TUESDAY, JULY 10, 2018

*Subject to change

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

7:00am- 5:15pm Registration Open
Location: West Registration Desk
7:00am Continental Breakfast  & Stakeholder Networking Opportunity
Location: Exhibit Hall 
7:15am Ask the Expert Breakfast for Pharmaceutical Manufacturers 
Location: Cabinet Room 

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 & Touche LLP (Moderator)
7:30am Breakfast: Pharmacy Technician Networking Opportunity
Location: Congressional A/B Room

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 establish connections with your colleagues.
7:30am Breakfast: 340B Lessons from the Field - Part 2
Location: Ambassador Ballroom

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.

Scott Ponaman, President, Ponaman Healthcare Consulting
Molly Pliszka, Strategic Accounts Director, Verity Solutions
Rhodie Smith, Vice President, Contract Pharmacy Sales, RxStrategies
Lee-Anne Gabrielli, Senior Manager, Partnerships & Exhibits (Moderator)
8:30am Legislative Update
Location: Regency Ballroom

This session will provide attendees with a comprehensive update on the political landscape in Washington, DC, related to 340B, including an examination of new 340B legislation in the House and Senate and other efforts to make changes to the program.

Congressional Staff Members
Kathryn DiBitetto, Vice President, Government Relations, 340B Health (Moderator)
9:15am 340B Update from Office of Pharmacy Affairs -- Captain Krista Pedley
Location: Regency Ballroom

Office of Pharmacy Affairs Director Captain Krista Pedley will update attendees on the agency’s plans for the remainder of 2018 and beyond. Captain Pedley will also address OPA’s continued oversight efforts and initiatives, including audits of covered entities and manufacturers.

Captain Krista Pedley, Director, Office of Pharmacy Affairs, Health Resources and Services Administration
10:00am Apexus Update
Location: Regency Ballroom

Apexus, as HRSA’s government contractor for the 340B Prime Vendor Program (PVP), is responsible for negotiating sub-ceiling discounts on 340B drugs and discounts on other pharmacy-related products and services for participating covered entities. The organization also plays an important role in providing 340B technical assistance to covered entities. Apexus will provide an update on its programs and initiatives.

Chris Hatwig, President, Apexus
10:30am Exhibits Open: Networking and Refreshment Break
Location: Exhibit Hall
10:30am Vendor Demo: Macro Helix (Open to All Attendees)
Location: Executive Room
11:30am Amy Walter, National Editor of the Cook Political Report Keynote Speaker
 Amy Walter, National Editor of the Cook Political Report

 Location: Regency Ballroom

Over the past 19 years, Amy Walter has built a reputation as an accurate, objective, and insightful political analyst with unparalleled access to campaign insiders and decision-makers. Known as one of the best political journalists covering Washington, she is the national editor of the Cook Political Report and the former political director of ABC News. From 1997–2007, Walter served as senior editor of the Cook Political Report. She is also a regular panelist on NBC’s Meet the Press, Fox News’ Special Report with Bret Baier, and CBS' Face the Nation. She provides political analysis every Monday evening for the PBS NewsHour. In her presentations, Walter expertly breaks down the electoral process, congressional culture, and the Washington political scene. Her astuteness, wit, and range of expertise create an engaging, compelling presentation, and her reliable and accurate analysis has earned her numerous accolades. Amy Walter takes audiences on an insider’s tour of Washington through the eyes of the woman with her finger on the pulse of politics. While at ABC, Walter oversaw the organization’s political coverage – including the daily political tip sheet The Note, guided the editorial content of all political news, and provided on air analysis. She co-hosted 2012 election night coverage for the Yahoo!-ABC News Network with Good Morning America weekend anchor Dan Harris. She and Harris also anchored the live-streamed coverage for the presidential and vice presidential debates. Before ABC, she was the editor-in-chief of The Hotline, Washington’s premier daily briefing on American politics. There she served as the political publication’s primary voice for three years, and she provided regular analysis of the national political environment in her weekly National Journal column, On the Trail. Walter has provided election night coverage and analysis since 1998 and was a member of CNN’s Emmy-award winning election night team in 2006. She has also been a regular contributor to PBS’ NewsHour with Jim Lehrer, and has provided political analysis on virtually every major political program on television. Named one of the “Top 50 Journalists” by Washingtonian magazine, Walter was dubbed one of the most powerful people in politics in George magazine for her insights into the mechanics that make the political machine run. She also won the Washington Post’s Crystal Ball Award for her spot-on election predictions and has been frequently quoted as a congressional election expert in newspapers such as the Wall Street Journal, Washington Post, and the New York Times. Charlie Cook, editor and publisher of the Cook Political Report, said, “Today, her work is trusted and respected by Democrats and Republicans alike. She knows how to get beyond bluster and spin to unearth – and explain – what really matters in a political arena. And, she has a proven track record of success, which is essential for those whose jobs depend on accurate political forecasting.” Walter graduated summa cum laude from Colby College, and was also honored by her alma mater her with an honorary PhD. She serves as a member of the College’s Board of Trustees. She is also a member of the Board of Advisors for the University of Chicago’s Institute of Politics.
12:30pm State Networking Opportunity Lunch
Location: Exhibit Hall
1:45pm Track One 340B Operations: Experiences from the Field

A) 340B Lessons from the Field - Part 3
Location: Diplomat Ballroom

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.

Jim Donnelly, Vice President of 340B Pharmacy Services, ATRIA 340B by Hudson Headwaters
Jeff Johnson, Pharmacy Performance Strategist, Omnicell
Lyn Mikesell, Director of Compliance, RPh Innovations
Juliet Quick, Director of Marketing and 340B Client Sales, Equiscript
Chris Wasik, Audit Director – 340B Solutions, Crowe LLP
Rob Miller, Senior Vice President of Business Development, Strategic Planning, and Operations, 340B Health (Moderator)

B) OPAIS Update from HRSA Staff
Location: Palladian Ballroom

HRSA staff will provide an update on that the agency is making to the 340B Office of Pharmacy Affairs Information Systems (OPAIS). Providers use OPAIS to register for the 340B Program and can be used to look up information regarding participating covered entities, manufacturers, and contract pharmacies.

CDR Joshua Hardin, Senior Public Health Analyst, IS Branch Chief, Office of Pharmacy Affairs, Health Resources and Services Administration
Joshua Volpe, Public Health Analyst, Operations Branch, Office of Pharmacy Affairs, Health Resources and Services Administration
Captain Eric Shih, IS Branch Chief, Office of Pharmacy Affairs, Health Resources and Services Administration (Moderator)

Track Two Policy & Compliance

A) Navigating HRSA Audits and Taking Corrective Action
Location: Regency Ballroom

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 may still 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.

Ashley Mains Espinosa, Director, System Pharmacy Business Services, SCL Health
William von Oehsen, Principal Powers Pyles Sutter & Verville, PC (Moderator) 

B) Medicaid Billing and Reimbursement 
Location: Ambassador Ballroom

Speakers will address developments at the intersection of the 340B and Medicaid programs, including California Medicaid’s mandatory carve-out proposal; 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. A pharmaceutical manufacturer representative will explain industry’s 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.

Kathleen Black, Director, Government Strategy, Pfizer Inc.
Charles Cooper, 340B Program Director, Fairview Pharmacy Services
Beth Malinowski, Deputy Director of Government Affairs, CaliforniaHealth+ Advocates
Shuchi Parikh, Associate, Powers Pyles Sutter & Verville PC
Greg Doggett, Vice President, Legal and Policy Counsel, 340B Health (Moderator)

C) First-Hand Accounts: Navigating Congressional Inquiries
Location: Executive Room

Join fellow covered entities for an interactive discussion on Congressional inquiries into the 340B program. Hear from hospitals and clinics who have gained first-hand experience gathering and presenting 340B data to Congress. 

Natalie Alpert, Director, Federal Government Relations, UC San Francisco 
Kevin Jones, 340B Program Director, Intermountain Healthcare 
Melisa Lindamood, Director of Federal Affairs, Johns Hopkins University 
Sue Veer, President and CEO, Carolina Health Centers 
Kathryn DiBitetto, Vice President, Government Relations, 340B Health (Moderator) 

Track Three Clinical Best Practices 

Provider Tales: Investing 340B Savings into Clinical Pharmacy
Location: Congressional A/B Room

Provider Tales: Investing 340B Savings into Clinical Pharmacy Location: Congressional A/B Room Hear how providers are strategically reinvesting their 340B savings into their mission through integrated clinical pharmacy services. Presenters will provide urban and rural perspectives and identify program results.

Mark Loafman, Chair, Family and Community Medicine, Cook County Health and Hospitals
Molly Rockstad, Clinical Pharmacist, Cook County Health and Hospitals
Ed Shanshala, CEO, Ammonoosuc Community Health Center
Rory Phillips, Director of Pharmacy Services and Respiratory Care, Southern Ohio Medical Center (Moderator)

Small Group Discussions/Roundtables

A) CHC Expert Session: Contracting and Consulting with Confidence
Location: Empire Room

It is essential to have confidence in any business relationship or affiliation, so how do you build confidence into the equation when evaluating potential 340B resources? This session will explore what to look for (and look-out for) when evaluating potential consultants, contract pharmacies, third parties, and other 340B business opportunities, as it relates to the specific needs of your covered entity. This session will be moderated by a health center 340B expert who can share perspectives from both sides of the aisle – that of a health center covered entity and that of an outside consultant. NACHC’s senior policy advisor will provide a risk benefit analysis regarding the use of outside resources from the statutory and regulatory perspective. We will hear from a 340B legal expert about the legal parameters and potential pitfalls that should be considered when vetting outside resources. Finally, we will wrap up with specific tools and techniques for conducting your due diligence when selecting outside resources for your 340B program.

Michael B. Glomb, Partner, Feldesman Tucker Leifer Fidell LLP
Kris Klein-Brandham, Manager, 340B Education and Compliance Support, Apexus
Colleen Meiman, Senior Policy Advisor, National Association of Community Health Centers
Tim Mallett, Consultant (Moderator)

B) Rural Provider Roundtable

Location: Cabinet Room

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. In particular, while some rural hospitals are unaffected by the recent reduction in Medicare drug payments and others are exempted from the new policy, many rural hospitals face reduced payments, effective January 1, 2018, and are required to use modifiers to identify 340B drugs. 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 may face similar challenges. Facilitators will be present to lead small group discussions on existing challenges and also share ways in which their facilities have been able to use 340B savings to meet the unique needs of rural populations such as using telemedicine and mobile treatment vehicles.

Carrie Galvan, 340B Program Coordinator, Boone County Hospital
Olivia Little, 340B Coordinator, Johnson County Hospital
Mary-Elizabeth Marr, CEO, Thrive Alabama
Susan Pilch, Senior Vice President of Legal & Advocacy, 340B Health (Moderator)
3:00pm Exhibits Open: Networking and Refreshment Break
Location: Exhibit Hall
3:00pm Vendor Demo: Sentry Data Systems 
Location: Executive Room
4:00pm Track One 340B Operations: Experiences from the Field

Contract Pharmacy Considerations and Practices
Location: Palladian Ballroom

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.

Caroline Chellamy, Stanford Healthcare
Jenni Hovell, 340B Operations Manager, Mayo Clinic
Tayiana Reed, Chief of DC ADAP, District of Columbia Department of Health
Jason Reddish, Partner, Feldesman, Tucker, Leifer, Fidell LLP (Moderator) 

Track Two Policy & Compliance

A) Covered Entity and Manufacturer Collaboration in 340B Compliance Oversight
Location: Ambassador Ballroom

Has your organization ever received a formal letter of inquiry from a manufacturer and wondered why it was receiving such a letter? This session will aim to provide answers to that question, as a manufacturer representative will share their perspective on the internal process behind these inquiries. Panelists will share methods and key indicators manufacturers might look for when determining whether to initiate the formal inquiry process, as well as their suggestions for responding to inquiries. This session will also review the audit authority of 340B manufacturers and outline strategies for covered entities responding to 340B manufacturer inquiries.

Charles Washington Director, Fraud Investigation Group, Pfizer, Inc.
Emily Cook, Partner McDermott Will & Emery (Moderator) 

B) Medicare Payment Cuts to 340B Hospitals -- Financial and Operational Impacts
Location: Regency Ballroom

On Jan. 1, 2018, new Medicare rules went into effect that reduce Medicare Part B drug payments to certain 340B hospitals by nearly 30 percent and require many 340B hospitals to identify 340B drugs with modifiers when billing Medicare Part B. CMS finalized the new policies last November under the 2018 Outpatient Prospective Payment System (OPPS) payment rule, and hospitals continue to pursue both litigation and congressional action to reverse the policies. This session will provide a recap of the advocacy efforts to undo the cuts and a discussion of next steps. It also will provide an overview of the operational challenges hospitals are facing to meet the modifier requirements. Attendees will learn about the new Medicare billing requirements in detail and hear from hospitals about the systems they have put in place to meet the modifier requirements. Note that the payment reduction and modifier requirements only apply to 340B hospitals paid under the OPPS, which excludes hospitals that meet the regulatory definition of “sole community hospital,” critical access hospitals and hospitals in Maryland as well as non-hospital covered entities.

Eileen Kelly Director, Revenue Cycle Analysis, Einstein Healthcare Network
Jeff Davis, Senior Advisor, Baker Donelson, PC (Moderator)


Track Three Clinical Best Practices

Provider Tales: Using 340B Savings to Improve Quality of Care
Location: Congressional A/B Room

Hear how organizations are using 340B savings to better manage chronic diseases, optimize pain management in the wake of the opioid crisis, and improve patient outcomes.

Matthew Bertsch, Director of Pharmacy, Sun Life Family Health Center
Jonathan Phung, Clinical Pharmacist, HealthPoint
Andrew Lowe, Clinical Director of Pharmacy, Arrohead Regional Medical Center (Moderator)

Small Group Discussions/Roundtables

A) Hospital Audit & Corrective Action Plan Roundtable Part 1 (Hospitals Only) (repeats Fri AM) 
Location: Executive Room

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.

Coley Deal, 340B Program Manager, HSO Pharmacy Services, Bon Secours
Kevin Jones, 340B Program Director, Intermountain Healthcare
Cindy Williams, Vice President/Chief Pharmacy Officer, Riverside Health System

Amanda Nagrotsky, Legal Counsel, 340B Health (Moderator) 
Steven Miller, Pharmacy Services Director, 340B Health (Moderator) 

B) 340B Advocacy and Communications: Telling Your Story and Why It Matters
Location: Empire Ballroom

Attendees will learn from communications and government relations experts and be given the tools to convey their 340B story to lawmakers and the media.

Julie Clements, Director of Health and Clinical Affairs, Federal Government Relations, University of California
Amanda Smith, Senior Manager of Grassroots Advocacy, 340B Health (Moderator)
Richard Sorian, Senior Vice President of Communications, 340B Health (Moderator)

5:15pm   Adjourn

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