News & Analysis as of

Healthcare Fraud Appeals

Hendershot Cowart P.C.

EKRA Gets Its Second Major Court Test: What the Schena Decision Means for Lab Marketing and Sales Compensation

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On July, 11, 2025, the Ninth Circuit Court of Appeals affirmed laboratory operator Mark Schena’s conviction under Eliminating Kickbacks in Recovery Act (EKRA). This is the first time a higher court has addressed the lab...more

McGuireWoods LLP

Seventh Circuit Allows Percentage-Based Marketing Relationship

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On April 14th, 2025, the U.S. Court of Appeals for the Seventh Circuit reversed the Anti-Kickback Statute (AKS) conviction of Mark Sorensen, the owner and operator of a Medicare-registered durable medical equipment...more

Benesch

Eleventh Circuit Upholds Dismissal of Qui Tam FCA Suit for Failure to Meet Rule 9(b) Specificity

Benesch on

In a qui tam action filed under the False Claims Act, the relator, Barbara Senters, appealed the district court’s dismissal of her fourth amended complaint (FAC), which alleged that Quest Diagnostics submitted false claims...more

Epstein Becker & Green

Complex Billing and Reasonable Interpretations: Jury Was Entitled to Find Fraud in Doctor’s Upcoding of Speedy COVID-19 Tests,...

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On July 17, 2025, the U.S. Court of Appeals for the Fourth Circuit held that a federal district court was “within bounds to order a do-over” in the case of Ron Elfenbein, a Maryland doctor who was found guilty of...more

King & Spalding

The Fourth Circuit Rejects a Non-Delegation Doctrine Challenge to the Anti-Kickback Statute

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On July 22, 2025, the Fourth Circuit published its opinion in United States v. Donald Booker, No. 23-461, affirming a 200-month prison sentence for the owner of United Youth Care Services, which billed North Carolina’s...more

King & Spalding

Ninth Circuit Decision Clarifies EKRA Enforcement

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On July 11, 2025, the Ninth Circuit issued a decision clarifying the scope of Eliminating Kickbacks in Recovery Act (EKRA). In affirming a Northern California-based medical testing laboratory’s convictions under EKRA, the...more

Warner Norcross + Judd

Federal Court Flags Stark and Anti-Kickback Risks in Physician Pay, Spotlights FCA Constitutional Questions on Appeal

On July 28, the federal district court in the Southern District of Ohio issued a pair of orders in related whistleblower cases under the False Claims Act (FCA): United States ex rel. Murphy v. TriHealth, Inc., et al., No....more

A&O Shearman

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

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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

A&O Shearman

Pharma Company Brings Latest Constitutional Challenge To False Claims Act In Third Circuit

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On April 29, 2025, a pharmaceutical company filed the latest constitutional challenge to the qui tam provision of the False Claims Act (“FCA”) when it appealed in the United States Court of Appeals for the Third Circuit a...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

Jackson Walker

Fifth Circuit Criminal Opinions: Insights and Analyses Part V

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Hi all. Below is the June edition of the Fifth Circuit criminal and civil case summaries, with a special focus on cases of interest to white-collar practitioners. In June, the Fifth Circuit considered a number of Bruen-based...more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

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In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more

Mintz - Health Care Viewpoints

Ninth Circuit Court of Appeals Affirms EKRA Conviction for Lab Operator and Provides Insight into Key Provisions

On July 11, 2025, the Ninth Circuit Court of Appeals affirmed the criminal conviction of laboratory operator Mark Schena for violations of the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220 (EKRA) based on...more

Polsinelli

EKRA Gets Teeth: Ninth Circuit Strengthens EKRA Enforcement in Schena Ruling

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Key Takeaways - First Appellate Interpretation of EKRA: The Ninth Circuit’s decision in United States v. Schena marks the first appellate court interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), affirming...more

Epstein Becker & Green

CMS Doubles Down on Medicare Advantage Recoupment: Announces Aggressive RADV Strategy to Reclaim Billions

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On May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced an aggressive plan (Plan) to expand its efforts to address fraud, waste, and abuse in Medicare Advantage (MA)....more

Jackson Walker

Fifth Circuit Criminal Opinions: Insights and Analyses Part III

Jackson Walker on

Hello again. Below are summaries from a variety of published Fifth Circuit cases from April 2025, along with a late addition from March. One benefit of releasing the April summaries in early June is that you get the Federal...more

Dinsmore & Shohl LLP

First Circuit Requires But-for Causation for AKS-Based FCA Liability, Bolsters Majority View

Dinsmore & Shohl LLP on

What is the proper causation standard for an Anti-Kickback Statute violation to trigger liability under the False Claims Act? The First Circuit has answered that question in a much anticipated interlocutory decision in...more

Rivkin Radler LLP

Seventh Circuit Rejects Extension of AKS to Marketing Companies Without Evidence of Intent to Induce Referrals

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The U.S. Court of Appeals for the Seventh Circuit recently rejected an effort by the federal government to extend the federal Anti-Kickback Statute (AKS) to a marketing company in the absence of influence by the company over...more

Cooley LLP

Compliance Implications for Healthcare Companies Post-First Circuit Decision

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The US Court of Appeals for the First Circuit’s landmark decision in United States v. Regeneron Pharmaceuticals will have some implications for healthcare compliance and defense strategies. In the case, the First Circuit...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

Epstein Becker & Green

Eleventh Circuit Addresses Rule 9(b) Heightened Pleading Standard in False Claims Act Case

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The U.S. Court of Appeals for the Eleventh Circuit has concluded that a successful False Claims Act (FCA) claim should “allege not just a scheme, but a scheme that actually led to false claims being submitted to the...more

Morgan Lewis

Seventh Circuit Overturns AKS Conviction in DME Marketing Case

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The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more

Cranfill Sumner LLP

Kickbacks and Causation: Supreme Court Could Soon Settle the Question of Anti-Kickback Statute and False Claims Act Causation...

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A decision by the First Circuit Court of Appeals has deepened the legal debate surrounding False Claims Act (FCA) actions based on violations of the Anti-Kickback Statute (AKS). This decision has increased speculation that...more

King & Spalding

Seventh Circuit Reverses AKS Conviction Involving Payments to Marketers and DME Manufacturer

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On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit issued its opinion in United States v. Sorensen, No. 24-1557, reversing the criminal conviction of Mark Sorensen, the owner of SyMed Inc., a...more

Venable LLP

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

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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

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