Drug manufacturers are increasingly restricting 340B contract pharmacy arrangements and demanding claims-level data as a condition of accessing discounted drug pricing. For covered entities these evolving policies can jeopardize 340B savings, disrupt pharmacy relationships, and create significant operational, legal, and financial challenges.
What can covered entities and their pharmacy partners do to protect their 340B programs and navigate these restrictions?
Join Frier Levitt attorneys Jesse C. Dresser and Geordan L. Ferguson for a practical discussion of evolving manufacturer policies, recent litigation, regulatory developments, and available legal and operational strategies. Attendees will gain insight into the risks associated with manufacturer restrictions, the implications of recent legal challenges, and considerations for evaluating their options.
What You’ll Learn
- 340B Program Overview: The evolution of manufacturer contract pharmacy restrictions and their impact on covered entities.
- Alternative Distribution Models: How alternative distribution models (ADMs) operate and the risks they may pose.
- 340B Litigation: Recent legal developments, ongoing challenges, and potential implications for covered entities and pharmacies.
- Navigating Manufacturer Restrictions: Strategies for addressing contract pharmacy limitations and claims-level data requirements.
- Administrative Dispute Resolution: The potential role of ADR in challenging manufacturer restrictions.
- State Legislative Developments: How states are responding to manufacturer restrictions and claims data policies.
- HRSA’s 340B Rebate Model Pilot: Recent developments and potential implications for 340B stakeholders.
Who Should Attend
This webinar is designed for professionals managing 340B programs, pharmacy operations, compliance, and legal risk, including:
- 340B covered entities, including hospitals, health centers, and other grantees
- 340B program directors, pharmacy directors, and compliance professionals
- Contract pharmacies, including specialty and community pharmacies
- Healthcare executives and in-house counsel
- Third-party administrators and other 340B service providers
Presenters:
Jesse C. Dresser
Jesse represents pharmacy providers nationwide, including community, specialty, and home infusion pharmacies. His practice focuses on pharmacy law, drug pricing, and the legal and economic challenges facing the pharmacy industry. He frequently speaks at national and regional healthcare conferences and industry webinars.
Geordan L. Ferguson
Geordan represents and advises 340B covered entities, contract pharmacies, wholesalers, distributors, and other healthcare providers in litigation and arbitration matters.
Why Frier Levitt
Frier Levitt is a national boutique law firm serving clients across the healthcare, life sciences, and pharmacy industries. Our attorneys work directly with 340B covered entities, hospitals, health systems, and pharmacies to address manufacturer restrictions, contract pharmacy disputes, audits, reimbursement challenges, and regulatory compliance matters.
With experience representing 340B stakeholders in complex litigation and disputes involving major industry participants, our team brings a practical understanding of the legal, financial, and operational issues affecting 340B programs. We help clients evaluate their rights, assess potential risks, and develop strategies to protect their interests as manufacturer policies and regulatory requirements evolve.
