Legal Capacity

Appropriately trained legal counsel needs to be readily accessible for all policy discussions in public health agencies to facilitate clear understanding of the legal basis for public health initiatives or interventions. The increasing availability of legal technical assistance from several existing national academic or not-for-profit sources, while beneficial, cannot take the place of an official legal advisor who is recognized by, and part of the same team as the health officer and the jurisdiction’s chief executive. The committee recognizes that many agencies are too small to have their own dedicated counsel, and that some type of resource-sharing arrangement, aside from broader restructuring such as consolidation or regionalization, would be needed.

Public health agency legal counsel requires training in public health and in public health law. Attorneys counseling public health agencies also must possess 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, and procedures and processes consistent with applicable laws and policies. Such training, knowledge, and experience can be obtained through adequate career ladders within a health department, through education or, ideally, through 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 (for example, for individuals wishing to pursue a JD/MPH, and for other public health students) and in schools of law for individuals interested in public policy, and especially its health dimensions.

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.

Federalism and Preemption

“Preemption occurs when a higher level of government restricts, or even eliminates, a lower level of government’s ability to regulate an issue” (NPLAN and Public health Law Center, 2010, p. 1). Preemption can advance or impede the achievement of population health objectives. States and localities play a vital and historic role in safeguarding the public’s health and safety. They can be “laboratories” of innovation, with greater flexibility than at the national level. Consequently, unless there are compelling reasons to the contrary, the federal government ought not preempt state and local authority in advancing the public’s health. A provision of the Affordable Care Act, for example, preempts state and local authority to require menu labeling in restaurants and vending machines that diverges from (e.g., is stricter than) the federal standards outlined in the Act. Although federal oversight of food manufacturing and processing may be appropriate because of its close nexus to interstate commerce, restaurants are locally regulated relative to sanitary standards and are locally permitted establishments. Other federal statutes, like the Health Insurance Portability and Accountability Act, create a national protective floor, but allow the states to enact stricter standards. This kind of “floor preemption” is usually preferable, enabling states and localities to enact more protective public health regulations.

Preemption in the field of public health may also lead to non-enforcement of a preemptive federal standard. When a federal agency is given preemptive authority to regulate in an area where local public health agencies have a greater capacity and infrastructure to regulate, the result is likely to be that the public health measure will not be enforced. In such instances preemption, and certainly “ceiling” preemption, should be avoided or arrangements for local enforcement should be put in place.

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 determine whether 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 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.

Some recent legislation, such as the Affordable Care Act’s establishment of menu labeling requirements, extends particular public health protections nationally, but also vests the Food and Drug Administration with regulatory authority over facilities it has not previously regulated, such as food service establishments that have been in the purview of state or local public health agencies. In these types of settings, the federal agency is unable to adequately enforce these requirements. Furthermore, federal efforts would be duplicative of state or local enforcement. Statutes and regulations need to allow public health agencies to enforce standards as necessary to protect and promote the public’s health. Collaborative efforts are needed to facilitate enforcement of federal standards by states or localities. However, mandating that states and localities assume this federal responsibility would not be helpful unless they have 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.

Intersectoral Laws and Policies That Contribute to the Public’s Health

Significant and compelling evidence indicates that policies enacted by government agencies beyond the health sector have substantial effects on the health of the population. A Health In All Policies approach requires policymakers, with the support of public health agencies, to adopt a collaborative and structured approach to consider the health effects of major public policies in all governmental sectors. This “all-of-government” approach offers the benefits of improving health while also achieving key objectives in other parts of government. Seen from the perspective of other sectors, HIAP approaches could enhance their ability to achieve their own objectives because improvements in population health can have wide-reaching effects on many aspects of society.

A multi-sector strategy that explicitly considers the impact of non-health sector action on U.S. health can create progress in that sector (e.g., transportation, agriculture) while simultaneously increasing the quality of life, longevity and economic productivity of the population.

Recommendation 7: The committee recommends that states and the federal government develop and employ a Health In All Policies (HIAP) approach to consider the health effects—both positive and negative—of major legislation, regulations, and other policies that could potentially have a meaningful impact on the public’s health.

As acknowledged in the committee’s report on measurement, there is no formal accountability process for private-sector entities that influence, for good or bad, the health outcomes for the community (IOM, 2011). This is significant because an estimated one-third of overall public health expenditures are incurred by nongovernmental public health partners, such as employers and schools (Mays et al., 2004). Although the committee proposed a measurement framework for accountability in its first report, it did not discuss in any detail the issues of governance and the types of organizational structures that may be useful in operationalizing the framework, especially outside governmental agencies.

As noted in the first report, private sector employers, community organizations, and other stakeholders in the multisectoral health system can contribute to health through their actions including through policy. These actions range from employee health and wellness initiatives to efforts to strengthen potentially health-enhancing features of communities. In its present discussion about law and policy, the committee uses the model of the National Prevention, Health Promotion, and Public Health Council and its associated public–private advisory group as a point of departure for envisioning how intersectoral action on population health could be planned and implemented across government agencies and between the public and private sectors.

Recommendation 8: The committee recommends that state and local governments

• create health councils of relevant government agencies convened under the auspices of the chief executive;
• engage multiple stakeholders in a planning process; and
• develop an ongoing, cross-sector, community health improvement plan informed by a HIAP approach. Stakeholders will advise in plan development and in monitoring its implementation.

Evidence to Inform Policy

The rationale for all population health interventions, including laws, must be based on the best evidence available while taking into consideration the strength of the available evidence, the level of uncertainty surrounding the evidence, and the risk of harm (economic or health-related) that arises from implementing or failing to implement. In some cases, the best available evidence may be limited. In those cases, new laws and judicial review of public health legal interventions will need to be built on sound theory and the opinion of content experts. Such limited evidence may be used to craft legal interventions when health threats and potential harms from inaction are large; when opportunity costs and unintended harms from action are within acceptable limits; and when the time or costs required for gathering more definitive evidence are substantial relative to the expected value of the additional evidence.

In some cases, assessments of health impact may not be necessary or useful, such as in the cases of modest-sized commercial developments in a community or policies that are largely unrelated to or expected to have negligible health impacts. In other cases, assessing the impact is imperative to determine a policy’s likely extent of negative or positive effects on population health and to take action to avert damaging consequences. Such cases would include several major health-consequential federal laws that require periodic reauthorization (e.g., the transportation bill).

Accurate and complete assessment of the outcomes and benefits of public health laws is complicated by the fact that the effects of laws are frequently distributed across multiple segments within the population, and affect multiple health and social endpoints over long periods of time. Thus, outcome measures for public health laws need to consider not only measures of mortality and morbidity, but also important intermediate outcome measures.

Legal interventions merit study for their effectiveness and comparative effectiveness (both against other legal intervention and compared to other kinds of interventions). Furthermore, a system of surveillance could be developed and pilot-tested to track the progress of efforts to expand the geographic reach of effective policies and laws, and to identify unmet needs for policy development and advocacy strategies. Although the administrative and methodological task of such research is challenging, the committee asserts as a general principle the obligation of policymakers to study, to whatever degree possible, the potential ramifications of policies in any sector that could substantially affect the health of the public.

Recommendation 9: The committee recommends that state and federal governments evaluate the health effects and costs of major legislation, regulations, and policies that could have a meaningful impact on health. This evaluation should occur before and after enactment.

This recommendation applies to both public health and non-public health agencies, working in concert. Before or after enactment, a scientific assessment would be conducted whenever possible. Before enactment of such policies, the vested authority (e.g., the public health agency) would study the potential health impact and/or cost-effectiveness. After enactment, the authority would review the health outcomes and costs associated with implementation of the policy and would, where appropriate, offer recommendations to the chief executive and legislature on changes that would improve outcomes.

Such evaluation and assessment could be conducted by the responsible agency, such as through National Environmental Policy Act (NEPA) requirements, or by the public health agency. Several models exist for requiring and conducting assessments of health policy impact, including government commissioning of assessments (e.g., actuarial analyses) of the impact of all health policies, and the requirements of NEPA. A knowledge base exists for crafting an accepted framework for evaluating the evidence of public policies, but an interdisciplinary team of experts is needed to build on the existing literature, review methodological challenges, and arrive at a consensus on preferred criteria.

Recommendation 10: The committee recommends that HHS convene relevant experts to enhance practical methodologies for assessing the strength of evidence regarding the health effects of public policies as well as to provide guidance on evidentiary standards to inform a rational process for translating evidence into policy.

Such guidance would include (1) methods for assessing the certainty of effectiveness (benefits and harms), and if a law or policy is effective, the magnitude of effect, for suitable populations; (2) methods for assessing the effectiveness of interventions (policies and programs) when used alone or in combination (i.e., their incremental and or synergistic benefits); and (3) priorities for and consideration of the contextual issues when determining whether (and where) to implement policies. The contextual issues to be considered include importance of the problem (severity, frequency, burden of disease, cost), feasibility (affordability, acceptability), availability of alternatives, demand, fairness (equity), preferences and values, cost-effectiveness, potential to advance other societal objectives, potential for harms, legal and ethical considerations, and administrative options.