Thursday, February 2, 2017

*Subject to change
Sessions indicating a badge color are limited to the respective covered entity, industry or government groups. Learn more about badge colors. Badge colors

 

7:00am

Continental Breakfast – Stakeholder Networking Opportunity
Location: Pacific Concourse

8:00am

Opening Remarks
Location: Grand Ballroom

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

8:30am

The State of 340B: Looking Back and Moving Forward
Location: Grand Ballroom

Over the past year, the 340B program and its stakeholders have witnessed many significant developments and the coming year will be even busier.  This session will cover the key 340B highlights and how you can take full advantage of the conference.

Ted Slafsky, President and Chief Executive Officer, 340B Health

9:00am

Keynote Speaker
Location: Grand Ballroom

We are pleased to announce this year’s keynote speaker, Lanhee Chen, Ph.D, who has been described by Politico as the "GOP's most courted ideas adviser." Dr. Chen is a veteran of several high-profile political campaigns and, currently serves as a Research Fellow at Stanford University's Hoover Institution and as a CNN commentator. He was a senior adviser on policy to Marco Rubio's presidential campaign and was the policy director for the Romney-Ryan 2012 presidential campaign. In that role, he served as Governor Mitt Romney’s chief policy adviser, a senior strategist on the campaign, and the person responsible for developing the campaign’s domestic and foreign policy. Dr. Chen, who has called for the repeal and replacement of the Affordable Care Act (ACA), is also counsel in the Health Care group at Arent Fox.

Lanhee Chen, Research Fellow, Stanford University's Hoover Institute
Maureen Testoni, Senior Vice President and General Counsel, 340B Health

10:00am

Exhibiting Forum, Refreshment Break, Networking Opportunity
Location: Pacific Concourse

11:00am

Transition to a New Administration and Potential Impact to 340B and Other Health Care Programs
Location: Grand Ballroom

Colleen Meiman, Director of Regulatory Affairs, National Association of Community Health Centers
Sonja Nesbit, Senior Government Relations Director, Arent Fox
Maureen Testoni, Senior Vice President and General Counsel, 340B Health

11:45am

Apexus Update
Location: Grand 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 key initiatives.

Chris Hatwig, President, Apexus/340B Prime Vendor Program

12:15pm

State Networking Opportunity Lunch
Location: Atrium

Note: The following sessions have been organized into three separate tracks to accommodate the varying interests of conference attendees. Track One sessions are designed for covered entities and other parties that are interested in learning about how to operationalize 340B. Track Two sessions will appeal to the broader community of 340B stakeholders, including the pharmaceutical industry, who might be more interested in hearing about (1) recent developments involving 340B policy and compliance and (2) expert analysis. Track Three sessions are designed for all attendees to discuss the patient care aspects of 340B and how savings from this vital program are utilized.  Although attendees may be drawn to all of the presentations organized under one track, they are free to attend any track that interests them. Roundtable sessions are designed to facilitate small group discussions primarily focused on the other tracks’ topics. These sessions, which are limited to 50 attendees each (first come, first served) allow for more dialogue with our expert panels.

1:30pm

Track One - 340B Operations: Experiences from the Field

340B Contract Pharmacy Implementation and Compliance Considerations
Location: Grand Ballroom A

340B covered entities are responsible for ensuring that their contract pharmacy arrangements comply with 340B program rules, such as patient definition and the duplicate discount prohibition, and covered entities must have systems in place to monitor these arrangements.  Therefore, 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.  Speakers will discuss specific challenges to be aware of when implementing an arrangement.  The session will also highlight how entities can continually monitor their contract pharmacies to ensure 340B compliance, including ways that contract pharmacies can help covered entities monitor compliance.

Nicole Crase, Pharmacy Manager, Five Rivers Health Centers
Kevin Jones, 340B Drug Pricing Program Director, Intermountain Healthcare
Kenneth Pacheco, Program Manager 340B and Lab, Access Community Health
Jason Reddish, Attorney, Powers Pyles Sutter & Verville PC (Moderator)

1:30pm

Track Two - 340B Policy and Compliance

A) Medicaid Billing & Reimbursement
Location: Grand Ballroom BC

In 2016, CMS published regulations affecting  how states reimburse 340B retails drugs provided to fee-for-service Medicaid patients and mandating that states take steps to ensure 340B Medicaid managed care claims are identified and excluded from the Medicaid rebate requests.  States are currently in the process of implementing these new requirements and evaluating their policies for 340B drugs, which could significantly impact covered entities  use of 340B for Medicaid patients.  This session will review the key parts of the regulations and address how they are being implemented in different states.

Charles Cooper, 340B Program Manager, Fairview Health Services
Rich Holsapple, Pharmacy Services Manager, HP Enterprise Services
Anja Wilkinson, Pharmacy Financial Analyst, Saint Francis Hospital
Jeff Davis, Legislative and Policy Counsel, 340B Health (Moderator)

B) 340B Ceiling Price Calculations & Manufacturer Civil Monetary Penalties
Location: Bayview Room

HRSA recently published a final rule regarding 340B ceiling price calculations and civil monetary penalties (CMPs) for manufacturers that knowingly and intentionally overcharge covered entities for 340B covered outpatient drugs.  The regulation codified the agency’s long-standing penny-pricing policy and established a standard methodology for manufacturers to use to estimate when setting a new drug’s 340B ceiling price.  The rule’s CMP provisions give the federal government a new enforcement mechanism to help ensure manufacturers are meeting their 340B program obligations. This session will provide an overview of the regulation, and panelists with share both provider and manufacturer perspectives on the rule.

Jonathan Connell, Senior Counsel, Bristol-Myers Squibb
Bill von Oehsen, Principal, Powers Pyles Sutter & Verville, PC
Greg Doggett, Legal and Policy Counsel, 340B Health (Moderator)

1:30pm

Track Three – Clinical Best Practices

Managing High Cost Illnesses and Improving Outcomes

Location: Seacliff CD

This session will address how covered entities have developed programs to help manage and treat patients with high cost illnesses and drug therapies, such as hepatitis, HIV, and cancer.  The speakers will focus on managing referrals for specialty drugs, patient compliance, and how 340B savings are used to provide more patient centered care to help manage the complex medical and social needs of chronically ill patients.

Matthew Bertsch, Director of Pharmacy, Sun Life Family Health Center
Laura Feeney, Clinical Pharmacist, Primary Care, San Francisco Department of Public Health
Jared Hatchard, Community Pharmacy Operations Manager, Sun Life Family Health Center
Todd Jackson, Director, Pharmacy Services, East Carolina University Brody School of Medicine
Anusha McNamara, Clinical Pharmacist, Primary Care, San Francisco Department of Public Health
Cindy Wilson, Manager, Pharmacy 340B Program, CHI Franciscan Health (Moderator)

 

1:30pm

Small Group Discussions/Roundtable Sessions

A) Hospital Audit Roundtable (hospitals only)
Badge Color: Hospitals
Location: Garden B

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).  The roundtable will provide an opportunity to discuss best practices in audit preparation and lessons learned from the audit experience and CAP development.

Maureen Testoni, Senior Vice President and General Counsel, 340B Health (Moderator)

B) Third-Party Payer Challenges and Developments
Location: Garden A

Over the last few years, a number of third-party payers have tried to contract with 340B pharmacies on different terms than those applied to non-340B pharmacies.  In most cases, the different terms include paying 340B pharmacies at lower rates.  Some payers are also requiring pharmacies to identify 340B claims at the point of sale.  Speakers will address a range of issues relating to 340B reimbursement, including why these trends are occurring, how they impact covered entities and their patients, and the payer’s perspective on the 340B program and reimbursement of 340B drugs.

Mark Malahosky, Vice President, Pharmacy Services, Trillium Health
Halena Leah Marcelin, 340B Program Manager, Memorial Healthcare System
Frank Messina, General Counsel, SCL 340B Care
Steven Miller, Pharmacy Services Director, 340B Health (Moderator)

C) CHC Expert: Sharpening our Focus on the points where 330 and 340B Intersect

Badge Colors: Community Health Centers
Location: Seacliff AB

This session will provide an overview of the key areas where the 340B Drug Discount Program intersects with the Program Expectations for Section 330 grantees – FQHCs and FQHC Look-Alikes.  A panel of experts will discuss compliance requirements and potential audit findings, as well as strategies for operational effectiveness with a particular focus on areas:

  • Sliding fee discounts
  • Clinic administered drugs
  • The 340B side of the HRSA Operational Site Visit
  • The full-scale 340B audit in the health center environment

Gretchen Beckham, Director of Pharmacy, Eau Claire Cooperative Health Center
Michael Glomb, Partner, Feldesman Tucker Leifer Fidell LLP; Counsel, National Association of Community Health Centers
Colleen Meiman, Director of Regulatory Affairs, National Association of Community Health Centers
Sue Veer, President and Chief Executive Officer, Carolina Health Centers (Moderator)

D) 340B Vendor Perspectives
Location: Marina Room

Covered entities rely on vendors to provide consulting and software services to support 340B operations in different ways.  This session is designed for vendors to discuss lessons learned and best practices from their extensive experience working with 340B covered entities. Questions are welcomed and encouraged during the session.

Jerry Chang, Vice President of Business Services, Parata
Sean Heard, Sales Director, Sales Director, Specialty and Home Infusion, Verity Solutions
Jeremiah McWilliams, Senior Director, 340B Account Services, Wellpartner
Joe Munson, Director of Client Relations, Equiscript LLC
Rob Nahoopii, Chief Executive Officer, Turnkey Pharmacy Solutions
Tammy Zukowski, Senior Director, Hospital and Health Systems Services, Visante
Rob Miller, Senior Vice President of Business Development, Strategic Planning, and Operations, 340B Health (Moderator)

2:45pm

Exhibitor Forum, Refreshment Break, Networking Opportunity
Location: Pacific Concourse

3:45pm

Stakeholder Breakout Sessions

A) Hospitals (DSH, Rural, Children’s and Cancer Hospitals)
Badge Color: Hospitals
Location: Grand Ballroom BC

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

Randy Barrett, Vice President, Communications, 340B Health
Anna Mangum, Vice President, Member and Board Relations, 340B Health
Rob Miller, Senior Vice President of Business Development, Strategic Planning, and Operations, 340B Health
Steven Miller, Pharmacy Services Director, 340B Health
Ted Slafsky, President and Chief Executive Officer, 340B Health
Maureen Testoni, Senior Vice President and General Counsel, 340B Health

B) Pharmaceutical Manufacturers

Badge Color: Pharmaceutical Manufacturers
Location: Seacliff CD

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’s plans to increase oversight over the pharmaceutical industry, and HRSA and manufacturer audits of covered entities.

Jonathan Connell, Senior Counsel, Bristol-Myers Squibb (Facilitator)
Marcy Imada, Principal, Deloitte & Touche LLP (Facilitator)

C) Community Health Centers

Badge Colors: Community Health Centers
Location: Grand Ballroom A

Join us to discuss the latest 340B issues and developments affecting community health centers (CHCs).  Likely topics will include the proposed mega-guidance and its implications for health centers, continuing scrutiny of the 340B program, Medicaid and other third-party billing and reimbursement issues, and an update on legislative matters impacting CHCs.  This session will be an opportunity to raise any issues affecting your CHC.

Michael Glomb, Partner, Feldesman Tucker Leifer Fidell LLP; Counsel, National Association of Community Health Centers
Colleen Meiman, Director of Regulatory Affairs, National Association of Community Health Centers
Michaela Keller, Manager of Federal Affairs, National Association of Community     Health Centers (Facilitator)
Sue Veer, President and Chief Executive Office, Carolina Health Centers, Inc. (Facilitator)

D) HIV/AIDS Clinics, ADAPs, and AIDS Service Providers
Badge Colors: HIV/AIDS Clinics, ADAPs, and AIDS Service Providers
Location: Seacliff AB

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.

Sean Dickson, Senior Manager, Health Systems Integration, National Alliance of State and Territorial AIDS Directors
Todd Jackson, Director, Pharmacy Services, East Carolina University Brody School of Medicine
Mark Malahosky, Vice President, Pharmacy Services, Trillium Health
Emily McCloskey, Senior Manager, Policy and Legislative Affairs, National Alliance of State and Territorial AIDS Directors
Britten Pund, Director, Health Care Access, National Alliance of State and Territorial AIDS Directors (Facilitator)

E) Hemophilia Treatment Centers
Badge Color: Hemophilia Treatment Centers
Location: Marina Room

This session will focus exclusively on matters impacting hemophilia treatment centers (HTCs), with an emphasis on 340B issues.  Likely topics include HRSA’s oversight efforts, including audits, and Medicaid billing and reimbursement issues.  This session also will be an opportunity to discuss other issues impacting your HTC.

Jeff Blake, Senior Vice President of Payer Relations, Hemophilia Alliance
Elizabeth Karan, Associate, Feldesman  Tucker Leifer Fidell; Counsel, Hemophilia Alliance
Joseph Pugliese, President, Hemophilia Alliance
Ellen Riker, Senior Vice President, Cavarocchi, Ruscio, Dennis Associates; Counsel to Hemophilia Alliance
Sean Singh, Vice President, Hemophilia Alliance

F) Family Planning Clinics, STD Clinics, and Other Non-Hospital Providers
Badge Colors: Family Planning Clinics, STD Clinics, and Other Non-Hospital Providers
Location: Regency A

This session will focus exclusively on family planning and STD clinics and programs, with an emphasis on 340B issues, including implications of the proposed mega-guidance on clinics and programs.  We will also discuss the political landscape around the program, 340B legislation, the status of 340B-related health care reform provisions, and issues related to third-party billing and reimbursement.

Rebekah L. Horowitz, Senior Policy Manager, National Coalition of STD Directors
Mindy McGrath, Policy Director, National Family Planning & Reproductive Health Association

G) 340B Service Providers (Contract Pharmacies, Consultants, PBMs, and Related Vendors)
Badge Colors: Industry
Location: Bayview Room

This session is designed for all 340B service providers.  Participants will share perspectives and information on a range of 340B hot topics, including Medicaid managed care, 340B claim identification, and contract pharmacy oversight.

Michael Keegan, Director, Policy and Regulatory Affairs, National Community Pharmacists Association
Fenton Markevich, Chief Executive Officer, RxStrategies
Jason Reddish, Attorney, Powers Pyles Sutter & Verville PC
Greg Doggett, Legal and Policy Counsel, 340B Health (Moderator)

5:00pm

Conclusion of Breakout Sessions 

5:15pm-6:30pm

Opening Reception
Location: Pacific Concourse

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