On August 2, 2021, the U.S. Food & Drug Administration (“FDA” or “the Agency”) published a final rule amending its medical product “intended use” regulations in an effort to provide direction and clarity to regulated industry...more
Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing -
Pursuant to a Court Order, implementation of the U.S. Dept. Health...more
2/4/2021
/ Anti-Kickback Statute ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Medicaid Drug Rebate Program ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Qualified Health Plans ,
Rebates ,
Safe Harbors
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
Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule -
On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more
6/24/2020
/ Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
MDRP ,
Medicaid ,
Medicare ,
Medicare Part B ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Reimbursements ,
Value-Based Purchasing