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.