The Health Resources and Services Administration (HRSA) has announced plans to strengthen oversight of both covered entities and manufacturers participating in the 340B drug discount program to ensure compliance with program requirements. In fiscal year 2012, the agency intends to, among other things: conduct targeted audits of 340B covered entities to monitor for program violations and prevent diversion and duplicate discounts; increase oversight of manufacturers to ensure that covered entities are not being overcharged; issue additional policy releases to increase program transparency; verify that covered entities meet statutory requirements for participation; and improve eligibility processes, including annual recertification of eligibility. Note that following this announcement, four Republican Senators sent a series of letters to 340B stakeholders seeking information on 340B compliance issues, warning that “exploding growth raises questions about program integrity.”