Reimbursement Framework for Biosimilars

(125 Ratings)

Produced on: February 24, 2017

Course Format On Demand Audio

Taught by

Categories:

Course Description

Time 62 minutes
Difficulty Intermediate

In this program, Stephanie Trunk, a health care partner at Arent Fox LLP in Washington, DC will examine the reimbursement framework that surrounds biosimilars. Stephanie counsels pharmaceutical and device manufacturers, distributors, and their customers, including pharmacy benefit managers, on regulatory, reimbursement, and compliance matters.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Attendees will learn about how biosimilars are currently treated and reimbursed under various programs, including:

  • Medicare Part B
  • Part D
  • Medicaid
  • Qualified Health Plans sold on Exchanges
  • Various commercial plans

The program will also discuss potential changes to biosimilar reimbursement under the new Administration.


Learning Objectives: 

  1. Gain an understanding of biosimilar products
  2. Learn how biosimilars are currently reimbursed under various programs
  3. Discuss potential changes to biosimilar reimbursement under the Trump Administration 

Faculty

Stephanie Trunk

Arent Fox LLP

STEPHANIE TRUNK is a partner in the Health Law Group at Arent Fox LLP in Washington, D.C. Ms. Trunk counsels pharmaceutical and device manufacturers, distributors and their customers, including pharmacy benefit managers, on regulatory, reimbursement and compliance matters.

Her practice extends to counseling on drug pricing and government price reporting, HIPAA and privacy matters, counseling on Medicare Part D, developing corporate compliance programs, representing clients in contract negotiations and providing transactional support to her clients.  Prior to joining Arent Fox LLP, Ms. Trunk was in-house counsel to a pharmacy benefit management company.

 Ms. Trunk She is a member of the BNA Pharmaceutical Law & Industry Advisory Board. Ms. Trunk is the author of numerous chapters in health law treatises including a chapter on Controlling Fraud, Waste and Abuse in the Medicare Part D Program in the ABA/BNA’s Health Care Fraud and Abuse: Practical Perspectives. She received a J.D. with Highest Honors from the George Washington University Law School in 2003 where she was elected to the Order of the Coif and a member of the George Washington Law Review.

Ms. Trunk also has as a graduate certificate in health management from the George Washington University School of Public Health (2003) and she received a B.S. in Accounting Summa Cum Laude from the University of Maryland in 1997.



Reviews

GI
Glen I.

Very concise and clear presentation.

JH
Julie H.

I appreciate the presenter's real life aspects of addressing reimbursement for biosimilars and the complexities in working with CMS.

AW
Adele W.

Very complicated topic. Speaker did a good job considering what a mess the area is in.

JD
Jeffery D.

Phenomenal speaker. Pragmatic and anecdotal. Organized and very interesting. Great CLE.

LT
Lynne T.

Thank you!

JR
Jason R.

Good job.

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