Drug Pricing Program: HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B Requirements, Report to Congressional Requesters   [open pdf - 1MB]

From the GAO (Government Accountability Office) Highlights: "Covered entities can realize substantial savings through 340B Program [340 B Drug Pricing Program] price discounts, enabling them to stretch federal resources to reach more eligible patients and provide more comprehensive services. GAO was asked to provide information on HRSA's [Health Resources and Services Administration's] efforts to oversee covered entities' compliance with 340B Program requirements. This report describes (1) the audit findings that HRSA issued to address covered entity noncompliance with 340B Program requirements; and (2) other efforts HRSA uses to help ensure that covered entities comply with 340B Program requirements. GAO reviewed documentation, including relevant federal laws and regulations and HRSA's policies, procedures, and guidance, related to 340B Program oversight. GAO also reviewed HRSA data on the number and type of audit findings made from audits finalized during fiscal years 2012 through 2019 as of September 2020--the latest data available at the time of the audit. GAO also interviewed officials from HRSA, agency contractors, and 340B Program stakeholders. GAO provided a draft of this report to HHS for review. The agency provided written and technical comments on the draft, both of which were incorporated as appropriate."

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Government Accountability Office: https://www.gao.gov/
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