Read Agenda for 2010 SNHPA Summer Conference (D0304705).DOC text version

15th Annual 340B Coalition Conference

Co-Hosted by Apexus/340B Prime Vendor Program

July 11-13, 2011 · Omni Shoreham Hotel · Washington, DC

AGENDA

SUNDAY, JULY 10, 2011 1:00 pm 3:00 pm 5:00 pm Exhibitor Setup Location: Exhibit Hall Location: West Registration

Early Registration Adjourn

MONDAY, JULY 11, 2011 7:00 am Registration and Exhibits Open Location: West Registration and Exhibit Hall

Pre-Conference Workshop (Two Options) 1

Option 1 - An Introduction to the Federal 340B Drug Pricing Program Location: Palladian Room ACPE 0085-9999-11-020-L03 P and T 2.75 Hours 7:00 am 8:30 am Continental Breakfast* Location: Exhibit Hall

340B Basics ­ Introduction to the Federal 340B Drug Pricing Program This session is designed for representatives of 340B providers and programs, pharmaceutical manufacturers, wholesalers, state Medicaid agencies and other 340B stakeholder groups who are new to the 340B program or need a refresher course. You will receive an overview of the program covering such topics as 340B eligibility and enrollment procedures, manufacturer discount requirements, inventory management standards, contract pharmacy guidelines, and general 340B compliance issues, especially with respect to diversion and Medicaid billing.

Clarissa Crain, Managing Director of Commercial Operations, Compliance Implementation Services Debra Demers, Consultant, Pharmacy Services Support Center Mary Ellen England, Director, Apexus/340B Prime Vendor Program Michelle Herzog, Public Health Analyst, Office of Pharmacy Affairs Jim Mitchell, Former Director, Office of Pharmacy Affairs (Moderator)

9:45 am 10:15 am

Networking and Refreshment Break*

Location: Exhibit Hall

340B Basics ­ Intro Session Continues In order for the 340B program to function properly, each party in the pharmaceutical supply chain must adjust to a unique set of requirements and procedures. Representatives of the 340B provider community and the manufacturer and wholesaler industries will expand upon the themes introduced in the first session by discussing implementation of the 340B program from their respective viewpoints.

Trish Dominic, Chief Executive Officer, Hemophilia of Georgia, Inc. Donavan Smith, Director of Pharmacy, Wayne Community Health Center Larry Stepp, Vice President of National Accounts, AmerisourceBergen Bill von Oehsen, President & General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

11:30 am 11:45 am

Question and Answer Session with 340B Intro Panelists Networking Lunch* Location: Exhibit Hall

* Workshop Attendees and Exhibitors Only 1 Please note there is an additional cost to attend the pre-conference workshop and Monday's lunch and you must register for them.

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Option 2 ­ Patient Assistance Programs: Current and Future Location: Diplomat Room ACPE 0085-9999-11-021-L04 P and T 2.75 Hours 7:00 am 8:30 am Continental Breakfast* Location: Exhibit Hall

Recent Developments in Patient Assistance Programs As a result of the economic downturn, more uninsured and vulnerable populations are relying on safety net pharmacies and pharmaceutical manufacturer patient assistance programs (PAPs) to access prescription drugs. This first session examines current activities, successes and challenges of PAP programs, both those aimed at individual patients and those "institutional" patient assistance programs operating in some hospitals and clinics. Our speakers will discuss innovative efforts by safety net providers, non-profit organizations and pharmaceutical companies to address unmet pharmaceutical care needs and will highlight opportunities to maximize pharmaceutical savings. We will also discuss a new initiative by safety net providers to develop industry-wide standards to reduce the burden of complying with institutional PAPs. There will be time allotted for questions and discussion at the end of each session.

- Pamela Powell, Patient Assistance Coordinator, Wishard Health Services Pharmacy - Glenn Rebber, Director of Pharmacy Services, Heart of Texas CHC - Rita Baskett, Dir. of Pharmacy & Educational Services, Safety Net Hospitals for Pharmaceutical Access (Moderator)

9:45 am 10:15 am

Networking and Refreshment Break*

Location: Exhibit Hall

Innovative PAP Models and Where Do We Go From Here This session will feature experts including drug manufacturers and drug industry consultants who help design and implement PAPs. You will also hear about two innovative approaches by nonprofit organizations that address unmet pharmaceutical needs including assisting in disaster relief. You will learn about their structure and how to apply for these programs. In addition, we will look at the future role of PAPs, including what PAPs will look like in light of health reform and the phasing out of the Part D "doughnut hole." We will also look at whether there will be an increased focus on the underinsured and whether there will be more emphasis on co-pay assistance rather than on directly providing pharmaceuticals.

Morris Lumpkin, Senior Director of Business Development, Lash Group Gary Pelletier, Executive Director, Patient Assistance Foundation, Pfizer Damon Taugher, Director, Direct Relief Dan Simpson, Chief Development Officer, Dispensary of Hope Rita Baskett, Director of Pharmacy and Educational Services, Safety Net Hospitals for Pharmaceutical Access (Moderator)

11:45 am

Networking Lunch*

Location: Exhibit Hall

Main Conference

1:00 pm

ACPE 0085-9999-11-022-L04 P and T

Opening Remarks from Conference Hosts & Lifetime Achievement Awards Ceremony

Location: Regency Ballroom · · Larry Gage, President, National Association of Public Hospitals and Health Systems Frederick Isasi, Senior Legislative Counsel for Healthcare, accepting award on Sen. Jeff Bingaman's behalf

1:30 pm

Federal Government Update

Location: Regency Ballroom ACPE: 1.25 Hours

The 340B program has undergone many changes in the past two years ­ the addition of new covered entities, new pricing transparency provisions, the ability of the government to impose civil monetary penalties, creation of a mandatory dispute resolution process, and database enhancements, among others. In addition, the Health Resources and Services Administration (HRSA) has issued a proposed rule on the orphan drug exemption and is preparing to release a substitute proposed guidance on patient definition. In this session, you will hear from the Office of Pharmacy Affairs (OPA) regarding implementation of these new requirements. OPA will be joined by senior executives from HRSA's two 340B federal contractors ­ the Pharmacy Services Support Center (PSSC) and Apexus-340B Prime Vendor Program (PVP).

* Workshop Attendees and Exhibitors Only 1 Please note there is an additional cost to attend the pre-conference workshop and Monday's lunch and you must register for them.

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Chris Hatwig, Vice President, Apexus/340B Prime Vendor Program CDR Krista Pedley, Director, Office of Pharmacy Affairs (Moderator) Lisa Scholz, Vice President, APhA/Pharmacy Services Support Center

2:45 pm 3:45 pm

Networking and Refreshment Break Legislative Update

Location: Regency Ballroom ACPE: 1 Hour

Health reform brought the most significant changes to the 340B program since its creation, but Congress is continuing to consider legislation that would make additional changes. In addition, Congress's watchdog agency is finishing up its first ever study on the program. All of this comes under the backdrop of a sweeping change in the composition of Congress, Republican efforts to roll back health reform and a renewed emphasis on cutting federal spending. During this session, you will hear different perspectives on how the changes in Washington will impact key 340B stakeholders. Among the topics to be covered are: the status of the Government Accountability Office (GAO) study on 340B mandated by health care reform; efforts to extend 340B pricing to the inpatient setting; implications of the orphan drug discount prohibition and HRSA's proposed implementation thereof; and a closer look at key priorities of 340B providers and drug industry.

· · · Kaitlin McColgan, Federal and State Affairs Director, National Association of Community Health Centers Ted Slafsky, Executive Director, Safety Net Hospitals for Pharmaceutical Access (Moderator) Cole Werble, Editor, RPM Report and former Publisher of the "Pink Sheet"

4:45 pm

Breakout Session for Various 340B Stakeholders · Community Health Centers

Location: Palladian Room ACPE: 1.25 Hours

This session will discuss the latest 340B issues specifically affecting health centers. Topics discussed will include Medicaid and other third party billing issues, contracting for pharmacy services, and the status of health center provisions in the Affordable Care Act including the GAO study. This is an opportunity to raise any issues that may be affecting your health center.

- Bob Brown, Pharmacy Director, CommUnity Care Health Center - Mike Glomb, Partner, Feldesman, Tucker, Leifer, Fidel, and Counsel to National Association of Community Health Centers - Kaitlin McColgan, Federal and State Affairs Director, National Association of Community Health Centers - Roger Schwartz, Associate VP and Legal Counsel, National Association of Community Health Centers (Facilitator)

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Family Planning Clinics

Location: Council Room ACPE: 1.25 Hours

This session will focus exclusively on family planning clinics and programs with a strong emphasis on issues relating to the 340B program. Topics discussed will include updates on meetings with and outreach to government agencies regarding patient definition, Medicaid billing, and other 340B issues. We will also discuss the status of 340B provisions that were included in health reform and issues related to third party billing.

- Julia Strasser, Policy Analyst, National Family Planning & Reproductive Health Assoc. - Dana Thomas, Director of Policy & Advocacy, National Family Planning & Reproductive Health Assoc. - Amy Yenyo, Assistant Dir. of Govt. Relations, Planned Parenthood (Facilitator)

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Hemophilia Treatment Centers

Location: Forum Room ACPE: 1.25 Hours

This session will focus exclusively on 340B issues relating to Hemophilia Treatment Centers. Topics discussed will include third party billing/reimbursement issues, the GAO study of the 340B program, program income and other issues directly impacting hemophilia treatment centers.

- Joe Pugliese, President, Hemophilia Alliance (Facilitator) - Sean Singh, Vice President, Hemophilia Alliance - Stacia Le Blanc, Attorney, Law Offices of Stacia Le Blanc & Counsel to Hemophilia Alliance

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HIV/AIDS Clinics, ADAPs, and AIDS Service Providers

Location: Senate Room ACPE: 1.25 Hours

This workshop provides an opportunity for AIDS service providers and policy makers to exchange ideas and share experiences in using the 340B program to expand access and save on costs for the HIV community.

- Tom Burns, Director of Pharmacy Programs, Oregon Health Authority - Ann Lefert, Associate Dir., Government Relations, National Alliance of State & Territorial AIDS Directors (Facilitator) - Britten Pund, Manager, Health Care Access, National Alliance of State & Territorial AIDS Directors

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Hospitals (DSH, Rural, Children's and Cancer Hospitals)

Location: Regency Ballroom ACPE: 1.25 Hours

This workshop provides an opportunity for 340B hospitals to learn about recent developments in the 340B program affecting hospitals. For example, hospitals will learn about a new SNHPA report demonstrating the value of the 340B program to safety net hospitals and patients as well as receive an update on key legislative matters and the GAO study. We will also provide a status update on 340B health care reform implementation. You will also learn about the new orphan drug guidance and SNHPA's efforts to address declining third party reimbursement for 340B drugs.

- Suzanne Herzog, Co-Founder & Consultant, Rx|X - Madeline Carpinelli Wallack, PRIME Institute Research Fellow, University of Minnesota - Bill von Oehsen, President & General Counsel, Safety Net Hospitals for Pharmaceutical Access (Facilitator)

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Pharmaceutical Manufacturers

Location: Congressional Room ACPE: 1.25 Hours

Pharmaceutical manufacturers will learn about the latest developments with the 340B program and how they will impact the pharmaceutical industry. You will receive more details about HRSA's new guidance on orphan drugs and how the industry plans to respond to the proposal. You will also learn about the anticipated new average manufacturer price (AMP) guidance from the Centers for Medicare and Medicaid Services (CMS) and how it will impact companies doing business with 340B providers and Medicaid. You will also receive an update from the government's Prime Vendor Program.

- Alice Valder Curran, Partner, Hogan Lovells - Chris Hatwig, Vice President, Apexus/340B Prime Vendor Program - Clarissa Crain, Managing Director of Commercial Operations, Compliance Implementation Services (Facilitator)

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State, Local and Tribal Governments

Location: Cabinet Room ACPE: 1.25 Hours

This workshop provides an opportunity for state and local government officials to exchange ideas and share experiences in using the 340B program to expand access and save on costs with respect to prescription drugs for Medicaid, correctional and other government supported patient populations.

- Tom Burns, Director of Pharmacy Programs, Oregon Health Authority - Kevin Gorospe, Principal, Health Management Associates, former Pharmacy Director of California Medicaid (Facilitator) - Jennifer Palow, Pharmacy Director, Office of MaineCare Services

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340B Contract Pharmacies (Chain, Independent, Specialty & Mail Order Pharmacies and Related Vendors)

Location: Diplomat Room ACPE: 1.25 Hours

This breakout allows participants to exchange ideas with fellow contract pharmacies and share information on initiating or implementing a contract pharmacy relationship with a 340B covered entity. Our panel will: update you on trends and new developments in the contract pharmacy area. We will also address the latest on new transparency standards being developed by the National Council for Prescription Drug Programs (NCPDP) and how they will impact business relationships with providers and pharmacy benefit managers (PBMs); discuss how others have implemented contract pharmacy models to improve medication access to the community. You will also hear about efforts by the pharmacy community to 4

educate policymakers about the win-win relationships between pharmacies and 340B covered entities.

- Lisa Scholz, Vice President, APhA/Pharmacy Services Support Center (Co-Facilitator) - Ted Slafsky, Executive Director, Safety Net Hospitals for Pharmaceutical Access (Co-Facilitator)

6:00 pm

Reception and Networking Opportunity

Location: Exhibit Hall

TUESDAY, JULY 12, 2011 7:15 am 8:30 am Continental Breakfast & Exhibits Open Track One ­ Operationalizing 340B Inventory Management

Location: Palladian Room ACPE: 1.25 Hours

Location: Exhibit Hall

As part of their participation in the 340B program, covered entities must establish inventory management systems to protect against the risk of drug diversion and duplicate discounts. Disproportionate share (DSH) hospitals and free-standing children's and cancer hospitals face the added challenge of ensuring that covered outpatient drugs are not purchased through a group purchasing agreement. Rural hospitals will need to have systems in place to track their purchases of orphan drugs. Community health centers and other 340B entities face their own unique challenges as well. With the advent of multiple contract pharmacy arrangements, finding suitable information technology solutions to meet these compliance needs can be even more challenging. This session will review current technology and split billing software options to support compliant inventory management practices. Speakers will address technological solutions, stock replacement/NDC substitution, split-billing and virtual inventories.

Dana Darger, Director of Pharmacy, Rapid City Regional Health Tim Mallett, Director of Pharmacy, Family Health Center Gary Horne, Director of Pharmacy, San Mateo Medical Center (Moderator)

Track Two ­ 340B Policy and Compliance: Concurrent Sessions (2 Choices) A. Patient Definition

Location: Regency Ballroom ACPE: 1.25 Hours

One of the most important compliance requirements 340B covered entities face is the prohibition against diversion, which prohibits covered entities from administering or dispensing 340B drugs to individuals who do not meet the definition of "patient." Since 1996, the Health Resources and Services Administration, the government agency that administers the 340B program, has used a three-part test to define patient. In 2007, HRSA proposed a new definition of patient but never finalized the changes. In just the last few months, HRSA has proposed to withdraw the 2007 guidance and to replace it with a new proposed patient definition. HRSA's proposals were recently cleared by the Office of Management and Budget which means that they should be published shortly. Learn about possible restrictions on the future use of 340B drugs and the anticipated responses by the 340B provider and manufacturer communities.

Mike Glomb, Partner, Feldesman, Tucker, Leifer, Fidel, and Counsel to National Association of Community Health Centers John Shakow, Partner, King & Spalding Bill von Oehsen, President & General Counsel, Safety Net Hospitals for Pharmaceutical Access Katheryne Richardson, Consultant, Apexus (Moderator)

B.

Pricing Primer

ACPE: 1.25 Hours

Location: Diplomat Room

Health care reform brought major changes to the world of drug pricing, including increasing the size of Medicaid rebates, redefining a drug's average manufacturer price and clarifying the inflationary penalty applicable to reformulated drugs. Drug pricing experts will summarize and analyze all of the changes specified under the Affordable Care Act. They will also discuss how these important changes are impacting 340B discounts. For example, you will learn about the additional discounts required when drug prices increase more quickly than the rate of inflation, how the penalty sometimes creates penny-priced drugs for 340B purchasers, and the effect of penny pricing on drug supplies. Speakers will also address stricter 340B refund requirements, including when manufacturers "true up" their AMP and best price submissions. You will also hear about the role the Prime Vendor Program (PVP) plays in the 340B pricing. 5

- Chris Hatwig, Vice President, Apexus/340B Prime Vendor Program - Mike Hepburn, Sr. Director, Government Contract Compliance, Ortho McNeil Janssen Pharmaceuticals, Inc. - Madeline Carpinelli Wallack, PRIME Institute Research Fellow, University of Minnesota School of Pharmacy (Moderator)

Track Three ­ Roundtables (Limit 50 attendees per session); Concurrent Sessions (2 Choices) A. Children's Hospitals

Location: Executive Room ACPE: 1.25 Hours

This roundtable is designed for children's hospitals that are enrolled in the 340B program or are still thinking about applying. Among the topics that will be discussed are: key 340B implementation challenges and solutions, securing rebates for orphan drugs purchased during discount ban, advocacy opportunities for accessing voluntary inpatient DSH pricing and accessing 340B prices at sites beyond 35 miles of the main hospital. You will also get an update on Medicaid billing and payment policies applicable to 340B drugs. Children's hospitals can propose additional topics during the session.

Steve Pate, Manager, Outpatient Pharmacy Services, St. Jude's Children's Hospital John VanEeckhout, Vice President, Clinical Services, Child Health Corporation of America Ted Slafsky, Executive Director, Safety Net Hospitals for Pharmaceutical Access (Co-Facilitator) Maureen Testoni, Assistant General Counsel, Safety Net Hospitals for Pharmaceutical Access (Co-Facilitator)

B. Prime Vendor Program

Location: Congressional A ACPE: 1.25 Hours

Representatives from Apexus-340B Prime Vendor Program will discuss different opportunities for maximizing the value of the PVP program. Providers will learn how to identify and take advantage of resources ­ from PVP directly and from PVP suppliers ­ to ensure that your organization is not missing any opportunities to lower its costs and improve outcomes under the program.

- John Barnes, Director of Supplier Services, Apexus/340B Prime Vendor Program - Bruce Boelter, Director, Apexus/340B Prime Vendor Program

Small Group Discussions (Limit 10 attendees per session; limited to stakeholder groups only; pre-registration required) A. Community Health Center 340B Expert

Location: Council Room ACPE: 1.25 Hours - Sabrina Johnson, Consultant Pharmacist, LifeLong Medical Center

B. Hemophilia Treatment Center 340B Expert

Location: Senate Room ACPE: 1.25 Hours - Stacia Le Blanc, Attorney, Law Offices of Stacia Le Blanc & Counsel to Hemophilia Alliance - Joe Pugliese, President, Hemophilia Alliance - Sean Singh, Vice President, Hemophilia Alliance

9:45 am 10:45 am

Exhibitor Forum, Refreshment Break, and Networking Opportunity Track One ­ Operationalizing 340B Contract Pharmacy

Location: Palladian Room ACPE: 1.25 Hours

Location: Exhibit Hall

One year after the final contract pharmacy guidelines were published, contract pharmacy arrangements between 340B covered entities and commercial pharmacies of all different types are flourishing. Whether you are interested in partnering with a small independent pharmacy, a large chain or a mail order operation, you will learn about the basics of establishing a contract pharmacy arrangement, as well as innovative models for improving access to care. You will also learn about the various compliance requirements established under the guidelines and how 340B providers are currently meeting those requirements. Issues to be discussed will include negotiating contract terms, "ship to/bill to" arrangements, inventory management and billing and collection functions. Panelists will discuss the role of pharmacy benefit managers and contract pharmacy management companies in operationalizing contract pharmacy arrangements and coordinating the activities of multiple contract pharmacies. 6

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Tom Burns, Director of Pharmacy Programs, Oregon Health Authority Paul Crowther, Pharmacy Director, Central Virginia Health Services John Lynch, Vice President of Operating Policy, Eaton Apothecary Scott Zweerink, Director of Corporate Outpatient Prescription Services, Truman Medical Center Bill von Oehsen, President & General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

Track Two ­ 340B Policy and Compliance: Concurrent Sessions (2 Choices) A. OPA's Challenges in Implementing Health Care Reform

ACPE: 1.25 Hours

Location: Diplomat Room

The Office of Pharmacy Affairs, the agency responsible for administering the 340B program, finds itself with a long list of implementation tasks as a result of last year's enactment of health reform legislation. From enrolling several new categories of covered entities to developing a formal dispute resolution process to increasing 340B pricing transparency, OPA is faced with implementation challenges that place a strain upon the agency's limited financial and human resources. Representatives from OPA and the 340B stakeholder community will discuss these challenges and their effects on the agency and the 340B program. Speakers will discuss the pros and cons of President Obama's budget proposal for Fiscal Year 2012, which called for a 0.1 percent user fee to be added to 340B ceiling prices to help fund OPA operations. Panelists will also explore alternative revenue sources for the agency.

CDR Krista Pedley, Director, Office of Pharmacy Affairs Bill Sarraille, Partner, Sidley Austin LLP Ted Slafsky, Executive Director, Safety Net Hospitals for Pharmaceutical Access Jim Mitchell, Former Director, Office of Pharmacy Affairs (Moderator)

B.

Expansion of the Medicaid Rebate Program to Managed Care: Implications for 340B Payors, Providers and Manufacturers

ACPE: 1.25 Hours

Location: Regency Ballroom

Manufacturers are protected under federal law from having to give both 340B discounts and Medicaid rebates on the same drugs. The prohibition against duplicate discounts often means that covered entities must pass their 340B discounts to Medicaid ­ in many cases by billing their 340B drugs at actual acquisition ­ to compensate states for the loss of the rebates they otherwise would have been able to collect if the drugs had not been purchased through 340B. When health care reform expanded the Medicaid rebate program to Medicaid managed care drugs, the safety net provider community convinced Congress to exempt 340B drugs from the expansion. Under the exemption, Congress intended for covered entities to continue to be able to bill and collect more favorable reimbursement for drugs covered by Medicaid managed care organizations (MCOs). The exemption protected an important revenue source for 340B providers but created many implementation challenges for state Medicaid programs and MCOs that must exclude 340B drugs from rebate requests to avoid duplicate discounts. 340B stakeholders will discuss how those challenges are being addressed.

- Bill Baxter, Strategic Advisor, Government Affairs, Compliance Implementation Services - Kevin Gorospe, Principal, Health Management Associates, former Pharmacy Director of California Medicaid - Roger Schwartz, Associate VP and Legal Counsel, National Association of Community Health Centers (Moderator)

Track Three ­ Roundtables (Limit 50 attendees per session); Concurrent Sessions (2 Choices) A. Unique Issues Impacting Rural Hospitals

ACPE: 1.25 Hours Location: Executive Room

This session is designed to address the unique needs and challenges that rural hospitals face in providing medical and pharmaceutical care. You will get an update on various health care policy matters affecting rural providers, including advocacy efforts to repeal the provision that prevents rural hospitals from receiving 340B discounts on orphan drugs. You will also receive an update on efforts to convince the government to allow rural hospitals to receive voluntary inpatient discounts and access to 340B pricing in remote locations. The roundtable format will give participants an opportunity to address their questions about program implementation relevant to their institution.

Mike Bonck, Pharmacy Manager, Franciscan Health System Nick Chang, Operations Manager, Pharmacy Services Support Center Maggie Elehwany, Vice President, Government Affairs & Policy, National Rural Health Association Lt. Lawrence Momodu, Program Management Officer, Office of Pharmacy Affairs

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- Maureen Testoni, Assistant General Counsel, Safety Net Hospitals for Pharmaceutical Access (Facilitator)

B.

Inventory Management

ACPE: 1.25 Hours

Location: Congressional A

This roundtable is designed for attendees interested in participating in an interactive small group discussion about the complexities and challenges of 340B inventory management. Learn about various inventory management solutions from individuals specializing in this area.

Bruce Boelter, Director, Apexus/340B Prime Vendor Program Dana Darger, Director of Pharmacy, Rapid City Regional Health Gary Horne, Director of Pharmacy, San Mateo Medical Center Linda Janowski, Pharmacy Director, Little River Medical Center Tim Mallet, Director of Pharmacy, Family Health Center Jamie Shaw, Informatics Specialist, Memorial Hospital of Colorado Springs

Small Group Discussions (Limit 10 attendees per session; limited to stakeholder groups only; pre-registration required) A. Hospital 340B Expert

ACPE: 1.25 Hours - Petra Fippen, Manager of Pharmacy Inventory, Contracting and Patient Assistance Programs, Wishard Health Services Pharmacy - Pamela Powell, Patient Assistance Coordinator, Wishard Health Services Pharmacy

Location: Senate Room

B.

Drug Pricing Calculations Expert (for Pharmaceutical Manufacturers)

ACPE: 1.25 Hours - Clarissa Crain, Managing Director of Commercial Operations, Compliance Implementation Services - Mike Hepburn, Sr. Director, Government Contract Compliance, Ortho McNeil Janssen Pharmaceuticals, Inc.

Location: Council Room

12:00 pm 1:30 pm

Networking Lunch

Location: Exhibit Hall

Track One ­ Operationalizing 340B Patient Safety and Clinical Pharmacy Programs

Location: Diplomat Room ACPE: 1.25 Hours

The Patient Safety and Clinical Pharmacy Services Collaborative (PSPC) is a breakthrough effort to improve the quality of health care across America by integrating evidence-based clinical pharmacy services into the care and management of high-risk, high-cost, complex patients. The PSPC works through teams representing community-based health care providers, including hospitals, health centers, Ryan White HIV/AIDS providers, poison control centers and rural health clinics. Through an intensive series of Learning Sessions and Action Periods, PSPC teams learn, implement and refine the leading practices that have been found to significantly improve health outcomes and patient safety through the integration of clinical pharmacy services. This session will discuss how PSPC works, lessons learned through its past three years of experience, and what to expect from PSPC in the coming year. You will hear from PSPC participants and learn why you should join this effort.

Bob Brown, Pharmacy Director, CommUnity Care Health Center Fred Butler, Public Health Advisor, Office of Pharmacy Affairs Tracey Cole, Pharmacy Director, Holyoke Health Center Linda Kwon, Public Health Advisor, Office of Pharmacy Affairs Eric Lai, Public Health Advisor, Office of Pharmacy Affairs Zandra Glenn, Senior Patient Safety Consultant, Pharmacy Services Support Center (Moderator)

Track Two ­ 340B Policy and Compliance: Concurrent Sessions (2 Choices) A. Specialty Pharmacies

ACPE: 1.25 Hours Location: Palladian Room

The past decade has witnessed a sharp increase in both the number of specialty pharmacies and the variety of specialty pharmaceuticals available in the U.S. drug market. Although this trend may offer new treatment options and improve health care outcomes, both the short-term and long-term impact on 340B providers is uncertain. Specialty pharmacy practice presents unique challenges for 340B covered entities, as manufacturer business arrangements and Food and Drug Administration (FDA) risk maps and agreements make it difficult to purchase drugs at 340B prices. This session examines the structure of the specialty pharmacy market, manufacturer and 8

wholesaler business arrangements, and options for 340B providers to consider when providing specialty pharmacy services and pharmaceuticals to their patients.

Jeff Blake, Pharmacy Marketing Director, Indiana Hemophilia & Thrombosis Center, Inc. Roland Lamy, Principal, Helms & Company Joe Pugliese, President, Hemophilia Alliance Dave Stibbe, Strategic Markets, Fairview Health Services Katheryne Richardson, Consultant, Apexus (Moderator)

B.

AMP: Implications of the New Guidance

ACPE: 1.25 Hours

Location: Regency Ballroom

340B price calculations have experienced dramatic changes as a result of recent Congressional action. Among them are changes to the definition of a drug's average manufacturer price, which serves as the benchmark for 340B discounts. Health reform redefined AMP to more closely reflect pricing in the retail class of trade. To address application of AMP to non-retail drugs, Congress revisited the definition and established a different AMP formula in subsequent legislation with respect to inhalation, infusion, instilled, implanted and injectable drugs. Federal law requires manufacturers to report AMP data to the Centers for Medicare and Medicaid Services, and because of the changes to the definition of AMP, manufacturers have faced significant confusion as to their reporting requirements. CMS is expected to publish a regulation redefining AMP soon. Our pricing experts will explain how the new AMP definition will affect 340B providers, manufacturers, and the state Medicaid programs.

Bruce Boelter, Director, Apexus/340B Prime Vendor Program David Chan, Principal, Marina Consulting Constance Wilkinson, Partner, Epstein Becker & Green Jeff Davis, Associate Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

Track Three ­ Roundtables (Limit 50 attendees per session) Contract Pharmacy

Location: Congressional Room ACPE: 1.25 Hours

Learn more about contract pharmacy agreements between covered entities and different types of pharmacies. Learn from experts in the provider and pharmacy communities that have implemented successful programs.

Tom Burns, Director of Pharmacy Programs, Oregon Health Authority Paul Crowther, Pharmacy Director, Central Virginia Health Services John Lynch, Vice President of Operating Policy, Eaton Apothecary Clint Peevy, System Director of Pharmacy, Baptist Health Terri Ward, 340B Implementation Manager, Walgreens Scott Zweerink, Director of Corporate Outpatient Prescription Services, Truman Medical Center Rita Baskett, Dir. of Pharmacy & Educational Services, Safety Net Hospitals for Pharmaceutical Access (Moderator)

Small Group Discussions (Limit 10 attendees per session; limited to stakeholder groups only; pre-registration required) A. Hospital 340B Expert

Location: Senate Room ACPE: 1.25 Hours - Burnis Breland, Director of Pharmacy, The Medical Center Department of Pharmacy - Debbie Nowlin, Associate Director, The Medical Center Department of Pharmacy

B. Community Health Center 340B Expert

Location: Council Room ACPE: 1.25 Hours - Linda Janowski, Pharmacy Director, Little River Medical Center

2:45 pm 3:45 pm

Exhibitor Forum, Refreshment Break, and Networking Opportunity Track One ­ Operationalizing 340B Optimizing Pharmacy Savings & Value

Location: Palladian Room ACPE: 1.25 Hours

Location: Exhibit Hall

As safety net providers struggle to adjust to a sluggish economy and a growing uninsured patient population, pharmacy departments are under increased pressure to reduce costs and find new 9

sources of revenue. This session will showcase success stories from various 340B covered entities that are maximizing savings opportunities and taking proactive steps to address a challenging environment. Providers will learn about different purchasing and contracting strategies designed to improve both access and affordability of medications for underserved populations. Likely topics to be covered include: formulary management tools; getting the most out of limited resources; patient assistance program maximization; maximizing the use of the prime vendor program and Medicare Part D success stories.

Mike Bonck, Pharmacy Manager, Franciscan Health System Tracey Cole, Director of Pharmacy, Holyoke Health Center Gary Johnson, Director of Pharmacy, University of Virginia Medical Center Rita Baskett, Dir. of Pharmacy & Educational Services, Safety Net Hospitals for Pharmaceutical Access (Moderator)

Track Two ­ 340B Policy and Compliance Concurrent Sessions (2 Choices) A. Drug Shortages

Location: Diplomat Room ACPE: 1.25 Hours

Safety net pharmacies nationwide are reporting severe shortages of widely used pharmaceuticals, including pain medicines, emergency drugs and some oncology products. 340B stakeholders are divided as to a manufacturer's obligation to provide covered drugs at 340B prices when there is a shortage. Providers claim they are discriminated against when they have difficulty purchasing drugs in short supply due to their status as 340B covered entities. They are anxious for implementation of a new health care reform law requiring drug manufacturers to sell their products to covered entities at 340B discounts if the same products are "made available to any other purchaser at any price." Others insist this form of drug allocation would limit access to scarce drugs for non-340B providers. Hear representatives from manufacturers and covered entities share their perspectives on this issue.

- Donna Evans, Senior Pharmacist, University of Alabama at Birmingham Hospital - Bill Sarraille, Partner, Sidley Austin LLP - Bill von Oehsen, President & General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

B. Trends and Challenges in Third Party Reimbursement

Location: Regency Room ACPE: 1.25 Hours

When Congress enacted the 340B law, it recognized that it was placing manufacturers at risk of giving two discounts on the same drug ­ an upfront discount to the pharmacy under 340B and a rebate to Medicaid under the Medicaid drug rebate program. Congress directed the Secretary of Health and Human Services (HHS) to develop procedures for protecting manufacturers from the duplicate discount problem, which has altered the traditional billing and payment relationships between covered entities and state Medicaid agencies. While the duplicate discount problem has historically been a Medicaid-only issue, the problem has increasingly arisen in other areas ­ including in Medicare Part D, TRICARE and commercial insurance ­ because the payment of rebates by manufacturers for preferred formulary status is a common business practice among private payers and PBMs. Manufacturers are responding by increasingly scaling back their rebate arrangements when 340B drugs are involved. To offset the loss of rebates, payers have begun ratcheting down reimbursement rates to 340B pharmacies, intensifying rate negotiations and raising questions as to who should benefit from 340B discounts. Our panel of experts will share their experiences and advice on third party billing and reimbursement of 340B drugs. They will also discuss the problems that have arisen involving TRICARE's contracting decisions.

David Balto, Attorney, Law Offices of David Balto Gary Reiss, Chief Operating Officer of SUNRx and Co-Chair of the NCPDP's 340B Task Group Donna Yesner, Partner, Morgan Lewis Greg Doggett, Associate Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

Track Three ­ Roundtables (Limit 50 attendees per session) Patient Safety and Clinical Pharmacy Programs

Location: Congressional Room ACPE: 1.25 Hours

Learn about HRSA's Patient Safety and Clinical Pharmacy Services Collaborative and lessons learned from safety net provider participants. This is a great opportunity to learn how PSPC can help providers and industry improve the delivery of care.

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Fred Butler, Public Health Advisor, Office of Pharmacy Affairs Eric Lai, Public Health Advisor, Office of Pharmacy Affairs Linda Kwon, Public Health Advisor, Office of Pharmacy Affairs Zandra Glenn, Senior Patient Safety Consultant, Pharmacy Services Support Center (Facilitator)

Small Group Discussions (Limit 10 attendees per session; limited to stakeholder groups only; pre-registration required) A. Hospital 340B Expert

ACPE: 1.25 Hours - Deborah Hauser, Network Director of Pharmacy, Albert Einstein Medical Center - Eileen Kelly, Manager of Revenue Cycle, Albert Einstein Medical Center Location: Senate Room

B.

Community Health Center 340B Expert

ACPE: 1.25 Hours - Janell Claudy, Pharmacy Manager, Family Health Pharmacy

Location: Council Room

5:00 pm

Adjourn

WEDNESDAY, JULY 13, 2011 7:00 am 8:15 am Continental Breakfast & Exhibits Open Keynote Speaker

Location: Regency Ballroom ACPE: 0.75 Hours - Chris Cillizza, Political Reporter and Author of "The Fix" blog, Washington Post

Location: Exhibit Hall

9:00 am

The OIG's Look at 340B Medicaid Billing Practices and Reimbursement Practices

Location: Regency Ballroom ACPE: 0. 5 Hours

Medicaid billing requirements applicable to 340B drugs are among the most complex compliance measures that 340B covered entities face when they enroll in the 340B program. The HHS Office of Inspector General (OIG) just released the results of a study determining how 340B pharmacies are billing Medicaid under the 340B program. The study also explores whether today's federal and state regulations sufficiently protect pharmaceutical manufacturers from "duplicate discounts," situations where manufacturers provide an upfront discount to the 340B provider and then are asked to provide a rebate to the Medicaid program. The study was conducted by the OIG's Office of Inspections and Evaluations, the same office that conducted a series of groundbreaking reports on the 340B program in recent years. Hear a firsthand a summary of the report from the OIG team that completed the study. You will also hear an update on a newly released OIG study that addresses NDC reporting and collection of Medicaid rebates for physician-administrated drugs.

- Kelly Waldhoff, Program Analyst, Office of Inspector General, U.S. Department of Health & Human Services - Bill von Oehsen, President & General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

9:30 am 10:00 am

Refreshment Break

Location: Exhibit Hall

ACPE: 1.25 Hours

The Plight of Medicaid and Its Implications for the 340B Program

Location: Regency Ballroom

The Medicaid program is facing increasing pressure at both the federal and state levels to contain or reduce costs. HHS Secretary Sebelius released a letter earlier this year outlining a variety of measures that states could employ to reduce Medicaid costs, including basing Medicaid drug payments on acquisition cost. Legislative and administrative policies have been proposed in a number of states that would modify how covered entities bill Medicaid for 340B drugs and/or dictate how revenue saved by Medicaid as a result of the 340B drug discount should be spent. At this session, you will hear about the challenges facing the Medicaid program at the state and federal levels, what steps states are taking to address the rising costs of prescription drugs, and what implications these steps will have on the 340B and Medicaid drug rebate programs.

- Debra Demers, Consultant, Pharmacy Services Support Center - Barbara Edwards, Director, Disabled and Elderly Health Programs Group, Centers for Medicare & Medicaid Services - Matt Salo, Executive Director, National Association of Medicaid Directors - Kelly Waldhoff, Program Analyst, Office of Inspector General, U.S. Department of Health & Human Services

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- Bill von Oehsen, President & General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

11:15 am

Track One ­ Operationalizing 340B "When Patients Can't Afford Their Drugs": Best Practices in Charity Care Management

Location: Palladian Room ACPE: 1.25 Hours

Safety net providers are constantly trying to balance their mission to serve indigent patients with the fiscal realities of having to stretch and conserve their limited resources. This balancing act is especially difficult at the pharmacy counter where tensions can run high and pharmacists often lack sufficient information and authority to make the right decision. This session will focus on the practical challenges of developing and implementing a charity care policy for pharmacy patients. Among the questions that will be addressed is what should a pharmacy charge an uninsured, underinsured or low income patient, if anything at all? Should the pharmacy, prior to dispensing any medications, refer the patient for a financial assessment to determine his or her eligibility for a patient assistance program? How should charity care patients be handled in a contract pharmacy arrangement? Our expert panelists will attempt to answer these questions and to present different models of meeting the charity care needs of indigent patients.

- Jeff Blake, Pharmacy Marketing Director, Indiana Hemophilia & Thrombosis Center, Inc. - Bob Brown, Pharmacy Director, CommUnity Care Health Center - Fern Paul-Aviles, Pharmacy Manager, Carolinas HealthCare (Moderator)

Track Two ­ 340B Policy and Compliance Concurrent Sessions (2 Choices) A. Orphan Drugs

ACPE: 1.25 Hours Location: Diplomat Room

Although the Affordable Care Act expanded the categories of safety net providers eligible to participate in the 340B program, Congress added another provision that limits access of the newly eligible providers to 340B prices on drugs developed to treat rare diseases and conditions, commonly referred to as "orphan drugs." These are often high-cost oncology drugs and specialty drugs. Children's hospitals were among the covered entities subject to the orphan drug ban, but Congress passed a fix in December 2010 allowing them to continue to access 340B prices on all covered outpatient drugs. For rural and free-standing cancer hospitals, however, 340B prices continue to be unavailable for orphan drugs. HRSA recently published a proposed regulation intended to implement the orphan drug ban. Our speakers will explain what the rule proposes and how it would affect manufacturers and covered entities if implemented. You will also learn about advocacy efforts to further limit or remove the orphan ban.

Charles Cooper, 340B Manager, University of Minnesota Medical Center Fairview Alice Valder Curran, Partner, Hogan Lovells Brad Lang, Public Health Analyst, Office of Pharmacy Affairs Madeline Carpinelli Wallack, PRIME Institute Research Fellow, University of Minnesota School of Pharmacy Jeff Davis, Associate Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

B.

Medicaid Billing and Reimbursement: Evolution of Shared Savings Arrangements

ACPE: 1.25 Hours

Location: Regency Ballroom

According to HRSA guidance, how 340B drugs are billed and reimbursed by Medicaid is a matter of state policy, not federal law. State reimbursement policies vary significantly, with some states requiring covered entities to pass on all of their 340B savings to Medicaid, others not differentiating between 340B and non-340B claims, and still others "sharing" the 340B savings with covered entities. This session will focus on state Medicaid reimbursement policy and the movement by states to win-win shared savings arrangements. Speakers will address the decision that covered entities must make as to whether to "carve in" or "carve out" Medicaid drugs from their 340B purchases and the implications to a state when covered entities carve out. Speakers will also discuss specific state Medicaid programs that have implemented reimbursement policies that represent win-win situations for states and covered entities and the importance of advocacy in this area.

Kevin Gorospe, Principal, Health Management Associates, former Pharmacy Director of California Medicaid Diane Goyette, Senior Policy Consultant, HRSA Pharmacy Services Support Center Jennifer Palow, Pharmacy Director, Office of MaineCare Services Maureen Testoni, Assistant General Counsel, Safety Net Hospitals for Pharmaceutical Access (Moderator)

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Track Three ­ Roundtables (Limit 50 attendees per session) Optimizing 340B

Location: Congressional A ACPE: 1.25 Hours

Attendees will have an opportunity to interact with the roundtable facilitators, as well as with each other, as they drill down deeper into the various strategies employed and challenges encountered when trying to maximize the benefits of the 340B program while complying with program requirements.

Mike Bonck, Pharmacy Manager, Franciscan Health System Tracey Cole, Director of Pharmacy, Holyoke Health Center Paul Crowther, Pharmacy Director, Central Virginia Health Services Donna Evans, Senior Pharmacist, University of Alabama at Birmingham Hospital Gary Johnson, Director of Pharmacy, UVA Medical Center Rita Baskett, Dir. of Pharmacy & Educational Services, Safety Net Hospitals for Pharmaceutical Access (Moderator)

12:30 pm

Conference Adjourns

Comprehensive Pharmacy Services, Inc. is accredited by the Accreditation Council on Pharmaceutical Education as a provider of continuing pharmacy education. In order to receive credit, each pharmacist must complete the CE Request form located in your folder. All completed forms must be turned in at the registration desk at the conclusion of the conference. PLEASE NOTE: Forms mailed in after the conclusion of the conference will not be accepted for continuing education credit. Your continuing education statement of credit will be sent via email within six weeks. If unable to receive statement by e-mail, a statement will be mailed to you. Thank you for your participation in the conference.

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Agenda for 2010 SNHPA Summer Conference (D0304705).DOC

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Agenda for 2010 SNHPA Summer Conference (D0304705).DOC