This year, the conference will be virtual, with CLE webinars offered throughout the week on important and timely topics for the industry.
Please log in 15 minutes prior to the start of the programs.
Safeguarding Medical Device IP Amid an Evolving “Right to Repair”
Monday, March 17th from 10:30am – 11:30am ET
Right to Repair advocates have successfully lobbied for access to information, including manufacturers’ intellectual property, for diagnostics, repair, and maintenance in several key states. The Library of Congress has recognized a three-year exemption from a federal anti-hacking law necessary for diagnosing, maintaining, and repairing medical devices. Third-party servicers are turning to federal and state antitrust laws to push back against companies that use access controls to ensure the safety and security of their products and protect their intellectual property.
Our presenters have litigated these issues across the country. Join them for a discussion regarding emerging risks and best practices for maximizing the value of medical device IP and aftermarket services.
Speakers: Gerard Donovan and Chris Brennan
Health Care Transactions: An Overview of Recent Developments and Predictions for What’s to Come
Monday, March 17th from 1pm – 2:30pm ET
This panel will discuss deal flow activity and developments in 2024. The presenters will also discuss predictions for the future given the administration change and shifting policy positions.
Please note: This session will qualify for 1.5 CLE credits in applicable jurisdictions.
Speakers: Brian Bewley, Nicole Aiken-Shaban, Katie Dunn and Arielle Lusardi
The 340B Program at a Crossroads
Tuesday, March 18th from 10am – 11am ET
This session will provide a brief overview of the 340B drug discount program, followed by an update on expanding program-related litigation affecting contract pharmacy and rebate models, state and federal legislative proposals affecting the program, and the interaction with other emerging federal drug price regulation programs under the Inflation Reduction Act.
Speaker: Joe Metro
The Future of Administrative Challenges
Tuesday, March 18th from 2pm – 3pm ET
This session will include a discussion about administrative challenges regarding payment rates, quality rankings, and other issues that may arise in the future.
Speakers: Lesley Reynolds and David Bender
Global Antitrust Hot Topics in Health Care: Preparing Health Care and Life Sciences Companies to Navigate the Complex Antitrust Landscape
Wednesday, March 19th from 10am – 11am ET
This program will provide companies with everything that they need to know about what’s currently hot in antitrust health care. Given the outcome of the U.S. election and changing global enforcement priorities, navigating antitrust issues has become front and center once again. This webinar will include a discussion of hot topics in health care antitrust to help prepare companies in the industry to navigate the complex antitrust landscape in the future.
Speakers: Michelle Mantine and Natasha Tardif
Legal Perspectives on HHS’s AI Strategic Plan for Health Care, Human Services, and Public Health
Wednesday, March 19th from 2:30pm – 3:30pm ET
Join us for an insightful session that will explore the essential elements of the U.S. Department of Health and Human Services’ (HHS) AI Strategic Plan for Health Care, Human Services, and Public Health. Our legal panel will break down HHS’s strategic roadmaps, providing industry stakeholders with a clear understanding of the plan’s objectives. The discussion will focus on how these roadmaps aim to foster a collaborative public-private effort to enhance the quality, safety, efficiency, accessibility, equity, and outcomes in health care, human services, and public health through the innovative, safe, and responsible development and application of AI.
Speakers: Vicki Tankle, Wendell Bartnick, Nan Halstead and Sarah Thompson Schick
What You Need to Know About the Current State of Affairs in Washington
Thursday, March 20th from 12pm – 1pm ET
This will be a lightning round update on regulatory and legislative developments in health care.
Speakers: Scot Hasselman and Matt Loughran
Is the FCA Unconstitutional?
Thursday, March 20th from 2:30pm – 3:30pm ET
During this session, the presenters will discuss recent case law suggesting the qui tam provisions of the FCA may be unconstitutional. This has been addressed by courts several times in the past few decades, but Justice Thomas’s dissenting opinion in SCOTUS’s Polansky decision suggesting that the qui tam provisions are unconstitutional reignited the possibility that this argument may have traction. Defendants across the country are now raising this argument in nearly every FCA case, suggesting that a new circuit split may quickly develop.
Speakers: Sarah Cummings-Stewart, Elizabeth Brandon and Jason Vendel (Arthrex)
Best Practices for Compliance Programs at a Time of Fast-Paced Change and Uncertainty
Friday, March 21st from 1pm – 2pm ET
During this panel, the presenters will discuss best practices for maintaining an effective compliance program for health care and life science companies. The session will include a discussion of areas of evolving compliance risk for health and life science companies, how a compliance program adopts to the ever-changing regulatory environment, how in-house and outside counsel interact effectively with compliance professionals, and indications of when a compliance program is effective or ineffective.
Speakers: Paul Pitts, Timothy Burke (Rad Partners), Christine Wiehl (McKesson) and Samantha Meadors (CVA USA)
CLE Information: Each of these programs are presumptively approved for 1.0 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Applications for CLE credit will be filed in Colorado, Delaware, Florida, Georgia, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.
