News & Analysis as of

Medicare Anti-Kickback Statute Fraud

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

Dorsey & Whitney LLP

New State-Level Anti-Kickback Statute Expands Minnesota AG’s Power to Prosecute Healthcare Fraud

Dorsey & Whitney LLP on

On May 23, 2025, Minnesota Governor Tim Walz signed the Human Services omnibus policy bill into law, which included in part, the addition of a new statutory provision in the state’s criminal code, Chapter 609....more

Foley & Lardner LLP

Unpacking the Federal Anti-Kickback Statute’s Application to Payments to Medicare Advantage Agents and Brokers

Foley & Lardner LLP on

On December 11, 2024, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG), issued a Special Fraud Alert (Alert) focusing on financial arrangements involving Medicare Advantage (MA) Organizations...more

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

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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

Quarles & Brady LLP

“It’s Okay, These Products Aren’t Paid for by Medicare” – Think Again

Quarles & Brady LLP on

A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...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

ArentFox Schiff on

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

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, 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

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

ArentFox Schiff on

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

ArentFox Schiff

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

ArentFox Schiff on

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...

ArentFox Schiff on

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

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

Hendershot Cowart P.C. on

Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...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 Newsletter: Former Healthcare Executives Convicted for Health Insurance Policy Fraud Scheme

ArentFox Schiff on

Former Healthcare Executives Convicted for Health Insurance Policy Fraud Scheme - Steven Dorfman, the former chief executive officer and owner of the Florida-based healthcare company Simple Health, and John Sand, a former...more

ArentFox Schiff

Investigations Newsletter: Ultragenyx to Pay $6 Million To Settle False Claims Act Case

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Ultragenyx to Pay $6 Million To Settle False Claims Act Case - Ultragenyx Pharmaceutical Inc. recently agreed to pay $6 million to settle a qui tam action filed under the False Claims Act (FCA). Ultragenyx manufactures a...more

ArentFox Schiff

Investigations Newsletter: Binance to Pay Historic $4 Billion Fine

ArentFox Schiff on

Binance to Pay Historic $4 Billion Fine - Binance Holdings Limited, the operator of the world’s largest cryptocurrency exchange, agreed to pay $4.3 billion to resolve allegations that it violated the Bank Secrecy Act (BSA)...more

ArentFox Schiff

Investigations Newsletter: Nevada Man Sentenced to 51 Months Imprisonment for Prize-Notification Fraud Scheme

ArentFox Schiff on

Nevada Man Sentenced to 51 Months Imprisonment for Prize-Notification Fraud Scheme - Earlier this week, a Nevada man was sentenced to 51 months in prison for perpetrating a prize-notification scheme that defrauded...more

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