The Implications of Cost-effectiveness Analysis of Medical Technology, Volume 2, Issue 1

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Congress of the United States, Office of Technology Assessment, 1980 - 219 pages

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Page 88 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is presented to have under the conditions of use prescribed, recommended,...
Page 48 - A), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA).
Page 88 - Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested...
Page 62 - ... (B) the quality of such services meets professionally recognized standards of health care ; and (C) in case such services and items are proposed to be provided in a hospital or other health care facility on an inpatient basis, such services and items could, consistent with the provision of appropriate medical care, be effectively provided on an outpatient basis or more economically in an inpatient health care facility of a different type.
Page 191 - Risk: A measure of the probability of an adverse or untoward outcome and the severity of the resultant harm to health of individuals in a defined population associated with use of a medical technology applied for a given medical problem under specified conditions of use.
Page 47 - Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services — (/) which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member...
Page 52 - Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided...
Page 3 - Medical technology: The drugs, devices, and medical and surgical procedures used in medical care, and the organizational and supportive systems within which such care is provided.
Page 190 - Effectiveness: Same as efficacy (see below) except that it refers to average or actual conditions of use. Efficacy: The probability of benefit to individuals in a defined population from a medical technology applied for a given medical problem under ideal conditions of use.
Page 182 - First, cost-benefit analysis as generally understood is only a technique for taking decisions within a framework which has to be decided upon in advance and which involves a wide range of considerations, many of them of a political or social character.

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