Government Accountability Office (GAO)
Definition
The Government Accountability Office (GAO) is often called the ‘congressional watchdog.’ It investigates how the federal government spends taxpayer dollars and provides objective, nonpartisan analysis to Congress on policy and program effectiveness. The GAO has conducted numerous studies of the 340B program at Congress’s request.
GAO reports on 340B have examined topics including covered entity compliance, the use of 340B savings, contract pharmacy arrangements, program oversight by HRSA, and the program’s impact on drug manufacturers. These reports have been influential in shaping Congressional hearings, legislative proposals, and regulatory activity related to the program.
For covered entities, understanding the GAO’s role helps explain why the 340B program faces ongoing legislative scrutiny and why program integrity and transparency are increasingly important. GAO findings that identify compliance weaknesses or questions about savings utilization create political pressure for program reform.
Frequently Asked Questions
Why Government Accountability Office (GAO) Matters
GAO reports shape the legislative and regulatory environment for the 340B program. Findings that raise questions about program integrity or savings utilization create political pressure for reforms that could restrict covered entity access to 340B pricing. Maintaining a well-documented, transparent program is part of the broader defense of the program.
How Virtue 340B Uses It
Virtue 340B monitors GAO reports and Congressional activity related to 340B to keep our clients informed of emerging regulatory and legislative risks. We help clients build programs that can withstand both HRSA scrutiny and broader public accountability.