What Has Changed in the Rulemaking Process?

Since 1971, the Richardson Waiver had required HHS to seek public comment on rules that were technically exempt under the Administrative Procedure Act (APA). Normally, the APA mandates that agencies:

• Publish a proposed rule in the Federal Register.
• Allow time for public comments (usually 30–60 days).
• Review and respond to comments before issuing a final rule.

These steps apply to most substantive or legislative rules (those that create new legal obligations or significantly change existing policies). However, the APA exempts certain categories of rules from this process, including those related to agency management or personnel, public property, loans, grants, benefits, or contracts.

Under the Richardson Waiver, HHS voluntarily waived these exemptions, requiring public comment even when it wasn’t legally necessary. The waiver was intended to ensure transparency and stakeholder input on policies impacting funding, programs, and administrative processes. Now that the waiver is rescinded, HHS no longer has to follow notice-and-comment procedures for these exempt rule categories unless another law explicitly requires it.

Why Did HHS Rescind the Richardson Waiver?

HHS justified the change with three arguments:

• The waiver created unnecessary procedural burdens that slowed down rulemaking.
• The waiver was not legally required under the Administrative Procedure Act (APA).
• The change is intended to increase efficiency and flexibility in policy decisions.

While HHS must still comply with the APA, where required by law, this rollback gives the agency greater discretion to issue certain policies without public input. For example, Medicare payment rules are still under the Social Security Act and still require public comment, but other funding-related decisions, grants, contracts, and administrative rules may now be issued without public feedback.

How This Affects Businesses and Industry Stakeholders

Public comment periods on Department of Health and Human Services (HHS) regulations attract a wide range of stakeholders, with industry and business groups playing a particularly influential role. Comments often come from healthcare providers, hospitals, health systems, professional associations, insurers, pharmaceutical and biotech companies, medical device manufacturers, technology firms, and more.

The public comment process serves as a key avenue for industries and businesses to shape HHS rulemaking. Analyses of public comments on various regulations indicate that, alongside the general public, researchers, and universities, industry stakeholders are among the most active participants in the public comment process. By often providing detailed, data-driven feedback, these groups seek to influence policies in ways that balance public health goals with operational and financial realities. Their engagement helps ensure that a diverse range of perspectives is considered before regulations are finalized.

An Example Why Comments Matter in HHS Rulemaking

In 2015, HHS undertook a major update to the Common Rule, which governs human subjects’ research. The proposal drew 2,186 public comments from a diverse range of stakeholders, including patients, academics, industry groups, and advocacy organizations.

One particularly controversial provision proposed requiring informed consent for research use of biospecimens. This sparked strong opposition from industry: 100% of pharmaceutical and biotech trade groups opposed the change, along with 94% of universities and researchers, arguing that it would significantly hinder medical research. Faced with overwhelming pushbacks from industry and research institutions, HHS ultimately removed the biospecimen consent requirement from the final rule. This case highlights how coordinated industry and research sector engagement in public comments can directly shape regulatory outcomes, ensuring that proposed policies account for operational and scientific feasibility.

Impact on Transparency

Policymakers across the political spectrum emphasize the importance of transparency and accountability in government decision-making, particularly in healthcare. However, this rule change raises concerns about maintaining those standards. By rescinding the Richardson Waiver, HHS has eliminated a key avenue for public input, allowing the agency to issue certain regulations with far less scrutiny. This shift could lead to:

• Surprise regulatory changes that catch businesses, healthcare providers, researchers, and other stakeholders off guard.
• Reduced government accountability, as HHS can now make decisions without a public record of stakeholder concerns.
• Weakened public trust in healthcare policymaking, as affected groups may feel sidelined from decisions that directly impact their operations, grant funding, and compliance obligations.

Instead of encouraging open dialogue and stakeholder engagement, this change shrinks opportunities for input and favors a top-down approach that risks alienating the very groups that must implement and comply with new regulations.

How Public Comment Periods Strengthen Transparency

For decades, public comment periods have been a critical mechanism for ensuring transparency and stakeholder engagement in HHS rulemaking. By requiring agencies to solicit feedback from those directly affected, public comments help prevent unintended consequences and improve regulatory decision-making. The Richardson Waiver was a safeguard that ensured even rules exempt under the APA underwent public review, giving businesses, healthcare providers, and advocacy groups a voice in the process. While HHS argues that rescinding the waiver will improve efficiency, this change may limit the ability of affected stakeholders to anticipate and adapt to major regulatory shifts, creating greater uncertainty for those who depend on stable and predictable policies.

The elimination of mandatory public comment potentially affects:

1. Businesses and Industry Stakeholders

• Healthcare providers, insurers, pharmaceutical companies, medical device manufacturers, and biotech firms all rely on clear, predictable regulations to operate effectively.
• Without public input requirements, major regulatory shifts could happen with little warning, forcing businesses to scramble to comply with new grant requirements, coverage mandates, or operational policies they had no chance to weigh in on.
• The lack of transparency increases regulatory risk, making it harder for companies to plan for compliance and long-term investments in healthcare innovation.

2. Academic and Research Institutions

• Universities, medical research organizations, and public health experts frequently submit public comments on HHS rules that could impact research and innovation.
• In past rulemakings, such as the Common Rule revision, input from research institutions helped balance scientific advancement with ethical considerations.
• Without formal public comment periods, new research-related policies impacting grants could be implemented without considering how they affect clinical trials, data privacy, or funding eligibility.

3. Patient Advocacy and Public Interest Groups

• Nonprofits, patient rights organizations, and advocacy groups often use public comments to push for policies that protect patient care and improve healthcare access.
• Removing structured public input opportunities weakens their ability to challenge policies that may disproportionately harm vulnerable populations

How Industry May Respond

With fewer formal opportunities to influence HHS rulemaking, businesses and industry groups will likely shift their strategies to maintain regulatory influence.

1. Increased Private Lobbying
   • Companies and trade associations will expand direct lobbying efforts, engaging HHS officials outside of the formal rulemaking process.
   • This could reduce transparency, as regulatory negotiations may occur behind closed doors rather than in publicly documented comment submissions.
2. Greater Use of Trade Associations and Coalitions
   • Industry groups may strengthen collective advocacy efforts to ensure a unified industry voice on key regulatory issues.
   • This strategy allows businesses to pool resources, present a cohesive policy stance, and increase their leverage when engaging with HHS.
3. Litigation and Congressional Intervention
   • If HHS issues regulations without sufficient stakeholder engagement, businesses may turn to lawsuits to challenge rules they see as unfair or burdensome.
   • Industry players may also lobby Congress to introduce legislation that reinstates transparency measures or limits HHS’s ability to bypass public input.

The Future of Transparency in HHS Rulemaking

The removal of mandatory public comment periods for certain regulations does not eliminate industry engagement, it simply changes how and where that engagement happens. Businesses, advocacy groups, and the public will continue to push for regulatory clarity, but they may have fewer direct opportunities to influence policy before it is finalized. This shift raises concerns about fairness and accountability in healthcare rulemaking. With fewer formal opportunities for stakeholder participation, regulatory policies may become less responsive to industry concerns and public needs, leading to:

• Unintended compliance burdens for businesses and providers.
• Policy confusion at the state and local levels.
• More frequent legal challenges, as affected parties seek alternative ways to push back against HHS decisions.

If the goal of modern governance is to make healthcare regulation more transparent, predictable, and responsive, this rule change is seemingly a step in the opposite direction. Instead of creating efficiency, it risks introducing uncertainty and eroding trust in the regulatory process.

The long-term impact of this shift will depend on how HHS uses its expanded discretion, and how stakeholders adapt their strategies to ensure their voices continue to be heard in healthcare policymaking.