The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment rulemaking.
By Nathan A. Beaton, Jason B. Caron, Eric C. Greig, William A. McConagha, and Elizabeth M. Richards
On March 3, 2025, the Department of Health and Human Services (HHS), under the leadership of Secretary Robert F. Kennedy, Jr., issued a policy statement titled “Policy on Adhering to the Text of the Administrative Procedure Act” (the Policy Statement).
The Policy Statement rescinds a 1971 policy statement issued under then-Secretary Elliott Richardson in which HHS directed its offices and subagencies to engage in notice and comment rulemaking even in circumstances exempt from the requirement for notice and comment under the Administrative Procedure Act (APA), referred to as the Richardson Waiver. By rescinding the Richardson Waiver, HHS is set to expand the circumstances under which it and its subagencies will issue rules without first providing a notice of proposed rulemaking and an opportunity for stakeholder comment.
Background
Historically, HHS offices and subagencies have frequently engaged in notice and comment rulemaking when promulgating new rules, modifying or rescinding existing ones, or establishing safe harbors or other enforcement discretion policies. HHS offices include the Office of Inspector General (HHS-OIG) and the Office of the National Coordinator for Health Information Technology (ONC), while HHS subagencies include the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC).
Under the APA, administrative agencies (including subagencies) generally are required to engage in notice and comment rulemaking before a final rule may be issued. Under these procedures, an administrative agency will publish a notice of proposed rulemaking in the Federal Register, providing stakeholders an opportunity to comment on the rule. When finalizing a rule, the administrative agency — after consideration of the data, views, or arguments put forward in stakeholder comments — must incorporate in the rule a concise general statement of the rule’s basis and purpose. This statement of basis and purpose is found in the rule’s preamble and typically acknowledges the content of stakeholder comments and provides responses detailing the agency’s decision to adopt or decline to adopt such feedback. The rule’s preamble often provides insight into how an agency interprets the rule and how it intends to implement it.
The APA provides exceptions to the notice and comment rulemaking requirement. Among these, the notice and comment provisions do not apply to matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts. Further, unless otherwise required by statute, the notice and comment requirement does not apply when an agency “for good cause” finds that notice and comment procedures are “impracticable, unnecessary, or contrary to the public interest.”
Under the Richardson Waiver, HHS “waived” some of the statutory exemptions by announcing that it would engage in notice and comment rulemaking in some situations where not required by the APA. The Richardson Waiver directed HHS offices and subagencies, despite the statutory exemption, to utilize notice and comment rulemaking when promulgating rules related to agency management or personnel or to public property, loans, grants, benefits, or contracts. The Richardson Waiver also provided that “good cause” exceptions should be used “sparingly,” such as for rules related to minor technical amendments or in emergencies.
The Richardson Waiver states that its approach would “result in greater participation by the public in the formulation of [HHS’s] rules and regulations” and that the “public benefit from such participation should outweigh any administrative inconvenience or delay which may result from use of the APA procedures.”
New Direction Under the Policy Statement
The Policy Statement immediately rescinds the Richardson Waiver. The Policy Statement concludes that the Richardson Waiver imposes extra-statutory requirements by requiring notice and comment rulemaking for matters relating to agency management or personnel or to public property, loans, grants, benefits, and contracts, which are exempt from such requirement under the APA. The Policy Statement states that the imposition of notice and comment rulemaking in these circumstances “impose[s] costs on [HHS] and the public, [is] contrary to the efficient operation of [HHS], and impede[s] [its] flexibility to adapt quickly to legal and policy mandates.”
The Policy Statement also asserts that it “is contrary to the clear text of the APA to use the good cause exception ‘sparingly’” and instead provides that “the good cause exception shall be used in appropriate circumstances.” However, the Policy Statement also states that HHS offices and subagencies still have “discretion to apply notice and comment procedures to these matters,” while emphasizing that HHS policy no longer requires them to do so.
Notably, the Policy Statement carveout for notice and comment rulemaking “otherwise required by law” may ensure that significant actions remain subject to regular rulemaking. For example, the Social Security Act requires CMS to engage in notice and comment rulemaking for any “rule, requirement, or other statement of policy (other than a national coverage determination) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services, or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits.”1 Similarly, the Federal Food, Drug, and Cosmetic Act requires that the FDA engage in notice and comment rulemaking before imposing standards on tobacco products, such as a ban on certain flavors.
Key Takeaways
The Policy Statement’s rescission of the Richardson Waiver not only offers the potential for more rapid action relating to agency personnel or management, but also for HHS and each of its offices and subagencies to promulgate or rescind certain rules without engaging in notice and comment rulemaking, unless otherwise required by law. If HHS takes an expansive view of the scope of the “good cause” exception, we may see an increase in direct final rulemaking affecting stakeholders (while also inviting potential litigation challenges to HHS’s conclusion that such rulemakings fit within the exception). Less use of notice and comment could result in reduced notice to stakeholders and opportunities for public participation as well as more rapid changes to the regulatory landscape. Latham & Watkins will continue to closely monitor developments with respect to rulemaking by HHS and its subagencies, including the FDA, CMS, and the CDC, as the new administration implements its agenda.
- This provision of the Social Security Act has been the focus of significant judicial review, including by the Supreme Court. ↩︎