals for the Eleventh Circuit (Eleventh Circuit) recently affirmed two grants of summary judgment in favor of defendant Lincare, Inc. d/b/a Diabetic Experts of America (collectively,...more

Bass, Berry & Sims PLC

Deeper Dive: Meeting the FCA’s Intent Requirement

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The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we will...more

Bass, Berry & Sims PLC

FCA Deeper Dive: Escobar and Its Aftermath – Part II

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The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we will...more

Bass, Berry & Sims PLC

Healthcare Fraud and Abuse Review 2016

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Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Akin Gump Strauss Hauer & Feld LLP

Recent Significant Case Law Developments Regarding What Constitutes a Reckless Interpretation of a Law and When Retention of an...

Key Points: - Learn the latest case law developments regarding what evidence the government or the relator must establish to prove that the defendant “recklessly” interpreted a statute or regulation in violation of the...more

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