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Policy Implications of the Computed Tomography (CT) Scanner

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Policy Implications of the Computed Tomography (CT) Scanner Policy Implications of the Computed Tomography (CT) Scanner November 1978 NTIS order #PB81-163917 Library of Congress Catalog Card Number 78-600078 For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, D.C. 20402 ii FOREWORD This study, Policy Implications of the Computed Tomography (CT) Scanner, was requested by the Senate Committee on Finance and the Senate Committee on Human Resources. It examines the CT scanner, an expensive, new diagnostic device that com- bines X-ray and computer equipment. The CT scanner has been rapidly and enthusiasti- cally accepted by the medical community in this country since its introduction in 1973. It is a medical technology whose development and use illustrate many important issues of health policy. The Senate Committee on Finance requested the Office of Technology Assessment (OTA) to consider such aspects of the CT scanner as “its usefulness, its costs, its effect on medical care delivery patterns, and ways to improve planning affecting such devices. ” The Senate Committee on Human Resources requested OTA “to examine current Federal policies and current medical practices to determine whether a reasonable amount of justification should be provided before costly new medical technologies and pro- cedures are put into general use. ” The Committee specifically asked that issues of efficacy and safety be addressed: “Before new drugs can be used, proof of efficacy and safety must be provided. However, no such legal requirement applies to other new technologies. ” The study was conducted by staff of the OTA Health Program with the assistance of the OTA Health Program Advisory Committee. The resulting report is a synthesis and does not necessarily reflect the position of any individual. In accordance with its mandate to provide unbiased information to Congress, OTA has attempted in this report to present information accurately and to analyze that in- formation objectively. The report contains no recommendations, but instead identifies a range of alternative policies for consideration by Congress. The views expressed in this report are not necessarily those of the OTA Board, the OTA Advisory Council, or their individual members. RUSSELL W. PETERSON Director Office of Technology Assessment . 111 — OTA HEALTH PROGRAM STAFF H. David Banta, Study Director (until December 1977) Jane Sisk Willems, Study Director (from May 1978) Other Research Staff Clyde J. Behney, Theresa A. Lukas, Joshua R. Sanes Administrative Staff Debra Datcher, Patricia Gomer, Ellen Harwood, Laurence S. Kirsch, Elizabeth Price Carole Stevenson, Cheryl Sullivan Carl A. Taylor, Program Manager (until May 1978) Gretchen Kolsrud, Acting Program Manager OTA PUBLISHING STAFF John C. Holmes, Publishing Officer Kathie S. Boss Joanne Heming OTA HEALTH PROGRAM ADVISORY COMMITTEE Frederick C. Robbins, Chairman Dean, School of Medicine, Case Western Reserve University Stuart H. Altman Sidney S. Lee Dean Associate Dean Florence Heller School Community Medicine Brandeis University McGill University Robert M. Ball C. Frederick Mosteller Senior Scholar Professor Institute of Medicine Department of Statistics National Academy of Sciences Harvard University Bernard Barber Professor Helen Ewing Nelson Department of Sociology Director Barnard College Center for Consumer Affairs Columbia University University of Wisconsin-Extension Rashi Fein Professor of the Economics of Medicine Anthony Robbins Center for Community Health and Executive Director Medical Care Department of Health Harvard Medical School State of Colorado Melvin A. Glasser Charles A. Sanders Director General Director Social Security Department Massachusetts General Hospital United Auto Workers Judith R. Lave Kerr L. White Associate Professor Chairman School of Urban and Public Affairs U.S. National Committee on Vital and Carnegie-Mellon University Health Statistics CONTENTS Chapter Page 1. SUMMARY . 3 Findings . 6 Policy Problems Identified . 9 Policy Alternatives. 10 Scope of the Study . 11 Organization of the Report. 12 2, BACKGROUND. 15 Principles of CT Scanning . 15 Operation of the CT Scanner . 16 Development of the CT Scanner. 19 3. EFFICACY AND SAFETY . 27 The Issue of Efficacy. 27 Evidence of Efficacy of CT Scanners. 29 Safety of CT Scanners . 38 Federal Policies Concerning Efficacy and Safety. 39 Shortcomings of Efficacy and Safety Policies . 42 4. NUMBER AND DISTRIBUTION . 47 Experience With CT Scanning . 47 Governmental and Nongovernmental Policies . 54 Federal Policies in Practice . 59 Shortcomings of Planning PoIicies . 62 5. PATTERNS OF USE. 67 Experience With CT Scanning . 68 Federal Policies Concerning Use. 75 Shortcomings of Utilization Policies . 77 6. REIMBURSEMENT . 81 Experience With CT Scanning . 81 Governmental and Nongovernmental Reimbursement Policies . 93 Shortcomings of Reimbursement Policies. 100 7. POLICY ALTERNATIVES . 105 l. Information inefficacy and Safety . 106 2. Government Regulatory Policies . 110 3. Financing Methods. 117 vii APPENDIXES I. LOCATION OF CT SCANNERS INSTALLED IN THE UNITED STATES, MAY 1977. 125 II. THEORETICAL CAPACITY AND ACTUAL OUTPUT OF A CT SCANNER . 137 III. INTERIM PLANNING GUIDELINES FOR COMPUTERIZED TRANSAXIAL TOMOGRAPHY (CTT) . 139 IV. ESTIMATES OF ANNUAL EXPENSES OF OPERATING A CT SCANNER. 143 v. CALCULATION OF NET EXPENDITURES FOR CT SCANNING, 1976. 145 VI. FEDERAL DEPARTMENTS AND AGENCIES WITH DIRECT INVOLVEMENT IN CT SCANNING . 147 VII. INTERNATIONAL VIGNETTES . 155 VIII. METHOD OF THE STUDY. 159 BIBLIOGRAPHY . 163 LIST OF TABLES Table Number 1. Characteristics of CT Scanners. 21 2. Diagnostic Accuracy of Head Scanning: Summary of Published Studies. 31 3. Comparison of CT Head Scanning With Other Neurodiagnostic Procedures . 34 4. Diagnostic Accuracy of Body Scanning: Summary of Initial Results. 37 5. Radiation Exposures From Use of Some Common Neurodiagnostic Procedures . 39 6. Type and Manufacturer of CT Scanners in Use, May 1977 . 48 7. Coordinates of Diffusion Curve . 50 8. Distribution of CT Scanners by State, Region, and Population. 51 9. Distribution of CT Scanners by Type of Facility. 53 10. States With Certificate-of-Need Legislation, Section 1122 Agreements, or CT Planning Criteria . 56 11. Criteria Used by Health Planning Agencies in Reviewing Applications for CT Head Scanners, August 1976 . 61 12. Some Diseases That Can Be Diagnosed by CT Scanning. 69 13. Major Diagnostic Uses of Head Scanning . 70 14. Estimated Types of Patients Diagnosed or Referred Annually Who Are Potential Cases for CT Head Scanning . 73 15. Estimated Annual Expenses of Operating a CT Scanner . 82 16. Prices of EMI Scanners, 1973-77 . 84 17. Estimated Average Cost of a CT Examination at Different Rates of output . 85 . Vlll Table Number Page 18. Fees Charged for CT Examinations, 1976 . 87 19. Reported Charges and Estimated Expenses of a CT Head Examination . 89 20. Estimated Average Annual Profits From a CT Head Scanner, 1976. 89 21. Estimated Expenditures for CT Scanning, 1976. 91 22. Federal Departments and Agencies With Direct Involvement in CT Scanning . 148 23. Numbers of Cerebral Angiographic and Pneumoencephalographic Examinations inVariousSwedish Hospital Categories . 158 LIST OF FIGURES Figure Number Page 1. Computed Tomography (CT) Head Scanner . 4 2. Computed Tomography (CT) Body Scanner . 5 3. Schematic Illustration of CT Scanner . 16 4. Normal Brain Cross-Section, CT Scan . 17 5. Examples of Graphically Reported CT Findings . 18 6. Typical Computed Tomography Installation Involving Divided Rooms.. 19 7. Configuration of First and Second Generation CT Scanners With Parallel-Beam Data Acquisition . 22 8. Third Generation CT Scanner Configuration With Fan-Beam Data Acquisition . 22 9. Malignant Lymphoma in Right Frontal Region Before and After Enhancement . 32 10. Cumulative Number of CT Scanners in the United States by Date of Installation . 49 m 1 ● SUMMARY The computed tomography (CT) scanner* is a revolutionary diagnostic device that combines X-ray equipment with a computer and a cathode ray tube (television-like device) to produce images of cross sections of the human body. The first machines were “head scanners,” designed to produce images of abnormalities within the skull, such as brain tumors (figure 1). More recently, “body scanners” have been marketed, which scan the rest of the body as well as the head (figure 2). CT scanning has been rapidly and enthusiastically accepted by the medical com- munity. Developed in Britain in the late 1960’s, the CT scanner was quickly hailed as the greatest advance in radiology since the discovery of X-rays. Head scanning has become a standard part of the practice of neurology and neuroradiology, and physicians believe that the potential of body scanning is great. Less than 4 years after the introduction of CT scanning into the United States, at least 400 scanners had been installed at a cost of about half-a-million dollars.
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