Guest Blog: The Impact of Patient Inputs on Policymaking

By Mekdes Agezew, NCL Health Policy Spring Intern

On February 28, 2025, HHS announced rescinding the Richardson Waiver, a decades-old policy requiring voluntary public notice-and-comment periods for regulations related to public benefits like Medicare and Medicaid. While the Administrative Procedure Act (APA) does not mandate such participation for these rules, HHS has followed the waiver since 1971 to promote transparency.  HHS Rescinds Richardson Waiver, Reducing Public Input in Rulemaking. While it may seem innocuous because it only applies to voluntary public notice regulations, the move could signal a general slide toward less transparency and openness at HHS. NCL opposes this action by HHS and Secretary Robert Kennedy Jr. (RFK Jr.)

Public Participation under the Administration Procedure Act (APA)

The Administrative Procedure Act (APA) requires federal agencies to consider a rule or regulation to ensure their timeline allows for notice and comment periods. Rulemaking requires every agency, with a few exceptions (Sec. 2a), to publish the agency’s plan of rulemaking or policy in the Federal Register. The statement must include (1) the locations of the agency’s main and field offices, the official in charge, and the means of communication for the public to get information or make requests, (2) the function of the agency and its requirements and standards for their work, including the steps, forms, and instructions needed for paperwork, reports, or examinations, and (3) a description of the agency’s rules and policies to help the public understand its operations (Sec 3a).

Under the law, government agencies, whether funded and operating under a federal department or independently, are mandated to consider and incorporate suggestions and comments from patients and consumers before finalizing any proposed policy.

However, on March 3rd, 2025, Health and Human Services (HHS) RFK Jr. published a policy statement directing the agency to no longer require standard federal regulatory rulemaking procedures for matters “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.” Notably, this allows the agency to forego issuing public comment opportunities for specific administrative actions. ¹

NCL does not support this action.  Public comment gives the public a chance to express concerns and viewpoints that may not have been considered by agency staff, helping improve health outcomes and advance public health goals. By involving patients and consumers, federal staff can enhance their awareness and knowledge of the strengths, problems, needs, challenges, and barriers experienced by the community they serve and learn more about the impact of any regulation they are considering. A study by the Office of Assistant Secretary for Planning and Evaluation (ASPE) within the U.S. Department of Human Health Services (HHS) and Inner City Fund (ICF) found that by engaging people with lived experience, products, tools, and resources were strengthened by increasing accessibility, responsiveness, and tailoring to consumers’ specific needs.

Why does the “Richardson Waiver” still matter today?

A little more information about the Richardson Waiver is helpful. In 1971, HHS issued a policy statement titled “Public Participation in Rule Making.” This policy directed the agency to use standard notice of proposed rulemaking procedures in instances not required by law, including matters relating to “agency management” and “public property, loans, grants, benefits, or contracts.” These procedures are codified by the Administrative Procedure Act (APA), which sets the rules for how administrative agencies create regulations and allows exemptions for agency actions under the listed categories.

In issuing the waiver, HHS cited a 1969 recommendation from the Administrative Conference of the United States, and a desire to see “greater participation by the public in the formulation of this Department’s rules and regulations.” This waiver has since been referred to as the “Richardson Waiver,” named after then-HHS Secretary Elliot L. Richardson, appointed by President Richard Nixon.

The Richardson Waiver (and Secretary Kennedy’s subsequent repeal) covered agency activities often considered “ ’proprietary functions,’ i.e., government control over its own resources.” These are distinct from agencies acting as regulators of other entities’ activities. For instance:

Agency Management: This exception only applies to agency management decisions that only affect the agency in question. This includes documents like employee handbooks and training materials. ²

Public Property: This doesn’t apply to rulemaking about managing public lands – it only applies to rules about the “distribution of public property.” ³

Under the APA requirement, the Agency has discretion to continue allowing comment opportunities, rescinding the waiver of some rules and policies, including:

Matters related to HHS grantmaking and methodology, such as through the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Administration for Children & Families (ACF), Agency for Healthcare Research and Quality, and other programs. HHS is the largest grant-making agency in the US and provides grants to state, local, and tribal governments and community organizations.

The 2025 Repeal: What to Expect

In the policy statement suggesting repeal of the Richardson Waiver, Secretary RFK Jr. claims that the Waiver “imposes costs on the Department and the public, is contrary to the efficient operation of the Department, and impedes the Department’s flexibility to adapt quickly to legal and policy mandates.” It is important to note that the statement still allows agencies to “have discretion to apply notice and comment procedures to these matters but are not required to do so, except as otherwise required by law” – it is not a blanket ban on comment opportunities. Additionally, the statement affirms that HHS “will continue to follow notice and comment rulemaking procedures in all instances in which it is required to do so by the statutory text of the APA.”  That is good news, but then again, we shall see. This could be a slippery slope where the Secretary begins to eat away at notice and comment opportunities that lie outside the Richardson Waiver parameters. NCL supports full opportunities for public comment. RFK Jr. uses the “good cause” exception and claims the waiver got in the way of. Now the question is, has the waiver genuinely hindered the agency’s efficiency, or is it a strategic move to divert attention?