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First Circuit Holds ‘But For’ Causation Required to Demonstrate Falsity in Kickback-Based FCA Cases, Growing Circuit Split

In United States v. Regeneron Pharmaceuticals Inc., the US Court of Appeals for the First Circuit held that when the government seeks to establish False Claims Act liability under the 2010 amendment to the Anti-Kickback...more

DOJ Officials Commit to Aggressive FCA Enforcement, Signal Its Value and Direction

In remarks delivered at the Federal Bar Association’s (FBA) annual Qui Tam Section Conference, Deputy Assistant Attorney General Michael Granston reiterated the US Department of Justice’s (DOJ or the Department) commitment to...more

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

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

How the End of the PHE Will Impact the Healthcare Industry

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

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