Specialty Drugs: FDA Approval, Medicare Coverage, and Controversy Over Aduhelm

Date: 03/03/22
Time: 2:00-3:30 PM ET

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.

• 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
  

Continuing Education:

CLE: AHLA’s live distance learning webinars are pre-approved for CLE credit in the following states: AL, IL, KS, ME, NE, OH, PA, RI, SC, TN, TX, VA and WV. Please refer to the Distance Learning CLE State Chart on our Continuing Education page to review the reporting procedure in these state 

CPE: AHLA is 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. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Nashville, TN 37219-2417. Website: www.nasba.org. For further information, please visit our Continuing Education Page.

AHLA is seeking CPE credits for live and on demand webinars. The maximum number of credits available is 1.80.