Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs -
A Special Fraud Alert issued by the U.S....more
11/25/2020
/ Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud ,
Healthcare Workers ,
Manufacturers ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
Over the last two months, the U.S. Department of Health and Human Services (“HHS”) published guidance regarding the enforcement of HIPAA and its privacy and security requirements in response to the COVID-19 public health...more
5/6/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Facebook ,
Good Faith ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Public Health ,
Public Health Emergency ,
SAMHSA ,
Telehealth
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
HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers -
In today’s Federal Register, the...more
10/17/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Proposed Rules ,
Safe Harbors ,
Value-Based Care
The Proposed Rule Would Make Clear that the Anti-Kickback Statute’s Discount Safe Harbor Does Not Protect Manufacturer Rebates to PBMs or Payors, But Would Create New Safe Harbors for Rebates Passed Through to the...more
2/4/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Manufacturers ,
Medicaid ,
Medicare Part D ,
Point of Sale Terminals ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Safe Harbors
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