340B Health

340B Insight Podcast

Episode Eighteen: Preparing for HRSA Audits

January 11, 2021

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This week we are joined by Steven Miller, vice president of pharmacy services at 340B Health. Steve discusses Health Resources & Services Administration (HRSA) audits of 340B hospitals and shares practical advice for how hospitals can best prepare, including the resources that are available to them. Prior to the interview, we provide a major news update you might have missed during the holiday season on the ongoing 340B contract pharmacy issue. (Transcript)

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Show Notes

  • HRSA Audits 101 In 2015, HRSA started auditing 200 covered entities each fiscal year, with 155 of those covered entities being 340B hospitals. HRSA uses an algorithm to determine 90% of the covered entities to audit. The more 340B purchases, child sites, and contract pharmacies an entity has, the more likely they are to be audited. The other 10% of audits focus on complaints from 340B stakeholders or on covered entities that had previous audit findings. Steve explains that auditors are usually pharmacists and have an in-depth knowledge of the 340B program.
  • Data Are Important Steve explains that hospitals must have a clear understanding of their data and how they connect between departments and relate to 340B eligibility. Software resources, third-party vendors, and split-billing tools can help hospitals monitor these data. It is important for the data to be clean and well-organized.
  • Following Policies and Procedures HRSA also will assess if covered entities are following their institutional policies and procedures. This is because the policies and procedures are considered the standard for any aspect of compliance that is not explicitly addressed in the 340B statute. The policies and procedures should be aligned with HRSA enforcement.
  • Internal Auditing vs. External Auditing 340B hospital staff conduct internal audits to ensure their data systems’ logic and filters are working as they should. HRSA expects hospitals to review their own systems and data routinely. Internal auditing can be biased, because the staff works in 340B operations and thus can accidentally miss how the system is working. That is why external auditing allows the hospital to obtain a more objective report. Steve explains that this can reassure the hospital, especially in addressing problems that might not be found in the internal review. Steve suggests hospitals conduct internal reviews weekly or monthly and external audits once a year.  
  • Resources for Preparing for Audits 340B Health has policy guides, compliance resources, and audit trends for hospitals to use in preparation for an audit. Steve encourages 340B Health members to contact 340B Health when they learn of an upcoming audit for a technical assistance call. 340B hospitals also should reference the website of the HRSA Office of Pharmacy Affairs (OPA). The HRSA Prime Vendor also provides additional resources.

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340BHealth.org.


  1. Office of the HHS General Counsel’s Advisory Opinion on Contract Pharmacies Under the 340B Program
  2. 340B Health and National Hospital and Pharmacists’ Organizations Lawsuit against HHS
  3. www.stop340bcuts.org   
  4. 340B Health Compliance Resources
  5. 340B Coalition 2021 Winter Conference