TUESDAY, JULY 16, 2019

*Subject to change

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

7:00am- 5:15pm Registration Open
Location: Lobby Level
7:00am-
8:30am

Continental Breakfast and Networking Opportunity
Location: Exhibit Hall, Exhibition Level

(If you have a morning session on the Exhibition Level, please take breakfast to your session.)**
7:10am-
8:25am
340B Lessons from the Field (Part 1)
Location: Washington 4/5, Exhibition Hall

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.

Learning Objectives:
  • Identify key 340B challenges as they relate to compliance, operations, or oversight
  • List best practices for improving 340B compliance, operations, or oversight
  • Describe how to work with vendors to strengthen 340B compliance, operations, or oversight
  • Address effective integration of different vendors to ensure 340B compliance, operations, or oversight
  • Discuss vendor perspectives on current 340B policy developments 
Christy Bryant, Vice President, Regulatory Affairs and Compliance, Macro Helix
Callie Lyons, Director, Pharmacy Support, Wellpartner, Inc.
Lisa Scholz, Head of Industry Relations, Sentry Data Systems
Jamie Shaw, Pharmacy Services Director, Verity Solutions 
Shane Kelley, Director, Member Services, 340B Health (Moderator)
7:15am-
8:15am
Ask the Expert Breakfast for Pharmaceutical Manufacturers 
Location: Washington 2, Exhibition Level

This session is an opportunity for pharmaceutical manufacturers to hear from an expert who works on a broad range of 340B-related issues. A consultant with significant experience with 340B and other federal drug pricing programs will field your questions in this small group discussion.

Marcy Imada, Principal, Deloitte Consulting, LLP (Moderator) 
7:15am-
8:15am
Pharmacy Technician Networking Breakfast - Developing and Enhancing Their Role and Contribution to the 340B Program
Location: Washington 3, Exhibition Level

Pharmacy technicians will gather for breakfast and a great networking opportunity to share ideas, challenges, and approaches for advancing the role of the pharmacy technician in 340B. Pharmacy technicians will describe how they took initiative and advantage of training to advance their responsibilities in the 340B program including through education, training, resources, websites, and mentoring. Learn how pharmacy technicians have focused their efforts in areas that include working with TPAs, compliance issues, and pharmacy contracting. Hear how pharmacy technicians have taken advantage of opportunities and developed special initiatives to move into leadership positions. 

Learning Objectives:
  • Identify roles and special opportunities for pharmacy technicians in 340B
  • Compare strategies for opening communication channels, securing the trust of colleagues and supervisors, and leveraging education
  • Describe how pharmacy technicians impact 340B and pharmacy practice areas including working with TPAs, compliance issues, hospital pharmacy operations, and contracting.
  • Evaluate how to advance the pharmacy technician role in 340B
Mishele Dufour, Pharmacy Analyst, Salem Health
Amy Satterwhite, Pharmacy Operations Manager, Carolina Health Centers, Inc.
Cameron Spendlove, 340B Contract Pharmacy Program Coordinator, Intermountain Healthcare
Leah West, Pharmacy 340B Business Manager, Riverside Health System
Steven Miller, Vice President, Pharmacy Services, 340B Health (Moderator)
8:30am-
9:15am
Keynote Speaker: Len Nichols, Director of the Center for Health Policy Research and Ethics, Professor of Health Policy, George Mason University
Location: Marriott Ballroom, Lobby Level

A nationally-recognized expert in health policy, Len Nichols will discuss the current national debates over the Affordable Care Act, drug pricing, and “Medicare for All” and how these discussions can impact 340B covered entities.

Learning Objectives:
  • Describe how the national debate over drug pricing could lead to federal legislation and explain the policies being debated to control the price of prescription drugs
  • Discuss how the debate over “Medicare for All” could lead to major changes in the American health care system and explain the implications of this debate for the Affordable Care Act insurance construct
  • Describe the impact of high deductible health plans on consumers’ ability to pay for prescription drugs and discuss whether the trend toward higher and higher deductibles will continue at its current pace
9:30am-10:45am Track One 
340B Operations: Experiences from the Field


A) 340B OPAIS Pricing Component from HRSA Staff
Location: Thurgood Marshall South/West, Mezzanine Level

Following the implementation of the 340B ceiling price and manufacturer civil monetary penalties regulation on Jan. 1, 2019, HRSA launched a secure online database that provides covered entities with information on the amounts they can be charged for 340B drugs. During this session, HRSA will provide an overview of the database and information on how to effectively use it as a resource.

Learning Objectives:
  • Explain the 340B OPAIS pricing components purpose as a vehicle for increased manufacturer transparency and accountability
  • Describe HRSA’s process for obtaining and reconciling pricing data
  • Identify the 340B OPAIS pricing component security features and their purpose in protecting pricing information
  • Outline the ceiling price data points and search/sort features
  • Describe lessons learned and best practices for reporting and using information in the 340B OPAIS pricing component 
CDR Joshua Hardin, Public Health Analyst, Office of Pharmacy Affairs, Health Resources and Services Administration
Julie Zadecky, Pharmacist, Office of Pharmacy Affairs, Health Resources and Services Administration
Rebecca Swartz, Policy and Compliance Manager, 340B Health (Moderator) 

B) Contract Pharmacy Considerations and Practices
Location: Virginia Suite, Lobby Level

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 through each stage of setting up and maintaining a contract pharmacy arrangement, including negotiation of the contract, implementation, and ongoing oversight. This session will address important legal, business, and operational considerations for covered entities and contract pharmacies as they evaluate whether to enter into an agreement and negotiate a contract pharmacy arrangement. The session will also highlight how entities can monitor their contract pharmacies to ensure 340B compliance.

Learning Objectives:
  • Describe program rules on contract pharmacy
  • Identify key elements of a compliant contract pharmacy
  • Discuss important considerations for covered entity and contract pharmacy negotiations for contract pharmacy arrangements
  • Outline possible strategies for monitoring contract pharmacy compliance 
Kenneth Pacheco, Manager, Pharmacy and Lab Services, Access Community Health Network
LeeAnn Scheer, Director, Pharmacy, Magnolia Regional Medical Center
Jason Reddish, Partner, Feldesman Tucker Leifer Fidell LLP (Moderator)

Track Two 
340B Policy & Compliance


A) Medicaid Billing and Reimbursement 
Location: Thurgood Marshall North/East, Mezzanine Level

This session will address the complex intersection of the 340B and Medicaid programs. Speakers will describe current federal rules for duplicate discount prevention and reimbursement of 340B drugs prescribed to Medicaid patients, trends regarding state requirements for 340B drugs, 340B-Medicaid issues commonly faced by covered entities, and the National Council for Prescription Drug Programs’ standards and resources related to 340B claim reporting.

Learning Objectives: 
  • Describe how the 340B and Medicaid programs interact
  • Detail federal rules governing 340B drugs
  • Address Medicaid state trends regarding billing, reimbursement, and identification of 340B drugs
  • Identify National Council for Prescription Drug Progams standards and resources related to 340B claim reporting 
John Coster, Director, Division of Pharmacy Disabled and Elderly Health Program Group, Center for Medicaid and CHIP Services, Centers for Medicare & Medicaid Services
Lynn Lewis, Director, Goverment Relations, IQVIA 
Gavin Magaha
, Manager, 340B Education and Compliance Support, Apexus
Greg Doggett, Vice President, Legal and Policy Counsel, 340B Health (Moderator)

B) 340B Research Landscape (Covered Entities Only)         

Location: Maryland Suite, Lobby Level

This session will provide covered entities an overview of the 340B research in the field and the implications this research will have for the future of the program. The session will 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 patients they serve who are living with low incomes.

Learning Objectives:
  • Outline current published research and data in the field evaluating the 340B drug pricing program
  • Outline how published research evaluating 340B can affect policymaking around the 340B program
  • Identify new areas of research in 340B that can be further explored
  • Identify the role covered entities can have in supporting research around 340B, including studying the effect of programs supported by 340B savings on health outcomes
Sean Dickson, Director, Health Policy, West Health Policy Center
Eric Jones
, PhD Candidate, Health Services Research, Boston Medical Center
Bharath Krishnamurthy, Senior Manager, Research, 340B Health (Moderator)

Track Three
Clinical Best Practices 


Using 340B Savings to Benefit Low Income Patients
Location: Wilson ABC, Mezzanine Level

Covered entities are encouraged to share how they use 340B savings to stretch scarce federal resources. This session will focus on three examples of how covered entities have looked at their savings and allocated funding to pharmacy or facility initiatives that provide better access and care for their patients. Learn from your peers about strategies and opportunities for telling your 340B story.

Learning Objectives:

  • Describe how 340B savings can be used to benefit and improve the health of patients with low incomes
  • Identify examples of how clinical pharmacy services support the community
  • Describe how stabilization programs can benefit patients with low incomes
  • Describe how a liaison program can lead to a better patient experience 
Matthew Bertsch, Director, Pharmacy, Sun Life Family Health Center 
Kathy Gaddis, Social Services Manager, University of Alabama 1917 Clinic 
Leslie Pires, 340B Program Manager, Care New England Health System (Moderator) 

Small Group Discussions/Roundtables

A) Rural Provider Roundtable
Location: Washington 2, Exhibition Level

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.

Learning Objectives:

  • Identify 340B issues specific to rural providers
  • Discuss unique challenges that rural providers face when meeting the needs of their patient populations
  • Discuss innovative methods of connecting rural providers with hard-to-reach and vulnerable populations 

Sandra Clark, 340B Coordinator, Meadville Medical Center
Olivia Little, 340B Director, Johnson County Hospital
Cameron S. Spendlove, 340B Contract Pharm. Coordinator, Intermountain Healthcare Pharmacy Services 
Amanda Smith, Assistant Counsel, 340B Health (Moderator)

B) Grantee Audit Roundtable (Non Hospital Covered Entities Only)      
Location: Washington 2, Exhibition Level

This roundtable is limited to non-hospital covered entities only. Attendees will hear from grantees that have been through a HRSA audit. Covered entities will share their perspective regarding what to expect during an audit, including steps taken when an audit results in findings. The roundtable will provide an opportunity to discuss best practices in audit preparation, lessons learned from the audit experience, and how to respond to audit findings.

Learning Objectives: 

  • Describe audit experiences
  • List ways to improve your grantee’s audit readiness
  • Discuss leading practices in audit preparation
  • Identify ways to respond to audit findings

Rafael Kirkpatrick, Pharmacy Manager, Valley AIDS Council
Paul Limberis, Pharmacy Manager, Hemophilia and Thrombosis Center
Lisa Nelson, Pharmacy Director, Unity Care NW
Elizabeth Karan, Senior Associate, Feldesman Tucker Leifer Fidell LLP (Moderator)

10:45am-11:45am Networking and Refreshment Break
Location: Exhibit Hall, Exhibition Level
10:45am-11:35am Vendor Demo: Sentry Data Systems
Location: Roosevelt 1, Exhibition Level

Dialing into Analytics and Innovation to Meet 340B Needs

Comprehensive 340B solution offerings should address the latest industry trends and needs. Analytics is becoming more and more of a core component to manage program compliance and balance financial outcomes. In this session, you will learn how Sentry continues to strive to meet the demands of the marketplace. Do you have analytics at your fingertips? Can you provide key auditable data on demand without any external merges or manipulation? Do you have options to access custom and standard reporting? Ready to learn more? Join us to see a presentation on Sentry’s latest product functionality to meet today’s evolving industry challenges — including claims manager plus, eRx Sentrex eligibility check and Sentinel Split to WAC when the Price is Better.

Dawn DeAngelo, Chief Pharmacy Officer, Sentry Data Systems
10:45am-11:35am
Vendor Demo: Verity Solutions 
Location: Roosevelt 2, Exhibition Level 

The Verity Solutions Difference 

All covered entities are concerned about maintaining 340B program compliance, improving operational efficiency, remaining audit-ready, optimizing their 340B program savings, and getting the most benefit from their TPA relationship. Join us for a demonstration and Q&A of our V340B solutions for split billing, contract pharmacy, specialty contract pharmacy and more, and find out why independent KLAS customer feedback ranked Verity as Category Leader for 340B Management Systems. 

Todd Behrman, Vice President, Product Management & Marketing, Verity Solutions
11:45am-12:30pm

Keynote Speaker: Mara Liasson, National Political Correspondent, NPR “A 2020 Vision of American Politics”
Location: Marriott Ballroom, Lobby Level

Ms. Liasson is a national political correspondent for National Public Radio, where she provides extensive coverage of politics and policy from Washington, D.C., focusing on the White House and Congress. She also reports on political trends beyond the Beltway.

Learning Objectives:

  • Discuss the role health care policy will play in the 2020 presidential and congressional elections.
  • Discuss whether or not the debate over high drug prices may become part of the national debate in 2020.
  • Discuss the extent that the “Medicare for All” issue may play out during the campaign
12:30pm-1:45pm Networking Lunch
Location: Exhibit Hall, Exhibition Level
1:45pm-3:00pm

Track One 
340B Operations: Experiences from the Field


A) Inventory Management Strategies for Compliance and Efficiency
Location: Thurgood Marshall North/East, Mezzanine Level

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, and maintain budgetary balance within their departments. Panelists will discuss strategies and ideas for solutions to 340B drug concerns, such as monitoring 340B pricing and various purchasing accounts, accessing and purchasing specialty drugs, following the definition of exceptions to covered outpatient drug, and monitoring/ auditing for compliance with inventory management policies and procedures.

Learning Objectives:

  • Describe how to evaluate exceptions to the definition of a covered outpatient drug
  • Identify inventory management systems that are compliant with 340B rules around patient definition and the duplicate discount prohibition
  • Identify strategies for monitoring 340B pricing
  • Evaluate various purchasing account set-ups to assure compliance with the GPO prohibition 
Chris Hilty, System Pharmacy Supply Chain and 340B Manager, Methodist Le Bonheur Healthcare
Hannah Rowell, Process Improvement Leader, Erie Family Health Center 
Shawn Wood, Pharmacy 340B and Inventory Supervisor, Beth Israel Deaconess Medical Center 
Steven Miller, Vice President, Pharmacy Services, 340B Health (Moderator)


B) Contract Pharmacy Basics
Location: Marriott Ballroom Salon 3, Lobby Level

Is your organization thinking about entering into contract pharmacy arrangements, but doesn’t know where to start? This session will introduce you to contract pharmacy. Panelists will address why their organizations use contract pharmacy, how to register contract pharmacies on OPA’s website, and how to follow basic compliance requirements.

Learning Objectives:

  • Describe why 340B covered entities use contract pharmacy
  • Identify key elements of a compliant contract pharmacy
  • Discuss registration process for contract pharmacy
  • Outline possible strategies for monitoring contract pharmacy compliance 
Kamile Johnson, Director, Pharmacy Services, Kansas City CARE Clinic
Kevin Jones, 340B Drug Pricing Program Director, Intermountain Healthcare
Jeff Davis, Of Counsel/Senior Advisor, Baker Donelson (Moderator)


Track Two 
340B Policy & Compliance

A) Understanding Medicare Provider Based Rules and Implications for 340B Child Site Registration
Location: Virginia Suite, Lobby Level

This session will provide an overview of the Medicare cost report and provider-based rules as they relate to the 340B program and HRSA’s policies for offsite facility registration. Topics to be addressed include how to use the cost report to support 340B eligibility of facilities, understanding child site registration under HRSA’s Office of Pharmacy Affairs Information System, and how to develop a trial balance crosswalk to help ensure compliance with HRSA requirements.

Learning Objectives:

  • Describe Medicare provider-based rules and criteria for provider-based status
  • Discuss the relationship of the Medicare cost report to 340B child site registration
  • Describe the importance of maintaining a Medicare crosswalk
  • Outline required processes for 340B child site registration  
Matthew Atkins, Manager, Draffin & Tucker, LLP 
Mara Pickard, 340B Compliance Analyst, University of North Carolina Hospitals
Barbara Straub Williams, Principal, Powers Pyles Sutter & Verville PC (Moderator)

B) Audit Update from HRSA Staff
Location: Thurgood Marshall South/West, Mezzanine Level

Hear from members of HRSA’s staff about the audit process, trends, and best practices.

Learning Objectives:

  • Describe HRSA's program integrity guiding principles
  • Discuss areas of focus for HRSA audits
  • Describe updates in the HRSA audits
  • Outline the HRSA audit process
  • Discuss audit trends and best practices 
Tracey Applebee-Cole, Pharmacist, Program Performance and Quality Branch, Health Resources and Services Administration
Jane McLaughlin, Pharmacist, Program Performance and Quality Branch, Health Resources and Services Administration
Thomas Pettin, Public Health Analyst, Program Performance and Quality Branch, Health Resources and Services Administration
Sherry Pontell, Branch Chief, Program Performance and Quality Branch, Health Resources and Services Administration
Rebecca Swartz, Policy and Compliance Manager, 340B Health (Moderator) 


Track Three
Clinical Best Practices

Health Equity and 340B Policy Solutions
Location: Wilson ABC, Mezzanine Level

Access to quality care remains a challenge for many communities. Geographic isolationism occurs in both rural and urban areas. Having access to a network of safety-net providers is critical to the cohorts of uninsured and underinsured patients. This session will discuss advancing the overall health equity dialogue and emphasize the importance of the 340B program as a key policy solution that removes barriers to care. 340B provides access to needed health care interventions for a wide range of chronic diseases and empowers patients with the opportunity to receive life-saving clinical support. 340B hospitals partner with communities to influence healthy behaviors, prevent and treat disease, provide education, and minimize disease progression. Panelists will discuss practical solutions to advance health equity through the 340B program and the intersectionality of public policy, access to care, and patients/ communities served.

Learning Objectives:

  • Examine the importance of health equity and 340B from the lens of policy solutions and patient care via programs and services that benefit underserved populations;
  • Recognize specific examples of how the 340B program serves as a solution for addressing access to care, recognizing the prevalence of health inequities in geographically and economically disparate communities;
  • Demonstrate the connection between health equity and advocacy for 340B as a critical policy measure to promote life-saving clinical support and opportunities to drive access to quality health care;
  • Discuss practical solutions and best practices amongst participants, and the importance of deepening partnerships, policy, access, and consumers around culturally inclusive health care. 
Philip Alberti, Senior Director, Health Equity Research and Policy, Association of American Medical Colleges
Edwin Corbin-Gutierrez, Senior Manager, Health Systems Integration, National Alliance of State and Territorial AIDS Directors
Stephen Lockhart, Chief Medical Officer, Sutter Health

Courtney Lang, Founder and Principal, Langco + Partners (Moderator)

Small Group Discussions/Roundtables

A) How to Advocate for 340B (Covered Entities Only)       
Location: Washington 3, Exhibition Level

Covered entities have compelling stories to tell about how they utilize the 340B program. Rising above all the noise to have those stories noticed by lawmakers, regulators, policy influencers, and the general public can be challenging. In this skills-focused roundtable discussion, our groups of experts will give you the tactical advice you need to advocate effectively for your 340B program and your patients. Strategies discussed will include how to cultivate positive relationships with your elected officials, place opinion pieces and news stories in your regional media outlets, and develop influential social media posts about your patient care work.

Learning Objectives:

  • Discuss why it is important for covered entities to communicate their 340B stories
  • Discuss how a covered entity can cultivate positive relationships with elected officials
  • Discuss how a covered entity can work with media outlets to reach intended audiences
  • Discuss how a covered entity can utilize social media to amplify your messaging 
Julie Clements, Director, Health and Clinical Affairs, Federal Governmental Relations, University of California
Elise Cranston, Grassroots and Advocacy Manager, 340B Health
David Glendinning, Director, Communications, 340B Health
Myles Goldman, Communications Manager, 340B Health
Cynthia Martens, Director of Pharmacy and Director of the Diabetes Education Program, Monroe County Hospital


B) Large System Roundtable
Location: Washington 2, Exhibition Level

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 topics including existing challenges in operating multiple 340B programs from a system level. The roundtable also will provide 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 its community.

Learning Objectives:

  • Identify 340B issues specific to large health systems
  • Describe 340B training programs in large systems
  • Discuss unique challenges that large health systems face when meeting the needs of their patient populations.
  • Discuss unique challenges that large health systems face when developing systems and policies across an integrated health system 
Craig Frost, System Vice President, Clinical Pharmacy Services, Catholic Health Initiatives
Vinny Polito, System Director Ambulatory Pharmacy Services, Centura Health
Sima Shah, Clinical Pharmacist and 340B Compliance Coordinator, University of Illinois Hospital & Health Sciences System             
Gregory Wilson, Director, Clinical Pharmacy Strategy, University of Pittsburgh Medical Center
Greg Doggett, Vice President, Government Relations, 340B Health (Moderator)

3:00pm-4:00pm Networking and Refreshment Break
Location: Exhibit Hall, Exhibition Level
3:00pm-3:50pm Vendor Demo: Sentry Data Systems
Location:  Roosevelt 1, Exhibition Level

Integrating Technology to Meet Compliance Obligations

You have been selected for a HRSA audit. Now what? At Sentry, we strive to best prepare the covered entity on what to expect during an audit – from the right tools to the right team, we are there to assist you every step of the way. Come learn about the importance of an integrated audit record and the role your vendor plays in supporting your organization. How do you ensure your vendor represents your best interest? Does your administrator provide mock audit support? How does your vendor assist pre-audit, onsite during the audit, and post-event? See how our solutions and services can help be your guide to optimize your 340B program performance from replenishment and location eligibility to transparency with a focus on what lies ahead in 2019 and beyond.

Lisa Scholz, Head of Industry Relations, Sentry Data Systems
3:00pm-3:50pm
Vendor Demo: Macro Helix 
Location: Roosevelt 2, Exhibition Level 

Reach your Uninsured and Underinsured Patient Population in a Meaningful and Transparent Manner 

Macro Helix Prescription Assistance Programs allow covered entities to use their 340B savings to help those patients who are most in need. Through our easy-to-use Patient Assistance Program, Macro Helix can help covered entities design a prescription benefit, which allows 340B savings to be passed directly to patients in the form of reduced or zero cost copays. No vendors allowed in this session. 

Marie Williams, Sales Solutions Consultant, Macro Helix 
4:00pm-5:15pm

Track One 
340B Operations: Experiences from the Field


A) 340B Lessons from the Field (Part 2)
Location: Washington 4/5, Exhibition Level

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.

Learning Objectives:

  • Identify key 340B challenges as they relate to compliance, operations, or oversight
  • List best practices for improving 340B compliance, operations, or oversight
  • Describe how to work with vendors to strengthen 340B compliance, operations, or oversight
  • Address effective integration of different vendors to ensure 340B compliance, operations, or oversight
  • Discuss vendor perspectives on current 340B policy developments 
Ross Halsne, Vice President, 340B Administration, Maxor National Pharmacy Services, LLC
Harry Norsworthy, Associate Principle 340B Services, Vizient
Kyle Vasquez, Shareholder, Polsinelli PC
Steven Zielinski, Director, Industry Relations, Kalderos
Shane Kelley, Director, Member Services, 340B Health (Moderator)


B) Navigating Recertification and New Documentation Requirements
Location: Thurgood Marshall South/West, Mezzanine Level

HRSA requires all covered entities to recertify annually. The purpose of annual recertification is twofold—it verifies the accuracy of entities’ information on the OPA covered entity database and it requires entities to certify that they meet 340B participation requirements. This session is designed to help covered entities prepare for recertification by providing an overview of the recertification process and lessons learned from previous recertification experiences. The session will also cover new HRSA documentation requirements for hospitals to support 340B eligibility.

Learning Objectives:

  • Provide an overview of recertification
  • Assist covered entities in preparing for recertification
  • Identify new documentation requirements for hospitals related to 340B eligibility
  • Describe documentation hospitals may use to support 340B eligibility 
Angela Campitelli, 340B Program Manager/Clarity Report Designer, Neighborhood Family Practice 
Alexsandra Soto, Manager, 340B & Pharmacy Affairs, Memorial Healthcare System 
Jeff Davis, Of Counsel/Senior Advisor, Baker Donelson (Moderator) 

Track Two 
340B Policy & Compliance

A) Navigating HRSA Audits and Taking Corrective Action
Location: Thurgood Marshall North/East, Mezzanine Level

Covered entities and manufacturers are responsible for complying with 340B program requirements and invest in knowledgeable staff and complex software systems to do so. Despite making sincere efforts to enhance 340B program integrity, covered entities still may experience compliance issues given the evolving and complex nature of the 340B program. What if a compliance problem is detected by HRSA or by your organization through an internal self-audit? What kind of corrective action will be needed? How does a provider make repayments to pharmaceutical manufacturers? Providers who have been audited by HRSA will address these questions and will review the audit process so that your entity can feel prepared when it receives an audit notice from HRSA.

Learning Objectives:

  • Outline the HRSA audit process
  • Identify effective strategies to prepare for a HRSA audit
  • Review covered entity options for responding to a HRSA audit report
  • Review elements of a corrective action plan 
Ronnah Alexander, Pharmacist, Regional Health Care Affiliates
Jason Mills, Pharmacy Supply Chain Manager, Medical University Hospital of South Carolina 
William von Oehsen, Principal, Powers Pyles Sutter & Verville PC (Moderator)

B) Strategies to Prevent Duplicate Discounts (Covered Entities Only)       
Location: Virginia, Lobby Level

Pharmaceutical manufacturers are protected from having to pay a 340B discount and a Medicaid rebate on the same drug. HRSA audits of 340B covered entities assess covered entity compliance with the prohibition against duplicate discounts. Duplicate discount findings appear to be increasing based on posted audit results on HRSA’s website. This session is designed to provide covered entities with strategies to prevent duplicate discounts. Attendees will hear from hospitals and a federally qualified health center on what their organizations do to prevent duplicate discounts. A hospital also will share its perspective on responding to a HRSA audit finding related to duplicate discounts.

Learning Objectives:

  • Provide an overview of covered entity obligations to prevent duplicate discounts
  • Identify causes of duplicate discounts
  • Describe strategies to prevent duplicate discounts
  • Outline how HRSA evaluates duplicate discount compliance in audits 
Seema Kakar, 340B Compliance Coordinator, Harbor Health Services
John Wessel, Pharmacy Technician, Mercy Health
Cindy Williams, Vice President and Chief Pharmacy Officer, Riverside Health System
Amanda Nagrotsky, Legal Counsel, 340B Health (Moderator)


Track Three 
Clinical Best Practices

Using 340B to Address Hepatitis C Infections
Location: Wilson ABC, Mezzanine Level

This session will provide an overview of how 340B hospitals are on the front lines of addressing the nation’s growing problem in hepatitis C infections. From specialized drugs to unique multi-disciplinary treatment programs, 340B hospitals share their efforts supported by 340B and insights on how to address this important clinical and policy issue.

Learning Objectives:

  • Identify the issues and challenges surrounding the treatment of hepatitis C infections
  • Identify the role that 340B hospitals are playing in addressing this important issue
  • Describe programs and services that 340B hospitals have successfully implemented to treat patients living with hepatitis C
  • Describe the role of 340B savings in supporting programs and services to effectively care for patients with hepatitis C 
Nicholas E. DiPirro, Supervisor, Specialty Pharmacy Services, UVA Specialty Pharmacy 
Robert Ferraro, General Manager of Specialty Pharmacy, Southern Ohio Medical Center 
Andy Lowe, Clinical Director of Pharmacy, Arrowhead Regional Medical Center
Bharath Krishnamurthy, Senior Manager, Research, 340B Health (Moderator)


Small Group Discussions/Roundtables

A) CHC Expert Session 1: Unraveling the Mysteries of Billing and Reimbursement in a Health Center 340B Pharmacy Program
Location: Maryland Suite, Lobby Level

This session opens with a brief overview of the basics of pharmacy billing and reimbursement and proceeds to several areas critical to the effectiveness and compliance of health center 340B pharmacy programs. Topics that will be explored by our experts include but are not limited to:

  • Establishing a pharmacy fee schedule for both 340B and open retail pharmacies;
  • Establishing an income based sliding fee discount program that complies with Section 330 requirements and is both affordable and financially sustainable; and
  • Evaluating compliance and financial impact of health center pharmacy 3rd party reimbursement policies and procedures. 

Learning Objectives:

  • Explain the fundamentals of pharmacy charges and reimbursement;
  • Identify key factors that must be considered when setting pharmacy charges;
  • Discuss the intersection of Section 330 Health Center Program Expectations with the health center 340B pharmacy program as it relates to patient charges; and
  • Evaluate the health center pharmacy’s third-party reimbursement policies for compliance and efficacy. 
Jared Hatchard, Community Pharmacy Operations Manager, Sun Life Family Health Center
Colleen Meiman, Senior Policy Advisor, National Association of Community Health Centers
Jason Reddish, Partner, Feldesman Tucker Leifer Fidell LLP
Sue Veer, President and CEO, Carolina Health Centers, Inc.
David W. Christian, Pharmacy Director, Central Virginia Health Services, Inc. (Moderator)


B) Hospital Audit and Corrective Action Plan Roundtable
(Hospitals Only) 
Location: Washington 2, Exhibition Level

This roundtable is limited to hospitals only. Attendees will hear from hospitals that have been through a HRSA audit and developed a corrective action plan (CAP). Hospitals that have successfully challenged audit findings will share their perspective. The roundtable will provide an opportunity to discuss best practices in audit preparation, lessons learned from the audit experience and CAP development.

Learning Objectives:

  • List ways to improve your hospital’s audit readiness
  • Discuss leading practices in audit preparation
  • Identify ways to develop a corrective action plan
  • Describe options for responding to a final audit report 
Kevin Jones, 340B Program Director, Intermountain Healthcare
Jacob Simons
, Pharmacy Business Administrator - 340B Program, University of Missouri Health Care
Leah West, Pharmacy 340B Business Manager, Riverside Health System             
Steven Miller, Vice President, Pharmacy Services, 340B Health (Moderator)
5:15pm Adjourn

FEATURED EXHIBITORS