In its 2011 report, the Government Accountability Office (GAO) found that the Health Resources and Services Administration’s (HRSA) oversight of the 340B Drug Pricing Program was insufficient to deliver an equitable guarantee that program participants were in compliance with program requirements.
In order to address oversight of program inadequacies, the GAO recommended that HRSA conduct selective audits of covered entities to deter potential diversion; further specify its nondiscrimination guidance in certain cases; finalize new, more specific guidance on the definition of a patent eligible to receive discounted drugs; and issue guidance to further specify the criteria that hospitals not publicly owned or operated must meet to be eligible for the 340B Program.
HRSA implemented two of the four recommendations during fiscal year 2012. The agency executed a systematic approach to conducting audits of covered entities and issued updated nondiscrimination guidance. HRSA planned to address the two other recommendations in a proposal submitted in April 2014, but withdrew the proposal in May 2014 after a federal district court ruling.
GAO conducted this progress study in order to describe program inadequacies identified in 2011 and to review the progress HRSA has made through implementing GAO’s recommendations.
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