340B Boot Camp—Education for Manufacturers by the HRSA 340B Prime Vendor

September 18, 2023

Learn about leading practices for manufacturers in the 340B Drug Pricing Program at the Medicaid Drug Rebate Program Summit, 340B Boot Camp—Education for Manufacturers. Our panel of experts, moderated by HRSA 340B Prime Vendor leaders, will address program challenges for positive outcomes. Panelists include representatives from covered entities, manufacturers, and wholesalers, and an attorney and consultant.

340B Compliance Cornerstones for Manufacturers

Monday, September 18

1:30–2:15 p.m. CT

Describes core 340B compliance requirements for pharmaceutical manufacturers

Learning Objectives

  • Discuss elements of the pharmaceutical pricing agreement
  • Describe 340B ceiling price calculation
  • Identify pricing responsibilities with HRSA and wholesalers

Introduction

Chris Hatwig, MS, RPh, FASHP
President
Apexus

Moderator

Cathy Gilgore
Associate Principal, Manufacturer Refund Service
Apexus

Panelist

Marcy Imada
Managing Director
Deloitte & Touche

Panelist

Mitesh Ghia
Director, Institutional Contracts, Chargebacks & Rebates
Novartis Pharmaceuticals

Panelist

Lisa Scholz
Vice President, 340B Enterprise Strategy, Health System and Government Services
AmerisourceBergen


HRSA 340B Integrity Initiatives—Manufacturer and Covered Entity Audits

Monday, September 18

2:15–3:00 p.m. CT

Discusses leading practices for maintaining program integrity and going through the HRSA audit process

Learning Objectives

  • Outline HRSA integrity initiatives for manufacturers and covered entities
  • Discuss leading practices to prepare and complete the HRSA audit process for manufacturers
  • Describe post-audit procedures, including implementation of a successful corrective action plan

Moderator

Chad Johnson, PharmD, MBA
Director, 340B Policy and Compliance
Apexus

Panelist

Jennifer Lospinoso
Managing Director & Consulting Lead
Riparian

Panelist

Christopher Schott
Partner
Latham & Watkins

Panelist

Chuck Stubbs, PharmD, MBA, 340B ACE
340B Pharmacist
Intermountain Healthcare


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

Monday, September 18

3:30–4:15 p.m. CT

Analyzes covered entity 340B inventory management models and manufacturer good-faith inquiries

Learning Objectives

  • Describe common 340B drug dispensing pathways in outpatient settings
  • Discuss covered entity inventory management models
  • Analyze differences between good-faith inquiries and HRSA-approved manufacturer audits of covered entities

Moderator

Gavin Magaha, PharmD, MS, 340B ACE
Director, 340B Policy and Compliance
Apexus

Panelist

Fern Paul-Aviles, PharmD, MS, BCPS
Assistant Vice President, Pharmacy Population Health Strategy, 340B and Non-acute Pharmacy Services, Division of Pharmacy
Atrium Health

Panelist

Lisa Nelson, PharmD, RPh
Pharmacy Director
Unity Care NW

Panelist

Cathy Burton-Meza
Associate Director, Government Rebates
Gilead Sciences


HRSA 340B Prime Vendor Update

Monday, September 18

4:15–5:00 p.m. CT

Describes the role of the 340B Prime Vendor Program, managed by Apexus, and resources provided to manufacturers

Learning Objectives

  • Identify resources the Prime Vendor provides to support manufacturers and the 340B community
  • Discuss contracting and other services available to manufacturers

Moderator

Broderick Olson, PharmD, MBA, MS, BCPS
Director, Contract Services, Pharmacy
Apexus

Panelist

Joseph Favatella, PharmD, MBA
Associate Director of Pharmacy
Penn Medicine, University of Pennsylvania Health System

Panelist

Althea Danzey
Director, Pricing and Contract Operations
Merz Therapeutics

Panelist

Lisa Scholz
Vice President, 340B Enterprise Strategy, Health System and Government Services
AmerisourceBergen

For 340B Prime Vendor Program Partners

Supplier access to 340B PVP secure database.

Access supplier resources > (login required)

As a contracted supplier partnered with the 340B Prime Vendor Program (PVP), you have confidential and secure access to the PVP participant database, a list of comprehensive data to validate PVP participant eligibility.

New on 340Bpvp.com: Customized Operational Resources

Learn how you can use new and improved customized tools on the 340B Prime Vendor Program (PVP) website to identify areas for savings.

Access top 340B Prime Vendor Program (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.

Manufacturer Contracting Solutions >

The 340B PVP 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.

340B 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.

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. Apexus Answers, celebrating ten years of service and support.