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U.S. Code as of:
01/19/04
Section 1320b-12. Research on outcomes of health care services and procedures
(a) Establishment of program
(1) In general
The Secretary, acting through the Director of the Agency for
Healthcare Research and Quality, shall -
(A) conduct and support research with respect to the
outcomes, effectiveness, and appropriateness of health care
services and procedures in order to identify the manner in
which diseases, disorders, and other health conditions can most
effectively and appropriately be prevented, diagnosed, treated,
and managed clinically; and
(B) assure that the needs and priorities of the program under
subchapter XVIII of this chapter are appropriately reflected in
the development and periodic review and updating (through the
process set forth in section 299b-2 (!1) of this title) of
treatment-specific or condition-specific practice guidelines
for clinical treatments and conditions in forms appropriate for
use in clinical practice, for use in educational programs, and
for use in reviewing quality and appropriateness of medical
care.
(2) Evaluations of alternative services and procedures
In carrying out paragraph (1), the Secretary shall conduct or
support evaluations of the comparative effects, on health and
functional capacity, of alternative services and procedures
utilized in preventing, diagnosing, treating, and clinically
managing diseases, disorders, and other health conditions.
(3) Initial guidelines
(A) In carrying out paragraph (1)(B) of this subsection, and
section 299b-1(d) (!1) of this title, the Secretary shall, by not
later than January 1, 1991, assure the development of an initial
set of the guidelines specified in paragraph (1)(B) that shall
include not less than 3 clinical treatments or conditions that -
(i)(I) account for a significant portion of expenditures
under subchapter XVIII of this chapter; and
(II) have a significant variation in the frequency or the
type of treatment provided; or
(ii) otherwise meet the needs and priorities of the program
under subchapter XVIII of this chapter, as set forth under
subsection (b)(3) of this section.
(B)(i) The Secretary shall provide for the use of guidelines
developed under subparagrah (!2) (A) to improve the quality,
effectiveness, and appropriateness of care provided under
subchapter XVIII of this chapter. The Secretary shall determine
the impact of such use on the quality, appropriateness,
effectiveness, and cost of medical care provided under such
subchapter and shall report to the Congress on such determination
by not later than January 1, 1993.
(ii) For the purpose of carrying out clause (i), the Secretary
shall expend, from the amounts specified in clause (iii),
$1,000,000 for fiscal year 1990 and $1,500,000 for each of the
fiscal years 1991 and 1992.
(iii) For each fiscal year, for purposes of expenditures
required in clause (ii) -
(I) 60 percent of an amount equal to the expenditure involved
is appropriated from the Federal Hospital Insurance Trust Fund
(established under section 1395i of this title); and
(II) 40 percent of an amount equal to the expenditure
involved is appropriated from the Federal Supplementary Medical
Insurance Trust Fund (established under section 1395t of this
title).
(b) Priorities
(1) In general
The Secretary shall establish priorities with respect to the
diseases, disorders, and other health conditions for which
research and evaluations are to be conducted or supported under
subsection (a) of this section. In establishing such priorities,
the Secretary shall, with respect to a disease, disorder, or
other health condition, consider the extent to which -
(A) improved methods of prevention, diagnosis, treatment, and
clinical management can benefit a significant number of
individuals;
(B) there is significant variation among physicians in the
particular services and procedures utilized in making diagnoses
and providing treatments or there is significant variation in
the outcomes of health care services or procedures due to
different patterns of diagnosis or treatment;
(C) the services and procedures utilized for diagnosis and
treatment result in relatively substantial expenditures; and
(D) the data necessary for such evaluations are readily
available or can readily be developed.
(2) Preliminary assessments
For the purpose of establishing priorities under paragraph (1),
the Secretary may, with respect to services and procedures
utilized in preventing, diagnosing, treating, and clinically
managing diseases, disorders, and other health conditions,
conduct or support assessments of the extent to which -
(A) rates of utilization vary among similar populations for
particular diseases, disorders, and other health conditions;
(B) uncertainties exist on the effect of utilizing a
particular service or procedure; or
(C) inappropriate services and procedures are provided.
(3) Relationship with medicare program
In establishing priorities under paragraph (1) for research and
evaluation, and under section 299b-3(a) (!1 of this title for
the agenda under such section, the Secretary shall assure that
such priorities appropriately reflect the needs and priorities of
the program under subchapter XVIII of this chapter, as set forth
by the Administrator of the Centers for Medicare & Medicaid
Services.
(c) Methodologies and criteria for evaluations
For the purpose of facilitating research under subsection (a) of
this section, the Secretary shall -
(1) conduct and support research with respect to the
improvement of methodologies and criteria utilized in conducting
research with respect to outcomes of health care services and
procedures;
(2) conduct and support reviews and evaluations of existing
research findings with respect to such treatment or conditions;
(3) conduct and support reviews and evaluations of the existing
methodologies that use large data bases in conducting such
research and shall develop new research methodologies, including
data-based methods of advancing knowledge and methodologies that
measure clinical and functional status of patients, with respect
to such research;
(4) provide grants and contracts to research centers, and
contracts to other entities, to conduct such research on such
treatment or conditions, including research on the appropriate
use of prescription drugs;
(5) conduct and support research and demonstrations on the use
of claims data and data on clinical and functional status of
patients in determining the outcomes, effectiveness, and
appropriateness of such treatment; and
(6) conduct and support supplementation of existing data bases,
including the collection of new information, to enhance data
bases for research purposes, and the design and development of
new data bases that would be used in outcomes and effectiveness
research.
(d) Standards for data bases
In carrying out this section, the Secretary shall develop -
(1) uniform definitions of data to be collected and used in
describing a patient's clinical and functional status;
(2) common reporting formats and linkages for such data; and
(3) standards to assure the security, confidentiality,
accuracy, and appropriate maintenance of such data.
(e) Dissemination of research findings and guidelines
(1) In general
The Secretary shall provide for the dissemination of the
findings of research and the guidelines described in subsection
(a) of this section, and for the education of providers and
others in the application of such research findings and
guidelines.
(2) Cooperative educational activities
In disseminating findings and guidelines under paragraph (1),
and in providing for education under such paragraph, the
Secretary shall work with professional associations, medical
specialty and subspecialty organizations, and other relevant
groups to identify and implement effective means to educate
physicians, other providers, consumers, and others in using such
findings and guidelines, including training for physician
managers within provider organizations.
(f) Evaluations
The Secretary shall conduct and support evaluations of the
activities carried out under this section to determine the extent
to which such activities have had an effect on the practices of
physicians in providing medical treatment, the delivery of health
care, and the outcomes of health care services and procedures.
(g) Research with respect to dissemination
The Secretary may conduct or support research with respect to
improving methods of disseminating information on the effectiveness
and appropriateness of health care services and procedures.
(h) Omitted
(i) Authorization of appropriations
(1) In general
There are authorized to be appropriated to carry out this
section -
(A) $50,000,000 for fiscal year 1990;
(B) $75,000,000 for fiscal year 1991;
(C) $110,000,000 for fiscal year 1992;
(D) $148,000,000 for fiscal year 1993; and
(E) $185,000,000 for fiscal year 1994.
(2) Specifications
For the purpose of carrying out this section, for each of the
fiscal years 1990 through 1992 an amount equal to two-thirds of
the amounts authorized to be appropriated under paragraph (1),
and for each of the fiscal years 1993 and 1994 an amount equal to
70 percent of such amounts, are to be appropriated in the
following proportions from the following trust funds:
(A) 60 percent from the Federal Hospital Insurance Trust Fund
(established under section 1395i of this title).
(B) 40 percent from the Federal Supplementary Medical
Insurance Trust Fund (established under section 1395t of this
title).
(3) Allocations
(A) For each fiscal year, of the amounts transferred or
otherwise appropriated to carry out this section, the Secretary
shall reserve appropriate amounts for each of the purposes
specified in clauses (i) through (iv) of subparagraph (B).
(B) The purposes referred to in subparagraph (A) are -
(i) the development of guidelines, standards, performance
measures, and review criteria;
(ii) research and evaluation;
(iii) data-base standards and development; and
(iv) education and information dissemination.
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