Join us for our upcoming Health Law Webinar, Hot Topics in 340B: Regulatory Updates, Manufacturer Restrictions, and Emerging Challenges.
The 340B program continues to evolve amid regulatory changes, manufacturer restrictions, reimbursement pressures, and new approaches to drug purchasing. This presentation will explore key developments affecting 340B covered entities, including HRSA audit updates and FY2027 audit protocol changes, manufacturer restrictions and data exchange requirements, OPPS reimbursement cuts, and the anticipated rebate model beginning in January 2027.
Attendees will gain insight into these emerging issues and their potential implications for 340B compliance, program operations, and financial sustainability.
Learning Objectives
- At the conclusion of this program, participants will be able to:
- Identify key HRSA audit updates and anticipated changes to FY2027 audit protocols.
- Describe manufacturer restrictions, data exchange requirements, and related audit considerations affecting 340B covered entities.
- Explain the potential impact of OPPS reimbursement cuts on hospitals and 340B program operations.
- Discuss the anticipated January 2027 340B rebate model and its potential implications for covered entities.
Session Speaker
Madeline Carpinelli Wallack, PhD, MS, 340B ACE is Co-Founder and CEO of Rx|X Advisory Services and Co-Founder of Avanti340B. A nationally recognized expert in the 340B Drug Pricing Program and Medicaid Drug Rebate Program, she brings 27 years of experience spanning federal oversight, program evaluation, compliance auditing, health-system operations, data analytics, and drug-pricing policy. Through Rx|X, she advises hospitals and health systems nationwide on complex 340B compliance, operational, and strategic matters. Through Avanti340B, a solution designed to strengthen purchase to dispense integrity, she helps entities audit 340B inventory and accumulations.
Dr. Wallack also provides expert witness and litigation support services and advises healthcare organizations on government relations, advocacy, and emerging 340B policy. A frequent speaker on 340B policy, compliance, governance, and stewardship, she is known for translating complex regulatory issues into practical strategies for healthcare leaders. She lives in Denver, Colorado, with her family.