News & Analysis as of

Medicare 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

Troutman Pepper Locke on

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

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

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

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025

Latham & Watkins LLP on

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more

ArentFox Schiff

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

ArentFox Schiff on

Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...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

Dorsey & Whitney LLP

DOJ & HHS Announce Reinvigoration of False Claims Act Working Group and Healthcare Fraud Enforcement Priorities

Dorsey & Whitney LLP on

The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...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

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

Perkins Coie

First Circuit Imposes Higher “But-for” Causation Standard for False Claims Act Liability Based on Alleged Anti-Kickback Statute...

Perkins Coie on

On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more

ArentFox Schiff

Investigations Newsletter: Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case

ArentFox Schiff on

Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case - A federal jury in Illinois recently found SuperValu not liable in a whistleblower lawsuit that accused the company of overcharging the...more

Ankura

Bona Fide Service Fees, Government Price Reporting, and the Inflation Reduction Act

Ankura on

“Manufacturers are responsible for meeting all four parts of the definition of bona fide service fee before a fee can qualify as a bona fide service fee.” ...more

Polsinelli

A Deepened Divide: Appellate Court Joins False Claims Act Circuit Split in Favor of Health Care Defendants

Polsinelli on

On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must...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

Polsinelli

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

Polsinelli on

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

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

ArentFox Schiff

Investigation Newsletter: Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims

ArentFox Schiff on

Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...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

ArentFox Schiff

Investigations Newsletter: Texas Pharmaceutical Marketer Sentenced for $59 Million Medications Fraud Conspiracy

ArentFox Schiff on

Texas Pharmaceutical Marketer Sentenced for $59 Million Medications Fraud Conspiracy - On July 12, Quintan Cockerell, a Texas pharmaceutical marketer, was sentenced to over two years in prison and ordered to pay more than...more

ArentFox Schiff

Investigations Newsletter: DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to...

ArentFox Schiff on

DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more

ArentFox Schiff

Investigations Newsletter: Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme

ArentFox Schiff on

Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme - The Chicago-based owner of two laboratories, Zoom Labs Inc. and Western Labs Co., has been charged with health care fraud...more

Goodwin

DOJ Files False Claims Act Complaint Against Regeneron, Alleging Fraudulent Eylea Drug Pricing

Goodwin on

​​​​​​​As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea...more

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