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Index Abernathy v. Prudential Insurance Co. of America, 118 Access to care Medicare coverage and, 89 social values in, 12 Adams v. Blue Cross and Blue Shield of Maryland, 122 Aetna Health Plans, 112-113 Agency for Health Care Policy and Research, 5, 56, 78, 81, 93, 137, 141, 168, 177-179, 198 outcomes research in, 154 role of, 127, 176 Alglucerase injection, 175 American College of Physicians (ACP), 176, 179 American Health Security Act, 197 American Medical Association, 19, 175 Antitrust law, 5, 62 Appropriateness studies, 137 Auranofin, 159 Australia, 50, 55 Autologous bone marrow transplant. See Bone marrow transplantation for breast cancer AZT,18,30, 103 217 Battelle Memorial Institute, 176 Benefit coverage Blue Cross/Blue Shield technology assessment, 97-98 for bone marrow transplantation in breast cancer, 112-116. See also Bone marrow transplantation for breast cancer cost-effectiveness as decision-making criterion in, 50, 55, 92 evaluation of special cases in, 106-107 experimental exclusion case law, 117- 123 Medicare, 87-90, 91-94 technology assessment in Kaiser Permanente, 102-108 Biotechnology, 164-165 Blue Cross and Blue Shield Association, 91-92 breast cancer treatment coverage, 98- 100 role of, 96 structure of, 96 technology assessment activities, 96-98, 176, 179

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218 Bone marrow transplantation for breast cancer, 5, 61, 98-100 controversy, 109-111 cost of, 110, 114 coverage decision-making model, 112- 113 coverage exclusion case law, 120, 122, 123 outcomes research, 111-112 Breast cancer autologous bone marrow transplantation for, 5, 61, 98-100, 109-113, 120, 122, 123 incidence, 114 Canada, 50, 55, 195-196 Captopril, 159 Carotid endarterectomy, 129 Catastrophic illness/injury, 14 Centoxin, 165 Certificate-of-need regulations, 62-63, 80 Chemotherapy, 89 for breast cancer, 98-100 Cholecystectomy, laparoscopic, 68, 77 Claims data, research in, 13~135 Clinical Efficacy Assessment Project, 179 Cochlear implants, 28, 80 Cohort-controlled studies, 133 Collaborative research, S. 56, 57, 113, 11~115, 185-186 Competition among different ownership types, 38-39 in model of hospital management, 63- 64 research in context of, 186-187 technology adoption and, 4 Coronary bypass procedures, 26, 29, 129 Cost containment diagnosis-related group system and, 10 evolution of, 14-15, lSS health care reform and, 3-4 outcomes research in, lSS price control strategies, 3~35 in prospective payment system, 34 technology assessment in, SO technology development and, 28-29 Cost-effectiveness INDEX concept of efficiency in medicine and, 31 consumer concerns, 182 in coverage/treatment decisions, S. SO, 1'1~1 145 . . . . . . as dec~s~on-mak~ng criterion In Medicare, 89, 92 as drug evaluation criterion, SS economic modeling for evaluation of, 161, 162 in pharmaceutical research, 160 in research and development process, 8- 9 standards for measuring, 190 as technology assessment criterion, 8, 104, 142-143 of vaccines, 23 n.21 Cost of care for catastrophic care, 14 cost of education vs., 40-41 cost of monitoring in, 34-35 inHDC-ABMT, 110 health care expenditures, 11, 14 in HMOs, 27 medical technology in, 19, 22, 25-26, 39 in myocardial infarction, 22 n.20 physician payment in, 71 prospective payment system and, 26-27 public understanding of, 146 retrospective payment system and, 25 26 See also Cost containment; Cost effectiveness Credentialing issues, 80 Cyclosporine, 30 Data registries, 133 Decision analysis, 138-139 Diabetic retinopathy, 78 Diagnosis-related groups (DRGs) as cost-containment strategy, IS, 34-35 HMO reimbursement vs., 34 n.33 length of stay decisions in, 37, 38 role of, 26 technological change and, 9-10 technology assessment and, 65

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INDEX Dialysis, 19-20, 27, 29, 37 Disabilities, 18 n.l3 Discharge planning, 67 Disposable medical supplies, 36 Dorza v. Crum and Forster Insurance Company, 122 Dronge v. Monarch Insurance of Ohio, 118 Drug formularies, 155 Echocardiography, 91 Employee assistance programs, 106 Equipment/supplies, disposable, 36 Erythropoietin, 91, 164-165 Evaluative research. See Outcomes research; Technology assessment Experimental therapies, 5 coverage exclusion, 107 in HMO Act, 102 insurance coverage and, 18 . . . ~ insurance exclusion as protection from, 122-123 legal history of coverage exclusion for, 117-123 Expert witnesses, 119-120 Fassio vs. Montana Physician Services, 118 Financial management models of hospital behavior, 63-65 technology assessment and, 51-53, 55- 56, 62-63, 104-105 Finasteride, 103-104 Food and Drug Administration, 24, 80, 97-98, 103, 128, 156, 157, 176 Gaucher's disease, 175 Government expenditures, 14 Group practice, 75 Harris v. Mutual of Omaha, 123 Hastings Center, 176 HDC-ABMT. See Bone marrow transplantation for breast cancer Health Care Cost Reduction Act, 194 Health Care Financing Administration, 5, 219 50, 55, 80, 156, 159, 164-165, 176, 179, 198 Medicare coverage decisionmaking in, 87,91-94 Uniform Clinical Data Set, 135 Health care market, 17-19 Health care reform comparative value decisions in, 145 goals of, 97 historical developments, 14-15, 16 legislative background, 193-195 medical technology and, 3 - , 196-199 private sector-public sector roles in, 195-196, 197-199 technology assessment in, 49, 185-186, 191 Health Equity and Access Reform Today Act, 195 Health Insurance Association of America, 53 Health maintenance organizations (HMOs) cost-containment in, 15, 27 experimental therapies in, 102 financial incentives to reduce quality in, 35 n.40 growth of, 16 technology adoption in, 39 n.47 technology assessment in, 51, 53, 54, 56 vs. DRG reimbursement, 34 n.33 Health Security Act, 195 Health Security Plan, 3-4 Heart transplants, 14, 92-93 Helicopter services, 63 Hospitals financial incentives in prospective payment, 26-27 financial management through service design, 27 n.27 models of management behavior, 63-65 ownership mix, 37 patient records in outcome research, 133 reimbursement systems for, 15, 16 technology adoption in, 4, 61-69 technology assessment in, 51-53, 54, 62 variation in behavior by ownership type, 37-39

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220 Imaging technologies, 26, 28, 80 Implant technologies, 26 Implementation of evaluative research findings, 143-147 of outcomes research in clinical practice, 167-168 In vitro fertilization, 18, 103 Innovation cost of outcomes research and, 169 as evaluation criterion in technology adoption, 73-74 health care reform and, 3-4 insurance demand and, 20-21 nature of, 6 in public education vs. health care, 40- 41 Insurance system. See also Reimbursement systems determinants of demand in, 20-21 evaluation of HDC-ABMT for breast cancer, 112-113 evaluation of special cases in, 106-107 evolution of, 10, 14-15, 16 expenditures, 14, 15 health care conceptualization in, 17-19 indemnity insurance, 25 n.24 judicial view of, 118 legal history of experimental exclusions in, 117-123 Medicare coverage decisionmaking and, 91-92 pharmaceutical coverage, 80 physician relations with, 119 preventive interventions and, 30-31 as public interest, 12-13, 118 social choice modeling of, 16-17 taxation in, 188 in technology assessment, 176, 182-187 technology development and, 11, 15-16, 19-33, 39-40 in technology research and development, 11, 15-16 International comparisons cost-effectiveness as decision-making criterion, 50, 55 R & D environment, 13 INDEX Jackson Hole Group, 185-186 Japan, 13 Joint Commission on Accreditation of Health Care Organizations, 35, 69 Kaiser Permanente organizational structure, 101-102 technology assessment activities, 98, 102-108 Laparoscopy, in cholecystectomy, 68, 77 Legal issues bone marrow transplantation in breast cancer, 110 coverage for experimental therapies, 117-123 expert witnesses, 119-120 hospital responsibilities, 62 in technology adoption, 62-63 in technology assessment, 106 Length of stay, 37, 67 Life expectancy, 20 Lithotripsy, 103 Liver transplants, 14, 21, 30, 92-93, 143 Magnetic resonance imaging, 80, 91 Managed care, 3 Managed competition, 196, 197 Managed Competition Act, 195 Medicaid, 12, 14, 145 cost-effectiveness as coverage criterion in, 55 Medical Assessment Directory, 175 Medical device manufacturers, technology assessment and, 155-159, 168-169, 175, 180-181 Medical technology in cost of care, 19, 22-23, 25-26, 39 coverage decisionmaking and, 4-5 definition, 173 diffusion of, 128-129 health care reform and, 196-199 historical development, 13-15 inappropriate use, 129 in insurance definition of health care, 17-19

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INDEX In model of hospital management, 63- 65 stage model, 22-23 See also Research and development; Technology adoption; and Technology assessment Medicare, 12, 14, 50, 164, 176, 188 capital budgets and, 62 cost-effectiveness as coverage criterion in, 89, 92 coverage decisionmaking in, 87, 88-90, 91-94 criticisms of, 88-90 diagnosis-related group system in, 9, 15 evolution of, 87-88, 94 outcomes data, 134 prospective payment system in, 27 reimbursement system, 90-91 Meta-analysis, 135-137 Methodology appropriateness, 137, 140-141 cost-effectiveness calculations, 142-143 decision analysis, 138-139 economic modeling, 161, 162 in manufacturer-sponsored technology assessment, 181 meta-analysis, 135-137 outcomes measurement, 130-135, 154 pharmaceutical industry outcomes research, 161-162 surrogate outcomes in technology assessment, 75-76 technology assessment standards, 189- 190 Minimum benefits package, 6 Myocardial infarction cost per case, 22 n.20 surrogate outcomes in treatment evaluation, 76 National Cancer Institute, 5, 110, 112 National Center for Health Statistics, 198 National Institutes of Health, 24, 175, 176, 177, 198 Nonprofit organizations, 37-39 221 Office of Health Technology Assessment, 53, 148, 157 Office of Technology Assessment, 53 Oregon, 55, 145-146, 147 Outcomes research, 6 appropriateness methodology and, 140- 141 in biotechnology pharmaceutical companies, 16~165, 166 clinical application, 167-168 consultants for, 162-163 cost of, 168 data sources, 131-135, 154 definition, 153-154 dissemination of, 76-78 economics of, 144 evaluation in, 135-137 evolution of, l5ilS5 future of, 166-170 HDC-ABMT, 111-112 by medical device manufacturers, 156, 157-158, 165-166, 168-169 meta-analysis in, 135-137 Patient Outcomes Research Teams for, 137-138, 167 by pharmaceutical companies, 159-161, 166, 169 surrogate outcomes in, 75-76 in technology assessment, 53, 56, 66- 68, 72, 75-76, 78, 113, 115, 153, 154-155 type of outcomes in, 130-131 See also Quality of care; Technology assessment Parenteral/enteral feeding, 89 Patient Outcomes Research Teams, 137- 138, 167 Patient Shared Decision-Making, 141-142 Peer review, 80, 93-94 Pharmacotherapy biotechnology research, 164-165 as complement to surgery, 29-30 drug formularies, 50 n.l, 155 experimental, insurance coverage for, 18 innovation in, 10 Medicare coverage for, 88-89

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222 Physicians new drug development, 24, 55, 103-104 reimbursement policy, 80 research incentives, 29, 30 surrogate outcomes in, 76 technology assessment in pharmaceutical companies, 159-164, 166, 169, 175, 180-181 consumer criticisms of, 12 consumerism in behavior of, 119-120 dissemination of research findings to, 76-78 Medicare reimbursement to, 91 as patient agents, 74 relations with insurance industry, 119 in technology adoption, 63, 71-81 Pirozzi v. Blue Cross-Blue Shield, 120 Polio, 20-21, 22-23 Ponder v. Blue Cross of Southern California, 121 Positron emission tomography (PET), 26, 28 Practice guidelines, 141 Premature birth, 26 Preventive interventions, insurance and, 30-31 Prospective payment cost of care and, 19, 26-27 discharge practices and, 67 in Medicare, 90-91 new drug development and, 29 origins of, 15, 16 provider ownership type and response to, 37-39 in public education, 40~1 quality of care and, 35-37 technology adoption/diffusion and, 3= 36, 68 utilization and, 27 See also Diagnosis-related groups (DRGs) Provisional coverage, 5-6 Public education system, 40~1 Public knowledge, 77-78 Quality-adjusted life years, 142 Quality of care INDEX conceptual evolution, 127-128 cost of monitonng, 3~35 ~ in prospective payment system, 33-37 See also Outcomes research; Technology assessment Randomized clinical seals expenditures, 177 in meta-analysis, 135-137 methodology, 132 role of, 154 as stage III technology assessments, 172-173 n.2, 173 Regulatory environment in Blue Cross/Blue Shield technology assessment, 97-98 development of health care reform in, 193-196 experimental exclusions in insurance coverage and, 121 pharmaceutical manufacturing in, 159 in technology assessment, 55, 62-63 Reilly v. Blue Cross and Blue Shield, 121- 122 Reimbursement systems cost-effectiveness as criterion in, 5 cost of care and, 25-27 development of, 1~15 discharge decisions and, 37-39 experimental therapies and, 5-6, 18 in HMOs, 15 in Medicare, 90-91 in Medicare DRG, 15 new drug development and, 29, 30 social choice modeling, 16-17 in technology adoption, 33-36 technology adoption and, 80, 91 technology assessment and, 62, 72 technology development and, 9, 25, 28 Research and development in biotechnology companies, 16~165 collaborative efforts, 5, 56, 57, 185-186 cost-effectiveness evaluation in, 8-10 coverage for experimental therapies, 5- 6 diagnosis-related group system and, 9- 10

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INDEX effects of insurance system on, 24-33, 39-40 effects on insurance system, 19-23 health care reform and, 3-4 incentives in, 9, 18-19 insurance system and, 11, 15-16, 17-19 international comparisons, 13 in medical device manufacturing, 155- 159 in pharmaceutical industry, 159-164 process, 24 Resource-based relative value scale, 91 Social values in delivery of health care, 12-13 in research and development process, 9 in technology assessment, 65-69, 105- 106, 107-108, 146-147 Streptokinase, 136-137 Surgical procedures cost-containment and, 28-29 cost per case, 29 n.28 Surrogate outcomes, 75-76 Sweeney v. Gerber Products Company Medical Benefits Plan, 120 Switzerland, 13 Taxes in funding of technology assessment, 188-189 on health care expenditures vs. insurance premiums, 188 Technology adoption cost considerations in, 25, 74 cost-effectiveness as criterion in, 8 cost of monitoring in, 34-35 . . . . . dec~s~on-mak~ng criteria, 4 diagnosis-related group system and, 9- 10 effects on technology development, 24 health care reform and, 3-4 in HMOs, 39 n.47 in hospitals, 61-69 individual physician characteristics in, 74-75, 76 insurance-related incentives in, 28 marketing considerations, 79 223 physician behavior in, 73, 80-81 process, 128-129 public participation in, 146-147 reimbursement systems and, 25, 33-36, 72, 80 reimbursement systems in, 91 research needs, 81 societal context of, 78-79 Technology assessment alternative funding mechanisms, 184- 188 appropriateness methodology for, 138, 140-141 in biotechnology pharmaceutical companies, 164-165 in Blue Cross and Blue Shield Association, 96-98 categories of technology for, 103-104 collaboration in, 56, 57, 113, 114-115, 185-186 committees for, 51, 54, 63 consumers and, 176, 182 cost-benefit analysis, 141-143, 144-145 cost-effectiveness as criterion in, 8 cost of research in, 54, 57 current practice in, 51-53, 63 decision analysis in, 139-139 decision-making criteria, 4 definition, 49-50, 152, 154, 173-174 drug formulary, 50 n.1, 54 early-stage sponsorship, 189 economic considerations in, 55-56, 62- 63, 104-105 education/training for, 57 effectiveness in, 130 efficacy as measure in, 130, 153, 173 evolution of, 154-155 expenditures, 176-177 experimental trials, 79 government support for, 127, 175, 176, 183, 187-189, 198-199 health care reform and, 198 in hospitals, 62-63 information resources, 4, 53, 54-55, 56, 57-58, 72, 75-78, 79, 198-199 in Kaiser Permanente, 102-108 marketing considerations in, 180-181

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224 INDEX medical device manufacturers and, 6, 155-159, 168-169, 175, 180-181 care in Medicare coverage decisions, 90, 92 models of management behavior in, 63 65 national body/procedures for, 113-115, 147-148, 185-186, 198 negative findings in, 181 obsolescence as evaluation criterion, 81 obstacles to, 56-57, 81, 143-147, 190 optimal process, 148-149 outcomes research in, 130-131, 153 patient perspective in, 141-142 by pharmaceutical companies, 159-164, 169, 175, 180-181 quality-adjusted life years, 142 quality of, 53-55 regulatory considerations, 55 responsibility for, 6 role of, 49, 50, 53, 128, 190-191 selection of technologies for, 177-179 short-term vs. long-term outcomes in, 66-68 societal perspectives in, 65-69, 105- system, 27 106, 107-108 sponsors of 174-176, 179-184, 181, 186-188, 190-191 stages of, 173-174 standards, 189-190 timing of, 66 trends, 56-58, 166 See also Outcomes research; Quality of Third-party payers in Medicare coverage decisionmaking, 91-92 technology assessment by, 51, 53, 54, 149, 156 Tissue plasminogen activator, 30 Transplant procedures, 14, 19, 21, 25-26, 30 in Medicare coverage, 92-93 Travelers' Insurance, 91-92 Treatment decisions cost-benefit analysis in, 145-146 coverage decisionmaking and, 4-5 influences in, 4 patient perspective in, 141-142 Uniform Clinical Data Set, 135 United Kingdom, 13 dialysis coverage in, 20 Unnecessary operations, 12 n.6 Utilization, in prospective payment Vaccines, 20-21, 22-23 Veterans Affairs, Department of, 176, 177 Victim v. Martin, 118 Zidovudine (AZT), 18, 30, 103