2012 Midyear Clinical Meeting
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340B Program Update: Transitioning from Access to Integrity
Track:
Education Sessions (CE)
Program Code: 315-L04
Date: Monday, December 3, 2012
Time: 7:30 AM to 9:00 AM EST
Location:
Mandalay Bay D, Level 2, South Convention Center
PRESENTER(S):
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Jason Atlas,
RPh, MBA, Director Ambulatory Pharmacy,
Denver Health and Hospital Authority
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Responsible for the planning and management of all regulatory and
strategic Outpatient Pharmacy projects within Denver Health & Hospital
Authority, a safety net health system consisting of a 477-bed teaching
hospital, eight family health centers and twelve school based health clinics,
serving one-third of Denvers population annually with 350,000 clinic visits and nearly 1 million outpatient prescriptions.
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Marcus joined Genentech in September 1986 as its first Washington, DC based Clinical Marketing Specialist. After 8 years in this position he joined the newly formed Managed Care Department at Genentech with responsibility for all Federal programs. In January of 2002 he moved to Government Affairs where he managed the Federal Programs, and worked on Public Payer Policy issues in some of the larger states. With the recent integration into the Roche Group, he currently he leads a team of Account Managers and analysts focused on 340B program integrity. Marcus is considered an expert on pharmaceutical procurement and has been an invited speaker at VA and 340B conferences.
Marcus holds an undergraduate degree in pharmacy from The Philadelphia College of Pharmacy and Science and an MBA in International Finance from Drexel University.
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Christopher A. Hatwig, M.S., R.Ph., FASHP is vice president of Apexus which is responsible for the managing the 340B Prime Vendor. Apexus is a non-profit entity located in Irving, Texas which serves as Health Resources and Services Administrations (HRSA) Prime Vendor for the 340b Drug Pricing Program. Apexus currently represents over 12,000 eligible 340B covered entities purchasing in excess of $5.0 billion in outpatient covered drugs, vaccines and pharmacy related supplies. Mr. Hatwig works closely with HRSAs Office of Pharmacy Affairs and the Pharmacy Services Support Center in Washington, D.C. to educate all stakeholders, and to improve the integrity and value of the 340B Drug Pricing Program for the nations safety-net providers which include HRSA grantees and disproportionate share hospitals.
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Michelle Herzog, Deputy Director,
Office of Pharmacy Affairs, Health Resources and Services Administration
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Michelle Herzog is the Deputy Director in the Office of Pharmacy Affairs. Prior to joining the office she was the program manager for the State Health Access Program. Ms. Herzog has held several other positions with the Bureau including Principal Staff Liaison to the Advisory Commission on Childhood Vaccines and senior public health analyst with the former Division of Healthcare Preparedness. She has spent a total of 20 years working in the Health Resources and Services Administration. She completed the USDAs Graduate School year long Womens Executive Leadership Program where she had the opportunity to work at the General Services Administration developing an information management system and with the Office for Personnel Management on the Presidents Award for Quality program.
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Krista Pedley,
PharmD, MS, Director, Office of Pharmacy Affairs,
HRSA
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CDR Krista M. Pedley is the Director of the Office of Pharmacy Affairs (OPA) in the Health Resources and Services Administration (HRSA). Her office administers the 340B Drug Pricing Program through which outpatient clinics and hospitals purchase approximately $6 billion annually in discounted drugs. The mission of OPA is to increase access to clinically and cost-effective pharmacy services. OPA, in partnership with CMS, also leads the Patient Safety and Clinical Pharmacy Services Collaborative. CDR Pedley is a Commissioned Officer in the United States Public Health Services.
CDR Pedley began her career as a pharmacist with the United States Public Health Service in 2000. She was assigned to the Food and Drug Administration, Office of Generic Drugs, as a Project Manager for Bioequivalence and then as Medical Affairs Coordinator reviewing topical drug protocol design. After five years, CDR Pedley transferred to the Health Resources and Services Administration (HRSA) and then the Office of the Secretary of Health and Human Services where she served as Senior Public Health Analyst for the National Bioterrorism Hospital Preparedness Program (NBHPP).
CDR Pedley received her Doctorate of Pharmacy degree at the University of Pittsburgh in 2000 and her Master of Science degree in Engineering Management and Systems Engineering, with a Concentration in Crisis, Emergency and Risk Management from George Washington University in 2008.
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PROGRAM CHAIR:
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Christopher A. Hatwig, M.S., R.Ph., FASHP is vice president of Apexus which is responsible for the managing the 340B Prime Vendor. Apexus is a non-profit entity located in Irving, Texas which serves as Health Resources and Services Administrations (HRSA) Prime Vendor for the 340b Drug Pricing Program. Apexus currently represents over 12,000 eligible 340B covered entities purchasing in excess of $5.0 billion in outpatient covered drugs, vaccines and pharmacy related supplies. Mr. Hatwig works closely with HRSAs Office of Pharmacy Affairs and the Pharmacy Services Support Center in Washington, D.C. to educate all stakeholders, and to improve the integrity and value of the 340B Drug Pricing Program for the nations safety-net providers which include HRSA grantees and disproportionate share hospitals.
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Description
Introduction, Chris Hatwig, MS. RPh, FASHP
OPA Update, Krista M. Pedley, PharmD, MS
Get Prepared: Audit Readiness for 340B Pharmacies, Michelle Herzog, Jason Atlas, Marcus Farbstein
Apexus Update and Wrap Up, Chris Hatwig, MS, RPh, FASHP
- Describe leading practices used by a recently-audited 340B compliant program.
- Describe the roles, priorities, and current activities of HRSA's Office of Pharmacy Affairs and its contractors in supporting new integrity initiatives.
- Discuss HRSA's, pharmaceutical manufacturers', and entity's perspectives on 340B integrity and the audit process.
