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340B Presentations at Manufacturer Conferences

Attend new 340B panel discussions moderated by the HRSA 340B Prime Vendor at key manufacturer conferences in 2021.

Join us to better understand 340B Program best practices.

Attend our Prime Vendor Program (PVP) moderated panel discussions to gain perspective from multiple 340B stakeholder experts. We look forward to providing opportunities to network with 340B experts—speakers, fellow 340B colleagues, and other stakeholders—through live Q&A and virtual booths.

Register to attend each of these conferences to participate in the PVP-led sessions. (Conference registration is required to participate).

Medicaid Drug Rebate Program (MDRP)

October 11-13, 2021 (In-Person New Brunswick, NJ)

October 18-20, 2021 (Online)

Session: 340B Manufacturer Education Series by the HRSA 340B Prime Vendor

Session participants will gain insight into 340B Drug Pricing Program expectations and best practices for pharmaceutical manufacturers, including:

  • 340B Drug Pricing Program Basics for Manufacturers
  • Manufacturer Best Practices for Managing 340B Overcharges and Refunds
  • Best Practices in Manufacturer Approaches to 340B Program Requirements
  • Understanding Covered Entity 340B Program Operations and Good Faith Inquiries (GFIs)
  • The Role of HRSA's 340B Prime Vendor

In-Person Speaker Sessions

340B Drug Pricing Program Basics for Manufacturers

October 11
11:30 am–12:15 pm ET

Participants will learn the basics of the 340B Drug Pricing Program as it relates to expectations and best practices for pharmaceutical manufacturers. These topics will be covered:

  • Pharmaceutical pricing agreement (PPA)
  • Calculation of the 340B ceiling price
  • 340B Office of Pharmacy Affairs Information System (OPAIS)
  • HRSA audits of manufacturers
  • Civil monetary penalties (CMP)
  • Refunding overcharges

Moderator:

John Barnes, CPM, MBA, 340B ACE

Associate Vice President Contract Services

Apexus


Panel: Distributor, Consultant, Manufacturer

Mark Jacobs

340B National Account Executive

Genentech

Miree Lee, MS, MBA

Bio/Pharma Pricing Consultant

M. Lee Consulting, LLC

Daniel Neal, MBA, 340B ACE

340B Product and Service Leader

Cardinal Health

Manufacturer Best Practices for Managing 340B Overcharges and Refunds

October 12
4:35–5:20pm ET

  • Review manufacturer 340B compliance requirements and CMP Final Rule
  • Calculation of the 340B ceiling price
  • Discuss how manufacturers are managing their operations to meet 340B program requirements
  • Learn about resources available to assist manufacturers in managing pricing restatements and 340B overcharges
  • Share best practices for managing 340B overcharges and refunds

Moderator:

Mike Benedict, RPh, MS

Senior Vice President Operations

Apexus

Panelists: Manufacturer, Covered Entity

Christopher H. Schott

Partner

Latham & Watkins LLP

Edward McAdam

Director, Government Pricing, Contracting Operations & Analytics

Indivior, Inc.

Scott Hoffman

Co-founder and Head of Client Services

Woven Data, Inc

Virtual Sessions:

Best Practices in Manufacturer Approaches to 340B Program Requirements

October 18
10:00 am–10:45 am ET

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

Moderator:

John Barnes, CPM, MBA, 340B ACE

Associate Vice President Contract Services

Apexus

Panel: Distributor, Consultant, Manufacturer

Philip Coburn

Director, U.S. Government Pricing Compliance

Pfizer, Inc.

Miree Lee, MS, MBA

Bio/Pharma Pricing Consultant

M. Lee Consulting, LLC


Lisa Penn

Director, 340B Operations

Cardinal Health

Understanding Covered Entity (CE) 340B Program Operations and Good-Faith Inquiries (GFIs)

October 18
10:50 am–11:35 am ET

Participants will gain insight into covered entity 340B Drug Pricing Program administration/dispensing pathways, and variances in purchasing patterns, as well as the process for more successful good faith inquiries, including:

  • Covered entity compliance elements
  • Patient definition-based inquiries
  • Medicaid duplicate discount-based inquiries

Moderator:

Gavin Magaha, PharmD, MS, 340B ACE

Manager, 340B Education and Compliance Support

Apexus


Panel: Distributor, Consultant, Manufacturer

Kenny Yu, PharmD, MBA, 340B ACE

Senior Director of Pharmacy

NYU Langone Health

Michael Lin, PharmD

Director of Pharmacy Services

Family Health Center

Tess Morgan, MBA

Senior Manager, Product Diversion and Program Integrity

Pfizer

The Role of HRSA’s 340B Prime Vendor

October 18
11:40 am–12:25 pm ET

  • Education and training
  • National call center
  • Distribution network
  • Pharmaceutical contracting

Moderator:

Adeola Chukwumah, PharmD, MPH, CIHC, 340B ACE

Sourcing Director, Pharmacy

Apexus


Panel: Distributor, Consultant, Manufacturer

Daniel Neal, MBA, 340B ACE

340B Product and Service Leader

Cardinal Health

Ronald Sargent, MBA

National Accounts Director

GSK US

Ron Hartmann, PharmD

Vice President, Pharmacy Solutions

Sagent Pharmaceuticals

Jason Mills, PharmD, MBA

Supply Chain System Administrator

Medical University of South Carolina (MUSC)

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 am-5:00 pm 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

Coming soon, read our updated 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 Online Learning (OnDemand) 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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