On June 8, 2021, four Executive Branch Departments issued reports mandated by President Biden’s February 24, 2021 Executive Order on America’s Supply Chains (the “America’s Supply Chains E.O.” or the “E.O.”). The E.O....more
6/24/2021
/ Batteries ,
Biden Administration ,
Buy American Act ,
Defense Production Act ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Federal Acquisition Regulations (FAR) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Semiconductors ,
Supply Chain ,
Supply Shortages ,
Unfair or Deceptive Trade Practices
Biden Administration Delays Effective Date and Opens Another Comment Period for New Medicare Coverage Pathway for Breakthrough Medical Devices and Definition of “Reasonable and Necessary” -
To the dismay of the medical...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