Key Drug Pricing Implications of the Inflation Reduction Act of 2022 -
I. Introduction -
On Sunday, August 7, 2022, the United States Senate passed the most consequential drug and biologics pricing legislation in almost...more
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
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
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
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
1/7/2020
/ Canada ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Drug Pricing ,
Enhanced Penalties ,
Food and Drug Administration (FDA) ,
Importers ,
Imports ,
Manufacturers ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory History ,
Regulatory Requirements ,
Supply Chain
Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more
On Friday, May 11, the Trump Administration released a 39-page “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs” (“Blueprint”). The Blueprint raises in very broad strokes potential Administration strategies to...more
State Budget Includes Medicaid Drug Expenditure Cap -
On April 20, 2017, New York Governor Andrew Cuomo signed into law certain cost-control measures that attempt to cap the state’s Medicaid drug spending, making New York...more
Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs -
On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule...more