On Friday, February 28, 2025, the Department of Health and Human Services issued a policy statement stating that it would limit the extent to which members of the public can participate in its rulemaking process. Details of the HHS policy statement are provided below.
HHS Policy Statement: The Administrative Act and How an Idea Becomes a Regulation
A federal law known as the Administrative Procedure Act (APA) sets forth the process by which federal agencies issue regulations. Generally, if an agency intends to issue a regulation, it first issues what is called a Notice of Proposed Rulemaking, or NPRM. The NPRM states the reason for a proposed regulation, the text of the proposed regulation, and provides for what is called a “notice and comment period.”
During this (usually 60-day) period, interested members of the public can submit comments on a proposed regulation – comments on, for example, why the proposed regulation is a good idea, why it is a bad idea, or comments on how to improve the proposed regulation. In some cases, an agency provides either a shorter or longer comment period. An agency may receive no comments or as many as thousands of comments or more. Some public comments contain one-sentence or one-paragraph comments, while others contain thousands of pages with detailed analysis, with supporting documents submitted as attachments.
Giving the public an opportunity to submit comments that the agency then reviews, is said to increase agency transparency and to encourage public participation in the lawmaking process.
Once a comment period expires, an agency reviews the comments that the public has submitted. After the comment period closes, the agency reviews all comments received and conducts a comment analysis. The agency then decides whether to finalize the proposed rule. In some cases, the agency will issue a new or modified proposal instead of finalizing a proposed rule.
If the agency decides to finalize a rule, the agency typically notes, in a publication setting forth the final rule, what kinds of comments it received during the notice and comment period, and addresses the comments. Sometimes, an agency may agree with comments, and incorporate their suggestions into a final rule.
The process of issuing a proposed rule, soliciting comments, reviewing the comments, and then issuing a final rule (or not), is referred to as the rulemaking process. The APA exempts certain activities from the “comment” requirement of the rulemaking process. These activities include “… public property, loans, grants, benefits, or contracts.” The APA also permits an agency to forgo soliciting public comments for “good cause” – that is, when the agency finds that soliciting public comments is “impracticable, unnecessary, or contrary to the public interest.”
HHS Policy Statement: The Richardson Waiver
In a 1971 Federal Register document, the Department of Health, Education, and Welfare (which underwent a name change to “Department of Health and Human Services” in 1980), adopted a policy (referred to as the “Richardson waiver”) that waived the APA’s rulemaking exemption for rules and regulations related to public property, loans, grants, benefits, or contracts. In other words, the Department of Health, Education, and Welfare decided to allow the public to participate in the formulation of rules and regulations related to these items. The Richardson waiver also instructed the Department of Health, Education, and Welfare to use the “good cause” exception sparingly.
HHS Policy Statement: Rescission of the Richardson Waiver
On February 28, 2025, HHS reversed course, rescinding the Richardson waiver in an HHS policy statement. The result: “Matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” are now generally exempt from the APA notice and comment requirements. The rationale for the rescission, as noted in the HHS policy statement, is that “…obligations of the Richardson Waiver impose costs on the Department and the public, are contrary to the efficient operation of the Department, and impede the Department’s flexibility to adapt quickly to legal and policy mandates.”
As a result of the HHS policy statement rescission, it is expected that HHS agencies can now move forward with many grants and benefits policy changes without public input.
HHS spends a significant portion of its resources on grants.
