July 7, 2014—The Health Resources and Services Administration has truncated the 340B audit dispute process, ending one of two opportunities health care providers had to challenge adverse findings.[ms-protect-content id=”2799″]
HRSA announced the change in audit procedures in a July 3 posting on the Office of Pharmacy Affairs website. Under the old process, if an audit resulted in adverse findings, HRSA outlined them in a preliminary audit report to the covered entity. The entity then had 30 days to disagree with HRSA’s conclusions and present supporting evidence. Next, HRSA issued a final audit report in which it either reversed or maintained the preliminary report’s findings. The entity again had 30 days to disagree with any findings. If HRSA again maintained the findings, the entity had 60 days to file a corrective action plan.
In last week’s website posting, HRSA said “the steps that take place after the audit has been conducted have undergone several enhancements.”
“The most notable change,” it said, “is that HRSA no longer issues preliminary reports to the audited covered entities. HRSA notifies audited covered entities of the audit findings in the HRSA Final Report….If a covered entity disagrees with the Final Report, they shall notify HRSA in writing within 30 calendar days with appropriate supporting documentation explaining the covered entity’s disagreement. OPA reviews the covered entity’s response and, if appropriate, may reissue the Final Report if changes are made based on the documentation submitted.”
The website posting repeated HRSA’s previously announced requirement that entities required to submit a corrective action plan also must give HRSA a letter, to be posted on the HRSA website, that outlines the adverse findings, states that repayment may be necessary, and provides contact information. Entities whose findings involve repayment also are now subject to an audit the following year.[/ms-protect-content]