8:00 am
David A. Neu
David A. Neu, PharmD, MSHSA
Vice President, Pharmacy
Saint Thomas Health

8:15 am

Explore the current state of the health reform debate in Washington, including policy changes that affect the pharmaceutical sector, covered entities, and pharmacies.

  • Gain insight into how CMS redistribution of 340B benefits may impact the program for both providers and manufacturers
  • Revise 340B compliance strategies and use transparency as a modality to ensure regulatory integrity and fidelity with 340B
  • Discuss strategies for alignment between providers and manufacturers to ensure the uninsured population is getting the support they need
David Pittman
David Pittman
Health Reporter

Gary Merchant
Gary Merchant
New Hampshire Board of Pharmacy
Member, Board of Directors
Ammonoosuc Community Health Services

William Sarraille
William Sarraille
Sidley Austin LLP

Edward D Shanshala II
Edward D Shanshala II, MSHSA, MSEd
Chief Executive Officer
Ammonoosuc Community Health Services, Inc.

9:00 am

As the HRSA-designated 340B Prime Vendor, Apexus brings together stakeholders to provide value and efficiency across the 340B community. Don’t miss this chance to hear about the success stakeholders have in working together, supporting transparency, and finding common value through the essential services of the Prime Vendor Program.

  • Hear the latest 340B hot topics from the Apexus national call center, which handles more than 2,000 340B-related inquiries a month
  • Get an update on the latest trends in contracting activity that brings together manufacturers, wholesalers, and covered entities to voluntarily participate in this unique public-private partnership
  • Highlight the current opportunities Apexus provides through its manufacturer refund service
Chris Hatwig
Chris Hatwig, MS, RPh, FASHP

10:15 am

Watch a claim go from its first initiation, all the way through to true ups and reimbursements. Join the discussion to uncover what a claim looks like when it is computed from each stakeholder’s perspective to better understand the process.

  • Discuss the journey of a dispute to truly grasp each stakeholder’s perspective on the dispute process
  • Hear from multiple stakeholders regarding top hurdles and lessons learned when dealing with disputes
  • Uncover best practices to ensure strongholds are in place to ease the dispute process for covered entities, pharmacies, and manufacturers
  • Discuss self-disclosure reporting, and what covered entities can do when finding themselves non-compliant

Pharmacy Perspective:

Don Bell
Don Bell
Senior Vice President
National Association of Chain Drug Stores

Manufacturer Perspective:

Amanda Tucker
Amanda Tucker
Senior Government Analyst

Covered Entity Perspective:

Edward D Shanshala II
Edward D Shanshala II, MSHSA, MSEd
Chief Executive Officer
Ammonoosuc Community Health Services, Inc.

11:15 am

As state Medicaid programs and other payers assess different value-based purchasing strategies to align drug reimbursement with performance, there is an important intersection with 340B that is not often discussed. Covered entities can play an important role not only in collecting data relevant to a drug’s performance, but also by entering into value-based arrangements with payers themselves that would, for example, tie reimbursement to the entity’s ability to manage medication therapy and patient compliance effectively. This session explores the opportunities associated with the movement towards value-based purchasing and how they may affect future contracting with payers and manufacturers.

  • Understand the legal and regulatory framework governing the structure of value-based contracting and discuss potential relationships among payers, manufacturers, and covered entities within that framework
  • Identify best practices for collaborating on pricing, data aggregation, data sharing, risk allocation, and other contracting issues
  • Recognize anti-kickback and other legal risks associated with value-based purchasing and adopt standards for mitigating such risks

Legal Perspective:

William H. von Oehsen
William H. von Oehsen
Powers Pyles Sutter & Verville, PC

12:00 pm
1:15 pm

HRSA has transferred 340B auditing responsibilities to an outside contractor and, as a result, the substance of the audits, the areas of focus, and the findings themselves have shifted. In this extended discussion, learn how to prepare for an audit in order to be fully compliant, and apply the lessons learned from recent audit experiences.

Ensure a Thorough Preparation and Self-Audit Strategy

  • Operationalize clear inventory separation (340B versus non-340B drugs) within your facility and if you have more than one entity type within your system
  • Discuss how to conduct mock audits and what to be looking for
  • Identify the purpose and goals of using an oversight committee to stay compliant
  • Understand and explain how to define “patient,” “covered outpatient drug,” “materiality,” and other key terms
  • Ensure split-billing software properly tracks and reports accumulation levels and replenishment orders by NDC number
  • Carefully monitor purchasing practices to make sure you’re not violating the GPO exclusion
  • Discuss the complexities associated with self-reporting, assessing whether a compliance issue is material, and what happens after you report a problem to HRSA

Assess Recent Audit Findings and Address Specific Areas of Focus

  • Hear case studies on recent audit findings from different entity types to better understand what being fully compliant means
  • Identify the specific areas under scrutiny by auditors and how conclusions are drawn
  • Learn how patient guidelines are being applied and how, for example, referral documents and other records must be in place when there is a physician consult outside of your entity


William H. von Oehsen
William H. von Oehsen
Powers Pyles Sutter & Verville, PC


Gary L. Horne
Gary L. Horne, RPh, MHSA
Director of Pharmacy
San Mateo Medical Center

Sue Veer
Sue Veer, MBA
President and Chief Executive Officer
Carolina Health Centers, Inc.

Tammy Zukowski
Tammy Zukowski, MBA
Senior Vice President, Hospital and Health Systems Services

3:15 pm

As more manufacturer inquiries are conducted — both from the manufacturers themselves as well as third parties — covered entities must be prepared with information that shows compliance. Hear the current status of findings from manufacturer inquiries, and how to best prepare for those requests and conversations.

  • Understand the purpose and consequences of good faith inquiries from manufacturers and third parties
  • Assess the challenges of dealing with a third party on compliance issues, and how to better communicate and provide what they are asking for
  • Discuss the trends found within these inquiries across different types of entities
Felicity Homsted
Felicity Homsted, PharmD, BCPS
Chief Pharmacy Officer
Penobscot Community Health Care

Bruce Thompson
Bruce Thompson, RPh, MS
Division Vice President, Compliance and Regulatory Consulting
Comprehensive Pharmacy Services

4:00 pm

Each audit is different, and the focus areas will depend on the requests for data and information from the entity. In this interactive session, experience an audit firsthand to better understand the process and identify areas for improvement.

  • Witness scenarios that highlight the most challenging questions/requests for information
  • Review the HRSA checklist to understand what areas will be emphasized
  • Navigate the “gray” areas where a clear answer or solution may not be present
Callie Lyons
Callie Lyons, PharmD
Director, Pharmacy Support
Wellpartner Inc.

4:45 pm

Meet, network, and share experiences with colleagues in similar situations when you break into roundtable discussion groups to address challenges specific to certain types of entities.

DSH Facilitator:

Maggie Williams
Maggie Williams, PharmD, BCPS
Director, Pharmacy
White River Medical Center

CH (Clinics, FQHCS) Facilitator:

Nichelle A. Mullins
Nichelle A. Mullins, Esq.
President and Chief Executive Officer
Charter Oak Health Center, Inc.

CAH Facilitator:

David A. Neu
David A. Neu, PharmD, MSHSA
Vice President, Pharmacy
Saint Thomas Health

Ryan White/ Other Facilitator TBA

Mary Elizabeth Marr
Mary Elizabeth Marr
Chief Executive Officer
Thrive Alabama