Specialty Drugs: FDA Approval, Medicare Coverage, and Controversy Over Aduhelm (On-Demand Webinar)
Time: On Demand
Overview: This webinar will provide an overview of the complicated relationships between FDA approval and coverage requirements for specialty drugs under Medicare Part B vs Medicare Part D, as well as the recent controversy over the FDA’s approval of Aduhelm. Speakers will discuss the FDA approval process for new drugs and how FDA approval impacts Medicare coverage under Part B and Part D, including CMS’s national coverage determinations for specialty medications and specialty tiers under Medicare Part D. Finally, we’ll discuss the recent controversy over Aduhelm, particularly the FDA’s use of its accelerated approval pathway.Speaker Information:
- Kathy Roe, Managing Attorney and Co-Founder, Health Law Consultancy
- Stephanie Trunk, Partner, Arent Fox
- Lauren Haley, Associate General Counsel, Spring Health
- Vanessa K. Burrows, Counsel, Simpson Thacher & Bartlett LLP
On-Demand Webinars are not included in AHLA Premium or other membership levels.
AHLA is now offering Continuing Education Credit for On-Demand Webinars held after March 2021. This is a 90-minute webinar. Credits earned for a 50 minute state are 1.8 CLEs, and 1.5 CLEs for a 50 minute state.