Editor's note: This story was originally published on Feb. 28 but has since been updated with additional industry group statements and other commentary.
Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is closing the main avenue for members of the public to weigh in on pending health regulations and policy changes.
Friday morning, the HHS uploaded a policy statement that is set to be published in the Federal Register on March 3.
Bylined by the secretary, it says the department is no longer required to undergo a public comment period it typically observes following the publication of proposed rulemaking in “matters relating to agency management or personnel or to public property, loans, grants, benefits or contracts.”
The HHS’ agencies and offices may follow the notice and comment status quo at their “discretion … but are not required to do so, except as otherwise required by law,” RFK Jr. wrote.
The department is also, in “appropriate circumstances,” encouraged to avoid public comment through the use of a “good cause” exception in the Administrative Procedure Act (APA)—the law that authorizes federal agencies to promulgate rules and outlines when notice and comment periods are required for certain “legislative” or “substantive” rulemaking.
The new instructions appear to run at odds with the secretary’s promises of leading a more transparent public health apparatus. In the statement, he describes the notice and comment procedure as a burden on the department.
“The extra-statutory obligations of [HHS’ prior policy] 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,” he wrote.
Public comments solicited by government agencies are reviewed prior to the finalization of rulemaking. They are an opportunity for those who may be impacted by a new regulation or policy—organizations and individuals alike—to warn of pitfalls, suggest changes, affirm support for proposed measures or lobby for the proposed rule to be pulled altogether.
Final rules later published by agencies generally include text that characterizes the received comments, outlines changes made as a result of the comments or rebuts criticisms and concerns.
RFK Jr., in Friday’s policy statement, said the HHS has been largely exempt from that process as outlined in the APA, but, since 1971, has made it a policy to waive that exemption and to “sparingly” use the “good cause” exception.
That policy, known as the Richardson Waiver, “is contrary to the clear text of the APA and imposes on the Department obligations beyond the maximum procedural requirements specified in the APA,” he wrote citing a 2015 Supreme Court decision as precedent.
In that waiver, then-Assistant Secretary for Administration Rodney H. Brady wrote that the department’s policy to follow the notice and comment procedure despite its exemptions “should result in greater participation by the public in the formulation of this Department’s rules and regulations. The public benefit from such participation should outweigh any administrative inconvenience or delay which may result from use of the APA procedures in the five exempt categories.”
Jeff Davis, health policy director for McDermott+ Consulting, said the “operative question” going forward is just how much of the department’s activity falls under those exempted areas.
“It is unclear how often this waiver has been used, and now that HHS has repealed it, what the scope of policies under the buckets of ‘public property, loans, grants, benefits, or contracts’ are that would now be exempt from rulemaking,” he wrote in an email to Fierce Healthcare.
“Another question to consider is how this would interact with the Supreme Court’s decision in [2019’s] Azar v. Allina Health Services … that found that the Department must use notice-and-comment rulemaking in certain circumstances where the APA does not require such rulemaking.”
Changes to Medicare, at least, are likely to still require public notice and comment under current statute that outlines separate requirements from the APA, partners at law firm Hogan Lovells wrote in a Monday blog post on the policy change. Laws codifying Medicaid and the Children's Health Insurance Program do not have independent notice-and-comment rulemaking requirements, however, meaning that HHS may choose not to do so for changes to the benefits of these programs.
HHS contracts and grants, with some notable exceptions such as the Department of Veterans Affairs' implementation of federal contractor requirements through guidance letters, could largely see a departure from notice and comment, the partners wrote.
"Ultimately, steps by HHS to implement Federal contract and grants rules and requirements without first following notice-and-comment rulemaking procedures could affect practical implementation and judicial review," they wrote. "Without published final rules and related comments, there is potential for less certainty as to the intended interpretation of rules applicable to contracts and grants, which can impact all aspects of performance."
Of note, the administration's apparent compliance with the Richardson Waiver was recently cited by state attorneys general opposing announced cuts to National Institutes of Health (NIH) funding.
'Astounding hypocrisy' after Kennedy's promises of 'radical transparency' at HHS
Outside of concerns over legality or implementation, RFK Jr.’s policy to limit the public’s role in rulemaking is a break from the leadership approach he promised lawmakers and the public ahead of his confirmation as secretary.
Speaking to concerns over declining trust in public health agencies, RFK Jr. told senators during hearings that those agencies “haven’t been trustworthy” on COVID-19 and other topics and that he would address the issue “through radical transparency.”
More broadly, transparency was also touted as a cornerstone of the Make America Healthy Again Commission launched by President Donald Trump shortly after RFK Jr. was confirmed and sworn in.
Per the executive order establishing the commission, the commission chaired by RFK Jr. would work to “restore the integrity of the scientific process” by increasing transparency of any data used to justify federally funded health research, for instance. The commission is also required to increase data transparency related to childhood chronic disease and to “establish a framework for transparency and ethics review in industry-funded projects.”
The HHS did not immediately respond to a request for comment on the new policy.
A slew of industry groups and policy experts are already warning of less effective rulemaking—while also highlighting the contrast between Kennedy's promises and the policy change.
Beth Feldpush, senior vice president of policy and advocacy for America's Essential Hospitals, said her group is "concerned that the elimination of public comment, particularly for Medicaid policies, will not only reduce transparency but also lead to weaker, error-filled regulations that have not been fully vetted. In addition, the rapid implementation of policy changes would give states, providers, and beneficiaries insufficient time to properly prepare for implementation."
Katie Smith Sload, president and CEO of nonprofit aging care provider association LeadingAge, said the possibility of eliminating or significantly scaling back public feedback "on policies impacting payment, regulations, safety, operations, and other critical areas is truly troubling—a move we can only hope will not have the negative impact that we fear it might. We will closely monitor its implementation.”
"Public input is not an obstacle; it is an essential to protect against uninformed policies, regulatory missteps, and failures in infection prevention and outbreak response," the Association for Professionals in Infection Control and Epidemiology (APIC) said in a statement calling for the policy's immediate reversal.
Sarita Mohanty, M.D., president and CEO of The SCAN Foundation, said that “while it is unclear which specific policies and programs this HHS memo affects, actions that eliminate the opportunity for public comment are deeply concerning, so we urge HHS to maintain its robust public comment approach and ensure transparency in rulemaking informed by people’s experiences and expertise.”
Jerome Adams, M.D., who served as surgeon general under President Donald Trump during his first term, highlighted the policy statement's "astounding hypocrisy" and questioned on X whether Kennedy and his supporters are "really for transparency."
Lawrence Gostin, director of the O'Neill Institute and its chair in Global Health Law at Georgetown Law, said the move "enables HHS to operate in secret & without public participation. HHS can ignore the views of key stakeholders like researchers & health advocates. HHS will make crucial public health decisions behind closed doors."
The decision also caught the attention of the administration's political opponents. In a statement, Rep. Raúl M. Grijalva, D-Arizona, said Kennedy "is proving he does not care about science or the actual impacts of his policies. He is denying the public’s right to comment on health policies because he is scared to face the truth.
"Public comment periods have been an essential part of rulemaking, especially for minority communities who are often underrepresented in clinical trials, health interventions and health policies. I call of RFK Jr. to reverse this action which will lead to uninformed policies," the lawmaker said.