Executive Summary

Regulating risks to human health and safety is an essential responsibility of government. At the federal level, agencies issue a wide range of regulations to protect human health and safety in areas that include improving air and water quality and safeguarding the food supply; reducing the risk of injury on the job, in transportation, and from consumer products; and minimizing exposures to toxic chemicals. Such regulations can substantially improve health and safety and typically impose costs, which may be considerable, to do so.

To ensure that these regulations address hazards to human life and health responsibly, fairly, and efficiently, policy makers and the general public need accurate and reliable information on the likely impacts of government actions. For economically significant rules, agencies are required to present an economic analysis—in the form of a benefit–cost analysis (BCA)—of the national impacts of alternative regulatory strategies and to assess the distribution of the impacts across different segments of society. These BCAs, which involve the monetary valuation of the impacts, are convenient because the index used to aggregate diverse types of improvements—to health and to ecosystems, for example—is money, the same unit in which costs are expressed. Such analyses help to inform analysts, decision makers, and the public at large about the benefits and costs of alternative interventions.

In 2003, the U.S. Office of Management and Budget (OMB) issued new guidance that requires agencies to supplement BCA with cost-effectiveness



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Valuing Health for Regulatory Cost-Effectiveness Analysis Executive Summary Regulating risks to human health and safety is an essential responsibility of government. At the federal level, agencies issue a wide range of regulations to protect human health and safety in areas that include improving air and water quality and safeguarding the food supply; reducing the risk of injury on the job, in transportation, and from consumer products; and minimizing exposures to toxic chemicals. Such regulations can substantially improve health and safety and typically impose costs, which may be considerable, to do so. To ensure that these regulations address hazards to human life and health responsibly, fairly, and efficiently, policy makers and the general public need accurate and reliable information on the likely impacts of government actions. For economically significant rules, agencies are required to present an economic analysis—in the form of a benefit–cost analysis (BCA)—of the national impacts of alternative regulatory strategies and to assess the distribution of the impacts across different segments of society. These BCAs, which involve the monetary valuation of the impacts, are convenient because the index used to aggregate diverse types of improvements—to health and to ecosystems, for example—is money, the same unit in which costs are expressed. Such analyses help to inform analysts, decision makers, and the public at large about the benefits and costs of alternative interventions. In 2003, the U.S. Office of Management and Budget (OMB) issued new guidance that requires agencies to supplement BCA with cost-effectiveness

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Valuing Health for Regulatory Cost-Effectiveness Analysis analysis (CEA) for economically significant health and safety regulations (OMB, 2003a). In CEA, the result is a ratio of monetary costs to a nonmonetary benefit measure, which can range from single-dimension measures, such as deaths averted, cases of illness or injury avoided, or tons of pollution reduced, to integrated measures such as health-adjusted life years (HALYs), which combine different types of health impacts in a single number. The single-dimension measures have the advantage of being relatively straightforward, but are of limited usefulness when more than one type of benefit is of interest. To address this problem, integrated measures that reflect both life expectancy and health-related quality of life (HRQL) traditionally have been developed and used in medical and public health studies. Such estimates are available for many more types of health effects than are estimates of the monetary measures used in BCA. This report of the Institute of Medicine’s (IOM’s) Committee to Evaluate Measures of Health Benefits for Environmental, Health, and Safety Regulation provides recommendations and guidance regarding the measurement of health and safety improvements using CEA. In response to a request from OMB, the Committee investigated alternative approaches for assessing health-related impacts in CEA by reviewing current federal agency practices; commissioning supporting research; reviewing the available literature; and completing three case studies of agency rulemakings. Based on its investigations, the Committee concludes that CEA provides useful information for the development of regulatory policies. At the same time, CEA (like BCA) poses significant challenges in this context. Some of these challenges are practical, relating to the time and cost of doing such analyses, while others relate to the strengths and limitations of the available data on the nature of the risk reductions and the measurement of their value. The magnitude of the impacts of major health and safety regulations argues for careful attention to the development of high-quality, unbiased analyses that include thorough documentation of their limitations. The Committee’s recommendations, both for selecting measures to value health outcomes in regulatory CEA and for supplementing these measures with other information, aim to ensure that the analytic results are accurate and reliable, and useful to a variety of audiences. After describing the charge to the Committee, this summary provides an overview of the key concepts and conclusions of this report and presents the Committee’s recommendations. The Charge to the Committee A consortium of federal sponsors charged the IOM Committee to identify current and proposed measures of health benefits for use in regulatory

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Valuing Health for Regulatory Cost-Effectiveness Analysis CEA, describe and evaluate these measures, recommend a subset of measures for use by federal regulatory agencies, and identify areas of research needed to enhance the use of such measures in regulatory analysis. Specifically, the Committee was asked to: Describe current practices among federal agencies for evaluating the costs and benefits of regulatory actions. Review measures for aggregating health improvements currently used in CEA, including specific instruments and assessment techniques for developing composite measures that combine consideration of longevity and HRQL. Develop criteria for choosing among measures potentially useful in the evaluation of health outcomes in regulatory CEA. Assess the various health benefit measures in terms of their data requirements, feasibility of application, theoretical validity, appropriateness for special populations (children, ethnic minorities), and ethical implications. Recommend measures appropriate for federal agency use in evaluating health outcomes in regulatory CEA, given the Committee’s criteria. Construct CEA case studies, using information from published BCAs, to illustrate the application of alternative health benefit measures in CEA and to compare the CEAs and BCAs. Discuss criteria for identifying regulations for which CEA will be informative. Recommend research that would improve the measurement of health benefits for regulatory CEAs. Regulatory Development and Economic Analysis Federal agencies are directed by Executive Order 12866 and other authorities to estimate and report the expected benefits of proposed major regulations in conjunction with their estimated costs (EOP, 1993). The current guidance for these analyses is provided in OMB Circular A-4, which addresses the use of both BCA and CEA to assess the effects of economically significant health and safety regulations (OMB, 2003a). The resulting analyses are considered, along with other factors, in determining whether to regulate a particular hazard and to select among regulatory strategies that differ in stringency or types of requirements. Researchers examining regulatory priorities also use the results of these analyses to compare the effectiveness of different types of interventions, for example, to compare the cost per life saved across investments in diverse areas such as reducing air pollution, increasing traffic safety, and applying new medical treatments.

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Valuing Health for Regulatory Cost-Effectiveness Analysis The starting point for assessing the costs of a proposed regulatory activity is identical for BCA and CEA; they use the same conceptual framework and estimation practices. On the benefits side, both BCA and CEA begin with a risk assessment, which involves estimating the change in the likelihood of illness, injury, or death associated with each regulatory option in comparison to a “without regulation” baseline. Regulations often result in small changes in individual risk, which become substantial when aggregated across all of those who are potentially affected. Most major regulations require the assessment of a variety of different health risks. For example, air pollution regulations reduce the incidence of several types of acute and chronic cardiovascular and respiratory conditions as well as associated mortality. In addition, some health and safety regulations provide nonhealth benefits, such as preserving natural resources. BCA is based on estimates of the monetary value of all risk reductions and other impacts. CEA, in contrast, uses nonmonetary effectiveness measures. When a regulation reduces the risks of different kinds of illness or injury, or of both fatal and nonfatal effects, analysts may use effectiveness measures that reflect impacts on both HRQL and longevity. These composite measures, referred to as HALYs or (more specifically) quality-adjusted life years (QALYs), convert different types of health effects to an integrated unit so that regulatory costs can be compared to a single measure of health-related effectiveness. Federal agencies have had substantial leeway in determining their specific approach to economic analysis. This flexibility is needed due to gaps and variability in the underlying research base as well as the substantial variation in the types of impacts associated with different regulations. Such analyses must often be conducted within tight time frames and with limited staff and budgetary resources (Robinson, 2004). The rulemaking schedule usually does not allow time for new valuation research; analysts generally rely on preexisting studies, analytic methods, and/or quantitative models. Some agencies have undertaken long-term efforts to develop approaches applicable across many of their regulations. Agencies have made substantial progress in implementing the 2003 OMB guidance requiring CEA and have completed HALY-based analyses. Some of these analyses use expert judgment to apply one of the available generic HRQL measurement tools (described later in this summary). Others use HRQL estimates from existing studies of similar health endpoints; this practice is often referred to as benefits transfer. Agencies are also conducting new valuation research to a limited extent. Because some agencies have used monetized HALY estimates in their regulatory analyses for many years, they are using the same approaches to develop effectiveness measures for CEA.

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Valuing Health for Regulatory Cost-Effectiveness Analysis Health-Related Effectiveness Measures While CEA based on integrated measures of effectiveness is just beginning to be more widely applied to regulatory decision making, HALYs and other mortality-based indicators have long been used to evaluate effectiveness in health care policy.1 Early analyses focused on the number of preventable deaths averted; now such analyses also routinely calculate years of life saved. The life-years approach provides more weight to averting deaths among persons who otherwise would have longer remaining life expectancies; an intervention that prevents deaths among children will generally lead to larger estimates of life years gained than an intervention that prevents deaths among adults. In recent years, measures have been developed to capture the effects of illness and injury on individual well-being prior to death. These impacts are usually represented with indexed estimates of HRQL, using a scale anchored by death (0) and perfect or optimal health (1.0). Adverse health effects associated with illness and injury can then be arrayed along this scale. The extent to which HRQL impacts are more or less important than changes in longevity depends on the nature of both the risk and the intervention. While the challenge of calculating composite measures is often attributed to the difficulty of valuing the changes in morbidity, changes in longevity may more significantly affect the results. The Committee’s own investigations suggest that the importance of mortality relative to HRQL effects varies substantially among regulatory interventions. Regardless, both mortality and HRQL impacts such as illness and disability are of interest to decision makers. HALYs address this interest by melding descriptive information about health status and longevity. QALYs are the most extensively developed and widely used HALY measure. As a measure of health, a QALY is a relatively simple building block that can be applied at both individual and population levels. HALY or QALY estimates for various scenarios are normally constructed in three steps: Describe or characterize health states or disease conditions and estimate their expected duration. Value the health states in comparison to other health states. Multiply the values for different health states by estimates of the duration in each state. 1   See Gold et al. (1996b) for recommendations for best practices in CEA for health and medicine.

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Valuing Health for Regulatory Cost-Effectiveness Analysis When used in policy or regulatory analysis, the resulting values can then be multiplied by the number of averted cases of each type to determine the total impact. For these estimates to be meaningful and useful, the characterization and valuation of the health states of interest should be part of a consistent set of estimates. Researchers may either survey a sample of individuals directly to elicit values for the health states of concern or use one of several available generic HRQL indexes, which are preference-weighted health state classification systems. The EuroQol-5D, Health Utilities Index, Quality of Well-Being Scale, and the SF-6D are among the most common such instruments. Generic indexes provide established values (based on surveys of general or community populations) for different states of health described in terms of the impacts of an overall condition on aspects of functioning and experience such as mobility, self-care, and pain. Once the characteristics of the health state of interest are matched to the functional and experiential domains used in the specific index, an HRQL index value can be calculated based on the results of the instrument’s underlying valuation survey. Regardless of whether the index used is generic or specially designed for a particular study, the index values for health states derived from valuation surveys are based on information about individuals’ relative preferences for different states of health. The three most commonly used elicitation techniques involve asking survey respondents to do the following: Trade off the time spent in different health states, Consider the trade-off between perfect health and the risks of different adverse health effects (standard gamble methods), or Locate different health states on a visual scale. A fourth, less developed, elicitation approach that attempts to address societal values (rather than the respondent’s preferences for own health) is the person trade-off method. This approach asks respondents to make choices between different health improvements for distinct groups of people. Each of these methods for establishing health state index values has strengths and weaknesses. All of them consider only relative preferences for different health states (not preferences for health compared to other aspects of welfare) and generally assume that the value elicited for a particular health state is the same regardless of its duration. When estimating HALYs for regulatory assessments, analysts may choose to use existing research or to conduct new primary research. In either case, the research may apply one of the generic indexes or be based on index values estimated specifically for the particular study. If a generic index is used, the research may rely on either patients or experts to describe

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Valuing Health for Regulatory Cost-Effectiveness Analysis or characterize the health states of interest using the index’s classification scheme. (In either case, however, the values attached to the health states characterized should represent those of the population affected by the policy or regulation.) Related decisions will depend on the nature of the health effects under consideration, as well as on the quality and suitability of available research. Judging the adequacy of a given approach for a particular regulatory application requires considering the match between the risks and population assessed in the study and the effects of the regulatory intervention. Criteria for Selecting Integrated Measures of Health Impacts for Regulatory Analysis The Committee developed the following criteria for applying HALYs in regulatory analysis. First, the measure should be applicable to the range of health states and conditions considered in regulatory analysis. Second, the measure should be sensitive or responsive to change, and not exhibit floor or ceiling effects within the range of measured values. Third, values for health states should be derived from a sample of adequate size that is representative of the population affected by the costs and benefits of the regulatory intervention. Fourth, the measure should be acceptable to users and to the public, including those involved or interested in the regulatory development process. Fifth, the measure should be practical in the regulatory context and as inexpensive to use as is compatible with other objectives. No single QALY instrument or estimation strategy is clearly superior to others on all of these criteria. Analysts and decision makers must exercise judgment in selecting an approach for a particular regulatory analysis. The Committee concludes that health-related CEA is both feasible and informative in the analysis of any regulation for which health benefits have been estimated. Ethically Informed Decisions Both BCA and CEA focus on the efficient allocation of economic resources. Implicit in each approach are value judgments regarding the appropriate weighting of different types of effects. It is important that the users of BCA and CEA understand these ethical assumptions and consider their implications when making decisions. For CEA, ethical considerations

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Valuing Health for Regulatory Cost-Effectiveness Analysis include concerns that are inherent in the QALY measure, along with aspects of regulatory impacts that the QALY measure does not capture. By itself, a QALY-based CEA cannot address an important and difficult set of distributive questions and choices, including how much priority to give to the sickest or the worst off in valuing health effects; when to allow modest benefits to many people to outweigh significant benefits to fewer; and when to allocate resources to produce “best outcomes” as compared with giving more people fair chances to receive some benefit. For example, some health risks subject to regulation disproportionately affect those in poor health already. This raises the question of whether it is appropriate to weight health improvements differently for persons with and without impaired health, given that “postregulatory” health status will be worse for the former than for the latter. The summary, the aggregate nature of a net benefit estimate or a cost-effectiveness ratio implies that it will not provide information on the distribution of regulatory benefits or costs in a population; such measures sum the effects on those who gain or lose under the regulation. A QALY is valued the same (e.g., at 1.0 if in perfect or optimal health) regardless of who is affected. Therefore, one of the most difficult issues to address in structuring a regulatory CEA is whether and how to disaggregate impacts that occur in different components of the general population. The basic values embedded in our political system and reflected in federal regulatory guidance require that decision makers consider the distributional implications of regulations. As a result, such considerations must be explicitly introduced into the process of developing and issuing regulations along with the summary analytic results. The most basic normative commitment from using QALYs as an outcome measure in CEA is valuing some form of life years, rather than the number of lives saved. This difference between treating all deaths prevented equivalently and estimating losses and gains in longevity across the affected population is illustrated by an example in Table ES-1. The table shows that the use of lives as an impact measure assigns the same value to preventable mortality regardless of whether the individual is middle aged or elderly, while the use of life years shows that such mortality more significantly affects younger individuals. Adjusting for HRQL increases the relative differences between older and younger people slightly, as shown by the ratios in the rows for life year and QALY estimates in Table ES-1. The standard practice of discounting to reflect the timing of the impacts and the general preference for receiving gains sooner and deferring losses, reduces this relative difference considerably, however. Summary BCA and CEA measures also omit both costs and benefits that cannot be easily expressed in numerical terms, either because the scientific research base is inadequate to support quantified estimates or because

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Valuing Health for Regulatory Cost-Effectiveness Analysis TABLE ES-1 Lives, Life Years, and Quality-Adjusted Life Years (QALYs)   Preventable Deaths Life Yearsa QALYsb Age (in years) 5 1 73 65 35 1 44 37 75 1 12 9.1 Ratio of values by age 5/35 1 1.7 1.8 5/75 1 6.1 7.1 35/75 1 3.7 4.1 NOTE: These calculations are undiscounted. Discounting future life years and QALYs diminishes the differences between results for younger and older persons. aBased on age-specific life expectancy for 2002 (NCHS, 2005). bBased on EQ-5D norms for the U.S. population (Hanmer et al., 2006). values have not been developed for those impacts. For example, it may be difficult to estimate the impact of a regulation on endangered species or to determine the value of reduced species diversity. Similarly, certain aspects of the risks, such as the extent to which individuals dread the prospect of lingering illness, typically are not captured in valuation. QALY-based CEA tracks only impacts on health and longevity, and it cannot account for the nature of the risk itself and societal perceptions and values related to it. Knowledge of risks, degree of personal control over risk exposures, and other features of risks may affect the justification for regulatory action as well as the value placed on the resulting risk reductions. These risk features deserve explicit consideration by decision makers alongside the summary results of economic analyses. The failure to account for the distinctive features of risks may in some circumstances lead to misinterpretation when cost-effectiveness ratios for different regulations are compared. CEA is a tool for determining the relative efficiency of different interventions to achieve a defined objective, such as maximizing life-year or QALY gains. Ignoring other qualitative features of the risks involved or the contexts of the risks may well produce misleading comparisons of different regulatory options or interventions and lead to poor societal and regulatory decisions. Conclusions and Recommendations The Committee’s investigations, analyses, and deliberations led to the following overarching conclusions.

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Valuing Health for Regulatory Cost-Effectiveness Analysis CEA, like BCA, offers a useful tool for the development and assessment of regulatory interventions to promote human health and safety. Different measures of effectiveness, including single-dimension units such as life years and units that combine estimates of HRQL and longevity such as QALYs, each provide useful perspectives on regulatory impacts. As in the case of BCA, the results of CEA for regulatory interventions are not by themselves sufficient for informed regulatory decisions. The results of economic analyses are routinely supplemented with other types of research and with information from the public to provide a more comprehensive assessment of the advantages and disadvantages of different regulatory strategies. These other sources of information are a necessary part of the decision-making process. Although it is feasible to apply CEA to regulatory interventions today, additional data and methodological improvements would enhance the quality and usefulness of such analyses. Federal regulatory agencies rely on disparate types of data and contemplate widely varying interventions and types of impacts. Consequently, they use diverse approaches to value health-related benefits. Greater consistency in the reporting of assumptions, data elements, and analytic methods and in presenting the resulting estimates of costs and benefits and summary measures (net benefits, cost-effectiveness) would increase the transparency and comparability of the results and lead to better informed policy decisions. Comparisons of cost-effectiveness ratios for diverse interventions can be misleading if they do not include information that highlights differences in methods, unmeasured effects, and distributional impacts across interventions. These conclusions led the Committee to develop recommendations in four areas: selecting integrated measures of effectiveness; constructing and reporting cost-effectiveness ratios; presenting information for regulatory decision making; and collecting data and conducting research to improve HRQL measurement for regulatory CEA. Selecting Integrated Measures of Effectiveness The QALY is the best measure at present on which to standardize HALY estimation because of its widespread use, flexibility, and relative simplicity. QALY estimates may be based on newly collected information or on previously conducted research. The Committee recognizes that, in the near term, regulatory agencies are likely to rely on published research and to adopt relatively simple approaches for developing QALY estimates.

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Valuing Health for Regulatory Cost-Effectiveness Analysis Recommendation 1: Regulatory CEAs that integrate morbidity and mortality impacts in a single effectiveness measure should use the QALY to represent net health effects. QALY estimates should be based, to the greatest possible extent, on research that considers the risk characteristics addressed and the population affected by the regulatory intervention. The index values estimated for health conditions or health states of interest should be based on information from the population affected by the costs, benefits, or other impacts of the regulatory intervention, which for most economically significant regulations will be best represented by the general U.S. population. In the absence of direct preference elicitation for health conditions of interest from the affected population, QALY estimates should be based on well-developed, generally accepted, and widely used generic HRQL indexes, whose valuation is based on general population samples. The characterization of the health states or conditions of interest using generic HRQL indexes should be based on information obtained from people who are familiar with the conditions, such as patients. Constructing and Reporting Cost-Effectiveness Ratios A central objective of the Committee’s recommendations is to improve the quality and comprehensiveness of the information available to policy makers to promote well-informed regulatory decisions. We believe this objective can be met through the provision of measures of cost-effectiveness that are standardized to the extent practical within and across agencies. Because different measures have particular advantages and limitations, all regulatory CEAs should report more than one measure of effectiveness. Reporting a variety of measures provides decision makers with a more comprehensive understanding of the impacts of different regulatory choices and responds to different questions. It is also important to increase the transparency of the presentation of analytic assumptions, methods, and results in regulatory analyses. Recommendation 2: Regulatory analyses should report four measures of cost-effectiveness: Compliance cost per death averted using the net number of deaths averted as the outcome measure. Compliance cost per life year gained using the net change in years of preventable mortality as the outcome measure.

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Valuing Health for Regulatory Cost-Effectiveness Analysis A health-benefits-only ratio using the net change in QALYs as the outcome measure. This ratio focuses on the value of health benefits. Costs would include those associated with compliance, offset by estimates of the net changes in health care treatment costs associated with the outcomes included in the QALY measure. A comprehensive ratio using QALYs as the outcome measure and incorporating the value of other benefits as offsets to compliance costs. The cost measure would incorporate both net changes in health care treatment costs and the value of any monetized nonhealth benefits as offsets. Recommendation 3: The life-year and QALY estimates used in regulatory analyses should reflect actual population health as closely as possible, comparing the predicted HRQL and life expectancy of the affected population in the absence of the intervention (i.e., the regulatory baseline) to the predicted postintervention HRQL and health-adjusted life expectancy. Recommendation 4: Incremental cost-effectiveness ratios are generally the most useful summary measure for comparing different regulatory interventions. Such ratios are not meaningful, however, for interventions that reduce both costs and risks. Options that are dominated (i.e., have higher costs and lower effectiveness) also should not be included in the incremental comparisons. Recommendation 5: In addition to reporting effects in the aggregate, regulatory analyses should report QALY impacts separately for each health endpoint. Impacts should also be reported in terms of single-dimension measures such as avoided cases of disease and cause-specific mortality. Recommendation 6: The reporting of all CEA results should be accompanied by information on related uncertainties and on nonquantified effects. Recommendation 7: Regulatory analyses should not assign monetary values to estimates of HALYs as a method for valuing health states. Presenting Information Needed for Regulatory Decision Making Regardless of whether it relies on BCA or CEA, economic analysis is but one of many inputs into the policy-making process. The Committee endorses the emphasis in current policy guidance on considering the distribution of impacts, the ethical implications of different options, and the implications of nonquantifiable effects, and believes the results of CEA

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Valuing Health for Regulatory Cost-Effectiveness Analysis should continue to be one of many elements considered in a deliberative policy development process. Numbers can be very powerful in policy contexts; thus it is important that decision makers not only consider the results of economic analyses but also engage in deliberations with all constituencies and affected parties. Recommendation 8: The regulatory decision-making process should explicitly address and incorporate the distributional, ethical, and other implications of a proposed intervention along with the quantified results of BCA and CEA. Comparisons of different interventions should highlight these distinctive features of the interventions and also any methodological differences, both in the case of cost-effectiveness ratios and of estimates of net benefits. Recommendation 9: Because of the many value dimensions encompassed by societal decisions regarding the mitigation of risks to health and safety and the far-ranging impacts of such decisions, policy makers and program administrators should work to ensure the substantive involvement of a broad range of individuals and groups at all stages of policy development for regulating risks. Collecting Data and Conducting Research to Improve HRQL Measurement and Regulatory CEA Although useful for regulatory analysis, the data and methods currently available for measuring and valuing health in CEA have limitations that should be addressed by a long-term research agenda. The areas where additional routine data collection and research are most needed and likely to be fruitful include the following. Recommendation 10: A high research priority should be improving the data used to assess the health risks (effects on incidence of particular types of illness, injuries, and deaths, and the duration and latency of effects) addressed by regulatory actions. Recommendation 11: The Department of Health and Human Services (DHHS) and other federal agencies should collect HRQL information through routinely administered population health surveys and other major studies and data collection efforts related to risk assessment and monitoring. Recommendation 12: DHHS should coordinate, with the involvement of federal regulatory offices and agencies, the development of an integrated research agenda to improve the quality, applicability, and breadth of HRQL

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Valuing Health for Regulatory Cost-Effectiveness Analysis measures for use in regulatory CEA. The Committee identifies the following areas as priorities for research: Methods for eliciting societal values for investments in health (such as person trade-off techniques). Methods for measuring children’s HRQL, including characterization of the impact of illness and injury and the valuation of these impacts. Methods to correlate QALY values based on different generic HRQL indexes so that estimates from different underlying valuation surveys are consistent and can be used in the same analysis. Given the substantial impact of major health and safety regulations on the national economy and societal welfare, it is imperative that related decisions be based on high-quality analyses, the results and limitations of which are clearly communicated in a form that is understandable by a wide variety of audiences. Because these rules vary significantly in the type of intervention, the characteristics of the affected population, and the characteristics of the risks addressed, benefit measures are needed that can apply to a broad range of health scenarios. These measures should be supplemented by discussion of any attributes of the scenarios that are not captured in the quantitative measures. Furthermore, the substantial uncertainty that accompanies the risk analysis that underlies the calculation of health-related effects, along with the uncertainty about the preference weighting of QALYs, should be conveyed in sensitivity and uncertainty analyses. Finally, the process of developing and issuing regulations should be publicly accessible and based on information (including that used in BCA and CEA) that is comprehensible and communicated to a wide audience. Policy makers should facilitate the involvement of affected individuals, populations, and organizations in deliberations about health and safety risks and proposed interventions. Presenting the information for regulatory analysis fully and consistently is an important aspect of an accountable policy process.