THURSDAY, JANUARY 31, 2019

*Subject to change

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

7:00am- 5:00pm Registration Open
Location: West Sapphire Foyer
7:00am Continental Breakfast  & Networking Opportunity
Location: Exhibit Hall
7:00am Breakfast: 340B Lessons from the Field (Part 1)
Location: Aqua ABC

Covered entities use 340B vendors to support 340B compliance operations in different ways, and there are a variety of vendors in the 340B marketplace offering support services. This session is designed for covered entities to hear vendors’ perspectives and lessons learned from working with clients on 340B issues.

Lisa Scholz, Head of Industry Relations, Sentry Data Systems
Rhodie Smith, Vice President, Contract Pharmacy Sales, RxStrategies
Rob Miller, Senior Vice President of Business Development, Strategic Planning and Operations, 340B Health (Moderator)
7:00am Pharmacy Technician Networking Breakfast: No Tech Left Behind - How to Gain Trust
Location: Sapphire 411

Pharmacy technicians will gather for breakfast and a great networking opportunity to share ideas, challenges, potential solutions, and other 340B Program operations’ strategies for success. Join us and hear from your peers about some strategies for advancing the role of the pharmacy technician in 340B.

Sandra Clark, 340B Coordinator, Meadville Medical Center
Carrie Galvan, 340B Coordinator, Boone County Hospital
Jennifer Rossi, 340B Program Manager, Eastern Maine Medical Center
8:00am Opening Remarks
Location: Indigo, Overflow: Sapphire AE

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

Taryn Couture, Senior Manager, Policy and Government Relations, National Coalition of STD Directors (Moderator)
Mindy McGrath, Director, Advocacy and Communications, National Family Planning & Reproductive Health Association
Colleen Meiman, Senior Policy Advisor, National Association of Community Health Centers
Joe Pugliese, President and CEO, Hemophilia Alliance
Maureen Testoni, President and CEO, 340B Health
Andrea Weddle, Executive Director, HIV Medicine Association
8:15am The State of 340B: Looking Back and Moving Forward
Location: Indigo, Overflow: Sapphire AE

Over the past year, the 340B program and its stakeholders have witnessed many significant legislative and regulatory developments, and the coming year is expected to be equally eventful. This session will cover these developments and set the stage for the rest of conference.

Maureen Testoni, President and CEO, 340B Health
8:45am Navigating the Conference
Location: Indigo, Overflow: Sapphire AE

This session will include key information regarding conference logistics, so you can get the most out of your conference experience.

Rob Miller, Senior Vice President of Business Development, Strategic Planning, and Operations, 340B Health
Jeffrey Norris, Medical Director, Father Joe’s VIllages
9:00am Expectations and Implications: A Conversation on the Shifting Policy Arena in 2019
Location:  Indigo, Overflow: Sapphire AE

This new year brings a new Congress, a continued administrative focus on drug pricing, and a shift in power of key policymakers. This session will delve into these shifting dynamics and what it means for health care providers and the communities that you serve. Michael McCaughan is a Founding Member of Prevision Policy LLC and a Senior Editor with The RPM Report, a leading publication focusing on the intersection between biopharmaceutical regulation, policy, and business. Previously, he was Editor-in-Chief of Elsevier Business Intelligence’s Biopharma Group, the publisher of The Pink Sheet. He is a graduate of Yale University. Rodney Whitlock is a veteran health care policy professional with more than 20 years of experience working with the US Congress, where he served as health policy advisor and as Acting Health Policy Director for Finance Committee Chairman Chuck Grassley of Iowa and, earlier, on the staff of former US Representative Charlie Norwood of Georgia.

Michael McCaughn, Founding Member, Prevision Policy LLC
Rodney Whitlock, Vice President, Health Policy, ML Strategies
10:00am Exhibits Forum, Refreshment Break, Networking Opportunity
Location: Exhibit Hall
10:00am Vendor Demo: Sentry Data Systems
Location: Sapphire 410
11:00am Track One 
340B Operations: Experiences from the Field


A) Inventory Management: Strategies for Compliance and Efficiency
Location: Sapphire IM

340B providers maintain complex inventory management systems to ensure compliance with 340B program rules, including patient definition, the duplicate discount prohibition, and the GPO prohibition for certain hospitals. In addition, covered entities must obtain access to drugs, monitor pricing across multiple accounts and settings, minimize loss (waste) of unused drug and maintain budgetary balance within their department. Panelists will discuss strategies and ideas for solutions to 340B drug concerns such as monitoring 340B pricing and various purchasing accounts, definition of exceptions to covered outpatient drug, and monitoring/auditing for compliance with inventory management policies and procedures.

Rebecca Cheek, Director of Pharmacy, Grace Health
Chris Godin, 340B Compliance Specialist, University of North Carolina Hospitals
Chris Hilty, System Pharmacy Supply Chain & 340B Manager, Methodist LeBonheur Healthcare

B) 340B Lessons From the Field (Part 2)
Location: Aqua ABC

Covered entities use 340B vendors to support 340B compliance operations in different ways, and there are a variety of vendors in the 340B marketplace offering support services. This session is designed for covered entities to hear vendors’ perspectives and lessons learned from working with clients on 340B issues.

Jessica Grossman, Chief Executive Officer, Medicines360
Cheryl Hetland, Director of Pharmacy Services, CliftonLarsonAllen
Melissa Opraseuth, Senior Vice President of Operations, par8o 340B Referral Capture
Shrujal Patel, Managing Partner, Alinea Group
Anthony Velasquez, Director of Operations, PharmaForce
Rob Miller, Senior Vice President of Business Development, Strategic Planning and Operations, 340B Health (Moderator)

Track Two 
340B Policy & Compliance


A) HRSA's Evolving Oversight of 340B Covered Entities: Implications for HRSA Audits and Taking Corrective Action
Location: Indigo AE

HRSA’s oversight of the 340B program has become an area of interest to lawmakers and other 340B program stakeholders. The Government Accountability Office (GAO) released a report in June that recommended ways to improve HRSA’s oversight of providers’ use of 340B contract pharmacies and commented on areas in HRSA’s oversight that the GAO found to impede HRSA’s ability to ensure compliance. This panel will feature a representative from the GAO who will review recommendations and findings made in the report. Speakers will also address what the GAO’s findings and recommendations may mean for HRSA audits of covered entities and corrective action plan implementation. Providers who have been audited by HRSA will share their experiences with the audit process.

Amanda Cherrin, Senior Health Policy Analyst, U.S. Government Accountability Office
Pete Hamilton, Pharmacy Director, Genesis Health
Angela Moreland, Director of Pharmacy Services, Community Health Centers of Pinellas, Inc.
Maureen Testoni, President and CEO, 340B Health (Moderator)

B) Medicaid Billing and Reimbursement 
Location: Sapphire AE

Speakers will address developments at the intersection of the 340B and Medicaid programs, including state trends regarding billing, reimbursement, and identification of 340B claims; and different strategies that can be used by covered entities to engage states on 340B issues. A covered entity will share what systems and processes it uses to prevent duplicate discounts and ensure 340B compliance. The session will also address pharmaceutical manufacturers’ concerns about duplicate discounts, how companies identify potential duplicate discounts, and how manufacturers can work in good faith with covered entities to resolve duplicate discount concerns.

Schuchi Parikh, Associate, Powers Pyles Sutter & Verville PC
Danielle Sestito, Senior Director, Procurement & 340B Operations, NYC Health + Hospitals
Steven Zielinski, Director of Industry Relations, Kalderos
Greg Doggett, Counsel, Dentons (Moderator)

C) Hot Topics in Contract Pharmacy Compliance
Location: Indigo CG

Covered entities are responsible for ensuring that their contract pharmacy arrangements comply with 340B program rules. As a result, covered entities must be mindful of program requirements and must be prepared to remedy non-compliance in contract pharmacy. This session will address 340B compliance elements for contract pharmacy, “hot topics” in contract pharmacy compliance, and best practices for resolving non-compliance. The session will also highlight how entities can monitor their contract pharmacies to ensure 340B compliance.

Kevin Jones
, 340B Program Director, Intermountain Healthcare 
Todd Nova
, Shareholder, Hall, Render, Killian, Heath & Lyman, P.C.
Kenneth Pachecho, 340B and Lab, Access Community Health Network 

Track Three
Clinical Best Practices 


Addressing the Opioid Epidemic: The Role of 340B
Location: Sapphire 400

The national epidemic of opioid dependence is challenging our healthcare system on a variety of fronts including prevention, treatment, and education. According to the Centers for Disease Control and Prevention (CDC), there were more than 70,000 drug overdose deaths in 2017—the highest number of drug overdose deaths for any single year in U.S. history. Hospitals participating in 340B are on the frontlines of this response with a variety of actions aimed at educating providers and patients, providing alternatives to addictive painkillers, and offering ways to get more opioids off the streets. Panelists will discuss a variety of approaches being taken to respond to the unique needs of communities across the country.

Andrew Lowe, Clinical Director/Pain Management Pharmacotherapy, Arrowhead Medical Center
Joan Papp, Medical Director, Office of Opioid Safety; Assistant Professor, Department of Emergency Medicine MetroHealth Medical Center
David Twitchell, Vice President and Chief Pharmacy Officer, Boston Medical Center Health System
Bharath Krishnamurthy, Senior Manager of Research, 340B Health (Moderator)

Small Group Discussions/Roundtables

A) CHC Expert Session: The Shifting 340B Reimbursement Landscape (Part 1)  
Location: Aqua DEF

When Congress enacted the 340B Drug Pricing Program in 1992, it was their intent that the program would support the viability and effectiveness of the nation’s health care safety net by enabling eligible entities serving the country’s most vulnerable populations to expand access and provide comprehensive and high-quality services. However, in recent months, the health center community has seen a rapidly escalating trend in the market that is effectively redirecting savings intended for covered entities to a variety of third parties in the supply chain. In Part One of our two-part coverage of this issue, participants will receive an overview of how savings are being shifted away from the intended covered entities. Participants will hear from two health centers about their recent experiences with discriminatory reimbursement models, and hear from the experts as to the legislative, regulatory and legal perspective on this critical issue.

Kris Chiplinski, Director of Pharmacy, Little River Medical Center
Colleen Meiman, Senior Policy Advisor, National Association of Community Health Centers
Derek Pihl, Pharmacy Director, Salina Family Healthcare Pharmacy
Jason Reddish, Partner, Feldesman, Tucker, Leifer, Fidell LLP
Sue Veer, President and CEO, Carolina Health Centers, Inc. (Moderator)
12:15pm Lunch and Networking Opportunity
Location: Bayfront Park, Exhibit Hall
1:30pm Track One 
340B Operations: Experiences from the Field


A) Exploring Changes to Medicare Part B Drug Reimbursement
Location: Indigo CG

President Trump has made clear that addressing high drug prices is a priority for his administration. This session will explore policies and proposals that seek to change Medicare Part B drug reimbursement in an effort to reduce drug prices. Panelists will review the Centers for Medicare & Medicaid Service’s 340B payment reduction policy for Medicare Part B drugs billed under the Hospital Outpatient Prospective Payment System (OPPS) and the Administration’s recent proposal to use an International Pricing Index Model to set reimbursement for Part B drugs. This session will discuss how these policies impact 340B hospitals and advocacy efforts that have been taken by the 340B hospital community in response. A hospital representative will also discuss compliance requirements related to Medicare modifiers for 340B drugs billed under the OPPS.

Jeff Davis, Of Counsel/Senior Advisor, Baker Donelson, PC
Charles Stubbs, 340B Pharmacist, Intermountain Healthcare
Amanda Nagrotsky, Legal Counsel, 340B Health (Moderator)

B) Opportunities and Challenges in Specialty Pharmacy
Location: Sapphire AE

The specialty pharmacy industry has experienced significant growth and change over the last few years and specialty drugs are expected to account for half of the total U.S. drug spend by 2020. This session will provide an overview of the evolving specialty drug landscape today. This session will also address the benefits for a covered entity to create their own specialty pharmacy as highlight some of the major concerns and issues inherent therein including managing specialty drug costs or spending, ensuring patient access in the face of limited distribution policies, specialty pharmacy accreditation, and gaining access to payor networks. Other topics covered in this session will include strategies to keep your oncology care in-house and the growing impact of vertically integrated entities that include an insurer, PBM and specialty pharmacy.

Jennifer Rossi, 340B Program Manager, Northern Light Health
Daryl Schiller, Director of Pharmacy Services, Nyack Hospital
Jason Reddish, Partner, Feldesman, Tucker, Leifer, Fidell LLP (Moderator)

Track Two 
340B Policy & Compliance

A) Monitoring and Pursuing 340B Pricing and Access Issues
Location: Aqua DEF

The 2010 Affordable Care Act required HHS to develop standards for 340B ceiling price calculations, civil monetary penalties for manufacturer overcharges, and a ceiling price database for covered entities. A final regulation implementing these statutory mandates was issued in January 2017. However, HHS proceeded to delay the rule’s effective five times. In the fall of 2018, the agency changed course and decided to make the rule effective January 1, 2019.

This session will review the regulation’s key provisions, its implications for 340B stakeholders, and the latest information regarding the ceiling price database, which HRSA said it plans to launch in April 2019. Panelists will also discuss potential strategies that covered entities can employ to detect possible 340B overcharges, including using the ceiling price database when it is released; how to address overcharge concerns with wholesalers and manufacturers; and to how to elevate overcharge matters to HRSA, if needed. Attendees will also hear about provider efforts to access covered outpatient drugs.

Christopher Trimbath, 340B Program Manager, ProMedica Health System
Greg Doggett, Counsel, Dentons
(Moderator)

B) 340B Research Landscape Sample Badge Colors
Location: Aqua 300

This session will provide covered entities an overview of the 340B research in the field and the implications these studies have for the future of the program. The session will also allow participants to hear how covered entities can conduct their own research to evaluate the impact of the 340B program on the health and well-being of the low-income patients they serve.

Isha Rana, Health System Pharmacy Administration Resident, University of Illinois at Chicago
Joey Mattingly, Assistant Professor of Pharmacy Practice and Science, University of Maryland School of Pharmacy
Bharath Krishnamurthy
, Senior Manager of Research (Moderator)


Track Three
Clinical Best Practices

In Pursuit of Equity for 340B Patients
Location: Sapphire 400

Access to healthcare continues to divide our nation. Social determinants of health, including neighborhoods, socioeconomic status, and environment contribute to the health of individuals and communities. Addressing these disparities and providing equitable solutions provides an opportunity for improving health outcomes and building stronger communities. 340B empowers care providers and addresses the needs of often underserved patients and communities.

Jeron Ravin, Chief Operating Officer, Community Health Center Association of Mississippi
Courtney Lang, Founder and Principal, Langco + Partners (Moderator)

Small Group Discussions/Roundtables

A) Large System Roundtable
Location: Sapphire 411

Many 340B professionals help multiple hospitals within a system operate a compliant 340B program. The complex relationship between each individual 340B hospital and its system requires a different approach to 340B program administration than if the professional is responsible for only one 340B covered entity. This session will feature a panel of facilitators each leading a small group discussion on existing challenges they face in operating multiple 340B programs from a system level, providing an opportunity to network with other system-level professionals that face similar challenges and discuss how 340B savings help each individual hospital meet the unique needs of each hospital’s community.

Nick Gnadt, Director of Ambulatory Pharmacy, UnityPoint Health
Jenni Hovell, Operations Manager, Midwest 340B Program, Mayo Clinic Health System
Michael Marchionda, Program Manager – 340B, Cleveland Clinic
Steven Miller, Vice President, Pharmacy Services, 340B Health (Moderator)


B) Rural Provider Roundtable
Location: Aqua 314

Rural safety-net providers in the 340B program face their own set of challenges that are unique to their geographic settings and the populations they treat. Their remote location and limited resources can require a different approach to 340B and how to meet the needs of their patient populations. Rural communities are witnessing an alarming increase in rural hospital closures, with many locations struggling to keep their doors open. In addition, rural hospitals are subject to the orphan drug exclusion, under which manufacturers are not required to offer discounted prices on drugs with an orphan designation. This informal session will offer rural providers the opportunity to network with other rural providers that face similar challenges. Facilitators will be present to lead small group discussions on existing challenges and share ways in which their facilities have been able to use 340B savings to meet the unique needs of rural populations.

Carrie Galvan, 340B Program Coordinator, Boone County Hospital
Olivia Little, 340B Coordinator, Johnson County Hospital
Vinny Polito, System Director, Ambulatory Pharmacy Services, Centura Health
Amanda Sellers Smith, Assistant Counsel, 340B Health (Moderator)
2:45pm Exhibits Open: Refreshment Break and Networking Opportunity
Location: Exhibit Hall
2:45pm Vendor Demo: Sentry Data Systems
Location: Sapphire 410
3:45pm Stakeholder Breakout Sessions

A) Community Health Centers 
Location: Aqua DEF

Join us to discuss the latest 340B issues and developments affecting CHCs. Likely topics will include continuing scrutiny of the 340B program, Medicaid, and 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.

Colleen Meiman, Senior Policy Advisor, National Association of Community Health Centers (Moderator)

B) Family Planning Clinics, STD Clinics, and Other Non-Hospital Providers 
Location: Aqua 314

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.

Taryn Couture, Senior Manager, Policy and Government Relations, National Coalition of STD Directors (Moderator)
Mindy McGrath, Director, Advocacy and Communications, National Family Planning & Reproductive Health Association (Moderator)

C) Hemophilia Treatment Centers 
Location: Aqua 311

This session will focus exclusively on matters impacting 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.

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

D) HIV/AIDS Clinics, ADAPs, and AIDS Service Providers 
Location: Sapphire 400

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

Andrea Weddle, Executive Director, HIV Medicine Association (Moderator) 

E) Hospitals (DSH, Rural, Children's, and Cancer) 
Location: Indigo AE

Hospitals will learn about the latest 340B program developments. This session also will address different ways hospitals can educate their local lawmakers and communities on the importance of the 340B program.

Kathryn DiBitetto, Vice President, Government Relations, 340B Health
Rob Miller, Senior Vice President of Business Development, Strategic Planning and Operations, 340B Health
Richard Sorian, Senior Vice President of Communications, 340B Health
Maureen Testoni, President and Chief Executive Officer, 340B Health

F) Pharmaceutical Manufacturers 
Location: Aqua 300

Pharmaceutical manufacturers will learn about the latest developments involving the 340B program and how those developments will impact the pharmaceutical industry. Likely topics include the latest developments related to HRSA’s rulemaking regarding 340B ceiling prices and manufacturer civil monetary penalties, as well as HRSA audits.

Speakers: TBA

G) 340B Service Providers 
Location: Aqua ABC

This session is designed for all 340B service providers. Participants will hear about emerging issues and concerns facing multiple supply chain partners including wholesalers, chain pharmacies and specialty pharmacies. Additional topics will highlight other challenges that may arise between vendors and covered entities.

Jason Atlas, Vice President, 340B Enterprise Strategy & Solution, AmerisourceBergen

5:15pm-6:15pm  Evening Reception
Location: Exhibit Hall

FEATURED EXHIBITORS

   Pharmaceutical Strategies Group

RxStrategies     Sentry Data Systems
    Verity Solutions
Wellpartner    340B Health
340Basics      CaptureRx

Comprehensive Pharmacy Services     Ponaman Healthcare Conuslting

SCL 340B Care      
Trellis Rx