Action Items for Upcoming HRSA 340 B audits

Over the past several months we have seen heightened attention on the 340B program from Health Resources and Services Administration (HRSA), and Capitol Hill. In HRSA’s response to Senator Grassley dated October 21, 2011, their intentions are clear. We anticipate covered entities will experience increased oversight and monitoring of the 340B program from HRSA. Specifically, “HRSA plans to conduct selected audits of participating covered entities beginning in FY 2012.” They state they will be using existing published 340B guidance previously published in the Federal Register.

If you currently participate in 340B, now would be a good time to assess your policies, procedures and internal controls. Pay special attention to policies and procedures to prevent the resale or transfer of drugs to a person who is not an outpatient of your hospital and verify the hospital has obtained a discount only for those outpatient areas authorized to receive discounts by section 340B of the PHS Act.