HRSA Administrator Sigounas, OPA Director Pedley Address 340B Coalition Conference and Discuss Program Changes

By , Published On: July 17, 2017

George Sigounas, Ph.D., delivered his first remarks to 340B Coalition conference-goers since assuming his role as Administrator of the Health Resources and Services Administration (HRSA) on May 1.  Dr. Sigounas, who last served as a Professor of Medicine at East Carolina University and hematology/oncology researcher, called the 340B program “wonderful” and cited its far-reaching impact.  He noted that the purpose of the program is to stretch scarce federal resources as far as possible in order to reach more eligible patients and provide more comprehensive services.

Dr. Sigounas also signaled that change is on the horizon for the 340B program.  He stated that Congress recognizes the importance of the program, and that HHS Secretary Tom Price expressed interest in the role of the 340B program and its impact on drug pricing.  Dr. Sigounas proposed to work with Congress to ensure that 340B benefits communities, and to meet with stakeholders.  He hinted that HRSA would need additional statutory authority to strengthen oversight or track how savings are used.  Grantees participating in the 340B program already formally account for how such dollars are spent, and hospitals report on how resources are deployed through a number of vehicles.

Captain Krista Pedley (Public Health Service), Director of HRSA’s Office of Pharmacy Affairs, also took the stage to deliver 340B program news.  Captain Pedley echoed Dr. Sigounas, and expressed her desire for Congress to give HRSA and OPA the regulatory authority to ensure that the 340B program benefits underserved populations.

Captain Pedley also updated attendees on OPA audit activities.  She stated that 805 covered entity audits have been conducted to date, with another 200 expected next year.  OPA is also now auditing manufacturers, and expects to audit approximately five per year.  OPA continues to use a risk-based audit selection tool that focuses on program complexity and could include re-audit of covered entities with corrective action plans requiring repayment.

OPA also announced a new database system, called the OPA Information System or OPAIS, that will combined long-awaited 340B ceiling price access with the ability to update and maintain accurate public database entries.  The username and password system will be launched soon, according to Captain Pedley.

For more information, or if you have any questions regarding this topic, please contact Jason Reddish (jreddish@ftlf.com), Michael Glomb (mglomb@ftlf.com), or the Feldesman Tucker Leifer Fidell LLP attorney with whom you regularly work.