MONDAY, JULY 15, 2019

*Subject to change

Sessions indicating a badge color are limited to the respective covered entity, industry or government groups.
          

* Please note there is an additional cost to attend the pre-conference workshops and registration is required.

7:00am-5:00pm Registration Open
Location: Lobby Level
7:00am-8:15am Continental Breakfast and Networking Opportunity (Workshop Attendees and Exhibitors Only)
Location: Exhibit Hall, Exhibition Level
Pre-Conference Workshop Option 1*
340B Essentials

8:15am-9:30am  340B Essentials, Part 1
Location: Thurgood Marshall North/East, Mezzanine Level

Are you brand new to the 340B program or in need of a refresher course? This introductory workshop will provide a foundation for 340B by covering key 340B compliance requirements, including patient definition, contract pharmacy, duplicate discounts, diversion, and the GPO prohibition. The first part of the workshop will feature a panel of 340B program stakeholders that will review the basic requirements of the 340B program and how to comply with them. You will hear from a DSH hospital with experience complying with the GPO prohibition as well as a HRSA grantee that will provide its perspective on contract pharmacy compliance. 

Learning Objectives:
  • Outline essential 340B program requirements/compliance elements
  • Identify the basic compliance elements of a 340B contract pharmacy arrangement
  • Identify the role of wholesalers and the prime vendor in the 340B program
  • Review the GPO prohibition and its implications for applicable hospitals 
Jennifer Harrison, Portfolio Executive, Apexus|340B Prime Vendor Program
Kamile Johnson, Director, Pharmacy Services, Kansas City CARE Clinic
Cindy Williams, Vice President and Chief Pharmacy Officer, Riverside Health System
Amanda Smith, Assistant Counsel, 340B Health (Moderator)
9:30am-10:30am Exhibits Open: Networking and Refreshment Break (Workshop Attendees and Exhibitors Only)
Location: Exhibit Hall, Exhibition Level
10:30am-11:45am 340B Essentials, Part 2
Location: Thurgood Marshall North/East, Mezzanine Level 

During the second part of the workshop, participants will be grouped by entity type and will work through a set of interactive discussion questions to reinforce the information presented during Part 1.

Learning Objectives:
  • Discuss challenges among 340B stakeholders
  • Outline resources available to covered entities to assist with 340B compliance
  • List required steps in the process of registering a covered entity in the 340B program
  • List required steps in the process of registering a contract pharmacy in the 340B program
  • Discuss strategies for complying with patient definition requirements 
Jason Atlas, Vice President, 340B Enterprise Strategy and Solution, AmerisourceBergen Drug Corporation
Matthew Bertsch, Pharmacist, Director of Pharmacy, Residency Program Director, PGY1 Community-Based Pharmacy
Jeff Davis, Of Counsel/Senior Advisor, Baker Donelson
Jennifer Harrison, Portfolio Executive, Apexus|340B Prime Vendor Program
Kamile Johnson, Director, Pharmacy Services, Kansas City CARE Clinic
Elizabeth Karan, Senior Associate, Feldesman Tucker Leifer Fidell LLP
Leslie Pires, 340B Program Manager, Care New England Health System
Andy Lowe, Clinical Director of Pharmacy, Arrowhead Regional Medical Center
Colleen Meiman, Senior Policy Advisor, National Association of Community Health Centers          
Cindy Williams, Vice President and Chief Pharmacy Officer, Riverside Health System
Greg Doggett, Vice President, Government Relations, 340B Health (Moderator)
Amanda Smith, Assistant Counsel, 340B Health (Moderator)
Pre-Conference Workshop Option 2*
Audits & Compliance (Covered Entities Only)
 
8:15am-9:30am Audit Findings Update and Improving Compliance (Covered Entities Only)         
Location: Thurgood Marshall South/West, Mezzanine Level

With HRSA now in its eighth year of conducting audits of 340B providers, stakeholders are observing trends in the audit results that can shed light on HRSA’s enforcement policies and where the agency is focusing its program oversight. The first part of this workshop will provide participants with an overview of HRSA’s published audit results, including trends in audit findings. Panelists will focus on diversion findings and how providers can implement compliance plans to be consistent with HRSA’s enforcement of the prohibition against diversion.

Learning Objectives: 
  • List frequency and trends of different findings in all HRSA audits since 2012
  • Identify audit finding trends over the past year
  • Discuss how a covered entity can change its 340B compliance program as a result of an audit
  • Describe strategies for preventing diversion findings 
Matthew Atkins, Manager, Draffin & Tucker, LLP
Meetali Desai, 340B Compliance Specialist, UMass Memorial Medical Center
Maureen Testoni, President and CEO, 340B Health (Moderator)
9:30am-10:30am Exhibits Open: Networking and Refreshment Break (Workshop Attendees and Exhibitors Only)
Location: Exhibit Hall, Exhibition Level
10:30am-11:45am Monitoring and Strengthening Compliance
Location: Thurgood Marshall South/West, Mezzanine Level

The second part of this workshop will focus on how covered entities can implement compliance plans that are consistent with HRSA audit enforcement of program rules and that adequately address the issues that commonly arise in audit findings. The session will assist covered entities and other stakeholders in identifying key compliance areas and the types of systems or procedures that should be in place to ensure and monitor compliance. Covered entities on the panel will share their experience developing 340B policies and procedures (P&Ps), conducting self-audits, and using other mechanisms to verify that their organization’s P&Ps are followed and are effective at assuring compliance.

Learning Objectives:
  • Identify critical components of a compliance plan that are consistent with HRSA audit enforcement
  • Identify sources of information that will aid 340B covered entities in forming a compliance plan
  • Evaluate organizational self-audit procedures compared to those of presenters, and identify areas for improvement
  • Describe the importance and effectiveness of robust 340B policies and procedures 
Ronnah Alexander, Pharmacist, Regional Health Care Affiliates
LeeAnn Scheer, Magnolia Regional Medical Center
Jacob Simons, Pharmacy Business Administrator - 340B Program, University of Missouri Health Care
Steven Miller, Vice President, Pharmacy Services, 340B Health (Moderator)
340B Career Development Workshop*
9:30am-10:15am Career Development Session 1: Opportunities in Pharmacy and Business
Location: Virginia Suite, Lobby Level

In the first session of the Career Development Workshop, we will address the growing trend toward the integration of pharmacy and business. For pharmacists, managing the pharmacy department’s financial health in addition to compliance and operations can be an arduous and complex task. This panel will compare different models of how pharmacy business managers approach their work.

Nicole Shoquist, Chief Pharmacy Officer, JPS Health Network
Kenny Yu, Direct, Pharmacy, 340B Program, NYU Langone Hospitals
Michelle Kroll, PAC and Advocacy Manager, 340B Health (Moderator)
10:15am-10:30am Refreshment Break (Career Development Workshop Attendees Only)
Location: Virginia Suite, Lobby Level
10:30am-11:15am Career Development Session 2: Broad Spectrum Strategies for Reducing Pharmacy Costs
Location: Virginia Suite, Lobby Level

Opportunities and challenges are often two sides of the same coin. In the second session of the Career Development Workshop, we’ll review the strategic planning process that goes into reducing pharmacy costs, as well as the success of various cost-saving initiatives. Participants will leave this session with tools to inspire conversations about reducing pharmacy costs.

Jerame Hill, Pharmacy Manager of Supply Chain and Financial Services, University of Wisconsin
Todd Nova, Attorney, Hall, Render, Killian, Health & Lyman, P.C.
Michelle Kroll, PAC and Advocacy Manager, 340B Health (Moderator)
 
11:45am-1:00pm Networking Lunch (Workshop Attendees and Exhibitors Only)
Location: Exhibit Hall, Exhibition Level

1:00pm Opening Remarks
Location: Marriott Ballroom, Lobby Level

This session will be your official welcome to the conference. Conference hosts will introduce themselves and get you prepared for the event.

George Fistonich, Senior Policy and Advocacy Manager, HIV Medicine Association
Max Isaacoff, Government Affairs and Policy Manager, National Rural Health Association
Jim Kaufman, Vice President, Public Policy, Children’s Hospital Association
Emily McCloskey, Director, Policy and Legislative Affairs, National Alliance of State and Territorial AIDS Directors
Mindy J. McGrath, Senior Director, Advocacy and Communications, National Family Planning & Reproductive Health Association
Colleen Meiman, Senior Policy Advisor, National Association of Community Health Centers
Stephanie Arnold Pang, Director, Policy and Government Relations, National Coalition of STD Directors
Joe Pugliese, President and CEO, Hemophilia Alliance
Bruce Siegel, President and CEO, America's Essential Hospitals
Maureen Testoni, President and CEO, 340B Health
1:15pm-1:35pm The State of 340B: Looking Back and Moving Forward
Location: Marriott Ballroom, Lobby Level;

The 340B program is an essential strand of America’s health care safety net. Working in tandem with Medicaid, Medicare, and other vital programs, 340B helps hospitals, health centers, and clinics care for patients with low incomes and those living in underserved rural communities at no cost to taxpayers. As policymakers look for ways to rein in the cost of prescription drugs, 340B stands as a model for a successful approach to be emulated. This session will cover recent 340B developments and set the stage for the rest of conference.

Learning Objectives:
  •  Identify the ways in which 340B can help you serve the needs of your community
  • List key developments that have affected 340B providers and stakeholders
  • Identify 340B policy developments expected in the remainder of 2019 
Maureen Testoni, President and CEO, 340B Health
1:35pm-1:45pm Navigating the Conference
Location: Marriott Ballroom, Lobby Level

This session will include key information regarding conference logistics, so you can get the most out of your conference experience and learn more about our charity.

Speakers TBD
1:45pm-2:15pm 340B Update from the Office of Pharmacy Affairs – Capt. Krista M. Pedley
Location: Marriott Ballroom, Lobby Level

Office of Pharmacy Affairs Director Captain Krista Pedley is the Director of the Office of Pharmacy Affairs (OPA) in the Health Resources and Services Administration (HRSA). Her office administers the 340B Drug Pricing Program, through which hospitals and certain federal grantees are eligible to purchase covered outpatient drugs at discounted prices. OPA publishes guidance for covered entities and manufacturers regarding compliance with 340B program requirements, provides oversight that includes audits of covered entities and manufacturers, and implements the recently released secure 340B ceiling price website.

Learning Objectives:
  • Identify agency priorities and plans for 2019 and beyond
  • Discuss the agency’s continued oversight efforts and initiatives
  • Discuss the new 340B ceiling price website
  • Address other agency developments related to 340B compliance 
Captain Krista M. Pedley, PharmD, MS, Director, Office of Pharmacy Affairs, Health Resources and Services Administration
2:15pm-2:45pm 340B PVP Update
Location: Marriott Ballroom, Lobby Level

Lower drug pricing and transparency have been key themes in the 340B marketplace; this update from the HRSA 340B Prime Vendor Program (PVP) will highlight examples that are bringing value to 340B stakeholders in these areas. Experts from the PVP will share how it facilitates collaboration among covered entities, manufacturers, and wholesalers to deliver voluntary, marketplace solutions to some of the biggest challenges facing the program. Learn how stakeholders benefit from lower drug pricing and transparency to HRSA-aligned 340B education and assistance. The latest hot topics regarding 340B compliance will be discussed, including trends from the PVP’s national call center.

Learning Objectives:
  • Identify different resources PVP provides to support covered entity and manufacturer compliance and technical assistance
  • Provide an update on PVP’s key initiatives 
Chris Hatwig, President Apexus
2:45pm-3:45pm Networking and Refreshment Break
Location: Exhibit Hall, Exhibition Level 
2:45pm-3:35pm Vendor Demo: RxStrategies
Roosevelt 1, Exhibition Level

Mastering 340B Program Administration

Please join RxStrategies in an interactive discussion of advanced system capabilities. • Optimization of your drug spend beyond just 340B with real-time purchase decision support • Increasing Specialty Pharmacy capture rate • Automation of routine tasks and reporting • Real-time sliding fee program development No vendors allowed in this session.

Jonathan Ghenn, Vice President of Enterprise Sales, RxStrategies
Rhodie Smith, Vice President of Contract Pharmacy Sales, RxStrategies
2:45pm-3:35pm
Vendor Demo: Macro Helix 
Roosevelt 2, Exhibition Level 

Navigate the Complexities of 340B with 340B Architect 

Navigating the complexities of 340B can be challenging and confusing. Staying compliant is just the start – you also need to ensure operational efficiency, achieve cost savings, and maximize program participation, all while staying focused on your core business – patient care. 340B Architect, with the integrated 340B Monitor, makes it easy to track the health of your covered entity, while ensuring your split billing program runs smoothly. No vendors allowed in this session. 

Marie Williams, Sales Solutions Consultant, Macro Helix 
3:45pm-5:00pm

Stakeholder Breakout Sessions

A) Community Health Centers    
Location: Thurgood Marshall South/West, Mezzanine Level

Join us to discuss the latest 340B issues and developments affecting CHCs. Likely topics will include continuing scrutiny of the 340B program, Medicaid, other third- party billing and reimbursement issues, and an update on legislative matters impacting CHCs. This session will be an opportunity to raise any issues affecting your CHC.

Learning Objectives:

  • List key 340B program developments
  • Discuss current 340B program challenges
  • Identify 340B issues that are unique to health centers and other providers
  • Review legislative challenges to the 340B program and the potential impact to CHCs 
Colleen Meiman, Senior Policy Advisor, National Association of Community Health Centers (Moderator) 

B) Family Planning Clinics, STD Clinics, and Other Non-Hospital Providers     

Location: Virginia Suite, Lobby Level

This session will focus exclusively on family planning and STD clinics, with an emphasis on the intersection of 340B and the qualifying grant programs. We also will discuss the political landscape around the 340B program, including possible legislation and administrative action.

Learning Objectives:

  • Identify 340B issues that are unique to family planning and STD clinics and programs
  • List key developments in the 340B program
  • Describe current challenges facing the program
  • Discuss non-340B issues of concern to family planning clinics, STD clinics, and other non-hospital providers

Mindy McGrath, Director, Advocacy and Communications, National Family Planning & Reproductive Health Association (Moderator)
Stephanie Arnold Pang, Director, Policy and Government Relations, National Coalition of STD Directors (Moderator)

C) Hemophilia Treatment Centers  

Location: Delaware Suite, Lobby Level

This session will focus exclusively on matters impacting Hemophilia Treatment Centers (HTCs), with an emphasis on 340B issues. Likely topics include HRSA’s oversight efforts, including audits, and Medicaid billing and reimbursement issues. This session also will be an opportunity to discuss other issues impacting your HTC.

Learning Objectives:

  • Identify 340B issues that are unique to hemophilia treatment centers
  • List key developments in the 340B program
  • Describe current challenges facing the program
  • Discuss non-340B issues of concern to hemophilia treatment centers

Joe Pugliese, President and Chief Executive Officer, Hemophilia Alliance (Moderator)

D) HIV Clinics, ADAPs, and HIV Service Providers   

Location: Maryland Suite, Lobby Level

This session will focus on 340B issues affecting Ryan White grantees and sub-grantees, ADAPs, and other HIV clinics and service providers. This will be a discussion-based session.

Learning Objectives:

  • List key 340B program developments
  • Identify 340B program issues that are specific to HIV clinics, ADAPs, and HIV services providers
  • Discuss challenges on most commonly identified 340B issues
  • Discuss solutions and best practices in the field to identified challenges

Tim Horn, Director, Medication Access and Pricing, National Alliance of State & Territorial AIDS Directors (Moderator)
Emily McCloskey, Director, Policy & Legislative Affairs, National Alliance of State and Territorial AIDS Directors (Moderator)

E) Hospitals (DSH, Rural, Children’s, and Cancer Hospitals)  
Location: Marriott Ballroom, Salon 3, Lobby Level

Hospitals will learn about the latest 340B program developments as speakers discuss various 340B research, Capitol Hill, regulatory and legal, and compliance topics.

Learning Objectives:

  • List key 340B developments
  • Discuss current 340B program challenges
  • Identify congressional areas of interest related to the 340B program
  • Identify HRSA audit finding trends and strategies for 340B compliance 
Kathryn DiBitetto, Vice President. Government Relations, 340B Health
Bharath Krishnamurthy, Senior Manager, Research, 340B Health
Steven Miller, Vice President, Pharmacy Services, 340B Health
Richard Sorian, Senior Vice President, Communications, 340B Health
Maureen Testoni, President and Chief Executive Officer, 340B Health 


F) Pharmaceutical Manufacturers   
Location: Wilson A/B, Mezzanine Level

Pharmaceutical manufacturers will learn about the latest developments involving the 340B program and how those developments will impact the pharmaceutical industry. Likely topics will include the 340B ceiling price website, manufacturer civil monetary penalties, and HRSA audits.

Sabrina Aery, Director, Federal Executive Branch Strategy, Bristol-Myers Squibb
Kathleen Black, Director, Government Strategy, Pfizer Inc.

G) 340B Service Providers    
Location: Thurgood Marshall North/East, Mezzanine Level

This session is designed for all 340B service providers. Participants will hear about emerging issues and compliance concerns facing contract and specialty pharmacies in the 340B program. Other topics will highlight other challenges that may arise between vendors and covered entities.

Learning Objectives:

  • Discuss key 340B developments
  • Explore challenges and solutions to 340B operations
  • Identify the role and responsibilities of 340B service providers
  • Address challenges that may arise between vendors and covered entities related to these issues 
Carrie Galvan, Hospital Program Manager, 340Basics
Daniel Neal, Director, 340B Product and Service Marketing, Cardinal Health, Inc.
Ryan Rushing, Senior Director, 340B Programs, BioPlus Specialty Pharmacy
Rhodie Smith, Vice President, Contract Pharmacy Sales, RxStrategies, Inc.
Greg Doggett, Vice President, Legal and Policy Counsel, 340B Health (Moderator)

5:00pm-6:15pm Evening Reception
Location: Exhibit Hall, Exhibition Level

 

FEATURED EXHIBITORS