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SERVING PATIENTS SUPPORTING SAFETY-NET PROVIDERS BENEFITING THE COMMUNITY

AGENDA

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February 5-7, 2014 • San Diego, CA

* Additional speakers will be added as they are confirmed. WEDNESDAY, February 5, 2014 7:00 am – 2:45 pm

Exhibit Set up Location: Crown/Coronet

12:00 – 5:00 pm

Early Registration Location: Group Registration Desk

1:30 – 5:15 pm

Pre-Conference Workshop (Three Options)

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Option 1 – 340B: The Essentials 1:30 pm

340B: The Essentials (Part 1) Location: Carousel Room

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Whether you are new to 340B or a veteran, going back to the essentials is an important foundation for all participants in the 340B program. From the day-to-day stakeholders and end users to leadership, everyone plays a role in understanding 340B requirements. Participants can use this course to refresh your 340B knowledge or to document training that may be required by your 340B operational policy and procedures. If you have been in health care for several years but have only recently become engaged in 340B, this pre-conference workshop is essential. This training will help you create an individual performance plan geared toward maintaining compliance in an ever changing program. Participants will discover 340B resources and the roles of the government, health care providers, distributors, manufacturers, pharmacies, and third-party vendors in making the 340B program work effectively. Participants will also learn how entities have operationalized necessary compliance elements. Ed McAdam, Senior Director, Payer Marketing & Contract Strategy, Daiichi Sankyo, Inc. Daniel Neal, Product/Market Senior Manager, Cardinal Health, Inc. Lisa Scholz, Chief Operating Officer and Chief Pharmacy Officer, Safety Net Hospitals for Pharmaceutical Access (Moderator)

2:45 pm

Exhibitor Forum, Refreshment Break, Networking Opportunity (Workshop Attendees and Exhibitors Only) Location: Crown/Coronet

3:45 pm

340B: The Essentials (Part 2) Location: Carousel Room

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Session Continues. Alan Arville, Member of the Firm, Epstein Becker Green Rebecca Cheek, Pharmacy Director, White House Clinics Daniel Nguyen, Director of Pharmacy, Oroville Hospital Lisa Scholz, Chief Operating Officer and Chief Pharmacy Officer, Safety Net Hospitals for Pharmaceutical Access (Moderator)

5:15 pm

Workshop Adjourns Option 2 – Making a 340B Compliance Plan Work

1:30 pm

Making a 340B Compliance Plan Work (Part 1) Location: Ballroom

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The laws governing the 340B program are complex. Compliance requires an understanding of these laws and how to apply them to the purchasing, dispensing, billing, and inventory management systems within your health care facility. Covered entities should establish not only policies and procedures (P&Ps) to comply with 340B requirements but also ongoing oversight mechanisms to verify that the institution’s P&Ps are being followed and are working. For covered entities considering enrollment in the program, these safeguards should be established before discounted drugs are ordered and dispensed. The need to be prepared is especially acute because the government continues to audit covered entities to ensure 340B compliance. Manufacturers have also started to launch audits and are increasingly raising questions about whether covered entities are complying with 340B program rules and guidance. This workshop is designed to assist covered entities and other 340B stakeholders in identifying key 340B compliance areas as well as the types of systems or procedures that should be in place to monitor compliance. ______________________________________ 1

Please note there is an additional cost to attend a pre-conference workshop and you must register for it.


AGENDA

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February 5-7, 2014 • San Diego, CA WEDNESDAY CONTINUED …

* Additional speakers will be added as they are confirmed.

The workshop consists of two parts. The first part will focus on general 340B compliance issues. The second part is divided into two breakout sessions – one for hospitals and one for federal grantees – and will discuss the specifics of how to develop compliance plans and to conduct self-audits. Among the topics that will be addressed are: 1. 2. 3. 4. 5.

Implementation of key 340B requirements Development of 340B P&Ps How to conduct a self-audit Inventory management procedures Involvement of pharmacy staff and senior executives in compliance planning

George Kenny, Associate Director, 340B Account Management, Genentech, Inc. Katheryne Richardson, Senior Director, 340B Program and Policy Analysis, Apexus Paulette Thomas, Corporate Counsel, Catholic Health Initiatives Maureen Testoni, General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

2:45 pm


3:45 pm

Making a 340B Compliance Plan Work (Part 2)

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A. Hospitals Location: Ballroom Reid Horning, Pharmacy Manager, New Ulm Medical Center Deborah Hauser, Network Pharmacy Director, Albert Einstein Medical Center Alexander Mansour, Director of Finance, Henry Ford Health System Greg Doggett, Associate Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

B. HRSA Grantees Location: Garden Room Brian Breitbard, Pharmacy Manager, CARES Community Health Carol Millage, Pharmacy Director, Santa Barbara Public Health Department Stacia Le Blanc, Principal, SL Attorney; Counselor at Law, Counsel to Hemophilia Alliance (Moderator)

5:15 pm

Workshop Adjourns Option 3 – 340B Boot Camp for Hospital Executives (Hospitals Only)

1:30 pm

Introduction to the Program and the Role of Senior Leadership in Promoting and Monitoring Compliance 1 (Limited to Hospital Senior Executives and SNHPA Corporate Partners Only) (Part 1) Location: Viceroy Hall The 340B Boot Camp will begin with an overview of the 340B program and will describe the dual responsibilities of hospital C-Suite executives: ensuring compliance and communicating the benefits of 340B. This will be followed by a panel of senior hospital leaders who will elaborate on the compliance aspects of working at a 340B hospital. Responsibility for compliance must be exercised at the highest levels and can no longer simply be delegated to the hospital pharmacy department. This is especially true now that hospitals are required to appoint a C-suite “authorizing official” to attest personally to his or her institution’s 340B compliance status. Both HRSA and manufacturers began auditing covered entities two years ago, and hospitals are increasingly being selected for onsite inspections. Failure to pass inspection subjects facilities to potential penalties, including having to offer refunds or even being terminated from the program. While it is unclear whether non-compliance creates personal liability for the authorizing official, federal regulators will seek appropriate corrective action by the hospital which, in turn, will demand time and resources from hospital personnel to implement. Panelists will share their experiences and provide practical advice on how best to promote and monitor 340B compliance within their hospitals. Charles Hart, M.D., President and Chief Executive Officer, Regional Health Raja Sekaran, Vice President and Associate General Counsel for Regulatory Affairs, Dignity Health Ted Slafsky, President and Chief Executive Officer, Safety Net Hospitals for Pharmaceutical Access Peter Tibone, Director of Reimbursement, University Medical Center of Southern Nevada William von Oehsen, Principal, Powers Pyles Sutter & Verville PC; Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

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February 5-7, 2014 • San Diego, CA WEDNESDAY CONTINUED …


2:45 pm


3:45 pm

Executive as Advocate and Communicator (Part 2) Location: Viceroy Hall

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Part 2 of the 340B Boot Camp will help hospital executives understand and embrace their role as a 340B advocate. For more than twenty years, the 340B program has helped safety-net hospitals stretch their scarce resources so that they can serve more patients and provide more services within their communities. Critics of the program allege, however, that 340B has grown too big, has strayed from its original purpose, and is not benefiting needy patients. It is now more important than ever for executives to respond effectively to these allegations – on behalf of both their institutions and the program in general. They need to share their stories on how 340B program savings have helped their hospitals, their patients, and their local communities. Our panelists will provide attendees with the tools and knowledge they need to act as successful advocates so that hospitals and patients may continue to benefit from the 340B program in the future. Randy Barrett, Senior Director of Communications, Safety Net Hospitals for Pharmaceutical Access Charles Hart, M.D, President and Chief Executive Officer, Regional Health Mary Ella Payne, Senior Vice President, Policy, Ascension Health Bruce Siegel, M.D, President and Chief Executive Officer, America’s Essential Hospitals Ted Slafsky, President and Chief Executive Officer, Safety Net Hospitals for Pharmaceutical Access (Moderator)

5:15 pm 6:00 pm

Workshop Adjourns, Exhibitor Forum, Networking Opportunity Location: Crown/Coronet

5:30 – 6:00 pm

Conference Primer Location: Carousel Room New to a 340B Coalition Conference, or has it been a few years since you attended? This session is designed with you in mind! Attendees will learn about who makes up the 340B Coalition, how to navigate the conference, and the secret “decoder” to tracks, attendees, and the networking events you don’t want to miss. Come here to learn tips and tricks to survive and get the most value out of your time at the conference. Start your networking early and join conference primer attendees for dinner afterwards (attendees are responsible for cost of dinner). Optional to all conference attendees. Lisa Scholz, Chief Operating Officer and Chief Pharmacy Officer, Safety Net Hospitals for Pharmaceutical Access (Facilitator)

THURSDAY, February 6, 2014 • Commencement of Main Conference 7:00 am

Continental Breakfast Location: Upper Grande Hall Registration Location: Group Registration Desk

8:00 am

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

8:30 am

Legislative Update Location: Ballroom As Congress continues to express concerns over implementation of the Affordable Care Act, the 340B program continues to face unprecedented attention from federal policymakers. Some key lawmakers are calling for more federal oversight and are looking into how covered entities are using program savings to benefit patients. At the same time, champions of the program from both sides of the aisle are reaffirming their support for 340B and are pushing back against what they believe are mischaracterizations of the program and its intent. During this session, you will hear the perspectives of safety-net providers and drug industry experts on what 340B participants and the pharmaceutical sector can expect to see during the upcoming Congressional session. Topics to be covered include a review of key developments in the 340B area over the past year, future 340B legislative initiatives, and other pressing matters impacting providers and the pharmaceutical industry.

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February 5-7, 2014 • San Diego, CA THURSDAY CONTINUED …


Michael McCaughan, Editor, RPM Report; Founding Member, Prevision Policy LLC John Coster, Senior Director of Government Relations, Safety Net Hospitals for Pharmaceutical Access (Moderator)

9:15 am

Federal Government Update Location: Ballroom HRSA continues to take steps to increase its oversight of the 340B program. Over the last year, the agency issued a policy release on the group purchasing organization exclusion that greatly impacted many hospitals both operationally and financially. HRSA also audited more health care providers, released more audit results, and implemented a system-wide annual recertification system. HRSA also initiated its first audit of a drug manufacturer. The agency published a final rule on the use of orphan drugs that is now being challenged in court by PhRMA. During this session, the agency will address what it learned from these activities and will outline its oversight plans for 2014. By June, HRSA is scheduled to issue a long-awaited proposed regulation addressing a range of hot-button issues, including patient definition, definition of covered outpatient drug, hospital eligibility requirements, and potentially new restrictions on contract pharmacies. In addition, the agency plans to continue auditing entities and to release more audit results, as well as information on corrective action plans and sanctions for noncompliance. The agency also just received an additional $6 million to improve oversight. Hear the latest developments from the Director of the agency that oversees the 340B program. Commander Krista Pedley, Director, Office of Pharmacy Affairs, Health Resources and Services Administration

9:45 am

Update from Apexus Location: Ballroom Apexus, as HRSA’s government contractor for the 340B Prime Vendor Program (PVP), is responsible for negotiating sub-ceiling discounts on outpatient drugs and discounts on other pharmacy-related products and services for participating covered entities. Over the last few years, the organization has taken on new responsibilities, including providing 340B technical assistance to all covered entities. Apexus will provide an update on PVP and other organizational initiatives. Christopher Hatwig, President, Apexus

10:15 am

Exhibitor Forum, Refreshment Break, Networking Opportunity Location: Crown/Coronet

11:15 am

HRSA & Manufacturer Audits As we enter the third year of HRSA conducting 340B audits, we are starting to move beyond the audit itself to the next steps of receiving and responding to HRSA’s preliminary and final findings, development of corrective action plans, and potential sanctions. We are also hearing of an increase in the number of audits by manufacturers. Because audits impact 340B stakeholders in different ways, there will be two sessions, one for hospitals and one for HRSA grantees. Manufacturers and other industry representatives may attend either session. A) Hospitals Location: Ballroom Panelists representing the hospital community will address how to prepare for a 340B audit, including gathering the data requested by HRSA and how to work with the auditors. A panelist representing the pharmaceutical industry will share her perspective on the manufacturer audit process and what steps the drug and biotech industry should be taking in this area. Christine Farmer, Manager, Deloitte & Touche LLP Alexander Mansour, Director of Finance, Henry Ford Health System Steve Silverstein, Pharmacy Health System Director, Mercy Hospital Maureen Testoni, General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

B) HRSA Grantees Location: Carousel Room Panelists representing HRSA grantees will share their experiences in preparing for a 340B audit, including gathering the data requested by HRSA, as well as working with HRSA to address audit findings and development of a corrective action plan. A panelist that consults with pharmaceutical manufacturers will share her perspective on the manufacturer audit process and what manufacturers are looking for when conducting audits.


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February 5-7, 2014 • San Diego, CA THRUSDAY CONTINUED …


Ben Avey, Government and Media Relations Manager, Family Health Centers of San Diego Janell Claudy, Pharmacy Manager, Family Health Pharmacy Marcy Imada, Principal, Deloitte & Touche LLP Michael Glomb, Partner, Feldesman Tucker Leifer Fidell; Counsel, National Association of Community Health Centers (Moderator)

12:30 pm

Luncheon and Networking Opportunity Location: Upper Grande Hall

2:00 pm

Track One – 340B Operations Recertification and Registration Location: Carousel Room In 2013, HRSA continued to implement changes in registration and recertification requirements and has incorporated OPA database accuracy into covered entity audits. Changes to the registration process have impacted both contract pharmacies and entities. Whether your entity will be adding or eliminating a child site or contract pharmacy, this session will help you identify key areas to enable successful registration or decertification. All entities are now required to recertify annually, and many lessons have been identified by the government, manufacturers, covered entities, and other program stakeholders. Panelists will explore these issues and will share their experiences and lessons learned. Emily Cook, Partner, McDermott Will & Emery LLP Joshua Hardin, 340B Program Recertification Manager, Office of Pharmacy Affairs, Health Resources and Services Administration Binita Patel, Director, Ambulatory Pharmacy, Froedtert Memorial Lutheran Hospital Lisa Scholz, Chief Operating Officer and Chief Pharmacy Officer, Safety Net Hospitals for Pharmaceutical Access (Moderator)

2:00 pm

Track Two – 340B Policy and Compliance Medicaid Billing and Reimbursement Location: Ballroom Though 340B is a federal program, it has significant implications for states. It can help safety-net providers fund the cost of care for the uninsured and other vulnerable populations, but it also limits states’ ability to collect rebates on Medicaid drugs that are purchased under the 340B program. As a result, many states have special systems in place to identify 340B claims, and many states impose specific billing requirements for 340B drugs. In this session, attendees will hear from individuals representing state perspectives on working with the 340B program, including conducting state audits of 340B entities. Panelists will also discuss the intersection of 340B and Medicaid from the perspective of covered entities and drug manufacturers. Jeff Davis, Associate Counsel, Safety Net Hospitals for Pharmaceutical Access Perry Knight, Senior Counsel, Johnson & Johnson Karen Nelson, Of Counsel, DLA Piper LLP Michael Glomb, Partner, Feldesman Tucker Leifer Fidell; Counsel, National Association of Community Health Centers (Moderator)

2:00 pm

Track Three – Clinical Best Practices Engaging Colleges and Universities in 340B Location: Crystal/Continental 340B entities have had a longstanding tradition of engaging their community to serve their neediest populations with innovative care models. Learn from entity leaders on how they have chartered new partnerships and collaborations with colleges and universities through best practice initiatives. These relationships present exciting opportunities for residents and students to utilize 340B to enhance patient care and outcomes. Nicole Crase, Pharmacy Manager, Five Rivers Health Centers Andrew Lowe, Director of Pharmacy, Arrowhead Regional Medical Center Mark Loafman, Lead, Patient Safety Clinical Pharmacy Collaborative, Northwestern Feinberg School of Medicine (Moderator)


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February 5-7, 2014 • San Diego, CA THURSDAY CONTINUED …


Please Note: Sessions indicating a badge color are limited to the respective covered entity, industry or government groups. For example, hospitals should not attend the pharmaceutical manufacturer’s session and vice versa. Please visit the conference help desk if you have questions regarding your badge color or attendance to sessions. 2:00 pm

Track Four – Peer Leader Roundtables Ask the Experts Tutorial for Pharmaceutical Manufacturers Location: Hanover Room

Badge Color:

This session is an opportunity for pharmaceutical manufacturers to learn from experts who work on a broad range of 340B-related issues. Consultants from two leading pharmaceutical industry consulting firms that have significant experience with 340B and other federal drug discount programs will be fielding your questions in this small group discussion. Linda Schock, Director, Government Programs, Compliance Implementation Services (Co-Facilitator) Kave Niksefat, Senior Principal, IMS Health (Co-Facilitator)

2:00 pm

Specialty Drugs & Limited Distribution Networks Location: Garden Room During this roundtable, attendees will have an opportunity to discuss and ask questions about the challenges covered entities encounter when trying to obtain specialty drugs available through limited distribution networks, potential solutions to those challenges, relevant HRSA policy, the manufacturing community’s perspective on these issues and where the specialty drug market is headed. Michael Bonck, Manager, Pharmaceutical Services, Franciscan Health System Michael McCaughan, Editor, RPM Report; Founding Member, Prevision Policy LLC Greg Doggett, Associate Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

3:15 pm

Exhibitor Forum, Refreshment Break, Networking Opportunity Location: Crown/Coronet

4:00 pm

Stakeholder Breakout Sessions A) Hospitals (DSH, Rural, Children’s and Cancer Hospitals) Location: Ballroom

Badge Color:

Hospitals will learn about recent 340B developments affecting hospitals, including Congressional and HRSA oversight, legislative and regulatory matters, and public awareness initiatives. Hospitals will have time to talk about hot topics in 340B, such as 340B operational requirements and Congressional interest in reforming the program. Randy Barrett, Senior Director of Communications, Safety Net Hospitals for Pharmaceutical Access John Coster, Senior Director of Government Relations, Safety Net Hospitals for Pharmaceutical Access Lisa Scholz, Chief Operating Officer and Chief Pharmacy Officer, Safety Net Hospitals for Pharmaceutical Access Maureen Testoni, General Counsel, Safety Net Hospitals for Pharmaceutical Access Ted Slafsky, President and Chief Executive Officer, Safety Net Hospitals for Pharmaceutical Access (Facilitator)

B) Pharmaceutical Manufacturers Location: Crystal/Continental Badge Color:

Pharmaceutical manufacturers will learn about the latest developments involving the 340B program and how those developments will impact the pharmaceutical industry. Likely topics include HRSA and manufacturer audits of covered entities, HRSA’s plans to audit manufacturers, HRSA’s anticipated 340B “mega-reg”, and PhRMA’s lawsuit challenging HRSA’s orphan drug regulation. Attendees will have an opportunity to ask questions on various topics and provide feedback during the session. Brian Duffant, Senior Principal, IMS Health, Linda Schock, Director, Government Programs, Compliance Implementation Services Edward McAdam, Senior Director, Payer Marketing & Contract Strategy, Daiichi Sankyo, Inc. (Facilitator)


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February 5-7, 2014 • San Diego, CA THRUSDAY CONTINUED …


C) Community Health Centers, Health Departments, Family Planning Clinics, and Other Non-Hospital Providers Location: Carousel Room Badge Colors:

Join us to discuss the latest 340B issues affecting federally qualified health centers (FQHCs), FQHC look-alikes, health departments, family planning clinics, and other HRSA grantees and sub-grantees eligible for the program. Likely topics will include how continuing scrutiny of the 340B program is impacting providers, lessons learned from HRSA’s 340B audits, Medicaid and other third-party billing and reimbursement issues, and an update on relevant legislative matters. This session also will be an opportunity to raise any issues affecting your organization. James Donnelly, Vice President, 340B Pharmacy Services, Hudson Headwaters Health Network Michael Glomb, Partner, Feldesman Tucker Leifer Fidell; Counsel, National Association of Community Health Centers Amir Khoyi, Pharmacy Program Coordinator, California Rural Indian Health Board, Inc. Susan Sumrell, Assistant Director of Regulatory Affairs, National Association of Community Health Centers (Facilitator)

D) Hemophilia Treatment Centers Location: Windsor Complex Badge Color:

This session will focus exclusively on hemophilia treatment centers (HTCs), with an emphasis on 340B issues impacting HTCs. Likely topics include HRSA’s oversight efforts including audits, Medicaid billing and reimbursement issues, and CMS issues regarding implementation of the Affordable Care Act and ensuring HTCs are included as Essential Community Providers. This session also will be an opportunity to raise any issues impacting your HTC. Stacia Le Blanc, Principal, SL Attorney; Counselor at Law, Counsel to Hemophilia Alliance Sean Singh, Vice President, Hemophilia Alliance Joe Pugliese, President, Hemophilia Alliance (Facilitator)

E) HIV/AIDS Clinics, ADAPs, and AIDS Service Providers Location: Hanover Room Badge Colors:

This session will focus on 340B issues affecting Ryan White grantees and sub-grantees, AIDS Drug Assistance Programs (ADAPs), and other HIV/AIDS clinics and service providers. This will be a discussion-based session addressing pertinent topics to participants. Brian Breitbard, Pharmacy Manager, CARES Community Health Emily McCloskey, Manager, Policy and Legislative Affairs, National Alliance of State and Territorial AIDS Directors Britten Pund, Senior Manager, Health Care Access, National Alliance of State and Territorial AIDS Directors (Facilitator)

F) 340B Contract Pharmacies and Pharmacy Service Providers (Chain, Independent & Mail Order Pharmacies and Related Vendors) Location: Regent Hall Badge Colors:

This session is designed exclusively for contract pharmacies and 340B contract pharmacy service providers. It will allow participants to exchange ideas and share information on HRSA’s contract pharmacy program and the challenges and solutions to implementing contract pharmacy arrangements. We will address the findings of a new HHS Office of Inspector General report expected to be published prior to the conference. With a comprehensive 340B regulation scheduled to be published by June that will address a range of issues from patient definition to contract pharmacy, stakeholders will work together to see if they can find common ground on key areas, including program growth, compliance, reimbursement, audits, and system administration. The group will have a facilitated discussion to address ways to ensure that contract pharmacy arrangements meet the needs of vulnerable populations along with other issues of importance to the contract pharmacy community. Don’t miss the opportunity to learn how the new regulations may impact your business model-whether government-initiated or service provider-driven. Alan Arville, Member of the Firm, Epstein Becker Green Lisa Scholz, Chief Operating Officer and Chief Pharmacy Officer, Safety Net Hospitals for Pharmaceutical Access (Facilitator)

5:15 pm

Conclusion of Breakout Sessions


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February 5-7, 2014 • San Diego, CA THURSDAY CONTINUED … 5:30 – 6:45 pm


Networking Reception, Exhibitor Forum – This Event is Sponsored by Cumberland Consulting Group Location: Crown/Coronet

FRIDAY, February 7, 2014 st

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7:00 am

1 Annual Charity 5K Fun Run/Walk Location: Hotel del Coronado Beachfront

8:30 am

Continental Breakfast Location: Upper Grande Hall Track One – 340B Operations

9:15 am

Inventory Management Location: Carousel Room To participate in 340B, covered entities must establish inventory management systems to protect against the risk of drug diversion and duplicate discounts. Covered entities that enter into contract pharmacy arrangements must also find suitable IT solutions to address the inventory management needs in these settings. Both hospitals and community health centers and other 340B clinics face unique challenges. Group purchasing organizations (GPO) guidance from HRSA in 2013 required many hospitals to overhaul their inventory management systems, and many of these hospitals are now facing increased drug costs as a result of having to purchase drugs through a wholesale acquisition cost (WAC) account. HRSA grantees attending this session will hear about the inventory management options available to meet the unique needs of health centers and other clinics. This session will also review inventory management best practices for all covered entities, including split-billing software options and manual systems. Attendees will hear strategies for how to minimize WAC purchases by hospitals that must comply with the GPO exclusion. Nicole Crase, Pharmacy Manager, Five Rivers Health Centers Reid Horning, Pharmacy Manager, New Ulm Medical Center Bruce Thompson, Director of Pharmacy, Hennepin County Medical Center Jeff Davis, Associate Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

9:15 am

Track Two – 340B Policy and Compliance Identifying and Addressing 340B Compliance Issues Location: Ballroom Even the best laid plans do not always work, and this is especially true for safety-net providers and drug manufacturers that seek to comply with the complex array of laws and policies that govern their participation in the 340B program. When inadvertent errors occur or compliance plans break down, program participants must be prepared for the possibility of having to disclose their non-compliance, taking corrective action, and/or being audited by HRSA. Providers have the added worry of being subject to audits by manufacturers and/or having to self-disclose and offer refunds to manufacturers. In short, having a well-developed 340B compliance plan is important, but equally important is being prepared to address errors when they occur. This session will address the challenges and opportunities that covered entities and manufacturers face in monitoring their compliance and responding to instances of non-compliance, whether intentional or inadvertent. Among the topics that will be covered are: effective self-auditing, knowing when and how to self-disclose, developing and implementing a corrective action plan, quantifying and offering refunds, dispute resolution, and how to protect against or minimize liability. Panelists will present from both the provider and manufacturer perspective. Katie Lapins, Director, Huron Consulting Group Tony Megna, Chief Executive Officer, Genesis Health Care, Inc. Jennifer Rossi, 340B Program Specialist, Eastern Maine Medical Center William von Oehsen, Principal, Powers Pyles Sutter & Verville PC; Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

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Please note there is an additional cost to participate in this event and you must register for it.


AGENDA

February 5-7, 2014 • San Diego, CA FRIDAY CONTINUED … 9:15 am

Track Three – Clinical Best Practices 1) 340B Savings Equal Improved Patient Care Location: Crystal/Continental Certain healthcare sites have the privilege to participate in the 340B program. These sites, known as 340B covered entities, have the responsibility to be good stewards of the program and ensure the program’s intent is carried out in their various practice settings. Learn from a hospital and community health center on how they calculate 340B savings and track and monitor how their institutions support their most needy patients. Also learn how you can use tools and resources to quantify your savings number and to gauge the impact you are making in the community because of the 340B program. What’s your number? Carol Millage, Pharmacy Director, Santa Barbara Public Health Department Binita Patel, Director, Ambulatory Pharmacy, Froedtert Memorial Lutheran Hospital Lisa Scholz, Chief Operating Officer and Chief Pharmacy Officer, Safety Net Hospitals for Pharmaceutical Access (Moderator)

9:15 am

Track Four – Peer Leader Roundtables (Limit 50 attendees per session) 1) Contract Pharmacy for Pharmacies Location: Windsor Complex This session, which is limited to pharmacies only, is designed for pharmacies that contract or are considering contracting with covered entities. Participants will be able to share and exchange information with other contract pharmacies about program challenges and opportunities, compliance issues, new trends, and how to prepare for the future. James Donnelly, Vice President, 340B Pharmacy Services, Hudson Headwaters Health Network Shelley Bailey, Pharmacy Owner, Central Drugs David Post, Chief Executive Officer and President, MedExpress (Facilitator)

2) Medi-Cal Roundtable Location: Garden Room California 340B covered entities will have an opportunity to learn about and discuss a federal court decision overturning Medi-Cal’s carve-in and actual acquisition cost billing requirements, the current status of that case and its possible impacts, and how entities are currently addressing billing and reimbursement of 340B drugs provided to Medi-Cal patients. Attendees can also use the informal roundtable format to discuss other California issues of interest. Laura Boudreau, Chief Counsel for Operations, AIDS Healthcare Foundation Gary Horne, Director of Pharmacy, San Mateo Medical Center Andrew Lowe, Director of Pharmacy, Arrowhead Regional Medical Center Steven Ramsland, Chief Executive Officer, Redwood Community Health Greg Doggett, Associate Counsel, Safety Net Hospitals for Pharmaceutical Access (Facilitator)

3) Contract Pharmacy for Health Care Providers & Vendors Location: Empress Hall

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This roundtable required advance enrollment to participate. Covered entities will be able to gather information about four 340B service providers in an appointment-based time slot and will be provided a support worksheet to address key 340B factors in choosing a service provider. Each covered entity will be given a list of service providers and select six to eight choices; best effort will be made to provide primary choices. Covered entities considering entering into contract pharmacy agreements or seeking information for a future proposal on existing contract pharmacies will have the opportunity to speak with service providers that have contract pharmacies, as well as representatives of companies that help entities set up their contract pharmacy arrangements (administrators). Service providers (contract pharmacies or administrators) will be notified in advance of your selection for the session and will be provided key areas their company will need to address with covered entities. Lee-Anne Gabrielli, Operations Coordinator, Safety Net Hospitals for Pharmaceutical Access Ted Slafsky, President and Chief Executive Officer, Safety Net Hospitals for Pharmaceutical Access (Facilitator)

10:30 am

Exhibitor Forum, Refreshment Break, Networking Opportunity (Passport prize drawing will be held at 10:45 in the middle of the exhibit hall.) Location: Crown/Coronet

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Please note this session required pre-registration to attend.

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AGENDA

February 5-7, 2014 • San Diego, CA FRIDAY CONTINUED … 11:00 am

Findings From New Government Report on 340B Contract Pharmacies Location: Ballroom The HHS Office of Inspector General (OIG) is expected to release a report prior to the conference on the use of 340B contract pharmacies, an area that has received much scrutiny and debate among program critics and supporters. The report, which is based on interviews with selected covered entities and administrators, will describe the entities’ contract pharmacy arrangements and their oversight of those arrangements to prevent diversion and duplicate discounts. An OIG representative who is working first-hand on the report will discuss the report’s results, which could have significant implications for how contract pharmacy is addressed in HRSA’s forthcoming “mega-reg”. If the report is not released prior to the conference, the OIG representative will discuss the OIG’s past work relating to the 340B program and plans for the future. Adam Freeman, Program Analyst, HHS Office of Inspector General, Office of Evaluation and Inspections Maureen Testoni, General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

11:45 am

Anticipating HRSA’s 340B “Mega-Reg” Location: Ballroom HRSA has announced it intends to publish a comprehensive 340B regulation by June 2014 that will have a substantial impact on covered entities, pharmaceutical manufacturers, contract pharmacies, and other program stakeholders. The regulation, which would be only the second regulation in the over 20-year history of the 340B program, is expected to address key program compliance issues, including patient definition and contract pharmacy arrangements. This session will feature experts representing covered entities and other perspectives on what to expect in the upcoming regulation. Maya Bermingham, Senior Assistant General Counsel, PhRMA Michael Glomb, Partner, Feldesman Tucker Leifer Fidell; Counsel, National Association of Community Health Centers Maureen Testoni, General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

12:30 pm

Conference Adjourns

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