Out of Sight, Out of Mind? Agency Rulemaking as an Overlooked Source of Health Disparities

Topics:
Health Disparities Health Law
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Health disparities—the differences in access to health care and related services as well as in health utilization and outcomes—are influenced by a wide variety of factors, including socio-economic status, education, ethnic and racial background, culture, environment, geography, gender, and sexual orientation. Yet, unquestionably, past and current governmental policies have partially contributed to these disparities by creating and perpetuating systemic barriers to achieving a more equitable and just society. Health policy and health services researchers from across numerous disciplines have actively sought to mitigate and reduce these disparities by not only identifying and meticulously documenting them but also by pinpointing effective evidence-based policy options. As such, we have seen dramatic disparity-reducing policy changes, including the Affordable Care Act’s Marketplace- and Medicaid-based coverage expansions to millions of Americans, reductions in administrative burdens throughout many government programs, the Healthy People initiatives, expanded subsidies to federally qualified health centers and school-based health centers, and various Medicaid expansions related to children and mothers, to name but a few. 

While these policy changes are important steps toward a better society, we argue that a key component of the policy process has continuously been overlooked by researchers and advocates alike: the vast public bureaucracies at both the federal and state level.1 These bureaucracies serve a crucial function in the policy process and are substantial venues for policymaking.1-3 Indeed, with increasing partisan gridlock elsewhere, most of the policy change comes not from the aisles of Congress or even from the desk of the president but from the vast corridors of hundreds of agencies in Washington, DC and the 50 state capitals.1,2,4

One of the crucial powers at the disposal of bureaucrats is a process called “rulemaking,” by which federal and state agencies develop and issue legally binding government rules and regulations.1,2,4 Rulemaking serves as the most common form of policymaking today, as agencies are tasked with the seemingly mundane job of “filling in the gaps” of thousands of existing and new statutes. To provide some perspective, in 2020, Congress passed a mere 178 bills into law. In the same year, federal agencies issued more than 3,300 rules taking up more than 87,000 pages in the Federal Register, the official journal of the federal government of the United States.4 Cumulatively, the Code of Federal Regulations, which compiles all federal administrative rules, contained a stunning 185,984 pages in 2019, up from 22,877 in 1960 and 71,224 in 1975.4

Rulemaking is particularly important for policies related to health and health-protective programs.4 Every year, bureaucrats develop and promulgate thousands of legally binding regulations in these areas alone, covering such diverse issue areas as provider networks, Medicare price negotiations, contraceptive coverage for women under the ACA, qualified health plans, short-term limited duration insurance products, and Medicare Advantage plans.4 The Affordable Care Act exemplified this point with its extensive delegations of authority to a number of federal agencies—even those not traditionally associated with health policy like the Departments of Treasury, Labor, and Justice, as well as agencies as diverse as the Social Security Administration, the Office of Personnel Management, and the Equal Employment Opportunity Commission.4 Unsurprisingly, rulemaking has featured prominently in the implementation of the ACA. In fact, by the end of 2019, federal agencies had initiated 265 rulemakings and issued more than 9,000 pages of rules establishing the policy details necessary to implement the law.4 By the end of 2022, the number of rules had increased to 450.4 And by no means does the ACA serve as an outlier when it comes to the prominence of rules-based policymaking related to health (or any other substantive issue).4

There are many positive aspects to rulemaking.1,4 For one, it allows for relatively constant adjustment of policies to better reflect the changing circumstances of the times and to minimize policy drift. Rulemaking also allows for more immediate responses to confront pressing policy challenges. Moreover, the process, at least in theory, is more transparent than legislative policymaking because (most) rules must follow the procedural requirements outlined by the Administrative Procedure Act. Rulewriters across agencies also seek to make extensive use of scientific information and expertise to develop these regulations so that they can withstand future judicial scrutiny. And rules, at least to a degree, are subject to congressional, presidential, and judicial oversight and accountability.

Yet, like all policymaking in the United States, policymaking via rulemaking is not free from influence by outside interests, which may hold important—and often overlooked—implications for health disparities. These outside actors include elected members of Congress as well as the president, who constantly seek to achieve their own (and their allies’) policy goals. However, sources external to government also play an important role in the rulemaking process. Interest groups, particularly those representing business,2 lobby rulemakers consistently, often even before the rulemaking process has officially begun. They frequently rely on ex parte meetings or phone calls and deploy a whole array of advocacy resources at their disposal. Furthermore, the most sophisticated of the interest groups also tend to lobby entities like the president’s Office of Information and Regulatory Affairs, a pivotal gatekeeper within the rulemaking process.2,3 Crucially, the available evidence indicates that interest groups are often successful in shifting policy outcomes in their favor during rulemaking.2

While there is nothing wrong with lobbying government agencies to support one’s preferred policy outcome, what makes lobbying related to the rulemaking process particularly notable is the fact that it is a political activity that is even less representative of the public than legislative lobbying or campaign contributions. Underserved, marginalized, and minority populations (and their advocates) are often excluded from this process because they lack the awareness and resources to become active participants. As a result, most available evidence indicates that the sources of influence in the rulemaking process may be even more skewed toward well-resourced interests than other parts of the policymaking process and with representatives of business interests playing a disproportionate role.2

To complicate matters further, federal and state governments also rely extensively on the guidance document process to make public policy decisions.4,5 Guidance documents are an umbrella term for agency actions that clarify existing statutes or regulations5 and include a diverse set of policy documents, such as agency policy statements, agency letters, agency handbooks, and even Frequently Asked Questions (FAQs) documents. While technically not legally binding on the public, guidance documents are often considered to be binding in practice because failure to abide by them may jeopardize an organization’s standing with an agency, they reflect the agency’s stance on policy enforcement, and they are difficult to challenge in court. Given the low level of transparency attached to the issuance of guidance documents, policymaking via guidance may be even more skewed toward powerful interests than the traditional rulemaking process.

We want to be clear: it is unreasonable to presume that the vast public assistance system of the United States (or any part of modern government) could effectively function without rulemaking and guidance. The modern administrative state serves a crucial role in ensuring a viable and active government. We also do not mean to imply in any way that agency rulewriters are intentionally biased or that interest groups, including business interests, are not important and valid sources of information during the rulemaking process. However, one can expect most business lobbying to represent its interests with much less of an eye toward larger societal implications, including health disparities. Hence, these policymaking processes raise important questions about accountability and democratic representation, including whose voices get heard and whose are most impactful.

Yet, these administrative processes also provide an opportunity for health policy and health services researchers to inject evidence into government decision-making that may reduce disparities and increase equity. For scholars, this may mean taking a more active role in applied and policy relevant research and then translating that evidence into the rulemaking process via the commenting process, as well as the guidance process when comments are accepted, such as at the U.S. Food and Drug Administration.6 It may also mean actively seeking out open access opportunities in publishing, as well as venues outside of traditional academic journals that are accessible to rulemakers seeking expertise. Ultimately, while researchers may not be able to counter powerful interests in all cases (nor wish to), providing a more balanced set of voices, particularly those based on rigorous scientific evidence, holds tremendous potential in reducing health disparities in the long run.

References

  1. Kerwin CM, Furlong SR. Rulemaking: How Government Agencies Write Law and Make Policy. 5th ed. CQ Press; 2018.
  2. Haeder SF, Yackee SW. Influence and the Administrative Process: Lobbying the U.S. President’s Office of Management and Budget. American Political Science Review. 2015;109(3):507-522. doi:doi:10.1017/S0003055415000246
  3. Haeder SF, Yackee SW. Presidentially Directed Policy Change: The Office of Information and Regulatory Affairs as Partisan or Moderator? Journal of Public Administration Research and Theory. 2018;28(4):475-488.
  4. Haeder SF. The Health Care Bureaucracy. In: Morone JA, Ehlke D, eds. Health Politics and Policy. 6th ed. Cengage; 2024:100-113.
  5. Parrillo NR. Federal Agency Guidance: An Institutional Perspective. Washington, DC: Administrative Conference of the United States; 2017.
  6. Lewis KM. Informal Guidelines and the FDA. Food and Drug Law Journal. 2011;66:507-550.


Citation:
Haeder S, Webb Yackee S. Out of Sight, Out of Mind? Agency Rulemaking as an Overlooked Source of Health Disparities. Milbank Quarterly Opinion. October 24, 2024.


About the Authors

Simon F. Haeder an Associate Professor of Public Health in the Department of Health Policy & Management in the School of Public Health at Texas A&M University. His research focuses on the politics and policies of access to health and health-protective services with a focus on administrative burden, provider networks, vaccinations, and school-based health services as well as the regulatory process. He was recently recognized by the American Political Science Association’s Health Politics and Policy section with the David Kline Jones Distinguished Scholar Award. The award is given to a mid-career scholar who has made significant contributions to the field of health politics and policy through their commitment to important research, health equity, and teaching. Previously, he has been a fellow in the Interdisciplinary Research Leaders Program, a national leadership development program supported by the Robert Wood Johnson Foundation to equip teams of researchers and community partners in applying research to solve real community problems. He was also part of the inaugural cohort of the American Enterprise Institute’s Emerging Poverty Scholars program as well as a Carl Albert Congressional Graduate Fellow at the University of Oklahoma. He earned an Master’s degree in Political Science (2011) and a Ph.D. in Political Science with a minor in Applied and Agricultural Economics (2016) from the University of Wisconsin–Madison. He also holds a M.A. in International Relations (2007) and a Master’s in Public Administration (2010) from California State University, Fresno.

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Susan Webb Yackee is Director of the La Follette School of Public Affairs and a Collins-Bascom Professor of Public Affairs at UW–Madison.

Her research and teaching interests include the U.S. public policymaking process, public management, regulation, health policy, and interest group politics. Yackee has published articles in a number of journals, including the American Political Science Review, Journal of Politics, Public Administration Review, Journal of Public Administration Research and Theory, British Journal of Political Science, and Journal of Policy Analysis and Management.

Yackee received the 2019 Herbert A. Simon Career Contribution Mid-Career Award from the Midwest Public Administration Caucus.  It is one of the highest awards in the field of political science for the study of bureaucracy and public administration. She also received the Kellett Mid-Career Award for her research from UW-Madison. Yackee’s article “Clerks or Kings? Partisan Alignment and Delegation to the U.S. Bureaucracy” (with Christine Palus) won the 2017 Beryl Radin Award for the best article published in the Journal of Public Administration Research and Theory.

Yackee is an elected member of the National Academy of Public Administration. In 2023, Yackee was appointed as a public member of the Administrative Conference of the United States (ACUS).  In the past, she was an elected Board member for the Public Management Research Association and served as member of the Board of Editors at the Journal of Public Administration Research and Theory, Public Administration Review, and Perspectives on Public Management & Governance. Yackee recently finished work on a $500,000 Innovations in Regulatory Sciences Award from the Burroughs Wellcome Fund to study regulatory policymaking at the U.S. Food and Drug Administration.

In the past, Yackee was a Robert Wood Johnson Foundation Scholar in Health Policy Research at the University of Michigan in Ann Arbor. She also served as a Smith Richardson Domestic Policy Fellow, a UW-Madison Vilas Associate Professor, a UW-Madison H.I. Romnes Faculty Fellowship, and a Harry S. Truman Scholar. As a junior scholar, Yackee’s research received four “Emerging Scholar Awards” from various professional associations. She worked as a legislative research assistant in the U.S. Senate before beginning her academic training.

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