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OCR for page 217
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
OCR for page 218
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
OCR for page 219
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
OCR for page 220
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
OCR for page 221
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
OCR for page 222
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
OCR for page 223
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
OCR for page 224
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
Representative terms from entire chapter:
breast cancer
