Assessing Medical Technologies (1985) / Chapter Skim
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This report addresses the present state of the assessment of medical technology; gives attention to processes, problems, interested parties, and successes and failures; and finally points to some needs and opportunities for improving the present system of medical technology assessment. Medical technology is a term that embraces a wide range of activities.
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Blue Cross and Blue Shield Association and other major insurers increasingly seek assistance from medical associations such as the American College of Physicians, the American College of Radiology, and the American College of Surgeons in formulating coverage policies. At congressional request, the Office of Technology Assessment has in recent years produced more than 60 reports and case studies of medical technology that have been widely circulated and cited throughout government, industry, and the public.
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Some programs devote most of their assessment resources to one type of technology, such as ECRI for medical devices; others may address a variety of technologies, as does the congressional Office of Technology Assessment. The total dollar level of effort in technology assessment including clinical trials, health services research, and synthesis activities such as consensus development conferences, state-of-the-art workshops, and 3 formulation of coverage decisions is small compared with the national effort in research and development (R&D)
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Based on an FDA survey of 20 manufacturers of various types of medical devices, the cost of bringing a new device to market through the PMAA process including device development, clinical trials, manufacturing and controls, application preparation, and other activities conducted during reviewranges from $370,000 to $1,02S,OOO. Medical device assessment has yet to emerge from a shakedown period, partly because of the relative newness of the 1976 Medical Device Amendments (as compared with the 1962 amendments to the Food, Drug, and Cosmetic Act)
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OTA estimates that randomized clinical trials have been applied to 10 or 20 percent of medical practices. The Office of Health Technology Assessment (OHTA)
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The increased support should come from the health dollar because groups such as the Health Care Financing Administration and private health insurance and service plans, as well as provider groups, would see the first savings from improved technology. ASSESSING MEDICAL TECHNOLOGY METHODS OF MEDICAL TECHNOLOGY ASSESSMENT Technology assessment offers the essential bridge between basic research and development and prudent practice 1 application of medical technology.
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When backed with strong empirical investigations, it may add much breadth to an evaluation. Although randomized clinical trials offer the strongest method of assessing the efficacy of a new therapy, we recognize that it is not possible to have randomized trials for every version of every innovation.
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Of special interest are studies that compare the influence of randomized and nonrandomized clinical trials. In some cases the patterns of practice over time conform partially to the findings of randomized controlled trials (RCTs)
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Methods such as case studies, consensus development, and nonrandomized trials can be improved through research, and such proved mainstays as randomized controlled trials can be more widely applied. Chapter 3 also supports this recommendation.
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to induce and even reward cost-saving behavior. Radical changes in federal reimbursement policy ASSESSING MEDICAL TECHNOLOGY have occurred through amendments related to Medicare.
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Still another way is to set aside for assessment a percent11 age of the health care dollar, as handled by third-party payers and both public and private providers. MEDICAL TECHNOLOGY ASSESSMENT ABROAD Medical technology increasingly is the object of public scrutiny not only in the United States but also in other industrialized countries.
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· Aninternationalclearinghouse should be established for information about clinical trials. A possible model is the British National Perinatal Epidemiology Unit at Oxford, which promotes clinical trials and conducts research on their effect on medical practice.
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The worth of technology assessment in medicine reaches beyond its warranty to the patient and its utility to the health professional. The results of assessment also are needed by hospitals and other facilities that buy and apply technologies; by industries that develop technologies; by the professional societies that disseminate information to health care practitioners; and by the insurance companies, government agencies, and corporate health plans that pay for the use of technologies.
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Financing The estimate that public and private spending on medical technology assessment totals over $1 billion yearly makes it seem like a big and costly enterprise. Yet this is a generous estimate for a broadly defined category that embraces controlled and uncontrolled clinical trials, health services research, and a wide variety of synthesis activities.
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· A portion of the health care dollar should he allocated to existing Public Health Service components that already have the task of supporting research in medical technology assessment. These components should solicit and fund research designed to fill gaps in knowledge about technologies where the profit motive 15 does not operate to catalyze the collection of primary data, such as occurs in the drug industry.
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