340B Manufacturer Boot Camp Header

Best Practices in Manufacturer Approaches to 340B Program Compliance

Wednesday, April 21 12:00–1:00 PM CDT

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

Register >

Moderated by:

John Barnes, CPM, MBA, 340B ACE
Associate Vice President Contract Services, 340B PVP
Apexus

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 Coburn, BS
Director, U.S. Government Pricing Compliance
Pfizer, Inc.

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.


Miree Lee, MS, MBA
Bio/Pharma Pricing Consultant
M. Lee Consulting, LLC

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
Director, 340B Operations
Cardinal Health

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.

Apexus Answers Call Center

For questions, or to request additional information regarding specific 340B Prime Vendor Program services or programs offered by Apexus, please see contact information below:

apexusanswers@340Bpvp.com

888 340 BPVP (2787)

8:00 a.m.- 5:00 p.m. CT

Apexus Answers
340B Prime Vendor Program (PVP) Resources to Support Manufacturers
Increase Operational Efficiency >

The 340B PVP Manufacturer Refund Service (MRS) facilitates refunds to covered entities by refunding directly to affected facilities, primarily through its authorized distribution network.

340B CMP Final Rule and OPAIS >

Read our article about 340B regulatory changes and their impact, as well as best practices for manufacturers.

340B Prime Vendor Program Managed by Apexus >

The Prime Vendor supports the HRSA 340B Drug Pricing Program as a voluntary program for covered entities and manufacturers.

Outpatient Pharmaceutical Contracting >

Partner with the 340B PVP to support mutual customers.

Customized 340B University OnDemand™ Training for Manufacturers >

Learn essential manufacturer compliance elements of the 340B Program at no cost, 24/7. Module descriptions available here.

340B Audit Tool for Manufacturers >

Proactively prepare the information you may need for a HRSA audit using the PVP’s Sample HRSA 340B Audit Data Request for Manufacturers.

340B Glossary of Terms >

Access common terms used in the 340B Program and their definitions.

340B PVP Distribution Network >

The 340B PVP nationwide distribution network facilitates covered entity product access and compliance.

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