Today, the Department of Health and Human Services (HHS) released a final rule designed to enhance HHS practices involving transparency and fairness in civil enforcement actions.  This final rule is part of HHS’ broader regulatory reform initiative and also implements Executive Order 13892, Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication.

The final rule supplements and builds on the HHS Good Guidance Practices rule released last year by setting forth rules for appropriate HHS reliance on guidance documents and requiring HHS to give fair notice of relevant agency positions before taking a civil enforcement action.

“A cornerstone of fair governance is transparency—regulated parties need to know in advance the standards by which the government will judge their conduct,” said HHS Chief of Staff Brian Harrison.  “When HHS takes civil enforcement actions, we will only do so in a manner that promotes accountability and ensures fairness.”

Today’s final rule reiterates HHS’ commitment to proper use of guidance documents, by generally prohibiting HHS from treating noncompliance with a standard or practice announced solely in a guidance document as itself a violation of law.  The final rule also sets forth a series of procedural requirements for HHS that are intended to ensure fairness in all HHS civil enforcement actions.  For example, under the terms of the final rule, HHS can only apply standards or practices that have been publicly stated in a manner that would not cause unfair surprise.  HHS must also conduct all civil administrative inspections according to published, and publicly available, rules of agency procedure.  Whenever HHS relies on a document arising out of litigation to establish jurisdiction in future civil enforcement actions, HHS must publish that document and an explanation of the document’s jurisdictional implications, either in the Federal Register or in the HHS guidance repository (available at hhs.gov/guidance).  Finally, prior to taking any civil enforcement action with legal consequence, the Department must (unless an exception applies) provide written notice and an opportunity to be heard, as well as a written response.

The final rule strengthens HHS’ commitment to the rule of law and ensures that the Department operates with transparency and fair warning, particularly in the context of civil enforcement actions and other actions with legal consequence for regulated parties.

The final rule is available here: