When most people think of health care advocacy, they typically think of legislative activities that can affect health coverage and health care. People generally know they can weigh in on legislation by contacting their members of Congress. Yet fewer people are aware of the opportunity to engage in administrative advocacy and weigh in on the policies that affect the way legislation is implemented. Regulations, also sometimes known as rules, are issued by federal agencies, like the Department of Health and Human Services (HHS), to fill in gaps not covered by legislation or provide more technical details. Before finalizing a regulation, an agency must first solicit feedback from the public (see below). Once a regulation is finalized, it carries the force and effect of law.
Why Regulations are Important in Health Policy and Health Care
Regulations serve an important role in protecting consumers, improving access to health coverage and health care, and ensuring that technical details of health care laws are implemented efficiently and effectively. Among other things, regulations can help ensure access to health programs and services; protect people from discrimination in health coverage and health care settings; safeguard that health care facilities, equipment, and medications are safe and accessible; protect data privacy; and improve the administration of health coverage and health care delivery systems. Unlike laws that are hard to change, regulations can be adapted and updated to reflect new developments in policy, science and technology. Of course, agencies can also use regulations to narrow the scope of civil rights, restrict access to certain types of care, or create technical burdens that make it difficult to administer various programs.
The Importance of Public Input
The Administrative Procedure Act (APA) is a federal law that establishes the procedures federal agencies must follow to develop and issue regulations. Under the APA, agencies are generally required to seek public input before finalizing a new regulation or modifying an existing regulation, most often through a public process known as notice and comment. To initiate the notice and comment process, an agency publishes its proposal in the Federal Register (a daily government publication) and explains why the rule or change is necessary. A public comment period then begins, often lasting 30 to 60 days. The notice and comment process provides an opportunity for transparency and accountability. The APA requires agencies to consider all comments that are received and agencies must address any significant issues that commenters raise during the process. Public comments, including individual stories, are powerful and can help shape the details of a final rule. Collected together, comments also help build an administrative record. If an agency’s rule is challenged in court, the administrative record is an important tool for courts to consider. Notice and comment procedures are also typically used before rescinding an existing regulation.
Attacks on the Regulatory Process and Administrative Advocacy
Over the past year, the White House and its Office of Management and Budget have encouraged federal agencies, including HHS, to promote deregulation, and to minimize public input into the regulatory process.
In January of 2025, the White House issued Executive Order (E.O.) 14192 directing federal agencies to eliminate 10 regulations for every 1 new regulation they proposed. This E.O. defines the term regulation broadly to include memoranda, policy statements and other types of guidance documents. In April, a presidential memorandum encouraged agencies to review existing regulations to ensure their compliance with recent Supreme Court decisions and to revoke regulations the agency determines are “unlawful” without using the notice and comment process. In October of 2025, the Office of Management and Budget (OMB) also issued a memorandum encouraging agencies to expedite and streamline these deregulatory processes.
Additionally, in March of 2025 the Department of Health and Human Services (HHS) rescinded its policy titled Public Participation in Rulemaking, also known as the “Richardson Waiver.” The Richardson waiver, which had been in effect for more than 50 years, required HHS to use the APA’s notice and comment procedures for rules related to public property, loans, grants, and benefits which normally would be exempt from public notice-and-comment processes. The Richardson waiver also directed HHS to use the APA’s good cause exception “sparingly.” The good cause exception allows agencies to waive notice and comment rulemaking where it is “impracticable, unnecessary, or contrary to the public interest.” In its statement, HHS claimed the Richardson waiver imposed unnecessary costs on the agency and created inefficient operating policies. Rescission of the Richardson waiver is significant because it potentially allows HHS the freedom to make sweeping changes to certain types of Medicaid regulations, Title X family planning grants, and other programs without seeking public input from stakeholders.
Proponents of deregulation argue that the regulatory process creates burdensome costs for the federal government, and stifles industry innovation. Yet, as noted above, regulations generally provide important technical details that help implement laws and provide important consumer protections. Feedback from stakeholders, particularly in the health care space, is critically important to understand how individuals may be affected by the nuances of regulations and increases transparency and accountability.
Looking Ahead
Despite the rhetoric around deregulation, in many instances, federal agencies continue to issue proposed regulations and utilize the APA’s notice and comment procedures. For example, the Department of Homeland Security (DHS) recently published a Notice of Proposed Rulemaking (NPRM) in the federal register to repeal a Biden public charge rule. Public charge is a policy that allows the government to review whether a person applying for entry to the U.S. or for a green card is likely to become primarily dependent on the government for their subsistence. The proposed rule would revoke the Biden area rule with one that would allow immigration officials to base public charge denials on any health or social services program the administration wants.
Despite the repeal of the Richardson waiver, HHS is still required to use the APA’s notice and comment procedures for many rules. Even when it is not required, HHS can still choose to utilize the notice and comment process. Despite rescinding the Richardson waiver, we expect that HHS will release several proposed rules for public comment over the next few months.
At the same time, given the repeal of the Richardson waiver, we do expect that agencies, including HHS will likely take advantage of processes that allow the agency to invoke the APA’s “good cause exception.” Typically, there are two ways agencies do this. An interim final rule (IFR) is a rule that is published in the Federal Register, without notice and comment, and takes effect immediately. Agencies typically will allow for a notice and comment period after the rule takes effect and may use public feedback to help shape the final rule. Similarly, a direct final rule (DFR) is typically published in the Federal Reister without notice and comment, however agencies will typically include a statement that unless it receives substantive adverse comments within a defined period, it will publish the rule as final at the end of that period. If significant adverse comments are received, agencies are typically required to withdraw the direct final rule. Even where agencies use IFRs and DFRs, it is critical that advocates and affected individuals weigh in and share feedback on how the proposed rules will impact the public. Doing so will promote agency accountability and help create a strong administrative record.
Administrative advocacy remains as important as ever. The public should continue to provide feedback where agency proposals restrict access to health care or civil rights protections. Advocates and experts must also weigh in and highlight instances where the federal agencies rescind regulations that improve access to health care, health coverage and civil rights. Finally, we must all continue to push for increased transparency and the opportunity to weigh in on administrative policies to protect access and prevent discrimination in health care.
