NEW DEVELOPMENTS IN 340B PROGRAM GUIDANCE: EFFECT ON MANUFACTURER STAKEHOLDERS

PRODUCT INFO

Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.

On August 28, 2015, the Health Resources and Services Administration (HRSA) released its proposed 340B Drug Pricing Program Omnibus Guidance, a long awaited proposal regarding many aspects of 340B Program compliance and operation. While thinking about comments to submit in response to the proposed guidance (due October 27, 2015), pharmaceutical and biotechnology manufacturers must consider how the guidance, if made final, would impact their compliance and discount obligations (and those of their covered entity customers). In addition to addressing the legal authority of finalized guidance, this webinar will address key substantive areas including:

  • “Must offer” and limited distribution plans
  • Manufacturer refunds to covered entities
  • Manufacturer certification
  • New rules on ADAP rebates
  • New proposed patient definition
  • Replenishment and recharacterization
  • Covered entity repayment to manufacturers
  • Covered entity termination
  • The GPO prohibition
  • Medicaid managed care and duplicate discounting
  • Contract pharmacy arrangements

Speaker:
John D. Shakow
Partner
King & Spalding

Brooke AkinsContact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 
bakins@q1productions.com