Specialty Drugs: FDA Approval, Medicare Coverage, and Controversy Over Aduhelm (On-Demand Webinar)

Date: 03/03/22
Time: On Demand

Difficulty: Intermediate

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 RoeManaging Attorney and Co-Founder, Health Law Consultancy
  • Stephanie TrunkPartner, Arent Fox
  • Lauren HaleyAssociate General Counsel, Spring Health
  • Vanessa K. Burrows, Counsel, Simpson Thacher & Bartlett LLP

Continuing Education:

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.

CPE: AHLA is a registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. AHLA is seeking CPE credits for live and on demand webinars. The maximum number of credits available is 1.8.