HRSA 340B audits reveal compliance concerns
Late last week, the Health Resources and Services Administration (HRSA) released the results of its FY 2012 audits of covered entity compliance with 340B drug discount program rules. Based on a review of 51 covered entities encompassing more than 410 outpatient facilities/sub-grantees and more than 860 contract pharmacy locations, HRSA identified “several recurring critical areas of non-compliance for hospitals and non-hospitals.”
For non-hospitals, HRSA flagged the following major non-compliance areas:
- The covered entity’s inability to maintain accurate database information;
- Billing contrary to the Medicaid Exclusion File (which may have resulted in duplicate discounts);
- Dispensing drugs to ineligible individuals (diversion) at the covered entity and contract pharmacies.
For hospitals, the major area of non-compliance cited by HRSA was obtaining covered outpatient drugs through a Group Purchasing Organization (GPO) in violation of statutory restrictions. The GPO prohibition is a statutory requirement that applies to disproportionate share hospitals (DSH), children’s hospitals, and free-standing cancer hospitals.
HRSA also identified best practices to minimize the risks of non-compliance by covered entities, including:
- 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 HRSA Office of Pharmacy Affairs database;
- Strong partnerships with state Medicaid agencies to meet state-specific requirements and prevent duplicate discounts.
For more information about 340B audits, and resources for providers, visit the website of HRSA's 340B Prime Vendor Program.
