AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors, SEC enforcement attorneys, and federal agency attorneys, has...more
AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics.
In this edition, we analyze a recent Eleventh Circuit decision addressing False Claims Act penalties and the...more
2/28/2022
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Discount Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Government Investigations ,
Healthcare ,
Healthcare Fraud ,
Infectious Diseases ,
OIG ,
Paycheck Protection Program (PPP)
In a recent Advisory Opinion, the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) stated that, although the Arrangement would generate prohibited remuneration, it would not impose...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
2/25/2021
/ Advertising ,
Anti-Kickback Statute ,
Biologics ,
Biotechnology ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Investigations ,
Life Sciences ,
Marketing ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Warning Letters
On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more
2/19/2021
/ Anti-Kickback Statute ,
Biotechnology ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Investigations ,
Life Sciences ,
OIG ,
Penalties ,
Pharmaceutical Industry ,
Speaker Programs
On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians...more
On August 8, 2018, INSYS Therapeutics, Inc. announced that it had reached an agreement in principle with the U.S. Department of Justice (DOJ) to settle DOJ’s investigation of INSYS’s marketing of the drug Subsys. Subsys is a...more
On January 19, 2018, in United States ex rel. Greenfield v. Medco Health Solutions, Inc., the Third Circuit Court of Appeals held that the plaintiff in a False Claims Act (FCA) suit premised on violations of the Anti-Kickback...more
On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more
On December 7, 2016, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a final rule to implement revisions to certain Anti-Kickback Statute (AKS) safe harbors, as well as revisions to...more
Tenet Healthcare Corporation, an investor-owned healthcare services company based in Texas, and two of its Atlanta-based subsidiaries have entered into an agreement with the government to resolve criminal charges and civil...more
Over the past few years, the government’s emphasis on conducting fraud and abuse investigations – especially in the healthcare industry – has resulted in scores of settlements and billions of dollars paid to the government...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more