Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule -
INTRODUCTION -
On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more
11/30/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Final Rules ,
Manufacturers ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors ,
Social Security Act
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
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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
Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more