The U.S. Department of Health and Human Services (HHS) has announced a significant shift in its regulatory approach, marking a departure from five decades of practice.
In a policy statement published in the Federal Register, HHS Secretary Robert F. Kennedy Jr. declared that the agency would no longer utilize notice-and-comment rulemaking procedures for matters related to agency management, personnel, public property, loans, grants, benefits, or contracts. This decision effectively rescinds the 1971 “Richardson Waiver” and aligns HHS rulemaking with the Administrative Procedure Act (APA).
Under the APA, agencies are generally required to provide notice of proposed rulemaking, allow for public comment, and consider those comments before finalizing regulations. However, the APA includes exemptions for certain categories of agency actions, including those related to internal management, grants, and contracts. The Richardson Waiver, implemented in 1971, voluntarily extended notice-and-comment procedures to these exempted matters within HHS, ensuring greater transparency and public participation in rulemaking.
By rescinding the waiver, HHS will now exercise discretion in determining when public input is sought on policies that fall under the APA’s exemptions. The agency’s new position is that the waiver imposed unnecessary procedural burdens beyond those legally required and was inconsistent with U.S. Supreme Court precedent, specifically the 2015 case Perez v. Mortgage Bankers Association.
For the general public, this policy change could significantly reduce opportunities to provide input on key HHS policies affecting healthcare benefits, grants, and contracts. Many government programs, including Medicare and Medicaid, operate under HHS regulations, and modifications to these programs could now be implemented more swiftly, but with less public scrutiny.
One immediate concern is that beneficiaries of federal healthcare programs may have fewer opportunities to voice their opinions on policy changes that directly affect them. Under the previous approach, stakeholders – including patients, healthcare providers, and advocacy groups – could submit comments on proposed rules, influencing final decisions. With the removal of this requirement, HHS has greater latitude to enact policies without external input, raising concerns about transparency and public accountability.
Additionally, healthcare providers who rely on federal grants and contracts may find themselves subject to new policies with little warning or opportunity to shape regulatory frameworks. This could create uncertainty in the healthcare sector, particularly for organizations dependent on government funding.
From an administrative perspective, rescinding the Richardson Waiver could streamline the policymaking process within HHS. By removing the procedural requirement for notice-and-comment on exempt matters, the agency can implement policies more efficiently, reducing delays associated with prolonged public feedback periods.
Supporters of the move argue that this will enable HHS to be more responsive to emerging healthcare challenges, such as public health crises or funding allocations. Agencies will no longer be obligated to undergo lengthy rulemaking procedures for administrative decisions that may need to be implemented quickly.
However, critics warn that the decision could lead to a lack of oversight and increased litigation. While HHS has the discretion to allow for public participation on a case-by-case basis, there is no guarantee that it will do so consistently. The absence of structured public engagement could make regulatory decisions more susceptible to challenges in court, particularly if stakeholders feel excluded from the policymaking process.
The shift also raises legal and constitutional questions about administrative authority and the balance between efficiency and democratic participation. The APA was designed to ensure that agencies do not act arbitrarily or without due consideration of public input.
While the APA allows exemptions for specific types of rules, agencies historically have taken a more inclusive approach to rulemaking to foster legitimacy and trust.
Moreover, the rescission of the Richardson Waiver may set a precedent for other federal agencies to similarly reduce public participation requirements. This could lead to broader regulatory shifts across the government, affecting transparency and the role of public engagement in shaping policies.
The HHS decision to rescind the Richardson Waiver represents a fundamental change in how the agency formulates policies affecting millions of Americans. While the move may improve bureaucratic efficiency, it also raises concerns about reduced transparency, public engagement, and the potential for unintended consequences in healthcare regulation. As HHS moves forward under this new framework, both citizens and policymakers will need to closely monitor its impact on healthcare access, administrative accountability, and government responsiveness.
EDITOR’S NOTE: This morning on Monitor Monday, senior healthcare analyst Frank Cohen related how he lost an extrapolation appeal because the Administrative Law Judge (AJL)
Within the healthcare regulatory landscape, there are a couple phrases that have become a bit played out of late: “let the courts decide” or “we’ll see what
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