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Pages 199-210

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From page 199...
... , 5, 55, 83, 144 drug therapies, 145, 172, 174-175, 178 Alcon Laboratories, Inc., 81 Allergan Medical Optics, 81 Allergy treatment, 89 Alzheimer's disease, 190 American Home Products Corporation, l90n.1 American Medical Association, 7, 107-108 Drug Evaluations, 7, 61 Ancillary services, 24 Anesthesia, 76, 94 Angina pectoris, 4, 99 Angioplasty equipment, 77 Animal research, 5, 99, 128, 17~171 Annual update factor, 28 Antibacterials, 160 199 Antibiotics, 37 Antihistamines, 89 Antihypertensive drugs, 25-26 Antitrust legislation, 2 Appendectomies, 97 Applied research, 188 Arterial switch surgery, 98 Arthroscopy, 96, 107, 108 Artificial heart, 85, 92 Artificial Heart Program (NIH) , 74, 75 Assessment of technology, 31, 84, 100, 111, 141, 144-145 "Assignment," 117, 120n.6 Association of Community Cancer Centers (ACCC)
From page 200...
... , 61, 62 Catheter ablation of abnormal cardiac conduction foci, 116 Cefazolin, 160 "Centers of excellence," 115 Cephalosporins, 25 Certificate-of-need regulations, 1, 113 Chemonucleolysis, 108 Chemotherapy innovations, 53-56, 64 reimbursement policies, 7, 56-65, 66 Chest radiographs, 30 Chiron Corporation, 81 Chiron Ophthalmics, Inc., 81 Cholecystectomy, 14, 97, 108 Cholesterol-reducing drugs, 26, 37, 162 Chronic disease drugs, 40 Ciba-Geigy Corporation, 158, 161 Cimetidine, 25 Class action suits, 136 Class I devices, 17n.8, 76 Class II devices, 17n.8, 76 Class III devices, 17n.8, 76, 79, 80-81 Clinical practice, 37, 55, 141 Clinical trials cancer therapies, 54, 55, 61, 62, 63, 64, 65, 66, 67 pharmaceutical, 7, 40, 128, 136, 158-159, 171-174, 178-179, 180n.2 Phases of, 5, 170-176, 180nn.2, 4, 5, and 7 surgical procedures, 13, 99, 102, 103 Cochlear implants, 11, 28, 109-110 Coding medical devices, 94-95 surgical procedures, 13, 97, 102, 105, 107-111, 118 Compassionate use, 7, 17n.5, 173, 178-179 Computerized tomography, 24, 29-30, 103, 146, 148-149, 151 Concurrent review, 13 Consensus NCEs, 37, 38 Consumer groups, 130 Contact lenses, 18n.12 Contingency fees, 136 Contraception, 10, 76 Coopervision G.m.b.H., 81 Copyrights, 182, 189 Coronary artery bypass grafting (CABG) , 24, 26, 98, 99, 112-113 reimbursement policy, 108, 111 selective contracting, 14, 115, 116 Coronary artery disease, 26
From page 201...
... , 179-180n.1 Diagnosis-related groups (DRG) , 1-2 hospitals and, 13, 27, 28, 56-57, 63, 77, 109, 110, 117, ll9n.2 medical devices, 10, 11, 77 pharmaceutical therapies, 5~57, 179 surgical procedures, 11, 109-110, 117 Diagnostic technologies, 26, 75, 144 Dialysis machines, 151 Diasonics, Inc., 79 Diffusion of technology, 16, 27, 29, 66 control of, 1, 2, 10, 21, 56, 73 and health care costs, 21-22, 24-26, 30-31 medical devices, 10, 70, 71, 72, 73, 85, 91, 141, 144, 146, 149-150 payment policies and, 14, 28, 53, 77, 109, 119, 144, 150-151 surgical procedures, 13, 96, 97, 101-102, 112-113, 114, 119 DiMasi, Joe, 39 Diuretics, 37, 50n.10 Dornier Medical Systems, 9, 79, 149-150 Dow Chemical Company, 183 Doxazosin, 156 Drug Amendments (1962, Food, Drug, and Cosmetic Act)
From page 202...
... applications, 9-10, 11, 18n.10, 93 generic drug regulations, 6, 139n.9, 170 medical device regulation, 4, 9-10, 11, 12, 18nn.10 and 11, 28, 76, 79-81, 82, 83, 85, 93, 100, 108 pharmaceutical regulation, 4, 5-6, 7, 8, 17n.3 and 6, 39, 47, 50n.19, 70, 76, 83, 92-93, 97, 100, 101, 102, 108, 128, 136, 169-176, 177, 179, 180nn.7 and 8, 188 Food Safety and Applied Nutrition Center (FDA) , 179-180n.1 Formularies, 7-8, 17n.7, 30, 4708, 50n.20, 61, 102 Fox, Renee, 4 France health care system, 138nn.3 and 6, 147148, 151 medical device industry, 81, 149, 150 pharmaceutical industry, 126, 127, 130, 134, 137-138 pharmaceutical regulation, 128, 132, 133 Fujisawa Pharmaceutical Company, Ltd., 160, 162 G Gallstone lithotripsy, 79-80, 98 Gastric balloon placement, 99 General Accounting Office (GAO)
From page 203...
... , 106 Cardiac Pacemaker Registry, 85 Common Procedure Coding System, ll9n.1 experimental therapy coverage, 62-63, 67, 179 medical device coverage, 10-11, 12, 80, 81-82, 85 Office of Coverage Policy, 10-11 pharmaceutical coverage, 17n.5, 178 surgical procedures coverage, 105, 106, 109-110, 113, 114, 115 Health care market, 3 Health insurance, 4, 22, 26, 138n.7, 148, 178 Health Insurance Association of America, 7, 62 Health maintenance organizations (HMO) , 57 cost containment, 1-2, 11-12, 58, 187 drug formularies, 17n.7 selective contracting, 105, 115 technology utilization, 29-30, 31 203 Health outcomes surgical, 14, 99, 100, 112-113, 114, 115, 116 technology and, 21, 22, 24-26, 28 Heart valves, 76 Hemodialysis, 25, 98 Herniorrhaphy, 14, 104, 106 Hewlett-Packard Company, 73, 149 High Technology Directive (1987)
From page 204...
... See National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS Laser atherectomies, 96 Lasers, 18n.12, 75, 77 Lawyers, 137 Lederle Laboratories, 158 Liability law and diffusion of technology, 2, 10, 71, 72, 75-76, 84, 94 Europe, 15, 136 Lilly, Eli, & Company, 160, 164, 190n.1 Linear accelerators, 151 Lithotripsy, 9, 28, 73, 78-80, 98, 149-150, 151 Liver transplantation, 98, 112, 151 Louisville, Ky., 104 Lung cancer, 56 M Magnetic resonance imaging, 26, 29, 146, 149, 151 Managed care plans, 13, 29-30, 48, 57, 58 Marion Laboratories, Inc., 183 Marketing, 185 Massachusetts General Hospital, 112 Mastectomy, 116 Medicaid, 1 and medical devices, 75, 77 pharmaceutical reimbursement, 8, 17n.7, 47-48, 50n.19, 178 surgical procedures coverage, 106-107 Medical care. See Health care
From page 205...
... See Clinical practice Medicare, 77 and demand for technology, 1, 75 medical device reimbursement, 12, 25, 28, 79, 80, 81, 82, 85 pharmaceutical reimbursement, 6, 57, 6263, 178 surgical procedure reimbursement, 105, 106, 107, 109, 113, 114, 115, 116-117, 120n.6 See also Prospective Payment System Medstone International, 79 Medtronic, Inc., 91 Meiji Seika Pharmaceutical International, Ltd., 157 Merck & Company, Inc., 158, 161, 164, 182, 183-184, 188, 190, l90n.1 Mergers, 183 Meta-analysis, 101 Methotrexate, 60 Methylmethacrylate, 96 Metropolitan Life Insurance Company, 115 Microprocessors, 93 Modifiable selective reimbursement, 14 Monitoring technologies, 94 Morbid obesity, 99 205 Mortality and morbidity, 14, 37, 99, 100, 111, 115 Mutamycin, 60 Myocardial infarction, 25 N National Aeronautics and Space Administration, 74-75 National Cancer Act (1971) , 54 National Cancer Institute (NCI)
From page 206...
... See Health outcomes Patients, 3, 185, 187 cancer, 5, 54, 55, 56, 61, 66 in clinical research, 50n.9, 62, 63 and payment policies, 56, 62, 63, 66, 120n.6, 131, 147 surgical, 99, 115, 116 Payers, 4 and health care costs, 27, 119 and medical devices, 94 and pharmaceuticals, 17n.5, 62, 102, 178, 180n.8, 187 Payment, 67, 96 denial of, 56, 58, 61, 63, 65 INDEX hospital, 75, 77, 105, 118 for investigational therapies, 62-63, 178179 Medicare, 62-63, 77, 81-82, 85, 116-117, 120n.6 physician, 1-2, 18n.13, 30, 105, 110, 118 public policy, 1-2, 5, 6-7, 12, 13-14, 1516, 16n.1, 75, 178-179 surgical procedure, 97, 104-117 See also Coverage; Prospective Payment System; Reimbursement Peer review, 13, 105, 111, 117 Penicillin, 156 Pepcid, 50n.10 Peptic ulcer disease, 25, 98, 99, 103 Percutaneous biopsy, 103 Percutaneous catheter ablation, 116 Percutaneous endoscopic techniques, 78 Percutaneous transluminal coronary angioplasty (PTCA) , 11, 108, 112 Peter Principle, 26 Pfizer, Inc., 73, 156, 158, 163, 190n.1 Pfizer Laser Systems, 73 Pharmaceutical Affairs Law (Japan)
From page 207...
... , 1-2, 11 Pre-marketing application (PMA) , 10, 79, 81, 82 Pre-marketing approval, 2, 15, 16, 136 medical devices, 9-10, 76, 79, 82, 83 pharmaceuticals, 5-6, 169 Prices, pharmaceutical, 8, 43, 44, 45, 50nn.13, 14, and 16, 139n.8, 186, 187 Europe, 123, 130-133, 134, 135, 136, 137, 138nn.6 and 7 generics and, 65, 133, 177 Japan, 157, 161, 166 Private foundations, 103 Private sector European health care systems, 148 insurance industry, 178 public policy and, 78 research, 48-49, 70, 75, 149 Professional Review Organizations, 117 Prospective Payment Assessment Commission (ProPAC)
From page 208...
... 208 Prudential Insurance Company of America, 115 Public Health Service, 10-11 Public policy, 16, 25, 31, 56 Europe, 14-15, 123-138, 141-153 Japan, 15-16, 165 medical device innovation, 69-86, 89, 92, 95, 141-142, 144-145 payment, 1-2, 5, 6-7, 12, 13-14, 75, 178179 pharmaceutical innovation, 5, 47-49, 123124, 135-138, 181-182, 183, 184, 185, 186, 188, 189, 190 Pulse oximetry, 89-90 Q Quality-adjusted life years, 25, 31n.1 Quality of life, 25-26, 142-143 Quinolones, 162 R Regulation, 2, 13 approval time, 17n.3, 37-38, 42, 172, 173, 174-176, 180nn.5 and 6 certificate-of-need, 1, 113 Classes of medical devices, 17n.8, 76, 79, 80-81 generic drugs, 6, 17n.4, 40-41, 42, 139n.9, 170, 177, 185 medical devices, 4, 9-10, 11, 12, 17nn.8 and 9, 18nn.10 and 11, 28, 71, 72, 7576, 78-81, 82, 83, 84, 85, 89, 92-93, 100, 108 medical devices, Europe, 15, 143-144, 150, 152 pharmaceuticals, 4, 5-6, 7, 8, 17nn.3 and 6, 39, 47, 50n.19, 70, 76, 83, 92-93, 97, 100-102, 108, 169-177, 186-187 pharmaceuticals, Europe, 15, 123, 128129, 131-132, 136, 137, 138n.1, 139n.11, 161 pharmaceuticals, Japan, 156, 158-159, 160-161, 164 Phases of clinical trials, 5, 170-176, 180nn.2, 4, 5 and 7 "polyintervention," 69-70, 73-74, 78, 8385, 86, 86n.1 surgical procedures, 97, 100, 113 See also Food and Drug Administration Reimbursement, 16n.1, 21, 96 and diffusion of technology, 26-30, 31, 53 Europe, 131, 144, 145-146, 147, 148, 150-151 INDEX HMOs and managed care plans, 13, 2930, 57, 58 hospital, 1, 27-29 Japan, 161, 164 Medicaid, 8, 17n.7, 47-48, 50n.19, 106107, 178 and medical devices, 71, 72, 77, 80, 83, 85, 94-95 Medicare, 6, 11, 12,25,27,28,31,5657, 62-63, 77, 79, 80, 81, 82, 85, 105, 106, 107, 109, 113, 114, 115, 116-117, 120n.6, 178 pharmaceutical, 6-8, 47-48, 56-65, 66, 177, 178-179, 180n.8 physician, 1, 30, 53, 58, 85 surgical procedures, 13, 96, 105, 106, 107, 109, 113, 114, 115, 116-117, 118, 120n.6 See also Coverage; Payment Reischauer, Edwin O., 155 Renal dialysis, 24, 151 Renal lithotripsy, 98, 110 Renal transplantation, 98, 107 Renin inhibitors, 162 Research, 16, 23-24, 74, 102, 103, 127, 142 animal studies, 5, 99, 128, 170-171 biomedical, 2-3, 48-49, 72, 75, 82, 138n.2, 182-183, 184, 188 cost-effectiveness, 8, 22, 24-26, 27 translation of, 70, 141 university, 13, 14, 54, 55, 92, 103, 149, 173, 184, 188 Research Councils (United Kingdom) , 149 Research and development cancer and AIDS drugs, 40, 54-55, 64, 144, 145 contraceptives, 10 demand for technology and, 3, 4-5 medical devices, 9, 11, 12, 70, 74-75, 85, 89, 90-91, 92, 95 medical devices, Europe, 144, 145, 149150, 152 patent protection and, 6, 9, 41-43, 47, 6465, 185, 186 payment policies and, 11, 47-48, 64, 187 pharmaceutical, 6, 35-49, 64-65, 66, 181190 pharmaceutical, costs of, 8, 37-40, 41, 42-43, 44, 45, 46~7, 49, 49nn.4, 5 and 6, 50n.17, 162, 182-183 pharmaceutical, Europe, 15, 123, 127, 131, 133-134, 135-136, 137, 186-187
From page 209...
... , 185-186, 190n.1 Rhone-Poulenc, Inc., 183 Risk-adjusted economic returns, 185 Rorer Group, Inc., 183 Roussel Uclaf, 158 S Safety medical devices, 12, 15, 18n.10, 79, 82, 83, 84, 85, 86 pharmaceuticals, 4, 5, 174, 175, 179180n.1, 180n.2, 185 Sandoz, Inc., 158 Schering AG, 158 Schering-Plough Corporation, 190n.1 Science, 2-3, 70, 102 education, 182, 188 research spending, 74, 75, 103, 127, 135 Selective contracting, 13-14, 113-118, 119, 120n.4 Self-insured employers, 67, 115 Shionogi & Company, Ltd., 164 Shumway, Norman Edward, 99 Sick Funds Council (Netherlands) , 151 Side effects, 6, 176, 180n.7 Siemens Corporation, 149 Small Business Innovation Research program, 92 Smallpox, 190 SmithKline Beecham P.L.C., 81, 183, 190n.1 Social security health care systems, 147-148 Spain health care system, 138n.3, 147, 148 pharmaceuticals in, 127, 129, 132, 133, 134, 138nn.5 and 6 Squibb Corporation, 183 Stanford University, 99, 112, 113, 120n.5 States, 1, 8, 47-48, 50n.19, 76, 85, 187 "Substantial equivalence," 17n.9 Supplemental NDA, 7, 61, 64, 176-177, 179 Supratentorial craniotomy, 107 Surgeons, 14, 115 209 Surgical procedures, 2, 22 cardiac, 28, 96-97, 98, 112, 113, 116 case loads, 112 cataract, 81 coding, 13, 97, 102, 105, 107-111, 118 innovation, 4, 12-14, 96-119 kidney stone, 78, 79 selective contracting, 13-14, 113-118, 119, 120n.4 Swan-Ganz catheter monitoring, 108 Sweden, 129, 136, 147, 150, 153n.2 Switzerland, 138n.3 pharmaceutical development, 126, 129, 132, 138, 166, 186-187, 191n.2 T Tagamet, 50n.10 Taito Corporation, 157 Taxation, 90, 183 Tax Equity and Fiscal Responsibility Act (1982)
From page 210...
... Congress, 25, 61, 62, 67 and cost containment, 8, 30, 77, 81, 85, 110 medical device regulation, 10, 76, 81, 83 pharmaceutical regulation, 170, 171, 177, 186, 189 INDEX U.S. Pharmacopeia, 7, 17n.6, 61 Universities, 13, 14, 54, 55, 92, 103, 149, 173, 184, 188 University of California at San Francisco, 111 "Upcoding," 108 Upjohn Company, 190n.1 Uruguay Round trade talks, 164, 165 Utilization review, 6-7, 29, 30, 62, 117 V Vagotomy techniques, 98 VAMP Ltd., 139n.14 Vasotec, 50n.10 Vepesid, 60 Vernon, John, 40, 41, 43 Veterinary Medicine Center (FDA)


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