As part of President Trump’s budget released today, HRSA submitted its budget justification that includes its pledge to “work with Congress to develop a legislative proposal to improve 340B Program integrity and ensure that the benefits derived from participation in the program are used to benefit patients, especially low-income and uninsured populations.” The proposal also seeks regulatory authority to improve 340B Program integrity. The 340B Program is discussed on pages 244-247 of the budget document.
The agency’s budget proposal reflects the demands from critics of the 340B Program for greater transparency and oversight. The budget proposal also includes measures to continue 340B oversight and audit activities by HRSA. For example, HRSA aims to conduct 200 covered entity audits in FY 2018 (HRSA also conducted 200 audits in FY 2017). HRSA plans to conduct only five manufacturer audits in FY 2018.
The President’s budget would maintain funding for the 340B Program at $10.2 million.