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Conclusions ant! Recommendations Over the years various organizations have developed assessments of medical technology in response to specific needs or demands. Many agencies and organiza- tions conduct programs in assessment and dissemination of information about medi- cal technology, each from its own perspec- tive (see Chapter 2~. Taken singly, each program fulfills a particular purpose. For example, the Food and Drug Administra- tion's premarketing approval process pro- tects the public from unsafe and ineffica- cious drugs; the Office of Technology Assessment (OTA) conducts assessments on a variety of other technologies. Taken in combination, however, these various re- sponses do not constitute a coherent system for assessing all types of medical technolo- g~es. Problems that result from the lack of a systematic approach can be readily identi- fied. · The information base for technology assessment is often inadequate in depth and coverage. The collection of relevant, valid, primary data about technologies has not kept pace with the development of new 244 technologies for the prevention, detection, and treatment of disease. Many assess- ments, including those by the Office of Technology Assessment (Congress), the Office of Health Technology Assessment (Public Health Service), or the Office of Medical Applications of Research (Na- tional Institutes of Health) mention a lack of cogent evidence on which to base secure conclusions. Nor are there good scientific methods for interpolating or adjusting to compensate for missing data for assess- ments. These matters are well covered in Chapter 3. · Retrieval, collation, and dissemina- tion of already available information is in- adequate. No organization comprehen- sively monitors, collects, indexes, and disseminates information on technologies. Medical technology assessment often may require information from many subject areas. Such information is developed in many different places by different investi- gators and is not easily available in appro- priate form for decision making. · No systematic procedures exist for identifying major emerging technologies that may require special attention. Tech-

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CONCLUSIONS AND RECOMMENDATIONS nologies with major consequences for soci- ety ethical or economic may appear and urgently require assessment. Examples of such technologies are liver transplanta- tion, the artificial heart, and magnetic res- onance imaging. Use of technologies can become widespread before the necessary research is available on which to base pol- icy decisions about use, reimbursement, or purchase. The required investigations may be extensive, diverse, and numerous for a new technology. · No organization is responsible for set- ting priorities for assessment of technolo- gies. No orderly system exists for identify- ing and setting priorities for studies of technologies that require assessment. The current system largely depends on the in- terest of many different organizations and agencies to sponsor research. These studies may not address society's most pressing questions about a technology. · Assessment of a technology may come too late or never. A systematic procedure exists for assessing the safety and efficacy of drugs and devices before widespread dis- semination. But there are no such ap- proaches for identifying and assessing med- ical and surgical procedures before they move into medical practice. Furthermore, cost considerations of new procedures are rarely studied. · New uses of established technologies may escape assessment altogether. Drugs and devices receive rigorous evaluation for safety and efficacy before introduction into the market, but once on the market many drugs are used for purposes other than those for which they were evaluated and approved. · Underutilization of certain technolo- gies may be wasteful. A possible example of a useful and relatively neglected tech- nology is percutaneous transluminal angio- plasty as a treatment for peripheral vascu- lar disease. Angioplasty alone is less costly but also less efficacious than surgery. A strategy that applies the two procedures 245 stepwise (angioplasty first, then surgery if angioplasty is unsuccessful or if occlusion recurs) is uniformly superior to surgery alone in patients who have lesions for which angioplasty can be considered. If 40 percent of all patients in the United States with severe iliac or femoral artery disease were treated according to the stepwise strategy, there would be an estimated yearly savings (as compared with surgery alone) of 352 lives and $82 million, as well as an additional 5,006 functioning limbs (Doubilet and Abrams, 1984~. · Assimilation of assessment findings into health care processes can be slow. When new technologies are shown to be valuable or obsolete it may take a long time before clinical evaluation influences the adoption or abandonment of them. Obstacles can be as simple as the publica- tion of studies in the wrong journal to have an impact on practice (Stross and Harlan, 1979~. Diffusion of new methods is en- hanced by the extent to which they are easy to use, require little effort to learn, impose little change in practice style, are highly remunerative and satisfying, and have no clinically worthy competitors. Also, some features of the setting in which physicians practice influence their use of medical technology; for example, physicians in group practices appear to adopt innova- tions more rapidly than physicians in solo practice. These and other determinants of diffusion of assessments are discussed in Chapter 4. The principal objective in assessment of medical technology is the improved health of people. The primary costs of the lack of an adequate system for technology assess- ment are to human well-being patients do not receive optimal care. But there also are economic costs when the most cost- effective technologies are not applied or when ineffective technologies are. The worth of technology assessment in medicine reaches beyond its warranty to

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246 the patient and its utility to the health pro- fessional. The results of assessment also are needed by hospitals and other facilities that buy and apply technologies; by indus- tries that develop technologies; by the pro- fessional societies that disseminate infor- mation to health care practitioners; and by the insurance companies, government agencies, and corporate health plans that pay for the use of technologies. A strategy for assessing medical technology, there- fore, must take into account not only the methods of assessment but also the needs, demands, and resistances of the partici- pants and beneficiaries in the process. Medical technology assessment has de- veloped piecemeal in response to specific demands rather than as a system designed to provide the information required to im- prove and protect the health of the public and inform national policy decisions. What is needed now is the creation of an overall system for the orderly conduct of medical technology assessment. THE CHALLENGE We believe that it is possible and desir- able to establish a coherent system for tech- nology assessment. As evident in Chapter 2, many elements of such a system already are in place and can be built on. Numerous agencies and organizations are supporting or conducting assessments. The committee endorses this pluralism, believing that it contributes to the richness and variety of assessment activities as well as serving as a system of checks and balances. Further- more, as seen in Chapter 3, practical meth- ods of inquiry into medical technology ex- ist- methods that are well developed, widely accepted, and often reliable and that have a core of practitioners in place to apply them. The challenge for the committee then was to devise one or more strategies for medical technology assessment that builds on current efforts, strengthening and sup- ASSESSING MEDICAL TECHNOLOGY plementing them. First, the problems cre- ated by the lack of any coherent system were identified. This helped to identify and describe the key functions (described below) of an adequate system. Second, the institutional arrangements now available or that could be devised to achieve a ra- tional approach for assessment were exam- ined. Third, the recommendations con- cluding this chapter were developed, outlining a series of steps for achieving a coherent medical technology assessment system while taking advantage of the cur- rent multiple arrangements. KEY FUNCTIONS NEEDING IMPROVEMENT In preparation for reviewing options, the functions that must be well executed to ensure adequate medical technology as- sessment will be described briefly. Information Monitoring and Acquisition Any system for technology assessment must have the ability to identify, select, ac- quire, process, and sort documents and other materials and provide indexes to the collection. Because technology assessment draws on many fields, its information is in subject areas as diverse as law, finance, management, economics, biostatistics, epi- demiology, and biomedicine. Further di- versity is occasioned by the variety of orga- nizations producing reports, tables, experi- ments, studies, and reviews. The extensive information needs for the assessment of medical technologies and the present lack of a central organization or agency make essential the creation of some systematic method for gathering information from multiple sources. In the committee's view, this monitoring function should extend be- yond the United States to collect informa- tion from international efforts in medical technology assessment. As seen in Chapter

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CONCLUSIONS AND RECOMMENDATIONS 6, many developed countries are actively involved in technology assessment, but there is no clearinghouse for this informa- tion. Combining Information from Different Sources For maximum utility to health care pro- fessionals and policymakers, the informa- tion available on medical technologies has to be assembled and then combined in a systematic fashion. Individual research studies can easily be equivocal, but a clear view may be gained from a collection of studies, no one of which is strong enough to enable a conclusion. Thus the whole body of information needs to be examined so as to determine the appropriate differential weight to be given to studies of different scope and rigor. In addition, these studies pose multiple issues that must be ad- dressed, such as safety, efficacy, costs, and social and ethical consequences of technol- ogies. Information on these varied dimen- sions of concern also will turn out to be dif- ferentially valuable, and some further needs for information will be apparent merely from the assembly. Dissemination of Information Dissemination of information is a neces- sary component of any technology assess- ment system, because results must be promulgated both widely and through ap- propriate channels of communication if they are to influence patient care or pro- vider reimbursement. The source of infor- mation or channel of communication can have varying degrees of influence on physi- cian practice, as illustrated in Chapter 4. Research on dissemination practices should be part of a coherent approach to technol- ogy assessment. 247 Identification of Gaps in Knowledge That Require Research In an orderly system, gaps in knowledge about medical technologies are identified and studies to acquire needed data are commissioned. As indicated, there are many gaps in knowledge that result from current efforts. For instance, drugs and de- vices are identified and evaluated for safety and efficacy as they emerge but not after dissemination. Some medical proce- dures and surgery may be widespread be- fore they are ever studied; economic, ethi- cal, and social effects of a technology are rarely studied. Therefore, any system for assessment must develop an approach for ascertaining what information is needed about what technology and when. Data and Information Acquisition When gaps in knowledge are identified, there must be the capability to acquire the necessary data or information. The most pressing problem of the current situation is the lack of valid, reliable primary data. In- dustry is now by far the largest investor in technology assessment research, mostly be- cause of the regulations imposed by the Food and Drug Administration (FDA). But as indicated in Chapters 2 and 3, this leaves major gaps in knowledge for mar- keted drugs and devices and for medical procedures and surgery. Priority Setting The large number of technologies in clinical use means that resources must be allocated wisely to address important problems in technology assessment in some orderly way. At present dependence is largely on the interest of many different or- ganizations and individuals, each ap- proaching technology from the perspective of their own interest and need. Therefore, some system for developing a research

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248 agenda with a societal perspective is re- quired. Manpower for Technology Assessment Technology assessment requires investi- gators with diverse backgrounds and di- verse, specialized training (see Chapter 3~. Vigorous research activity is the key to con- tinual progress in most scientific and tech- nical fields, and technology assessment is no exception. To maintain the quality and vitality of research conducted in these fields, any system must ensure an adequate supply of well-trained scientists. The most comprehensive effort to esti- mate the number of active researchers in health services research, which overlaps the field of technology assessment, was a 1978 survey conducted by the then Na- tional Research Council of the National Academy of Sciences (NAS) Committee on National Needs for Biomedical and Behav- ioral Research Personnel. More than 1,370 persons were identified as once having re- ceived support from the National Center for Health Services Research (NCHSR) as principal investigators on research grants or contracts or as having received federal funds from the NCHSR or the Alcohol, Drug Abuse, and Mental Health Adminis- tration (ADAMHA) for training in health services research. As a point of compari- son, in 1977 there were 31,000 biomedical science Ph.D.s (excluding postdoctoral ap- pointees in academic employment) and about 9,800 M.D.s primarily engaged in research (NAS, 1983~. Unfortunately, fed- eral traineeships and fellowships for grad- uate students in health services research have essentially disappeared. NAS reports (1978, 1981) have consistently cited a lack of biostatisticians and epidemiologists. Manpower development and education of individuals should go beyond educating only those scientists charged with conduct- ing technology assessment, because a broader community of individuals need ASSESSING MEDICAL TECHNOLOGY the results of these studies. They should be able to understand and take advantage of ongoing work; results should be diffused promptly and reliably to those who can act on the information. Research and Development of Methods for Assessment Any system for technology assessment must also foster the improvement of meth- ods for technology assessment and the de- velopment of new approaches. Chapter 3 describes specific methods for evaluating technologies and also how these can be strengthened by further development through research. Each method has its strengths, weaknesses, and limitations for detecting favorable or unfavorable out- comes associated with a technology. Tech- niques for appraising the joint message of a set of related studies are in a flux of devel- opment; research in these methods for meta-studies is an important need. Some methods have not even been invented yet; for example, as pointed out in Chapter 3 there is limited ability to assess the social, legal, or ethical consequences of technolo- gies. Other very weak methods, such as case studies, have been shown to have im- pacts far beyond their validity on clinical care; enhancing their reliability as guides to clinical action could produce large health benefits. The introduction of Diag- nosis-Related Groups (DRGs) as a renew payment mechanism suddenly brought a new dimension to technology assessment. Much research will be required to discover the changes needed to make the DRG sys- tem operate for cost-containment and technology assessment. If there were a sys- tem for technology assessment, it would be alert to such methodologic issues and would move promptly to develop the field. Not only is knowledge limited about the characteristics of technologies, such as their safety, efficacy, costs, etc., but also little is known about how technology de-

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CONCLUSIONS AND RECOMMENDATIONS velops and diffuses into the health care sys- tem. Without such knowledge there is little hope of rationalizing health care services. BUILDING A SYSTEM As this analysis has revealed, existing in- stitutional arrangements, and probably ex- isting legislative authorities, are inade- quate to support an orderly system for technology assessment. Ways must be found to organize and finance the func- tions described here. In addition, because some elements of an effective system al- ready are in place, opportunities for build- ing and strengthening existing functions may be as important as establishing new institutional arrangements when war- ranted. ADVANTAGES AND DISADVANTAGES OF VARIOUS INSTITUTIONAL ARRANGEMENTS Technology assessment now has multi- ple participants both in the private and public sectors. Therefore, the committee sought to understand the advantages and disadvantages of different kinds of enti- ties public or private or some combina- tion of the two. Could one simply extend the functions of an existing body or is a new entity required? In its 1982 report, the OTA described various kinds of institu- tional arrangements (OTA, 1982~: (1) con- gressional sponsorship of a private-public body or chartering of an organization to undertake medical technology assessment activities, (2) reinstatement of the author- ity or funding of the National Center for Health Care Technology (NCHCT), or (3) encouragement of the secretary of the De- partment of Health and Human Services (DHHS) to develop a coherent system of medical technology assessment under powers already vested by law. Another possible approach is creation of a new fed- eral institution. 249 Private-Public Body An organization could be chartered as a separate nonprofit organization or as part of an organization. Examples of such orga- nizations include those in the proposal by Bunker and coworkers for an Institute for Health Care Evaluation (Bunker et al., 1982a,b) and in the Institute of Medicine (IOM) plan for a Consortium for Assessing Medical Technology (IOM, 1983~. One advantage of this approach would be the ability to capitalize on private sector initiative and interest and reliance on pri- vate as well as possible public funding. A combination of private and public sector involvement may be essential for any sys- tem of technology assessment to be accept- able to all parties concerned. Apart from the very real possibility that such an arrangement could not be forged or not be effective, disadvantages of this approach include the difficulties of obtain- ing adequate levels of funding to be effec- tive over time, lack of authority to enforce decisions, and possible bias toward mar- keting and profits for private sponsors. An additional limitation of the proposed Insti- tute for Health Care Evaluation is the close relationship of medical technology assess- ment to the reimbursement system because of its proposed financing, which can be re- strictive. For example funding might not be provided for examining social and ethi- cal issues. Existing private-public organizations have provided successful approaches to technical issues, such as building technol- ogy, health effects of vehicle emissions, and energy research and development. Ex- amples include the National Institute of Building Sciences (NIBS), the Health Ef- fects Institute, and the Electric Power Re- search Institute (EPRI) (Fox, 1981; EPRI Current Information, 1984~. A new pri- vate-public Council on Health Care Tech- nology, recently legislatively authorized,

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250 offers potential for coordinating technol- ogy assessment efforts (P. L. 98-551) . Whether a private-public organization could in fact develop a viable, effective sys- tem for medical technology assessment would depend in large measure on the se- curing of adequate resources to carry out the proposed functions and on maintaining a proper balance of all the vested interests. Reestablish the NCHCT ~ , ASSESSING MEDICAL TECHNOLOGY The National Center for Health Care Technology had good enabling legislation that permitted it to meet many of the ob- jectives of the proposed system. However, the levels of funding it attained were too modest for the goals and objectives envi- sioned here. In addition, presumably many of the same opposing interests that led to the demise of NCHCT would still be active. During its short life NCHCT pro- vided a focal point for the Health Care Fi- nancing Administration (HCFA) to inter- act with the Public Health Service, and thus the bulk of its resources were commit- ted to medical technology assessment as it related to the reimbursement system. Thus, while the legislative mandate of NCHCT was broadly drafted to permit it to develop a system for technology assess- ment, it never reached its full potential. The research program of the NCHCT was transferred to the National Center for Health Services Research (NCHSR) as were the responsibilities for providing ad- vice to the Health Care Financing Admin- istration. Funding levels for the NCHSR A Separate Federal Agency have been falling steadily for a number of years, and current expenditures of approxi- mately $14 million for technology assess- ment primarily health services re- search are meager in comparison with the tasks to be achieved. New legislation changes the name of NCHSR to the Na- tional Center for Health Services Research and Health Care Technology Assessment (NCHSRHCTA) and provides it with an Advisory Council on Health Care Technol- ogy to advise on technology assessment functions. Funding levels and functions still fall considerably short of what is envi- sioned in this report. There are advantages to having a federal agency charged with developing a system- atic approach to the assessment of medical technologies. Such an agency would be less encumbered by legal constraints, for exam- ple antitrust violations. Its interest would be the public interest, and it would be able to draw more easily on other government resources than would a private organiza- tion. In addition, a federal agency appears more likely than a private organization to obtain the necessary resources for such an endeavor. Development of a System by the DHHS Secretary Under powers vested by law, the secre- tary of the Department of Health and Hu- man Services could proceed to develop a coherent system of medical technology as- sessment. In the committee's view, unless new sources of funds were infused, com- peting priorities of other department func- tions probably would never permit alloca- tion of sufficient resources to develop an effective system. And if the function were placed in HCFA, the focus would primar- ily be limited to the reimbursement con- cerns of Medicare. Congress could establish an independent federal agency and charge it with develop- ing a system for medical technology assess- ment. The 1983 amendments to the Social Security Act (P.L. 98-21) authorize the creation of a Prospective Payment Assess- ment Commission, appointed by the direc- tor of the congressional Office of Technol- ogy Assessment, and give it broad powers, including medical technology assessment

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CONCLUSIONS AND RECOMMENDATIONS and the evaluation of appropriateness of medical practice patterns. The commission is to collect and assess information on costs, productivity, technological advances, and cost-effectiveness of hospital services. The commission is expected to synthesize exist- ing data in framing its recommendations and reimbursement rate setting, where those data are available, but it also is em- powered to conduct research and to award grants and contracts for research. A major provision of this legislation allows the com- mission to obligate Medicare Trust Fund resources for external research activities, with the approval of the DHHS secretary. Current levels of funding for this effort are too modest to accomplish the task set out by this committee. Furthermore, the focus of the activity is limited to Medicare prospective payment for inpatient hospital services. The commission cannot single- handedly develop a system for medical technology assessment. Legal questions still remain about the use of trust fund monies to fund research. Nevertheless, be- cause the commission can address the con- cerns of HCFA in a very focused way, if it does so vigorously, then fewer resources may be required to develop the system out- lined in this chapter. An independent federal agency would be advantageous in that it could be charged with setting priorities in technol- ogy assessment so as to reflect the needs of the nation.* It would likely be far more successful than an entity in the private sec- tor in soliciting data and opinion from fed- eral agencies involved in biomedical re- search, health care financing, or other areas relevant to medical technology. This would also probably hold true for obtain- * This is particularly important because recent im- position of the prospective payment system; informa- tion from technology assessment will be essential if there are to be sound decisions about which technolo- gies to use when caring for patients. 251 ing information from organizations in- volved in technology assessment in the pri- vate sector. Prospects for adequate long-term financial support seem brighter for a federal agency than for a privately chartered institution. Finally, an indepen- dent federal agency, as contrasted with NCHCT or an agency in a cabinet depart- ment, would be less susceptible to the whims of a new administration or Con- gress. However, enormous barriers exist to establishing yet another independent fed- eral agency, given pressures to decrease the number of or consolidate existing agencies. NOT THE REGULATORY APPROACH We notice that the fullest and most trust- worthy health care technology assessment is to be found in the fields where regulatory authority and the profit motive are most operative: drugs and class III medical de- vices. The principal reason for this seems to be simply that the FDA requires substan- tial amounts of high-quality data as a part of its licensing process. Regulation can be used to demand the collection of missing data especially since the profits from mar- keting the drugs and devices can support the necessary research. The committee would like to ensure new kinds of data acquisition by developing nonregulatory approaches, believing that cooperation may flow from an approach that offers incentives. One example is the development of reimbursement incentives for collection of data of prescribed scope and quality, for example, obtaining third- party contracts or grants for evaluating ex- perimental technologies in exchange for data. But other ways of tapping the health care dollar might also be developed, e. g., a tax on each hospital bed or outpatient pro- cedure, provider contributions, patient as- sessments. Another example is the indepen- dent, nonregulatory drug surveillance unit established at the University of Southamp- ton, England (Inman, 1981; Drug Surveil-

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252 lance Research Unit, 1983~. The unit is jointly funded by the government and by industry to establish a national scheme for detecting adverse events occurring during drug therapy. FINANCING In Chapter 2, it was stated that $1.3 bil- lion is a generous estimate for the amount spent on technology assessment. The drug industry, by far the largest investor, spends approximately $700 million-$750 million on technology assessment, the device in- dustry, $30 million-$50 million; and the federal government contributes about $450 million if the amount spent by NIH on clin- ical trials is added to the vastly smaller amounts spent by the Office of Medical Applications of Research (NIH), National Center for Health Services Research and Health Care Technology Assessment, and other government agencies. This may ap- pear to be a very large sum, until one real- izes that it is about 0.3 percent of the nearly $400 billion spent on health care in 1984. Given the preponderance of money spent on health care and the comparatively vanishing amount spent on assessing medi- cal technologies, the great need for pri- mary data cited in many different studies and by different groups for making deci- sions about patient care, and the need to choose among technologies, the committee believes that the additional resources re- quired to develop a coherent system should come from a larger share of the health care dollar. Various proposals have been made for tapping this dollar as outlined in Chapters 2 and 5, but further study is needed to map out exactly how to do this. The Prospective Payment Assessment Commission is an ex- ample of a group established to undertake technology assessment funded from the health care dollar (U.S. Congress, House, 1983~. As previously noted, the enabling legislation allows the commission to obli- ASSESSING MEDICAL TECHNOLOGY gate Medicare Trust Fund resources for ex- ternal research activities. Relman (1982, 1980) has suggested that 0.2 percent of all third-party expenditures for medical care might be an appropriate allocation for additional technology assess- ment. Such an allocation would have amounted to $490 million in 1984. Although it would be helpful to have more alternatives for additional funding of technology assessment, the actual solution will require political action. Whatever ap- proach or combination of approaches is used for tapping the health care dollar, the committee believes that the modest sum of $30 million should promptly be set aside for improving some of the described func- tions. Though not adequate to support the system envisioned, this amount would per- mit valuable first steps to be taken in the development of a coherent system. But the committee also cautions that this support should grow in about 10 years to $300 mil- lion (in 1984 dollars) to finance the accu- mulation of primary data on which all as- sessment must depend. Chapter 2 suggests how such funds might be spent. RECOMMENDATIONS The committee wishes to promote the development of a coordinated system for medical technology assessment that would both capitalize on the strengths and re- sources of the free-market economy and meet societal needs to make available safe, effective medical care. We recommend an incremental approach to achieve this pur- pose. These recommendations (in italics), distinct from the very specific ones in the preceding chapters and the boldface con- tributions to a research agenda throughout the report, are intended to help in building an assessment system. · The monitoring, synthesizing, and disseminating functions of medical tech- nology assessment should be established in

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CONCLUSIONS AND RECOMMENDATIONS some entity with a chartered mission and financing. We put this first because it is not very intrusive or expensive, it is highly rele- vant in itself, and its success and products would illuminate wiser choices among fur- ther possible actions. A private-public or- ganization seems the most appropriate set- ting for such a function because it is possible to coordinate both private and public activities, provide a neutral forum, elicit broad-based support, and impose on both sectors the responsibility to make the functions of the body useful. · The same entity should d evelo p the research agenda for filling gaps in knowl- edge relevant to assessment. One product of the entity might be state-of-the-art re- ports with clear recommendations for fu- ture research and some priority setting. This function flows quite directly from the task of monitoring and synthesis. · There should be a substantial increase in the accumulation of primary data for as- sessment. We have proposed that funds to support this research come from the health care dollar. The crucial bridge of technol- ogy assessment between science, research, and development on the one side and pa- tient care on the other receives too little at- tention. This circumstance may grow partly from the lack of an entity solely con- cerned with assessment. Inattention to as- sessment is prevalent in the private sector, where financial considerations are promi- nent. An initiative that does not directly produce revenues to cover outlays tends not to be well supported. A longer view would be hoped to reveal ample basis for a higher priority in the private sector if in- deed use of more cost-effective technology proves to be advantageous for the health care industry. · A portion of the health care dollar should he allocated to existing Public Health Service components (such as NCHSRHCTAJ that already have the task of supporting research on technology as- sessment. A close link between their activ- 253 ity and the public-private sector entity is required both for programmatic and fi- nancial concerns. A natural vehicle for this could be obtained by commissioning the development of a research agenda from the public-private sector entity, which could guide funding priorities by the government components. The additional funds should be used to fill gaps in knowledge about technologies when the profit motive does not operate to catalyze the collection of primary data such as in the drug industry. · Those organizations that support re- search in technology assessment should en- gage in developing it as a scientific field, such as improving methodologies and sup- porting education and training of assess- ment personnel. We have pointed out the need for supporting doctoral programs in epidemiology and biostatistics as well as quantitative training for physicians. The products of these research training pro- grams are needed both to carry out tech- nology assessments and to develop im- provements in methodology. Improved quantitative training for physicians is re- quired so that the need for careful technol- ogy assessment will be more widely appre- ciated in the medical community. Close links could be forged with the private-pub- lic sector entity by requesting this group to convene experts for advice and by using them as a forum for continuing education programs. · Support for medical technology as- sessment should rise over the next 10 years to reach an annual level $300 million greater (:in 1984 dollars) than at present. This should be phased in over a 10-year pe- riod. Funding continuity and stability should be emphasized to ensure a firm foundation for the enterprise. CLOSING COMMENT The committee believes that the func- tions identified for improvement should

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254 guide the strategy for developing a coher- ent technology assessment system. Chapter 2 describes many different or- ganizations and agencies doing technology assessment. This at once contributes to the richness and breadth of activities and to the need for some system. In a pluralistic society such as that of the United States, it would not be surprising to find functions for achieving a system of technology assess- ment distributed among several organiza- tions or agencies. But to build on the strength of the current system, no single proposed option seems sufficient in itself to accomplish our objectives. Accordingly, different functions may need to be either strengthened or newly established in some combination of two or more organizations. We have outlined the functions that are needed for a coherent technology assess- ment system and have suggested the divi- sion of these into two different organiza- tions one a private-public partnership and the other the strengthening of one or more existing government agencies. We acknowledge that there are other ways to achieve an overall strategy for assessment of medical technology, and we are not op- posed to other approaches. What we are concerned about is that there be a system that deals with the total problem. Of one thing we are certain, technology assess- ment can help ensure that patients are get- ting the most appropriate and the highest- quality care available and that the money we spend on health care is spent wisely. Our study has convinced us that we now are doing far too little assessment, and not even doing that well. We urge policyma- kers to shore up the current assessment ac- tivities and build upon them a national sys- tem of technology assessment. ASSESSING MEDICaL TECHNOLOGY REFERENCES Bunker, J. P., et al. 1982a. Evaluation of medical technology strategies: Effects of coverage and reim- bursement. N. Engl. J. Med. 306:620-624. Bunker, J. P., et al. 1982b. Evaluation of medical technology strategies: Proposal for an institute of health-care evaluation (second of two parts). N. Engl. J. Med. 306:687-692. Doubilet, P., and H. L. Abrams. 1984. The cost of underutilization: Percutaneous transluminal angio- plasty for peripheral vascular disease. N. Engl. J. Med. 310:95-102. Drug Surveillance Research Unit, University of Southampton. 1983. PEM News 1: 1-16. -~ EPRI Current Information. 1984. The Electric Power Research Institute, Palo Alto, California Fox, J. R., Breaking the regulatory deadlock. 1981. Harvard Business Review 81506:97-105. Inman, W. H. 1981. Postmarketing surveillance of adverse drug reactions in general practice. II. Pre- scription event monitoring at the University of Southampton. Br. Med. J. 282:1216-1217. Institute of Medicine. 1983. Planning Study Re- nort: A Consortium for Assessing Medical Technol- ogy. Washington, D.C.: National Academy Press. National Academy of Sciences. 1978. Personnel Needs and Training for Biomedical and Behavioral Research. Washington, D.C. National Academy of Sciences. 1981. Personnel Needs and Training for Biomedical and Behavioral Research. Washington, D. C.: National Academy Press. National Academy of Sciences. 1983. Personnel Needs and Training for Biomedical and Behavioral Research. Washington, D. C.: National Academy Press. Office of Technology Assessment. 1982. Strategies for Medical Technology. Washington, D. C.: Superin- tendent of Documents, U. S. Government Printing Of- fice. Relman, A. 1982. An institute for health-care eval- uation. N. Engl. J. Med. 306:669-670. Relman, A. 1980. Assessment of medical practice: A simple proposal. N. Engl. J. Med. 303:153-154. Stross, J. K., and W. R. Harlan. 1979. The dissem- ination of new medical information. J. Am. Med. As- soc. 241:2622-2624. U. S. Congress, House. 1983. Social Security Amendments of 1983, Conference Report. Report #98-47. 98th Cong., 1st sess.