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
Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule -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
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
11/24/2020
/ Administrative Procedure Act ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Affordable Care Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Interim Final Rules (IFR) ,
Medicare ,
Medicare Part D ,
OECD ,
Social Security Act ,
Stark Law ,
Trump Administration
On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more
7/31/2020
/ Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Notice of Proposed Rulemaking (NOPR) ,
Prescription Drugs ,
Public Safety ,
State Implementation Plans (SIPs) ,
Trump Administration ,
Waivers