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OIG’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

8/1/2025 / Advisory Opinions , Anti-Kickback Statute , Department of Health and Human Services (HHS) , Fraud and Abuse , Health Care Providers , Manufacturers , Medical Devices , OIG , Regulatory Oversight

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

2/26/2025 / Anti-Kickback Statute , Causation , Department of Justice (DOJ) , False Claims Act (FCA) , Healthcare Fraud , Kickbacks , Medicaid , Medicare , Pharmaceutical Industry

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

2/12/2025 / Anti-Kickback Statute , Department of Health and Human Services (HHS) , Enforcement Actions , False Claims Act (FCA) , Healthcare Fraud , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs

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