On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more
11/25/2020
/ Coronavirus/COVID-19 ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more
3/14/2017
/ Corporate Integrity Agreement ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
New Guidance ,
OIG ,
Permissive Exclusion Authority ,
White Collar Crimes
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more
12/14/2016
/ 21st Century Cures Initiative ,
Barack Obama ,
Cancer ,
Civil Monetary Penalty ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
HCEI ,
Health Information Technologies ,
Healthcare Fraud ,
Hospitals ,
Infectious Diseases ,
Innovation ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Mental Health ,
National Institute of Health (NIH) ,
New Legislation ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Software Developers
For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more
1/22/2016
/ Caronia ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Healthcare Fraud ,
Inducements ,
Life Sciences ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Physicians ,
Yates Memorandum