News & Analysis as of

Department of Justice (DOJ) Anti-Kickback Statute

Cozen O'Connor

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

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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

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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

Noteworthy False Claims Act Settlement Demonstrates DOJ’s Continued Scrutiny of Arrangements Between Hospitals and Physician...

On May 14, 2025, Fresno Community Hospital and Medical Center d/b/a Community Health System (CHS) and its technology partner, Physicians Network Advantage, Inc. (PNA), agreed to pay $31.5 million (the Settlement Agreement)...more

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

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

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Cozen O'Connor

Justice Department Continues Pattern of False Claims Act Suits Due to Alleged Kickbacks

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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

Lowenstein Sandler LLP

Two False Claims Act Cases From SDNY Highlight Continuing Bite of Aggressive Healthcare Enforcement

The U.S. Attorney’s Office for the Southern District of New York last week announced the resolution of two significant False Claims Act (FCA) cases—one from a large settlement and the other the result of a jury verdict after...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

White & Case LLP

Life Science Private Equity Risk

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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

ArentFox Schiff

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

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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

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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

ArentFox Schiff

Investigations Newsletter: Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising

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Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising - On April 14, the US Court of Appeals for the Seventh Circuit reversed the criminal conviction of Mark Sorensen after a...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

Rivkin Radler LLP

Lab Operator Convicted in Drug-Testing Scheme

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Conspiracies to rip off the Medicare system are prevalent due to the vast amounts of money flowing through the program. On February 25, Sherif Khalil of Redondo Beach, California man was convicted by a federal jury in Detroit...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

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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

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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

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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

A&O Shearman

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

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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

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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

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