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  3. Program Integrity

Program Integrity

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.

Audits of Covered Entities

340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.

HRSA has the authority to audit covered entities for compliance with 340B Drug Pricing Program (340B Program) requirements (42 USC 256b(a)(5)(C)):

Covered entities are subject to audit by the manufacturer or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts or cause the covered entity to be removed from the 340B Program.

Audits of Manufacturers

Under section 340B(a)(1) of the Public Health Service Act, manufacturers of covered outpatient drugs that participate in the 340B Drug Pricing Program (340B Program) must offer all covered outpatient drugs at no more than the 340B ceiling price to a covered entity listed on HRSA’s 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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