In this essay by Rachel Fabi, Associate Professor and Vice Chair for Education in the Center for Bioethics and Humanities at SUNY Upstate Medical University, Dr. Fabi provides a helpful explainer about the public comment process in the United States federal government, its role in policymaking (including policies related to healthcare with important bioethical components), how processes are potential avenues for bioethics advocacy, but also how they are imperiled by the current federal administration changes.

Public Notice-and-Comment In Federal Rulemaking: An Avenue for Advocacy (For Now?)

by Rachel Fabi

When I appeared on Jeopardy! in 2019, I confessed that I am a bioethicist who studies the ethics of health, science, and medicine as my  “fun fact” for Alex Trebek. Alex (in a part of the conversation that was ultimately cut from the show) asked, “Oh, so do you work on things like cloning?”, to which I responded “Well, some bioethicists work on things like cloning, but I work on much more exciting topics, like federal rulemaking around Medicaid policy.” This was a laugh line, of course, but I didn’t really mean it as a joke: federal rulemaking for Medicaid policy, and other policies related to public insurance, can be very exciting! Unfortunately, as I’ll explain in a moment, the process of federal rulemaking for Medicaid policy is also undergoing a significant and harmful sea change.

But first: what exactly are we talking about, here? “Rules,” also called “regulations,” are policies that shape how legislation enacted by Congress is implemented. Under the Administrative Procedure Act (APA), rulemaking by federal agencies must involve a public notice-and-comment period. In order to create a new regulation, an agency must publish a notice of proposed rulemaking (NPRM) in the Federal Register and then provide an opportunity for the public to respond with “written data, views, or arguments.”

Public comments inform rulemaking not as a plebiscite, where comments for or against a policy are tallied and the “winning” side rules the day. Rather, scholars of administrative law have argued that commenting presents an opportunity for both policy “insiders” (advocacy groups, trade associations, and industry) and “outsiders” to provide input on the policy in question. Insiders typically contribute comments grounded in quantitative data and analytic reasoning, while outsiders contribute “situated knowledge,” which is “highly contextualized, experiential information, often communicated in the form of personal stories.” Although agencies may not weigh insider and outsider comments equally, situated knowledge is often used to supplement the expertise of insiders, providing important context on the potential downstream effects and unintended consequences of a proposed rule. Scholars of health and bioethics are positioned to provide analysis of proposed rules that may straddle this insider/outsider dichotomy; while we can elevate narratives and stories, we can also integrate cogent moral and practical arguments for or against proposed rules. 

The public comment process is also a simple, straightforward way for regulatory outsiders (i.e., most people reading this) to engage in policy advocacy, in a low-hanging-fruit kind of way, because these comments don’t just disappear into the ether. In addition to being stored on Regulations.gov, they are also reviewed by the agency engaging in rulemaking, which is required to respond to every comment they receive when they publish the final regulation, or at least to every broad theme that commenters raise. They are expected to consider these comments without an “unalterably closed mind” on the issue, and a failure by the agency to address substantive concerns raised by commenters can, and has, led to successful court challenges to new regulations. For instance, in the recent Ohio v. Environmental Protection Agency, 603 U.S. 279 (2024), a conservative majority of Supreme Court justices ruled that the EPA had failed to seriously consider the points raised by some commenters, and thus had issued its final rule in violation of the APA’s requirement that rulemaking not be “arbitrary and capricious.” 

The “arbitrary and capricious” designation was also used to enjoin the first Trump administration’s so-called “public charge rule” by several courts, including the 9th Circuit Court of Appeals, before that rule was ultimately dropped by the Biden administration. That decision pointed to the vast number of public comments opposing the public charge rule and the reasons those commenters cited, and the agency’s failure to substantively engage with the issues commenters had raised. The legal battles that ensued slowed the timeline on which the final rule was actually enforceable, demonstrating the effectiveness of organizing and activating members of the public to oppose unjust policies through the public comment process.

Unfortunately, a recent development has created a roadblock for health policy advocates who hoped to use this process to oppose unjust policies that are expected to flow from the second Trump administration through the rulemaking process. Since 1971, the Department of  Health and Human Services (HHS) adopted what is known as the “Richardson Waiver,” which committed the Department to engaging in public notice-and-comment for “procedural rulemaking requirements for rules and regulations relating to public property, loans, grants, benefits, or contracts” (in essence, an enormous chunk of the functions of HHS). Given this 54-year precedent, it came as a surprise to many when Robert F. Kennedy Jr., the newly-confirmed HHS Secretary, announced in early March 2025 that “Effective immediately, the Richardson Waiver is rescinded and is no longer the policy of the Department. In accordance with the APA, ‘matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,’ are exempt from the notice and comment procedures.”

Opposition to this withdrawal from the public comment process has been swift in coming. Within days, a coalition of 22 patient advocacy groups published a letter expressing their concerns and asking HHS to reverse course, and other critics have noted that this move is in stark contrast to RFK’s pledge of “radical transparency” within the Department. What happens next is anyone’s guess. Legal scholars indicate that this move by HHS is likely legal, so it seems unlikely that HHS will be forced to reverse course. This could change if Congress were to amend the APA to eliminate the exceptions covered by the Richardson Waiver, although such a move seems unlikely in the current Congress. That said, public comment remains, for now, a good avenue for the public (and bioethicists!) to engage in advocacy relating to non-HHS policies and HHS policies not covered by the withdrawal of the Richardson Waiver.