HRSA recently added language to its written policies on covered entity audits which suggests that the agency may conduct more follow-up audits. Those follow-up audits could result in tougher sanctions, including removal from the 340B program, if HRSA continues to make the same findings of non-compliance.
Under HRSA’s new policies, if the agency makes the same finding in the first and second audit, the covered entity will be required to submit additional documentation to support its corrective action plan and will be subject to a third audit. If HRSA again makes the same finding in the third audit, HRSA may determine that the violation is “systematic and egregious” as well as “knowing and intentional” and therefore warrants removal of the covered entity from the 340B program for a reasonable period of time.
HRSA also expanded its policies related to manufacturer audits by adding policies addressing the pre-audit process, onsite audits, post audits, notice and hearing, and corrective action plans/repayment. HRSA’s written policies on manufacturer audits do not include follow-up audits for manufacturers.
HRSA’s audit policies are posted on the Program Integrity section of its website.