Best Practices in Manufacturer Approaches to 340B Program Compliance

Gain insight into 340B Drug Pricing Program requirements and best practices for pharmaceutical manufacturers

Participants will gain insight into 340B Drug Pricing Program requirements and best practices for pharmaceutical manufacturers, including:

• Pharmaceutical pricing agreements (PPAs)
• Ceiling price calculations
• Office of Pharmacy Affairs Information System (OPAIS)
• HRSA audits of manufacturers
• Civil monetary penalty (CMP) regulation
• Refunding overcharges

Wednesday, April 21
12:00–1:00 PM CDT
Webinar

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Moderated by:

John Barnes, CPM, MBA, 340B ACE, is Associate Vice-President of Contract Services for Apexus, the HRSA 340B Prime Vendor. He has 34 years of experience in the health care supply chain, with expertise in pharmaceutical, medical, surgical, and capital contracting. In his current role, he leads a team that executes market-competitive contracts for branded and generic pharmaceuticals for 340B hospitals and federal grantee clinics enrolled in the 340B Prime Vendor Program (PVP). John has extensive experience in the US pharmaceutical industry, employing analytics and data management for designing and evaluating pricing strategies, developing financial models, and understanding drug pricing data sources as they relate to the 340B Drug Pricing Program. At Apexus, John helps manufacturers and covered entities to successfully navigate the compliance and business aspects of the 340B Program.
John received his certified purchasing manager (CPM) credentials through the Institute for Supply Management. He earned a bachelor’s and master’s degrees in business administration from Northwood University in Michigan.

Panel: Distributor, Consultant, Manufacturer

Philip A. Coburn, BS, has been with Pfizer for 10 years and currently holds the position of the Director of US Government Pricing Compliance. Before coming to Pfizer, he worked in consulting, assisting pharmaceutical manufacturers in implementing policies and procedures to build compliant organizations. He has more than 20 years of experience, specializing in contract management, contract compliance, government pricing compliance, customer relationship management, and employee training.
Philip holds a BS degree in marketing from Central Connecticut State University.

Specializing in government and commercial contracting, pricing, and reimbursement, Miree Lee, MS, MBA provides her clients with a broad range of support services from the preapproval phase through commercialization, with emphasis on innovative strategies to maximize the potential of each client’s product portfolio.
Miree has spent more than 25 years working with international corporations, with her responsibilities focused on commercial operations, pricing, analytics, and strategic planning. For more than 20 years, her area of practice has been dedicated specifically to government and commercial contracting, pricing, and reimbursement within the pharmaceutical, biotechnology, and biologics industries.
Miree holds a BA degree in political science from Boston University, an MS degree in criminal justice from Iona College, and an MBA degree in health care administration from Baker College Center for Graduate Studies.

Lisa Penn, BA, is Director, 340B Operations, at Cardinal Health. She leads all aspects of 340B operational performance across Cardinal Health, with a focus on customer and vendor relationships. Her skills include managing major customer and vendor relationships, resolving complex issues, and streamlining and improving processes, policies, and technology capabilities to deliver a cost-effective, best-in-class experience. With more than 20 years of industry experience, she is an expert in improving processes, driving collaboration, and supporting all stakeholders in the complex 340B landscape.
Lisa holds a BA degree from The Ohio State University.