News & Analysis as of

Medicare False Claims Act (FCA) Appeals

A&O Shearman

Pharma company challenges the US False Claims Act: what’s at stake for whistleblowers and government enforcement?

A&O Shearman on

A pharmaceutical company is currently appealing a record USD1.6 billion judgment in the US, arguing that a key part of the US False Claims Act (FCA) is unconstitutional. This case, now before the Court of Appeals for the...more

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Arnall Golden Gregory LLP

Limitations to the Anti-Kickback Statute? Seventh Circuit Reverses Conviction Finding “Aggressive” Marketing Tactics Insufficient...

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit reversed the conviction of the owner of a durable medical equipment (“DME”) distributor, ruling that there was insufficient evidence to support a...more

Jackson Walker

Fifth Circuit Criminal Opinions: Insights and Analyses Part II

Jackson Walker on

As we continue our series summarizing recent Fifth Circuit criminal opinions, the latter half of March proved to be particularly noteworthy. The Fifth Circuit addressed a range of cases, including those involving the False...more

ArentFox Schiff

Investigations Newsletter: Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising

ArentFox Schiff on

Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising - On April 14, the US Court of Appeals for the Seventh Circuit reversed the criminal conviction of Mark Sorensen after a...more

Perkins Coie

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

Perkins Coie on

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

McGuireWoods LLP

Fifth Circuit Concurrence Adds Voice to FCA Constitutionality Questions

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A first appellate circuit judge has questioned the False Claim Act’s constitutionality. In the Fifth Circuit’s decision last month in United States ex rel Montcrief v. Peripheral Vascular Assocs., P.A., No. 24-50176, — F....more

Health Care Compliance Association (HCCA)

UPIC Audits

An audit by a Unified Program Integrity Contractor auditor, better known as a UPIC audit, can be a very scary thing. Healthcare providers are often shocked and even indignant to receive a letter notifying them of the audit...more

Harris Beach Murtha PLLC

First Circuit Decision Raises Bar on Anti-Kickback Statute-Premised Liability Under the False Claims Act

The United States Court of Appeals for the First Circuit recently joined the Sixth Circuit (2023) and Eighth Circuit (2022) in holding that the term “resulting from” in the Federal Anti-Kickback Statute (“AKS”) (as amended in...more

McGuireWoods LLP

First Circuit Adopts “But For” AKS Standard, Leaving Third Circuit Alone in Causal-Link Standard

McGuireWoods LLP on

On Feb. 18, 2025, the U.S. Court of Appeals for the First Circuit adopted the “but for” causality standard for violations of the federal Anti-Kickback Statute (AKS) that give rise to violations of the federal False Claims Act...more

Proskauer - Health Care Law Brief

First Circuit Clarifies FCA Liability Standard for AKS Violations, Deepening Circuit Split

The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”)...more

Skadden, Arps, Slate, Meagher & Flom LLP

First Circuit Demands ‘But For’ Causation Between Alleged Kickback and Claim Submission

On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more

Goodwin

First Circuit Adopts Defense-Friendly “But-For” Causation Standard for AKS-Predicated FCA Claims

Goodwin on

In a unanimous panel opinion filed on February 18, 2025, the First Circuit held that False Claims Act cases predicated on violations of the Anti-Kickback Statute (“AKS”), require proof that alleged kickbacks were the...more

Stevens & Lee

First Circuit Rules Against Government in False Claims Act Case

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On Feb. 18, in U.S. v. Regeneron Pharmaceuticals, the First Circuit Court of Appeals joined the Sixth Circuit and the Eighth Circuit in holding that, for purposes of establishing that a claim for payment of items or services...more

Foley & Lardner LLP

Anti-Kickback Statute Premised False Claims Cases: The “But For” Causation Standard Finds Support from First Circuit

Foley & Lardner LLP on

It’s now 3–1, with the First Circuit (2025) aligning with the Sixth (2023) and Eighth (2022) Circuits finding the meaning of the words “resulting from” — as used in a 2010 amendment to the federal Anti-Kickback Statute (AKS)...more

Husch Blackwell LLP

Are the qui tam provisions of the False Claims Act unconstitutional?

Husch Blackwell LLP on

The qui tam provisions of the False Claims Act allow individuals to file suit on behalf of the United States and to receive a share of the resulting financial settlement or judgment. Filing a qui tam case is not just a formal...more

ArentFox Schiff

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

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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

ArentFox Schiff

Investigations Newsletter: Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims

ArentFox Schiff on

Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims - Last week, the Second Circuit Court of Appeals affirmed the district court’s ruling that dismissed allegations from a whistleblower who claimed that...more

ArentFox Schiff

Investigation Newsletter: Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims

ArentFox Schiff on

Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more

Holland & Knight LLP

Opposing Endless Extensions of the 60-Day Seal Period in False Claims Act Cases

Holland & Knight LLP on

Is there a limit on the number of times the federal government can request extensions of the 60-day period under seal to decide whether to intervene in a qui tam relator's False Claims Act (FCA) case? The appellants in U.S....more

Bradley Arant Boult Cummings LLP

Third Circuit Finds Documentation Issues May Be “Material” under the FCA

On August 25, 2023, the Third Circuit continued its trend of rulings unfavorable to FCA healthcare defendants in the latest appeal of U.S. ex rel. Druding et al. v. Care Alternatives et al., No. 22-1035, 2023 WL 5494333 (3d...more

ArentFox Schiff

Investigations Newsletter: Supreme Court Again Tightens FCA Intent, But Tricky Questions Linger

ArentFox Schiff on

The US Supreme Court brushed aside novel assertions from two pharmacy retailers on June 1 and ruled unanimously that False Claims Act liability hinges on whether defendants subjectively believed their claims were “false.” In...more

McDermott Will & Schulte

Federal Jury Returns $43 Million Verdict for Kickback Scheme in Violation of the False Claims Act

After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more

ArentFox Schiff

Investigations Newsletter: DOJ Issues Corporate Self-Disclosure Policy

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DOJ Issues Corporate Self-Disclosure Policy - The US Department of Justice (DOJ) released a Voluntary Self-Disclosure Policy that sets a consistent standard for corporate self-disclosures for all US Attorney’s Offices. The...more

ArentFox Schiff

Investigations Newsletters: US Supreme Court Requests Solicitor General's Views in FCA Rule 9(b) Context

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US Supreme Court Requests Solicitor General’s Views in FCA Rule 9(b) Context - On May 16, 2022, the US Supreme Court requested a brief from the US Solicitor General on the level particularly required by Federal Rule of...more

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