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  3. Program Integrity

Program Integrity

HRSA's program integrity efforts aim to maximize oversight reach and manage compliance risks. We perform program integrity checks on eligibility requirements and documentation needed for compliance. Our self-disclosure process allows covered entities to evaluate and correct aspects of their 340B Program through self-reporting.

Other efforts include annual recertification. This gives covered entities a chance to review their 340B Drug Pricing Program (340B Program) responsibilities and let us know they're still in full compliance.

We also perform audits of covered entities and manufacturers. Covered entities participating in the 340B Drug Pricing Program must maintain accurate records to ensure compliance. Under section 340B(a)(5)(C) (PDF - 39 KB), we have authority to audit these entities for program adherence. Non-compliance may lead to refunds to drug manufacturers or removal from the program.

Audits of manufacturers

Under section 340B(a)(1), manufacturers of covered outpatient drugs that participate in the 340B Program, must offer all covered outpatient drugs at no more than the 340B ceiling price to a covered entity listed on our public 340B database if such drug is made available to any other purchaser at any price.

Manufacturers are subject to auditing by HRSA to ensure compliance with the 340B Program, pursuant to section 340B(d)(1)(B)(v) of the PHSA. Failure to comply with 340B pricing requirements may make the manufacturer liable to covered entities for refunds of overpriced 340B drugs.

HRSA correspondence to stakeholders

Audit results

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