A federal drug discount program authorized under section 340B of the Public Health Service Act. The 340B
program requires drug manufacturers to enter into pharmaceutical pricing agreements (PPAs) with the Secretary
of HHS as a condition of Medicaid and/or the Medicare Part B program covering and paying for the manufacturer’s
covered outpatient drugs. The PPAs specify, among other things, that manufacturers may not sell covered
outpatient drugs above 340B ceiling prices to covered entities.