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340B Patient Definition Compliance Resources

Program integrity is a top priority for the 340B Program. Section 340B(a)(5)(C) of the Public Health Service Act (PHSA) (PDF - 39 KB) authorizes HRSA to conduct audits of covered entities to ensure compliance with 340B Program requirements. In accordance with section 340B(d)(2), HRSA also carries out covered entity oversight activities. HRSA’s 340B Program audits review covered entity compliance with several statutory provisions, including eligibility status, duplicate discounts, and diversion in accordance with sections 340B(a)(4), (5)(A) and (B) of the PHSA.

Since the beginning of HRSA’s audit program in 2012, HRSA has communicated its approach for implementing this audit authority to stakeholders through program policies, guidance documents, and regulations. More than 25 years ago, HRSA published Patient Definition Guidelines (PDF - 31 KB), which contain HRSA’s interpretation of several key statutory requirements and which continue to guide HRSA’s audit activities. To further assist covered entities with 340B Program compliance activities, HRSA has compiled existing resources on how it conducts audits and determines non-compliance to ensure compliance with the 340B statutory prohibition against diversion:

HRSA Resources

340B Prime Vendor Program Resources

*HRSA notes that the decision in Genesis Health Care, Inc., v. Becerra, Civ. 4:19-cv-01531-RBH (D.S.C. November 3, 2023), is applicable solely to Genesis Health Care.

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