Policy & Medicine

Teva Pharmaceuticals Settles for $450 Million: The DOJ’s Latest Enforcement Under the…

Thomas Sullivan Nov 6, 2024 0

The United States Department of Justice (DOJ) recently announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to resolve allegations of violating the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). The settlement represents a significant enforcement action under these statutes and may have broader…

Policy and Medicine Compliance Update – November 2023…

Thomas Sullivan Dec 1, 2023 0

Policy and Medicine Compliance Update October 2023 Issue…

Thomas Sullivan Oct 20, 2023 0

Teva Pharmaceuticals Settles for $450 Million: The DOJ’s Latest…

The United States Department of Justice (DOJ) recently announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to resolve allegations of violating the…

Teva Pharmaceuticals Fined €462.6 Million Over Anti-Competitive…

On October 31, 2024, the European Commission issued a fine of €462.6 million to Teva Pharmaceuticals, citing abuse of its market dominance by delaying competition for Copaxone, a leading multiple…

HHS OIG Says Humana Received More than $13 Million in CMS…

The United States Department of Health and Human Services Office of Inspector General (HHS OIG) recently released results from its audit of Humana Health Plan, Inc. In the audit, HHS OIG was reviewing…

John Marshall Oncology Unscripted “Gut Feeling: Is Our…

In Episode 8 of Oncology Unscripted, Dr. John Marshall explores the intricate relationship between the human microbiome and cancer treatment outcomes. This episode, titled "Gut Feeling: Is Our…

FDA Releases Draft Guidance on Randomized Controlled Drug Trials…

Recently, the United States Food and Drug Administration (FDA) issued a draft guidance, Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice…

United States Agencies Release New Final Rules Implementing the…

The United States Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) released new final rules implementing the Mental Health Parity and Addiction…

CMS Proposes Changes to Reporting and Returning Medicare Parts A…

Tucked into the Physician Fee Schedule is a provision that should be of interest to False Claims Act attorneys. Regarding Medicare overpayments, CMS proposed to change Medicare regulations regarding…

St. Peter’s Health Reaches $10.8 Million False Claims Act…

St. Peter’s Health in Helena, Montana recently reached a $10.8 million False Claims Act settlement over self-reported False Claims Act violations in which the company falsely billed several federal…

Strategic Allocation of Opioid Settlement Funds: A Conversation…

As the opioid epidemic continues to devastate communities, attention has turned to how best to allocate the billions in opioid settlement funds. With over $50 billion from settlements, states and…

John Marshall Oncology Unscripted: CROs and the Rising Costs of…

Clinical research organizations (CROs) have become an essential yet contentious part of modern medical research. Originating in the 1980s, CROs were created to enhance data quality in clinical trials,…

NIH Scientific Integrity Policy 2024: Eliminates Detailed…

The National Institutes of Health (NIH) has released a comprehensive update to its Scientific Integrity Policy, marking a significant evolution from the framework established in 2012. This overhaul…

CMS Releases Prices for Inflation Reduction Act Drug Price…

On Thursday, August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the prices for the first 10 prescription drugs selected for negotiation with manufacturers under the…