In this issue, we provide an overview of 62 recently unsealed qui tam cases and take an in-depth look at four of those cases. Two of the featured cases concern alleged schemes to provide unnecessary therapy to residents of...more
11/9/2018
/ Anti-Kickback Statute ,
False Claims Act (FCA) ,
Former Employee ,
Health Care Providers ,
Healthcare ,
Medicare ,
Medicare Part D ,
Physicians ,
Qui Tam ,
Relators ,
Settlement Agreements ,
TRICARE
Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel...more
5/23/2018
/ Anti-Kickback Statute ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Medicare ,
Off-Label Use ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Qui Tam ,
RICO ,
TRICARE
On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more
3/8/2018
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Disclosure Requirements ,
Enforcement Actions ,
Failure to Report ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Open Payments ,
Physicians ,
PPSA ,
Regulatory Oversight ,
Reporting Requirements ,
Social Security Act
In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more
10/27/2017
/ Caronia ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Inducements ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Physicians ,
Universal Health Services Inc v United States ex rel Escobar
This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more
6/22/2017
/ Amarin ,
Caronia ,
Commercial Speech ,
Criminal Convictions ,
FDAMA ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Misbranding ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Physicians ,
Prescribing Authority ,
Prescription Drugs ,
Public Health ,
Public Safety ,
Sorrell
In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more