8:30 am
Shannon Stephenson
Shannon Stephenson, CPA, MBA
Chief Executive Officer,
Cempa Community Care

Charles Washington
Charles Washington, CFE, CPP, CICA
Director, Fraud Investigation Group

8:45 am

Apexus, the HRSA-designated Prime Vendor for the 340B Drug Pricing Program, leads a 340B update on trends in the current environment. Hear the hot topics that manufacturers and entities ask the national call center, Apexus Answers. Also, gain insights on new and updated tools that support compliance and learn about opportunities to partner with other stakeholders to address 340B challenges for positive outcomes.

  • Review 340B trends and hot topics
  • Discuss new and updated tools that support compliance
  • Share solutions that involve partnership among stakeholders and address 340B challenges
Christopher A. Hatwig

10:15 am

Covered entities and manufacturers agree that a sustainable 340B Program will better serve their patients and lead to more successful outcomes. But as program enforcement continues to rise, while rules and guidance from OPA remain limited in nature, what do manufacturers and covered entities need to do better to work more effectively together?

  • Share ways to ensure program compliance
  • Discuss ways to prevent diversion, duplicate discounts, and/or GPO prohibition
  • Explore how to avoid escalation leading to potential audits while educating on when/if it’s appropriate to consider submitting an audit work plan to HRSA


Mujeeb Rafiuddin
Mujeeb Rafiuddin
National Account Manager, 340B

Manufacturer Perspective:

Pam Politis
Pam Politis
Executive Director, US Legal
Incyte Corporation

Covered Entity Perspective Speaker TBA

11:00 am

In 2016 HRSA proposed a rule that would help resolve dispute findings between covered entities and manufacturers. Although that rule was never implemented, covered entities and manufacturers can rely on the 340B ADR process; an informal, voluntary dispute resolution process for overcharges, duplicate discounts, and diversion. Hear from different stakeholders as they discuss the covered entity and manufacturer environments, and how to work jointly to act in good faith to resolve disputes.

  • Discuss the challenges that arise from various data sources and vendor systems, such as disparities that trigger 340B eligibility
  • Review purchase histories and chargeback data
  • Work jointly to act in good faith to resolve disputes between both parties
  • Identify and address the error and effects on processes, data sharing, and reporting
  • Recognize the opportunities arising from GFDR-Auditing based on dispute findings to strengthen the 340B program

Manufacturer Perspectives:

Tess Morgan
Tess Morgan
Senior Manager, Product Diversion, Program Integrity

Covered Entity Perspective:

Katy Lees
Katy Lees
340B Business Manager
University of Rochester

11:45 am
1:00 pm
Charles Washington
Charles Washington, CFE, CPP, CICA
Director, Fraud Investigation Group

1:15 pm

It’s been evident that the 340B Drug Pricing Program has grown exponentially over the years. We have seen services expanded to ineligible patients, which in turn negatively impact manufacturers’ revenue. With this expansion comes rising concerns about program oversight and financial viability. Take this opportunity to engage in open discussions with your peers to address some of the biggest challenges within this federal program.

  • Create transparency for increased oversight
  • Emphasize patient care through the outpatient pharmacy
  • Discuss the next phase of pharmacy and how essential this will be for adherence
  • Know who the internal pharma and biotech stakeholders are that need to have aligned vision and buy in
Rob Philo
Rob Philo
Vice President, Market Access
Veloxis Pharmaceuticals

2:00 pm

HRSA’s Ceiling Price (CP) and Manufacturer Civil Monetary Penalty (CMP) Final Rule, Federal Register Notice (FRN) became effective January 1, 2019. Following more than a year of implementation, assess how manufacturers are abiding by these requirements around Medicaid pricing restatements, new product launches, and the true-up PHS 340B Ceiling Prices with covered entities.

  • Identify the challenges and opportunities of reporting the Ceiling Price into OPAIS (visible to Covered Entities as of July 1, 2019)
  • Examine best practices in complying with the Penny Price rules
  • Explore experiences faced when offering refund or credit to covered entities within 120 days for any overpayments that may be due to:
    • pricing errors
    • true-up of Provision PHS 340B Prices for newly launched products
    • restatements of underlying Medicaid Drug Rebate Program pricing
3:15 pm

Do you know where your chargebacks and rebates are going? When statutes require the offering of substantial mandatory product discounts, you need to have total confidence that the right customer and customer account is accessing the correct product pricing. Discover how analytics can help drive best practices for preventing and rectifying duplicate discounts and GPO Prohibition violations to ensure fair 340B program participation for all stakeholders.

  • Recognize the value and impact of deep analytics
  • Analyze chargebacks in your 340B program
  • Expand data transparency and accountability across the program
Patrick Greene
Patrick Greene
PharmD, Director, Contracts
Chiesi USA, Inc

4:00 pm

To maintain a successful program, manufacturers and covered entities must work together to address negotiations and drive compliance within the program. In order to do so, covered entities are required, that if they identify a material breach in the 340B program, they have to reveal that to HRSA and the manufacturer.

  • Discuss strategies for manufacturers to work effectively with covered entities to assist in self-disclosures
  • Learn how to develop an effective inquiry process to remain compliant
  • Develop communication strategies that increase collaboration