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340B Prime Vendor at MDRP Conference

340B Boot Camp - Education for Manufacturers by the HRSA 340B Prime Vendor
October 12, 2022

Join us at the Medicaid Drug Rebate Program Summit to gain insights into 340B Drug Pricing Program leading practices for manufacturers. Attend four panel discussions moderated by the HRSA 340B Prime Vendor, Apexus, to address program challenges for positive outcomes.


Understanding Covered Entity 340B Program Operations and Good-Faith Inquiries

1:30 - 2:15pm ET

The objective of this panel session is to increase participants’ understanding of covered entity 340B Program operations and good-faith inquiries. Specific topics covered include:

  • 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

Panelist

Kenny Yu, PharmD, MBA, 340B ACE
Senior Director of Pharmacy Services
New York University Langone Hospitals (NYULH)

Panelist

Dave Reesman, 340B ACE
Director, Key Customers - GPO
Sandoz Inc.

Panelist

Hannah Rowell
Associate Director of Pharmacy Programs
Erie Family Health Centers

Leading Practices for 340B Manufacturer Operations

2:15 - 3:00pm ET

Participants will learn the basics of the 340B Drug Pricing Program as it relates to expectations and leading 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)
  • Civil monetary penalties (CMP)

Moderator

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

Panelist

Daniel Neal, MBA
Director, 340B Product and Service Leader
Cardinal Health

Panelist

Marcy Imada
Principal
Deloitte & Touche LLP

The Role of HRSA’s 340B Prime Vendor

3:30 - 4:15pm ET

Learn more about how the HRSA 340B Prime Vendor can assist manufacturers and other program stakeholders in their 340B Program strategies while meeting program requirements through:

  • Education and training
  • National call center
  • Distribution network
  • Pharmaceutical and value-added contracting
  • Refund assistance

Moderator

Adeola Chukwumah, PharmD, MPH, CIHC, 340B ACE
Senior Director, Contract Services
Apexus

Panelist

Daniel Neal, MBA
Director, 340B Product and Service Leader
Cardinal Health

Panelist

Lisa Nelson, PharmD, RPh, 340B ACE
Pharmacy Director
Unity Care Northwest

Panelist

Dave Reesman, 340B ACE
Director, Key Customers - GPO
Sandoz Inc.

Panelist

Charles (Chuck) Stubbs, PharmD, MBA, 340B ACE
340B Pharmacist
Intermountain Healthcare

HRSA Manufacturer Audits—Leading Practices

4:15 - 5:00pm ET

HRSA integrity initiatives include auditing both covered entities and manufacturers. The most recently published manufacturer audit results (FY2021) indicate that four of the five companies audited were required to develop and implement corrective action plans (CAP). Panelists for this session will:

  • Review manufacturer 340B compliance requirements and HRSA integrity initiatives
  • Discuss how manufacturers can prepare for an audit
  • Share leading practices for going through the HRSA audit process
  • Highlight key steps toward developing and implementing a successful CAP

Moderator

Cathy Gilgore, MBA
Manufacturer Refund Service Director
Apexus

Panelist

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

Panelist

Christopher H. Schott
Partner
Latham & Watkins LLP

Visit the Education Library

Easily find the resource or training you need with our new 340B Univeristy search tool. Filter by stakeholder group to see educational resources for manufacturers.

Learn More >

340B Frequently Asked Questions for All 340B Stakeholders
Access top PVP resources created for suppliers
340B University for Manufacturers >

The PVP provides educational events customized for manufacturers that offer a broad overview of 340B Program requirements, manufacturer best practices for 340B program implementation shared by peers, and insight into partnerships between suppliers and the Prime Vendor.

340B University OnDemand >

A manufacturer curriculum offering essential compliance elements of the 340B Program from the manufacturer’s perspective. Allows you to complete the curriculum at your own pace from your home or office. Users who complete all modules and the course evaluation will receive a statement of completion.

PVP Secure Website >

Partnering as a supplier in the PVP grants you access to the PVP secure website, a password-protected online portal that provides resources for suppliers such as PVP participant lists, templates, tools and more.

Manufacturer Refund Service >

Facilitates refunds to covered entities by sending refunds directly to affected facilities, primarily through its authorized distribution network. This service helps support manufacturers to bring efficiency to the task of processing these refunds.

Sample HRSA 340B Audit Data Request for Manufacturers >

Download a sample data request list for a HRSA 340B audit..

Education Roadmap for Manufacturers >

View all education available for manufacturers and common paths to advance your 340B knowledge. Learn skills commonly needed to fulfill employers' annual 340B training requirements.

Manufacturer Contracting Solutions >

The 340B Prime Vendor Program partners with suppliers; together they support 340B covered entities’ needs to deliver quality, cost-effective care for our nation’s safety-net providers.

340B PVP Distribution Network >

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

How Can We Help?

All 340B stakeholders have equal access to technical assistance by contacting the Apexus Answers call center. We provide HRSA-aligned answers ranging from basic to complex, via phone 888.340.BPVP (2787), live chat, and email. We are here to help you navigate the 340B Program.