News & Analysis as of

Department of Justice (DOJ) Anti-Kickback Statute Enforcement Actions

McDermott Will & Emery

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

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

Haynes Boone on

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

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

Cozen O'Connor

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

Cozen O'Connor on

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

Harris Beach Murtha PLLC

Scrutiny of Hospital–Physician Relationships Continues

Despite changes in many priorities, the federal government’s scrutiny of relationships between hospitals and physicians continues well into 2025. Last month, Community Health System (CHS) in California and its affiliate,...more

Arnall Golden Gregory LLP

Government Investigations Team Insights - May 2025

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

ArentFox Schiff

Investigations Newsletter: DOJ Plans to Use the FCA to Attack DEI Initiatives

ArentFox Schiff on

DOJ Plans to Use the FCA to Attack DEI Initiatives - On May 19, the US Department of Justice (DOJ) announced a novel use of the False Claims Act (FCA) to enforce Trump Administration policies against antisemitism, gender...more

Morgan Lewis - Health Law Scan

Mass. USAO Focuses on Healthcare Fraud in Private Equity Investments, Broker Arrangements at Annual Conference

On May 8, 2025, the Boston Bar Association hosted its annual White Collar Crime Conference, a reoccurring theme of which was the recognition of changing times, while also maintaining that the core principles of criminal and...more

Mintz - Health Care Viewpoints

Speaker Programs: Two Recent Enforcement Actions Serve as a Reminder of the Government's Longstanding Scrutiny

The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker...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

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

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

ArentFox Schiff

Investigations Newsletter: Gilead to Pay $202 Million to Settle DOJ Claims Over Speaker Program Kickbacks

ArentFox Schiff on

Gilead to Pay $202 Million to Settle DOJ Claims Over Speaker Program Kickbacks - Gilead Sciences, Inc. has agreed to pay $202 million to resolve allegations brought by the US Department of Justice (DOJ) that it violated...more

Morrison & Foerster LLP

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

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

ArentFox Schiff

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

ArentFox Schiff on

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

Wiley Rein LLP

As Health Care Enforcement Surges, Buckle Up for a Bumpy Ride

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As the saying goes, the more things change, the more they stay the same – and the world of health care fraud enforcement is no exception. Recent years have seen a wave of novel technologies, emerging threats to our nation’s...more

Fenwick & West LLP

CLE Takeaways: Federal Sales: Partner Compliance Programs and Investigations

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Channel partners offer significant benefits when your original equipment manufacturer, software manufacturer, or cloud-service provider is contracting with the federal government....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

Bass, Berry & Sims PLC

False Claims Act Enforcement in Healthcare: Insights from the 13th Annual Fraud & Abuse Review

Bass, Berry & Sims PLC on

The False Claims Act (FCA) remains one of the government’s most powerful tools in combating healthcare fraud, with a growing focus on opioid-related cases and violations of the Anti-Kickback Statute....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

A&O Shearman

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

A&O Shearman on

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

Latham & Watkins LLP

First Circuit Reins In Broad Theory of Liability Under AntiKickback Statute by Adopting “But-For Causation” Standard

Latham & Watkins LLP on

The First Circuit joins the Sixth and Eighth Circuits in adopting a more exacting causation standard for False Claims Act liability premised on Anti-Kickback Statute violations. In a victory for False Claims Act (FCA)...more

Womble Bond Dickinson

For Whom the Bell Tolls? The Impact of Wisconsin Bell v. United States ex rel. Todd Heath and United States v. Regeneron...

Womble Bond Dickinson on

The Supreme Court’s decision in Wisconsin Bell v. United States ex rel. Todd Heath clarifies what constitutes a “claim” under the federal False Claims Act (FCA). ...more

King & Spalding

Recent Decisions and DOJ Policy Announcements Signal Key Changes to FCA Enforcement and Litigation Environment

King & Spalding on

Recent legal and political False Claims Act (“FCA”) developments signal a potentially turbulent time for the defense of investigations and lawsuits brought under the FCA...more

K&L Gates LLP

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

K&L Gates LLP on

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

Bass, Berry & Sims PLC

13th Annual Healthcare Fraud & Abuse Review - 2024

Bass, Berry & Sims is pleased to announce the release of the 13th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2024. Compiled by the firm's Healthcare Fraud & Abuse Task Force,...more

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