Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more
On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more
9/29/2020
/ Canada ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Approvals ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Final Rules ,
Food and Drug Administration (FDA) ,
Importation Limits ,
MDRP ,
Medicaid ,
Medicaid Drug Rebate Program ,
Prescription Drugs
As many of our astute readers are aware, on June 17, 2020 CMS released a long-awaited Medicaid proposed rule addressing a number of far-ranging issued involving Medicaid coverage and payment for prescription drugs, including...more
I. Introduction -
In May 2018, the Department of Health and Human Services (HHS) introduced a “Blueprint” and Request for Information setting forth proposed actions and policies as a means to purportedly help lower...more
On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (the “MMA”) was signed into law by former President George W. Bush1. Prior to the enactment of the MMA, Medicare prescription drug...more
Foley Hoag and the Advanced Medical Technology Association (AdvaMed) collaborated on an important resource guiding manufacturers, importers, and producers of taxable medical devices through the newly released Internal Revenue...more