340B Insight Podcast
Episode One: HRSA’s OPA Response to COVID-19 with Rear Admiral Krista Pedley
May 18, 2020
The inaugural episode of 340B Insight features 340B Health President and CEO Maureen Testoni interviewing Rear Admiral Krista M. Pedley, the Director of the Office of Pharmacy Affairs (OPA) in the Health Resources & Services Administration (HRSA). OPA administers the 340B drug pricing program. Rear Admiral Pedley offers numerous insights into critical 340B issues, including HRSA Provides Flexibility During the COVID-19 Pandemic. (Transcript)
340B Insight is a podcast hosted by 340B Health that provides its members and supporters with timely news updates and discussion around the 340B drug pricing program.
This inaugural episode includes news updates on the Centers for Medicare and Medicaid Services going ahead with a controversial survey of 340B hospitals, and lawmakers on Capitol Hill asking congressional leaders to protect 340B during the COVID-19 pandemic.
In the feature interview for this episode, the President and CEO of 340B Health, Maureen Testoni, speaks with Rear Admiral Krista M. Pedley, the Director of the Office of Pharmacy Affairs (OPA) in the Health Resources & Services Administration (HRSA). OPA administers the 340B drug pricing program, which requires drug manufacturers to provide outpatient drugs to eligible safety-net providers at reduced prices.
During the interview, Rear Admiral Pedley offers numerous insights into critical 340B issues, including:
- HRSA Provides Flexibility During the COVID-19 Pandemic: HRSA is offering certain flexibilities for covered entities to ensure that they can remain focused on patient care during the pandemic. For example, it will conduct remote 340B audits for the next several months.
- HRSA Has Limited Enforcement Powers During Audits: HRSA can only enforce 340B guidance if it discovers a clear and direct violation of the 340B statute. As such, HRSA states that it has limited capacity to broadly enforce 340B guidance.
- The New 340B Ceiling Price Website Improves Transparency: Last year, HRSA launched the new 340B ceiling price website, which has improved transparency and communications with external stakeholders in relation to price reporting and price comparisons.
- Eligible 340B Participants Must Continue to Document and Track Activities: Rear Admiral Pedley urges all 340B participants to document how they follow HRSA guidance in their policies and procedures and to keep auditable records of what makes them eligible to participate. It is also critical that 340B participants have a system in place to track every purchase of a 340B drug to an eligible patient.
- HRSA Finds Common Ground Between All Stakeholders: Rear Admiral Pedley highlights her role in listening to all sides of the 340B ecosystem to help find common ground and a sustainable path forward on reduced drug pricing.
340B Health expresses our gratitude to Rear Admiral Pedley for more than 10 years of dedication to the 340B program. Under her leadership, the 340B program continues to improve in its role as a vital health care safety net to patients in the U.S.
HRSA OPA website
340B Health COVID-19 Resource Center
340B Health OPPS Resource Center
340B Health press release on Reps. Matsui-Stewart letter
Maureen Testoni op-ed about the 340B ceiling price website
Rear Admiral Krista Pedley’s Bio
Rear Admiral Krista M. Pedley is the Director of the Office of Pharmacy Affairs (OPA) in the Healthcare System Bureau, Health Resources & Services Administration (HRSA). Her office administers the 340B drug pricing program, through which more than 700 drug manufacturers provide discounted outpatient drugs to more than 46,700 hospitals and clinics, and more than 24,500 pharmacies purchase more than $24 billion in 340B drugs annually. The 340B program spans HHS and focuses on drug pricing transparency and reducing the cost of medications for the country’s most vulnerable safety-net patient populations.
RADM Pedley began her career as a pharmacist with the United States Public Health Service in May 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, RADM Pedley transferred to 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). In 2007, RADM Pedley began working with OPA, where she led a national collaborative that focused on integrating clinical pharmacy services into primary care to improve the health of patients with multiple chronic conditions. She then became the Director of OPA in July 2010 and was promoted to Rear Admiral and Assistant Surgeon General in February 2020.
RADM Pedley received her Doctor of Pharmacy degree at the University of Pittsburgh in 2000 and her Master of Science in Engineering Management and Systems Engineering, with a Concentration in Crisis, Emergency and Risk Management, from The George Washington University in 2008. She is also a 2011 graduate of the Public Health Leadership Institute (PHLI) Scholar Program.
RADM Pedley has participated in numerous deployments, including Hurricanes Frances, Ivan, Isabel, and Katrina as well as the Presidential Inauguration in 2005. RADM Pedley was also a contributor on the Report to the Surgeon General on Clinical Pharmacy and co-author on PHS Pharmacy Prevention Strategy.
RADM Pedley is the recipient of numerous awards, including an Exceptional Promotion to Captain in 2015, the Meritorious Service Medal in 2018, the PHS Commendation Medal in 2012, 2009, 2005, and the APhA Foundation Pinnacle Award in 2016 and 2011.