Jesse Witten

Faegre Drinker Biddle & Reath LLP

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OIG Issues Favorable Advisory Opinion for Free Genetic Testing and Counseling Program Offered by a Pharmaceutical Company

On April 11, 2022, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion No. 22-06 (AO 22-06), which approved a biopharmaceutical company’s proposed arrangement to...more

5/3/2022 / Advisory Opinions , Anti-Kickback Statute , Civil Monetary Penalty , Genetic Testing , OIG , Pharmaceutical Industry , Vendors

HHS-OIG Updates Its Self-Disclosure Protocol

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated and renamed its Self-Disclosure Protocol (SDP). The OIG had last updated the SDP in 2013. The update changes and...more

11/19/2021 / Anti-Kickback Statute , Civil Monetary Penalty , Corporate Integrity Agreement , Department of Health and Human Services (HHS) , False Claims Act (FCA) , OIG , Self-Disclosure Requirements

OIG Issues Advisory Opinion Allowing Pharmaceutical Company’s Payment of Travel, Food and Lodging Expenses for Indigent and Rural...

In its final Advisory Opinion of 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) approved a pharmaceutical company’s request to provide financial assistance to patients who were...more

1/15/2021 / Advisory Opinions , Anti-Kickback Statute , Civil Monetary Penalty , Food and Drug Administration (FDA) , OIG , Pharmaceutical Industry

Did the OIG Just End In-Person Speaker Programs?

On November 16, 2020, the Department of Health and Human Services, Office of Inspector General (OIG) published a Special Fraud Alert for Speaker Programs. The Special Fraud Alert "highlights some of the inherent fraud and...more

11/23/2020 / Anti-Kickback Statute , Department of Health and Human Services (HHS) , False Claims Act (FCA) , Health Care Providers , OIG

HHS-OIG: Pharma Manufacturer’s Proposed Copayment Assistance Program ‘Highly Suspect’ Under Federal Anti-Kickback Statute

On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a...more

10/2/2020 / Anti-Kickback Statute , Co-payments , Department of Health and Human Services (HHS) , Health Care Providers , Manufacturers , Medicare , Medicare Part D , OIG , Pharmaceutical Industry , Prescription Drugs

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