This chapter first describes the basic components of the public health infrastructure1 and the organization of governmental public health in the United States. Next, the committee discusses the laws that establish the mission, mandate, structure, capacity, governance, powers, and limits of public health agencies at the national, state, tribal, and local levels. The committee then reviews the recent history of public health law reform, and discusses the changes needed to equip the governmental public health sector to lead and support efforts to improve population health. Finally, the committee discusses the critical question of public health federalism—that is, the optimal locus of responsibility and authority among the levels of government with regard to health-relevant public policy.
The primary reason for the existence of government is to provide for the health, safety, and welfare of the people (Gostin, 2010; Lopez and Frieden, 2007). In the United States, governmental public health responsibilities and roles exist at three different levels: federal, state/tribal, and local/municipal. The fundamental division of responsibility among these levels is defined by
1 The 2003 report The Future of the Public’s Health in the 21st Century used the term public health infrastructure in reference to the array of public entities charged with keeping the public healthy (e.g., agencies, laboratories, and partners) and to their operational capacity. CDC has also defined three components of the basic public health infrastructure: workforce capacity and competency, information and data systems, and organizational capacity (CDC, 2008).
the fact that the Constitution leaves untouched the states’ sovereign power (sometimes called “police powers,” discussed below) over most health issues and limits the role of the federal government primarily to (1) regulation of foreign and interstate commerce issues—and by extension, health issues and threats that could affect commerce, and (2) the power to tax and spend for the public welfare (Gostin, 2010; Grad, 2005).
The organization of public health at the federal level consists of the Department of Health and Human Services (HHS), which includes the Centers for Disease Control and Prevention (CDC) that function as the nation’s lead public health agency, the Food and Drug Administration (FDA), and several other pertinent agencies each of which has multiple functions relevant to health. Other federal departments and agencies have health-related duties. These include the Department of Agriculture, whose functions include setting dietary guidelines, ensuring food safety, and administering the national program that sets and enforces organic standards; the Environmental Protection Agency, which is charged with protecting Americans from risks to health and to their environment; and the Occupational Health and Safety Administration, in the Department of Labor, which is given oversight of workplace safety and health issues. The federal public health agencies were created by administrative statute, and their actions are authorized by the Public Health Service Act first passed by Congress in 1944 and by a host of other laws (Goodman et al., 2006).
Below the federal level, the organization of public health is similarly complex, and the existing classification system for how public health is structured has had numerous iterations over several decades (see for example the earliest descriptions in DeFriese et al., 1981 and Miller et al., 1977). Each structural arrangement may have advantages and disadvantages in terms of the agencies’ ability to function and shape public policy, cultivate legislative champions, and secure needed funding, but given the heterogeneity among agencies and locales, there is little research on the topic and very limited resources to support it. First, there are four primary organizational models for state public health agencies, depending on whether the public health component is stand-alone or combined with other functions, such as mental health, substance abuse and human services programs, although this typology is often abridged to stand-alone agencies and umbrella agencies (ASTHO, 2007) (see Box 2-1). The statutes or laws that authorize state public health agencies are grounded in the US Constitution which both constrains their actions and allows them significant powers. Second, three models describe the administrative relationship between state and local public health organizations (or how states deliver services). These include a decentralized or home rule arrangement, under which local public health agencies operate independently of the state and report to local government; a centralized model in which there are no local public health agencies,
Four Models of State Public Health Agency
Traditional Public Health Agency—an agency that oversees public health and primary care only. While it may also administer one other health-related program (i.e., environmental health, alcohol and drug abuse), its responsibilities are usually limited to improving or protecting the overall health status of the public
Super Public Health Agency—an agency that oversees both public health and primary care and substance abuse and mental health. This usually includes administering services supported by the federal Substance Abuse Prevention and Treatment Block Grant and the Community Mental Health Services Block Grant programs
Super Health Agency—an agency that oversees public health and primary care as well as the state Medicaid program
Umbrella Agency—an agency that oversees public health and primary care, substance abuse and mental health, the Medicaid program, and other human services programs
SOURCE: ASTHO, 2007.
though the state agency may have regional offices; and shared and mixed authority models where the local agencies are responsible to both the state public health agency and to local government, or where some local agencies in a state report to the state agency while others operate solely under local government control (NACCHO, 1998; Novick and Mays, 2005). Local public health agencies in 29 states have decentralized (also called “home rule,” or local) governance; local agencies in 6 states and the District of Columbia have centralized (or state) governance, and 13 have shared or mixed (state and local) governance (NACCHO, 2008). Local public health agencies may also be categorized by geographic distribution as county, city, city/county, township, and multi-county/district/regional—60 percent are classified as county-type (NACCHO, 2001, 2008).2
Public health responsibilities at both the state and local levels generally reside in multiple agencies, in addition to the public health agency. Each state has its own legal framework for public health. All state public health agencies have one or more foundational (or enabling) statutes (laws) that provide the agencies with authority to conduct public health activities and
2 A similar typology, but one that describes five types of local public health agencies, may be found in NACCHO’s Local Public Health Agency Infrastructure: A Chart Book (2001).
permit them to promulgate regulations and take action. Some state statutes are detailed in outlining duties and powers, while others are broadly worded and permit the agency to promulgate regulations as needed (ASTHO, 2007). State public health statutes have been reviewed and well-characterized by model Act efforts such as the Turning Point Model State Public Health Act and the Model State Emergency Health Powers Act, both of which provide templates for updating the statutory foundations of public health practice. The rights, powers, and authorities of local governments have no special standing under the U.S. Constitution, and are instead “either delegated by the state legislature or derived directly as a grant of authority from the state constitution” (Goodman et al., 2007, p. 57). Public health statutes of local governments are less well characterized, in part because there are 2,794 local public health agencies (NACCHO, 2008) and “18,000 local jurisdictions (e.g., counties, cities, boroughs, and special districts)” (McCarty et al., 2009, p. 458). McCarty et al. (2009) have begun a process of identifying the major categories of local ordinances that pertain to public health for a range of local jurisdictions.
Boards of health are a historical mechanism for public health governance at the state and local level, but their roles have evolved over time, and some have been dismantled entirely (Nicola, 2005). Eighty percent of local public health agencies have an associated local board of health (NACCHO, 2008), and 23 states have a state board of health (Hughes et al., 2011). Some local boards are advisory, and others play a role in governance and policymaking. Their functions may include adopting public health regulations, setting and imposing fees, approving the agency budget, hiring or firing the top agency administrator, and requesting a public health levy (Beitsch et al., 2010; Leahy and Fallon, 2005). State boards play varying roles as well, including agency oversight, appointing the health officer, and a quasi-legislative function (i.e., adopting/rejecting rules) and a quasi-judicial function (i.e., enforcing rules) (Hughes et al., 2011).
State Police Powers
Police powers, which the states possess as sovereign governments preceding the U.S. Constitution, are the powers to safeguard the health, safety, welfare, and morals of the population and may be exercised by public health agencies (also called health departments), along with police, fire, and sanitation departments (Lopez and Frieden, 2007) (see Box 2-2). States may delegate this power to local governments and for health purposes to public health and related agencies. Surveillance and required disease reporting are exercises of state police powers. In some states, disease reporting is mandated in decades-old statutes, while in others, the statutes may be general, and simply empower the state health commissioner or board of health to
State Police Powers
Refers to authority of state to enact laws, promulgate regulations, and adjudicate to
(1) Protect, preserve, and promote
- General welfare
(2) Restrict private interests (within limits set by federal and state Constitutions):
- Personal interests—Autonomy, privacy, association, expression, liberty
- Economic interests—Contractual freedom, property uses, pursue trades and occupations
SOURCE: Gostin, 2010.
“create, monitor, and revise the list of reportable diseases and conditions” (Neslund et al., 2007, p. 224). In other states, this may be done either by statute or by regulations promulgated by the health department. The First, Fourth, Fifth, and Fourteenth Amendments provide procedural and substantive safeguards that constrain the exercise of police powers, such as due process and equal protection of the laws (see for example, Gostin, 2008).
The 3 Core Functions and 10 Essential Public Health Services
The fundamentals of government public health work have been distilled in three Core Public Health Functions outlined in the Institute of Medicine (IOM) report The Future of Public Health (1988). The functions are assessment, policy development, and assurance. In 1994, the Core Public Health Functions Steering Committee, which included federal government agencies and major public health organizations, developed the 10 Essential Public Health Services (10 EPHS) framework (see Box 2-3).3 The 10 EPHS have been used as a tool for planning, implementation, and evaluation in public health. Given their purpose to illustrate the range of public health practice,
3 The American Public Health Association, the Association of Schools of Public Health, the Association of State and Territorial Health Officials, the Environmental Council of the States, the National Association of County and City Health Officials, the National Association of State Alcohol and Drug Abuse Directors, the National Association of State Mental Health Program Directors, and the Public Health Foundation.
The 10 Essential Public Health Services
- Monitor health status to identify and solve community health problems.
- Diagnose and investigate health problems and health hazards in the community.
- Inform, educate, and empower people about health issues.
- Mobilize community partnerships and action to identify and solve health problems.
- Develop policies and plans that support individual and community health efforts.
- Enforce laws and regulations that protect health and ensure safety.
- Link people to needed personal health services and assure the provision of health care when otherwise unavailable.
- Assure a competent public and personal health care workforce.
- Evaluate effectiveness, accessibility, and quality of personal and population-based health services.
- Research for new insights and innovative solutions to health problems.
SOURCE: Public Health Functions Steering Committee, 1994.
they are extremely broad and somewhat vague. Also, the 10 EPHS are not simply the province of governmental public health agencies. Other organizations deliver services and conduct activities that may be categorized under one or more of the EPHS. However, the 10 EPHS do necessarily spell out the roles of non-health or non-governmental public health actors, or provide a map for implementing health in all policies approaches (intersectoral efforts to consider the health implications of non-health policies).
Essential Service 7 warrants attention in the context of implementing the Affordable Care Act. For decades, the public health practitioner community has expressed ambivalence about its role in the provision of limited, generally primary clinical care services as part of a safety net for uninsured and vulnerable populations. This role—providing, not just assuring the delivery of care—has channeled some additional resources to public health agencies, but has both perpetuated the misperception of public health as primarily publicly-funded medical care for the indigent and has been seen by many public health leaders as a programmatic distraction from discharging population-oriented responsibilities (Brooks et al., 2009; IOM, 2003a). Work by Honoré in Missouri (Honoré and Schlechte, 2007) and Brooks and colleagues in Florida (Brooks et al., 2009) has showed that a large, disproportionate percentage of public health funds are dedicated to Essential Service 7 to the detriment of agency ability to adequately attend
to the other nine essential services. As discussed in and since the IOM report The Future of the Public’s Health in the 21st Century (IOM, 2003b), many public health commentators believe that a well-functioning medical care system and expanded access to all or most of the population will free the public health agencies to focus on the “assurance” aspect of Essential Service 7 (e.g., ensuring access to care, linking people to needed care, assessing the quality of the care delivered in the community, and assessing and strengthening community supports for good health), rather than engage in the direct provision of clinical services (IOM, 2003b).
Many public health statutes have not been systematically updated in decades or more. They do not reflect current circumstances, provide insufficient mandates and powers, and guarantee human rights protections that might be interpreted judicially as overbroad (Meier et al., 2009b; National Association of Attorneys General, 2003). Antiquated laws can be confusing, fragmented, and duplicative. Older public health laws were, of course, informed by the scientific standards of the day and by the statutory context and constitutional jurisprudence of their time, including conceptions of individual rights. In addition, some laws were enacted in piecemeal fashion in reaction to a specific health problem (e.g., a disease outbreak), leading to layers of statutory accretion rather than holistic or comprehensive legislation (Gostin et al., 2008, p. 676).
Public health laws need to be sufficiently broad to deal with unforeseen threats, while still giving public officials clearly specified powers and limits. Many of the antiquated laws currently on the books focus on infectious diseases, but lack specific powers and responsibilities for chronic diseases and injuries. They also lack specific authority to exercise modern functions such as managing immunization registries and syndromic surveillance systems, and conducting interventions, in collaboration with other sectors, to alter the built environment. At the same time, antiquated statutes predate the vast expansion of knowledge about the socioeconomic determinants of health and their role in the complex pathways to chronic disease and other poor health outcomes. Extant statutes also frequently fail to protect individual rights such as privacy, nondiscrimination, and due process. Consequently, policymakers must systematically and comprehensively review public health statutes to ensure that sufficient and clear authority is in place, together with safeguards of individual rights.
The challenges presented by outdated laws are most starkly apparent in the context of preparedness for public health emergencies (see Box 2-4). The preparedness component of public health agency activities developed significantly in the last decade of the 20th century because of federal and
Preparedness Laws: Still in Need of Reform
“Existing state laws may thwart effective surveillance activities. Many states do not require timely reporting for the most dangerous agents of bioterrorism. Most states do not require immediate reporting for all the critical agents identified by the CDC [Centers for Disease Control and Prevention]. At the same time, states do not require, and may actually prohibit, public health agencies from monitoring data collected through the health care system. Private information held by hospitals, managed care organizations, and pharmacies that might lead to early detection of a public health threat, such as unusual clusters of fevers or gastrointestinal symptoms, may be unavailable to public health officials because of insufficient reporting mechanisms or privacy concerns” (The Centers for Law and the Public’s Health, 2010).
Although the Model State Emergency Health Powers Act was implemented to varying degree by a number of jurisdictions around the country, the general state of legal preparedness of public health emergencies such as epidemics and bioterrorist attacks remains deficient.
The CDC, the nation’s top public health agency, has powers “to quarantine, inspect, disinfect and even destroy animals that are sources of dangerous infection to humans” that have “limited applicability to a few diseases. If the CDC did try to exercise power in response to swine flu, its legal authority would surely be challenged, causing needless delays and uncertainty—and its actions might be ruled unconstitutional. To its credit, the CDC has tried for more than a decade to modernize its legal authority. But its proposed
congressional interest in public health readiness for deliberately introduced biological, chemical and other threats to the public’s health. These efforts, which received legislative attention in the late 1990s, intensified after the events of September and October 2001, including a major focus on the legal aspects of preparing for bioterrorism and other types of disasters. Goodman and colleagues have described the core elements of public health legal preparedness: essential legal authorities, competencies to apply laws, coordination across jurisdictions and sectors, and information about public health law best practices (Goodman et al., 2006). Preparedness cuts across many of the 10 EPHS.
In addition to the factors described above, other major shifts have occurred in the backdrop to public health laws, including demographics, health challenges, and in aspects of public health practice. For example, the population lives much longer and the age distribution of the population ranges across a much wider lifespan than was the case when some early public health laws were framed. Americans live very different lives than they did even 30 years ago. Examples are changes in how they communicate, grow food, and transport themselves. The infectious diseases common a century ago pose far less of a threat in contemporary life in
fundamental revision was submitted more than three years ago, and regulations have yet to be finalized” (Gostin, 2009).
In addition, based on reports from Association of State and Territorial Health Officials (2010) and the National Association of County and City Health Officials (2010) that were prepared for the CDC following the H1NI epidemic, O’Connor and colleagues (2011) identified several areas where laws and policies at all levels of government were not adequate to meet the needs of the public. They stated that “although progress in public health legal preparedness has been made since 2001, it is apparent from the law and policy challenges encountered during H1N1 that no single U.S. jurisdiction—state, local, tribal, or federal—is yet fully legally prepared to respond to a major public health threat.” Key issues they identified include vaccine allocation, distribution, and dispensing issues; coordination among levels of government about the use of stockpiled material; and the need for sustainable public health response funding. The authors noted that the laws and policies related to the vaccine campaign “presented significant challenges, especially for state and local public health responders,” including decisions on vaccine availability, formulation, allocation, prioritization, and guidance as well as tracking, recalls, and adverse event reporting. “Use and accounting for stockpiled materiel raised many policy and legal questions during 2009 H1N1.” Funding from Public Health Emergency Response was also restricted. The allowable methods for distributing the funds limited state and local flexibility for their use which ultimately slowed their ability to implement public health measures (O’Connor et al., 2011, pp. 53, 54).
the United States compared to chronic disease and the potential of longer life in diminished health (Kominski et al., 2002; Vaca et al., 2011; Woolf et al., 2010). Approximately two thirds of the adult population (Calle and Kaaks, 2004) and a growing proportion of children are overweight or obese (Center for Health Improvement, 2009), changing the profile of chronic disease patterns in the U.S. population. The empirical evidence about what creates and impairs health on the population level has continued to evolve, clarifying that medical care contributes far less to health outcomes than do the broader societal, environmental, and economic conditions that strongly influence human behavior (see Braveman et al., 2011; Cutler et al., 2006; McGinnis et al., 2002). Given the enhanced and evolving understanding of the causes of poor health and death in the population, public health tools and approaches are also changing. Furthermore, fundamental transformations are taking place in public health practice and in the health system in general. These changes offer opportunities for legal reforms to ensure modern laws and regulations meet contemporary needs, in addition to conforming to evolving science and evidence to address the major health hazards facing the population.
Public health statutes at the state level do not generally reflect the con-
temporary causes of poor health. State laws often feature specific references to communicable disease duties of public health agencies, while making no explicit reference to chronic diseases and injuries. Meier et al. (2009a) conducted a 50-state comparison of enabling public statutes against the standards of the 10 Essential Public Health Services and the 6-part mission of public health (like the EPHS, the mission4 was defined in the 1994 HHS document Public Health in America). The study’s findings aside, it is important to note that the mission statements refer to injuries and infectious disease, and the 10 EPHS refer very broadly to “health problems.” However, the lack of explicit reference to, for example, the leading causes of death (i.e., chronic disease), may lead to a limited understanding among policymakers and the public about the role of public health agencies. Such narrow understanding leads to inadequate funding for the full breadth of public health services necessary to safeguard the health of the public.
When considering the need for change in contemporary public health law, there are several contextual factors and fundamental transformations that must be considered, including
- national health legislation that holds the promise of expanding access to medical care, thus partially releasing public health agencies from the need to provide safety net clinical services;
- a renewed emphasis on and commitment to quality performance and accountability of public health agencies (e.g., the national Public Health Accreditation effort, the 2008 HHS Consensus Statement on Quality in the Public Health System 2009), and the 2007 Pandemic and All Hazards Preparedness Act provision requiring development of performance standards and measures by (Nelson et al., 2007); and
- multiple recent developments—legislative, technologic, and practical or operational—in the health information arena that have profound implications for public health practice and for its relationship to clinical care (e.g., the American Recovery and Reinvestment Act of 2009 provisions for health information technology, including payments to spur adoption of electronic medical records; the establishment of Regional Health Information Organizations to facilitate health information exchange across institutions in a community or region; and the development of the Meaningful Use concepts which
4 The mission of public health: (1) Prevents epidemics and the spread of disease; (2) Protects against environmental hazards; (3) Prevents injuries; (4) Promotes and encourages healthy behaviors; (5) Responds to disasters and assists communities in recovery; and (6) Ensures the quality and accessibility of health services (Public Health Functions Steering Committee, 1994).
include some consideration of public or population health needs as part of health information networks).
The changes outlined above are likely to have implications for the legal and policy aspects of public health practice. The growing understanding of the multiple determinants of health also requires attention to the adequacy of existing public health statutes. It also will require public health agencies to have greater public policy expertise and capacity in interactions with the heads of the Executive Branch to whom they report (e.g. mayors, governors), the Legislative Branch, and other sectors of government.
Prior Efforts to Update Public Health Law
Two major efforts to review and update public health law took place around the turn of the 21st century: the Turning Point Model State Public Health Act (1997–2003) and Model State Emergency Health Powers Act (MSEHPA, 2001–2002) (Gostin et al., 2002). The Turning Point Model State Public Health Act was a broad (though not comprehensive) sample law composed of nine articles and incorporated two other model acts—a revised version of the MSEHPA in the article pertaining to emergency powers, and the Model State Privacy Act (Gostin et al., 2001). The Turning Point Act presents the broad mission of state and local public health agencies to be conducted in collaboration with other stakeholders, and provides language for updating laws pertinent to the traditional powers of public health agencies (e.g., communicable disease control nuisance abatement, inspections) (Public Health Statute Modernization National Excellence Collaborative, 2003). As of August 2007, “subject matter or specific language from the Turning Point Act” was featured or introduced in whole or part through 133 bills or resolutions in 33 states, and 48 of these bills or resolutions have passed (The Centers for Law and the Public’s Health, 2007). Box 2-5 provides some lessons from the experience of four states that participated in the Turning Point Collaborative. These illustrate how widely circumstances may vary from one state to another: the level of interest of public health attorneys in the public health agency; the array and relationships among champions and advocates of public health law reform; the nature of the political establishment; and the level of interest in the administration and legislature currently in power.
Despite the development and dissemination of the model Acts and their generally partial adoption, by some state governments, much of public health law in jurisdictions around the country was crafted in the late 19th and early 20th centuries and remains largely unchanged. Also, Meier et al. (2009a) have demonstrated on the basis of an analysis of state codes in comparison to the public health mission and essential services described in
Using the Turning Point Model Act:
Lessons from Four States
Meier and colleagues (2007, 2009a) developed detailed case studies of four state efforts (Alaska, South Carolina, Nebraska, and Wisconsin) to enact public health reforms that provide useful lessons on factors that impeded or facilitated changes in public health law. Despite some important differences among these states, some of the themes that emerged are frequently encountered across the country.
All four states participated in the Turning Point Collaborative and considered changes to their public health statutes. However, in each case study, the facts on the ground were somewhat different, as were the outcomes—three out of four states successfully enacted legislation adopting some aspects of the model Act. In Alaska, public health statute reform coincided with the looming threat posed by Severe Acute Respiratory Syndrome, and this helped to generate broad support for legal changes. It is also instructive that there were two attempts at reform in two consecutive sessions of the legislature. The first, advanced by the state public health association, failed because it did not find “the support of those with the political capital necessary to advance these ideas into law” given the majority in power in the Alaskan legislature, but the second emerged from the Republican governor’s administration, developed by highly competent leadership of the state public health agency, and was successfully enacted.
In the South Carolina case study, a beleaguered public health leadership did not want to risk existing authority by trying to get greater specificity in their enabling statutes, and ultimately did not seek to enact public health reform.
Wisconsin proponents of public health statute reform (under the lead of the state public health agency) were highly successful, in part because the state legislature included a committee on public health, which called for a comparison of current law to the Model Act, including determining what was most important for the Wisconsin public health system and assessing political feasibility.
The Nebraska case study is interesting because it occurred in the context of public health reorganization from a previous total of 12 health departments covering 22 of 93 counties in the state, to the addition of 4 new health departments and reorganization of 16 single or multi-county agencies to cover all 93 counties in the state.
the Turning Point Model Act that statutes in only 17 of the states are highly congruent with the services (defined as 7 or more of the essential services are reflected in their enabling statute), statutes in 26 states are congruent (4 to 6 of the essential services are reflected in their statutes), and 7 remaining states have divergent statutes (defined as having statutes that reflect zero to 3 of the essential services). As learned from the Turning Point experience, the condition of state public health laws varies greatly in completeness,
quality, quantity, and the level of flexibility they permit, as does lawmakers and practitioners’ satisfaction with what is available in a given state, and the two are not necessarily connected. At the local level, the picture is similarly complex. As in the case of states, laws that protect the public’s health may be found scattered throughout a local jurisdiction’s entire body of law. Under the best of circumstances (e.g., a focus on optimizing the statutory underpinnings for population health), bodies of public health law (and law in general) at all levels of government would be subjected to close examination to assess their applicability and usefulness to addressing current public health challenges and would be updated, or “modernized” to effectively meet those challenges. Although this can be accomplished at the state level, it may be less immediately realistic at the local level given the existence of 18,000 local jurisdictions.
Recommendation 1: The committee recommends that state and local governments, in collaboration with their public health agencies, review existing public health laws and modernize these as needed to assure that appropriate powers are in place to enable public health agencies to address contemporary challenges to population health.
The phrase “contemporary challenges to population health” refers to the range of problems handled by public health agencies, including chronic diseases, injuries, new and (re)emerging infectious diseases (some facilitated by globalization and travel), and deliberate threats to health such as those presented by terrorism. The term “modernize” is used to denote updating laws to address contemporary circumstances and challenges, such as those described above. The committee also suggests that periodic (e.g., every 5 to 10 years) review of recent legislation could be conducted by each jurisdiction. The committee considers benchmarking potentially useful, given that most of the laws contained in the model Acts were drawn from extant high-quality law in place in various jurisdictions. In other words, Turning Point and MSEHPA provide some benchmarks, as would a comparison of public health priorities to the statutory authorities available to address them (especially in the area of chronic diseases, which were not a focus of the extant model laws).
Although the 10 EPHS are widely accepted and incorporated in the practice of public health and in current strategies to measure and improve public health performance, they are generally not incorporated into law (with the exceptions noted above by Meier et al. [2009b])—there is no statutory obligation to provide these services as the standard of practice in public health. The committee believes that all people deserve access to the same public health protections and services regardless of where they reside in the country. A consistent set of public health services is needed, to not
only protect and improve the health of residents in all jurisdictions, but to ensure that diseases are less likely to be transmitted across the nation. There is an urgent need to reexamine and revise these legal impediments to improving the effective use of existing public health resources and improving the impact of needed investments.
Recommendation 2: The committee recommends that states enact legislation with appropriate funding to ensure that all public health agencies have the mandate and the capacity to effectively deliver the 10 Essential Public Health Services.
Recommendation 2 has the purpose of alerting decision makers to the importance of adequate support for and the potential need for structural transformation to develop public health agency capacity to fulfill statutory duties. The 10 EPHS can be delivered directly by the state health department, by each local health department, by public health system partners, or by various permutations thereof through shared services, centralization, regionalization or interjurisdictional compacts. One way to verify a level of capability or offer sample mechanisms available to help enforce a standard is to link to quality improvement and performance measurement efforts, including actual or potential strategies such as public health accreditation, continuous quality improvement efforts, peer ranking, performance measurement by third parties, and evaluation (Lewis, 2007).
Public Health Accreditation
The national public health accreditation effort has intensified discussions about the challenges and opportunities of restructuring local public health in order to enhance capacity and quality of service delivery. These discussions have also sharpened the debate about agency size and ability to meet standards of organizational competence or performance.
The public health field has long engaged in a variety of evaluation, accreditation, and performance measurement activities, some at the national level and others in regional or local use. These include the National Public Health Performance Standards developed by the CDC. However, the field has lagged far behind many social services, education, and medical systems in the uniform adoption of external assessments of quality assurance and improvement systems by professional accreditation bodies.
Reviews of accreditation efforts across different fields have concluded that the evidence about the effectiveness and value of accreditation as a quality improvement tool is uneven, though there are some encouraging findings as well as some lessons (see for example, Hamm and Associates, 2007; Lewis, 2007; Mays, 2004). Although accrediting bodies generally
find an association between accreditation and performance improvement, academic researchers often measure different things, and may draw different conclusions about the effects of accreditation on performance (Lewis, 2007). For example, agencies that are accredited may be committed to a specific set of metrics, and may to some extent “perform to the test.” Unaccredited organizations may simply prefer other sets of metrics. In his summation of the defense and critique of accreditation Lewis (2007) found evidence that accreditation alone is not a guarantee of high performance, may be too occasional and general, may mask deficiencies due to incomplete data, and may value uniformity over performance. On the positive side, he found that accreditation does ensure a minimum level of quality, provides a common basis for comparison, is relatively inexpensive and cost saving compared to other quality improvement strategies, and prevents many disasters.
Accreditation efforts in multiple fields have inadequate quantitative data to help document quality improvement (Hamm and Associates, 2007; Lewis, 2007). Mays (2004, p. i) wrote that “[r]elatively few accreditation programs rely on evidence-based performance standards that are tightly linked to desired service outcomes,” although there is some movement in that direction, and he also found that the successful adoption of accreditation programs depends “on the strength of the incentives faced by organizations within the industry to pursue and maintain accreditation.” Greenfield and Braithwaite (2008) conducted an extensive review of the clinical care accreditation literature and found a fragmented evidence base and highly uneven evidence on the correlation between accreditation and performance (e.g., the outcome of quality), and the gaps filled by anecdotes, preferences, and ideology. However, they also found evidence that accreditation was correlated with improvements in professional development and promoted change through the organizational activities and preparation required for accreditation.
The rationale for the public health accreditation effort includes addressing the gaps and variations and inadequacies in public health infrastructure. The literature on clinical care system accreditation appears to indicate that the success of accreditation in improving or raising the bar on quality is dependent on factors such as institutional commitment and the collection of quality and better data collection (Greenfield and Braithwaite, 2008; Lewis, 2007). Additional research seems to indicate that steps are being taken across the accreditation enterprise in the United States, Australia, and other countries to expand and strengthen the evidence base on accreditation (Chuang and Inder, 2009; Greenfield and Braithwaite, 2008).
Given the long-standing requirements for and widespread use of accreditation in clinical care and the limited, but promising evidence about the effectiveness of accreditation in improving some aspects of performance under certain conditions, the committee views it as desirable that the pub-
lic health community adopt a system of accreditation as a first step in the direction of guaranteeing a standard of quality across governmental public health agencies. Although the subject of public health accreditation has been under discussion for decades, and was noted in the 2003 IOM report on public health, a national accreditation effort began only in 2007 (with the founding of the Public Health Accreditation Board), beta-testing of accreditation standards was finalized in 2010, and the national launch of the program is scheduled for 2011. Implementing public health accreditation has several barriers, including the capacity of smaller agencies, resource requirements, and existing accreditation or similar programs at the state and local level. Some states, such as Illinois, Michigan, Minnesota, Missouri, North Carolina, and Washington operate their own accreditation or performance and capacity assessment and reporting systems for public health agencies (sometimes along with other government agencies) (Beitsch et al., 2007; Minnesota Department of Health, 2010; Public Health Law Network, 2010). Some of these states have enacted legislation that may deter the participation of their public health agencies in national accreditation because they require specific participation in state level accreditation or certification activities (see Table 2-1).
The committee believes that governmental public health agencies need to adopt an accreditation process to demonstrate minimum structural and
TABLE 2-1 The Relationship Between Existing State-Based Accreditation or Performance Assessment Systems and State Statutes
|State||Type of Program||Relationship to Statute|
|Illinois||Certification program required for counties wanting responsibility for delegated public health programs||Not addressed in statute, but supported under authorities of the state department of public health|
|Michigan||Accreditation program based on minimum program requirements and required to receive state funding||No specific references in statute, but agency draws general authority from statute|
|Missouri||Voluntary accreditation program for local public health agencies||Not specifically called for in legislation; independent accreditation body for resource reasons|
|North Carolina||Accreditation||Required by state legislation that even specifies three categories of accreditation status|
|Washington||An assessment program for each local health department or state public health program (Public Health Improvement Plan)||Required by legislation|
quality process capabilities as performance evaluation is extended to the governmental public health sector. States that have their own accreditation processes in place will ideally ensure that these resemble (i.e., require no less than) those set by the Public Health Accreditation Board. Although the committee recognizes that the national accreditation effort is not mature, continues to evolve, and must remain dynamic and responsive to a changing system, the committee urges all states to move in the direction of implementing the actual Public Health Accreditation standards no later than 2020. By calling for support of national public health accreditation, the committee calls on state legislatures or agencies that do not permit participation in national accreditation to modify their laws or requirements to allow, and then require their health departments to participate.
SOURCE: Beitsch et al., 2007.
Recommendation 3: The committee recommends that states revise their laws to require public health accreditation for state and local health departments through the Public Health Accreditation Board accreditation process.
Legal and Policy Capacity and Resources of Public Health Agencies
The issue of local agency capabilities and human resources is relevant to this report for two reasons. First, it may in part be remedied through legal means, by addressing statutory obstacles to consolidation or regionalization of agencies into, for example, multi-county health departments. Second, one crucial element that is lacking in many smaller health departments is legal, policy development, and policy analysis capability.
Addressing Capacity Challenges of Multiple Small Public Health Agencies
The local level of the public health infrastructure described above is highly fragmented among 2,794 local public health agencies (Fielding et al., 2010; Salinsky, 2010), many of which are small agencies with limited resources and capabilities in many areas, including legal and policy analysis capabilities. Sixty-four percent of public health agencies serve populations of 50,000 or less (Salinsky, 2010). The size of local public health agency is the strongest predictor of performance of the 10 EPHS, so combining resources and operations, and sharing different types of capacities (e.g., legal guidance and policy analysis) and specialized positions (e.g., epidemiologists) could help smaller agencies meet standards (Konkle, 2009; Libbey and Miyahara, 2011; Mays et al., 2006).
Frequent calls have been made for organizational restructuring (consolidation of services or merging of) public health agencies, including in the IOM report The Future of the Public’s Health in the 21st Century (2003b),
but multiple barriers exist, including concerns about diminished service and responsiveness to communities; loss of local control over the provision of public health services; questions about formal governance mechanisms that may be adopted; and the statutory requirements of local and state government (Baker and Koplan, 2002; IOM, 2003b). However, given the social, political, scientific, and disciplinary complexity of the contemporary public health landscape, and the exigencies imposed by great economic strain, the existence of myriad small agencies appears increasingly untenable and inefficient. Proposals have been made on different ways to reorganize local public health structure toward greater effectiveness. Understandably, given the difficulty and lack of resources invested in studying and interpreting findings on this subject, there is a dearth of research and evidence on optimal public health agency structures and related statutory and governance issues. The Robert Wood Johnson Foundation has included organizational restructuring on its list of possible areas of focus for its practice-based research networks program.5 In addition to experiments in some states, such as Connecticut, Kansas, and New Jersey, some research or analysis on the subject of agency structure has been conducted by Bates et al. (2010), Koh et al. (2008), Libbey and Miyahara (2011), Stoto and Morse (2008).6 This work has described rationales, barriers, and benefits of regionalization, and has reviewed evidence on structural changes in police and fire organizations, but findings have been inconsistent about effects of various arrangements. Other examples of organizational restructuring and associated debates may be found in the realm of environmental protection, such as regionalization of water systems.7 Koh and colleagues and Stoto and Morse have described the objectives of restructuring approaches, including improving local public health capacity, making more efficient use of funds and achieving economies of scale, and optimizing coordination, for example in managing social problems that are not bounded by municipal borders (Koh et al., 2008; Stoto and Morse, 2008). Libbey and Miyahara (2011) conducted a series of interviews with public health officials from Colorado, Wyoming, South Carolina, Connecticut, New Hampshire, Nebraska, and Illinois, and with the leaders of pertinent national organizations ranging from the U.S. Conference of Mayors to the National Governors’ Association. They found,
5 See for example the Foundation’s 2009 call for proposals on Public Health Practice-Based Research Networks (RWJF, 2009).
6 See for example HHS’s testimony before the assembly joint legislative committee on consolidation and shared government services (David Gurber: Testimony before the assembly joint legislative committee on consolidation and shared government services, 2006) and New Jersey Health Officers Association’s Testimony before the local unit alignment reorganization and consolidation commission (Peter N. Tabbot: Testimony before the local unit alignment reorganization and consolidation commission, 2008).
7 For an example, see Jesperson (2004).
in discussions about cross-jurisdictional sharing, “state and local public health interviewees tended to focus on efforts to collaborate as a means to accomplish a specific purpose or address a programmatic need, such as chronic disease prevention, rather than to create a shared generic capacity that could be applied to a broad range of issues as the jurisdictions saw fit” (Libbey and Miyahara, 2011, p. 4).
The issues of restructuring or at least of regionalization or other ways to expand local public health capacity have arisen most prominently in the context of emergency preparedness in public health. Disasters and major public health threats cast a bright light on public health agency capabilities and limitations. The National Association of City and County Health Officials has identified four structural and operational approaches to achieving optimal emergency preparedness functioning, but these may be more broadly useful in describing what is currently available in the field. These include (1) networking, consisting of sharing of plans and other information; (2) coordinating, consisting of joint planning among entities in a region; (3) standardizing, denoting uniformity across a region through mutual adoption of the same planning and communication tools and response procedures; and (4) centralizing, referring to bringing together resources under one entity (Koh et al., 2008).
Specific Requirements for Public Health Legal Capacity
The considerations brought forth in this chapter regarding critical needs in public health, such as updating or modernization of statutes and modification of public health infrastructure, clarify the need for dedicated legal counsel to serve as advisor to the agency and its leadership. Having dedicated in-house legal counsel is the gold standard in legal and policy capability, and ideally, counsel would serve the entire department, and preferably report to the health officer as opposed to the mayor or other executive (Monroe, 2010; Stier, 2010). However, the committee recognizes that an agency’s ability to retain and make the most use of in-house counsel depends on an agency’s size, resources, and agenda (e.g., does it have a policy orientation, or is it more intensely involved in service provision?). Legal counsel to a public health agency helps the agency carry out the core functions of “assessment, policy development, and assurance” as set forth in the agency’s enabling statutes, which typically focus on the agency’s role of mitigating morbidity and mortality (Lopez and Frieden, 2007). The roles of legal counsel to the health officer and agency include
- Legal advisor: Participates in policy planning discussions to advise on legal authority for, exposure to liability inherent in, and pro-
cedural requirements of a given course of action; and undertakes research and provides legal opinions
- Protector of confidentiality: Exercise vigilance to protect information in the custody of a health department from Freedom of Information Law8 (FOIL) requests and subpoenas, but also role as educator on the public health exception to Health Insurance Portability and Accessibility Act (HIPAA) (disclosures required by law, e.g., in the case of public health surveillance or epidemiologic investigations)
- Legislative and regulatory counsel: Ensure that changes to the health code or regulations enacted comply with the law (will analyze the statutory basis and legal viability of health officer’s proposals, will prepare language for the basis and purpose of the rule, and the actual language of the resolution)
- Enforcement: Agency exercises police powers by issuing valid and enforceable orders (compelling directly observed tuberculosis treatment, or ordering lead abatement in a rental residence with peeling lead paint and children ages 10 or younger).
- Miscellaneous duties: Public health counsel may be called on to carry out additional duties, including preparing contracts with outside organizations and vendors; advise in cases of employee-related conflicts of interest; handle disciplinary matters (other than criminal or corrupt behavior requiring the inspector general); investigate when human rights cases, such as involving discrimination or sexual harassment are brought against the department; and act as litigation liaison in cases of litigation against the health agency or by the local government (Lopez and Frieden, 2007).
Public health agencies access legal counsel in different ways, and their choices may in part be influenced by their size, governance structure, or both (IOM, 2010b; Pestronk, 2010). Some agencies have internal counsel that is part of the agency staff. Other agencies have external counsel that is drawn from the state attorney general’s office, state health department, county or city counsel, or simply private counsel. Some agencies may have both types. The type of legal counsel available to a public health officer may present challenges for the work of agencies. For example, legal counsel that serves another client (e.g., local government or the mayor) may be influenced by potentially conflicting agendas, political influences, timelines, and various priorities. This may also mean that counsel has expertise in public policy, but not necessarily specific public health knowledge or any appreciable understanding of public health law. Respondents to an Association of State and
8 In some states, this is known as the Open Records Act.
Territorial Health Officials survey reported that many local public health agencies have counsel that is only part-time and frequently lacks public health knowledge (ASTHO, 2008).
Although it is preferable for the public health counsel to report to the health officer, sometimes it may be necessary for the attorney to organizationally report to an outside entity such as an attorney general. Because the vast majority of attorneys general are independently elected, such arrangements raise the potential for the public health legal advisor to report to someone other than the person to whom the health officer reports, typically the chief executive. Adequate legal counsel needs to be readily accessible to be present at all high-level policy discussions in the department to facilitate clear understanding of the legal rationale underlying public health initiatives or interventions before issues become crises. Hiring attorneys with grant funds and embedding them within particular grant-funded programs to work in an isolated manner may also not be optimal.9 Moreover, the increasing availability of legal assistance from several existing national academic or not-for profit sources such as the Public Health Law Network, while beneficial, cannot take the place of an official legal advisor that is recognized by, and part of the same team as the health officer and the jurisdiction’s chief executive.
Public health agency legal counsel would require training in public health and in public health law, and should have knowledge and experience in the following areas:
- Laws that establish the public health agency and set forth its jurisdiction and authorities
- Programmatic aspects of the agency’s work
- Procedures and processes consistent with applicable laws and policies
Such experience can be obtained through adequate career ladders within a health department, through education or, ideally, a combination of both. One of the prerequisites for strengthening public health law capacity in health departments is the availability of legal training in schools of public health (e.g., for individuals wishing to pursue a J.D./M.P.H. degree and for other public health students) and in schools of law for individuals interested in public policy and especially health policy. Schools of law offer little on public health law, and the professional education resources available to train public health personnel and legal professionals on public
9 Personal communication with Wilfredo Lopez, Former General Counsel for Health to the New York City Department of Health and Mental Hygiene Current Counsel Emeritus to the New York City Health Department and Board of Health , May 19, 2011; and Steve M. Teutsch, Chief Science Officer Los Angeles County Public Health, May 19, 2011.
health law are generally limited (Goodman et al., 2002; IOM, 2003c; PHLA, 2004).
Recommendation 4: The committee recommends that every public health agency in the country have adequate access to dedicated governmental legal counsel with public health expertise.
The committee emphasizes “access to” to make it clear that it is not recommending a one-size-fits-all approach (e.g., a full-time public health attorney for every public health agency, no matter how small), but rather, that different strategies are needed to ensure that public health agencies can obtain quality legal advice from attorneys with pertinent expertise. For example, approaches such as regionalization will be needed to ensure that every public health agency possesses the needed capabilities, either on its own, or through collaborative linkages.
Even in today’s constrained fiscal environment, solutions to a shortage of adequate legal counsel could potentially be addressed by placing a lawyer from the attorney general’s office who is currently assigned to advise the health department within the health department thus facilitating close working relationships between counsel and practitioners.
In this section, the committee addresses central issues that emerge from the preceding discussion of the ways in which laws define and constrain the roles and authorities of the federal, state, and local levels of government. These include the duty and responsibility of each level of government pertaining to population health and the optimal level of government to act to create the most beneficial conditions for the population’s health.
Gostin has written that “[t]he level of government best situated for dealing with public health threats depends on the evidence identifying the nature and origin of the specific threat, the resources available to each unit for addressing the problem, and the probability of strategic success” (Gostin and Powers, 2006, p. 1056). Following logically from this is that national-level crises such as pandemics and bioterrorism threats require the substantial resources of the federal government, while a localized environmental threat may only require the involvement of the local public health agency.
Preemption is an area of considerable contention among the three levels of government because it involves a higher level of government restricting or eliminating a lower level of government’s regulatory ability on an issue (NPLAN and Public Health Law Center, 2010). The Constitution grants Congress and federal regulators broad authority to preempt, and states
have similarly broad powers to preempt municipalities (this may depend somewhat on how municipal powers are granted or revoked by the state) (Public Health Law Center, 2010).
“Floor” preemption refers to federal or state laws or regulations that set and enforce a minimum standard, and permit lower levels of government to not enact statutes or promulgate regulations that go above that minimal standard. For example, the Health Insurance Portability and Accessibility Act, HIPAA, sets a protective floor for privacy protection, but allows the states to enact stricter privacy standards. Ceiling preemption refers to federal or state laws or regulations that set a maximum standard that lower-level governments may not exceed. The recently passed federal Affordable Care Act effectively preempts state and local authorities from requiring menu labeling that differs from the federal standards in restaurants and vending machines covered by the federal law. Many public health advocates express concern with ceiling preemption because it does not allow ample scope for states and localities to innovate in the field of public health (NPLAN, 2009). Federal or state (ceiling) preemption of state and local authority can often be harmful from a public health standpoint because it can compromise the ability of public health practitioners to implement more stringent standards that may be important and well accepted in a local setting. Ceiling preemption also interferes with local control over local needs and with local-level accountability, and it could limit the ability of jurisdictions to meet the needs of constituents.
In a few areas of public health, federal preemption seems highly appropriate. For example, federal oversight of food manufacturing and processing may be appropriate because of its close nexus to interstate commerce. (However, localities regulate sanitary standards for and grant permits to food establishments.) Another example may be found in the federal ban on smoking on airplanes—the interstate nature of airline flight makes this area ideally suited to federal preemption. Ceiling preemption is appropriate in situations where national uniformity is absolutely necessary and only after the impact on public health and enforceability has been thoroughly assessed and mitigated. A good example of preemption with strong public health benefit is found in the 2011 U.S. Supreme Court case of Bruesewitz v. Wyeth LLC. In that case, the Court held that the National Childhood Vaccine Injury Act of 1986 preempts all claims against vaccine manufacturers for injuries or death purported to be related to a vaccine (NEDSS, 2001). The Court’s decision upheld the law that established the Vaccine Injury Compensation Program that requires vaccine safety and effectiveness while removing the threat of litigation from vaccine manufacturers.
A recent White House document cautioned against excessive agency preemption because “[t]hroughout our history, state and local governments have frequently protected health, safety, and the environment more
aggressively than has the national government.”10 Furthermore, the federal government does not have the police powers granted to states in the area of health and safety.
Another example where federal ceiling preemption is relevant is the content, packaging, or labeling of packaged foods that are manufactured or processed in one state and shipped across many states in packaged form for distribution and consumption. However, in an area such as public health that is primarily the province of a state’s police power, the need for preemption and the kind of preemption that may be warranted should be closely examined on a case-by-case basis, and the presumption should be that “floor” preemption is the more appropriate option in the area of public health. For example, one can argue that the preemption provisions put into the 1969 amendments to the Federal Cigarette Labeling and Advertising Act should not prohibit a local health department from requiring local cigarette retailers to post warning signs about the dangers of smoking. Such a requirement would not affect the manufacturing, packaging, or labeling of cigarettes produced in one state and transported in interstate commerce. Yet, a recent federal court decision struck down such a requirement in New York City on the grounds that it was preempted by the language of the federal statute.11 Here, the need for preemption would seem to be outweighed by the detrimental impact on public health and local control.
Preemption in the field of public health may also lead to non-enforcement of a preemptive federal standard. As discussed below, when a federal agency is given preemptive authority to regulate in an area that local public health agencies have a greater capacity and infrastructure to regulate, the result will likely be that the public health measure will not be enforced. In such instances preemption, and certainly “ceiling” preemption, needs to be avoided or arrangements for local enforcement should be put in place.
The use of law as a tool often requires an integrated strategic approach. When considering the appropriateness of preemption the impact on public health and enforceability must be assessed. As the federal government embarks on a regulatory review to ascertain if federal regulations unnecessarily hamper business activity, the committee urges that this principle be upheld and efforts be made to avoid creating new or interpreting existing preemptive laws in ways that may have unintended and unhealthful consequences.
Recommendation 5: The committee recommends that when the federal government regulates state authority, and the states regulate
10 See Memorandum for the Heads of Executive Departments and Agencies, Office of the Press Secretary, The White House, 2009 WL 1398319 (May 20, 2009).
11 See Grocery Corps v. New York City Health Department Case 1:10-cv-04392-JSR Document 63 (12-29-10).
local authority in the area of public health, their actions, wherever appropriate, should set minimum standards (floor preemption) allowing states and localities to further protect the health and safety of their inhabitants. Preemption should avoid language that hinders public health action.
The IOM recently recommended that the FDA modify its GRAS (Generally Regarded as Safe) standard relative to the amount of sodium in packaged food and in food prepared in restaurants (IOM, 2010a). Such an initiative would extend helpful public health protections nationally, but they would vest the FDA with regulatory authority over facilities that it has not regulated in the past. Food service establishments such as restaurants have historically been regulated and inspected by state and local health departments, and these agencies have well-established, albeit strained, inspection workforces in place. There is also an adjudicatory infrastructure, such as state courts or administrative tribunals, to enforce the sanitary laws and regulations under the auspices of public health agencies. Whether a state or local health department can enforce a federal health standard in a restaurant, for example, can be a legally complex matter potentially subject to interpretation. One example of such complexity can be found in Section 337(a) of the Food, Drug, and Cosmetics Act (FDCA), which in part reads, “Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of the chapter shall be by and in the name of the United States.” That is, only the federal government can enforce that chapter. However, subdivision (1) of subsection (b) specifies that, “A State may bring in its own name and within its jurisdiction proceedings for the civil enforcement, or to restrain violations of” eight listed sections of the FDCA. This provision would seem to authorize at least states, if not their municipal subdivisions, to enforce those listed sections in state courts and possibly state tribunals.
The intended point is that in times of increasing fiscal distress at all levels of government, protective federal health measures that are vested within the jurisdiction of a federal agency to enforce should not be allowed to go unheeded, unimplemented, and unenforced if there are cost-effective means to implement them. For example, if a state or local health department has a workforce that regularly inspects restaurants, and a judicial or administrative body to adjudicate violations, it would appear obvious that it would be more efficient for such an agency to enforce a federal standard than it would for the federal agency to create a new infrastructure to directly enforce a federal standard in a domain entirely new to it. Federal agencies must make every effort to leverage resources, and work cooperatively with the states to facilitate enforcement of federal standards by states or localities where the statutory or regulatory structure would allow. However, it
would not be helpful to mandate that states and localities assume this federal responsibility without adequate funding to do so.
Recommendation 6: The committee recommends that federal agencies, in collaboration with states, facilitate state and local enforcement of federal public health and safety standards, including the ability to use state or local courts or administrative bodies where appropriate. Federal, state, and local agencies should combine their resources, especially in areas where regulatory authority is vested in one level of government but enforcement capacity exists in another level.
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