The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible covered healthcare facilities at a significantly reduced price. The intent of the program is to permit covered entities “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” H.R.REP.NO.102-384(II), AT 12(1992)

Currently, the 340B program is under intense scrutiny and the number of covered entities audited for 340B program compliance has increased significantly. The concerns surrounding the 340B program include 340B qualification, patient definition and prohibited practices such as diversion, Medicaid duplicate discounts and GPO prohibition violations.  As of February 5, 2016, 76% of the covered entities audited in FY 2015 received adverse audit findings and 44% of those had multiple identified deficiencies.  It is essential that participating facilities maintain auditable records and assess their level of compliance with ALL 340B programs rules. Covered entities should be performing regular self-audits and it is expected by HRSA that an annual independent audit is conducted.  Violations could put the facility at risk of being prohibited from future participation in the program and/or repayments to drug manufacturers.

Our 340B team has conducted approx. 70 independent 340B audits in the last two years and has been involved in 12 HRSA audits.  Of the 19 HRSA auditors, we have met 10 during audits (which has given us significant insight into the Agency's view of many issues within the 340B program).

  • Annual independent external audits
  • Quarterly data reviews of contract pharmacy arrangements
  • Revenue optimization
  • HRSA audit support including remediation plans
  • 340B qualification, enrollment, certification & recertification guidance
  • Policy and procedure guidance
  • Staff training
  • 340B compliance reviews & mock HRSA audits
  • Mixed use area assessment
  • Contract pharmacy audits
  • Medicaid duplicate discount review










Are you 340B audit ready?  Let SCA help your facility identify areas of risks and provide necessary steps to achieve full 340B compliance.  Contact Jeff Norman at 972-732-8100 or email This email address is being protected from spambots. You need JavaScript enabled to view it. to request a proposal and more detailed information on what SCA's 340B external audit program entails.