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CONCLUSIONS AND RECOMMENDATION
The committee's conclusions, overall recommendation, and components
of the recommendation follow.
Organization
THE COMMITTEE RECOMMENDS THE ESTABLISHMENT OF A MEDICAL
TECHNOLOGY ASSESSMENT CONSORTIUM ASSOCIATED WITH THE INSTITUTE
OF MEDICINE.
In searching for the appropriate organizational structure, the
committee was especially interested in the extent of governmental
control, responsiveness to the needs of potential constituencies, and
fuming of various organizational models that were public, private, or
some hybrid of the two.
Reasonable and effective approaches to such technical issues as
energy regulation, consumer product safety, occupational health and
safety, and technology assessment require that business and government
become successful partners in accommodating divergent views (Fox, 1981~.
Various government agencies approach technology assessment from different
perspectives and with different needs. Likewise, industry and the
professional groups have differing needs, concerns, and goals. One way
to bring all these interests together, in the committee's view, is to
establish an organization or forum outside the formal judicial,
legislative, and regulatory processes of government.
Two examples of organizations that have successfully accommodated
divergent industry and government views are the National Institute of
Building Sciences (NIBS) and the Health Effects Institute (HEI).
NIBS is a private non-profit organization established by Congress to
provide for the evaluation of building technology, and to facilitate the
introduction and acceptance of desirable technologies at the federal,
state and local levels (Fox, 1981~. NIBS received an initial five-year
congressional authorization, and was mandated to provide its own
financial support by no later than 1983 (PL 93-383, 1974~. Its first
board of directors was appointed by the President of the United States
but later was to be nominated by the housing and building industry and
voted upon by the NIBS board.
HEI was formed in 1980 as an independent entity to conduct
assessments of the health effects of emissions from automobiles and
trucks. Its research informs both the vehicle manufacturers and the
Environmental Protection Agency, which writes and enforces air pollution
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regulations. HEI is directed by a board whose three members come neither
from the affected industry nor from government (Fox, 1981~. It was given
an initial federal 1 ine of credit in 1981 to begin developing its organi-
zational add research capacity, and has secured agreement of 24 private
companies to reimburse 50 percent of its operational expenditures, within
the federal credit limit. This support--half public, half private--is
expected to continue indefinitely (Powers, 1983~.
The committee chose to blend these two examples, deciding that a
private/public partnership for technology assessment could best be
fostered under the auspices of a private non-profit organization,
established either _ nova or as an appendage to an existing private
non-profit corporation. A privately based organization was seen as
likely to attract broader support from the private sector because it
would be less subject to governmental pressures and perhaps more
accessible and responsive to its supporters. Better coordinated, more
balanced, and leas polarized assessments should be possible when
conducted outside of a regulatory framework and in a neutral setting.
The committee chose to name the new entity the Medical Technology
Assessment Consortium.
The committee recommends that the Medical Technology Assessment
Consortium begin under the auspices of the Institute of Medicine, because
of the expense and difficulties of establishing a new organization and
because there are decided advantages for such a new effort if located in
this component of the National Academy of Sciences. Such a locus would
provide visibility and credibility for the new entity, would offer a
clear indication of neutrality and objectivity, and would facilitate the
recruitment of board members, senior staff, and panel members of high
caliber. In addition, prior Institute experience with issues of
technology assessment would be a resource for the activity of the new
entity.
The committee recognizes that a permanent relationship between the
consortium and the Institute of Medicine may neither be desirable nor
necessary and that the consortium might become an independent entity
after a period of development. A reasonable developmental period, the
committee felt, would be five years. Careful monitoring of growth and
potential for independence should be formalized on an annual review basis
while the consortium is in the Institute.
One of the documents used by the committee in developing the
organization of the new entity was a chart describing the mission, scope,
role, funding, and functions of other existing or proposed technology
assessment organizations (Appendix 1 ) . The committee determined that the
following characteristics would be a desirable statement of the mission,
scope, role, operations, and financial support of the new entity.
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Mission
THE MISSION OF THE ENTITY IS MEDICAL TECHNOLOGY ASSESSMENT. FOR THE
PURPOSES OF THIS ENTITY, MEDICAL TECHNOLOGY IS DEFINED AS A DRUG, DEVICE,
MEDI CAL OR SURGICAL PROCEDURE, OR COMBINATION OF THE ABOVE AND THE
KNOWLEDGE NECESSARY FOR THEIR APPROPRIATE USE IN THE DELIVERY OF PATIENT
CARE .
Scope
MEDICAL TECHNOLOGY ASSESSMENT INCLUDES THE DEVELOPMENT AND EVALUATION
OF EVIDENCE, OR THE EVALUATION OF EVIDENCE DEVELOPED BY OTHERS, CONCERNING
EFFECTIVENESS, SAFETY, COST, COST-EFFECTIVENESS, UNINTENDED CONSEQUENCES,
AND, WlIEN APPROPRIATE, THE POLICY IMPLICAT IONS OF THE DEVELOPMENT AND/OR
USE OF A SPECIFIC TECHNOLOGY, COMklENSURATE WITH ITS STAGE OF DEVELOPMENT.
IT MAY ALSO INCLUDE THE EVALUAt ION OF KNOWLEDGE, PROFES S IONAL COMPETENCE;,
INDICATIONS, FACILITIES, AND PERSONNEL NECESSARY FOR APPROPRIATE USE.
Role
THE ROLE OF THE ENTITY IS TO PROMOTE THE EMERGENCE AND APPLICATION OF
APPROPRIATE MEDICAL TECHNOLOGIES, AND THE RETIREMENT OF INAPPROPRIATE OR
OBSOLETE HELICAL TECHNOLOG IES BY:
o SERVING AS A CLEARINGHOUSE OF INFORMATION ON MEDICAL
TECHNOLOGIES AND MEDICAL TECHNOLOGY ASSES SMENT
o AS SEMBLING AND EVALUATING INFORMAT ION AND MAKING RECOMMENDAT IONS
CONCERNING INDIVIDUAL MEDICAL TECHNOLOGIES
o ACTING WHEN NECKS SARY AND APPROPRIATE TO STIMULATE, COORDINATE,
UNDERTAKE, OR COMMISSION MEDICAL TECHNOLOGY ASSESSMENT,
INCLUDING ACTIVITIES TILAT WOULD COMPLEMENT THOSE OF OTHERS
0 IDENTIFYING NEEDS IN THE ASSESStIE:NT OF SPECIFIC MEDICAL
TECHNOLOGIES
o DEVELOPING AD EVALUATING ASSESSMENT CRITERIA AD METHODS
0 PROVIDING EDUCATION, TRAINING, AND TECHNICAL ASSISTANCE IN THE
USE OF MEDICAL TECHNOLOGY ASSESSMENT METHODS AND RESULTS.
In identifying the breadth of functions of the proposed consortium,
the committee chose to endow it with enough f legibility to be maximally
responsive to its users. This flexibility should enable the consortium
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to evolve into as comprehensive an institution as is commensurate with
its operational concept and finances. The committee recognized the
breadth of the role it had defined, and consequently ordered the six
primary functions by priority, both in terms of perceived need within
the technology assessment community and in terms of the probability of
funding for early implementation.
Expecting that the consortium's initial operating capital may be
relatively small, the committee proposes the clearinghouse function be
established first. The principal components of the clearinghouse
function, as described in the OPERATIONS section later in this report,
are an information management system and a scanning and surveillance
function. The committee recognized the complexity of setting up a truly
expert clearinghouse, but that complexity would be greatly reduced by
the consortium's association with the IOM/NAS.
Current resources of the NAS complex that would aid the consortium's
clearinghouse function include: the NAS Library, with state-of-the-art
bibliographic and electronic retrieval capability; the IOM experience in
convening its members and other experts for specific inquiries; and the
information-gathering experience gained by this committee and the
parallel Committee on Evaluating Medical Technologies in Clinical Use,
which have become conversant with most other existing technology assess-
ment entities and with rosters of entities in other countries developed
by staff of the congressional Office of Technology Assessment.
The committee endorses pluralism in technology assessment, believing
that the involvement of multiple entities in technology assessment is
desirable. The proposed consortium is not intended to replace or elimi-
nate other assessment entities, but should be complementary to them.
The consortium's products--evaluations, recommendations, reports--should
be available both to other assessment entities and to the public.
Because the consortium should have the capability to consider
societal, ethical, legal, and other aspects of technology assessment,
the statement of scope provides for the development and evaluation of
all kinds of evidence about technological policy implications.
Addressing policy implications, however, is deemed secondary to the
consortium's prime task of providing evaluation information with which
other entities can f ormulate policy.
Although the committee did not delve into specific methods used in
"technology assessment", it noted that the greatest research need is for
the generation of primary data f or analysis. The mos t prevalent method
of conducting assessments entails the synthesis and interpretation of
primary research done by others--secondary analysis. However great the
need for primary data development and analysis, the very high costs of
such assessments require funding at a rate substantially greater than
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that which the committee felt the consortium could attract at the onset
of its activities. Assessments requiring primary data likely would be
conducted later in the consortium's existence.
Governing Board
THE INITIAL GOVERNING BOARD OF THE CONSORT IUM WILL BE APPOINTED BY,
ITS TERMS OF OFFICE DETERMINED BY, AND ITS CHAIR DESIGNATED BY THE
PRESIDENT OF THE NATIONAL ACADEMY OF SCIENCES, ON RECOMMENDATION OF THE
PRES IDENT OF THE INSTITUTE OF MEDIC INK, FOLLOWING APPROPRIATE
CONSULTATION. OFFICERS, OTHER THAN THE INITIAL CHAIR AND NEW BOARD
MEMBERS, WILL BE NOMINATED AND ELECTED BY THE BOARD IN ACCORDANCE WITH
SUCH BYLAWS AND OTHER RULES OF CONDUCT AS THE BOARD SHALL HAVE ADOPTED.
THE BOARD HILL CONSIST OF 15 MEMBERS DRAWN FROM THE PUBLIC AND PRIVATE
SEC TORS .
It is the intention of the committee that board members will be
representative of an array of expertises, but should not be represen-
tative of specific organizational entities. Board members, selected
from both private and public sectors, should be knowledgeable in such
matters as the financing of health care, the provision of health care,
the management of health care institutions, and research, development,
and marketing of health care technologies.
The responsibilities of the board will be to:
o adopt by-laws for the consortium
o set policy for the consortium
o establish broad priorities for the consortium
o employ the chief executive officer
o approve the budget.
The members of the initial board will take whatever actions are
necessary to establish the consortium.
Professional Staf f
The new entity will require a highly qualified and committed staff.
The chief executive officer, appointed by the board, will have
responsibility for:
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recommending the organizational and operational s tructure of
the consort ium
managing the operations of the consortium, including developing
budgets
0 employing s tat f
o developing specific priorities and tasks consistent with board
approval
developing and recommending to the board technical review and
evaluation panels
developing funding sources
o entering into contracts authorized by the board.
Operations
The management of the consortium will involve the interaction of
several basic functions discussed briefly below. The organization
should be able to accept and sort requests and problems, draw upon and
manage relevant information, make evaluations' and report findings and
recommendations. The organization should be able to evaluate and learn
from its own performance. The organization also should be able to
detect trends and developments that could affect the development,
diffusion, and utilization of medical technology and the need for its
assessment. The operations described below may be implemented in any
of a number of organizational frameworks, depending upon such factors
as the resources available to the consortiums its relationship to a
parent organization, and preferences of its governing board and
administration.
O Information Management The organization should have the
capability to acquires process, store, retrieve, and disseminate
information. The acquisition of information includes the capabi-
lity of seeking new information by conducting or sponsoring
studies and other inquiries, as required by the decision making
operation.
0 Scanning/Surveillance Beyond acquiring and managing information,
the organization should have the capability of discerning indi-
cations that merit its attention. These include trends, cycles,
and new and projected developments in medical technology and
other relevant fields. Changes in technology utilization
patterns, relevant developments in biology, engineering, elec-
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tropics, and communications, population trends and disease
patterns, political and international developments all are
examples of indications to be picked up by the scanning operation
and provided to other organizational operations as appropriate.
O Issue Identification and Triage The organization will receive
. ~
~ ram both external and internal sources a broad variety of
requests, problems and issues. It should be capable of
accepting, identifying, clarifying, and sorting these. Some
will be handled on a routine basis by staff, some will be
referred to the decision making operation of the organization,
and certain inquiries will be referred to outside agencies
better able to handle them.
o Recommendations The organization should have the capability of
conducting evaluations or assessments in a timely and effective
manner, and of rendering findings and recommendations. Decision
processes and findings should be recorded in ways that facili-
tate performance evaluation.
Performance Evaluation The organization should have the
capability of monitoring its own decisions, findings, and
recommendations for internal management purposes. This entails
maintaining records of information and processes used in making
decisions and any expected outcomes or effects of those
decisions, and comparing these with actual outcomes. Besides
documenting the decision process, performance evaluation would
provide information to the organization's decision makers to
enable them to identify ways of improving their performance.
Financial Support
THE CONSORTIUM SHOULD BECOME SELF-SUFFICIENT AS SOON AS POSSIBLE.
IN MOVING TOWARD SELF-SUFEICIENCY, IT SHOULD SEEK BOTH PUBLIC AND
PRIVATE SEC rOR FINANCIAL SUPPORT.
The committee determined that several different strategies should
be used to secure sufficient funds for operating the Medical Technology
Assessment Consortium. Two kinds of funds would be required: core
support and project or program support. Ideally the private/public
partnership in the enterprise would be reflected by 50 percent of funds
coming from each sector. However, the ratio could vary depending on
the organization's functions. The committee believes that an endowment
would provide the most stability for the organization. One approach to
an endowment would be to solicit a congressional appropriation to
initiate the entity.
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Both the National Institute of Building Sciences (NIBS) and the
Health Effects Institute (HEI) began with appreciable federal funding,
NIBS through direct appropriations, and HEI through budgeted contribu-
tions from the Environmental Protection Agency (Fox, 1981~. The NIBS
Congressional commitment for support extended f ive years in declining
appropriations of one million dollars in the first year to one-half
million dollars in the fifth (PL 93-383, 1974) . In 1983, technically
the sixth year, NIBS received a "last appropriation" of $1.42 million
and was expected to be self-sufficient thereafter (Dillon, 1983~.
This last appropriation may be the closest approximation to a
congressionally appropriated "endowment".
HEI had an initial one million dollar "line of credit" from the
federal government, administered through the EPA, and the agreement of
24 automakers (8 domestic and 16 foreign) to contribute half of HEI' 6
operational expenditures. Federal budgetary reauthorizations in
subsequent years have extended HEI's line of credit to $2.5 million,
although its operational expenditures currently amount to only
$640,000. With its major research efforts only beginning, HEI will
have rapidly increas ing costs. The current federal budget will
provide HEI with a $3 million line of credit in fiscal year 1984, and
private sector agreements will match the federal share of HEI 's
expenditures (Powers, 1983~.
Other than the consortiums receiving a start-up congressional
appropriation, an endowment might be obtained by pooling funds
solicited from a number of interested parties, including industry,
third-party payers, professional associations, foundations, and the
like. Such sources and pooling of funds would permit maximum freedom
of operation to the new entity.
Another source of revenue for the organization might be in grants,
contracts, or other research or fee-for-service arrangements. Such
support for specific programs or projects might be available from both
public and private sources. Most government support of the entity
probably would come in the £onm of grants or contracts for specific
projects.
Once launched,, the entity would have the ability to raise
additional funds from publication fees, subscriptions, and conference
registration fees. Potential users or supporters of services and
products of the consort ium might include:
0 federal, state 5 and local governmental agencies
0 health care financing organizations
0 health and medical care professionals and related associations
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health care institutions
manufacturers of health industry devices, drugs, and other
products
0 employers
o labor and consumer groups
o academic and research institutions
o individuals
Membership fees or assessments were seen as less desirable sources
of support because they might restrict the freedom of the organization
by creating direct relationships with a given health industry, or
because assessments would be very difficult to implement in a fair
manner.
A.
In contemplating possible budget figures for such an organization,
the committee found the budgets of other proposed or existing entities
instructive (See Appendix 1~. The NCHCT had a yearly budget of
approximately $3 million when it ceased to exist. During start-up
years, the budget had been substantially smaller but was programmed to
grow in size. Over its three-year life the NCHCT engaged in
approximately 75 technology evaluations (Perry, 1982~.
A budget was unspecified in the authorizing legislation for the
proposed new DOG Commission, although a ceiling of 25 staff personnel
was stipulated. Appropriation legislation recently passed by the
Congress provides $1.5 million for the first year of that co~mission's
operation. The largest budget for any entity was proposed by Relman
(1980), who suggested that an assessment of two-tenths of one percent
of total expenditures by private and public third-party payers would
yield $100-$200 million for a new national program of support for a
comprehensive system of technology assessment.
The committee believes that because it would take time to hire
staff, develop programs, and establish the consortium, first- and
second-year operations might call for budgets of one-third and
two-thirds of a million dollars, respectively. In the third year of
development the consortium should have an operating budget of
approximately $1 million. In subsequent years the consortium might
require annual budgets substantially greater than $1 million, but such
estimates might be better made during the first three years of
development. An initial budget of $300,000 could support a small
professional and clerical staff (including the chief executive
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officer), cover travel costs for the board members and a small number
of panels, and would cover officing, supplies, telephone, printing,
etc. This budget should be sufficient to support preliminary efforts
needed to develop the coordinating and clearinghouse functions. As
activities of the new entity grow, additional funds could be raised to
parallel increasing functions. The committee felt that the new entity
would have a better chance of surviving if it began as an organization
of modest size, growing as its services increased in importance and
effectiveness.
20
Representative terms from entire chapter:
medical technologies
