CHA News Article

HRSA Posts Details of 340B Audits

The Health Resources and Services Administration (HRSA) has released information about its audits of covered entities in the 340B drug pricing programs. The audits, conducted for FY 2012, show the primary non-compliance area for hospitals is obtaining covered outpatient drugs through a group purchasing organization. According to HRSA, the audits “have allowed HRSA and 340B stakeholders opportunities to improve oversight, monitor for potential violations, prevent and detect diversion and duplicate discounts and, importantly, share information gained to increase compliance across all entities.” Some hospital best practices shared as part of the audit details include:

  • Development and documentation of comprehensive 340B program policies and procedures;
  • Development of concrete methodologies for routine self-auditing;
  • Routine processes for internal corrective action;
  • Verification that contract pharmacy arrangements comply with the 340B requirements and are properly listed in the Office of Pharmacy Affairs database; and
  • Strong partnerships with state Medicaid agencies to meet state-specific requirements and to ensure prevention of duplicate discounts.