May 9, 2014—The Health Resources and Services Administration has published a brief statistical analysis of findings from its first round of 340B covered entity audits. [ms-protect-content id=”2799″]
HRSA notified stakeholders about the release via email and through a notice on the Office of Pharmacy Affairs webpage.
“We wanted to give you a sense of some of the lessons we have learned in the early years of our investments, and how we plan to apply these lessons in our efforts moving forward,” OPA Director Cmdr. Krista Pedley wrote in the memo summarizing the audit findings. “The ‘sentinel effect’ of these audits has been remarkable—we have seen many more covered entities prioritizing compliance, seeking technical assistance, and taking steps to rectify violations. These 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.”
HRSA’s analysis of the 51 audits conducted in fiscal year 2012 found that:
- For non-hospitals, the three main problem areas were the covered entity’s inability to maintain accurate database information (39 percent), billing contrary to the Medicaid Exclusion File which may have resulted in duplicate discounts (33 percent), and dispensing drugs to ineligible individuals (33 percent).
- The main area of policy confusion for hospitals was obtaining covered outpatient drugs through a group purchasing organization (42 percent of hospital to which the exclusion applies). HRSA clarified its policy on the GPO purchasing exclusion (which applies to disproportionate share, children’s, and free-standing cancer hospitals) only last year, and that policy took effect on August 7, 2013. “Therefore, during an audit, if a hospital is found to have violated the GPO prohibition and that violation occurred before August 7, 2013, that non-compliance will be identified as an area for improvement for the covered entity,” the memo states. “Violation of the GPO prohibition will be deemed as a finding and be grounds for removal from the 340B Program if the sample period of the audit is after August 7, 2013. All violations of the GPO Prohibition that were found in the FY 12 audits occurred before the August 7 deadline for compliance.”[/ms-protect-content]