World Congress Manufacturers’ 340B Summit

May 16, 2017 to May 17, 2017

Morgan Lewis is pleased to announce that FDA partner Stephen Ruscus will speak at the World Congress Manufacturers’ 340B Summit.

Wednesday, May 17, 2017
Panel Discussion | May 17, 2017 | 10:45–11:30 am

Legal Roundtable: Top Legal Insights and Considerations Around 340B

The Health Resources and Services Administration is now implementing program integrity provisions that were added to the 340B statute, but, with each enactment, compliance and management of the program become progressively more difficult. Manufacturers need to understand the current regulations to stay abreast of forthcoming regulations.

  • Understand both the civil monetary penalties (CMP) and the administrative dispute resolution (ADR) requirements
  • Examine the covered entity corrective action and manufacturer repayment process
  • Gain insights on best practices for calculating duplicate discounts
  • Uncover the “patient” definition to mitigate risk and legal action