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False Claims Act (FCA) Anti-Kickback Statute Medicare

Alston & Bird

Government Pivots to False-Certification Theory in Regeneron Case

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Our Health Care Litigation Team discusses a District of Massachusetts case holding that allows the government to switch liability theories in its False Claims Act lawsuit against Regeneron Pharmaceuticals....more

ArentFox Schiff

Investigations Newsletter: Regeneron Court Permits Government to Pursue False Certification Theory

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Regeneron Court Permits Government to Pursue False Certification Theory - On August 4, the district court in the closely watched Regeneron case granted the government’s request to file a second partial summary judgment...more

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

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On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

Haynes Boone

False Claims Act - 2025 Mid-Year Review

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The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...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

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Cozen O'Connor

AGs Inject Accountability into Pharma Practices via $202M Gilead Settlement

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New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2025

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

Cozen O'Connor

Justice Department Continues Pattern of False Claims Act Suits Due to Alleged Kickbacks

Cozen O'Connor on

On May 1, the federal government brought a False Claims Act (“FCA”) suit against three health insurers, as well as three insurance brokers. The Justice Department’s suit alleges that the insurers paid millions of dollars in...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

Lowenstein Sandler LLP

Two False Claims Act Cases From SDNY Highlight Continuing Bite of Aggressive Healthcare Enforcement

The U.S. Attorney’s Office for the Southern District of New York last week announced the resolution of two significant False Claims Act (FCA) cases—one from a large settlement and the other the result of a jury verdict after...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

ArentFox Schiff

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

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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...

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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

Rivkin Radler LLP

Lab Operator Convicted in Drug-Testing Scheme

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Conspiracies to rip off the Medicare system are prevalent due to the vast amounts of money flowing through the program. On February 25, Sherif Khalil of Redondo Beach, California man was convicted by a federal jury in Detroit...more

ArentFox Schiff

Investigations Newsletter: Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme

ArentFox Schiff on

Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme - A Long Island, New York, businessman was arrested on conspiracy, kickback, and money laundering charges stemming from an alleged scheme to defraud...more

Husch Blackwell LLP

Beware of Offers Too Good to Be True: Recent Federal Lawsuit Highlights Kickback and False Claims Risks

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As of February 18, 2025, the First Circuit Court of Appeals requires the government to prove “but-for” causation in Anti-Kickback Statute (AKS)-based False Claims Act (FCA) cases. The court reasoned in United States v....more

A&O Shearman

First Circuit Ruling Requiring “But-For” Causation In FCA Kickback Claims Deepens Circuit Split

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In an opinion that may complicate the U.S. Department of Justice’s (“DOJ”) efforts to enforce the False Claims Act (“FCA”), the U.S. Court of Appeals for the First Circuit held in a unanimous opinion on February 18, 2025 that...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

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

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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

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Rivkin Radler LLP

Online DME Company Billed Insurers for Unnecessary Medical Supplies

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DMERx, an online DME platform, served as the basis for a massive fraud against Medicare and other insurers. Gregory Schreck, a Kansas man who was the vice president of DMERx, orchestrated a sophisticated fraud scheme to bill...more

Morgan Lewis

First Circuit Holds ‘But For’ Causation Required to Demonstrate Falsity in Kickback-Based FCA Cases, Growing Circuit Split

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In United States v. Regeneron Pharmaceuticals Inc., the US Court of Appeals for the First Circuit held that when the government seeks to establish False Claims Act liability under the 2010 amendment to the Anti-Kickback...more

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