HHS Rule Blocks Enforcement Actions Based Solely on Guidance

On January 12, the U.S. Department of Health and Human Services (HHS) released a final rule on “Transparency and Fairness in Civil Administrative Enforcement Actions.” The rule, which was effective immediately, states that HHS can rely only on statutes and regulations in bringing civil enforcement actions. Standards set forth in agency guidance documents may not be the sole basis for HHS actions.

The new rule follows up on a “Good Guidance Practices” rule, released by HHS in December, that covered similar ground. Both rules confirm that under the Administrative Procedure Act and recent case law, HHS and other federal agencies generally must publish notice and provide an opportunity for public comment before adopting a rule that binds regulated parties. The new rule will not apply to any action related to a criminal investigation or prosecution, or to any civil enforcement action or related investigation by the U.S. Department of Justice.