News & Analysis as of August 15, 2025

Pharmaceutical Industry

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

First Circuit Adopts But-For Causation Standard for Kickback-Premised False Claims Act Actions

K&L Gates LLP on 3/11/2025

On 18 February 2025, the First Circuit Court of Appeals issued its decision in United States v. Regeneron Pharmaceuticals, Inc., determining that “but-for” causation is the proper standard for False Claims Act (FCA) actions...more

First Circuit upholds but-for causation standard for False Claims Act cases premised on Anti-Kickback Statute violations

Hogan Lovells on 2/21/2025

On February 18, 2025, the First Circuit joined a growing list of circuit courts to hold that “but-for causation” is the correct causation standard in most False Claims Act (FCA) cases premised on alleged violations of the...more

First Circuit Rules Against Government in False Claims Act Case

Stevens & Lee on 2/21/2025

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

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

ArentFox Schiff on 1/13/2025

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

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

Pietragallo Gordon Alfano Bosick & Raspanti,... on 1/8/2025

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

Supreme Court Declines to Hear “Willfulness” Case

Polsinelli on 10/16/2024

On Monday, October 7, 2024, the U.S. Supreme Court declined to consider a petition for certiorari in United States ex rel. Hart v. McKesson Corp., Case No. 23-1293, where relator, Adam Hart (“Relator”), sought review of a...more

Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the...

Mintz - Health Care Viewpoints on 7/9/2024

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the...more

Health Care Fraud and Abuse 2023 Year in Review

Polsinelli on 4/12/2024

Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more

Second Circuit: Whistleblower Must Adequately Allege Willfulness to Assert FCA Claims Based on AKS Violations

ArentFox Schiff on 3/19/2024

On March 12, the Second Circuit affirmed in part and reversed in part a district court dismissal of False Claims Act (FCA) claims predicated on alleged Anti-Kickback Statute (AKS) violations. Adam Hart brought the claims...more

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

Bass, Berry & Sims PLC on 2/27/2024

We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

American Conference Institute (ACI) on 11/22/2023

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

Whistleblower Watch - A quarterly update on FCA Enforcement and Qui Tam Litigation

Cozen O'Connor on 8/9/2023

Summer 2023- Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the...more

Recent False Claims Act Decisions to Know

Bass, Berry & Sims PLC on 5/1/2023

In this post, we summarize noteworthy False Claims Act (FCA) decisions so far from 2023. Each of the three circuit court opinions discussed here ruled in favor of the defendants on different aspects of the FCA: the Sixth...more

11th Annual Healthcare Fraud & Abuse Review 2022

Bass, Berry & Sims PLC on 2/13/2023

We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Department of Justice and State Attorneys General Pursue Private Equity Firms Under the False Claims Act

Robinson & Cole LLP on 12/20/2021

On October 14, 2021, the Massachusetts Attorney General (MA AG) announced a $25 million settlement with South Bay Mental Health Center, Inc.’s (SBMHC) private equity owner and two former executives for allegedly causing false...more

The California Insurance Frauds Prevention Act: What to Know About California’s Powerful Commercial Health Insurance Fraud Statute

Bass, Berry & Sims PLC on 12/16/2021

Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention...more

Investigations Newsletter: DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller

ArentFox Schiff on 11/15/2021

DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more

Healthcare Law Update: October 2021

Holland & Knight LLP on 10/18/2021

Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

D.C. District Court Upholds HHS’s 2013 Policy of Including Part C Days in the Medicare Fraction of the DSH Calculation

King & Spalding on 7/16/2021

On July 7, 2021, the U.S. District Court for the District of Columbia ruled in favor of HHS and upheld HHS’s 2013 rule readopting its policy of including Part C days in the Medicare fraction of the disproportionate share...more

Healthcare Fraud & Abuse Review 2020

Bass, Berry & Sims PLC on 2/4/2021

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

DOJ False Claims Act Statistics 2020: Over 80% of all Recoveries Came from the Health Care Industry

Epstein Becker & Green on 1/22/2021

On January 14, 2021, the U.S. Department of Justice (DOJ) reported its False Claims Act (FCA) statistics for fiscal year (FY) 2020. More than $2.2 billion was recovered from both settlements and judgments in 2020, the lowest...more

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Skadden, Arps, Slate, Meagher & Flom LLP on 8/24/2020

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

Bass, Berry & Sims PLC on 2/4/2020

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

Investigations Newsletter: Health Information Technology Developer to Pay $145 Million to Resolve Kickback Allegations

ArentFox Schiff on 2/3/2020

In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more

The Granston Memo in 2019: Recent Cases Highlight the Granston Memo’s Effectiveness as a Tool to Dismiss False Claims Act Cases

Sheppard Mullin Richter & Hampton LLP on 12/5/2019

The “Granston Memo” has proven to be a boon again in 2019 for False Claims Act (“FCA”) defendants. In a January 15, 2019 Sheppard Mullin FCA Defense Blog article, we highlighted a growing movement by the Department of Justice...more

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