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Enforcement Actions False Claims Act (FCA) Prescription Drugs

Husch Blackwell LLP

DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center

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In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a...more

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

Ropes & Gray LLP

[Podcast] Patient Assistance Programs: Enforcement Trends and Regulatory Challenges

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On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...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

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Epstein Becker & Green

The First National Health Care Fraud Takedown of the Second Trump Administration: What Stayed the Same and What is New?

Epstein Becker & Green on

On June 30, 2025, the U.S. Department of Justice (“DOJ”), together with the U.S. Department of Health and Human Services Office of Inspector General (“HHS OIG”) and other law enforcement partners, announced the results of the...more

King & Spalding

District Court Orders CVS Caremark to Pay U.S. Government $95 Million

King & Spalding on

On June 25, 2025, Chief Judge Mitchell S. Goldberg of the U.S. District Court for the Eastern District of Pennsylvania issued a ruling in the case of U.S. ex rel. Sarah Behnke v. CVS Caremark Corp. et al., ordering CVS...more

Warner Norcross + Judd

Insights from the Largest DOJ Health Care Fraud Enforcement Effort in U.S. History

On June 30, the Department of Justice (DOJ) announced the largest coordinated health care fraud enforcement effort in U.S. history, involving criminal charges against over 300 defendants and over $14.6 billion in health care...more

Miles & Stockbridge P.C.

DOJ Remains Focused on Domestic Health Care Fraud

The Department of Justice (DOJ) recently issued its annual Health Care Fraud Takedown results, announcing a record-breaking 324 defendants, including 96 doctors and licensed professionals, as well as more than $14.6 billion...more

Husch Blackwell LLP

False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement

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Host Jonathan Porter welcomes back to the show Husch Blackwell attorney Abe Souza to discuss False Claims Act (FCA) enforcement in the pharmacy context. Pharmacies face multiple pressures, from disruptive online enterprises...more

Mintz - Health Care Viewpoints

DOJ Civil Division Publishes Memo Outlining Trump Administration Civil Enforcement Priority Related to Health Care

In May 2025 the Department of Justice (DOJ) Criminal Division published its enforcement priorities, and the Civil Division has now followed suit with a memorandum of its own (the “Civil Division Memo”)...more

Robinson+Cole Health Law Diagnosis

False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens Cases

The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government...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

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

Morgan Lewis on

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

Morgan Lewis - As Prescribed

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more

Morgan Lewis - As Prescribed

FCA Enforcement Risk Remains for Rare Disease Stakeholders

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Arnall Golden Gregory LLP

Lowering the Bar: Second Circuit Finds “At-Least-One-Purpose” Sufficient for Proving Anti-Kickback Statute Violation

On December 27, 2024, the United States Court of Appeals for the Second Circuit joined other federal circuit courts in adopting the “at-least-one-purpose” rule (generally shortened to the “one purpose rule”)....more

Polsinelli

Swing and a Miss: the Government Strikes Out in Pharmacy Executive Kickback Trial

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Last week, the government submitted its decision to the federal court not to retry partially-acquitted pharmacy executive, Chad Beene, for conspiracy and illegal kickback allegations. At the end of last year, a New Jersey...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

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The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...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

Cozen O'Connor

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

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Whistleblower Watch is a critical resource for in-house counsel and compliance professionals. Each quarter, Cozen O’Connor summarizes the most notable False Claims Act (FCA) enforcement actions, settlements, and legal trends,...more

Benesch

Third-Party Co-Pay Assistance Program Kickback Scheme Results in $450 Million DOJ Settlement

Benesch on

Teva Pharmaceuticals, the largest generic drug manufacturer in the United States, has agreed to pay $450 million to resolve allegations of violating the False Claims Act and Anti-Kickback Statute arising from purported...more

Health Care Compliance Association (HCCA)

The Latest on Healthcare Enforcement

Healthcare enforcement is never quiet. There’s always something, or many things, going on, and compliance teams need to stay on top of the trends to ensure that their programs are staying ahead of the risks. To find out...more

Polsinelli

Health Care Fraud and Abuse 2023 Year in Review

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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

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

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