Index

A

Abbreviated Injury Scale (AIS), 216, 218, 222–223, 234

Acceptability of risks, dimensions of value affecting, 140–143

Accounting statements, 313–315

categories of benefits and costs, 313

effects on state, local, and tribal governments, small business, wages and economic growth, 315

precision of estimates, 314

qualitative benefits and costs, 313

quantifying and monetizing benefits and costs, 313

separate reporting of transfers, 314–315

treatment of benefits and costs over time, 313–314

treatment of risk and uncertainty, 314

Activities of daily living (ADL), 115n, 126n, 318

Administrative guidance, history of regulatory analysis, 22

Administrative Procedure Act (APA), 21

Air quality, 145

improving, 1

AIS. See Abbreviated Injury Scale

Alternative assumptions, 310

Alternative HALY metrics for regulatory CEA, 86–91

choosing a HALY measure for regulatory analysis, 91

disability-adjusted life years, 88–90

healthy year equivalents, 88

quality-adjusted life years, 86–88

saved-young-life equivalents, 90–91

Alternative regulatory approaches, 266–269

different choices defined by statute, 266

different compliance dates, 266

different degrees of stringency, 267

different enforcement methods, 266

different requirements for different geographic regions, 267

different requirements for different sized firms, 267

informational measures rather than regulation, 268–269

market-oriented approaches rather than

direct controls, 268

performance standards rather than design standards, 267

Alternatives, evaluation of, 277–278

American Petroleum Institute v. OSHA, 45

Analytical approaches, 269–275

benefit–cost analysis, 269–270

cost-effectiveness analysis (CEA), 270–272



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Valuing Health for Regulatory Cost-Effectiveness Analysis Index A Abbreviated Injury Scale (AIS), 216, 218, 222–223, 234 Acceptability of risks, dimensions of value affecting, 140–143 Accounting statements, 313–315 categories of benefits and costs, 313 effects on state, local, and tribal governments, small business, wages and economic growth, 315 precision of estimates, 314 qualitative benefits and costs, 313 quantifying and monetizing benefits and costs, 313 separate reporting of transfers, 314–315 treatment of benefits and costs over time, 313–314 treatment of risk and uncertainty, 314 Activities of daily living (ADL), 115n, 126n, 318 Administrative guidance, history of regulatory analysis, 22 Administrative Procedure Act (APA), 21 Air quality, 145 improving, 1 AIS. See Abbreviated Injury Scale Alternative assumptions, 310 Alternative HALY metrics for regulatory CEA, 86–91 choosing a HALY measure for regulatory analysis, 91 disability-adjusted life years, 88–90 healthy year equivalents, 88 quality-adjusted life years, 86–88 saved-young-life equivalents, 90–91 Alternative regulatory approaches, 266–269 different choices defined by statute, 266 different compliance dates, 266 different degrees of stringency, 267 different enforcement methods, 266 different requirements for different geographic regions, 267 different requirements for different sized firms, 267 informational measures rather than regulation, 268–269 market-oriented approaches rather than direct controls, 268 performance standards rather than design standards, 267 Alternatives, evaluation of, 277–278 American Petroleum Institute v. OSHA, 45 Analytical approaches, 269–275 benefit–cost analysis, 269–270 cost-effectiveness analysis (CEA), 270–272

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Valuing Health for Regulatory Cost-Effectiveness Analysis distributional effects, 274–275 the effectiveness metric for public health and safety rulemakings, 272–274 scope of, 275 to unfunded mandates, 311 Ancillary benefits and countervailing risks, 289–290 Anderson, Henry A., 326–327 Annualized values, 212 APA. See Administrative Procedure Act Applicability issues, 117 Assessment of Quality of Life (AQoL) instrument, 126n Assignment of health states by experts or other proxies, 106–109 expert assignment of health states using generic HRQL instruments, 110–111 Asymmetric information, 263–264 Availability issues, 98–102 Averaging, banking and/or trading (ABT) of credits, 268 B Bacillus cereus, 204–210 Baseline, developing, 276–277 BAT. See “Best available technology” Bayesian methods, 318 Benefit–cost analysis (BCA), 1–4, 7, 10–12, 15–22, 27–59, 64, 67, 129–134, 143–146, 151, 157, 168–174, 178–182, 188–189, 194, 197, 204, 214, 217, 229, 238, 241, 269–272, 292, 300, 318 calculation of net benefits, 31 valuation approach, 29–30 Benefit point transfer, 289 Benefits, 4, 318 Benefits analysis guidelines, 51–55 monetized health-adjusted life years in benefit–cost analysis, 53 OMB criteria for evaluating stated preference studies, 54 Benefits and costs ancillary benefits and countervailing risks, 289–290 benefit-transfer methods, 287–289 categories of, 313 developing estimates of, 279–296 discount rates, 296–303 identifying and measuring, 275–310 methods for treating non-monetized, 290–292 monetizing health and safety, 292–296 other key considerations, 303–305 qualitative, 313 quantifying and monetizing, 291–292, 313 revealed preference methods, 282–285 stated preference methods, 285–287 treatment of uncertainty, 305–310 treatment over time, 313–314 Benefits transfer, 4, 116–121, 318 methods for, 287–289 BenMAP model, 229 “Best available technology” (BAT), 44 Best practices, 258 in stated preference surveys and benefits transfer, 125 Board on Environmental Studies and Toxicology, 121 Brauer, Carmen, 120 “Break-even” analysis, 260 Bush, George H.W., 22 Bush, George W., 22 C Calculation of cost-effectiveness, 36–37 of health gains, 149–151 Carter, Jimmy, 22 Case study analytic approach, 193–244 conclusion, 240–241 EPA’s nonroad engine air emissions regulation, 228–240 FDA’s juice processing regulation, 204–215 general approach, 195–203 NHTSA estimates of annual quantified benefits, 218 NHTSA’s child restraints regulation, 215–228 purpose and scope, 193–195 Case study process, 196 Category rating (CR), 77–81, 98 CDS. See Crashworthiness Data System CEA. See Cost-effectiveness analysis CEA Registry, 118, 228, 235, 240 Center for Risk Analysis, 117 “Cessation lag,” 300 CFR. See Code of Federal Regulations

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Valuing Health for Regulatory Cost-Effectiveness Analysis Charge to the committee, 2–3, 16–19 background, 16–18 OMB’s rationale for requiring CEA as part of regulatory analysis, 17 the task, 18–19 Child restraints anchoring, 145 Children, 146–148, 156 Choices, different, defined by statute, 266 Chronic condition HRQL values, catalogues of, 111–113 Circular A-4, 3, 16, 23, 40, 50, 53–56, 62–65, 134, 146, 152–154, 174, 194–196, 217, 258–315 accounting statement, 313–315 alternative regulatory approaches, 266–269 analytical approaches, 269–275 effective date, 315 identifying and measuring benefits and costs, 275–310 introduction, 259–261 key components of, 50 need for Federal regulatory action, 261–265 regulatory analysis, 258–259 specialized analytical requirements, 310–313 Clean Air Act, 43–44, 55 Clean Air Interstate Rule, 58, 156 Clinton, Bill, 22, 25 Code of Federal Regulations (CFR), 21 COI. See Cost of illness Collecting data and conducting research to improve HRQL measurement and regulatory CEA, 13–14 recommendation 10, 13 recommendation 11, 13 recommendation 12, 13–14 Committee on Estimating the Health-Risk-Reduction Benefits of Proposed Air Pollution Regulations, 18 Committee on Summary Measures of Population Health, 18 Committee to Evaluate Measures of Health Benefits for Environmental, Health, and Safety Regulation, 2, 5, 15, 40, 94, 193 Common property resource and public good, externality of, 262–263 Communicating methods and results, 64–65 “Community” index values, 93, 136 Comparisons of cost-effectiveness ratios, 176 of key features of BCA and CEA, 39 to “with condition” values based on expert assignment, 202 to “with condition” values based on patient self-assessments, 202–203 Comparisons among elicitation methods, 81–86 empirical validity, 83–85 feasibility, 81–82 reliability, 82–83 theoretical reliability, 83 Competitive Enterprise Institute v. NHTSA, 49–50 Compliance cost per death averted, 167, 170 per life year gained, 167, 170 Compliance dates, different, 266 Comprehensive ratio, 167, 170–171 Condition-specific indexes and applications to special populations, 102–106 HRQL measurement for children, 106–107 special populations, 104–105 Congress, 42 Construct validity, 318 Consumer Product Safety Act, 43 Consumer Product Safety Commission (CPSC), 26, 46 Consumer surpluses, 281 Content validity, 70, 318 Contingent valuation approach, 125, 318 “Control of Emissions from Nonroad Diesel Engines,” 303 Convergent validity, 318 Correlations, 318 and conversions among HRQL measures, 123–124 and cross-walks of HRQL measures, 126–127 Corrosion Proof Fittings v. EPA, 45 Cost, 319 Cost-effectiveness analysis (CEA), 1–4, 7–22, 27–28, 31–41, 46–58, 64–73, 83–88, 92, 103–105, 109–110, 116–119, 123–189, 194, 214, 217, 228, 236–241, 270–272, 285, 292, 300, 319 calculation of, 36–37 valuation approach, 32–36

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Valuing Health for Regulatory Cost-Effectiveness Analysis Cost-effectiveness ratios, 10, 212–215, 237–240 comparison of, 154–155, 176 compliance cost per death averted, 170 compliance cost per life year gained, 170 components of, 168 comprehensive ratio, 170–171 constructing and reporting, 11–12, 167–181 defining, 171–173 disaggregated impacts, 177 examples of, 169 examples of cost-effectiveness ratios, 169 health-benefits-only ratio, 170 nonmonetized benefits of the Environmental Protection Agency’s nonroad diesel rule, 179–180 recommendation 2, 11–12, 167–173 recommendation 3, 12, 173–174 recommendation 4, 12, 174–175 recommendation 5, 12, 175–177 recommendation 6, 12, 177–180 recommendation 7, 12, 181 Cost of illness (COI), 30, 33n, 319 Cost per life year ($/LY), 73 Cost per quality adjusted life year ($/QALY), 36, 73 CPSC. See Consumer Product Safety Commission CR. See Category rating Crashworthiness Data System (CDS), 218 Criteria for selecting integrated effectiveness measures for regulatory CEA, 7, 162 Criteria for selecting HALY metrics for regulatory CEA, 68–72 standard performance criteria for HRQL instruments, 70 Criterion validity, 319 Cryptosporidium parvum, 204–210 Current practices for regulatory analysis, 50–65 benefits analysis guidelines, 51–55 current valuation practices, 55–62 key analytic requirements of OMB guidelines, 51 other guidelines relavant to CEA, 62–65 Current valuation practices, 55–62 EPA’s morbidity inclusive life year (MILY) approach, 60–61 FDA’s benefit valuation approach, 59 maximum abbreviated injury scale (MAIS) categories used in NHTSA analyses, 58 NHTSA’s equivalent lives saved (ELS) approach, 60–61 quantified benefits of EPA’s nonroad diesel rule, 56 quantified benefits of the FDA’s juice processing rule, 57 D DALY. See Disability-adjusted life year Data collection and research needed to improve HRQL measurement and CEA for regulatory decision making, 184–188 direct and indirect uses of data, 283–285 recommendation 10, 185–186 recommendation 11, 186 recommendation 12, 187–188 Deaths averted, defined, 171 Decision analysis, 319 Decomposed valuation approach, 97 Degrees of stringency, different, 267 Delayed effects, risks with, 142 “Delphi methods,” 111, 309, 319 Department of Agriculture, 58 Department of Energy (DOE), 278 Department of Health and Human Services (DHHS), 13, 116, 186–187 Direct health care costs, 33 Direct non-health care costs, 33 Direct rating, category rating and visual analogue scales, 79–80 Direct uses of market data, 283–284 Disability, defined, 319 Disability-adjusted life year (DALY), 80–81, 88–91, 319 the WHO’s DALY, 89 Disaggregated impacts, 176–177 Disclosure, full, 314 Discount rates, 296–303 intergenerational discounting, 301–302 the rationale for discounting, 297–298 real discount rates of 3 percent and 7 percent, 298–300 social, 323 time preference for health-related benefits and costs, 300–301 time preference for non-monetized benefits and costs, 302–303

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Valuing Health for Regulatory Cost-Effectiveness Analysis Discounting, 152–154, 209, 319 the rationale for, 297–298 and timing of impacts, 63, 153 Distributional concerns about risks and regulatory interventions, 144–155, 183 calculation of health gains, 149–151 children, 146–148 comparing cost-effectiveness ratios, 154–155 distributional considerations in regulatory decisions, 147 population health data and subgroups, 148–149 risk-related considerations for regulatory decisions, 145 the treatment of future generations in CEA, 151–154 Distributional effects, 274–275 Documentation, 70 DOE. See Department of Energy Domains, 34, 98–102, 319 and number of attribute levels for generic HRQL indexes, 95 Double-counting issues, 30, 62 E Economic analysis, the role of, 19–26 Economic efficiency, 319–320 Economic regulation, the presumption against, 265 Economic values of uncertain outcomes, 310 “Economically significant” regulations, defining, 24 Effective date, 315 Effectiveness constructing measures of, 272 selecting integrated measures of, 10–11, 272–273 Effectiveness metric, for public health and safety rulemakings, 272–274 ELS. See Equivalent lives saved Emission reduction benefits, non-monetized, 303 Empirical validity, 83–85 mean valuations for 13 EQ-5D health states with four estimation methods, 85 the TTO method and discounting, 84 Endpoints, 207 describing, 197–198 Energy impacts, 312–313 Enforcement, 157 different methods for, 266 Environmental impact statements, 312 Environmental Protection Agency (EPA), 43–48, 58, 62, 101, 117, 120, 139, 143, 147–151, 156, 178, 194–199, 202, 228–232, 237–241, 276, 299, 303 New Source Review program, 291 Science Advisory Board, 294–295 violating TSCA, 48 EO. See Executive Orders EOP. See Executive Office of the President EPA. See Environmental Protection Agency EPA analysis, 229–230 EPA estimates of annual quantified benefits, 230 EPA’s morbidity inclusive life year (MILY) approach, 60–61 EQ-5D. See EuroQoL-5D Equivalent lives saved (ELS), 60, 215–217, 273 Escherichia coli O157:H7, 204–210 Estimates of QALY gains, 207–212, 223–228, 233–237 HRQL with illness at average age of incidence, 235 HRQL with injury, 227 HRQL with pathogen-related illness, 208 QALY total losses, 210, 224, 236 sensitivity analysis for QALY losses, 211, 226, 237 Estimating the Contributions of Lifestyle-Related Factors to Preventable Death, 186 Estimating the Public Health Benefits of Proposed Air Pollution Regulations, 121 Estimation of costs, 62–63 Estimation of “with condition” HRQL, 198–199 approaches for determining “with condition” HRQL, 200 Ethical and nonquantifiable aspects of regulatory decisions beyond ratios, 130–158 conclusions, 157–158 distributional concerns about risks and regulatory interventions, 144–155

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Valuing Health for Regulatory Cost-Effectiveness Analysis improving regulatory decision making, 155–157 value of a QALY, 134–140 Ethical and other implications of risks and of interventions to address risks, 140–144 dimensions of value affecting the acceptability of risks, 140–143 nonquantifiable impacts, 143 summary, 143–144 Ethical assumptions in QALY-based CEA, 132–134 valuing life years compared with valuing lives, 132–134 Ethically informed decisions, 7–9 EuroQoL-5D (EQ-5D), 6, 18, 72, 79, 83–85, 94, 99–104, 111–112, 119–124, 128, 136, 165–166, 198–204, 214–215, 222–228, 232–234, 238, 252 availability, 101 domains, 100 history, 100 valuation, 100–101 EuroQoL-5D (EQ-5D) health states, mean valuations, with four estimation methods, 85 EVGGFP. See Global health status measure (EVGGFP—excellent, very good, good, fair, poor) Executive Office of the President (EOP), 16 Executive Orders (EOs), 25 No. 12044—Improving Government Regulations, 22 No. 12291—Federal Regulation, 22 No. 12866—Regulatory Planning and Review, 3, 22–26, 258–262, 266, 275, 278, 310–311 No. 12898—Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 25 No. 13045—Protection of Children from Environmental Health Risks and Safety Risks, 25, 312 No. 13211, 312–313 No. 13272, 311 Expert assignment of health states, using generic HRQL instruments, 110–111 Externality, common property resource and public good, 262–263 “Extra-welfarists,” 27 F Fatality risks, 293–296 FCI. See Functional Capacity Index FDA. See Food and Drug Administration Feasibility, 70, 81–82 defined, 44 Federal Insecticide, Fungicide, and Rodenticide Act, 43 Federal Motor Carrier Safety Administration (FMCSA), 46 Federal Register, 20–21 Federal regulatory action market failure or other social purpose, 262–264 need for, 261–265 the presumption against economic regulation, 265 showing that regulation at the Federal level is the best way to solve the problem, 264–265 “Feeling thermometer,” 79 Firms, different requirements for different sized, 267 FMCSA. See Federal Motor Carrier Safety Administration Food and Drug Administration (FDA), 46, 53, 57, 114, 117, 151–152, 194, 197, 214, 222, 225–228, 232, 238, 241 analysis by, 204–205 benefit valuation approach of, 59 case study analytic approach, 205–207 cost-effectiveness ratios, 212–215 estimates of annual quantified benefits, 206 estimates of QALY gains, 207–212 juice processing regulation, 194, 204–215 Food Quality Protection Act, 45 Food safety, 145, 147, 209 Food Safety and Inspection Service (FSIS), 46, 58 Food supply, safeguarding, 1 Ford, Gerald, 22 FSIS. See Food Safety and Inspection Service Full disclosure, 314 Functional Capacity Index (FCI), 103, 198, 215, 222–226, 254–257 Functional status, 74, 320 Future generations in CEA, 152–154 discounting and timing of impacts, 153

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Valuing Health for Regulatory Cost-Effectiveness Analysis future effects, 151–152 future generations, 152–154 treatment of, 151–154 G Generic HRQL indexes, 6, 93–102, 320 domains and number of attribute levels for generic HRQL indexes, 95 the EuroQol-5D, 100–101 Health Utilities Index, 98–99 measuring HRQL with generic instruments—community value, 97 Quality of Well-Being Scale, 97–98 the SF-6D, 101–102 valuation surveys for generic HRQL instruments, 96 Generic indexes, 165–166 characterizing health states with, 166 Geographic regions, different requirements for, 267 Global Burden of Disease, 81 Global health status measure (EVGGFP—excellent, very good, good, fair, poor), 126n Graham, John, 17 Guidelines relevant to CEA, 62–65 assessing uncertainty and nonquantified effects, 64 communicating the methods and results, 64–65 determining the distribution of impacts, 64 discounting impacts over time, 63 estimating costs, 62–63 using ratios, 64 H HALYs. See Health-adjusted life years Harvard Center for Risk Analysis, 120 Harvard School of Public Health (HSPH), 199 Center for Risk Analysis, 117 Health-adjusted life years (HALYs), 2–10, 15–19, 27–28, 32–40, 52–56, 63–91, 122, 135, 159–163, 181, 320 alternative HALY metrics for regulatory CEA, 86–91 describing health states, 74–76 metrics of, 69 monetized, 52, 65 valuing health states and preference elicitation methods, 77–86 Health and Retirement Survey 2000, 99 Health and safety rulemakings, 47 Health-based requirements, 42–43 Health benefit values for regulatory analysis correlations and cross-walks of HRQL measures, 126–127 criteria for selecting HALY metrics for regulatory CEA, 68–72 health-adjusted life years, 73–91 measures and strategies for obtaining, 67–129 research and development of metrics and valuation methodologies, 123–125 single-dimension measures of health-related outcomes, 72–73 sources of health state values for regulatory analysis, 92–123 summary and conclusions, 125–129 Health-benefits-only ratio, 167, 170 Health care policy, effectiveness in, 5 Health-care-treatment-cost impacts, defined, 172 Health effects likely to be quantified in forthcoming major health and safety rulemakings, 48 Health endpoints, describing, 197–198 Health gains, calculation of, 149–151 “Health–health” analysis, 49 Health indexes, 245–257 EuroQoL-5D, 252 Functional Capacity Index, 254–257 Health Utilities Index, 247–251 Quality of Well-Being Scale, 245–246 SF-6D, 253 Health profiling instruments, disease-specific, 103 Health-related effectiveness measures, 5–7 Health-related quality of life (HRQL), 2–16, 34–40, 52–53, 57–62, 67–79, 83–129, 133–137, 148–150, 156, 160–170, 177–189, 195–209, 214–218, 222, 227, 232–241, 273, 320 with illness at average age of incidence, 235 with injury, 227 measurement and regulatory CEA, conducting research to improve, 13–14

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Valuing Health for Regulatory Cost-Effectiveness Analysis measurement for children, 106–107 measurement quality, 166–167 with pathogen-related illness, 208 Health risks, regulating, 1 Health state index values and benefits transfer, 116–121 the CEA Registry, 118 defined, 34n from published sources, 120–121 Health state values for regulatory analysis, 92–123 approaches based on population survey data, 110–116 assignment of health states by experts or other proxies, 106–109 condition-specific indexes and applications to special populations, 102–106 generic HRQL indexes, 93–102 health state index values from prior studies and benefits transfer, 116–121 primary elicitation of condition-specific index values, 92–93 uncertainty in health status and preference measurement, 121–123 Health states, 74, 320 changes in, 136 concepts and domains used in defining self-reported health status, quality of life, and health-related quality of life, 76 describing, 74–76 health-adjusted life years, 75 “postregulatory,” 8 Health Utilities Index (HUI), 6, 71, 98–99, 104, 119–120, 124, 165–166, 198, 247–251 availability, 99 domains, 99 history, 98–99 Mark 1 (HUI-1), 99 Mark 2 (HUI-2), 99, 104, 107, 215, 222, 227, 247–248 Mark 3 (HUI-3), 72, 99–100, 120, 124, 202–204, 209, 214, 233, 249–251 valuation, 99 Healthy year equivalent (HYE), 88, 91, 320–321 “Hedonic price equations,” 281 Holistic approach, 97 HRQL. See Health-related quality of life HRQL valuation, using ordinal data for, 124 HRQL values, 135–139 individual preferences and societal values, 138–139 whose values count, 135–138 HSPH. See Harvard School of Public Health HUI. See Health Utilities Index Hybrid requirements, 44–46 HYE. See Healthy year equivalent I IADL. See Immediate activities of daily living ICD. See International Classification of Disease codes Immediate activities of daily living (IADL), 115n Impacts on children, 312 determining the distribution of, 64 on small businesses and other small entities, 310–311 Indirect uses of market data, 284–285 Individual preferences, and societal values, 138–139 Informal caregiver time, 33 Information collection, paperwork, and recordkeeping burdens, 311 Information needed for regulatory decision making, 12–13, 181–184 distributional and other aspects of risk and regulation, 183 inadequate, 263–264 recommendation 8, 13, 181–184 recommendation 9, 13, 184 Information quality guidelines, 311–312 Information Quality Law, 311 Informational measures, rather than regulation, 268–269 Injuries, 321 reducing the risk of, 1 to restrained children, 219–221 Institute of Medicine (IOM), 2, 18, 116, 186, 193, 274 Committee on Summary Measures of Population Health, 18 Intangibles, 290

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Valuing Health for Regulatory Cost-Effectiveness Analysis Integrated measures of effectiveness, 10–11, 161–167 characterizing health states with generic indexes, 166 criteria for selecting integrated effectiveness measures for health-related CEA, 162 generic indexes, 165–166 HRQL measurement quality, 166–167 recommendation 1, 11, 161–167 valuation, 164–165 Interagency Working Group on Summary Measures of Population Health, 116 Intergenerational discounting, 301–302 International Classification of Disease (ICD) codes, 113, 233 International Classification of Impairments, Disabilities, and Handicap, 89 Interobserver reliability. See Intrarater test-retest reliability Intrarater test-retest reliability, 321 of the SG, TTO and visual analogue scale techniques, 82 IOM. See Institute of Medicine J Judicial review of regulatory analyses, 47–50 Juice processing. See Food safety K KABCO injury categories, 216 Kaldor-Hicks criterion, 31 L Latency period, 300 “Learning curve” effects, 303 Life expectancy (LE), 87, 115n, 321 Life years (LYs), 8–9, 132–133 gaining, 172 Lives, 9, 133 Longevity, 4, 35, 38 changes in, 5 trading off, 139 LYs. See Life years M MAIS. See Maximum Abbreviated Injury Scale Mapi Research Institute, 102n Market data, direct and indirect uses of, 283–285 Market failure or other social purpose, 262–264 externality, common property resource and public good, 262–263 inadequate or asymmetric information, 263–264 market power, 263 other social purposes, 264 Market-oriented approaches rather than direct controls, 268 Market power, 263 Maximum Abbreviated Injury Scale (MAIS), 60–61, 216–218, 222 categories used in NHTSA analyses, 58 Maximum Abbreviated Injury Scale 2 (MAIS 2), 225 Medical Expenditure Panel Survey (MEPS), 101–102, 111, 123, 148, 199, 203, 228, 232–237 Methods for treating non-monetized benefits and costs, 290–292 benefits and costs that are difficult to monetize, 291 benefits and costs that are difficult to quantify, 291–292 MILY. See Morbidity-Inclusive Life Year Monetized emission reduction benefits, 303 Monetized health-adjusted life years in benefit cost analysis, 53 Monetizing benefits and costs, 292–296, 313 fatality risks, 293–296 nonfatal health and safety risks, 292–293 valuation of reductions in health and safety risks to children, 296 Monopoly issues, 263 Monte Carlo simulations, 309, 321 Morbidity, 321 changes in, 5 combining in a single measure with mortality, 139–140 Morbidity-Inclusive Life Year (MILY), 58–61, 156

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Valuing Health for Regulatory Cost-Effectiveness Analysis Mortality-based indicators, 5 Motor vehicle accidents, national costs of, 55 Multiple regression analysis, 281 N National Automotive Sampling System (NASS), 218, 221–223 National Environmental Policy Act (NEPA), 312 National Health Interview Survey (NHIS), 98, 114, 126n, 148 National Highway Traffic Safety Administration (NHTSA), 46, 50–58, 103–104, 147, 194–202, 215–217, 221, 226–227, 232, 238, 241 case study analytic approach, 217–223 child restraints regulation, 194, 215–228 equivalent lives saved (ELS) approach, 60–61 estimates of annual quantified benefits, 218 estimates of QALY gains, 223–228 National Institute on Aging, 124 National Medical Expenditure Survey (NMES), 126n National Research Council Board on Environmental Studies and Toxicology, 121 Committee on Estimating the Health-Risk-Reduction Benefits of Proposed Air Pollution Regulations, 18, 185 NEPA. See National Environmental Policy Act Net benefits, calculation of, 31 Neumann, Peter, 120 New Source Review program, 291 NHIS. See National Health Interview Survey NHTSA. See National Highway Traffic Safety Administration Nixon, Richard, 22 NMES. See National Medical Expenditure Survey “Non-use values,” 284–285 Nonfatal health and safety risks, 292–293 Nonmonetized benefits and costs of the EPA’s nonroad diesel rule, 179–180, 303 methods for treating, 290–292 Nonquantifiable impacts, 143 Nonquantified effects, assessing, 64 Nonroad diesel rule, 178, 194–195 Nonroad engine air emissions regulation, 228–240 case study analytic approach, 231–233 cost-effectiveness ratios, 237–240 EPA analysis, 229–230 estimates of QALY gains, 233–237 Notice of Proposed Rulemaking, 21 NRDC v. EPA, 44 Nuclear Regulatory Commission, 26 O Occupational Safety and Health Act of 1970, 42, 45 Occupational Safety and Health Administration (OSHA), 42–43, 46, 58 Office of Information and Regulatory Affairs (OIRA), 17, 315 Statistical and Science Policy Branch, 312 Office of Management and Budget (OMB), 1–4, 16–22, 26, 41, 50–55, 62–65, 93, 108n, 116, 121, 143, 149, 274, 279, 313–315 Circular A-4, 3, 16, 23, 40, 50, 53–56, 62–65, 134, 146, 152–154, 174, 194–196, 217, 258–315 criteria for evaluating stated preference studies, 54 rationale for requiring CEA as part of regulatory analysis, 17 OIRA. See Office of Information and Regulatory Affairs OMB. See Office of Management and Budget OSHA. See Occupational Safety and Health Administration Outcome measures, 8, 322 P Panel on Cost-Effectiveness in Health and Medicine (PCEHM), 18, 32–33, 67, 93, 103–105, 110, 118–119, 122, 125, 128, 149, 172, 241 Paperwork Reduction Act, 93, 108n, 311 Pareto Principle, 31, 38

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Valuing Health for Regulatory Cost-Effectiveness Analysis Particulate matter (PM) emissions, 229 Patient self-assessments, 222 Patient time, 33 PCEHM. See Panel on Cost-Effectiveness in Health and Medicine Performance standards, rather than design standards, 267 Person trade-off (PTO), 6, 77–81, 89–91, 138–139, 155, 322 Personal control, degree of, 142 PM. See Particulate matter emissions Population-based, condition-specific HRQL values, 112–113 Population health data, and subgroups, 148–149 Population survey data-based approaches, 110–116 catalogues of chronic condition HRQL values, 111–113 incorporation of health profiles and HRQL questions and instruments in routine population surveys, 114–116 sources for population-based, condition-specific HRQL values, 112–113 statistically inferred HRQL values, 114 “Postregulatory” health status, 8 Precision of estimates, 314 Preference-based indexes, 103, 322 “Preference weights,” 34n Premature mortality, 72–73 Preventable mortality, 72–73, 211, 322 Primary elicitation of condition-specific index values, 92–93 Probabilistic analysis, of uncertainty, 64 Producer surpluses, 281 Professional judgment, 286 Proposed regulatory actions, need for analysis of, 259–260 PTO. See Person trade-off Publicity, 157 Published sources, using health state index values from, 120–121 Purpose and scope issues, 193–195 EPA’s nonroad diesel rule, 194–195 FDA’s juice processing rule, 194 NHTSAs child restraint rule, 194 Q QALDs. See Quality-adjusted life days QALYs. See Quality-adjusted life years Qualitative benefits and costs, 313 Quality defined for benefit transfer studies, 116 of life, 74, 322 Quality-adjusted life days (QALDs), 59, 204 Quality-adjusted life years (QALYs), 4–16, 34–37, 57–62, 68–71, 78–92, 103–105, 109, 117, 122–135, 139–154, 158–185, 193–197, 204–205, 214–217, 224–226, 234–241, 273, 322 gain in defined, 172 total losses, 210, 224, 236 Quality of Life Instruments Database, 102n Quality of Well-Being Scale (QWB), 6, 58–59, 71–72, 97–98, 114, 122, 165–166, 198–204, 212–215, 222–227, 245–246 availability, 98 domains, 98 history, 97–98 self-administered version, 98 valuation, 98 Quantified benefits, 313 EPA estimates of annual, 230 of EPA’s nonroad diesel rule, 56 of the FDA’s juice processing rule, 57 QWB. See Quality of Well-Being Scale R Radon exposure levels, 30 RAND Health Insurance Experiment, 101 Rating scale (RS), 85, 90, 119, 322 Ratios ethical and nonquantifiable aspects of regulatory decisions beyond, 130–158 scale of, 322 using, 64 Rawls, John, 17 Real discount rates, of 3 percent and 7 percent, 298–300 “Real options” methods, 306 Recent regulations examples of, 46–47 health effects likely to be quantified in forthcoming major health and safety rulemakings, 48 summary of recent major health and safety rulemakings, 47

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Valuing Health for Regulatory Cost-Effectiveness Analysis Recommendations for regulatory cost-effectiveness analysis, 11–14, 159–189 constructing and reporting cost-effectiveness ratios, 167–181 data collection and research needed to improve HRQL measurement and CEA for regulatory decision making, 184–188 information needed for regulatory decision making, 181–184 selecting integrated measures of effectiveness, 161–167 summary, 188–189 Regulations compliance costs defined, 172 at the Federal level, 264–265 recent, 46–48 summary, 65–66 types of risk regulations, 41–50 Regulatory analysis choosing a HALY measure for, 91 current practices for, 50–65 key elements of, 260–261 Regulatory Analysis. See Circular A-4 Regulatory decision making, 155–157 enforcement, 157 presenting information needed for, 12–13 publicity, 157 relevance, 157 revisability and appeals, 157 Regulatory development and economic analysis, 3–4 key requirements of the Administrative Procedure Act, 21 process of, 20–22 requirements for regulatory analysis and decision making, 22–26 the role of economic analysis in, 19–26 Regulatory Flexiblity Act, 267, 310 “Regulatory flexiblity analysis” (RFA), 310–311 Regulatory interventions, 10 “Regulatory Right-to-Know Act,” 26, 258, 275, 278 Relevance, 157 Reliability, 70, 82–83, 323 intrarater test-retest reliability of the SG, TTO and visual analogue scale techniques, 82 Reporting cost-effectiveness ratios, 11–12, 167–181 Representativeness issues, 70 Reproducibility of results, 278–279 Requirements for regulatory analysis and decision making, 22–26 definition of “economically significant” regulations, 24 Executive Orders, 25 history of administrative guidance on regulatory analysis, 22 Research and development of metrics and valuation methodologies, 123–125 best practices in stated preference surveys and benefits transfer, 125 correlations and conversions among HRQL measures, 123–124 using ordinal data for HRQL valuation, 124 Resource Conservation and Recovery Act, 43 Resources for the Future, 17 Revealed preference methods, 282–285, 323 direct uses of market data, 283–284 indirect uses of market data, 284–285 Revisability and appeals, 157 RFA. See “Regulatory flexiblity analysis” RIA, 279 “Risk neutrality,” 310 Risk-related considerations for regulatory decisions, 145 “Risk–risk” analysis, 49 Risks with delayed effects, 142 detecting, 141–142, 145 dimensions of value affecting the acceptability of, 140–143 and dread, 142, 145 personal control over, 142, 145 treatment of, 314 Routine population surveys, incorporation of health profiles and HRQL questions and instruments in, 114–116 RS. See Rating scale S SAB. See Science Advisory Board Safe Drinking Water Act (SDWA), 44–45

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Valuing Health for Regulatory Cost-Effectiveness Analysis Salmonella (non typhi), 204–210 Saved young life equivalent (SAVE), 90–91 Science Advisory Board (SAB), 294–295 SDWA. See Safe Drinking Water Act Self-reported health status (SRHS), 115n “Senior discount” controversy, 134 Sensitivity analysis, 156, 225, 308–309, 323 for QALY losses, 211, 226, 237 SF-6D, 6, 71, 75, 94, 101–102, 123–124, 165–166, 198, 204, 214, 253 availability, 102 domains, 101–102 history, 101 valuation, 102 SF-12 data sets, 71, 101–102, 123–124, 165 SF-36 data sets, 71, 75, 101–102, 165 version 2, 102, 124 SG. See Standard gamble “Shadow price” approach, 298 Single-dimension measures of health-related outcomes, 72–73 Small Business Administration, Chief Counsel for Advocacy of, 311 Social purposes, 264 “Social rate of time preference,” 299 Special populations, 104–105 Specialized analytical requirements, 310–313 analysis of unfunded mandates, 311 energy impacts, 312–313 environmental impact statements, 312 impact on small businesses and other small entities, 310–311 impacts on children, 312 information collection, paperwork, and recordkeeping burdens, 311 information quality guidelines, 311–312 SPM. See “Stated preference” methods SRHS. See Self-reported health status Standard gamble (SG), 77–78, 80–86, 90, 105–107, 119, 124, 323 Standard performance criteria, for HRQL instruments, 70 “Stated preference” methods (SPM), 30, 285–287, 323 Statistical and Science Policy Branch, 312 Statistically inferred HRQL values, 114 Statutory standards, 42–46 health-based requirements, 42–43 hybrid requirements, 44–46 technology-based requirements, 44 Summarizing Population Health, 116 Supreme Court, 43 “Switch points,” 308 T Technology-based requirements, 44 Theoretical reliability, 83 “Threshold” analysis, 260 Time preference, 323 for health-related benefits and costs, 300–301 for non-monetized benefits and costs, 302–303 Time trade-off (TTO), 77–90, 100, 105, 114, 119–124, 128, 324 Toxic chemicals, minimizing exposure to, 1 Toxic Substances Control Act (TSCA), 45, 48 Trade-off based methods, 80 for longevity, 139 Transfers, separate reporting of, 314–315 Transparency, 70, 261, 278–279, 314 TSCA. See Toxic Substances Control Act TTO. See Time trade-off TTO method and discounting, 84 U Uncertain outcomes, economic values of, 310 Uncertainty alternative assumptions, 310 assessing, 64 economic values of uncertain outcomes, 310 in health status and preference measurement, 121–123 probabilistic analysis of, 64 quantitative analysis of, 307–309 treatment of, 305–310, 314 Unfunded Mandates Act, 311 U.S. Constitution, 42 U.S. Public Health Service, 32 “Use values,” 284–285 Utility function, 324 Utility-theoretical model, 86 Utility theory, 70 “Utility weights,” 34n

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Valuing Health for Regulatory Cost-Effectiveness Analysis V Validity, 324 concurrent, 318 convergent, 318 criterion, 319 Valuation, 29–30, 32–36, 70, 98–102, 137n, 164–165, 288–289 contingent, 125 decomposed, 97 of reductions in health and safety risks to children, 296 Valuation surveys, for generic HRQL instruments, 96 Value, 19n, 324 Value of a QALY, 134–140 combining morbidity and mortality in a single measure, 139–140 source of HRQL values, 135–139 summary, 140 Value of a statistical life (VSL), 59, 294–295, 324 Value of a statistical life year (VSLY), 59, 295 Valuing Health Outcomes conference, 17 Valuing health states and preference elicitation methods, 77–86 comparisons among elicitation methods, 81–86 direct rating—category rating and visual analogue scales, 79–80 person trade-off, 80–81 standard gamble, 78 time trade-off, 78–79 Valuing life years compared with valuing lives, 132–134 lives, life years (LYs), and quality-adjusted life years (QALYs), 133 the “senior discount” controversy, 134 Visual analogue scale (VAS), 77, 80–85, 100, 107, 324 VSL. See Value of a statistical life VSLY. See Value of a statistical life year W Wage-risk studies, 30n Water quality, improving, 1 Weitzman, Martin, 302 Welfare economics, 83, 324 Well-being, 74, 76, 324 White House Council on Environmental Quality, 312 Whitman v. American trucking, 41 WHO. See World Health Organization WHO’s DALY, 89 Willingness to accept (WTA), 29n, 280, 324 Willingness to pay (WTP), 16, 29–30, 34–38, 62, 65, 85, 195, 229, 280, 288, 292, 325 “With condition” HRQL, approaches for determining, 200 “With condition” values, 234 “With injury” values, 223 “With pathogen-related illness,” 215 “Without condition” HRQL, 199–203 comparison to “with condition” values based on expert assignment, 202 comparison to “with condition” values based on patient self-assessments, 202–203, 211 “Without condition” values, 234 “Without pathogen-related illness,” 215 World Health Organization (WHO), 87–89, 126n Global Burden of Disease, 81 WTA. See Willingness to accept WTP. See Willingness to pay Y Yellowstone National Park, 289