Legal Update, September 2021

Legal Update

Reorganization of HRSA and Change in Office of Pharmacy Affairs Leadership
by Elizabeth “Issie” Karan

At the end of August, the Biden Administration released a notice in the Federal Register regarding the reorganization of the Health Resources and Services Administration (HRSA), including the 340B Program. The Office of Special Health Initiatives (OSHI) now will oversee the 340B Program and the Office of Pharmacy Affairs. Additionally, Rear Admiral Krista Pedley will no longer directly oversee the 340B Program because she is slated to be promoted to the inaugural Director of OSHI, which has not yet been publicly announced.

According to information on the HRSA website, OSHI provides a crosscutting focal point for HRSA to deliver on population health and Secretarial priorities, especially those that may be more clinical in nature. Specifically, OSHI: (1) coordinates and collaborates with components in HHS that align with the work of OSHI; (2) serves as the principal advisor within HRSA on global health issues; (3) provides agency-wide leadership and policy development in the administration of the 340B Drug Pricing Program to promote access to clinically and cost effective pharmacy services to the country’s most vulnerable patient populations; (4) serves as the lead on behavioral health issues that span HRSA; and (5) provides cross-cutting leadership on HRSA oral health programs.

OSHI is more closely connected to the Office of the Secretary of Health and Human Services. Theoretically, this could signal HHS’ priority to monitor the 340B Program more closely and/or coordinate its impact across the Department. The Hemophilia Alliance will continue to monitor developments in the 340B Program’s structure and leadership.

Also in this Issue…

Notes from Joe
· Finally, and thank you!

Washington Update
· Washington Update

Payer Update
· Open Enrollment Beginning

Alliance Update
· Meeting Update
· Harmony in Hemophilia – HTC Wall of Walkers Unite Walk Challenge Update

Notes from the Community
· Update from the Hemophilia Alliance Foundation