[Author: Brittany Bratcher]

On Friday, July 22, 2022, HHS issued a final rule (Final Rule), rescinding two regulations issued at the end of the Trump Administration on December 7, 2020, and January 14, 2021, that would have significantly altered the agency’s practices around issuing and using guidance in enforcement actions. Specifically, these rules would have, among other mandates, required HHS to maintain a repository of guidance documents, required Secretary-level approval of agency guidance and prevented HHS from enforcing standards in agency guidance that had not been “publicly stated.” The Trump Administration justified the previous rules as necessary to ensure that the public receives notice of new standards adopted in agency guidance and, further, to ensure that these new standards do not impose obligations that are not reflected in existing statutes or regulations. The current Administration rescinded the previous rules after finding that “they create unnecessary hurdles that hinder the Department’s ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department’s mission.” The Final Rule is effective immediately and did not undergo a proposed rule or notice-and-comment period. Our previous summary of the Previous Rules can be read here.

Following the 2020 Presidential election, the outgoing Trump Administration sought to codify the Administration’s policies regarding HHS’s adoption, implementation and use of agency “guidance.” Agency guidance is typically described as sub-regulatory agency pronouncements that are non-binding, but explain, interpret or advise parties about the agency’s regulations and procedures. The assumption behind the Trump Administration’s prior regulations was that agencies, at times, apply guidance as legally binding standards without giving the public adequate notice that these standards will be enforced in this way and the public should have an opportunity to comment in advance of an agency’s adoption of legally binding rules. While initially issued as Executive Orders, the Trump Administration codified these principles in two separate final rules during the last days of the Administration. The final rules were entitled: “Department of Health and Human Services Good Guidance Practices” (December 7, 2020) and “Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions” (January 14, 2021).

The two final rules required HHS to comply with the following procedures before adopting, implementing and using agency guidance in civil enforcement actions against regulated parties:

1. Include in guidance documents a statement that the guidance does not have the force and effect of law and is non-binding;
2. Include a notice-and-comment period for “significant guidance;”
3. Create a central repository for all HHS guidance documents while clarifying that guidance not included in the repository is rescinded;
4. Adopt procedures for the public to petition HHS to withdraw or modify particular guidance documents;
5. Limit civil enforcement actions to agency “standards and practices” that have been “publicly stated;”
6. Publish in the Federal Register any decision by the agency to assert “new or expanded claims of jurisdiction;” and
7. Before HHS takes a civil enforcement action, give the target party written notice of the agency’s legal and factual determinations and an opportunity to respond in writing and, in some cases, orally.

As of July 22, 2022, the Trump Administration’s rules identified above are no longer in force or effect. The Biden Administration’s Final Rule, adopted on that date, states that the regulations set out in the previous rules run counter to the Administration’s goals of advancing public health and welfare, impose burdensome standards and procedures, harm historically underserved constituencies, impede department flexibility, and divert limited HHS resources. The new Final Rule further states that the previous rules inhibit HHS’s ability to respond to public health matters in an efficient manner, emphasizing the importance of robust tools to address national priorities and issue critical information on public health and HHS programs in a timely manner.

The Final Rule also states that the previous rules’ requirements for the issuance of certain guidance documents would unnecessarily delay or prevent the issuance of agency guidance. According to the Biden Administration’s Final Rule, this is not desirable since HHS needs to be able to move quickly, especially when evolutions in public health issues need to be communicated to the public. The Final Rule is effective immediately.

Read the HHS Final Rule in its entirety here.