The 340B Drug Pricing Program Explored: A 2013 Perspective

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. 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.

Lidia A. Rodriguez-Hupp has 10 – 12 years of experience with 340B software and program maintenance. She has been with Sentry Data Systems, Inc. since its early years, originally joining Sentry as the Director of Implementation and also serving as the Director of Client Services and Vice President of Client Services before her promotion to Sentry’s Senior Vice President. The Client Services and Marketing departments report directly to her and she provides expertise in both strategic planning and account management, as well as serving as the 340B Compliance Officer. Prior to joining Sentry, Ms. Rodriguez-Hupp was Director of Implementation for RxStrategies, Inc., a company specializing in 340B for the FQHC market. From 1999-2001, Ms. Rodriguez-Hupp was the Investor Relations Manager for PNV, Inc. and was a member of the IPO Road Show Team when it went public in 2000. Prior to returning to Florida in 1999, Ms. Rodriguez-Hupp held various positions for members of Congress in the U.S. House of Representatives.

Maureen Testoni is General Counsel of Safety Net Hospitals for Pharmaceutical Access (SNHPA), which represents hospitals and health systems enrolled in the 340B program. She oversees a team of attorneys that work to influence law and policy regarding the 340B program. Ms. Testoni also provides assistance to hospitals on 340B implementation and compliance matters as well as policy guidance. Ms. Testoni has extensive experience in health care regulatory law and policy. While in private practice, Ms. Testoni represented hospitals and other providers regarding compliance with Medicare and Medicaid reimbursement and fraud and abuse laws. Ms. Testoni also has extensive trade association experience, having spent five years with the American Psychological Association, most recently serving as Senior Director for Legal and Regulatory Affairs. In the area of health care policy, Ms. Testoni spent several years as a health care advisor on Capitol Hill, working for both Senator Max Baucus and Congressman Marty Russo. Maureen Testoni is a member of the DC and Virginia bars. Ms. Testoni received her law degree from The George Washington University National Law Center, with honors, and her B.A. in public policy from the University of Chicago.

Aaron Vandervelde is a Principal with Berkeley Research Group’s Health Analytics practice in Washington, DC. He has over 10 years of experience providing strategy, health policy and litigation consulting services to clients in the health care industry. He specializes in financial and economic analysis of health policy and provides litigation consulting services related to issues arising from contracts and transactions between health care entities. Specifically, he focuses on deriving strategic insight through the integration and analysis of large, complex data sets including claims data, internal and external sales data and publicly available health data. Mr. Vandervelde’s practice is focused primarily on clients across the healthcare continuum, including Fortune 500 pharmaceutical manufacturers and biotech companies, health insurers, PBMs, and others.