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 Statute (PDF - 39 KB)
- 1996 Patient Definition Guidelines (PDF - 31 KB)
- Policy Release 2012.1-1 (PDF - 30 KB)
- Policy Release 2012.2 (PDF - 36 KB)
- 340B Program Update
- 340B Program Patient Definition FAQs
- HRSA Audits of Covered Entities
340B Prime Vendor Program Resources
- 340B Prime Vendor Program Patient Definition FAQs
- 340B Prime Vendor Program Audit FAQs
- Some Specific 340B Prime Vendor Program Tools for Preventing Diversion and Tools for Audits:
- Self-Audit: Policy and Procedure (DOCX)
- Self-Audit: Prevention of Diversion and GPO Violation (DSH/PED/CAN) (DOCX)
- Self-Audit: Prevention of Diversion (CAH/RRC/SCH) (DOCX)
- Self-Audit: Prevention of Diversion (CHC/FQHC) (DOCX)
- Sample HRSA 340B Audit Data Request for Covered Entities (PDF)
- Community Health Center Sample Policy and Procedure Manual (CHC) (DOCX)
- GPO Prohibition Hospitals Sample Policy and Procedure Manual (DSH/PED/CAN) (DOCX)
- Grantees – Title X Family Planning Sample Policy and Procedure Manual (FP) (DOCX)
- Grantees – Hemophilia Treatment Center Sample Policy and Procedure Manual (HM) (DOCX)
- Rural Hospitals Sample Policy and Procedure Manual (CAH/RRC/SCH) (DOCX)
- All 340B Prime Vendor Program Tools
*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.