News & Analysis as of

Department of Justice (DOJ) Fraud Anti-Kickback Statute

ArentFox Schiff

Investigations Newsletter: DOJ Announces Updated White-Collar Enforcement Priorities and Revised Policies

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DOJ Announces Updated White-Collar Enforcement Priorities and Revised Policies - Earlier this week, the Criminal Division of the US Department of Justice (DOJ) introduced a new white-collar enforcement plan, which sets...more

ArentFox Schiff

Investigations Newsletter: Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions

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Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions - Walgreens Boots Alliance has agreed to pay more than $300 million to resolve allegations brought by the US Department of Justice (DOJ)...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

Rivkin Radler LLP

Online DME Company Billed Insurers for Unnecessary Medical Supplies

Rivkin Radler LLP on

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

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

Polsinelli

A Deepened Divide: Appellate Court Joins False Claims Act Circuit Split in Favor of Health Care Defendants

Polsinelli on

On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must...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

Arnall Golden Gregory LLP

Narrowing FCA Cases Based on Kickback Allegations: What Healthcare and Life Sciences Companies Need to Know About the Regeneron...

On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more

Bradley Arant Boult Cummings LLP

False Claims Act: 2024 Year in Review

Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2024 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. ...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Bradley Arant Boult Cummings LLP

2024 False Claims Act Statistics Show More Cases Filed Than Ever Before

The Justice Department released its annual False Claims Act statistics on Wednesday, January 15, detailing the number of cases filed, recoveries made, and relators’ shares awarded in fiscal year 2024. The government recovered...more

Mintz - Health Care Viewpoints

EnforceMintz — Telemedicine Enforcement: Trends in 2024 Suggest More Sophisticated Enforcement to Come in 2025

The Department of Justice (DOJ) and the Office of the Inspector General for the Department of Health and Human Services (OIG) have historically focused their virtual health care enforcement efforts on “traditional”...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

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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

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

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Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

ArentFox Schiff

Investigations Newsletter: Seventh Circuit Considers When Legal Marketing Transforms Into Illegal Kickbacks

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Seventh Circuit Considers When Legal Marketing Transforms Into Illegal Kickbacks - On December 4, the US Court of Appeals for the Seventh Circuit heard oral arguments regarding whether the January 2023 jury conviction of...more

ArentFox Schiff

Investigations Newsletter: Connecticut State Court Finds Defunct Pharmacy Liable for $39.2 Million in Damages and Penalties

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Connecticut State Court Finds Defunct Pharmacy Liable for $39.2 Million in Damages and Penalties - A Connecticut Superior Court judge found Assured Rx, LLC, a Florida-based pharmacy, liable for violating the Connecticut...more

Epstein Becker & Green

The Department of Justice’s COVID-19 Enforcement Task Force 2024 Report: A Continued Commitment to Combatting COVID-19-Related...

Since the pandemic, COVID-19-related fraud has been a consistent target of the Department of Justice....more

ArentFox Schiff

Investigations Newsletter: Precision Lens Pays $12 Million to Resolve FCA and AKS Violations

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Precision Lens Pays $12 Million to Resolve FCA and AKS Violations - Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more

ArentFox Schiff

Investigations Newsletter: DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to...

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DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more

ArentFox Schiff

Investigations Newsletter: Teva and DOJ May Reach Settlement in Closely Watched AKS Lawsuit

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Teva and DOJ May Reach Settlement in Closely Watched AKS Lawsuit - On June 16, Teva Pharmaceuticals filed a request with the First Circuit Court of Appeals seeking to hold in abeyance its interlocutory appeal concerning...more

Hendershot Cowart P.C.

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

Hendershot Cowart P.C. on

Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more

ArentFox Schiff

Investigations Newsletters: Georgia Laboratory Owner Pleads Guilty to Felony Anti-Kickback Statute Violations

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Georgia Laboratory Owner Pleads Guilty to Felony Anti-Kickback Statute Violations - On February 28, the US Department of Justice (DOJ) announced the guilty plea of Andrew Maloney, who, along with his clinical laboratory...more

Bass, Berry & Sims PLC

DOJ Releases Annual Civil Fraud Recovery Statistics and Results…A Look Behind the Numbers

Bass, Berry & Sims PLC on

On February 22, the Department of Justice (DOJ) released its annual report of civil fraud recoveries for FY2023, along with a press release highlighting DOJ’s civil enforcement efforts.  Our top ten observations from...more

Dickinson Wright

6 Key Steps to Respond to a Health Care Investigation (and Related Issues)

Dickinson Wright on

Originally published in Healthcare Michigan, Volume 41,  No. 2 - The United States Department of Justice (“DOJ”) and state law enforcement agencies have robust teams investigating and prosecuting health care fraud. Law...more

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