HRSA's Program Integrity guiding principles are to maximize oversight reach and manage compliance risks. Efforts to follow these principles include audits of covered entities and manufacturers to enforce requirements for these stakeholders.
Other efforts include annual recertification to give covered entities an opportunity to review their 340B Drug Pricing Program (340B Program) responsibilities and re-attest to being currently in full compliance.
HRSA performs program integrity checks regarding eligibility requirements and documentation necessary to demonstrate compliance. Also, OPA's self-disclosure process allows covered entities to evaluate and correct aspects of their 340B Program through self-reporting.