Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
11/19/2019
/ Biologics ,
Chief Compliance Officers ,
Compliance ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Diagnostic Tests ,
Export Controls ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internal Investigations ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Risk Assessment ,
Risk Management ,
Supply Chain
The Updated Code Includes Several New Topics and Additional Guidelines on Existing Topics -
The Advanced Medical Technology Association (AdvaMed) published in late December 2018 an updated version of its widely-adopted...more
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more
12/14/2016
/ Ambulance Providers ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Cost-Sharing ,
Deductibles ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Life Sciences ,
OIG ,
Pharmacies ,
Remuneration ,
Safe Harbors