K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of...more
On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more
On December 30, 2020, the HHS Office of General Counsel (OGC) issued Advisory Opinion No. 20-06 finding the 340B Federal Drug Pricing Program requires drug manufacturers to extend 340B pricing to covered outpatient drugs...more
Businesses await clarity from the federal government on liability protections for injuries resulting from COVID-19. Current federal law provides liability protection to businesses but is limited to COVID-19 related...more