[House Report 106-305]
[From the U.S. Government Publishing Office]
106th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 106-305
======================================================================
HEALTH RESEARCH AND QUALITY ACT OF 1999
_______
September 8, 1999.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Bliley, from the Committee on Commerce, submitted the following
R E P O R T
[To accompany H.R. 2506]
[Including cost estimate of the Congressional Budget Office]
The Committee on Commerce, to whom was referred the bill
(H.R. 2506) to amend title IX of the Public Health Service Act
to revise and extend the Agency for Health Care Policy and
Research, having considered the same, report favorably thereon
with an amendment and recommend that the bill as amended do
pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 13
Background and Need for Legislation.............................. 14
Hearings......................................................... 18
Committee Consideration.......................................... 19
Committee Votes.................................................. 19
Committee Oversight Findings..................................... 19
Committee on Government Reform Oversight Findings................ 19
New Budget Authority, Entitlement Authority, and Tax Expenditures 19
Committee Cost Estimate.......................................... 19
Congressional Budget Office Estimate............................. 20
Federal Mandates Statement....................................... 22
Advisory Committee Statement..................................... 22
Constitutional Authority Statement............................... 22
Applicability to Legislative Branch.............................. 22
Section-by-Section Analysis of the Legislation................... 22
Changes in Existing Law Made by the Bill, as Reported............ 36
Amendment
The amendment is as follows:
Strike out all after the enacting clause and insert in lieu
thereof the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Health Research and Quality Act of
1999''.
SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.
(a) In General.--Title IX of the Public Health Service Act (42 U.S.C.
299 et seq.) is amended to read as follows:
``TITLE IX--AGENCY FOR HEALTH RESEARCH AND QUALITY
``PART A--ESTABLISHMENT AND GENERAL DUTIES
``SEC. 901. MISSION AND DUTIES.
``(a) In General.--There is established within the Public Health
Service an agency to be known as the Agency for Health Research and
Quality, which shall be headed by a director appointed by the
Secretary. The Secretary shall carry out this title acting through the
Director.
``(b) Mission.--The purpose of the Agency is to enhance the quality,
appropriateness, and effectiveness of health services, and access to
such services, through the establishment of a broad base of scientific
research and through the promotion of improvements in clinical and
health system practices, including the prevention of diseases and other
health conditions. The Agency shall promote health care quality
improvement by--
``(1) conducting and supporting research that develops and
presents scientific evidence regarding all aspects of health,
including--
``(A) the development and assessment of methods for
enhancing patient participation in their own care and
for facilitating shared patient-physician decision-
making;
``(B) the outcomes, effectiveness, and cost-
effectiveness of health care practices, including
preventive measures and long-term care;
``(C) existing and innovative technologies;
``(D) the costs and utilization of, and access to
health care;
``(E) the ways in which health care services are
organized, delivered, and financed and the interaction
and impact of these factors on the quality of patient
care;
``(F) methods for measuring quality and strategies
for improving quality; and
``(G) ways in which patients, consumers, purchasers,
and practitioners acquire new information about best
practices and health benefits, the determinants and
impact of their use of this information;
``(2) synthesizing and disseminating available scientific
evidence for use by patients, consumers, practitioners,
providers, purchasers, policy makers, and educators; and
``(3) advancing private and public efforts to improve health
care quality.
``(c) Requirements With Respect to Rural Areas and Priority
Populations.--In carrying out subsection (b), the Director shall
undertake and support research, demonstration projects, and evaluations
with respect to--
``(1) the delivery of health services in rural areas
(including frontier areas);
``(2) health services for low-income groups, and minority
groups;
``(3) the health of children;
``(4) the elderly; and
``(5) people with special health care needs, including
disabilities, chronic care and end-of-life health care.
``SEC. 902. GENERAL AUTHORITIES.
``(a) In General.--In carrying out section 901(b), the Director shall
support demonstration projects, conductand support research,
evaluations, training, research networks, multi-disciplinary centers,
technical assistance, andthe dissemination of information, on health
care, and on systems for the delivery of such care, including
activities with respect to--
``(1) the quality, effectiveness, efficiency, appropriateness
and value of health care services;
``(2) quality measurement and improvement;
``(3) the outcomes, cost, cost-effectiveness, and use of
health care services and access to such services;
``(4) clinical practice, including primary care and practice-
oriented research;
``(5) health care technologies, facilities, and equipment;
``(6) health care costs, productivity, organization, and
market forces;
``(7) health promotion and disease prevention, including
clinical preventive services;
``(8) health statistics, surveys, database development, and
epidemiology; and
``(9) medical liability.
``(b) Health Services Training Grants.--
``(1) In general.--The Director may provide training grants
in the field of health services research related to activities
authorized under subsection (a), to include pre- and post-
doctoral fellowships and training programs, young investigator
awards, and other programs and activities as appropriate. In
carrying out this subsection, the Director shall make use of
funds made available under section 487.
``(2) Requirements.--In developing priorities for the
allocation of training funds under this subsection, the
Director shall take into consideration shortages in the number
of trained researchers addressing the priority populations.
``(c) Multidisciplinary Centers.--The Director may provide financial
assistance to assist in meeting the costs of planning and establishing
new centers, and operating existing and new centers, for
multidisciplinary health services research, demonstration projects,
evaluations, training, and policy analysis with respect to the matters
referred to in subsection (a).
``(d) Relation to Certain Authorities Regarding Social Security.--
Activities authorized in this section shall be appropriately
coordinated with experiments, demonstration projects, and other related
activities authorized by the Social Security Act and the Social
Security Amendments of 1967. Activities under subsection (a)(2) of this
section that affect the programs under titles XVIII, XIX and XXI of the
Social Security Act shall be carried out consistent with section 1142
of such Act.
``(e) Disclaimer.--The Agency shall not mandate national standards of
clinical practice or quality health care standards. Recommendations
resulting from projects funded and published by the Agency shall
include a corresponding disclaimer.
``(f) Rule of Construction.--Nothing in this section shall be
construed to imply that the Agency's role is to mandate a national
standard or specific approach to quality measurement and reporting. In
research and quality improvement activities, the Agency shall consider
a wide range of choices, providers, health care delivery systems, and
individual preferences.
``PART B--HEALTH CARE IMPROVEMENT RESEARCH
``SEC. 911. HEALTH CARE OUTCOME IMPROVEMENT RESEARCH.
``(a) Evidence Rating Systems.--In collaboration with experts from
the public and private sector, the Agency shall identify and
disseminate methods or systems that it uses to assess health care
research results, particularly methods or systems that it uses to rate
the strength of the scientific evidence behind health care practice,
recommendations in the research literature, and technology assessments.
The Agency shall make methods or systems for evidence rating widely
available. Agency publications containing health care recommendations
shall indicate the level of substantiating evidence using such methods
or systems.
``(b) Health Care Improvement Research Centers and Provider-Based
Research Networks.--
``(1) In general.--In order to address the full continuum of
care and outcomes research, to link research to practice
improvement, and to speed the dissemination of research
findings to community practice settings, the Agency shall
employ research strategies and mechanisms that will link
research directly with clinical practice in geographically
diverse locations throughout the United States, including--
``(A) Health Care Improvement Research Centers that
combine demonstrated multidisciplinary expertise in
outcomes or quality improvement research with linkages
to relevant sites of care;
``(B) Provider-based Research Networks, including
plan, facility, or delivery system sites of care
(especially primary care), that can evaluate outcomes
and promote quality improvement; and
``(C) other innovative mechanisms or strategies to
link research with clinical practice.
``(2) Requirements.--The Director is authorized to establish
the requirements for entities applying for grants under this
subsection.
``SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND
DELIVERY.
``(a) Support for Efforts To Develop Information on Quality.--
``(1) Scientific and technical support.--In its role as the
principal agency for health research and quality, the Agency
may provide scientific and technical support for private and
public efforts to improve health care quality, including the
activities of accrediting organizations.
``(2) Role of the agency.--With respect to paragraph (1), the
role of the Agency shall include--
``(A) the identification and assessment of methods
for the evaluation of the health of--
``(i) enrollees in health plans by type of
plan, provider, and provider arrangements; and
``(ii) other populations, including those
receiving long-term care services;
``(B) the ongoing development, testing, and
dissemination of quality measures, including measures
of health and functional outcomes;
``(C) the compilation and dissemination of health
care quality measures developed in the private and
public sector;
``(D) assistance in the development of improved
health care information systems;
``(E) the development of survey tools for the purpose
of measuring participant and beneficiary assessments of
their health care; and
``(F) identifying and disseminating information on
mechanisms for the integration of information on
quality into purchaser and consumer decision-making
processes.
``(b) Centers for Education and Research on Therapeutics.--
``(1) In general.--The Secretary, acting through the Director
and in consultation with the Commissioner of Food and Drugs,
shall establish a program for the purpose of making one or more
grants for the establishment and operation of one or more
centers to carry out the activities specified in paragraph (2).
``(2) Required activities.--The activities referred to in
this paragraph are the following:
``(A) The conduct of state-of-the-art research for
the following purposes:
``(i) To increase awareness of--
``(I) new uses of drugs, biological
products, and devices;
``(II) ways to improve the effective
use of drugs, biological products, and
devices; and
``(III) risks of new uses and risks
of combinations of drugs and biological
products.
``(ii) To provide objective clinical
information to the following individuals and
entities:
``(I) Health care practitioners and
other providers of health care goods or
services.
``(II) Pharmacists, pharmacy benefit
managers and purchasers.
``(III) Health maintenance
organizations and other managed health
care organizations.
``(IV) Health care insurers and
governmental agencies.
``(V) Patients and consumers.
``(iii) To improve the quality of health care
while reducing the cost of health care
through--
``(I) an increase in the appropriate
use of drugs, biological products, or
devices; and
``(II) the prevention of adverse
effects of drugs, biological products,
and devices and the consequences of
such effects, such as unnecessary
hospitalizations.
``(B) The conduct of research on the comparative
effectiveness, cost-effectiveness, and safety of drugs,
biological products, and devices.
``(C) Such other activities as the Secretary
determines to be appropriate, except that a grant may
not be expended to assist the Secretary in the review
of new drugs.
``(c) Reducing Errors in Medicine.--The Director shall conduct and
support research and build private-public partnerships to--
``(1) identify the causes of preventable health care errors
and patient injury in health care delivery;
``(2) develop, demonstrate, and evaluate strategies for
reducing errors and improving patient safety; and
``(3) promote the implementation of effective strategies
throughout the health care industry.
``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.
``(a) In General.--In carrying out 902(a), the Director shall--
``(1) conduct a survey to collect data on a nationally
representative sample of the population on the cost, use and,
for fiscal year 2001 and subsequent fiscal years, quality of
health care, including the types of health care services
Americans use, their access to health care services, frequency
of use, how much is paid for the services used, the source of
those payments, the types and costs of private health
insurance, access, satisfaction, and quality of care for the
general population and also for populations identified in
section 901(c); and
``(2) develop databases and tools that provide information to
States on the quality, access, and use of health care services
provided to their residents.
``(b) Quality and Outcomes Information.--
``(1) In general.--Beginning in fiscal year 2001, the
Director shall ensure that the survey conducted under
subsection (a)(1) will--
``(A) identify determinants of health outcomes and
functional status, the needs of special populations in
such variables as well as an understanding of changes
over time, relationships to health care access and use,
and monitor the overall national impact of Federal and
State policy changes on health care;
``(B) provide information on the quality of care and
patient outcomes for frequently occurring clinical
conditions for a nationally representative sample of
the population; and
``(C) provide reliable national estimates for
children and persons with special health care needs
through the use of supplements or periodic expansions
of the survey.
In expanding the Medical Expenditure Panel Survey, as in
existence on the date of enactment of this title) in fiscal
year 2001 to collect information on the quality of care, the
Director shall take into account any outcomes measurements
generally collected by private sector accreditation
organizations.
``(2) Annual report.--Beginning in fiscal year 2003, the
Secretary, acting through the Director, shall submit to
Congress an annual report on national trends in the quality of
health care provided to the American people.
``SEC. 914. INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT.
``(a) In General.--In order to foster a range of innovative
approaches to the management and communication of health information,
the Agency shall support research, evaluations and initiatives to
advance--
``(1) the use of information systems for the study of health
care quality and outcomes, including the generation of both
individual provider and plan-level comparative performance
data;
``(2) training for health care practitioners and researchers
in the use of information systems;
``(3) the creation of effective linkages between various
sources of health information, including the development of
information networks;
``(4) the delivery and coordination of evidence-based health
care services, including the use of real-time health care
decision-support programs;
``(5) the structure, content, definition, and coding of
health information data and medical vocabularies in
consultation with appropriate Federal entities and shall seek
input from appropriate private entities;
``(6) the use of computer-based health records in outpatient
and inpatient settings as a personal health record for
individual health assessment and maintenance, and for
monitoring public health and outcomes of care within
populations; and
``(7) the protection of individually identifiable information
in health services research and health care quality
improvement.
``(b) Demonstration.--The Agency shall support demonstrations into
the use of new information tools aimed at improving shared decision-
making between patients and their care-givers.
``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN UNDERSERVED
AREAS.
``(a) Preventive Services Task Force.--
``(1) Purpose.--The Agency shall provide ongoing
administrative, research, and technical support for the
operation of the Preventive Services Task Force. The Agency
shall coordinate and support the dissemination of the
Preventive Services Task Force recommendations.
``(2) Operation.--The Preventive Services Task Force shall
review the scientific evidence related to the effectiveness,
appropriateness, and cost-effectiveness of clinical preventive
services for the purpose of developing recommendations for the
health care community, and updating previous recommendations,
regarding their usefulness in daily clinical practice. In
carrying out its responsibilities under paragraph (1), the Task
Force shall not be subject to the provisions of Appendix 2 of
title 5, United States Code.
``(b) Primary Care Research.--
``(1) In general.--There is established within the Agency a
Center for Primary Care Research (referred to in this
subsection as the `Center') that shall serve as the principal
source of funding for primary care practice research in the
Department of Health and Human Services. For purposes of this
paragraph, primary care research focuses on the first contact
when illness or health concerns arise, the diagnosis, treatment
or referral to specialty care, preventive care, and the
relationship between the clinician and the patient in the
context of the family and community.
``(2) Research.--In carrying out this section, the Center
shall conduct and support research concerning--
``(A) the nature and characteristics of primary care
practice;
``(B) the management of commonly occurring clinical
problems;
``(C) the management of undifferentiated clinical
problems; and
``(D) the continuity and coordination of health
services.
``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION.
``(a) In General.--The Director shall promote innovation in evidence-
based clinical practice and health care technologies by--
``(1) conducting and supporting research on the development,
diffusion, and use of health care technology;
``(2) developing, evaluating, and disseminating methodologies
for assessments of health care practices and health care
technologies;
``(3) conducting intramural and supporting extramural
assessments of existing and new health care practices and
technologies;
``(4) promoting education, training, and providing technical
assistance in the use of health care practice and health care
technology assessment methodologies and results; and
``(5) working with the National Library of Medicine and the
public and private sector to develop an electronic
clearinghouse of currently available assessments and those in
progress.
``(b) Specification of Process.--
``(1) In general.--Not later than December 31, 2000, the
Director shall develop and publish a description of the methods
used by the Agency and its contractors for practice and
technology assessment.
``(2) Consultations.--In carrying out this subsection, the
Director shall cooperate and consult with the Assistant
Secretary for Health, the Administrator of the Health Care
Financing Administration, the Director of the National
Institutes of Health, the Commissioner of Food and Drugs, and
the heads of any other interested Federal department or agency,
and shall seek input, where appropriate, from professional
societies and other private and public entities.
``(3) Methodology.--The Director shall, in developing the
methods used under paragraph (1), consider--
``(A) safety, efficacy, and effectiveness;
``(B) legal, social, and ethical implications;
``(C) costs, benefits, and cost-effectiveness;
``(D) comparisons to alternate technologies and
practices; and
``(E) requirements of Food and Drug Administration
approval to avoid duplication.
``(c) Specific Assessments.--
``(1) In general.--The Director shall conduct or support
specific assessments of health care technologies and practices.
``(2) Requests for assessments.--The Director is authorized
to conduct or support assessments, on a reimbursable basis, for
the Health Care Financing Administration, the Department of
Defense, the Department of Veterans Affairs, the Office of
Personnel Management, and other public or private entities.
``(3) Grants and contracts.--In addition to conducting
assessments, the Director may make grants to, or enter into
cooperative agreements or contracts with, entities described in
paragraph (4) for the purpose of conducting assessments of
experimental, emerging, existing, or potentially outmoded
health care technologies, and for related activities.
``(4) Eligible entities.--An entity described in this
paragraph is an entity that is determined to be appropriate by
the Director, including academic medical centers, research
institutions and organizations, professional organizations,
third party payers, governmental agencies, and consortia of
appropriate research entities established for the purpose of
conducting technology assessments.
``SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY IMPROVEMENT
EFFORTS.
``(a) Requirement.--
``(1) In general.--To avoid duplication and ensure that
Federal resources are used efficiently and effectively, the
Secretary, acting through the Director, shall coordinate all
research, evaluations, and demonstrations related to health
services research, quality measurement and quality improvement
activities undertaken and supported by the Federal Government.
``(2) Specific activities.--The Director, in collaboration
with the appropriate Federal officials representing all
concerned executive agencies and departments, shall develop and
manage a process to--
``(A) improve interagency coordination, priority
setting, and the use and sharing of research findings
and data pertaining to Federal quality improvement
programs, technology assessment, and health services
research;
``(B) strengthen the research information
infrastructure, including databases, pertaining to
Federal health services research and health care
quality improvement initiatives;
``(C) set specific goals for participating agencies
and departments to further health services research and
health care quality improvement; and
``(D) strengthen the management of Federal health
care quality improvement programs.
``(b) Study by the Institute of Medicine.--
``(1) In general.--To provide Congress, the Department of
Health and Human Services, and other relevant departments with
an independent, external review of their quality oversight,
quality improvement and quality research programs, the
Secretary shall enter into a contract with the Institute of
Medicine--
``(A) to describe and evaluate current quality
improvement, quality research and quality monitoring
processes through--
``(i) an overview of pertinent health
services research activities and quality
improvement efforts conducted by all Federal
programs, with particular attention paid to
those under titles XVIII, XIX, and XXI of the
Social Security Act; and
``(ii) a summary of the partnerships that the
Department of Health and Human Services has
pursued with private accreditation, quality
measurement and improvement organizations; and
``(B) to identify options and make recommendations to
improve the efficiency and effectiveness of quality
improvement programs through--
``(i) the improved coordination of activities
across the medicare, medicaid and child health
insurance programs under titles XVIII, XIX and
XXI of the Social Security Act and health
services research programs;
``(ii) the strengthening of patient choice
and participation by incorporating state-of-
the-art quality monitoring tools and making
information on quality available; and
``(iii) the enhancement of the most effective
programs, consolidation as appropriate, and
elimination of duplicative activities within
various federal agencies.
``(2) Requirements.--
``(A) In general.--The Secretary shall enter into a
contract with the Institute of Medicine for the
preparation--
``(i) not later than 12 months after the date
of enactment of this title, of a report
providing an overview of the quality
improvement programs of the Department of
Health and Human Services for the medicare,
medicaid, and CHIP programs under titles XVIII,
XIX, and XXI of the Social Security Act; and
``(ii) not later than 24 months after the
date of enactment of this title, of a final
report containing recommendations.
``(B) Reports.--The Secretary shall submit the
reports described in subparagraph (A) to the Committee
on Finance and the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on
Ways and Means and the Committee on Commerce of the
House of Representatives.
``PART C--GENERAL PROVISIONS
``SEC. 921. ADVISORY COUNCIL FOR HEALTH CARE RESEARCH AND QUALITY.
``(a) Establishment.--There is established an advisory council to be
known as the Advisory Council for Health Care Research and Quality.
``(b) Duties.--
``(1) In general.--The Advisory Council shall advise the
Secretary and the Director with respect to activities proposed
or undertaken to carry out the purpose of the Agency under
section 901(b).
``(2) Certain recommendations.--Activities of the Advisory
Council under paragraph (1) shall include making
recommendations to the Director regarding--
``(A) priorities regarding health care research,
especially studies related to quality, outcomes, cost
and the utilization of, and access to, health care
services;
``(B) the field of health care research and related
disciplines, especially issues related to training
needs, and dissemination of information pertaining to
health care quality; and
``(C) the appropriate role of the Agency in each of
these areas in light of private sector activity and
identification of opportunities for public-private
sector partnerships.
``(c) Membership.--
``(1) In general.--The Advisory Council shall, in accordance
with this subsection, be composed of appointed members and ex
officio members. All members of the Advisory Council shall be
voting members other than the individuals designated under
paragraph (3)(B) as ex officio members.
``(2) Appointed members.--The Secretary shall appoint to the
Advisory Council 18 appropriately qualified individuals. At
least 14 members of the Advisory Council shall be
representatives of the public who are not officers or employees
of the United States. The Secretary shall ensure that the
appointed members of the Council, as a group, are
representative of professions and entities concerned with, or
affected by, activities under this title and under section 1142
of the Social Security Act. Of such members--
``(A) 3 shall be individuals distinguished in the
conduct of research, demonstration projects, and
evaluations with respect to health care;
``(B) 3 shall be individuals distinguished in the
practice of medicine of which at least 1 shall be a
primary care practitioner;
``(C) 3 shall be individuals distinguished in the
other health professions;
``(D) 3 shall be individuals either representing the
private health care sector, including health plans,
providers, and purchasers or individuals distinguished
as administrators of health care delivery systems;
``(E) 3 shall be individuals distinguished in the
fields of health care quality improvement, economics,
information systems, law, ethics, business, or public
policy; and
``(F) 3 shall be individuals representing the
interests of patients and consumers of health care.
``(3) Ex officio members.--The Secretary shall designate as
ex officio members of the Advisory Council--
``(A) the Assistant Secretary for Health, the
Director of the National Institutes of Health, the
Director of the Centers for Disease Control and
Prevention, the Administrator of the Health Care
Financing Administration, the Assistant Secretary of
Defense (Health Affairs), and the Under Secretary for
Health of the Department of Veterans Affairs; and
``(B) such other Federal officials as the Secretary
may consider appropriate.
``(d) Terms.--Members of the Advisory Council appointed under
subsection (c)(2) shall serve for a term of 3 years. A member of the
Council appointed under such subsection may continue to serve after the
expiration of the term of the members until a successor is appointed.
``(e) Vacancies.--If a member of the Advisory Council appointed under
subsection (c)(2) does not serve the full term applicable under
subsection (d), the individual appointed to fill the resulting vacancy
shall be appointed for the remainder of the term of the predecessor of
the individual.
``(f) Chair.--The Director shall, from among the members of the
Advisory Council appointed under subsection (c)(2), designate an
individual to serve as the chair of the Advisory Council.
``(g) Meetings.--The Advisory Council shall meet not less than once
during each discrete 4-month period and shall otherwise meet at the
call of the Director or the chair.
``(h) Compensation and Reimbursement of Expenses.--
``(1) Appointed members.--Members of the Advisory Council
appointed under subsection (c)(2) shall receive compensation
for each day (including travel time) engaged in carrying out
the duties of the Advisory Council unless declined by the
member. Such compensation may not be in an amount in excess of
the maximum rate of basic pay payable for GS-18 of the General
Schedule.
``(2) Ex officio members.--Officials designated under
subsection (c)(3) as ex officio members of the Advisory Council
may not receive compensation for service on the Advisory
Council in addition to the compensation otherwise received for
duties carried out as officers of the United States.
``(i) Staff.--The Director shall provide to the Advisory Council such
staff, information, and other assistance as may be necessary to carry
out the duties of the Council.
``SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.
``(a) Requirement of Review.--
``(1) In general.--Appropriate technical and scientific peer
review shall be conducted with respect to each application for
a grant, cooperative agreement, or contract under this title.
``(2) Reports to director.--Each peer review group to which
an application is submitted pursuant to paragraph (1) shall
report its finding and recommendations respecting the
application to the Director in such form and in such manner as
the Director shall require.
``(b) Approval as Precondition of Awards.--The Director may not
approve an application described in subsection (a)(1) unless the
application is recommended for approval by a peer review group
established under subsection (c).
``(c) Establishment of Peer Review Groups.--
``(1) In general.--The Director shall establish such
technical and scientific peer review groups as may be necessary
to carry out this section. Such groups shall be established
without regard to the provisions of title 5, United States
Code, that govern appointments in the competitive service, and
without regard to the provisions of chapter 51, and subchapter
III of chapter 53, of such title that relate to classification
and pay rates under the General Schedule.
``(2) Membership.--The members of any peer review group
established under this section shall be appointed from among
individuals who by virtue of their training or experience are
eminently qualified to carry out the duties of such peer review
group. Officers and employees of the United States may not
constitute more than 25 percent of the membership of any such
group. Such officers and employees may not receive compensation
for service on such groups in addition to the compensation
otherwise received for these duties carried out as such
officers and employees.
``(3) Duration.--Notwithstanding section 14(a) of the Federal
Advisory Committee Act, peer review groups established under
this section may continue in existence until otherwise provided
by law.
``(4) Qualifications.--Members of any peer-review group
shall, at a minimum, meet the following requirements:
``(A) Such members shall agree in writing to treat
information received, pursuant to their work for the
group, as confidential information, except that this
subparagraph shall not apply to public records and
public information.
``(B) Such members shall agree in writing to recuse
themselves from participation in the peer-review of
specific applications which present a potential
personal conflict of interest or appearance of such
conflict, including employment in a directly affected
organization, stock ownership, or any financial or
other arrangement that might introduce bias in the
process of peer-review.
``(d) Authority for Procedural Adjustments in Certain Cases.--In the
case of applications for financial assistance whose direct costs will
not exceed $100,000, the Director may make appropriate adjustments in
the procedures otherwise established by the Director for the conduct of
peer review under this section. Such adjustments may be made for the
purpose of encouraging the entry of individuals into the field of
research, for the purpose of encouraging clinicalpractice-oriented or
provider-based research, and for such other purposes as the Director
may determine to be appropriate.
``(e) Regulations.--The Director shall issue regulations for the
conduct of peer review under this section.
``SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION,
AND DISSEMINATION OF DATA.
``(a) Standards With Respect to Utility of Data.--
``(1) In general.--To ensure the utility, accuracy, and
sufficiency of data collected by or for the Agency for the
purpose described in section 901(b), the Director shall
establish standard methods for developing and collecting such
data, taking into consideration--
``(A) other Federal health data collection standards;
and
``(B) the differences between types of health care
plans, delivery systems, health care providers, and
provider arrangements.
``(2) Relationship with other department programs.--In any
case where standards under paragraph (1) may affect the
administration of other programs carried out by the Department
of Health and Human Services, including the programs under
title XVIII, XIX or XXI of the Social Security Act, or may
affect health information that is subject to a standard
developed under part C of title XI of the Social Security Act,
they shall be in the form of recommendations to the Secretary
for such program.
``(b) Statistics and Analyses.--The Director shall--
``(1) take appropriate action to ensure that statistics and
analyses developed under this title are of high quality,
timely, and duly comprehensive, and that the statistics are
specific, standardized, and adequately analyzed and indexed;
and
``(2) publish, make available, and disseminate such
statistics and analyses on as wide a basis as is practicable.
``(c) Authority Regarding Certain Requests.--Upon request of a public
or private entity, the Director may conduct or support research or
analyses otherwise authorized by this title pursuant to arrangements
under which such entity will pay the cost of the services provided.
Amounts received by the Director under such arrangements shall be
available to the Director for obligation until expended.
``SEC. 924. DISSEMINATION OF INFORMATION.
``(a) In General.--The Director shall--
``(1) without regard to section 501 of title 44, United
States Code, promptly publish, make available, and otherwise
disseminate, in a form understandable and on as broad a basis
as practicable so as to maximize its use, the results of
research, demonstration projects, and evaluations conducted or
supported under this title;
``(2) ensure that information disseminated by the Agency is
science-based and objective and undertakes consultation as
necessary to assess the appropriateness and usefulness of the
presentation of information that is targeted to specific
audiences;
``(3) promptly make available to the public data developed in
such research, demonstration projects, and evaluations;
``(4) provide, in collaboration with the National Library of
Medicine where appropriate, indexing, abstracting, translating,
publishing, and other services leading to a more effective and
timely dissemination of information on research, demonstration
projects, and evaluations with respect to health care to public
and private entities and individuals engaged in the improvement
of health care delivery and the general public, and undertake
programs to develop new or improved methods for making such
information available; and
``(5) as appropriate, provide technical assistance to State
and local government and health agencies and conduct liaison
activities to such agencies to foster dissemination.
``(b) Prohibition Against Restrictions.--Except as provided in
subsection (c), the Director may not restrict the publication or
dissemination of data from, or the results of, projects conducted or
supported under this title.
``(c) Limitation on Use of Certain Information.--No information, if
an establishment or person supplying the information or described in it
is identifiable, obtained in the course of activities undertaken or
supported under this title may be used for any purpose other than the
purpose for which it was supplied unless such establishment or person
has consented (as determined under regulations of the Director) to its
use for such other purpose. Such information may not be published or
released in other form if the person who supplied the information or
who is described in it is identifiable unless such person has consented
(as determined under regulations of the Director) to its publication or
release in other form.
``(d) Penalty.--Any person who violates subsection (c) shall be
subject to a civil monetary penalty of not more than $10,000 for each
such violation involved. Such penalty shall be imposed and collected in
the same manner as civil money penalties under subsection (a) of
section 1128A of the Social Security Act are imposed and collected.
``SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND CONTRACTS.
``(a) Financial Conflicts of Interest.--With respect to projects for
which awards of grants, cooperative agreements, or contracts are
authorized to be made under this title, the Director shall by
regulation define--
``(1) the specific circumstances that constitute financial
interests in such projects that will, or may be reasonably
expected to, create a bias in favor of obtaining results in the
projects that are consistent with such interests; and
``(2) the actions that will be taken by the Director in
response to any such interests identified by the Director.
``(b) Requirement of Application.--The Director may not, with respect
to any program under this title authorizing the provision of grants,
cooperative agreements, or contracts, provide any such financial
assistance unless an application for the assistance is submitted to the
Secretary and the application is in such form, is made in such manner,
and contains such agreements, assurances, and information as the
Director determines to be necessary to carry out the program involved.
``(c) Provision of Supplies and Services in Lieu of Funds.--
``(1) In general.--Upon the request of an entity receiving a
grant, cooperative agreement, or contract under this title, the
Secretary may, subject to paragraph (2), provide supplies,
equipment, and services for the purpose of aiding the entity in
carrying out the project involved and, for such purpose, may
detail to the entity any officer or employee of the Department
of Health and Human Services.
``(2) Corresponding reduction in funds.--With respect to a
request described in paragraph (1), the Secretary shall reduce
the amount of the financial assistance involved by an amount
equal to the costs of detailing personnel and the fair market
value of any supplies, equipment, or services provided by the
Director. The Secretary shall, for the payment of expenses
incurred in complying with such request, expend the amounts
withheld.
``(d) Applicability of Certain Provisions With Respect to
Contracts.--Contracts may be entered into under this part without
regard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C.
529; 41 U.S.C. 5).
``SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.
``(a) Deputy Director and Other Officers and Employees.--
``(1) Deputy director.--The Director may appoint a deputy
director for the Agency.
``(2) Other officers and employees.--The Director may appoint
and fix the compensation of such officers and employees as may
be necessary to carry out this title. Except as otherwise
provided by law, such officers and employees shall be appointed
in accordance with the civil service laws and their
compensation fixed in accordance with title 5, United States
Code.
``(b) Facilities.--The Secretary, in carrying out this title--
``(1) may acquire, without regard to the Act of March 3, 1877
(40 U.S.C. 34), by lease or otherwise through the Director of
General Services, buildings or portions of buildings in the
District of Columbia or communities located adjacent to the
District of Columbia for use for a period not to exceed 10
years; and
``(2) may acquire, construct, improve, repair, operate, and
maintain laboratory, research, and other necessary facilities
and equipment, and such other real or personal property
(including patents) as the Secretary deems necessary.
``(c) Provision of Financial Assistance.--The Director, in carrying
out this title, may make grants to public and nonprofit entities and
individuals, and may enter into cooperative agreements or contracts
with public and private entities and individuals.
``(d) Utilization of Certain Personnel and Resources.--
``(1) Department of health and human services.--The Director,
in carrying out this title, may utilize personnel and
equipment, facilities, and other physical resources of the
Department of Health and Human Services, permit appropriate (as
determined by the Secretary) entities and individuals to
utilize the physical resources of such Department, and provide
technical assistance and advice.
``(2) Other agencies.--The Director, in carrying out this
title, may use, with their consent, the services, equipment,
personnel, information, and facilities of other Federal, State,
or local public agencies, or of any foreign government, with or
without reimbursement of such agencies.
``(e) Consultants.--The Secretary, in carrying out this title, may
secure, from time to time and for such periods as the Director deems
advisable but in accordance with section 3109 of title 5, United States
Code, the assistance and advice of consultants from the United States
or abroad.
``(f) Experts.--
``(1) In general.--The Secretary may, in carrying out this
title, obtain the services of not more than 50 experts or
consultants who have appropriate scientific or professional
qualifications. Such experts or consultants shall be obtained
in accordance with section 3109 of title 5, United States Code,
except that the limitation in such section on the duration of
service shall not apply.
``(2) Travel expenses.--
``(A) In general.--Experts and consultants whose
services are obtained under paragraph (1) shall be paid
or reimbursed for their expenses associated with
traveling to and from their assignment location in
accordance with sections 5724, 5724a(a), 5724a(c), and
5726(C) of title 5, United States Code.
``(B) Limitation.--Expenses specified in subparagraph
(A) may not be allowed in connection with the
assignment of an expert or consultant whose services
are obtained under paragraph (1) unless and until the
expert agrees in writing to complete the entire period
of assignment, or 1 year, whichever is shorter, unless
separated or reassigned for reasons that are beyond the
control of the expert or consultant and that are
acceptable to the Secretary. If the expert or
consultant violates the agreement, the money spent by
the United States for the expenses specified in
subparagraph (A) is recoverable from the expert or
consultant as a statutory obligation owed to the United
States. The Secretary may waive in whole or in part a
right of recovery under this subparagraph.
``(g) Voluntary and Uncompensated Services.--The Director, in
carrying out this title, may accept voluntary and uncompensated
services.
``SEC. 927. FUNDING.
``(a) Intent.--To ensure that the United States investment in
biomedical research is rapidly translated into improvements in the
quality of patient care, there must be a corresponding investment in
research on the most effective clinical and organizational strategies
for use of these findings in daily practice. The authorization levels
in subsections (b) and (c) provide for a proportionate increase in
health care research as the United States investment in biomedical
research increases.
``(b) Authorization of Appropriations.--For the purpose of carrying
out this title, there are authorized to be appropriated $250,000,000
for fiscal year 2000, and such sums as may be necessary for each of the
fiscal years 2001 through 2004.
``(c) Evaluations.--In addition to amounts available pursuant to
subsection (b) for carrying out this title, there shall be made
available for such purpose, from the amounts made available pursuant to
section 241 (relating to evaluations), an amount equal to 40 percent of
the maximum amount authorized in such section 241 to be made available
for a fiscal year.
``SEC. 928. DEFINITIONS.
``In this title:
``(1) Advisory council.--The term `Advisory Council' means
the Advisory Council on Health Care Research and Quality
established under section 921.
``(2) Agency.--The term `Agency' means the Agency for Health
Research and Quality.
``(3) Director.--The term `Director' means the Director of
the Agency for Health Research and Quality.''.
(b) Rules of Construction.--
(1) In general.--Section 901(a) of the Public Health Service
Act (as added by subsection (a) of this section) applies as a
redesignation of the agency that carried out title IX of such
Act on the day before the date of enactment of this Act, and
not as the termination of such agency and the establishment of
a different agency. The amendment made by subsection (a) of
this section does not affect appointments of the personnel of
such agency who were employed at the agency on the day before
such date.
(2) References.--Any reference in law to the Agency for
Health Care Policy and Research is deemed to be a reference to
the Agency for Health Research and Quality, and any reference
in law to the Administrator for Health Care Policy and Research
is deemed to be a reference to the Director of the Agency for
Health Research and Quality.
SEC. 3. GRANTS REGARDING UTILIZATION OF PREVENTIVE HEALTH SERVICES.
Subpart I of part D of title III of the Public Health Service Act (42
U.S.C. 254b et seq.) is amended by adding at the end the following
section:
``SEC. 330D. CENTERS FOR STRATEGIES ON FACILITATING UTILIZATION OF
PREVENTIVE HEALTH SERVICES AMONG VARIOUS
POPULATIONS.
``(a) In General.--The Secretary, acting through the appropriate
agencies of the Public Health Service, shall make grants to public or
nonprofit private entities for the establishment and operation of
regional centers whose purpose is to identify particular populations of
patients and facilitate the appropriate utilization of preventive
health services by patients in the populations through developing and
disseminating strategies to improve the methods used by public and
private health care programs and providers in interacting with such
patients.
``(b) Research and Training.--The activities carried out by a center
under subsection (a) may include establishing programs of research and
training with respect to the purpose described in such subsection,
including the development of curricula for training individuals in
implementing the strategies developed under such subsection.
``(c) Quality Management.--A condition for the receipt of a grant
under subsection (a) is that the applicant involved agree that, in
order to ensure that the strategies developed under such subsection
take into account principles of quality management with respect to
consumer satisfaction, the applicant will make arrangements with one or
more private entities that have experience in applying such principles.
``(d) Priority Regarding Infants and Children.--In carrying out the
purpose described in subsection (a), the Secretary shall give priority
to various populations of infants, young children, and their mothers.
``(e) Evaluations.--The Secretary, acting through the appropriate
agencies of the Public Health Service, shall (directly or through
grants or contracts) provide for the evaluation of strategies under
subsection (a) in order to determine the extent to which the strategies
have been effective in facilitating the appropriate utilization of
preventive health services in the populations with respect to which the
strategies were developed.
``(f) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2000 through 2004.''.
Purpose and Summary
H.R. 2506 establishes the Agency for Health Research and
Quality (AHRQ) to conduct and support research on the quality,
outcomes, cost, and utilization of health care services and
access to those services. The Agency will promote quality by
building our knowledge regarding what works best in health
care, working in close partnership with the health care
community to identify and address opportunities for
improvement, and supporting the rapid translation of its
research findings into daily practice. AHRQ will support the
evidence-based practice of medicine and facilitate innovation
in patient care by developing, synthesizing, and disseminating
scientific knowledge regarding the outcomes, effectiveness and
cost-effectiveness of health care services, health care
technologies and information systems, and the ways that these
services and technologies are purchased, financed, organized,
and delivered. The Agency will foster the development of the
science of health care quality measurement and quality
improvement, build public-private partnerships to advance and
share quality measures and effective strategies for quality
improvement, report annually to Congress on the state of
quality in the Nation, and coordinate Federal quality
improvement efforts to avoid duplication. AHRQ will promote
access and quality through research on the most effective ways
for delivering primary care services, meeting the health care
needs of under-served populations, providing services within
underserved rural and urban areas, and facilitating the
utilization of effective clinical preventive health care
services. Finally, the Agency will support improved health care
decisionmaking at all levels of the health care system through
the entire spectrum of its activities: collecting and
developing data on the quality, cost, and use of health care
services, conducting and supporting research and evaluations,
supporting demonstrations, serving as an ``honest broker''
among competing interests, and acting as a ``science partner''
with the public and private sector.
Background and Need for Legislation
Background
The health care system in America today is dramatically
different from the system that existed a decade ago when
Congress established the Agency for Health Care Policy and
Research (AHCPR). This transformation is due in large part to
the changing nature of our insurance system--the growing
dominance of managed care plans; increased plan complexity;
increasing concentration as a result of consolidations and
mergers; demands of purchasers for accountability and value
from health care providers; shifting financial incentives; and
the growing tension between caregivers, patients, and the
policies of the systems through which care is delivered. At the
same time, there has been an explosion in the number of medical
journals and peer-reviewed articles published each year,
reflecting in part the Congressional support for basic and
biomedical research over the last few years.
As a result, even the most conscientious clinicians face
increasing difficulty in keeping abreast of the medical
literature and putting the latest scientific findings into
perspective. In fact, it has been estimated that if physicians
were to read two peer-reviewed journal articles each night
after a long day of practice, they would be 800 years behind in
their reading at the end of the year. The exponential growth in
health-related Internet web sites poses additional challenges
for patients and caregivers alike in determining which
information is based upon science and which information is less
reliable.
While concern regarding variations in the rates at which
physicians conduct medical procedures contributed to the
decision to create AHCPR in 1989, public concern regarding the
quality of patient care is growing and requires a more direct
and coordinated response. While millions of Americans receive
high-quality care every day, peer-reviewed research has
documented too many instances of underuse, overuse, and misuse
of services. In addition, there is growing public concern
regarding the number of medical errors that take place, in
which patients suffer from adverse drug events, treatment or
even amputation of the wrong limb, or other oversights. The
pioneering Harvard study in which Dr. Lucian Leape and his
colleagues looked at the records of more than 30,000 hospital
patients in New York found that nearly 4 percent suffered
serious injuries that were related to the management of their
illness rather than the illness itself. To their credit, health
professionals have recognized the problem. To tackle these
systemic issues successfully, there is a need for a sustained
health services research initiative that is undertaken in
partnership with the health professions and provider community.
As demonstrated by the debate on managed care reform,
issues such as the cost and appropriate use of, and access to,
health services remain significant public policy concerns. Many
of these concerns developed, in part, because of the lack of
reliable evidence about the risks and benefits of alternative
approaches for containing health care costs, organizing health
care delivery systems, and structuring the policies that govern
systems of care. Similarly, the debate on the long-term
stability of the Medicare program only serves to reinforce the
critical need for this type of scientific evidence. These
developments have highlighted as never before the need for
objective, science-based information at all levels of the
health care system:
at the clinical level, providing patients
and those who deliver care the information they need to
make informed decisions regarding treatment options;
at the system level, getting good
information to those who manage systems of care about
alternative approaches to organizing and delivering
care, and, for individual consumers and those who make
purchasing decisions for their employees or members,
information that will enable them to make more informed
decisions in selecting health plans and providers and
in comparing and assessing the value of the care that
they are purchasing; and
at the public policy level, providing
scientific findings--about the impact on quality, cost,
and access--concerning the ways we structure and
deliver care, the incentives that are provided to
clinicians, decisions regarding which services to
offer, as well as information (not currently available)
on national trends in quality.
The methods and tools of health services research are well
suited for addressing these information needs. While AHCPR
serves as the lead Federal Agency supporting health services
research, it does not have the necessary budget or requisite
coordinating authority to address these pressing information
needs adequately. This legislation will transform the agency
into the new Agency for Health Research and Quality (AHRQ),
which will have the stature, resources, and authority to work
in close collaboration with the private sector to meet the
Federal responsibilities in these areas.
Need for Legislation
In developing this legislation, the Committee undertook a
thorough review of the research and other activities of AHCPR
to determine whether these activities were an appropriate
Federal responsibility, whether they warranted the continued
existence of a separate agency, and, if so, whether the
Agency's mission needed to be refocused. The Committee reached
several conclusions. First, the Agency's research and other
activities provide the science-based evidence that will improve
the quality of patient care. The kind of objective, reliable
information developed by the Agency is essential for the
successful functioning of our competitive health care
marketplace. Second, the Committee found that the continued
existence of a separate agency is justified because of its
unique focus on the effectiveness of care in daily practice,
its demonstrated ability to bridge the worlds of research and
practice, and the multiple focus of its research on the
clinical aspects of care, as well as the economics,
organization, and delivery of health care. Third, the Committee
believes that a reformed and strengthened Agency can playa
critical role as the hub and driving force for the Federal government's
quality improvement efforts and in supporting private sector quality
efforts by advancing the young science of health care quality
measurement and improvement. Finally, the Committee found that a
substantial investment in building our scientific knowledge regarding
quality health care is an essential complement to the patient
protections provided in the other titles of this legislation.
The rationale for a significant Federal commitment to the
type of health services research supported by the AHRQ is
strong. The Federal government has a compelling interest in
ensuring that patients and society reap the full rewards of our
growing investment in basic and biomedical research. This
requires a corresponding investment in the kind of health
services research that will support the effective use of these
developments. Experience has shown that great opportunities for
improving health, developed through biomedical research, are
easily lost if physicians and patients are unable to make the
best use of the knowledge in everyday care. The private sector
often lacks the incentive to address these issues because the
cost of the research investment is far greater than the
benefits to the individual health plan, which occurs when
clinical conditions are common, but not costly or when they are
expensive but extremely rare. By contrast, the Federal
government has both an obligation to the American people and a
responsibility to see that the goal of its investment in basic
and biomedical research (higher quality patient care) is
realized.
The Agency has demonstrated its ability to close this gap
between the promise of biomedical research and improvements in
daily practice. For example, National Institutes of Health
(NIH)-supported research at the University of Wisconsin
demonstrated the potential of warfarin (an anticoagulant) to
prevent stroke in patients with atrial fibrillation, yet this
lifesaving innovation was underused in daily practice. An
Agency-supported research team at Duke University conducted a
meta-analysis that established warfarin as the treatment of
choice, undertook research that identified the reasons that
physicians were often reluctant to use this effective
intervention, and conducted a trial to develop effective
approaches for administering warfarin that addressed the
concerns of physicians. Findings from this research project led
in part to development of guidelines from the American College
of Physicians, the American Hospital Association (AHA), and the
Joint Council of Vascular Surgeons. Medicare Peer Review
Organizations (PROs) implemented 73 projects in 42 States, to
increase anticoagulation. Rates from 28 projects in 20 States
showed that patients discharged on anticoagulation therapy
increased from 58 percent to 71 percent. Improved
anticoagulation rates through the PRO projects are projected to
prevent 1285 strokes. As a result of the Agency's research, the
promise of the Federal investment in the basic research that
identified warfarin's potential is increasingly being realized.
The final demonstration project, for which the private sector
contributed $2.50 for every $1.00 of Agency funds, also
demonstrated for the first time the Agency's ability to
collaborate with and leverage private sector funding.
In addition to supporting new research that identifies what
works best in practice and how to make more effective use of
existing innovations, the Federal government can support the
work of busy health care professionals by assessing new
scientific advances and putting them into perspective. The
development of such syntheses requires methodologists to assess
the research design of the studies and the scientific controls
and statistics that were employed to determine the extent to
which clinicians can use the studies to guide their daily
practice. This is another area where there appear to be few
incentives in academia or the private sector to undertake such
studies, and health professionals are seldom trained to
undertake such methodological assessments. Yet the development
and updating of such assessments are essential for clinicians
and patients to benefit from investments in basic and
biomedical research. They provide essential information to
clinicians which, when combined with a patient examination,
medical history, and the clinicians' own clinical experience,
can ensure that their patients receive care that is informed by
the best science available.
As a purchaser and provider of health care services, the
Federal government has a compelling need for information that
will help it to manage its programs more effectively and
efficiently and provide information to beneficiaries of those
programs. Dr. Stuart Butler of The Heritage Foundation has
argued that the Agency should play an even greater role in this
area. Citing the potential conflicts of interest faced by
Federal Agencies in attempting both to run programs and to
provide dispassionate and objective information, he has argued
for the importance of the Agency's independence ``free from any
interest in a particular way of providing care'' (Senate Report
106-82, p. 14). The unique focus of the health services
research supported by the Agency on the cost and appropriate
use of and access to health care services is especially
critical to the efforts of the Congress to ensure the long-term
viability of the Medicare program.
Such research is an important public good in its own right.
Scientific information on how to relieve suffering, maintain or
restore health, and improve the effectiveness of the way health
services are delivered needs to be in the public domain to the
extent possible. Public funding ensures that the research
methods are scrutinized, are publicly available, are peer
reviewed, and are accessible.
During the Subcommittee on Health and Environment's hearing
on April 29, 1999, the witnesses agreed on the need for a
Federal role in advancing the science of quality, developing
and validating measures and tools for evaluating and improving
quality, and making that information widely available. An
analogy has been suggested that the government's role in health
care should be similar to the way it provides consumers with
information to assess the safety of airlines or automobiles. In
making those choices, consumers also have a variety of other
standards or measures they can use in assessing which
automobile to buy or which airline to fly. The Committee
concurs with this general framework and has provided the Agency
with broad authority to develop and advance the science of
quality but prohibits it from mandating a single approach or
national standard toward assessing quality.
The Committee concludes that, despite the Agency's past
problems, a renewed and reinvigorated agency is necessary to
carry out these legitimate Federal functions. As the conference
report to accompany the Food and Drug Administration
Modernization Act of 1997 (P.L. 105-115, H. Rpt. 105-399, p.
101) noted on the decision to assign responsibility for Centers
on Education and Research on Therapeutics (CERTs) to the
Agency:
The conferees designated AHCPR as the lead agency
because of its expertise in the evaluation of the
effectiveness of clinical care, its non-regulatory
role, and its close working relationship with the
health care community in the improvement of the quality
of care.
The Committee reaffirms that position in this report. The
Agency has demonstrated an ability to maintain its role as an
independent, objective, scientific research agency while
developing close working relationships with disparate portions
of the health care community. Its three-way partnership in the
National Guideline Clearinghouse with the American Medical
Association and the managed care trade association, the
American Association of Health Plans, is an excellent example
of its ability to bridge the worlds of research and practice in
a way that supports private-sector efforts without Federal
mandates or intrusive policy. The Agency's development of the
Consumer Assessment of Health Plans Survey (CAHPS) kit, which
has been voluntarily adopted by private sector and public
sector plans, employers, and accreditors, is another example of
the Agency's responsiveness in providing the tools that the
private sector needs to improve the quality of patient care. In
light of the increasing user-direction of its work and the
growing number and success of these public-private sector
partnerships, it is the Committee's view that shifting these
activities to another agency would be shortsighted and
destructive. The Committee's bill takes the opposite approach
by recognizing the Agency's success in reorienting its
activities, and strengthening its mandate and its resources.
The Committee especially values the Agency's demonstrated
ability to serve as a facilitator of groups with different
philosophies, ideologies, and economic agendas. It should be
noted that the Committee includes a provision in the bill that
clarifies that the role of the Agency is not to mandate
national standards of clinical practice or any specific
approach to quality measurement and reporting. The Committee
accepts the premise that definitions and measurement of quality
is an evolving science.
Hearings
The Subcommittee on Health and the Environment held a
hearing on Reauthorization of the Agency for Health Care Policy
and Research on April 29, 1999. The Subcommittee received
testimony from the following witnesses: Dr. John M. Eisenberg,
Administrator, Agency for Health Care Policy and Research; Ms.
Mary Wooley, President, Research! America; Mr. Charles N. Kahn
III, President, Health Insurance Association of America; Dr.
Charles S. Mahan, Dean, College of Public Health, University of
South Florida; and Mr. Brian Lindberg, Executive Director,
Consumer Coalition for Quality Health Care.
Committee Consideration
On July 27, 1999, the Subcommittee on Health and the
Environment met in open markup session and approved H.R. 2506,
the Health Research and Quality Act of 1999, for Full Committee
consideration, without amendment, by a voice vote. On August 5,
1999, the Full Committee met in open markup session and ordered
H.R. 2506 reported to the House, amended, by a voice vote, a
quorum being present.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House requires
the Committee to list the record votes on the motion to report
legislation and amendments thereto. There were no record votes
taken in connection with ordering H.R. 2506 reported. An
amendment offered by Mr. Bilirakis, No. 1, to make two
technical changes to the bill by adding the word ``outcomes''
which was inadvertently omitted from the bill to clarify that:
(1) Provider-Based Research Networks shall evaluate outcomes as
well as promote quality improvement; and (2) information
systems shall be used for the study of health care quality and
outcomes, was agreed to by a voice vote. A motion by Mr. Bliley
to order H.R. 2506 reported to the House, amended, was agreed
to by a voice vote, a quorum being present.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held a legislative
hearing and made findings that are reflected in this report.
Committee on Government Reform Oversight Findings
Pursuant to clause 3(c)(4) of rule XIII of the Rules of the
House of Representatives, no oversight findings have been
submitted to the Committee by the Committee on Government
Reform.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
2506, the Health Research and Quality Act of 1999, would result
in no new or increased budget authority, entitlement authority,
or tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 7, 1999.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 2506, the Health
Research and Quality Act of 1999.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Jeanne De Sa.
Sincerely,
Barry B. Anderson
(For Dan L. Crippen, Director).
Enclosure.
H.R. 2506--Health Research and Quality Act of 1999
Summary: CBO estimates that enacting H.R. 2506 would cost
$28 million in fiscal year 2000 and about $900 million over the
2000-2004 period, assuming appropriation of the authorized
amounts. The bill would amend title IX of the Public Health
Service Act to reauthorize the Agency for Health Care Policy
and Research (AHCPR), revise and extend its functions, and
rename it the Agency for Health Research and Quality (AHRQ). In
addition, H.R. 2506 would amend title III of the Public Health
Service Act to require the Secretary of Health and Human
Services to make grants to public or nonprofit entities for the
establishment of regional centers that improve utilization of
preventive health services for families and children.
H.R. 2506 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would not affect the budgets of state, local, or tribal
governments. The bill would not affect direct spending or
receipts; therefore pay-as-you-go procedures would not apply.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 2506 is shown in the following able.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal years, in millions of dollars--
-----------------------------------------------
1999 2000 2001 2002 2003 2004
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
With Adjustments for Inflation
Spending Under Current Law:
Budget Authority \1\........................................ 100 0 0 0 0 0
Estimated Outlays........................................... 88 70 40 14 3 0
Proposed Changes:
Estimated Authorization Level............................... 0 225 263 268 275 280
Estimated Outlays........................................... 0 28 143 222 252 266
Spending Under H.R. 2506:
Estimated Authorization Level \1\........................... 100 255 263 268 275 280
Estimated Outlays........................................... 88 98 183 236 255 266
Without Adjustments for Inflations
Spending Under Current Law:
Budget Authority \1\........................................ 100 0 0 0 0 0
Estimated Outlays........................................... 88 70 40 14 3 0
Proposed Changes:
Estimated Authorization Level............................... 0 255 255 255 255 255
Estimated Outlays........................................... 0 28 142 218 243 250
Spending Under H.R. 2506:
Estimated Authorization Level \1\........................... 100 255 255 255 255 255
Estimated Outlays........................................... 88 98 182 232 246 250
----------------------------------------------------------------------------------------------------------------
\1\ The 1999 level is the amount appropriated for that year.
Basis of estimate: H.R. 2506 has two separate authorization
provisions. First, the bill would authorize $250 million in
fiscal year 2000 and such sums as may be necessary for fiscal
years 2001-2004 to support the activities of AHRQ. Since
authorization for AHCPR has expired, CBO estimates that this
provision would increase authorizations of appropriations by
$250 million in 2000. Assuming appropriation of the authorized
amounts and adjusting for inflation, CBO estimates that this
provision would increase discretionary spending by $25 million
in fiscal year 2000 and $888 million over the 2000-2004 period.
Without adjustments for inflation after 2000, outlays of AHRQ
over the five-year period would total $858 million. The outlay
estimate is based on historical spending patterns for AHCPR.
Second, H.R. 2506 would authorize such sums as may be
necessary for fiscal years 2000-2004 for the establishment of
centers that would facilitate utilization of preventive health
services. CBO estimated that implementing the provision would
cost about $3 million in 2000 and $5 million a year from 2001
through 2004. The estimate assumes $1 million in annual grants
to each of five regional centers, whose programs would be based
on a model program currently operating at the University of
South Florida. Although the proposed legislation does not
specify which agency of the Public Health Services would
administer the program, the estimate reflects historical
spending patterns for health centers operated by the Health
Resources Services Administration.
Intergovernmental and private-sector impact: H.R. 2506
contains no intergovernmental or private-sector mandates as
defined in UMRA and would not affect the budgets of state,
local, or tribal governments.
Estimate prepared by: Federal Costs: Jeanne De Sa. Impact
on State, Local, and Tribal Governments: Leo Lex. Impact on the
Private Sector: Jennifer Bullard.
Estimate approved by: Robert A. Sunshine, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
Section 915 of H.R. 2506 creates the Preventative Services
Task Force to review the evidence related to the effectiveness,
appropriateness, and cost-effectiveness of clinical
preventative services for the purpose of developing
recommendations for the health care community regarding their
usefulness in daily clinical practice. Further, section 921
establishes the Advisory Council for Health Care Research and
Quality to make certain recommendations to the Director.
Pursuant to the requirements of subsection 5(b) of the Federal
Advisory Committee Act, the Committee finds that the functions
of the proposed advisory committees are not and cannot be
performed by an existing Federal agency or advisory commission
or by enlarging the mandate of an existing advisory committee.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
This section provides the short title of the legislation,
the ``Health Research and Quality Act of 1999''.
Section 2. Amendment to the Public Health Service Act
Subsection (a) amends Title IX of the Public Health Service
Act (PHS; 42 U.S.C. Sec. 299 et. seq.) in the following manner:
TITLE IX--AGENCY FOR HEALTH RESEARCH AND QUALITY
PART A--ESTABLISHMENT AND GENERAL DUTIES
Section 901. Mission and duties
This section strengthens and renames the Agency,
specifically outlines its mission, and structures the Agency to
serve as a ``science partner'' in its work with the private and
public sectors. The Committee explicitly included directions
for the Agency to work in collaboration and partnership with
the public sector and private sector users of its research in
this and subsequent sections of the bill. The Committee deleted
the word ``Policy'' from the Agency's name to eliminate any
potential confusion regarding the Agency's role in policy
making. The Committee clearly intends that the Agency's
research and other activities should inform public policy, not
make public policy.
Subsection (a) establishes the Agency for Health Research
and Quality within the Public Health Service (hereinafter
referred to as ``the Agency'') and authorizes the Secretary of
Health and Human Services (the Secretary) to appoint a Director
to serve as head of the Agency and directs the Secretary to
carry out this title through the Director.
Subsection (b) states that the purpose of the Agency is to
enhance the quality, appropriateness, and effectiveness of
health care services, and access to such services, through the
establishment of a broad base of scientific research and
through the promotion of improvements in clinical practice,
including the prevention of diseases and other health
conditions. The bill requires the Agency to promote health care
quality improvement by:
(1) conducting and supporting research that develops
and presents scientific evidence regarding all aspects
of health, including--
methods of enhancing patient
participation in their own care and for
facilitating shared patient-physician decision-
making;
the outcomes, effectiveness, and
cost-effectiveness of health care practices,
including preventive measures and long-term
care;
existing and innovative
technologies;
the costs, utilization, and access
to health care;
the ways in which health care
services are organized, delivered, and financed
and the interaction and impact of these factors
on the quality of patient care;
methods for measuring and strategies
for improving quality; and
ways in which patients, consumers,
and practitioners acquire and use new
information about best practices and health
benefits;
(2) synthesizing and disseminating available
scientific evidence for use by patients, consumers,
practitioners, providers, purchasers, policy makers,
and educators; and
(3) advancing private and public efforts to improve
health care quality.
Subsection (c) requires the Director to undertake and
support research, demonstration projects, and evaluations with
respect to the delivery of health services: (a) in rural areas
(including frontier areas); (b) for low-income groups, and
minority groups; (c) for children; (d) for the elderly; and (e)
for people with special health care needs, including
disabilities, chronic care, and end-of-life health care.
Section 902. General authorities
Subsection (a) requires the Director to support
demonstration projects, conduct and support research,
evaluations, training, research networks, multi-disciplinary
centers, technical assistance, and the dissemination of
information, on health care, and on systems for the delivery of
such care, including activities with respect to--
the quality, effectiveness, efficiency,
appropriateness and value of health care services;
quality measurement and improvement;
the outcomes, cost, cost-effectiveness, and
use of health care services and access to such
services;
clinical practice, including primary care
and practice-oriented research;
health care technologies, facilities, and
equipment;
health care costs, productivity,
organization, and market forces;
health promotion and disease prevention,
including clinical preventive services;
health statistics, surveys, database
development, and epidemiology; and
medical liability.
Subsection (b) authorizes the Director to provide training
grants in the field of health services research to include pre-
and post-doctoral fellowships and training programs, young
investigator awards, and other programs and activities as
appropriate. Training funds for carrying out these activities
are made available under section 487 of the Public Health
Service Act. The bill requires the Director, in developing
priorities for the allocation of such funds, to take into
consideration shortages of trained researchers addressing the
priority populations outlined in section 901(c).
Subsection (c) authorizes the Director to provide financial
assistance toward the costs of planning, establishing, and
operating centers for multidisciplinary health services
research, demonstration projects, evaluations, training, and
policy analysis.
Subsection (d) states the policy that activities of the
Agency should be appropriately coordinated with experiments,
demonstration projects, and other related activities authorized
by the Social Security Act and the Social Security Amendments
of 1967. The Director must carry out activities that affect
Medicare, Medicaid, and the State Child Health Insurance
Program consistent with provisions of the Social Security Act
affecting outcomes research.
Subsection (e) prohibits the Agency from mandating national
standards of clinical practice or health care quality.
Published recommendations that result from the Agency's
projects must include a disclaimer to that effect.
Subsection (f) clarifies that it is not the role of the
Agency to mandate a national standard or specific approach to
quality measurement and reporting. In determining research and
quality improvement activities, the Agency must consider a wide
range of choices, providers, health care delivery systems, and
individual preferences. This provision reflects the Committee's
response to concerns expressed during the hearing about the
need for limitations in the overall Federal role in quality.
PART B--HEALTH CARE IMPROVEMENT RESEARCH
Section 911. Health care outcome improvement research
Subsection (a) requires that the Agency collaborate with
experts from the public and private sector to identify and
disseminate methods or systems to assess health care research
results, and rate the strength of the scientific evidence
behind health care practice, technology assessments, and
recommendations in the research literature. It also requires
the Agency to make such evidence assessment methods and systems
widely available, especially those that the Agency or its
contractors use. Agency publications containing clinical
recommendations must indicate the level of substantiating
evidence using such methods or systems.
Subsection (b) requires the Agency to use research
strategies and mechanisms to link research directly with
clinical practice in geographically diverse locations,
including: Health Care Improvement Research Centers that
provide access to multidisciplinary expertise in outcomes or
quality improvement research with linkages to relevant sites of
care; Provider-based Research Networks, including plan,
facility, or delivery systems sites of care (especially primary
care), that can evaluate outcomes and promote quality
improvement; and other innovative mechanisms or strategies. It
authorizes the Director to establish the requirements for
entities applying for grants under this subsection.
Section 912. Private-public partnerships to improve organization and
delivery
Subsection (a) designates the Agency as the principal
agency for health care quality research and authorizes the
Agency to provide scientific and technical support for public
and private efforts to improve health care quality, including
accrediting organizations. The role of the Agency is to:
identify and assess methods for evaluating
the health of health plan enrollees by type of plan,
provider, and provider arrangements; and of other
populations, including those receiving long-term care
services;
develop, test, and disseminate quality
measures, including measures of health and functional
outcomes;
compile and disseminate health care quality
measures developed in the private and public sector;
assist in the development of improved health
care information systems;
develop survey tools to measure enrollee
assessments of their health care; and
identify and disseminate information on
mechanisms to integrate quality information into
purchaser and consumer decision-making.
Subsection (b) requires the Secretary, acting through the
Director and in consultation with the Commissioner of Food and
Drugs, to establish a program for making one or more grants to
establish centers to conduct state-of-the-art research to:
increase awareness of new uses and
improvements in the use of drugs, biological products,
and devices and risks of new uses and combinations of
drugs and biological products;
provide objective clinical information to
health care practitioners and providers, pharmacists,
pharmacy benefit managers and purchasers, health
maintenance organizations and other managed health care
organizations, insurers and governmental agencies,
patients and consumers; and
improve the quality of health care while
reducing the cost through an increase in the
appropriate use of drugs, biological products, or
devices and the prevention of adverse effects.
In addition, this section requires the conduct of research on
the comparative effectiveness, cost-effectiveness, and safety
of drugs, biological products, and devices and such other
activities as the Secretary determines to be appropriate.
Subsection (c) requires that the Director conduct and
support research and build public-private partnerships to
identify the causes of preventable errors and patient injury in
health care delivery; develop, demonstrate, and evaluate
strategies for reducing errors and improving patient safety;
and promote implementation of strategies for reducing errors
and improving patient safety.
Section 913. Information on quality and cost of care
Subsection (a) requires that the Director:
conduct a survey to gather data on the cost
and use of health care services and, beginning in
Fiscal Year 2001 and subsequent years, the quality of
health care, including the types of health care
services Americans use, their access to health care
services, frequency of use, how much is paid for the
services used, the source of those payments, the types
and costs of private health insurance, access,
satisfaction, and quality of care for the general
population and also for children, the uninsured, poor
and near-poor individuals, and persons with special
health care needs; and
develop databases and tools that enable
States to track the quality, access, and use of health
care services.
Subsection (b) further requires that, beginning in Fiscal
Year 2001, the above survey:
identify determinants of health outcomes and
functional status, the needs of special populations
with respect to such variables as well as an
understanding of these changes over time, relationships
to health care access and use, and monitor the overall
national impact of Federal and State policy changes on
health care;
provide information on the quality of care
and patient outcomes for frequently occurring clinical
conditions for a nationally representative sample of
the population; and
provide reliable national estimates for
children and persons with special health care needs
through the use of supplements or periodic expansions
of the survey if necessary.
Beginning in Fiscal Year 2003, an annual report is required to
be submitted to Congress on national trends in the quality of
health care.
Section 914. Information systems for health care improvement
Subsection (a) directs the Agency to support research,
evaluations, and initiatives to advance:
the use of information systems for the study
of health care quality and outcomes, including the
generation of both individual and plan-level
comparative performance;
training for health care practitioners and
researchers in the use of information systems;
the creation of effective linkages between
various sources of health information, including
information networks;
the delivery and coordination of evidence-
based health care services, including the use of real-
time decision-support programs;
the structure, content, definition, and
coding of health information data and medical
vocabularies in consultation with appropriate Federal
entities and shall seek input from appropriate private
entities;
the use of computer-based health records in
outpatient and inpatient settings as a personal health
record for individual health assessment and
maintenance; and
the protection of confidential patient
information.
In addition, the Agency is directed to support demonstration
projects on the use of information tools for improving shared
decision-making between patients and providers.
The Committee notes that this legislation places an
emphasis on research and other activities related to the
outcomes of medical interventions. In particular, the Agency is
directed to link research and clinical practice using not only
Health Care Improvement Research Centers but also Provider-
Based Research Networks that can evaluate outcomes. Further,
the Agency is required to support research and other
initiatives to advance the use of information systems for the
study of health care quality and outcomes. The Committee is
aware of the importance of outcomes research and information
dissemination in the continuous improvement of patient care, in
virtually every area of medical practice. In the area of cancer
care, for example, the ability to chart patient outcomes from a
variety of interventions and use of varying clinical practices,
and to communicate these outcomes effectively among
practitioners, allows significant improvement in the treatment
of this extremely complex set of diseases. As resources expand,
the Committee anticipates that the Agency will focus greater
attention on this essential area. In addition, the Agency
should emphasize outcomes research activities that encompass a
broad geographical dispersion of study subjects and that
compile longitudinal data resulting from long- term follow-up
to support efforts to improve the quality of patient care.
Section 915. Research supporting primary care and access in underserved
areas
Subsection (a) clarifies the role of the Preventive
Services Task Force (PSTF or the Task Force), which is to
review the evidence related to the effectiveness,
appropriateness, and cost-effectiveness of clinical preventive
services for the purpose of developing recommendations for the
health care community regarding their usefulness in daily
clinical practice. (Authority for the PSTF was transferred by
the Secretary to the Agency several years ago.) The Agency is
directed to provide ongoing administrative, research, and
technical support for the operation of the Preventive Services
Task Force and to coordinate and support the dissemination of
Task Force recommendations. The operation of the Task Force is
exempt from the requirements of the Federal Advisory Committee
Act.
Subsection (b) establishes a Center for Primary Care
Delivery Research within the Agency (referred to in this
subsection as the ``Center'') to serve as the principal source
of funding for primary care delivery research in the Department
of Health and Human Services. The legislation specifies the
focus of primary care research as the first contact when
illness or health concerns arise, the diagnosis, treatment or
referral to specialty care, preventive care, and the
relationship between the clinician and the patient in the
context of the family and community.
The legislation also requires the Center to conduct and
support research on the nature and characteristics of primary
care delivery practice, producing evidence for the management
of common clinical problems, the management of undifferentiated
clinical problems, and the continuity and coordination of
health services.
Section 916. Clinical practice and technology innovation
Subsection (a) requires that the Director promote
innovation in evidence-based clinical practice and health care
technologies by conducting and supporting research on the
development, diffusion, and use of health care technology;
developing, evaluating, and disseminating methodologies for
assessments; conducting and supporting assessments of new and
existing health care practices and technologies; promoting
education and training and providing technical assistance in
the use of assessment methodologies; and working with the
National Library of Medicine and the public and private sectors
to develop an electronic clearinghouse of such assessments.
Subsection (b) specifies the process for clinical practice
and technology assessment. It requires that the Director, not
later than December 31, 2000, develop and publish a description
of the methods used by the Agency and its contractors in
conducting such assessments. It also requires that the Director
cooperate and consult with a specified list of Federal
officials and the heads of other interested Federal departments
and agencies, and other private and public entities (such as
manufacturers, professional societies, or consumer advocacy
organizations that have relevant, scientifically-credible
knowledge and information bearing on issues integral to the
assessment). It also specifies that methods used in such
assessments must consider: safety, efficacy, and effectiveness;
legal, social, and ethical implications; costs, benefits, and
cost-effectiveness; comparisons to alternative technologies and
practices; and, to avoid duplication, data previously submitted
to the Food and Drug Administration.
Subsection (c) requires that the Director conduct and
support specific assessments of health care technologies and
practices and authorizes the Director to conduct or support
assessments on a reimbursable basis for other Federal agencies
and other public or private entities. In addition, the Director
may make grants to, or enter into cooperative agreements or
contracts for the purpose of conducting assessments of,
experimental, emerging, existing, or potentially outmoded
health care technologies, and for related activities with
entities determined to be appropriate by the Director. Such
entities can include academic medical centers, research
institutions, professional organizations, third party payers,
other governmental agencies, and consortia of appropriate
research entities established for the purpose of conducting
technology assessments.
Section 917. Coordination of Federal Government quality improvement
efforts
Subsection (a) requires that the Secretary, acting through
the Director, coordinate all Federal research, evaluations, and
demonstrations related to health services research and quality
measurement and improvement activities. With respect to such
activities, it requires that the Director, in collaboration
with the appropriate Federal officials, develop and manage a
process to improve interagency coordination, priority setting,
and the use and sharing of research findings and data
pertaining to Federal quality improvement programs, technology
assessments, and health services research; strengthen the
research information infrastructure, including databases; set
specific goals; and strengthen the management of Federal health
care quality improvement programs.
While this legislation instructs the Agency to have an
expanded role in the coordination of Federal quality
improvement efforts undertaken by the Federal government, the
Committee does not intend for the Agency to have an
administrative role in the operation of programs under titles
XVIII, XIX, and XXI of the Social Security Act.
Subsection (b) directs the Secretary to enter into a
contract with the Institute of Medicine to describe and
evaluate current quality improvement, quality research, and
quality monitoring processes; provide a summary of existing
partnerships that the Department of Health and Human Services
has pursued with private sector accreditation, quality
measurement and improvement organizations; and identify options
and make recommendations to improve the efficiency and
effectiveness of such quality improvement programs. The
requirements of the contract include the preparation of (i) a
report providing an overview of the quality improvement
programs of the Department of Health and Human Services for the
Medicare, Medicaid, and Child Health Insurance Programs under
titles XVIII, XIX, and XXI of the Social Security Act (not
later than 12 months after the date of enactment), and (ii) not
later than 24 months after the date of enactment of this title,
of a final report containing recommendations for a
comprehensive system and public-private partnerships for health
care quality improvement. This subsection requires that the
Secretary submit the reports to the Committee on Finance and
the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Commerce and the Committee on Ways
and Means of the House of Representatives.
The Committee recognizes that other agencies conduct and
support health services research and quality measurement and
improvement activities. To eliminate unnecessary duplication of
effort and to streamline existing functions, the Committee has
included two important provisions in this section. The first,
described above in subsection (a) is to provide the Director
with authority to coordinate these activities across other
agencies and departments. The second provision, described above
in subsection (b), directs the Institute of Medicine to review
existing quality activities across departments, with special
emphasis on programs under Titles XVIII, XIX, and XXI of the
Social Security Act that are administered by the Department of
Health and Human Services, and develop recommendations for
consolidation and coordination.
PART C--GENERAL PROVISIONS
Section 921. Advisory Council for Health Care Research and Quality
Subsection (a) establishes the Advisory Council for Health
Care Research and Quality (the Advisory Council).
Subsection (b) directs the Advisory Council to advise the
Secretary and the Director with respect to activities to carry
out the purpose of the Agency under section 901(b) and to make
recommendations to the Director regarding:
health care research priorities, especially
studies related to quality, outcomes, cost and the
utilization of, and access to, health care services;
the field of health care research and
related disciplines, especially issues related to
training needs, and dissemination of information on
quality; and
the appropriate role of the Agency in each
of these areas in light of private sector activity and
identification of opportunities for public-private
sector partnerships.
Subsection (c) requires the Secretary to appoint 18 voting
members, ensuring that they represent professions and entities
concerned with, or affected by, activities under this title and
under section 1142 of the Social Security Act. The appointed
members must include three distinguished researchers; three
individuals distinguished in the practice of medicine of which
at least one is a primary care practitioner; three individuals
distinguished in other health professions; three individuals
either representing the private health care sector, including
health plans, providers, and purchasers or individuals
distinguished as health care administrators; three individuals
distinguished in the fields of health care quality, economics,
information systems, law, ethics, business, or public policy;
and three individuals representing the interests of patients
and consumers. The latter group may include consumer advocates
with expertise regarding the needs and interests of patients
and consumers of health care. At least 14 members are required
to be representatives of the public who are not officers or
employees of the United States.
The Secretary also must designate several ex officio
members of the Advisory Council, including the Assistant
Secretary for Health, the Director of the National Institutes
of Health, the Director of the Centers for Disease Control and
Prevention, the Administrator of the Health Care Financing
Administration, the Assistant Secretary of Defense (Health
Affairs), and the Under Secretary for Health of the Department
of Veterans Affairs, and such other Federal officials as the
Secretary considers appropriate.
Subsection (d) requires appointed members of the Advisory
Council to serve for a term of 3 years. They may continue to
serve after the expiration of the term until a successor is
appointed.
Subsection (e) states that if a member of the Advisory
Council does not serve the full term, the individual appointed
to fill the resulting vacancy shall be appointed for the
remainder of the predecessor's term.
Subsection (f) states that the Director will designate a
member to serve as the chair of the Advisory Council.
Subsection (g) requires that the Advisory Council meet at
least once during each discrete 4-month period and may
otherwise meet at the call of the Director or the chair.
Subsection (h) requires that members of the Advisory
Council receive compensation for each day (including travel
time) engaged in carrying out the duties of the Advisory
Council unless declined by the member. Such compensation may
not be in an amount in excess of the GS-18 of the General
Schedule. Ex officio members may not receive compensation for
service on the Advisory Council in addition to the compensation
otherwise received for duties carried out as officers of the
United States.
Subsection (i) requires that the Director provide the
Advisory Council with such staff, information, and other
assistance as may be necessary to carry out the duties of the
Advisory Council.
Section 922. Peer review with respect to grants and contracts
Subsection (a) requires that appropriate technical and
scientific peer review be conducted with respect to each
application for a grant, cooperative agreement, or contract
under this title. Each peer review group to which an
application is submitted must report its finding and
recommendations with respect to the application to the Director
in such form and in such manner as the Director shall require.
Subsection (b) prohibits the Director from approving an
application (described above) unless the application is
recommended for approval by a peer review group established
under subsection (c).
Subsection (c) requires the Director to establish technical
and scientific peer review groups to carry out this section.
Such groups must be established without regard to the
provisions of title 5, United States Code, that govern
appointments in the competitive service, and without regard to
the provisions of chapter 51, and subchapter III of chapter 53,
of such title that relate to classification and pay rates under
the General Schedule.
Peer review group members are to be eminently qualified
individuals. Not more than 25 percent of such groups'
membership are to be officers and employees of the United
States and such officers and employees may not receive
additional compensation for service. Peer review groups
established under this section may continue in existence until
otherwise provided by law.
This subsection also requires that peer review group
members agree in writing to treat information received,
records, reports, and recommendations as confidential
information and to recuse themselves from participation in the
peer-review of specific applications which present a potential
personal conflict of interest or appearance of a conflict.
Subsection (d) authorizes, in the case of applications for
financial assistance whose direct costs will not exceed
$100,000, the Director to make adjustments in the peer review
procedures to encourage the entry of individuals into the field
of research and to encourage clinical practice-oriented
research, and for such other purposes as the Director may
determine to be appropriate.
Subsection (e) grants the Director the authority to issue
regulations for the conduct of peer review under this section.
Section 923. Certain provisions with respect to development,
collection, and dissemination of data
Subsection (a) requires that the Director establish
standard methods to ensure the utility, accuracy, and
sufficiency of data collected by or for the Agency and requires
that the Director, in doing so, take into account other Federal
data collection requirements and differences among health care
plans, delivery systems, providers, and provider arrangements.
If the methods proposed by the Director affect the
administration of other programs, including the programs under
titles XVIII, XIX or XXI of the Social Security Act, they shall
be issued in the form of recommendations to the Secretary.
Subsection (b) requires that the Director take appropriate
action to ensure that statistics and analyses developed under
this title are of high quality, timely, and comprehensive; that
the statistics are specific, standardized, and adequately
analyzed and indexed; and that the Director make such
information available on as wide a basis as is practicable.
Subsection (c) provides the Director the authority, upon
request of a public or private entity, to undertake research or
analyses otherwise authorized under this title, the cost of
which would be paid by the entity and such funds would remain
available to the Agency until expended.
Section 924. Dissemination of information
Subsection (a) requires that the Director: promptly
publish, or make broadly available, in an understandable form,
the results of research, demonstration projects, and
evaluations; ensure that information disseminated by the agency
is science-based, objective, and useful; promptly make data
available to the public; provide, in collaboration with the
National Library of Medicine where appropriate, indexing,
abstracting, translating, publishing, and other services
leading to a more effective dissemination of research
information, and undertake programs to develop new or improved
methods for making such information available; and, as
appropriate,provide technical assistance to State and local
government and health agencies and conduct liaison activities to such
agencies to foster dissemination.
Subsection (b) prohibits the Director from restricting the
publication or dissemination of data or results from projects
conducted or supported under this title except for those
limitations described below.
Subsection (c) protects and restricts information about
identifiable persons or establishments. The provision states
that such information cannot be used for any purpose other than
that for which it was supplied, unless the person or
establishment supplying the information or described in it
consents to its use for such other purpose. The provision also
prohibits the publication of such data, or release in any form,
unless the person who supplied the data or described in it has
consented to its publication or release.
Subsection (d) establishes a civil monetary penalty of not
more than $10,000 for each violation of subsection (c).
Section 925. Additional provisions with respect to grants and contracts
Subsection (a) requires that the Director define by
regulation the circumstances under which financial interests in
projects may be reasonably expected to create a bias in favor
of obtaining results that are consistent with such interests,
and the actions the Director will take in response to such
financial interests.
Subsection (b) provides that applications for grants,
cooperative agreements, or contracts, may not be approved
unless the application is submitted to the Secretary in the
required form and contains such agreements, assurances, and
information as determined by the Director to be necessary to
carry out the program involved.
Subsection (c) provides that, upon request of an entity
receiving a grant, cooperative agreement, or contract, the
Secretary may, subject to paragraph (2), provide supplies,
equipment, and services for the purpose of aiding an entity in
carrying out the project involved and, for such purpose, may
detail to the entity any officer or employee of the Department
of Health and Human Services.
With respect to a request described for services, supplies
or equipment, the Secretary is required to reduce the amount of
the financial assistance by an amount equal to the costs of
detailing personnel and the fair market value of any supplies,
equipment, or services provided by the Director. The Secretary
shall, for the payment of expenses incurred in complying with
such request, expend the amounts withheld.
Subsection (d) provides that contracts may be entered into
under this part without regard to sections 3648 and 3709 of the
Revised Statutes (31 U.S.C. Sec. 529; 41 U.S.C. Sec. 5).
Section 926. Certain administrative authorities
Subsection (a) specifies that the Director may appoint a
deputy director for the Agency, and that the Director may
appoint and fix the compensation of such officers and employees
as may be necessary to carry out this title. Except as
otherwise provided by law, such officers and employees shall be
appointed in accordance with the civil service and compensation
laws.
Subsection (b) authorizes the Secretary to lease or
otherwise acquire through the Director of General Services,
buildings or portions of buildings in the District of Columbia
or communities located adjacent to the District of Columbia for
use for a period not to exceed 10 years; and acquire,
construct, improve, repair, operate, and maintain laboratory,
research, and other necessary facilities and equipment, and
such other real or personal property (including patents) as the
Secretary deems necessary.
Subsection (c) authorizes the Director to make grants to
public and nonprofit entities and individuals, and enter into
cooperative agreements or contracts with public and private
entities and individuals.
Subsection (d) authorizes the Director to utilize personnel
and equipment, facilities, and other physical resources of the
Department of Health and Human Services, permit appropriate (as
determined by the Secretary) entities and individuals to
utilize the physical resources of such Department, and provide
technical assistance and advice. In addition, the Director may
use with their consent, the services, equipment, personnel,
information, and facilities of other Federal, State, or local
public agencies, or of any foreign government, with or without
reimbursement of such agencies.
Subsection (e) authorizes the Secretary to engage
consultants from time to time and for such periods as the
Director deems advisable in accordance with provisions of
Section 3109 of title 5, United States Code, on the assistance
and advice of consultants from the United States or abroad.
Subsection (f) authorizes the Secretary to obtain the
services of not more than 50 experts or consultants who have
appropriate scientific or professional qualifications. Such
experts and consultants whose services are obtained must be
paid or reimbursed for their expenses associated with traveling
to and from their assignment location in accordance with
sections of Government Organization and Employees (title 5,
United States Code) on travel, transportation and subsistence
expenses for government employees. Expenses may not be allowed
in connection with an expert or consultant unless the expert
agrees in writing to complete the entire period of assignment,
or 1 year, whichever is shorter, unless separated or reassigned
for reasons that are beyond the control of the expert or
consultant and that are acceptable to the Secretary. If the
expert or consultant violates the agreement, the money spent by
the United States for the expenses specified in subparagraph
(A) is recoverable from the expert or consultant as a debt of
the United States. The Secretary may waive in whole or in part
a right of recovery under this subparagraph.
Subsection (g) allows the Director to accept voluntary and
uncompensated services.
Section 927. Funding
Subsection (a) clarifies that the Congress intends to
ensure that the United States' investment in biomedical
research is rapidly translated into improvements in the quality
of patient care, with a corresponding investment in research on
the most effective clinical and organizational strategies for
use of these findings in daily practice, and notes that funds
authorized provide for a proportionate increase in health care
research as the United States' investment in biomedical
research increases.
Subsection (b) authorizes to be appropriated, for the
purpose of carrying out this title, $250,000,000 for Fiscal
Year 2000, and such sums as may be necessary for each of the
Fiscal Years 2001 through 2004.
Subsection (c) provides that, in addition to appropriated
amounts available above, there shall be made available for each
fiscal year an amount equal to 40 percent of the maximum amount
authorized in section 241 (relating to evaluations).
Section 928. Definitions
This section defines the terms ``Advisory Council,''
``Agency,'' and ``Director.''
Section 2 (b) of the bill provides that Section 901(a) of
the Public Health Service Act as amended by this bill applies
as a redesignation of the Agency for Health Care Policy and
Research, and not as the termination of such agency and the
establishment of a different agency. Subsection (a) of this
section does not affect appointments of the personnel of such
agency who were employed at the agency on the day before the
enactment of this bill.
This subsection also provides that, effective upon the date
of enactment of this Act, any reference in law to the ``Agency
for Health Care Policy and Research'' shall be deemed to be a
reference to the ``Agency for Health Research and Quality'' and
any reference to the ``Administrator'' shall be deemed a
reference to the ``Director.''
Section 3. Grants regarding utilization of preventive health services
This section amends subpart I of part D of title III of the
Public Health Service Act (42 U.S.C. 254b et seq.) by adding at
the end a new section, 330D, entitled ``Centers for Strategies
on Facilitating Utilization of Preventative Health Services
Among Various Populations.''
Subsection (a) directs the Secretary, acting through the
appropriate agencies of the Public Health Service, to make
grants to public or nonprofit private entities for the
establishment and operation of regional centers whose purpose
is to identify particular populations of patients and
facilitate the appropriate utilization of preventive health
services by patients in the identified populations through
developing and disseminating strategies to improve the methods
used by public and private health care programs and providers
in interacting with such patients.
Subsection (b) provides that, in carrying out subsection
(a), centers may establish programs of research and training,
including the development of curricula for training individuals
in implementing the strategies developed under such subsection.
Subsection (c) provides that, to ensure that the strategies
developed under subsection (a) account for principles of
quality management with respect to consumer satisfaction,
applicants must agree as a condition of a grant award that they
will make arrangements with one or more private entities that
have experience in applying such principles.
Subsection (d) directs the Secretary to give priority to
various populations of infants, young children, and their
mothers.
Subsection (e) directs the Secretary, acting through the
appropriate agencies of the Public Health Service, to provide
for the evaluation of strategies under subsection (a) directly
or through grants or contracts to determine the extent to which
the strategies have been effective in facilitating the
appropriate utilization of preventive health services in the
populations with respect to which the strategies were
developed.
Subsection (f) authorizes to be appropriated, for the
purpose of carrying out this section, such sums as may be
necessary for each of the Fiscal Years 2000 through 2004.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part D--Primary Health Care
* * * * * * *
Subpart I--Health Centers
* * * * * * *
SEC. 330D. CENTERS FOR STRATEGIES ON FACILITATING UTILIZATION OF
PREVENTIVE HEALTH SERVICES AMONG VARIOUS
POPULATIONS.
(a) In General.--The Secretary, acting through the
appropriate agencies of the Public Health Service, shall make
grants to public or nonprofit private entities for the
establishment and operation of regional centers whose purpose
is to identify particular populations of patients and
facilitate the appropriate utilization of preventive health
services by patients in the populations through developing and
disseminating strategies to improve the methods used by public
and private health care programs and providers in interacting
with such patients.
(b) Research and Training.--The activities carried out by a
center under subsection (a) may include establishing programs
of research and training with respect to the purpose described
in such subsection, including the development of curricula for
training individuals in implementing the strategies developed
under such subsection.
(c) Quality Management.--A condition for the receipt of a
grant under subsection (a) is that the applicant involved agree
that, in order to ensure that the strategies developed under
such subsection take into account principles of quality
management with respect to consumer satisfaction, the applicant
will make arrangements with one or more private entities that
have experience in applying such principles.
(d) Priority Regarding Infants and Children.--In carrying
out the purpose described in subsection (a), the Secretary
shall give priority to various populations of infants, young
children, and their mothers.
(e) Evaluations.--The Secretary, acting through the
appropriate agencies of the Public Health Service, shall
(directly or through grants or contracts) provide for the
evaluation of strategies under subsection (a) in order to
determine the extent to which the strategies have been
effective in facilitating the appropriate utilization of
preventive health services in the populations with respect to
which the strategies were developed.
(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2000 through 2004.
* * * * * * *
[TITLE IX--AGENCY FOR HEALTH CARE POLICY AND RESEARCH
[Part A--Establishment and General Duties
[SEC. 901. ESTABLISHMENT.
[(a) In General.--There is established within the Service
an agency to be known as the Agency for Health Care Policy and
Research.
[(b) Purpose.--The purpose of the Agency is to enhance the
quality, appropriateness, and effectiveness of health care
services, and access to such services, through the
establishment of a broad base of scientific research and
through the promotion of improvements in clinical practice
(including the prevention of diseases and other health
conditions) and in the organization, financing, and delivery of
health care services.
[(c) Appointment of Administrator.--There shall be at the
head of the Agency an official to be known as the Administrator
for Health Care Policy and Research. The Administrator shall be
appointed by the Secretary. The Secretary, acting through the
Administrator, shall carry out the authorities and duties
established in this title.
[SEC. 902. GENERAL AUTHORITIES AND DUTIES.
[(a) In General.--In carrying out section 901(b), the
Administrator shall conduct and support research, demonstration
projects, evaluations, training, guideline development, and the
dissemination of information, on health care services and on
systems for the delivery of such services, including activities
with respect to--
[(1) the effectiveness, efficiency, and quality of
health care services;
[(2) subject to subsection (d), the outcomes of
health care services and procedures;
[(3) clinical practice, including primary care and
practice-oriented research;
[(4) health care technologies, facilities, and
equipment;
[(5) health care costs, productivity, and market
forces;
[(6) health promotion and disease prevention;
[(7) health statistics and epidemiology; and
[(8) medical liability.
[(b) Requirements With Respect to Rural Areas and
Underserved Populations.--In carrying out subsection (a), the
Administrator shall undertake and support research,
demonstration projects, and evaluations with respect to--
[(1) the delivery of health care services in rural
areas (including frontier areas); and
[(2) the health of low-income groups, minority
groups, and the elderly.
[(c) Health Services Training Grants.--The Administrator
may provide training grants in the field of health services
research related to activities authorized under subsection (a),
to include pre- and post-doctoral fellowships and training
programs, young investigator awards, and other programs and
activities as appropriate.
[(d) Multidisciplinary Centers.--The Administrator may
provide financial assistance to public or nonprofit private
entities for meeting the costs of planning and establishing new
centers, and operating existing and new centers, for
multidisciplinary health services research, demonstration
projects, evaluations, training, policy analysis, and
demonstrations respecting the matters referred to in subsection
(a).
[(e) Relation to Certain Authorities Regarding Social
Security.--Activities authorized in this section may include,
and shall be appropriately coordinated with, experiments,
demonstration projects, and other related activities authorized
by the Social Security Act and the Social Security Amendments
of 1967. Activities under subsection (a)(2) of this section
that affect the programs under titles XVIII and XIX of the
Social Security Act shall be carried out consistent with
section 1142 of such Act.
[SEC. 903. DISSEMINATION.
[(a) In General.--The Administrator shall--
[(1) promptly publish, make available, and otherwise
disseminate, in a form understandable and on as broad a
basis as practicable so as to maximize its use, the
results of research, demonstration projects, and
evaluations conducted or supported under this title and
the guidelines, standards, and review criteria
developed under this title;
[(2) promptly make available to the public data
developed in such research, demonstration projects, and
evaluations;
[(3) provide indexing, abstracting, translating,
publishing, and other services leading to a more
effective and timely dissemination of information on
research, demonstration projects, and evaluations with
respect to health care to public and private entities
and individuals engaged in the improvement of health
care delivery and the general public, and undertake
programs to develop new or improved methods for making
such information available; and
[(4) as appropriate, provide technical assistance to
State and local government and health agencies and
conduct liaison activities to such agencies to foster
dissemination.
[(b) Prohibition Against Restrictions.--Except as provided
in subsection (c), the Administrator may not restrict the
publication or dissemination of data from, or the results of,
projects conducted or supported under this title.
[(c) Limitation on Use of Certain Information.--No
information, if an establishment or person supplying the
information or described in it is identifiable, obtained in the
course of activities undertaken or supported under this title
may be used for any purpose other than the purpose for which it
was supplied unless suchestablishment or person has consented
(as determined under regulations of the Secretary) to its use for such
other purpose. Such information may not be published or released in
other form if the person who supplied the information or who is
described in it is identifiable unless such person has consented (as
determined under regulations of the Secretary) to its publication or
release in other form.
[(d) Certain Interagency Agreement.--The Administrator and
the Director of the National Library of Medicine shall enter
into an agreement providing for the implementation of
subsection (a)(3).
[(e) Required Interagency Agreement.--The Administrator and
the Director of the National Library of Medicine shall enter
into an agreement providing for the implementation of section
478A.
[SEC. 904. HEALTH CARE TECHNOLOGY AND TECHNOLOGY ASSESSMENT.
[(a) In General.--In carrying out section 901(b), the
Administrator shall promote the development and application of
appropriate health care technology assessments--
[(1) by identifying needs in, and establishing
priorities for, the assessment of specific health care
technologies;
[(2) by developing and evaluating criteria and
methodologies for health care technology assessment;
[(3) by conducting and supporting research on the
development and diffusion of health care technology;
[(4) by conducting and supporting research on
assessment methodologies;
[(5) by promoting education, training, and technical
assistance in the use of health care technology
assessment methodologies and results; and
[(6) by conducting assessments and reassessments of
existing and new health care technologies.
[(b) Specific Assessments.--
[(1) In general.--In carrying out section 901(b), the
Administrator shall conduct and support specific
assessments of health care technologies.
[(2) Consideration of certain factors.--In carrying
out paragraph (1), the Administrator shall consider the
safety, efficacy, and effectiveness, and, as
appropriate, the legal, social, and ethical
implications, and appropriate uses of such
technologies, including consideration of geographic
factors. In carrying out such paragraph, the
Administrator shall also consider the cost
effectiveness of such technologies where cost
information is available and reliable.
[(c) Agenda and Priorities.--
[(1) Establishment of priorities.--In accordance with
paragraph (2), the Administrator, in consultation with
the Advisory Council established under section 921,
shall establish an annual list of technology
assessments under consideration by the Agency,
including those assessments performed at the request of
the Health Care Financing Administration and the
Department of Defense and those assessments performed
under subsections (d) and (f).
[(2) Public notice.--The Administrator, in
consultation with the Advisory Council, shall publish
the list established in paragraph (1) annually in the
Federal Register.
[(d) Conduct of Assessments.--
[(1) Recommendations with respect to health care
technology.--The Administrator shall make
recommendations to the Secretary with respect to
whether specific health care technologies should be
reimbursable under federally financed health programs,
including recommendations with respect to any
conditions and requirements under which any such
reimbursements should be made.
[(2) Considerations of certain factors.--In making
recommendations respecting health care technologies,
the Administrator shall consider the safety, efficacy,
and effectiveness, and, as appropriate, the appropriate
uses of such technologies. The Administrator shall also
consider the cost effectiveness of such technologies
where cost information is available and reliable.
[(3) Additional assessments.--The Administrator may
conduct technology assessments in addition to those
assessments performed at the request of the
Administrator of the Health Care Financing
Administration or of the Secretary of Defense.
[(4) Criteria.--The Administrator shall develop
criteria for determining the priority of assessments
performed under this subsection. Such criteria shall
include--
[(A) the prevalence of the health condition
for which the technology aims to prevent,
diagnose, treat and clinically manage;
[(B) variations in current practice;
[(C) the economic burden posed by the
prevention, diagnosis, treatment, and clinical
management of the health condition, including
the impact on publicly-funded programs;
[(D) aggregate cost of the use of technology;
[(E) the morbidity and mortality associated
with the health condition; and
[(F) the potential of an assessment to
improve health outcomes or affect costs
associated with the prevention, diagnosis, or
treatment of the condition.
[(5) Consultations.--In carrying out this subsection,
the Administrator shall cooperate and consult with the
Director of the National Institutes of Health, the
Commissioner of Food and Drugs, and the heads of any
other interested Federal department or agency.
[(e) Description of Process.--Not later than January 1,
1994, the Administrator shall develop and publish a description
of the methodology used to establish priorities for technology
assessment and the process used to conduct its technology
assessments under this section.
[(f) Program of Innovative Assessments.--
[(1) In general.--The Administrator may make grants
to, or enter cooperative agreements or contracts with,
entities described in paragraph (2) for the
establishment of collaborative arrangements for the
purpose of conducting assessments of experimental,
emerging, existing, or potentially outmoded health care
technologies, and for related activities. Such
assessments may include controlled clinical trials,
large simple trials, and other methodologies that can
be conducted in partnership between the public and
private sectors or among multiple government agencies.
[(2) Eligible entities.--The entities referred to in
paragraph (1) are entities determined to be appropriate
by the Administrator, which entities may include
academic medical centers, research institutions,
nonprofit professional organizations, public or private
third party payers, other governmental agencies, and
consortia of appropriate research entities established
for the purpose of conducting technology assessments.
[(3) Use of award.--A grant, cooperative agreement,
or contract under paragraph (1) may be expended for
data collection, data analysis, protocol development,
report development, dissemination and evaluation, and
other activities determined to be appropriate by the
Administrator. Such funds shall not be used for direct
services.
[(4) Application for award.--To be eligible to
receive a grant, cooperative agreement, or contract
under paragraph (1), an entity shall prepare and submit
to the Administrator an application, at such time, in
such form, and containing such information as the
Administrator may require.
[(5) Interagency memoranda of understanding.--In
carrying out paragraph (1), the Administrator may enter
into memoranda of understanding with the heads of other
Federal agencies.
[SEC. 905. DEMONSTRATION PROGRAM REGARDING CENTERS FOR EDUCATION AND
RESEARCH ON THERAPEUTICS.
[(a) In General.--The Secretary, acting through the
Administrator and in consultation with the Commissioner of Food
and Drugs, shall establish a demonstration program for the
purpose of making one or more grants for the establishment and
operation of one or more centers to carry out the activities
specified in subsection (b).
[(b) Required Activities.--The activities referred to in
subsection (a) are the following:
[(1) The conduct of state-of-the-art clinical and
laboratory research for the following purposes:
[(A) To increase awareness of--
[(i) new uses of drugs, biological
products, and devices;
[(ii) ways to improve the effective
use of drugs, biological products, and
devices; and
[(iii) risks of new uses and risks of
combinations of drugs and biological
products.
[(B) To provide objective clinical
information to the following individuals and
entities:
[(i) Health care practitioners or
other providers of health care goods or
services.
[(ii) Pharmacy benefit managers.
[(iii) Health maintenance
organizations or other managed health
care organizations.
[(iv) Health care insurers or
governmental agencies.
[(v) Consumers.
[(C) To improve the quality of health care
while reducing the cost of health care
through--
[(i) the appropriate use of drugs,
biological products, or devices; and
[(ii) the prevention of adverse
effects of drugs, biological products,
and devices and the consequences of
such effects, such as unnecessary
hospitalizations.
[(2) The conduct of research on the comparative
effectiveness and safety of drugs, biological products,
and devices.
[(3) Such other activities as the Secretary
determines to be appropriate, except that the grant may
not be expended to assist the Secretary in the review
of new drugs.
[(c) Application for Grant.--A grant under subsection (a)
may be made only if an application for the grant is submitted
to the Secretary and the application is in such form, is made
in such manner, and contains such agreements, assurances, and
information as the Secretary determines to be necessary to
carry out this section.
[(d) Peer Review.--A grant under subsection (a) may be made
only if the application for the grant has undergone appropriate
technical and scientific peer review.
[(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $2,000,000 for fiscal year 1998, and $3,000,000
for each of fiscal years 1999 through 2002.
[Part B--Forum for Quality and Effectiveness in Health Care
[SEC. 911. ESTABLISHMENT OF OFFICE.
[There is established within the Agency an office to be
known as the Office of the Forum for Quality and Effectiveness
in Health Care. The office shall be headed by a director, who
shall be appointed by the Administrator. The Administrator
shall carry out this part acting through the Director.
[SEC. 912. DUTIES.
[(a) Establishment of Forum Program.--The Administrator
shall establish a program to be known as the Forum for Quality
and Effectiveness in Health Care. For the purpose of promoting
the quality, appropriateness, and effectiveness of health care,
the Administrator, using the process set forth in section 913,
shall arrange for the development and periodic review and
updating of--
[(1) clinically relevant guidelines that may be used
by physicians, educators, and health care practitioners
to assist in determining how diseases, disorders, and
other health conditions can most effectively and
appropriately be prevented, diagnosed, treated, and
managed clinically; and
[(2) standards of quality, performance measures, and
medical review criteria through which health care
providers and other appropriate entities may assess or
review the provision of health care and assure the
quality of such care.
[(b) Certain Requirements.--Guidelines, standards,
performance measures, and review criteria under subsection (a)
shall--
[(1) be based on the best available research and
professional judgment regarding the effectiveness and
appropriateness of health care services and procedures;
[(2) be presented in formats appropriate for use by
physicians, health care practitioners, providers,
medical educators, and medical review organizations and
in formats appropriate for use by consumers of health
care;
[(3) include 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; and
[(4) include information on risks and benefits of
alternative strategies for prevention, diagnosis,
treatment, and management of a given disease, disorder,
or other health condition; and
[(5) include information on the costs of alternative
strategies for the prevention, diagnosis, treatment,
and management of a given disease, disorder, or other
health condition, where cost information is available
and reliable.
[(c) Authority for Contracts.--In carrying out this part, the
Administrator may enter into contracts with public or nonprofit
private entities.
[(d) Date Certain for Initial Guidelines and Standards.--The
Administrator, by not later than January 1, 1991, shall assure
the development of an initial set of guidelines, standards,
performance measures, and review criteria under subsection (a)
that includes not less than 3 clinical treatments or conditions
described in section 1142(a)(3) of the Social Security Act.
[(e) Relationship With Medicare Program.--To assure an
appropriate reflection of the needs and priorities of the
program under title XVIII of the Social Security Act,
activities under this part that affect such program shall be
conducted consistent with section 1142 of such Act.
[(f) Development of Certain Guidelines and Standards.--Not
later than January 1, 1996, the Administrator shall ensure that
a set of guidelines, standards, performance measures, and
review criteria, are developed under subsection (a)(1) that
address the prevention of not fewer than three conditions that
account for significant national health expenditures. In
carrying out this subsection the Administrator shall consult
with the United States Preventive Services Task Force and other
recognized experts in the field of disease prevention.
[SEC. 913. PROCESS FOR DEVELOPMENT OF GUIDELINES AND STANDARDS.
[(a) Development Through Contracts and Panels.--The
Administrator shall--
[(1) enter into contracts with public and nonprofit
private entities for the purpose of developing and
periodically reviewing and updating the guidelines,
standards, performance measures, and review criteria
described in section 912(a); and
[(2) convene panels of appropriately qualified
experts (including practicing physicians with
appropriate expertise) and health care consumers for
the purpose of--
[(A) developing and periodically reviewing
and updating the guidelines, standards,
performance measures, and review criteria
described in section 912(a); and
[(B) reviewing the guidelines, standards,
performance measures, and review criteria
developed under contracts under paragraph (1).
[(b) Authority for Additional Panels.--The Administrator may
convene panels of appropriately qualified experts (including
practicing physicians with appropriate expertise) and health
care consumers for the purpose of--
[(1) developing the standards and criteria described
in section 914(b); and
[(2) providing advice to the Administrator and the
Director with respect to any other activities carried
out under this part or under section 902(a)(2).
[(c) Selection of Panel Members.--The Administrator shall
select the chairpersons and the members of the panels convened
as well as other participants in the guideline process under
this section. In selecting individuals to serve on panels
convened under this section, the Administrator shall consult
with a broad range of interested individuals and organizations,
including organizations representing physicians in the general
practice of medicine and organizations representing physicians
in specialties and subspecialties pertinent to the purposes of
the panel involved. The Administrator shall seek to appoint
physicians reflecting a variety of practice settings. In making
such selections, the Administrator shall ensure that a balance
is maintained between individuals selected from academic
settings and individuals selected without full-time academic
appointments. At least two other members of such panels shall
be individuals who do not derive their primary source of
revenue directly from the performance of procedures discussed
in the guideline. The Administrator shall ensure that at least
one participant in the guideline process shall have expertise
in epidemiology as well as familiarity with the clinical
condition or treatment in question. The Administrator shall
also ensure that at least one participant in the guideline
process shall have expertise in health services research or
health economics as well as familiarity with the clinical
condition or treatment in question.
[SEC. 914. ADDITIONAL REQUIREMENTS.
[(a) Program Agenda.--
[(1) In general.--The Administrator shall provide for
an agenda for the development of the guidelines,
standards, performance measures, and review criteria
described in section 912(a), including--
[(A) with respect to the guidelines,
identifying specific diseases, disorders, and
other health conditions for which the
guidelines are to be developed and those that
are to be given priority in the development of
the guidelines; and
[(B) with respect to the standards,
performance measures, and review criteria,
identifying specific aspects of health care for
which the standards, performance measures, and
review criteria are to be developed and those
that are to be given priority in the
development of the standards, performance
measures, and review criteria.
[(2) Consideration of certain factors in establishing
priorities.--
[(A) Factors considered by the Administrator
in establishing priorities for purposes of
paragraph (1) shall include consideration of
the extent to which the guidelines, standards,
performance measures, and review criteria
involved can be expected--
[(i) to improve methods for disease
prevention;
[(ii) to improve methods of
diagnosis, treatment, and clinical
management for the benefit of a
significant number of individuals;
[(iii) to reduce clinically
significant variations among physicians
in the particular services and
procedures utilized in making diagnoses
and providing treatments; and
[(iv) to reduce clinically
significant variations in the outcomes
of health care services and procedures.
[(B) In providing for the agenda required in
paragraph (1), including the priorities, the
Administrator shall consult with the
Administrator of the Health Care Financing
Administration and otherwise act consistent
with section 1142(b)(3) of the Social Security
Act.
[(C) The Administrator shall develop and
publish a methodology for establishing
priorities for guideline topics. Such
methodology may include the considerations
described in section 904(d)(2) or 914(a)(2),
and other considerations determined by the
Administrator to be appropriate. Using such
methodology, the Administrator shall establish
and publish annually in the Federal Register a
list of guideline topics under consideration.
[(b) Standards and Criteria.--
[(1) Process for development, review, and updating.--
The Administrator shall establish standards and
criteria to be utilized by the recipients of contracts
under section 913, and by the expert panels convened
under such section, with respect to the development and
periodic review and updating of the guidelines,
standards, performance measures, and review criteria
described in section 912(a).
[(2) Award of contracts.--The Administrator shall
establish standards and criteria to be utilized for the
purpose of ensuring that contracts entered into for the
development or periodic review or updating of the
guidelines, standards, performance measures, and review
criteria described in section 912(a) will be entered
into only with appropriately qualified entities.
[(3) Certain requirements for standards and
criteria.--The Administrator shall ensure that the
standards and criteria established under paragraphs (1)
and (2) specify that--
[(A) appropriate consultations with
interested individuals and organizations are to
be conducted in the development of the
guidelines, standards, performance measures,
and review criteria described in section
912(a); and
[(B) such development may be accomplished
through the adoption, with or without
modification, of guidelines, standards,
performance measures, and review criteria
that--
[(i) meet the requirements of this
part; and
[(ii) are developed by entities
independently of the program
established in this part.
[(4) Improvements of standards and criteria.--The
Administrator shall conduct and support research with
respect to improving the standards and criteria
developed under this subsection.
[(c) Dissemination.--The Administrator shall promote and
support the dissemination of the guidelines, standards,
performance measures, and review criteria described in section
912(a). Such dissemination shall be carried out through
organizations representing health care providers, organizations
representing health care consumers, peer review organizations,
accrediting bodies, and other appropriate entities.
[(d) Pilot Testing.--The Administrator may conduct or support
pilot testing of the guidelines, standards, performance
measures, and review criteria developed under section 912(a).
Any such pilot testing may be conducted prior to, or
concurrently with, their dissemination under subsection (c).
[(e) Evaluations.--The Administrator shall conduct and
support evaluations of the extent to which the guidelines,
standards, performance standards, and review criteria developed
under section 912 have had an effect on the clinical practice
of medicine. Evaluations shall be developed prior to the
completion and release of the guideline, so that baseline data
concerning practice patterns and health care costs may be
obtained as part of the evaluation.
[(f) Recommendations to Administrator.--The Director shall
make recommendations to the Administrator on activities that
should be carried out under section 902(a)(2) and under section
1142 of the Social Security Act, including recommendations of
particular research projects that should be carried out with
respect to--
[(1) evaluating the outcomes of health care services
and procedures;
[(2) developing the standards and criteria required
in subsection (b); and
[(3) promoting the utilization of the guidelines,
standards, performance standards, and review criteria
developed under section 912(a).
[Part C--General Provisions
[SEC. 921. ADVISORY COUNCIL FOR HEALTH CARE POLICY, RESEARCH, AND
EVALUATION.
[(a) Establishment.--There is established an advisory council
to be known as the National Advisory Council for Health Care
Policy, Research, and Evaluation.
[(b) Duties.--
[(1) In general.--The Council shall advise the
Secretary and the Administrator with respect to
activities to carry out the purpose of the Agency under
section 901(b).
[(2) Certain recommendations.--Activities of the
Council under paragraph [(1) shall include making
recommendations to the Administrator regarding
priorities for a national agenda and strategy for--
[(A) the conduct of research, demonstration
projects, and evaluations with respect to
health care, including clinical practice and
primary care;
[(B) the development and application of
appropriate health care technology assessments;
[(C) the development and periodic review and
updating of guidelines for clinical practice,
standards of quality, performance measures, and
medical review criteria with respect to health
care; and
[(D) the conduct of research on outcomes of
health care services and procedures.
[(c) Membership.--
[(1) In general.--The Council shall, in accordance
with this subsection, be composed of appointed members
and ex officio members. All members of the Council
shall be voting members, other than officials
designated under paragraph (3)(B) as ex officio members
of the Council.
[(2) Appointed members.--The Secretary shall appoint
to the Council 17 appropriately qualified
representatives of the public who are not officers or
employees of the United States. The Secretary shall
ensure that the appointed members of the Council, as a
group, are representative of professions and entities
concerned with, or affected by, activities under this
title and under section 1142 of the Social Security
Act. Of such members--
[(A) 8 shall be individuals distinguished in
the conduct of research, demonstration
projects, and evaluations with respect to
health care;
[(B) 3 shall be individuals distinguished in
the practice of medicine;
[(C) 2 shall be individuals distinguished in
the health professions;
[(D) 2 shall be individuals distinguished in
the fields of business, law, ethics, economics,
and public policy; and
[(E) 2 shall be individuals representing the
interests of consumers of health care.
[(3) Ex officio members.--The Secretary shall
designate as ex officio members of the Council--
[(A) the Director of the National Institutes
of Health, the Director of the Centers for
Disease Control, the Administrator of the
Health Care Financing Administration, the
Assistant Secretary of Defense (Health
Affairs), the Chief Medical Officer of the
Department of Veterans Affairs; and
[(B) such other Federal officials as the
Secretary may consider appropriate.
[(d) Terms.--
[(1) In general.--Except as provided in paragraph
(2), members of the Council appointed under subsection
(c)(2) shall serve for a term of 3 years.
[(2) Staggered rotation.--Of the members first
appointed to the Council under subsection (c)(2), the
Secretary shall appoint 6 members to serve for a term
of 3 years, 6 members to serve for a term of 2 years,
and 5 members to serve for a term of 1 year.
[(3) Service beyond term.--A member of the Council
appointed under subsection (c)(2) may continue to serve
after the expiration of the term of the member until a
successor is appointed.
[(e) Vacancies.--If a member of the Council appointed under
subsection (c)(2) does not serve the full term applicable under
subsection (d), the individual appointed to fill the resulting
vacancy shall be appointed for the remainder of the term of the
predecessor of the individual.
[(f) Chair.--The Administrator shall, from among the members
of the Council appointed under subsection (c)(2), designate an
individual to serve as the chair of the Council.
[(g) Meetings.--The Council shall meet not less than once
during each discrete 4-month period and shall otherwise meet at
the call of the Administrator or the chair.
[(h) Compensation and Reimbursement of Expenses.--
[(1) Appointed members.--Members of the Council
appointed under subsection (c)(2) shall receive
compensation for each day (including traveltime)
engaged in carrying out the duties of the Council. Such
compensation may not be in an amount in excess of the
maximum rate of basic pay payable for GS-18 of the
General Schedule.
[(2) Ex officio members.--Officials designated under
subsection (c)(3) as ex officio members of the Council
may not receive compensation for service on the Council
in addition to the compensation otherwise received for
duties carried out as officers of the United States.
[(i) Staff.--The Administrator shall provide to the Council
such staff, information, and other assistance as may be
necessary to carry out the duties of the Council.
[(j) Duration.--Notwithstanding section 14(a) of the Federal
Advisory Committee Act, the Council shall continue in existence
until otherwise provided by law.
[SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.
[(a) Requirement of Review.--
[(1) In general.--Appropriate technical and
scientific peer review shall be conducted with respect
to each application for a grant, cooperative agreement,
or contract under this title.
[(2) Reports to administrator.--Each peer review
group to which an application is submitted pursuant to
paragraph (1) shall report its finding and
recommendations respecting the application to the
Administrator in such form and in such manner as the
Administrator shall require.
[(b) Approval as Precondition of Awards.--The Administrator
may not approve an application described in subsection (a)(1)
unless the application is recommended for approval by a peer
review group established under subsection (c).
[(c) Establishment of Peer Review Groups.--
[(1) In general.--The Administrator shall establish
such technical and scientific peer review groups as may
be necessary to carry out this section. Such groups
shall be established without regard to the provisions
of title 5, United States Code, that govern
appointments in the competitive service, and without
regard to the provisions of chapter 51, and subchapter
III of chapter 53, of such title that relate to
classification and pay rates under the General
Schedule.
[(2) Membership.--The members of any peer review
group established under this section shall be appointed
from among individuals who by virtue of their training
or experience are eminently qualified to carry out the
duties of such peer review group. Officers and
employees of the United States may not constitute more
than 25 percent of the membership of any such group.
Such officers and employees may not receive
compensation for service on such groups in addition to
the compensation otherwise received for duties carried
out as such officers and employees.
[(3) Duration.--Notwithstanding section 14(a) of the
Federal Advisory Committee Act, peer review groups
established under this section shall continue in
existence until otherwise provided by law.
[(d) Categories of Review.--
[(1) In general.--With respect to technical and
scientific peer review under this section, there shall
be two categories of peer review groups as follows:
[(A) One category of such groups shall,
subject to subparagraph (B), review
applications with respect to research,
demonstration projects, or evaluations.
[(B) The other category of such groups shall
review applications with respect to
dissemination activities or the development of
research agendas (including conferences,
workshops, and meetings). If the purpose of a
proposal presented in an application is a
matter described in the preceding sentence, the
application shall be reviewed by the groups
referred to in such sentence, notwithstanding
that the proposal involves research,
demonstration projects, or evaluations.
[(2) Authority for procedural adjustments in certain
cases.--In the case of applications described in
subsection (a)(1) for financial assistance whose direct
costs will not exceed $50,000, the Administrator may
make appropriate adjustments in the procedures
otherwise established by the Administrator for the
conduct of peer review under this section. Such
adjustments may be made for the purpose of encouraging
the entry of individuals into the field of research,
for the purpose of encouraging clinical practice-
oriented research, and for such other purposes as the
Administrator may determine to be appropriate.
[(e) Regulations.--The Secretary shall issue regulations for
the conduct of peer review under this section.
[SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION,
AND DISSEMINATION OF DATA.
[(a) Standards With Respect to Utility of Data.--
[(1) In general.--With respect to data developed or
collected by any entity for the purpose described in
section 901(b), the Administrator shall, in order to
assure the utility, accuracy, and sufficiency of such
data for all interested entities, establish guidelines
for uniform methods of developing and collecting such
data. Such guidelines shall include specifications for
the development and collection of data on the outcomes
of health care services and procedures.
[(2) Relationship with medicare program.--In any case
where guidelines under paragraph (1) may affect the
administration of the program under title XVIII of the
Social Security Act, the guidelines shall be in the
form of recommendations to the Secretary for such
program.
[(b) Statistics.--The Administrator shall--
[(1) take such action as may be necessary to assure
that statistics developed under this title are of high
quality, timely, and comprehensive, as well as
specific, standardized, and adequately analyzed and
indexed; and
[(2) publish, make available, and disseminate such
statistics on as wide a basis as is practicable.
[(c) Authority Regarding Certain Requests.--Upon the request
of a public or nonprofit private entity, the Administrator may
tabulate and analyze statistics under arrangements under which
such entity will pay the cost of the service provided. Amounts
appropriated to the Administrator from payments made under such
arrangements shall be available to the Administrator for
obligation until expended.
[SEC. 924. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND CONTRACTS.
[(a) Financial Conflicts of Interest.--With respect to
projects for which awards of grants, cooperative agreements, or
contracts are authorized to be made under this title, the
Administrator shall by regulation define--
[(1) the specific circumstances that constitute
financial interests in such projects that will, or may
be reasonably expected to, create a bias in favor of
obtaining results in the projects that are consistent
with such interests; and
[(2) the actions that will be taken by the
Administrator in response to any such interests
identified by the Administrator.
[(b) Requirement of Application.--The Administrator may not,
with respect to any program under this title authorizing the
provision of grants, cooperative agreements, or contracts,
provide any such financial assistance unless an application for
the assistance is submitted to the Secretary and the
application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the
Administrator determines to be necessary to carry out the
program involved.
[(c) Provision of Supplies and Services in Lieu of Funds.--
[(1) In general.--Upon the request of an entity
receiving a grant, cooperative agreement, or contract
under this title, the Secretary may, subject to
paragraph (2), provide supplies, equipment, and
services for the purpose of aiding the entity in
carrying out the project involved and, for such
purpose, may detail to the entity any officer or
employee of the Department of Health and Human
Services.
[(2) Corresponding reduction in funds.--With respect
to a request described in paragraph (1), the Secretary
shall reduce the amount of the financial assistance
involved by an amount equal to the costs of detailing
personnel and the fair market value of any supplies,
equipment, or services provided by the Administrator.
The Secretary shall, for the payment of expenses
incurred in complying with such request, expend the
amounts withheld.
[(d) Applicability of Certain Provisions With Respect to
Contracts.--Contracts may be entered into under this part
without regard to sections 3648 and 3709 of the Revised
Statutes (31 U.S.C. 529; 41 U.S.C. 5).
[SEC. 925. CERTAIN ADMINISTRATIVE AUTHORITIES.
[(a) Deputy Administrator and Other Officers and Employees.--
[(1) Deputy administrator.--The Administrator may
appoint a deputy administrator for the Agency.
[(2) Other officers and employees.--The Administrator
may appoint and fix the compensation of such officers
and employees as may be necessary to carry out this
title. Except as otherwise provided by law, such
officers and employees shall be appointed in accordance
with the civil service laws and their compensation
fixed in accordance with title 5, United States Code.
[(b) Facilities.--The Secretary, in carrying out this title--
[(1) may acquire, without regard to the Act of March
3, 1877 (40 U.S.C. 34), by lease or otherwise through
the Administrator of General Services, buildings or
portions of buildings in the District of Columbia or
communities located adjacent to the District of
Columbia for use for a period not to exceed 10 years;
and
[(2) may acquire, construct, improve, repair,
operate, and maintain laboratory, research, and other
necessary facilities and equipment, and such other real
or personal property (including patents) as the
Secretary deems necessary.
[(c) Provision of Financial Assistance.--The Administrator,
in carrying out this title, may make grants to, and enter into
cooperative agreements with, public and nonprofit private
entities and individuals, and when appropriate, may enter into
contracts with public and private entities and individuals.
[(d) Utilization of Certain Personnel and Resources.--
[(1) Department of health and human services.--The
Administrator, in carrying out this title, may utilize
personnel and equipment, facilities, and other physical
resources of the Department of Health and Human
Services, permit appropriate (as determined by the
Secretary) entities and individuals to utilize the
physical resources of such Department, and provide
technical assistance and advice.
[(2) Other agencies.--The Administrator, in carrying
out this title, may use, with their consent, the
services, equipment, personnel, information, and
facilities of other Federal, State, or local public
agencies, or of any foreign government, with or without
reimbursement of such agencies.
[(e) Consultants.--The Secretary, in carrying out this title,
may secure, from time to time and for such periods as the
Administrator deems advisable but in accordance with section
3109 of title 5, United States Code, the assistance and advice
of consultants from the United States or abroad.
[(f) Experts.--
[(1) In general.--The Secretary may, in carrying out
this title, obtain the services of not more than 50
experts or consultants who have appropriate scientific
or professional qualifications. Such experts or
consultants shall be obtained in accordance with
section 3109 of title 5, United States Code, except
that the limitation in such section on the duration of
service shall not apply.
[(2) Travel expenses.--
[(A) Experts and consultants whose services
are obtained under paragraph (1) shall be paid
or reimbursed for their expenses associated
with traveling to and from their assignment
location in accordance with sections 5724,
5724a(a), 5724a(c), and 5726(c) of title 5,
United States Code.
[(B) Expenses specified in subparagraph (A)
may not be allowed in connection with the
assignment of an expert or consultant whose
services are obtained under paragraph (1)
unless and until the expert agrees in writing
to complete the entire period of assignment, or
one year, whichever is shorter, unless
separated or reassigned for reasons that are
beyond the control of the expert or consultant
and that are acceptable to the Secretary. If
the expert or consultant violates the
agreement, the money spent by the United States
for the expenses specified in subparagraph (A)
is recoverable from the expert or consultant as
a debt of the United States. The Secretary may
waive in whole or in part a right of recovery
under this subparagraph.
[(g) Voluntary and Uncompensated Services.--The
Administrator, in carrying out this title, may accept voluntary
and uncompensated services.
[SEC. 926. FUNDING.
[(a) Authorization of Appropriations.--For the purpose of
carrying out this title, there are authorized to be
appropriated $115,000,000 for fiscal year 1993, $145,000,000
for fiscal year 1994, and $175,000,000 for fiscal year 1995.
[(b) Evaluations.--In addition to amounts available pursuant
to subsection (a) for carrying out this title, there shall be
made available for such purpose, from the amounts made
available pursuant to section 241 of this Act (relating to
evaluations), an amount equal to 40 percent of the maximum
amount authorized in such section 241 to be made available.
[(c) Information Center.--For purposes of carrying out the
activities under section 903(e), there are authorized to be
appropriated $3,000,000 for fiscal year 1993, and such sums as
may be necessary for each of the fiscal years 1994 and 1995.
[(d) Health Care Technology Assessment.--For the purpose of
carrying out technology assessment activities under section
904(d), there are authorized to be appropriated $2,000,000 for
fiscal year 1993, and such sums as may be necessary for each of
the fiscal years 1994 and 1995.
[(e) Program of Innovative Assessments.--For purposes of
establishing the program of innovative assessments under
section 904(f), there are authorized to be appropriated
$2,000,000 for fiscal year 1993, and such sums as may be
necessary in each of the fiscal years 1994 and 1995.
[SEC. 927. DEFINITIONS.
[For purposes of this title:
[(1) The term ``Administrator'' means the
Administrator for Health Care Policy and Research.
[(2) The term ``Agency'' means the Agency for Health
Care Policy and Research.
[(3) The term ``Council'' means the National Advisory
Council on Health Care Policy, Research, and
Evaluation.
[(4) The term ``Director'' means the Director of the
Office of the Forum for Quality and Effectiveness in
Health Care.]
TITLE IX--AGENCY FOR HEALTH RESEARCH AND QUALITY
PART A--ESTABLISHMENT AND GENERAL DUTIES
SEC. 901. MISSION AND DUTIES.
(a) In General.--There is established within the Public
Health Service an agency to be known as the Agency for Health
Research and Quality, which shall be headed by a director
appointed by the Secretary. The Secretary shall carry out this
title acting through the Director.
(b) Mission.--The purpose of the Agency is to enhance the
quality, appropriateness, and effectiveness of health services,
and access to such services, through the establishment of a
broad base of scientific research and through the promotion of
improvements in clinical and health system practices, including
the prevention of diseases and other health conditions. The
Agency shall promote health care quality improvement by--
(1) conducting and supporting research that develops
and presents scientific evidence regarding all aspects
of health, including--
(A) the development and assessment of methods
for enhancing patient participation in their
own care and for facilitating shared patient-
physician decision-making;
(B) the outcomes, effectiveness, and cost-
effectiveness of health care practices,
including preventive measures and long-term
care;
(C) existing and innovative technologies;
(D) the costs and utilization of, and access
to health care;
(E) the ways in which health care services
are organized, delivered, and financed and the
interaction and impact of these factors on the
quality of patient care;
(F) methods for measuring quality and
strategies for improving quality; and
(G) ways in which patients, consumers,
purchasers, and practitioners acquire new
information about best practices and health
benefits, the determinants and impact of their
use of this information;
(2) synthesizing and disseminating available
scientific evidence for use by patients, consumers,
practitioners, providers, purchasers, policy makers,
and educators; and
(3) advancing private and public efforts to improve
health care quality.
(c) Requirements With Respect to Rural Areas and Priority
Populations.--In carrying out subsection (b), the Director
shall undertake and support research, demonstration projects,
and evaluations with respect to--
(1) the delivery of health services in rural areas
(including frontier areas);
(2) health services for low-income groups, and
minority groups;
(3) the health of children;
(4) the elderly; and
(5) people with special health care needs, including
disabilities, chronic care and end-of-life health care.
SEC. 902. GENERAL AUTHORITIES.
(a) In General.--In carrying out section 901(b), the Director
shall support demonstration projects, conductand support
research, evaluations, training, research networks, multi-disciplinary
centers, technical assistance, andthe dissemination of information, on
health care, and on systems for the delivery of such care, including
activities with respect to--
(1) the quality, effectiveness, efficiency,
appropriateness and value of health care services;
(2) quality measurement and improvement;
(3) the outcomes, cost, cost-effectiveness, and use
of health care services and access to such services;
(4) clinical practice, including primary care and
practice-oriented research;
(5) health care technologies, facilities, and
equipment;
(6) health care costs, productivity, organization,
and market forces;
(7) health promotion and disease prevention,
including clinical preventive services;
(8) health statistics, surveys, database development,
and epidemiology; and
(9) medical liability.
(b) Health Services Training Grants.--
(1) In general.--The Director may provide training
grants in the field of health services research related
to activities authorized under subsection (a), to
include pre- and post-doctoral fellowships and training
programs, young investigator awards, and other programs
and activities as appropriate. In carrying out this
subsection, the Director shall make use of funds made
available under section 487.
(2) Requirements.--In developing priorities for the
allocation of training funds under this subsection, the
Director shall take into consideration shortages in the
number of trained researchers addressing the priority
populations.
(c) Multidisciplinary Centers.--The Director may provide
financial assistance to assist in meeting the costs of planning
and establishing new centers, and operating existing and new
centers, for multidisciplinary health services research,
demonstration projects, evaluations, training, and policy
analysis with respect to the matters referred to in subsection
(a).
(d) Relation to Certain Authorities Regarding Social
Security.--Activities authorized in this section shall be
appropriately coordinated with experiments, demonstration
projects, and other related activities authorized by the Social
Security Act and the Social Security Amendments of 1967.
Activities under subsection (a)(2) of this section that affect
the programs under titles XVIII, XIX and XXI of the Social
Security Act shall be carried out consistent with section 1142
of such Act.
(e) Disclaimer.--The Agency shall not mandate national
standards of clinical practice or quality health care
standards. Recommendations resulting from projects funded and
published by the Agency shall include a corresponding
disclaimer.
(f) Rule of Construction.--Nothing in this section shall be
construed to imply that the Agency's role is to mandate a
national standard or specific approach to quality measurement
and reporting. In research and quality improvement activities,
the Agency shall consider a wide range of choices, providers,
health care delivery systems, and individual preferences.
PART B--HEALTH CARE IMPROVEMENT RESEARCH
SEC. 911. HEALTH CARE OUTCOME IMPROVEMENT RESEARCH.
(a) Evidence Rating Systems.--In collaboration with experts
from the public and private sector, the Agency shall identify
and disseminate methods or systems that it uses to assess
health care research results, particularly methods or systems
that it uses to rate the strength of the scientific evidence
behind health care practice, recommendations in the research
literature, and technology assessments. The Agency shall make
methods or systems for evidence rating widely available. Agency
publications containing health care recommendations shall
indicate the level of substantiating evidence using such
methods or systems.
(b) Health Care Improvement Research Centers and Provider-
Based Research Networks.--
(1) In general.--In order to address the full
continuum of care and outcomes research, to link
research to practice improvement, and to speed the
dissemination of research findings to community
practice settings, the Agency shall employ research
strategies and mechanisms that will link research
directly with clinical practice in geographically
diverse locations throughout the United States,
including--
(A) Health Care Improvement Research Centers
that combine demonstrated multidisciplinary
expertise in outcomes or quality improvement
research with linkages to relevant sites of
care;
(B) Provider-based Research Networks,
including plan, facility, or delivery system
sites of care (especially primary care), that
can evaluate outcomes and promote quality
improvement; and
(C) other innovative mechanisms or strategies
to link research with clinical practice.
(2) Requirements.--The Director is authorized to
establish the requirements for entities applying for
grants under this subsection.
SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND
DELIVERY.
(a) Support for Efforts To Develop Information on Quality.--
(1) Scientific and technical support.--In its role as
the principal agency for health research and quality,
the Agency may provide scientific and technical support
for private and public efforts to improve health care
quality, including the activities of accrediting
organizations.
(2) Role of the agency.--With respect to paragraph
(1), the role of the Agency shall include--
(A) the identification and assessment of
methods for the evaluation of the health of--
(i) enrollees in health plans by type
of plan, provider, and provider
arrangements; and
(ii) other populations, including
those receiving long-term care
services;
(B) the ongoing development, testing, and
dissemination of quality measures, including
measures of health and functional outcomes;
(C) the compilation and dissemination of
health care quality measures developed in the
private and public sector;
(D) assistance in the development of improved
health care information systems;
(E) the development of survey tools for the
purpose of measuring participant and
beneficiary assessments of their health care;
and
(F) identifying and disseminating information
on mechanisms for the integration of
information on quality into purchaser and
consumer decision-making processes.
(b) Centers for Education and Research on Therapeutics.--
(1) In general.--The Secretary, acting through the
Director and in consultation with the Commissioner of
Food and Drugs, shall establish a program for the
purpose of making one or more grants for the
establishment and operation of one or more centers to
carry out the activities specified in paragraph (2).
(2) Required activities.--The activities referred to
in this paragraph are the following:
(A) The conduct of state-of-the-art research
for the following purposes:
(i) To increase awareness of--
(I) new uses of drugs,
biological products, and
devices;
(II) ways to improve the
effective use of drugs,
biological products, and
devices; and
(III) risks of new uses and
risks of combinations of drugs
and biological products.
(ii) To provide objective clinical
information to the following
individuals and entities:
(I) Health care practitioners
and other providers of health
care goods or services.
(II) Pharmacists, pharmacy
benefit managers and
purchasers.
(III) Health maintenance
organizations and other managed
health care organizations.
(IV) Health care insurers and
governmental agencies.
(V) Patients and consumers.
(iii) To improve the quality of
health care while reducing the cost of
health care through--
(I) an increase in the
appropriate use of drugs,
biological products, or
devices; and
(II) the prevention of
adverse effects of drugs,
biological products, and
devices and the consequences of
such effects, such as
unnecessary hospitalizations.
(B) The conduct of research on the
comparative effectiveness, cost-effectiveness,
and safety of drugs, biological products, and
devices.
(C) Such other activities as the Secretary
determines to be appropriate, except that a
grant may not be expended to assist the
Secretary in the review of new drugs.
(c) Reducing Errors in Medicine.--The Director shall conduct
and support research and build private-public partnerships to--
(1) identify the causes of preventable health care
errors and patient injury in health care delivery;
(2) develop, demonstrate, and evaluate strategies for
reducing errors and improving patient safety; and
(3) promote the implementation of effective
strategies throughout the health care industry.
SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.
(a) In General.--In carrying out 902(a), the Director shall--
(1) conduct a survey to collect data on a nationally
representative sample of the population on the cost,
use and, for fiscal year 2001 and subsequent fiscal
years, quality of health care, including the types of
health care services Americans use, their access to
health care services, frequency of use, how much is
paid for the services used, the source of those
payments, the types and costs of private health
insurance, access, satisfaction, and quality of care
for the general population and also for populations
identified in section 901(c); and
(2) develop databases and tools that provide
information to States on the quality, access, and use
of health care services provided to their residents.
(b) Quality and Outcomes Information.--
(1) In general.--Beginning in fiscal year 2001, the
Director shall ensure that the survey conducted under
subsection (a)(1) will--
(A) identify determinants of health outcomes
and functional status, the needs of special
populations in such variables as well as an
understanding of changes over time,
relationships to health care access and use,
and monitor the overall national impact of
Federal and State policy changes on health
care;
(B) provide information on the quality of
care and patient outcomes for frequently
occurring clinical conditions for a nationally
representative sample of the population; and
(C) provide reliable national estimates for
children and persons with special health care
needs through the use of supplements or
periodic expansions of the survey.
In expanding the Medical Expenditure Panel Survey, as
in existence on the date of enactment of this title) in
fiscal year 2001 to collect information on the quality
of care, the Director shall take into account any
outcomes measurements generally collected by private
sector accreditation organizations.
(2) Annual report.--Beginning in fiscal year 2003,
the Secretary, acting through the Director, shall
submit to Congress an annual report on national trends
in the quality of health care provided to the American
people.
SEC. 914. INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT.
(a) In General.--In order to foster a range of innovative
approaches to the management and communication of health
information, the Agency shall support research, evaluations and
initiatives to advance--
(1) the use of information systems for the study of
health care quality and outcomes, including the
generation of both individual provider and plan-level
comparative performance data;
(2) training for health care practitioners and
researchers in the use of information systems;
(3) the creation of effective linkages between
various sources of health information, including the
development of information networks;
(4) the delivery and coordination of evidence-based
health care services, including the use of real-time
health care decision-support programs;
(5) the structure, content, definition, and coding of
health information data and medical vocabularies in
consultation with appropriate Federal entities and
shall seek input from appropriate private entities;
(6) the use of computer-based health records in
outpatient and inpatient settings as a personal health
record for individual health assessment and
maintenance, and for monitoring public health and
outcomes of care within populations; and
(7) the protection of individually identifiable
information in health services research and health care
quality improvement.
(b) Demonstration.--The Agency shall support demonstrations
into the use of new information tools aimed at improving shared
decision-making between patients and their care-givers.
SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN UNDERSERVED
AREAS.
(a) Preventive Services Task Force.--
(1) Purpose.--The Agency shall provide ongoing
administrative, research, and technical support for the
operation of the Preventive Services Task Force. The
Agency shall coordinate and support the dissemination
of the Preventive Services Task Force recommendations.
(2) Operation.--The Preventive Services Task Force
shall review the scientific evidence related to the
effectiveness, appropriateness, and cost-effectiveness
of clinical preventive services for the purpose of
developing recommendations for the health care
community, and updating previous recommendations,
regarding their usefulness in daily clinical practice.
In carrying out its responsibilities under paragraph
(1), the Task Force shall not be subject to the
provisions of Appendix 2 of title 5, United States
Code.
(b) Primary Care Research.--
(1) In general.--There is established within the
Agency a Center for Primary Care Research (referred to
in this subsection as the ``Center'') that shall serve
as the principal source of funding for primary care
practice research in the Department of Health and Human
Services. For purposes of this paragraph, primary care
research focuses on the first contact when illness or
health concerns arise, the diagnosis, treatment or
referral to specialty care, preventive care, and the
relationship between the clinician and the patient in
the context of the family and community.
(2) Research.--In carrying out this section, the
Center shall conduct and support research concerning--
(A) the nature and characteristics of primary
care practice;
(B) the management of commonly occurring
clinical problems;
(C) the management of undifferentiated
clinical problems; and
(D) the continuity and coordination of health
services.
SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION.
(a) In General.--The Director shall promote innovation in
evidence-based clinical practice and health care technologies
by--
(1) conducting and supporting research on the
development, diffusion, and use of health care
technology;
(2) developing, evaluating, and disseminating
methodologies for assessments of health care practices
and health care technologies;
(3) conducting intramural and supporting extramural
assessments of existing and new health care practices
and technologies;
(4) promoting education, training, and providing
technical assistance in the use of health care practice
and health care technology assessment methodologies and
results; and
(5) working with the National Library of Medicine and
the public and private sector to develop an electronic
clearinghouse of currently available assessments and
those in progress.
(b) Specification of Process.--
(1) In general.--Not later than December 31, 2000,
the Director shall develop and publish a description of
the methods used by the Agency and its contractors for
practice and technology assessment.
(2) Consultations.--In carrying out this subsection,
the Director shall cooperate and consult with the
Assistant Secretary for Health, the Administrator of
the Health Care Financing Administration, the Director
of the National Institutes of Health, the Commissioner
of Food and Drugs, and the heads of any other
interested Federal department or agency, and shall seek
input, where appropriate, from professional societies
and other private and public entities.
(3) Methodology.--The Director shall, in developing
the methods used under paragraph (1), consider--
(A) safety, efficacy, and effectiveness;
(B) legal, social, and ethical implications;
(C) costs, benefits, and cost-effectiveness;
(D) comparisons to alternate technologies and
practices; and
(E) requirements of Food and Drug
Administration approval to avoid duplication.
(c) Specific Assessments.--
(1) In general.--The Director shall conduct or
support specific assessments of health care
technologies and practices.
(2) Requests for assessments.--The Director is
authorized to conduct or support assessments, on a
reimbursable basis, for the Health Care Financing
Administration, the Department of Defense, the
Department of Veterans Affairs, the Office of Personnel
Management, and other public or private entities.
(3) Grants and contracts.--In addition to conducting
assessments, the Director may make grants to, or enter
into cooperative agreements or contracts with, entities
described in paragraph (4) for the purpose of
conducting assessments of experimental, emerging,
existing, or potentially outmoded health care
technologies, and for related activities.
(4) Eligible entities.--An entity described in this
paragraph is an entity that is determined to be
appropriate by the Director, including academic medical
centers, research institutions and organizations,
professional organizations, third party payers,
governmental agencies, and consortia of appropriate
research entities established for the purpose of
conducting technology assessments.
SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY IMPROVEMENT
EFFORTS.
(a) Requirement.--
(1) In general.--To avoid duplication and ensure that
Federal resources are used efficiently and effectively,
the Secretary, acting through the Director, shall
coordinate all research, evaluations, and
demonstrations related to health services research,
quality measurement and quality improvement activities
undertaken and supported by the Federal Government.
(2) Specific activities.--The Director, in
collaboration with the appropriate Federal officials
representing all concerned executive agencies and
departments, shall develop and manage a process to--
(A) improve interagency coordination,
priority setting, and the use and sharing of
research findings and data pertaining to
Federal quality improvement programs,
technology assessment, and health services
research;
(B) strengthen the research information
infrastructure, including databases, pertaining
to Federal health services research and health
care quality improvement initiatives;
(C) set specific goals for participating
agencies and departments to further health
services research and health care quality
improvement; and
(D) strengthen the management of Federal
health care quality improvement programs.
(b) Study by the Institute of Medicine.--
(1) In general.--To provide Congress, the Department
of Health and Human Services, and other relevant
departments with an independent, external review of
their quality oversight, quality improvement and
quality research programs, the Secretary shall enter
into a contract with the Institute of Medicine--
(A) to describe and evaluate current quality
improvement, quality research and quality
monitoring processes through--
(i) an overview of pertinent health
services research activities and
quality improvement efforts conducted
by all Federal programs, with
particular attention paid to those
under titles XVIII, XIX, and XXI of the
Social Security Act; and
(ii) a summary of the partnerships
that the Department of Health and Human
Services has pursued with private
accreditation, quality measurement and
improvement organizations; and
(B) to identify options and make
recommendations to improve the efficiency and
effectiveness of quality improvement programs
through--
(i) the improved coordination of
activities across the medicare,
medicaid and child health insurance
programs under titles XVIII, XIX and
XXI of the Social Security Act and
health services research programs;
(ii) the strengthening of patient
choice and participation by
incorporating state-of-the-art quality
monitoring tools and making information
on quality available; and
(iii) the enhancement of the most
effective programs, consolidation as
appropriate, and elimination of
duplicative activities within various
federal agencies.
(2) Requirements.--
(A) In general.--The Secretary shall enter
into a contract with the Institute of Medicine
for the preparation--
(i) not later than 12 months after
the date of enactment of this title, of
a report providing an overview of the
quality improvement programs of the
Department of Health and Human Services
for the medicare, medicaid, and CHIP
programs under titles XVIII, XIX, and
XXI of the Social Security Act; and
(ii) not later than 24 months after
the date of enactment of this title, of
a final report containing
recommendations.
(B) Reports.--The Secretary shall submit the
reports described in subparagraph (A) to the
Committee on Finance and the Committee on
Health, Education, Labor, and Pensions of the
Senate and the Committee on Ways and Means and
the Committee on Commerce of the House of
Representatives.
PART C--GENERAL PROVISIONS
SEC. 921. ADVISORY COUNCIL FOR HEALTH CARE RESEARCH AND QUALITY.
(a) Establishment.--There is established an advisory council
to be known as the Advisory Council for Health Care Research
and Quality.
(b) Duties.--
(1) In general.--The Advisory Council shall advise
the Secretary and the Director with respect to
activities proposed or undertaken to carry out the
purpose of the Agency under section 901(b).
(2) Certain recommendations.--Activities of the
Advisory Council under paragraph (1) shall include
making recommendations to the Director regarding--
(A) priorities regarding health care
research, especially studies related to
quality, outcomes, cost and the utilization of,
and access to, health care services;
(B) the field of health care research and
related disciplines, especially issues related
to training needs, and dissemination of
information pertaining to health care quality;
and
(C) the appropriate role of the Agency in
each of these areas in light of private sector
activity and identification of opportunities
for public-private sector partnerships.
(c) Membership.--
(1) In general.--The Advisory Council shall, in
accordance with this subsection, be composed of
appointed members and ex officio members. All members
of the Advisory Councilshall be voting members other
than the individuals designated under paragraph (3)(B) as ex officio
members.
(2) Appointed members.--The Secretary shall appoint
to the Advisory Council 18 appropriately qualified
individuals. At least 14 members of the Advisory
Council shall be representatives of the public who are
not officers or employees of the United States. The
Secretary shall ensure that the appointed members of
the Council, as a group, are representative of
professions and entities concerned with, or affected
by, activities under this title and under section 1142
of the Social Security Act. Of such members--
(A) 3 shall be individuals distinguished in
the conduct of research, demonstration
projects, and evaluations with respect to
health care;
(B) 3 shall be individuals distinguished in
the practice of medicine of which at least 1
shall be a primary care practitioner;
(C) 3 shall be individuals distinguished in
the other health professions;
(D) 3 shall be individuals either
representing the private health care sector,
including health plans, providers, and
purchasers or individuals distinguished as
administrators of health care delivery systems;
(E) 3 shall be individuals distinguished in
the fields of health care quality improvement,
economics, information systems, law, ethics,
business, or public policy; and
(F) 3 shall be individuals representing the
interests of patients and consumers of health
care.
(3) Ex officio members.--The Secretary shall
designate as ex officio members of the Advisory
Council--
(A) the Assistant Secretary for Health, the
Director of the National Institutes of Health,
the Director of the Centers for Disease Control
and Prevention, the Administrator of the Health
Care Financing Administration, the Assistant
Secretary of Defense (Health Affairs), and the
Under Secretary for Health of the Department of
Veterans Affairs; and
(B) such other Federal officials as the
Secretary may consider appropriate.
(d) Terms.--Members of the Advisory Council appointed under
subsection (c)(2) shall serve for a term of 3 years. A member
of the Council appointed under such subsection may continue to
serve after the expiration of the term of the members until a
successor is appointed.
(e) Vacancies.--If a member of the Advisory Council appointed
under subsection (c)(2) does not serve the full term applicable
under subsection (d), the individual appointed to fill the
resulting vacancy shall be appointed for the remainder of the
term of the predecessor of the individual.
(f) Chair.--The Director shall, from among the members of the
Advisory Council appointed under subsection (c)(2), designate
an individual to serve as the chair of the Advisory Council.
(g) Meetings.--The Advisory Council shall meet not less than
once during each discrete 4-month period and shall otherwise
meet at the call of the Director or the chair.
(h) Compensation and Reimbursement of Expenses.--
(1) Appointed members.--Members of the Advisory
Council appointed under subsection (c)(2) shall receive
compensation for each day (including travel time)
engaged in carrying out the duties of the Advisory
Council unless declined by the member. Such
compensation may not be in an amount in excess of the
maximum rate of basic pay payable for GS-18 of the
General Schedule.
(2) Ex officio members.--Officials designated under
subsection (c)(3) as ex officio members of the Advisory
Council may not receive compensation for service on the
Advisory Council in addition to the compensation
otherwise received for duties carried out as officers
of the United States.
(i) Staff.--The Director shall provide to the Advisory
Council such staff, information, and other assistance as may be
necessary to carry out the duties of the Council.
SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.
(a) Requirement of Review.--
(1) In general.--Appropriate technical and scientific
peer review shall be conducted with respect to each
application for a grant, cooperative agreement, or
contract under this title.
(2) Reports to director.--Each peer review group to
which an application is submitted pursuant to paragraph
(1) shall report its finding and recommendations
respecting the application to the Director in such form
and in such manner as the Director shall require.
(b) Approval as Precondition of Awards.--The Director may not
approve an application described in subsection (a)(1) unless
the application is recommended for approval by a peer review
group established under subsection (c).
(c) Establishment of Peer Review Groups.--
(1) In general.--The Director shall establish such
technical and scientific peer review groups as may be
necessary to carry out this section. Such groups shall
be established without regard to the provisions of
title 5, United States Code, that govern appointments
in the competitive service, and without regard to the
provisions of chapter 51, and subchapter III of chapter
53, of such title that relate to classification and pay
rates under the General Schedule.
(2) Membership.--The members of any peer review group
established under this section shall be appointed from
among individuals who by virtue of their training or
experience are eminently qualified to carry out the
duties of such peer review group. Officers and
employees of the United States may not constitute more
than 25 percent of the membership of any such group.
Such officers and employees may not receive
compensation for service on such groups in addition to
the compensation otherwise received for these duties
carried out as such officers and employees.
(3) Duration.--Notwithstanding section 14(a) of the
Federal Advisory Committee Act, peer review groups
established under this section may continue in
existence until otherwise provided by law.
(4) Qualifications.--Members of any peer-review group
shall, at a minimum, meet the following requirements:
(A) Such members shall agree in writing to
treat information received, pursuant to their
work for the group, as confidential
information, except that this subparagraph
shall not apply to public records and public
information.
(B) Such members shall agree in writing to
recuse themselves from participation in the
peer-review of specific applications which
present a potential personal conflict of
interest or appearance of such conflict,
including employment in a directly affected
organization, stock ownership, or any financial
or other arrangement that might introduce bias
in the process of peer-review.
(d) Authority for Procedural Adjustments in Certain Cases.--
In the case of applications for financial assistance whose
direct costs will not exceed $100,000, the Director may make
appropriate adjustments in the procedures otherwise established
by the Director for the conduct of peer review under this
section. Such adjustments may be made for the purpose of
encouraging the entry of individuals into the field of
research, for the purpose of encouraging clinicalpractice-
oriented or provider-based research, and for such other purposes as the
Director may determine to be appropriate.
(e) Regulations.--The Director shall issue regulations for
the conduct of peer review under this section.
SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION,
AND DISSEMINATION OF DATA.
(a) Standards With Respect to Utility of Data.--
(1) In general.--To ensure the utility, accuracy, and
sufficiency of data collected by or for the Agency for
the purpose described in section 901(b), the Director
shall establish standard methods for developing and
collecting such data, taking into consideration--
(A) other Federal health data collection
standards; and
(B) the differences between types of health
care plans, delivery systems, health care
providers, and provider arrangements.
(2) Relationship with other department programs.--In
any case where standards under paragraph (1) may affect
the administration of other programs carried out by the
Department of Health and Human Services, including the
programs under title XVIII, XIX or XXI of the Social
Security Act, or may affect health information that is
subject to a standard developed under part C of title
XI of the Social Security Act, they shall be in the
form of recommendations to the Secretary for such
program.
(b) Statistics and Analyses.--The Director shall--
(1) take appropriate action to ensure that statistics
and analyses developed under this title are of high
quality, timely, and duly comprehensive, and that the
statistics are specific, standardized, and adequately
analyzed and indexed; and
(2) publish, make available, and disseminate such
statistics and analyses on as wide a basis as is
practicable.
(c) Authority Regarding Certain Requests.--Upon request of a
public or private entity, the Director may conduct or support
research or analyses otherwise authorized by this title
pursuant to arrangements under which such entity will pay the
cost of the services provided. Amounts received by the Director
under such arrangements shall be available to the Director for
obligation until expended.
SEC. 924. DISSEMINATION OF INFORMATION.
(a) In General.--The Director shall--
(1) without regard to section 501 of title 44, United
States Code, promptly publish, make available, and
otherwise disseminate, in a form understandable and on
as broad a basis as practicable so as to maximize its
use, the results of research, demonstration projects,
and evaluations conducted or supported under this
title;
(2) ensure that information disseminated by the
Agency is science-based and objective and undertakes
consultation as necessary to assess the appropriateness
and usefulness of the presentation of information that
is targeted to specific audiences;
(3) promptly make available to the public data
developed in such research, demonstration projects, and
evaluations;
(4) provide, in collaboration with the National
Library of Medicine where appropriate, indexing,
abstracting, translating, publishing, and other
services leading to a more effective and timely
dissemination of information on research, demonstration
projects, and evaluations with respect to health care
to public and private entities and individuals engaged
in the improvement of health care delivery and the
general public, and undertake programs to develop new
or improved methods for making such information
available; and
(5) as appropriate, provide technical assistance to
State and local government and health agencies and
conduct liaison activities to such agencies to foster
dissemination.
(b) Prohibition Against Restrictions.--Except as provided in
subsection (c), the Director may not restrict the publication
or dissemination of data from, or the results of, projects
conducted or supported under this title.
(c) Limitation on Use of Certain Information.--No
information, if an establishment or person supplying the
information or described in it is identifiable, obtained in the
course of activities undertaken or supported under this title
may be used for any purpose other than the purpose for which it
was supplied unless such establishment or person has consented
(as determined under regulations of the Director) to its use
for such other purpose. Such information may not be published
or released in other form if the person who supplied the
information or who is described in it is identifiable unless
such person has consented (as determined under regulations of
the Director) to its publication or release in other form.
(d) Penalty.--Any person who violates subsection (c) shall be
subject to a civil monetary penalty of not more than $10,000
for each such violation involved. Such penalty shall be imposed
and collected in the same manner as civil money penalties under
subsection (a) of section 1128A of the Social Security Act are
imposed and collected.
SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND CONTRACTS.
(a) Financial Conflicts of Interest.--With respect to
projects for which awards of grants, cooperative agreements, or
contracts are authorized to be made under this title, the
Director shall by regulation define--
(1) the specific circumstances that constitute
financial interests in such projects that will, or may
be reasonably expected to, create a bias in favor of
obtaining results in the projects that are consistent
with such interests; and
(2) the actions that will be taken by the Director in
response to any such interests identified by the
Director.
(b) Requirement of Application.--The Director may not, with
respect to any program under this title authorizing the
provision of grants, cooperative agreements, or contracts,
provide any such financial assistance unless an application for
the assistance is submitted to the Secretary and the
application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the
Director determines to be necessary to carry out the program
involved.
(c) Provision of Supplies and Services in Lieu of Funds.--
(1) In general.--Upon the request of an entity
receiving a grant, cooperative agreement, or contract
under this title, the Secretary may, subject to
paragraph (2), provide supplies, equipment, and
services for the purpose of aiding the entity in
carrying out the project involved and, for such
purpose, may detail to the entity any officer or
employee of the Department of Health and Human
Services.
(2) Corresponding reduction in funds.--With respect
to a request described in paragraph (1), the Secretary
shall reduce the amount of the financial assistance
involved by an amount equal to the costs of detailing
personnel and the fair market value of any supplies,
equipment, or services provided by the Director. The
Secretary shall, for the payment of expenses incurred
in complying with such request, expend the amounts
withheld.
(d) Applicability of Certain Provisions With Respect to
Contracts.--Contracts may be entered into under this part
without regard to sections 3648 and 3709 of the Revised
Statutes (31 U.S.C. 529; 41 U.S.C. 5).
SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.
(a) Deputy Director and Other Officers and Employees.--
(1) Deputy director.--The Director may appoint a
deputy director for the Agency.
(2) Other officers and employees.--The Director may
appoint and fix the compensation of such officers and
employees as may be necessary to carry out this title.
Except as otherwise provided by law, such officers and
employees shall be appointed in accordance with the
civil service laws and their compensation fixed in
accordance with title 5, United States Code.
(b) Facilities.--The Secretary, in carrying out this title--
(1) may acquire, without regard to the Act of March
3, 1877 (40 U.S.C. 34), by lease or otherwise through
the Director of General Services, buildings or portions
of buildings in the District of Columbia or communities
located adjacent to the District of Columbia for use
for a period not to exceed 10 years; and
(2) may acquire, construct, improve, repair, operate,
and maintain laboratory, research, and other necessary
facilities and equipment, and such other real or
personal property (including patents) as the Secretary
deems necessary.
(c) Provision of Financial Assistance.--The Director, in
carrying out this title, may make grants to public and
nonprofit entities and individuals, and may enter into
cooperative agreements or contracts with public and private
entities and individuals.
(d) Utilization of Certain Personnel and Resources.--
(1) Department of health and human services.--The
Director, in carrying out this title, may utilize
personnel and equipment, facilities, and other physical
resources of the Department of Health and Human
Services, permit appropriate (as determined by the
Secretary) entities and individualsto utilize the
physical resources of such Department, and provide technical assistance
and advice.
(2) Other agencies.--The Director, in carrying out
this title, may use, with their consent, the services,
equipment, personnel, information, and facilities of
other Federal, State, or local public agencies, or of
any foreign government, with or without reimbursement
of such agencies.
(e) Consultants.--The Secretary, in carrying out this title,
may secure, from time to time and for such periods as the
Director deems advisable but in accordance with section 3109 of
title 5, United States Code, the assistance and advice of
consultants from the United States or abroad.
(f) Experts.--
(1) In general.--The Secretary may, in carrying out
this title, obtain the services of not more than 50
experts or consultants who have appropriate scientific
or professional qualifications. Such experts or
consultants shall be obtained in accordance with
section 3109 of title 5, United States Code, except
that the limitation in such section on the duration of
service shall not apply.
(2) Travel expenses.--
(A) In general.--Experts and consultants
whose services are obtained under paragraph (1)
shall be paid or reimbursed for their expenses
associated with traveling to and from their
assignment location in accordance with sections
5724, 5724a(a), 5724a(c), and 5726(C) of title
5, United States Code.
(B) Limitation.--Expenses specified in
subparagraph (A) may not be allowed in
connection with the assignment of an expert or
consultant whose services are obtained under
paragraph (1) unless and until the expert
agrees in writing to complete the entire period
of assignment, or 1 year, whichever is shorter,
unless separated or reassigned for reasons that
are beyond the control of the expert or
consultant and that are acceptable to the
Secretary. If the expert or consultant violates
the agreement, the money spent by the United
States for the expenses specified in
subparagraph (A) is recoverable from the expert
or consultant as a statutory obligation owed to
the United States. The Secretary may waive in
whole or in part a right of recovery under this
subparagraph.
(g) Voluntary and Uncompensated Services.--The Director, in
carrying out this title, may accept voluntary and uncompensated
services.
SEC. 927. FUNDING.
(a) Intent.--To ensure that the United States investment in
biomedical research is rapidly translated into improvements in
the quality of patient care, there must be a corresponding
investment in research on the most effective clinical and
organizational strategies for use of these findings in daily
practice. The authorization levels in subsections (b) and (c)
provide for a proportionate increase in health care research as
the United States investment in biomedical research increases.
(b) Authorization of Appropriations.--For the purpose of
carrying out this title, there are authorized to be
appropriated $250,000,000 for fiscal year 2000, and such sums
as may be necessary for each of the fiscal years 2001 through
2004.
(c) Evaluations.--In addition to amounts available pursuant
to subsection (b) for carrying out this title, there shall be
made available for such purpose, from the amounts made
available pursuant to section 241 (relating to evaluations), an
amount equal to 40 percent of the maximum amount authorized in
such section 241 to be made available for a fiscal year.
SEC. 928. DEFINITIONS.
In this title:
(1) Advisory council.--The term ``Advisory Council''
means the Advisory Council on Health Care Research and
Quality established under section 921.
(2) Agency.--The term ``Agency'' means the Agency for
Health Research and Quality.
(3) Director.--The term ``Director'' means the
Director of the Agency for Health Research and Quality.