Highlights of GAO-11-836, a report to
congressional committees

Why GAO Did This Study

The Health Resources and Services
Administration (HRSA), within in the
Department of Health and Human
Services (HHS), oversees the 340B
Drug Pricing Program, through which
participating drug manufacturers give
certain entities within the health care
safety net—known as covered
entities—access to discounted prices
on outpatient drugs. Covered entities
include specified federal grantees and
hospitals. The number of covered
entity sites has nearly doubled in the
past 10 years to over 16,500.
The Patient Protection and Affordable
Care Act (PPACA) mandated that GAO
address questions related to the 340B
program. GAO examined: (1) the
extent to which covered entities
generate 340B revenue, factors that
affect revenue generation, and how
they use the program; (2) how
manufacturers’ distribution of drugs at
340B prices affects covered entities’ or
non-340B providers’ access to drugs;
and (3) HRSA’s oversight of the 340B
program. GAO reviewed key laws and
guidance, analyzed relevant data, and
conducted interviews with 61 340B
program stakeholders selected to
represent a range of perspectives,
including HRSA, 29 covered entities,
10 manufacturers and representatives,
and 21 others. Selection of
stakeholders was judgmental and thus,
responses are not generalizable.

What GAO Recommends

To ensure appropriate use of the 340B
program, GAO recommends that
HRSA take steps to strengthen
oversight regarding program
participation and compliance with
program requirements. HHS agreed
with our recommendations.

Click Here to go to the full 54 page report.