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Anti-Kickback Statute › False Claims Act (FCA) › Life Sciences

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... more +
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 -
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

McDermott Will & Schulte

DOJ-HHS False Claims Act Working Group will pursue healthcare, life sciences enforcement priorities

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The US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) recently announced the relaunch of the DOJ-HHS False Claims Act Working Group, intended to “strengthen[] [the agencies’] ongoing...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

Arnall Golden Gregory LLP

Government Investigations Team Insights - May 2025

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AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors, SEC enforcement attorneys, and federal agency attorneys, has...more

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

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On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more

White & Case LLP

Life Science Private Equity Risk

White & Case LLP on

Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: False Claims Act

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Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more

Skadden, Arps, Slate, Meagher & Flom LLP

First Circuit Demands ‘But For’ Causation Between Alleged Kickback and Claim Submission

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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...

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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

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

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Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

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On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

Mintz - Health Care Viewpoints

EnforceMintz — Scienter, Causation, and Constitutional Questions: 2024’s Three Key FCA Litigation Issues

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In 2024, federal courts issued a number of important decisions in False Claims Act (FCA) cases that are particularly noteworthy for the health care and life sciences industries. We focus here on decisions that further develop...more

Hinshaw & Culbertson - Health Care

Healthcare Providers, Agents, and Brokers: Please Stop, Look, and Listen Before Entering Into Suspect Medicare Advantage Plan...

Hinshaw & Culbertson - Health Care on

The Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) issues Special Fraud Alerts regarding healthcare fraud and abuse patterns or practices it has recently identified and intends to...more

Husch Blackwell LLP

False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict

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Host Jonathan Porter welcomes Tynan Kugler, Principal with PYA, P.C., and Mara Smith Kouba, legal and compliance counsel with Bristol Myers Squibb, to discuss a recent False Claims Act trial verdict from a New Jersey federal...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part III

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In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part II

Jones Day on

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part I

Jones Day on

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

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Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

Morrison & Foerster LLP

Artificial Intelligence in Healthcare: New Avenues for Liability

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Artificial Intelligence (AI), specifically generative AI technologies, hold significant promise for improving the healthcare industry by streamlining clinical operations, freeing service providers from mundane tasks, and...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

Mintz

EnforceMintz — Practical Lessons Learned from FCA Litigation in 2023

Mintz on

In 2023, the Supreme Court and the United States Courts of Appeals published a number of significant decisions with implications for entities in the health care and life science industries facing False Claims Act (FCA)...more

Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

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Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more

Morrison & Foerster LLP

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

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The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Troutman Pepper Locke

8 Ways Life Sciences Cos. Can Adapt to the Social Media Era

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Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

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