H. R. 1—373
SEC. 1013. RESEARCH ON OUTCOMES OF HEALTH CARE ITEMS AND
SERVICES.
(a) RESEARCH, DEMONSTRATIONS, AND EVALUATIONS.—
(1) IMPROVEMENT OF EFFECTIVENESS AND EFFICIENCY.—
(A) IN GENERAL.—To improve the quality, effectiveness,
and efficiency of health care delivered pursuant to the
programs established under titles XVIII, XIX, and XXI
of the Social Security Act, the Secretary acting through
the Director of the Agency for Healthcare Research and
Quality (in this section referred to as the ‘‘Director’’), shall
conduct and support research to meet the priorities and
requests for scientific evidence and information identified
by such programs with respect to—
(i) the outcomes, comparative clinical effectiveness,
and appropriateness of health care items and services
(including prescription drugs); and
(ii) strategies for improving the efficiency and
effectiveness of such programs, including the ways in
which such items and services are organized, managed,
and delivered under such programs.
(B) SPECIFICATION.—To respond to priorities and
information requests in subparagraph (A), the Secretary
may conduct or support, by grant, contract, or interagency
agreement, research, demonstrations, evaluations, tech-
nology assessments, or other activities, including the provi-
sion of technical assistance, scientific expertise, or methodo-
logical assistance.
(2) PRIORITIES.—
(A) IN
GENERAL.—The Secretary shall establish a
process to develop priorities that will guide the research,
demonstrations, and evaluation activities undertaken
pursuant to this section.
(B) INITIAL LIST.—Not later than 6 months after the
date of the enactment of this Act, the Secretary shall
establish an initial list of priorities for research related
to health care items and services (including prescription
drugs).
(C) PROCESS.—In carrying out subparagraph (A), the
Secretary—
(i) shall ensure that there is broad and ongoing
consultation with relevant stakeholders in identifying
the highest priorities for research, demonstrations, and
evaluations to support and improve the programs
established under titles XVIII, XIX, and XXI of the
Social Security Act;
(ii) may include health care items and services
which impose a high cost on such programs, as well
as those which may be underutilized or overutilized
and which may significantly improve the prevention,
treatment, or cure of diseases and conditions (including
chronic conditions) which impose high direct or indirect
costs on patients or society; and
(iii) shall ensure that the research and activities
undertaken pursuant to this section are responsive
to the specified priorities and are conducted in a timely
manner.
(3) EVALUATION AND SYNTHESIS OF SCIENTIFIC EVIDENCE.—
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(A) IN GENERAL.—The Secretary shall—
(i) evaluate and synthesize available scientific evi-
dence related to health care items and services
(including prescription drugs) identified as priorities
in accordance with paragraph (2) with respect to the
comparative clinical effectiveness, outcomes, appro-
priateness, and provision of such items and services
(including prescription drugs);
(ii) identify issues for which existing scientific evi-
dence is insufficient with respect to such health care
items and services (including prescription drugs);
(iii) disseminate to prescription drug plans and
MA–PD plans under part D of title XVIII of the Social
Security Act, other health plans, and the public the
findings made under clauses (i) and (ii); and
(iv) work in voluntary collaboration with public
and private sector entities to facilitate the development
of new scientific knowledge regarding health care items
and services (including prescription drugs).
(B) INITIAL RESEARCH.—The Secretary shall complete
the evaluation and synthesis of the initial research required
by the priority list developed under paragraph (2)(B) not
later than 18 months after the development of such list.
(C) DISSEMINATION.—
(i) IN GENERAL.—To enhance patient safety and
the quality of health care, the Secretary shall make
available and disseminate in appropriate formats to
prescription drugs plans under part D, and MA–PD
plans under part C, of title XVIII of the Social Security
Act, other health plans, and the public the evaluations
and syntheses prepared pursuant to subparagraph (A)
and the findings of research conducted pursuant to
paragraph (1). In carrying out this clause the Sec-
retary, in order to facilitate the availability of such
evaluations and syntheses or findings at every decision
point in the health care system, shall—
(I) present such evaluations and syntheses or
findings in a form that is easily understood by
the individuals receiving health care items and
services (including prescription drugs) under such
plans and periodically assess that the require-
ments of this subclause have been met; and
(II) provide such evaluations and syntheses
or findings and other relevant information through
easily accessible and searchable electronic mecha-
nisms, and in hard copy formats as appropriate.
(ii) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as—
(I) affecting the authority of the Secretary or
the Commissioner of Food and Drugs under the
Federal Food, Drug, and Cosmetic Act or the Public
Health Service Act; or
(II) conferring any authority referred to in sub-
clause (I) to the Director.
(D) ACCOUNTABILITY.—In carrying out this paragraph,
the Secretary shall implement activities in a manner that—
H. R. 1—375
(i) makes publicly available all scientific evidence
relied upon and the methodologies employed, provided
such evidence and method are not protected from public
disclosure by section 1905 of title 18, United States
Code, or other applicable law so that the results of
the research, analyses, or syntheses can be evaluated
or replicated; and
(ii) ensures that any information needs and unre-
solved issues identified in subparagraph (A)(ii) are
taken into account in priority-setting for future
research conducted by the Secretary.
(4) CONFIDENTIALITY.—
(A) IN
GENERAL.—In making use of administrative,
clinical, and program data and information developed or
collected with respect to the programs established under
titles XVIII, XIX, and XXI of the Social Security Act, for
purposes of carrying out the requirements of this section
or the activities authorized under title IX of the Public
Health Service Act (42 U.S.C. 299 et seq.), such data and
information shall be protected in accordance with the con-
fidentiality requirements of title IX of the Public Health
Service Act.
(B) RULE OF CONSTRUCTION.—Nothing in this section
shall be construed to require or permit the disclosure of
data provided to the Secretary that is otherwise protected
from disclosure under the Federal Food, Drug, and Cos-
metic Act, section 1905 of title 18, United States Code,
or other applicable law.
(5) 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 outcomes and utilization of health care items and
services.
(6) IMPROVING INFORMATION AVAILABLE TO HEALTH CARE
PROVIDERS, PATIENTS, AND POLICYMAKERS.—Not later than 18
months after the date of enactment of this Act, the Secretary
shall identify options that could be undertaken in voluntary
collaboration with private and public entities (as appropriate)
for the—
(A) provision of more timely information through the
programs established under titles XVIII, XIX, and XXI
of the Social Security Act, regarding the outcomes and
quality of patient care, including clinical and patient-
reported outcomes, especially with respect to interventions
and conditions for which clinical trials would not be feasible
or raise ethical concerns that are difficult to address;
(B) acceleration of the adoption of innovation and
quality improvement under such programs; and
(C) development of management tools for the programs
established under titles XIX and XXI of the Social Security
Act, and with respect to the programs established under
such titles, assess the feasibility of using administrative
or claims data, to—
(i) improve oversight by State officials;
(ii) support Federal and State initiatives to
improve the quality, safety, and efficiency of services
provided under such programs; and
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(iii) provide a basis for estimating the fiscal and
coverage impact of Federal or State program and policy
changes.
(b) RECOMMENDATIONS.—
(1) DISCLAIMER.—In carrying out this section, the Director
shall—
(A) not mandate national standards of clinical practice
or quality health care standards; and
(B) include in any recommendations resulting from
projects funded and published by the Director, a cor-
responding reference to the prohibition described in
subparagraph (A).
(2) REQUIREMENT FOR IMPLEMENTATION.—Research, evalua-
tion, and communication activities performed pursuant to this
section shall reflect the principle that clinicians and patients
should have the best available evidence upon which to make
choices in health care items and services, in providers, and
in health care delivery systems, recognizing that patient sub-
populations and patient and physician preferences may vary.
(3) RULE OF CONSTRUCTION.—Nothing in this section shall
be construed to provide the Director with authority to mandate
a national standard or require a specific approach to quality
measurement and reporting.
(c) RESEARCH WITH RESPECT
TO DISSEMINATION.—The Sec-
retary, acting through the Director, may conduct or support research
with respect to improving methods of disseminating information
in accordance with subsection (a)(3)(C).
(d) LIMITATION ON CMS.—The Administrator of the Centers
for Medicare & Medicaid Services may not use data obtained in
accordance with this section to withhold coverage of a prescription
drug.
(e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized
to be appropriated to carry out this section, $50,000,000 for fiscal
year 2004, and such sums as may be necessary for each fiscal
year thereafter.
SEC. 1014. HEALTH CARE THAT WORKS FOR ALL AMERICANS: CITIZENS
HEALTH CARE WORKING GROUP.
(a) FINDINGS.—Congress finds the following:
(1) In order to improve the health care system, the Amer-
ican public must engage in an informed national public debate
to make choices about the services they want covered, what
health care coverage they want, and how they are willing
to pay for coverage.
(2) More than a trillion dollars annually is spent on the
health care system, yet—
(A) 41,000,000 Americans are uninsured;
(B) insured individuals do not always have access to
essential, effective services to improve and maintain their
health; and
(C) employers, who cover over 170,000,000 Americans,
find providing coverage increasingly difficult because of
rising costs and double digit premium increases.
(3) Despite increases in medical care spending that are
greater than the rate of inflation, population growth, and Gross
Domestic Product growth, there has not been a commensurate
improvement in our health status as a nation.