7

The Appropriate Use of Technology

PREVIOUS CHAPTERS HAVE DISCUSSED specific aspects of decisions that the National Heart, Lung, and Blood Institute (NHLBI) must make in coming years about the artificial heart program. This chapter addresses the appropriate use of mechanical circulatory support systems (MCSSs). These devices present a special occasion: Perhaps never before in the modern history of health care technologies has there been such an opportunity to take steps to promote appropriateness of use in advance of a technology's widespread diffusion. The committee believes that this opportunity should be recognized by all those concerned with MCSSs and with the general appropriateness of technology use as one too valuable to be passed by. The anticipated substantial volume of MCSS use and high cost involved are additional reasons to take such early actions.

The past three decades have seen the development of numerous examples of high-technology health care that have yielded important patient care gains. Yet some appear to have been used inappropriately to varying degrees including, in the cardiovascular arena, percutaneous transluminal coronary angioplasty and coronary artery bypass surgery (Cardiology Working Group, 1991).

In principle, subject to discussion elsewhere of such topics as cost-effectiveness, the committee supports the use of long-term ventricular assist devices (VADs) and total artificial hearts (TAHs) to provide optimal patient care. It is concerned, however, about the possibility of their inappropriate use. If NHLBI were in a position to manage how these devices are used after their approval by the Food and Drug Administration (FDA), this report would include specific recommendations for such activities. However, the



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The Artificial Heart: Prototypes, Policies, and Patients 7 The Appropriate Use of Technology PREVIOUS CHAPTERS HAVE DISCUSSED specific aspects of decisions that the National Heart, Lung, and Blood Institute (NHLBI) must make in coming years about the artificial heart program. This chapter addresses the appropriate use of mechanical circulatory support systems (MCSSs). These devices present a special occasion: Perhaps never before in the modern history of health care technologies has there been such an opportunity to take steps to promote appropriateness of use in advance of a technology's widespread diffusion. The committee believes that this opportunity should be recognized by all those concerned with MCSSs and with the general appropriateness of technology use as one too valuable to be passed by. The anticipated substantial volume of MCSS use and high cost involved are additional reasons to take such early actions. The past three decades have seen the development of numerous examples of high-technology health care that have yielded important patient care gains. Yet some appear to have been used inappropriately to varying degrees including, in the cardiovascular arena, percutaneous transluminal coronary angioplasty and coronary artery bypass surgery (Cardiology Working Group, 1991). In principle, subject to discussion elsewhere of such topics as cost-effectiveness, the committee supports the use of long-term ventricular assist devices (VADs) and total artificial hearts (TAHs) to provide optimal patient care. It is concerned, however, about the possibility of their inappropriate use. If NHLBI were in a position to manage how these devices are used after their approval by the Food and Drug Administration (FDA), this report would include specific recommendations for such activities. However, the

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The Artificial Heart: Prototypes, Policies, and Patients responsibility of NHLBI and other components of the National Institutes of Health (NIH) typically ends with clinical trials designed to demonstrate a technology's safety and efficacy. An emerging technology is rarely scrutinized to the degree reflected in this report and the previous NHLBI evaluations, and none has been so publicly examined this many years in advance of its routine clinical use. The committee is thus able to express its concerns about inappropriate use becoming a problem area for MCSSs and to suggest how those involved with MCSS development and diffusion can minimize the likelihood of inappropriate use. Further, the interim period until general, widespread MCSS use begins provides an unprecedented opportunity to debate, decide upon, and implement a group of mechanisms to promote their appropriate use. WHAT APPROPRIATE TECHNOLOGY USE IS The term “appropriateness” has no special definition when applied to the provision of health care services. Appropriateness of use can perhaps best be explained by viewing it as one important aspect of the quality of care, where quality is defined as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” (IOM, 1990b, p. 21). Using this definition of quality of care, appropriateness is one of the elements of quality that links health services to “desired health outcomes”; it is “using what works” (Berwick, 1989). Clinical trials and technology assessments help to define what works by determining efficacy, effectiveness, risks, and cost-effectiveness. All of these are important measures in providing quality care or, as the Institute of Medicine (IOM) definition noted, care that is “consistent with current professional knowledge.” This dissection of quality care into small elements reinforces the importance of appropriate care. Appropriateness becomes the bottom line—using what works, only when it is expected to work, and only with those for whom it is expected to work. Consideration of cost leads to the additional conclusion that appropriate care uses resources to produce more improvement in health outcome than could be achieved by alternative uses of those same resources. Later sections of this chapter explore issues relevant to “using what works.” Several groups have studied appropriateness of use of specific technologies. For example, both Wennberg and colleagues (1988) and Chassin and his colleagues at the RAND Corporation (1987) have focused on variations in physician practice patterns, in particular the overuse or underuse of surgical procedures. Appropriateness is a concept that is applicable to any type of health care technology or service, whether a drug, medical device, or medical or surgical intervention and whether new or routinely used.

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The Artificial Heart: Prototypes, Policies, and Patients The Relationship Between Technology Use and Cost For almost 15 years (Altman and Blendon, 1979), researchers have linked use—and overuse—of technology to the steady rise in health care costs. In some studies, the technologies involved are low in cost on a per-procedure basis but used in large volumes, such as laboratory tests (Fineberg, 1979). Other studies have examined technologies with high capital costs and perprocedure charges in the hundreds of dollars (Hillman, 1986). Identifying precisely the portion of the year-to-year increase in total U.S. health care expenditures that derives from the use of new technologies is generally considered impossible (Neumann and Weinstein, 1991), as is separately measuring the contribution of inappropriate technology use to total expenditures. Yet, whether on cost or quality-of-care grounds, attention to improving the overall appropriateness of health care services is warranted. Factors That May Affect Future Use of New Technologies Technologies that emerge into routine clinical practice in the coming 20 years face a health care environment very different from that of the 1970s and 1980s. Three major factors will affect technology diffusion. First, capital spending for costly equipment is likely to be more constrained than at any time since the Medicare program 's enactment in 1965. Tightening limits on revenue from Medicare prospective payment and similar systems of paying for inpatient care on a per-admission basis directly affect the hospital “operating profits” that are a major source of capital-budget funds. Restrictions on year-to-year revenue growth have had a particularly dramatic impact on capital spending by hospitals with per-case costs that are higher than payments received, because of the impact of such losses. This situation may, further, become even more restrictive when the Medicare program eliminates “pass through” reimbursement of capital costs and incorporates them into prospective payment. Second, hospitals and other providers are likely to resist the adoption of technologies that have substantial operating costs on a per-patient basis especially when, as is typical, the cost is not matched by increased revenue from using the technology. Third, resistance to new technologies will also arise because of efforts by large employers to constrain the cost of health insurance for their employees by imposing restrictions in their plans' benefit structures. Continuing federal and state budget deficits that restrain Medicare and Medicaid expenditure increases will have a similar effect. Yet none of these approaches can be counted upon as an ideal restraining mechanism for a technology such as an MCSS once its clinical effectiveness has been established, because the appeal of its life-sustaining capability may overwhelm these restraints.

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The Artificial Heart: Prototypes, Policies, and Patients Past Failures to Limit Technology Use Efforts to affect the diffusion of technologies, some discarded and others still in use, have relied on either an aggregate or patient-by-patient approach. The most notable of the aggregate approaches was the health planning and certificate-of-need (CON) program initiated by Congress in 1974 (P.L. 93-641) and still in effect in some states. Its provisions were regulatory in nature, prohibiting hospitals from acquiring major capital equipment, undertaking construction, or opening a new service without a CON from the state health planning agency. Because P.L. 93-641 did not mandate that states require nonhospital facilities (e.g., freestanding diagnostic imaging centers, physician offices) to obtain a CON before acquiring costly technologies, it had only limited impact on the diffusion of costly technologies such as computed tomography scanners and magnetic resonance imaging systems (Hillman, 1986). In part because of the law's ineffectiveness, federal support of the CON process was terminated in the early 1980s. Most of the states retaining their own CON controls have dollar thresholds set so high that they exert little or no restraint on technology diffusion. Until recently, few controls have existed over the use of technology in the care of specific patients. Since 1972 legislation (P.L. 92-603), professional standards review organizations, now peer review organizations (PROs), have reviewed the appropriateness of hospital admissions and lengths of stay, but rarely the individual components of the care that is provided. Some PROs now review ambulatory care for other payers, as do many managed care providers and payers, themselves, but their impact on technology use has not yet been examined. Third-party payment restrictions such as those of Medicare Part B have had some effect on technology use in individual cases, in particular when used in physicians' offices and other ambulatory settings or, for inpatients, when a specific physician fee is involved. This is particularly true where the new technology is clearly identified on claims submitted to third-party payers, but coding of services sometimes does not reveal that an unapproved technology has been used. Concurrent with overall fiscal pressures, patient-by-patient attention to the quality of the care that is provided—and to its cost—is growing. The share of the total insured population whose coverage is “managed” (e.g., by health maintenance organizations or preferred provider organizations) is likely to increase steadily through the 1990s. Additionally, activities of the Public Health Service's Agency for Health Care Policy and Research (AHCPR) are already stimulating the development of clinical practice guidelines for use in patient care decisions (IOM, 1990a), as well as increased attention to comprehensive studies of treatment outcomes with both new and established forms of treatment.

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The Artificial Heart: Prototypes, Policies, and Patients An important question is whether the mechanisms discussed below are seen by policymakers as sufficient to ensure the appropriate diffusion of MCSSs. If they are not, this technology may well provide both an opportunity and a reason for Congress to review the need for new legislation concerning technology use. Past legislative attempts to manage technology diffusion and use, either in the aggregate or case by case, failed because they did not address the problem broadly enough. From today's perspective of continuing increases in health care costs, legislators may well decide the time has come to formulate new mechanisms that, for the first time, effectively manage the diffusion of MCSSs and other costly technologies. WAYS TO PROMOTE APPROPRIATE USE OF MECHANICAL CIRCULATORY SUPPORT DEVICES Because of the cost of implanting a long-term MCSS, this technology is likely to receive at least as much attention from third-party payers, health care providers, and others as any previous technology has received. Even that degree of scrutiny, however, may not suffice to prevent inappropriate use that could have an adverse impact on the quality of care and also increase aggregate health care costs substantially, because of the high perpatient cost. Several types of activities can promote the appropriateness of MCSS diffusion and use. Clinical Practice Guidelines Developing Practice Guidelines Under the 1989 legislation that established AHCPR, Congress directed that it arrange for the development of clinical practice guidelines to help in assuring the effective and appropriate delivery of health care (Omnibus Budget Reconciliation Act of 1989, sec. 912). AHCPR sought planning guidance from the IOM, which provided one report to the agency in 1990 (IOM, 1990a) and is currently studying additional issues. Whether developed under AHCPR auspices, independently by physician organizations, or through other means, practice guidelines covering many clinical conditions are likely to be developed and implemented in the coming years.1 This activity will be an integral part of a broad range of efforts 1   In addition to defining practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances, ” the IOM has differentiated them from “medical review criteria” to be used in assessingthe appropriateness of care (IOM, 1990a). This committee's discussion of clinical practice guidelines should be construed, however, to include the medical review criteria derived from them.

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The Artificial Heart: Prototypes, Policies, and Patients to improve health outcomes and the quality of care. In parallel with the development and use of clinical practice guidelines, strengthened quality assurance programs (including emphasis on the concepts of continuous quality improvement and total quality management) will represent another means of achieving quality-of-care gains, as will increased levels of scrutiny that can be expected from pretreatment payment authorization programs of Medicare and other third-party payers. Practice guidelines for long-term MCSS use might be developed by the existing Task Force of the American College of Cardiology and American Heart Association that has developed a number of guidelines for the use of cardiovascular technologies; other organizations in the cardiothoracic surgery or cardiology field might also be involved. These or similar groups could also monitor MCSS clinical effectiveness and revise the guidelines at suitable intervals, as clinical experience gained in the early years of routine use clarifies detailed indications for use. In contrast to many other technologies, the TAH is a special case because of its life-or-death quality and because once implanted in the human body, its use is irreversible. With both VADs and TAHs, the committee concludes that the development of practice guidelines at an early time is important in promoting the appropriateness of their use. In the committee's view, indications for use should be developed and disseminated as soon as possible. They could be developed on a provisional basis during the time FDA is reviewing clinical trial results, or even during the trial, to be revised later based on clinical-use experience. The early availability of such guidelines, developed by experts and reviewed by key professional organizations, would greatly aid third-party payers in making MCSS coverage decisions. The Medicare program may well take the lead in developing MCSS guidelines, because of its substantial stake in the appropriate use of these devices. Implementing Practice Guidelines It is not yet clear what incentives and other implementation techniques will be developed for use with practice guidelines. Whatever is used generally, however, such as educational programs and financial incentives, may not be useful with MCSSs because they are a new technology and will be used, at least initially, in only a few hospitals. In the early years, guidelines for MCSS use will be implemented and enforced by two parallel mechanisms. Third-party payers will apply them when considering physician requests for preprocedure authorizations, and hospitals will also likely oversee MCSS use closely because of the high cost involved and the uncertainty of receiving adequate payments.

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The Artificial Heart: Prototypes, Policies, and Patients Appropriate Use of Other Technologies Those developing indications for MCSS use should not overlook the need to ensure appropriate use of alternative forms of treatment, such as conventional medical treatment for heart failure. One study, for instance (Walden et al., 1989), found that stable heart failure patients survived as long without a transplant, but with intensive medical management, as did those who received a donor organ. A similar result may also occur, at least initially, with MCSS candidates who, for whatever reason, do not receive an implant. The appropriate use of conventional drug treatment for heart failure should therefore not be overlooked in the rush to use MCSSs. Technology Assessment Technology assessment and its frequent component, cost-effectiveness analysis (CEA), are increasingly being recognized as useful in determining the most effective future role for new and emerging technologies. They will often be performed as part of the development of practice guidelines. When a technology assessment or CEA is performed before the technology has diffused widely, the information concerning the new technology may be at a lower level of accuracy than is the case with technologies already in general use. For this reason, terms other than CEA and technology assessment may be more appropriate for estimate-based studies such as the one performed in connection with this evaluation and discussed in Chapter 6. Nonetheless, a technology assessment should be an integral part of any effort to oversee the diffusion and use of a technology as complex and costly as this one. By assessing particular MCSSs periodically, the information about clinical effectiveness developed for this study can be verified and updated. Other forms of postmarketing surveillance also are important. The committee concludes that a technology assessment should be performed as soon as data based on actual MCSS use are available and periodically thereafter. It suggests further that appropriate organizations such as the congressional Office of Technology Assessment and AHCPR be charged with conducting such assessments or ensuring that they are carried out. Postmarketing Surveillance Postmarketing surveillance of safety and effectiveness after FDA approval for general use, one aspect of scrutiny of a technology, occurs to a limited extent with both new pharmaceuticals and medical devices but not with new surgical procedures that do not involve specific devices. For pharmaceuticals and medical devices, the manufacturer is obligated to re-

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The Artificial Heart: Prototypes, Policies, and Patients port to FDA certain adverse reactions and product-related deaths, serious injuries, and malfunctions that have the potential to cause death or serious injury; under 1990 legislation, medical device users will be required to report device-related deaths and serious injuries. New surgical procedures are, of course, developed and diffused throughout the surgical community with no governmental oversight other than what is provided indirectly by providers' quality assurance programs and third-party payers' case review procedures. These formal requirements reveal unsafe performance more effectively than they identify changing levels of a new technology's clinical effectiveness. Additional requirements may therefore be appropriate and should be considered for MCSSs and similar implantable, life-supporting devices. A 1990 law requires manufacturers of implanted devices to submit a formal postmarketing surveillance protocol for FDA approval after review by an independent review group. One manner in which routine surveillance can be accomplished is through the use of a patient registry to which physicians who use the device submit data pertaining to specific patients, both at time of implantation and after each follow-up visit. The committee concludes that a registry of long-term MCSS use is highly desirable and suggests that interested parties jointly explore possible mechanisms by which it might be established and funded. Registries have been created for two cardiovascular technologies, cardiac pacemakers and percutaneous transluminal coronary angioplasty. The latter was supported primarily by NHLBI, at a cost of about $350,000 per year. The current era of severely constrained federal budgets, however, makes it difficult to envision a major commitment to support another registry on the part of either NHLBI or FDA. Other funding means must therefore be considered. The most feasible alternative is probably a registry that is funded, as part of the cost of the implantation, through payments by hospitals when they purchase each device. Further, because of the value of registry data to third-party payers, they could consider making their agreement to pay particular providers for MCSS implantation conditional on the provider's participation in a registry; see the discussion of selective coverage, below. Such arrangements could also provide explicitly for payment levels that support the registry's operation, in recognition of the indirect benefits to payers. Specific provisions as a part of physician fee structures also would enhance future submission of information to the registry by physicians. A registry's value will be enhanced by consistent, accurate reporting of clinical and technical data both at the time of MCSS implantation and at regular intervals thereafter, if those involved in creating the registry agree in advance on a detailed protocol for data collection by each implantation

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The Artificial Heart: Prototypes, Policies, and Patients and follow-up site. The periodic visits that all MCSS patients will make, to have the performance of their device checked, offers an easy, efficient opportunity for collecting both clinical and quality-of-life data on a continuing basis. In addition to physician and hospital participation, patients could be asked, as part of the process of granting informed consent to implant the device, to agree to provide periodic information to the registry, such as by responding to questionnaires when visiting their physician or hospital for a device checkup, or through telephone interviews. Patients cannot be required to provide such information but, if the benefits to society at large from their participation are explained adequately, most patients would likely agree to cooperate. Follow-Up Studies Clinical trials of new implantable medical devices typically provide for a two-year postimplantation follow-up period, but this is not long enough, with life-sustaining technologies such as an MCSS, to reveal all possible problems. Further, neither a registry nor routine FDA-required postmarketing surveillance is likely to reveal all long-term risks and complications because these mechanisms record only limited information. Comprehensive long-term follow-up studies are very costly if done properly, and could probably be conducted only with a sample of all persons receiving MCSSs. Nonetheless, NHLBI should support such long-term studies for patients in the clinical trials that it funds, and AHCPR should support studies of patients who later receive an MCSS. A registry, if established, could be used as a pool from which patients can be drawn for more detailed follow-up studies. Funding of follow-up studies must be adequate to support study designs that have sufficient statistical power to reveal serious problems with the technology. They should also be designed to compare MCSS outcomes with those of alternative forms of treatment such as conventional medical treatment. The level of funding should support periodic measures of patients' quality of life and other nonphysiologic factors, without reducing the amount or quality of the general clinical data that are gathered. Credentialing for Technology Use A relatively recent development in managing the use of complex technologies is the formulation and implementation of appropriate requirements calling for specific levels of training and experience, and their documentation, before a physician is allowed to use a new medical device (ECRI, 1987). The committee recognizes the importance of such guidelines as a

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The Artificial Heart: Prototypes, Policies, and Patients means of ensuring patient safety as well as enhancing appropriate technology use but acknowledges that the concept has, by no means, met with wide acceptance and use. Most credentialing guidelines have been developed by physician organizations and are intended for nationwide use, but their application usually relies on the individual hospital or other provider and its system of clinical privileges. Such guidelines typically apply to new medical devices and surgical procedures. In contrast, the use of new pharmaceuticals is controlled by the item's unavailability until approved by each institution's “pharmacy and therapeutics” or similar committee for entry into its formulary. The physicians involved in a particular MCSS's development and clinical trials will likely be the early trainers of additional physicians in using the device; these physicians, perhaps through their specialty societies, are the most logical individuals to develop training and experience requirements. Once such guidelines are adopted and disseminated, individual hospitals can and should apply them to limit users of the device to those physicians who are deemed qualified. Third-party payers can also apply them to formulate and announce policies under which they would refuse advance authorizations for unqualified physicians to perform MCSS implantations. Such restrictive payment practices have rarely been applied by third-party payers but are particularly appropriate for a costly, life-sustaining technology of the nature of MCSSs. Selective Coverage The Medicare program and several third-party payers in the private sector have developed selective coverage programs applicable to heart transplantation and other high-cost technologies, in effect an extension of the physician credentialing concept to the hospitals in which they practice. These programs achieve a quality-related goal by limiting payment for technology use to specific institutions, sometimes referred to as “centers of excellence,” that meet explicit staffing requirements and can document experience (e.g., patient volumes, specific minimum survival rates) with use of the particular technology. Improved safety and quality of care as a result of regular use of the technology by physicians and other health professionals also support this goal. A second goal relates to the lower cost that results from concentrating the service instead of having it offered widely, motivating third-party payers to develop these programs and institutions to offer favorable payment rates. The selective coverage concept can include provisional approval, based on an institution's experience with analogous types of care. If this is not done, each institution must initially use the technology only with patients who pay for their own care or must somehow absorb the cost of the initial

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The Artificial Heart: Prototypes, Policies, and Patients cases, in order to build the experience base required for selective coverage approval. In implementing selective coverage, especially if it is to be adopted by numerous health insurers, consistency of criteria on such issues as minimum volumes and provisions for reasonable geographic access is important. To date, however, each insurer has developed its own program details. The committee concludes that programs of selective coverage for the implantation of long-term MCSSs are desirable. It suggests that third-party payers cooperate in developing coverage policies for MCSS use, recognizing such possible constraints as antitrust laws. INVOLVING THE RIGHT PARTICIPANTS Mechanisms to oversee technology use have traditionally been developed in closed processes by either physician groups or third-party payers. With rare exceptions (e.g., Blue Shield of California's Medical Policy Committee, as described by Schaffarzick [1985]), only members or employees of the organization developing the mechanism participate in the process. The current attention to clinical practice guidelines is causing a reexamination of the past process of developing such measures in private. It is premature to describe the procedures by which diverse parties (including patients) will come to be involved in developing guidelines. Practice guidelines are, however, almost certain not to remain the private preserve of individual organizations, at least not those guidelines formally recognized by AHCPR. The committee expresses the hope that all activities to promote appropriate MCSS use will be formulated by widely representative groups. Others can also be involved through mechanisms such as advisory committees and public hearings on proposed guidelines. Certainly, the clinicians and researchers involved in developing MCSSs and in clinical trials are important participants in guideline development because of their intimate knowledge of the devices' impact on patient care. Other less obvious participants should include other physicians and allied health professionals, personnel from NHLBI 's artificial heart program, representatives of third-party payers, health services researchers, economists, ethicists, and either MCSS patients themselves or others (e.g., family members, caregivers) who can speak from that perspective. NIH institutes have not usually participated in overseeing the diffusion of new NIH-sponsored technologies, beyond the consensus development conferences held periodically by the NIH Office of Medical Applications of Research about various diagnostic and therapeutic technologies. The depth of NHLBI's involvement in developing MCSSs is, however, a strong argument for its personnel's participation in formulating mechanisms for

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The Artificial Heart: Prototypes, Policies, and Patients these devices' appropriate use. NHLBI's mid-1980s role in formulating guidelines used to approve heart transplant programs for participation in Medicare serves as a precedent for the agency's involvement in clinicaluse issues. NHLBI officials could also aid in promoting the appropriateness of MCSS diffusion and use by interpreting to AHCPR the reasons that the latter agency should accord high priority to developing guidelines for MCSS implantation and to supporting posttrial studies of MCSS use. AVOIDING UNREASONABLE PATIENT EXPECTATIONS To a considerable extent, the public's expectations about MCSSs will be shaped, not by what cardiologists and cardiothoracic surgeons tell patients and their families, but by how the use of these devices is described on television and in newspapers and magazines. MCSS developers and clinical trial investigators have a particularly difficult task ahead, as trials of long-term devices begin. The privacy of patients and their relatives must be respected, but somehow balanced with the public's interest in each patient's day-to-day progress. Investigators, device developers, and reporters all have roles in portraying the potential and the limitations of these devices realistically. A patient's ability to get out of bed soon after receiving an MCSS may have little or no bearing on long-term survival prospects, and media representatives should be helped to appreciate that long-term results are the true test of the technology's value. Similarly, those involved directly with the sale and implantation of MCSSs have a natural incentive to portray the technology in a positive light. Others knowledgeable about MCSSs, such as representatives of medical specialty societies and NHLBI, may sometimes find it appropriate to offer counterbalancing statements to the media. In the early years of MCSS clinical trials and routine use, the degree to which reporters and commentators understand this technology's potential and limitations and reflect that understanding to their viewers and readers will have considerable influence on the appropriateness of MCSS use. Public attitudes on the part of such key individuals as union leaders, business executives, and elected officials will likely be influential in early coverage decisions by third-party payers. Only when a large body of clinical data is available will decisions become more readily based on evidence of long-term patient outcomes and quality-of-life gains. All concerned can learn from the TAH experience of a decade ago (Blakeslee and Shaps, 1986; DeVries, 1988) and plan accordingly. A reasonably informed public will be the best environment for developing reasonable policies about MCSS use.

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The Artificial Heart: Prototypes, Policies, and Patients SUMMARY AND CONCLUSIONS Each of the mechanisms discussed in this chapter is important in promoting the appropriateness of the use of long-term circulatory support devices. If the law governing FDA allowed it, this committee would recommend that FDA approval of MCSSs for general use be withheld until such measures can be developed, supported financially, and implemented by the relevant parties. The timetable for MCSS development does, however, permit other sectors of the health care community to respond to the concerns and suggestions expressed here. Ample time exists before the first model of a long-term VAD goes into wide use in the late 1990s, and the TAH in perhaps 2005 or 2010, to formulate and implement mechanisms that promote appropriate MCSS use and reduce the likelihood of inappropriate use. The committee would be reluctant to advise NHLBI to continue its support of MCSS development if it believed that substantial inappropriate use of these devices would occur. The committee regards this eventuality as unlikely, but is nonetheless concerned about what it perceives as the possibility of even a small amount of inappropriate use. It therefore encourages all essential participants to join in the activities discussed in this chapter. VADs and TAHs should benefit the patients who most need them and, at the same time, not excessively burden the nation's health care system with unnecessary expenditures as a result of inappropriate use. REFERENCES Altman, S. H., and R. Blendon, eds. 1979. Medical Technology: The Culprit Behind Health Care Costs? Washington, D.C.: U.S. Government Printing Office. Berwick, D. M. 1989. Health services research and quality of care: Assignments for the 1990s. Medical Care 27:763-771. Blakeslee, S., and D. E. Snaps, eds. 1986. Human Heart Replacement: A New Challenge for Physicians and Reporters. Los Angeles: The Foundation for American Communication. Cardiology Working Group. 1991. Cardiology and the quality of medical practice. Journal of the American Medical Association 265:482-485. Chassin, M. R., J. Kosecoff, R. E. Park, C. M. Winslow, K. L. Kahn, N. J. Merrick, et al. 1987. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. Journal of the American Medical Association 258:2533-2537. DeVries, W. C. 1988. The physician, the media, and the “spectacular” case. Journal of the American Medical Association 259:886-890. ECRI. 1987. Credentialing for technology use: An important issue for hospitals . Health Technology 1:3-10.

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The Artificial Heart: Prototypes, Policies, and Patients Fineberg, H. V. 1979. Clinical chemistries: The high costs of low-cost diagnostic tests . In: S. H. Altman and R. Blendon, eds. Medical Technology: The Culprit Behind Health Care Costs? Washington, D.C.: U.S. Government Printing Office, pp. 144-165. Hillman, B. J. 1986. Government health policy and the diffusion of new medical devices . Health Services Research 21:681-711. IOM (Institute of Medicine). 1990a. Clinical Practice Guidelines: Directions for a New Program. M. J. Field and K. N. Lohr, eds. Washington, D.C.: National Academy Press. IOM. 1990b. Medicare: A Strategy for Quality Assurance. Vol. I. K. N. Lohr, ed. Washington, D.C.: National Academy Press. Neumann, P. J., and M. C. Weinstein. 1991. The diffusion of new technology: Costs and benefits to health care . In: Institute of Medicine. Medical Innovation at the Crossroads. Vol. II. The Changing Economics of Medical Technology. A. C. Gelijns and E. A. Halm, eds. Washington, D.C.: National Academy Press, pp. 21-34. Schaffarzick, R. W. 1985. Cost containment: Technology assessment and health benefits determination . QRB/Quality Review Bulletin 11:222-225. Walden, J. A., L. W. Stevenson, K. Dracup, J. Wilmarth, J. Kobashigawa, and J. Moriguchi. 1989. Heart transplantation may not improve quality of life for patients with stable heart failure. Heart & Lung 18:497-506. Wennberg, J. E., A. G. Mulley, Jr., D. Hanley, R. P. Timothy, F. J. Fowler, Jr., N. P. Roos, et al. 1988. An assessment of prostatectomy for benign urinary tract obstruction: Geographic variations and the evaluation of medical care outcomes . Journal of the American Medical Association 259:3027-3030.