By Rescinding the Richardson Waiver, RFK, Jr Shuts Out Patient Advocates at HHS

By: Ranier Simons, ADAP Blog Guest Contributor

The federal government seeks input from the public to make “informed policy decisions” that affect many aspects of citizens' daily lives. A recent guidance letter from the Office of Management and Budget (OMB) concerning broadening public participation and community engagement states, “Hearing from the individuals and communities most or uniquely affected by a particular issue can help agencies better understand how to address that issue, leading to more responsive and efficient policies and programs…Federal agencies are committed to making it easier for the American people to share their knowledge, needs, ideas, and lived experiences1 to improve how government works for and with them” (OMB, 2025). Yet, a recent rule change issued by the U.S. Department of Health & Human Services (HHS) published in the Federal Register seems to be in opposition to this transparency and public discourse. The rule rescinds the current policy regarding public participation in rulemaking in many areas governed by HHS (HHS, 2025).

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The new rule upends over 50 years of precedent. The American Procedures Act (APA) established regulations governing how agencies are to operationally issue rules and regulations, including giving the public ample opportunity to comment and provide feedback and data as rules are developed. The law carved out certain exemptions from the requirements: “matter(s) relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” (5 U.S.C. 553(a)(2)). Through the Richardson Waiver (36 FR 2532), in 1971, HHS waived the APA statutory exemptions requiring the Department to subject those matters to the APA’s notice and comment rulemaking guidelines. 

By rescinding the Richardson Waiver (McGrath, 2025), which is basically what is being done, newly minted HHS Secretary Robert F. Kennedy, Jr. effectively removes the legal mandate of meaningfully including the public in developing and implementing policies that significantly affect the lives of individuals and industries. Usually, agencies post rules in the Federal Register, open a set comment period of, on average, 60 days to receive public feedback, and then evaluate all the input before they enact finalized rules. Linda Malek, a partner at global law firm Crowell and Moring, points out, “The public comment period is an iterative and educational process that often results in changes of mutual benefit to the government and affected stakeholders (Pugh, 2025).

Numerous stakeholders are alarmed at the potential adverse consequences. Stella Dantas, MD, president of the American College of Obstetricians and Gynecologists (ACOG), said in a statement, “The practice, delivery, and regulation of medicine is incredibly complex. The experiences of patients, clinicians, administrators, and other stakeholders across medicine must be taken into account in order to avoid unintended outcomes.” She added, “Expert input from medical societies, researchers, and patient advocates is necessary "to inform regulatory bodies and ensure the soundness of final rules and other actions” (Clark, 2025).

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The broadness of the rule also concerns many stakeholders because it is unclear how many crucial areas of HHS policy will be affected. The rule rescinds the notice-and-comment practice for HHS “rules and regulations relating to public property, loans, grants, benefits, or contracts.” This does not apply to Medicare because Medicare falls under the provision of the Medicare Act. However, Medicaid, the Substance Abuse and Mental Health Services Administration (SAMHSA), the Administration for Children and Families (ACF), and other agencies under HHS are subject to the new rule (Clark, 2025). 

The ability to push through policies, regulations, and initiatives without partnering with the public means decisions with potentially harmful outcomes would only be public after they were finalized. At that point, the only recourse for remedy from bad policy is suing in court. Alice Bers, JD, litigation director for the Center for Medicare Advocacy, explained that the new rule attempts to avoid public comment on policies that HHS knows will be unpopular (Clark, 2025). 

Verbiage is key when it comes to legal proceedings and government regulations. The new rule states, “The extra-statutory 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” (HHS, 2025). This adds to the concern that the impetus for the rule is to swiftly enact policies, such as ones that would adversely affect Medicaid, that otherwise would not survive public scrutiny or would take longer to modify and implement. Samuel Bagenstos, JD, who served as general counsel to OMB and HHS during the Biden Administration, explains, "For example, if they wanted to allow work requirements under Medicaid, they could do that now ... without going through rule-changing policies" (Clark, 2025). 

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HHS is a federal department that exercises policies that directly influence the health and well-being of all Americans. Transparency, communication, and public collaboration are key to ensure HHS policies are developed with the best interests of all affected stakeholders in mind. When the Richardson Waiver was first enacted, it was because there was a recognized need to include scholars, scientists, clinicians, economists, and even patients with lived experiences as part of the policy development process. HHS’s Office of the Assistant Secretary for Planning and Evaluation (Ramirez, 2023) even defines lived experience as “knowledge based on someone’s perspective, personal identities, and history, beyond their professional or educational experience” (Ramirez, 2023). 

Shutting the public out of a means of informing legislators with real-world data, expertise, and perspectives they otherwise would not have access to is a problematic way to produce public policy. Clinicians, legal experts, and patient advocates, among many others, will be watching to see how this new rule is enforced.

[1] Clark, C. (2025, March 3). New HHS Rule Wipes Out Some Public Comment on Rulemaking. Retrieved from https://www.msn.com/en-us/politics/government/new-hhs-rule-wipes-out-some-public-comment-on-rulemaking/ar-AA1AaWmQ?ocid=socialshare

[2] McGrath, C. (2025, March 4). HHS overturns 54-year-old public comment rule. Healthcare Brew. Retrieved from https://www.healthcare-brew.com/stories/2025/03/04/hhs-overturns-54-year-old-public-comment-rule

[3] Policy on Adhering to the Text of the Administrative Procedure Act, 90 FR 11029 (proposed March 3, 2025). Retrieved from https://www.federalregister.gov/documents/2025/03/03/2025-03300/policy-on-adhering-to-the-text-of-the-administrative-procedure-act

[4] Pugh, T. (2025, March 5). RFK Jr.'s Limits on Rule Comments Have Risk for Medicaid, Grants. Retrieved from https://news.bloomberglaw.com/health-law-and-business/rfk-jr-s-limits-on-rule-comments-have-risk-for-medicaid-grants

[5] Ramirez, G., et. al. (2023, January 25). What is Lived Experience?. Office of Human Services Policy, U.S. Department of Health & Human Services. Retrieved from https://aspe.hhs.gov/reports/what-lived-experience.

[6] Young, S. (2025, January 15). Memorandum for the Heads of Executive Departments and Agencies. Office of Management and Budget, Executive Office of the President. Retrieved from https://www.whitehouse.gov/wp-content/uploads/2025/01/M-25-07-Broadening-Participation-and-Engagement.pdf

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.