Assessing Medical Technologies (1985) / Chapter Skim
Currently Skimming:
2. The Scope of U.S. Medical Technology Assessment
2. The Scope of U.S. Medical Technology Assessment
Pages 32-69
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 32... ...
Estimates are given for the relative magnitude of expenditures made for medical technology assessment, biomedical research and development, and national health care. Major assessment programs in the federal government, the drug industry, the medical device industry, and other sectors are described.
|
From page 33... ...
report recommends the establishment of a private-public medical technology assessment consortium (IOM, 1983~. In 1984, Congress set aside funds for the expansion of medical technology assessment functions of the National Center for Health Services Research and earmarked a portion of these as matching funds for a National Academy of Sciences council on health care technology similar to that proposed by the IOM (P.L.
|
From page 34... ...
In addition to drugs, medical devices, and medical and surgical procedures, we include study of support systems and organizational, delivery, and administrative systems generally known as health services research. Thus, in the discussion of various organizations engaged in
|
From page 35... ...
of America Smith Kline & French Cost Benefit Studies Program X University of California, San Diego, Institute for Health Policy Studies X X X X X X X X X X X X X Veterans Administration Cooperative Studies Program X X X X X technology assessment, agencies such as the cited that are primarily involved in health National Center for Health Services Be- services research. This broader view recog search and Health Care Technology As- nizes the interdependence of health care sessment (NCHSRHCTA, formerly known technologies and that making policies to as NCHSR)
|
From page 36... ...
American College of Cardiology/American Heart Association Assessment of Cardiovascular Procedures b. American College of Physicians Clinical Efficacy Assessment Project American Hospital Association Hospital Technology Series American Medical Association Diagnostic and Therapeutic Technology Assessment Service Battelle Health and Population Study Center Blue Cross and Blue Shield Medical Necessity Program g.
|
From page 37... ...
Health R&D All health technology assessment Clinical trials Health services research Other technology assessment 1.3 billion 1.1 billion under 0.2 billion under 0.05 billion A brief look at national health research and development (R&D) expenditures will provide a context for later appreciation of expenditures for medical technology assessment.
|
From page 38... ...
. Total estimated expenditures in 1984 for medical technology assessment activities other than clinical trials and health services research are well under $S0 milASSESSING MEDICAL TECHNOLOGY lion.
|
From page 39... ...
, roughly $100 million to $150 million for health services research, and $30 million for other assessment activities including consensus development conferences and other syntheses and special studies by NIH, HCFA, NCHSRHCTA, FDA, CDC, OTA, and other agencies as described below. Federal expenditures for medical technology assessment including health services research expenditures constitute about 7 percent of federal health R&D expenditures and 0.4 percent of federal health care expenditures.
|
From page 40... ...
As the nation's main engine for basic and applied biomedical research, NIH does not particularly set its priorities to address current issues of medical practice. ASSESSING MEDICAL TECHNOLOGY Resources devoted by NIH to clinical trials and other technology assessment comprise a small portion of its total budget.
|
From page 41... ...
g., treatment with drugs versus surgical treatment. In 1984 the FDA spent about $2 million to conduct and support postmarketing surveillance of drugs and roughly $1 million to support its network for reporting problems with medical devices.
|
From page 42... ...
Prospective Payment Assessment Commission The Prospective Payment Assessment Commission was established by Congress under the Social Security Act Amendments of 1983 (P.L.
|
From page 43... ...
Expenditures for HCFA technology assessment activities, including the $31 million ORD budget (devoted largely to health services research and demonstrations rather than clinical technologies) and the indeterminate but certainly minor cost of the HCFA coverage decision process, are imperceptible in the estimated $88.3 billion paid by HCFA for health care in 1984.
|
From page 44... ...
OHTA activities, supported primarily by the Medicare Trust Fund, were budgeted for $0.7 million in FY 1984 and again in FY 1985. Most of the FY 1985 NCHSRHCTA research budget of $15.5 million is for intramural and extramural health services research, with perhaps a few million dollars for other technology assessment activities, including the OHTA budget.
|
From page 45... ...
g., to the National Heart, Lung, and Blood Institute for its cardiovascular intervention trials, and to the FDA for investigating medical devices (especially laboratory test kits) and assistance in developing FDA guidelines and performance standards for these products.
|
From page 46... ...
Among the medical technologies under development and evaluation are field-operated imaging systems, noncontact monitoring systems, and combat information systems. Expenditures for clinical trials are probably under $10 million annually (Vorosmarti, 1985; H
|
From page 47... ...
The Pharmaceutical Manufacturers Association (1984) estimates that its member firms devote over 14 percent of sales to R&D and that 80 percent of pharmaceutical firm R&D expenditures is devoted to new product development, and the remaining 20 percent is devoted to improvement and modification of existing products.
|
From page 48... ...
. Expenditures for Drug Assessment Data for making direct estimates of drug industry expenditures devoted to technology assessment activities such as clinical trials and postmarketing surveillance are not available, as company budgets do not generally show line items for such activities.
|
From page 49... ...
MEDICAL DEVICE INDUSTRY The medical device industry generates a great diversity of products. More than 8,500 device establishments currently registered with the FDA have listed some 42,000 makes and models in 1,740 generic categories of medical devices (FDA Center for Devices and Radiological Health [CDRH]
|
From page 50... ...
ASSESSING MEDICAL TECHNOLOGY Assessment of Medical Devices Assessment of medical devices is influenced by and may be described in terms of the device classification and premarket notification and approval processes stipulated in the Medical Device Amendments of 1976. This legislation gave the FDA significant authority to regulate the testing and marketing of medical devices to ensure their safety and efficacy.
|
From page 51... ...
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 review ranges from $370,000 to $1,025,000 (Blozan and Tucker, 1984~. Pursuant to the 1976 Amendments, FDA published in 1984 final rules on medical device reporting (MDR)
|
From page 52... ...
(A company's expenditures for clinical trials in a given year depend on the stage of development of its new products.) Medical device industry expenditures for clinical evaluation were probably on the order of $35 million in 1984, or about 4 percent of medical device industry R&D expenditures.
|
From page 53... ...
OTHER PRIVATE SECTOR ASSESSMENT ACTIVITIES There is widespread and increasing interest in technology assessment among organizations in the private sector in addition to those in medical product industries. Private insurers, medical associations, professional and industry associations, hospital corporations and other major uroviders, policy institutes, and voluntary health agencies conduct and sponsor assessment activities to suit their varied needs.
|
From page 54... ...
Very few insurers are able to assign dollar amounts to their assessment activities, because these generally are not budget line items and involve the efforts of a variety of personnel having additional responsibilities. The Blue Cross and Blue Shield (BCBS)
|
From page 55... ...
A notable exception is ECRI (formerly the Emergency Care Research Institute) , a self-sufficient organization that provides a number of assessment services, including published reports of comparative laboratory testing of medical devices and equipment and information on device alerts and related developments ($5.0 million 1985 budget; M
|
From page 56... ...
Particularly active with regard to FDA regulation of drugs and medical devices and related congressional activity are the Pharmaceutical Manufacturers Association and the Health Industry Manufacturers Association. The American Hospital Association (AMA)
|
From page 57... ...
Currently, providers seek concise comparative purchasing information regarding product price and value, useful life, operating costs, and service support, as well as product updates, alerts, and corrective actions such as are provided by ECRI and the American Hospital Association. In addition, more hospital corporations, HMOs, and other large provider organizations are undertaking their own assessment of medical devices, equipment, supplies, and facilities.
|
From page 58... ...
Academic Institutions ASSESSING MEDICAL TECHNOLOGY biomedical research supported by NIH; amounts for technology assessment are relatively small. Universities perform health services research, clinical trials, and other technology assessment activities supported by federal (especially NIH, HCFA, and NCHSRHCTA)
|
From page 59... ...
CONCLUSIONS The estimate that public and private spending on 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 embracing controlled and uncontrolled clinical trials, epidemiologic and other observational studies, health services research, and a wide variety of synthesis activities.
|
From page 60... ...
Certain important aspects of medical device assessment are still being clarified pursuant to the 1976 Medical Device Amendments, which address many thousands of ASSESSING MEDICAL TECHNOLOGY diverse products. Most medical devices do not require rigorous clinical evaluation; roughly $35 million was spent in 1984 on clinical evaluation of medical devices, much of which was devoted to the relatively few class III devices subject to FDA premarketing approval requirements.
|
From page 61... ...
Assessment Concerns We recommend increased commitment to technology assessment, especially for the following: . · generation of primary data on the safety and efficacy of nest:, accepted, and possibly outmoded medical and surgical procedures, with emphasis on information useful in making medical practice decisions and coverage decisions, especially comparative data on the safety and efficacy of alternative technologies; · determination of cost-effectiveness and public policy implications of adopting selected drugs, medical devices, and medical and surgical procedures; and · postmarketing surveillance of drugs and medical devices.
|
From page 62... ...
The bulk of this new funding would be devoted to generating primary data for assessing medical and surgical procedures, with remaining funds allocated to assessments for assisting payers in administering plans and making coverage and reimbursement decisions, postmarketing study of drugs and medical devices, health services research, medical information system assessments, group judgment efforts, training, and clearinghouse activity. A substantial effort is needed to find the costs of various kinds of research in efficacy and effectiveness.
|
From page 63... ...
· $10 million to $20 million in increased support for assessment activities intended to assist private payers in administering plans and making coverage and reimbursement policy, including, e.g., studies of alternative benefits plans, determining appropriate reimbursement levels for technologies, and support of medical association group judgment efforts. · $5 million to $15 million in increased support for postmarketing study and surveillance of drugs and medical devices, to be coordinated by the FDA.
|
From page 64... ...
. The bulk of NCHSR's $15 million FY 1984 research budget was for health services research; some was for assessment activities involving other medical technologies (J.
|
From page 65... ...
Specialized centers do get funds for basic research, clinical trials, and related activities, but these funds are for the most part listed under other categories. Approximately $176 million of the 1982 technology assessment and transfer budget was for clinical trials.
|
From page 66... ...
. As is the case in the drug industry, many medical device concerns are part of large, multiproduct firms which manufacture low it&D-intensive products in addition to medical devices.
|
From page 67... ...
1983b. Regulatory Requirements for Medical Devices.
|
From page 68... ...
Study No. 80205, report submitted to the Bureau of Medical Devices, ASSESSING MEDICAL TECHNOLOGY Food and Drug Administration, Washington, D.C.: Louis Harris and Associates.
|
From page 69... ...
1983. Federal regulation of medical devices—problems still to be overcome.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.