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Court Upholds OIG Advisory Opinion Shooting Down a Patient Assistance Program

Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more

Recent Medicare Advantage Plan Settlement Highlights Anti-Kickback Statute's Breadth

A recent settlement involving a Medicare Advantage plan should serve as a reminder that the federal Anti-Kickback Statute (AKS) is broad and far-reaching, both on its face and in practice. On July 1, 2022, the U.S. Department...more

OIG Issues Favorable Advisory Opinion on Manufacturer-Provided Travel Assistance

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more

DOJ's Updated Compliance Guidance is Important for Healthcare Entities

• The U.S. Department of Justice (DOJ) recently updated its guidance to Criminal Division prosecutors in evaluating a corporation's compliance program when making charging decisions (Guidance). • The Guidance directs...more

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