As directed by the Patient Protection and Affordable Care Act (“PPACA”), the U.S. Government Accountability Office (“GAO”) released a report on September 23, 2011 on the federal 340B Drug Discount Program (the “340B Program”). Under the 340B Program, eligible safety-net health care providers (“covered entities”) receive discounts on outpatient prescription drugs. In addition to commissioning the GAO report, PPACA expanded eligibility for the 340B Program and included a number of provisions to improve program compliance by covered entities and drug manufacturers.

To develop the report, GAO interviewed several different types of covered entities (e.g., federally qualified health centers, family planning clinics, AIDS Drug Assistance Programs, hemophilia treatment centers and certain hospitals) as well as a number of pharmaceutical manufacturer representatives. GAO also interviewed the Health Resources and Services Administration ("HRSA") and reviewed information from other departments within the U.S. Department of Health and Human Services.