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PART I: SETTING THE STAGE
Pages 1-34

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From page 1...
... Part I Setting the Stage
From page 3...
... workshops whose intent is to critically examine medical innovation that is, the process by which medical research findings are translated into actual benefits in clinical practice. The raison d'etre for this third workshop (see Appendix A)
From page 5...
... . This volume defines the term medical technology broadly to encompass medical devices, instrumentation, pharmaceuticals, biologicals, diagnostic and therapeutic procedures, and integrated systems of care delivery.
From page 6...
... These decision-making processes reflect an idealized, unrealistic understanding of both medical practice and medical innovation. In sum, previous work of the committee indicates that the net social benefit of some of the anticipated technology policies of a restructured American health care system may be positive.
From page 7...
... Numerous countries have successfully implemented public policies to counterbalance the innovation-suppressing effects of health care regulation; for example, the British National Health Service and the French and Japanese governments retain explicit incentives for innovation in their pharmaceutical pricing formulas (Burstall, 1991; Neimeth, 19914. Thus, policies to compensate for unintended suppression of innovation in health care can be crafted and indications are that they do, indeed, work.
From page 8...
... Vol. 2, The Changing Economics of Medical Technology.
From page 9...
... Patient demand and medical progress now make the health care system so expensive that it can no longer be available on equal terms to everyone; moreover, the nation simply cannot afford to pay for everything that works and that patients want. This predicament arises because of the successes of biomedical research, the resulting 9
From page 10...
... Policies are needed to set limits on specific services, to develop explicit methods to ration effective care that brings less than socially acceptable marginal returns. The effect of such policies is to deny access to care that works and that patients want on the basis that it is not cost-effective.
From page 11...
... It then looks at the struggle between two competing models for reforming the doctor-patient relationship. One is based on the assumption that the agency role of the physician can be essentially replaced by the guardianship of the third-party payer through m~cromanaged care and that the delegated decision model inherent in the agency role can be preserved by prescriptive rules of practir`~ `1~.v~.1on~.~1 hv competing health care organizations or the state.
From page 12...
... The target in this approach is to reform the ethical status of the doctor-patient relationship so that what is known and not known are explicitly shared and so that patient preferences become dominant in the choice of treatment from among reasonable and available plans of care. The paper also examines why neither micromanaged care nor the shared decision model are sufficient to achieve the goal of rationalizing utilization and containing costs.
From page 13...
... For this to occur, however, physicians must know and respond to decisions their colleagues have made. There is no feedback loop currently operating in health care markets that would make this feasible; indeed, it is difficult to conceive what such a mechanism would look like.
From page 14...
... Over the past few years, my colleagues and I have been involved in an in-depth investigation of the fine structure of a clinical decision problem: the choices that face men with a common form of prostate disease called benign prostatic hyperplasia, or BPH. The inquiry was motivated by small area variation studies showing that the chances that a man would undergo a prostate operation by the time he reached age 85 varied from about 15 percent in some communities to more than 50 percent in others.
From page 15...
... The outcomes research we undertook showed that the preventive theory was incorrect.4 Early surgery appeared to lead to a slight decrease in life expectancy because for most men BPH does not progress to life-threatening obstruction. Those without evidence of such obstruction were better off with watchful waiting if the expected value of treatment was an increase in life expectancy.
From page 16...
... Indeed, as it turned out, when they were informed about the alternatives and offered a choice, nearly 80 percent of men with severe symptoms choose watchful waiting, at least initially. Preferences for outcomes and level of aversion to risk cannot be intuited reliably by physicians based on objective knowledge; to know what patients want, physicians must ask them.
From page 17...
... , our studies predict that only 4 would want surgery and tab 1be 4 choosing surgery would not be compelled with urine now imp~rmenL If surgery were preschhed for an 16 men on the basis of the delegated decision model tab is, without informing patients bout their options and asking them abut they wanted most patients would receive cage they did not want. Whereas the patients ranked second, Pugh, tenth, and tbi~eenth may want surgery, the Thorny do not.
From page 18...
... . The results of our preference research thus indicate the likelihood of significant negative returns on current patterns of resource deployment under the delegated decision model.
From page 19...
... Unlike the classic staff-model health maintenance organization (HMO) in which cost containment is achieved through global restrictions on the quantity of supply, the strategy of micromanaged care is to force efficiency by setting parameters of practice to define the available options and to guide a myriad of everyday clinical decisions.
From page 20...
... This critique is also based on the ethical weakness of micromanaged care-that is, its tendency to preserve the delegated decision-making model by substituting the guardianship of the third party for the benevolent authoritarianism of the physician. There is little pretense that this model of reform concerns itself with the preferences of individual patients.
From page 21...
... There, the conversation takes place between the payer and the physician; in shared decision making, discourse is between the physician and the patient. Because of its explicitly ethical basis, the shared decision-making model is preferable when fateful choices must be made between elective treatment options that entail differing risks and benefits.
From page 22...
... The effect of the supply of beds on the clinical thresholds for hospitalizing patients is a good example. The supply of hospital resources varies remarkably across geographic areas, and the amount allocated is unrelated to illness rates or to explicit theories about the numbers of beds required to treat most diseases.
From page 23...
... In the upside-down economy of medical care, supply comes first and theory follows, in virtual equilibrium as practice style adjusts to ensure the utilization of available resources. Thus, treatment theories governing the use of hospital beds are sufficiently flexible to allow the use of available beds, no matter what the per-capita level of supply; theories that establish the legitimacy of the use of particular procedures justify professional workloads, virtually without regard for the number of specialists; and underevaluated medical treatment theory is sufficiently rich to permit the employment of internists and family practitioners virtually without regard to how many there may be per capita.
From page 24...
... The medical care landscape in the United States is contoured by the jagged profiles of resource allocation exemplified by Boston, New Haven, Waterville, and Augusta. In each example, the intensity of construction is determined by dynamics that are indifferent to theories of efficacy or even to
From page 25...
... Although it is reasonable to conjecture that more of such surgeries might produce some benefit, the studies noted earlier suggest that the amount of neurosurgery now being supplied under the delegated decision model could well exceed the amount patients want when they choose according to well-informed preferences. SEEKING LIMITS It is quite possible that the current crisis in health care in this country may stem from the excesses of an economic sector dominated by supplierinduced demand and professional uncertainty about the value of medical care and not from patient demand based on medical progress.
From page 26...
... The first principle concerns the general welfare: it is safe for patients and in the public interest to place global restrictions on growth in the capacity to provide medical care. Studies of geographic variation in services in this country provide solid evidence that the capacity of the hospital industry and of the physician work force is now well in excess of that required to provide services that are efficacious and that patients actually want.
From page 27...
... The third principle concerns the interests of patients for whom expensive medical care is effective in a system characterized by excess capacity: the resources required to meet unmet needs (e.g., prenatal care, bone marrow transplants, long-term care) should be obtained by reallocation of excess capacity and not by rationing effective care.
From page 28...
... A successful policy of global limits has the immediate consequence of buying time to learn what works in medicine and to sort out the many conflicting, explicit theories governing resource deployment in the treatment of discrete conditions such as those listed in Table 2-1. But the several European and the Canadian models for managing the macroeconomy show clearly that setting global limits does not of itself lead to improvement in clinical science or to the development of models for clinical decision making that emphasize patient preferences.
From page 29...
... Strategies for avoiding explicit health care rationing by reallocating excess capacity to meet unmet needs for effective medical care depends on the successes of the evaluative sciences in identifying examples of excess capacity and establishing evidence that care is, indeed, effective. It should be much easier to build the necessary infrastructure in systems of care in which the societal commitment to set limits is in place once the problem of professional uncertainty and excess capacity is understood by policymakers.
From page 30...
... One of the most constructive steps consistent with the principles outlined in the previous section would be to allocate a substantial proportion of the health care budget to the task of building the necessary professional infrastructure in the evaluative sciences. Canada offers an example of what could be done in a system with global limits in place.
From page 31...
... The linkage of practice guidelines to outcomes research and the growth of the idea that micromanaged care will contain costs brought together the critical support needed for a new federal initiative, the Agency for Health Care Policy and Research, at a time of budget deficit and reluctance by Congress to take on new tasks. The tensions between the trend toward cost containment based on micromanaged care and the needs and requirements for rational innovation continue to grow.
From page 32...
... Whatever the shape of the new American health care economy, the policies of reform, if they are to promote rather than retard medical innovation, must assume the obligation to build the scientific and ethical basis of clinical medicine and contain resource consumption within limits acceptable to the wider society. The obligation to reform the scientific and ethical basis of clinical medicine can be summarized in four guiding principles: 1.
From page 33...
... 1990b. What is outcomes research?


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