340B Audits Are Here!

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340B Audits Are Here!


The Patient Protection and Affordable Care Act (PPACA) mandated that GAO address questions related to the 340B program. GAO examined: (1) the extent to which covered entities generate 340B revenue, factors that affect revenue generation, and how they use the program; (2) how manufacturers’ distribution of drugs at 340B prices affects covered entities’ or non-340B providers’ access to drugs; and (3) HRSA’s oversight of the 340B program.1


After the GAO report was published, GAO recommended 4 main issues to HRSA to resolve and understand:

  1. Conduct selective audits to deter potential diversion.
  2. Provide a more specific definition of a “patient”.
  3. Issue eligibility guidance to hospitals that are not publicly owned.
  4. Further specify 340B nondiscrimination policies for distribution restriction.


What is our company doing? 

  • Reviewing our 340B policies and procedures.
  • Tightening up our audit procedures.
  • Preparing pharmacy directors on expectations of an audit.
  • Gathering all appropriate documents (cost reports, Medicaid exclusion documents, DSH% reports, contracts, audit reports), and centralizing to one Team Space location.


We are hoping to gain some more insight to the audit process at the Winter Conference in San Diego later this month.  Oh yeah, and warm weather!


1 GAO-11-836 – Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement

1 Comment

Rob, PharmD, MS

February 16, 2012at 11:05 pm

I hope I am not one of the lucky ones who gets to experience this first hand!

PS: It is nice to see other articles on the site, I am sure other people like that too.

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