(Sec. 2) Establishes within the Agency the Office on Special Populations through which the Agency Director shall conduct and support research and evaluations, and support demonstration projects, with respect to health services and needs of various groups, including minorities, children, the elderly, and the disabled.
Requires the Agency Director to annually submit to Congress a report on health care delivery disparities with regard to racial and socioeconomic factors in priority populations.
Directs the Agency to identify and disseminate methods or systems used to assess health care research results, particularly to rate the strength of the scientific evidence behind health care practice and technology recommendations in the research.
Requires the Agency to employ research strategies and mechanisms that will link research directly with clinical practice in geographically diverse locations throughout the United States, including: (1) health care improvement research centers that combine demonstrated multidisciplinary expertise in outcomes or quality improvement research with linkages to relevant sites of care; (2) provider-based research networks, including plan, facility, or delivery system sites of care (especially primary care), that can evaluate outcomes and evaluate and promote quality improvement; and (3) other innovative mechanisms or strategies.
Authorizes the Agency to provide specified scientific and technical support for private and public efforts to improve health care quality, including accrediting organizations.
Requires the Director to: (1) conduct and support research and build private-public partnerships to enhance the quality, appropriateness, and effectiveness of and access to health services regarding cancer and cardiovascular diseases in women; and (2) conduct studies of the organization, delivery, and financing of health services to determine the cost and quality effects of various methods of increasing the number of individuals who have access to such services.
Requires the Agency to conduct and support initiatives to establish, on a web site maintained by the Agency Director, various links to enable users to evaluate the quality of health care, including health care through health maintenance organizations.
Directs the Secretary, acting through the Agency Director, to establish a program of grants for one or more centers to conduct: (1) state-of-the-art research on drugs, biological products, and devices; (2) research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices; (3) research on methods to reduce consumer costs of prescription drugs; and (4) other appropriate activities (excluding the review of new drugs).
Requires the Agency Director to: (1) collect certain data on the cost and quality of health care; (2) support research on and initiatives to advance the use of information systems for the study of health care quality; and (3) provide ongoing administrative, research, and technical support for the Preventive Services Task Force, which shall review scientific evidence on the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services regarding their usefulness in daily clinical practice.
Establishes within the Agency a Center for Primary Care Research to serve as the principal funding source for Department of Health and Human Services primary care delivery research and demonstrations with respect to 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.
Requires the Agency Director by specified activities to promote innovation in evidence-based health care practices and technologies, including: (1) promoting evidence-based clinical practices for health professionals with regard to medical examinations for victims of child or elder abuse, sexual assault, or domestic violence; and (2) developing recommendations regarding the placement of automatic external defibrillators in Federal buildings for improving the survival rates for cardiac arrest.
Requires the Secretary, acting through the Director, to coordinate all research, evaluations, and demonstrations related to health services research and quality measurement and improvement activities undertaken and supported by the Federal Government.
Establishes the National Advisory Council for Health Care Research and Quality to replace the current Advisory Council for Health Care Policy, Research, and Evaluation.
Requires the Agency Director to establish technical and scientific peer review groups to review each application for a grant, cooperative agreement, or contract under the provisions of this Act relating to the new Agency and its mission and duties.
Repeals the mandates for: (1) a demonstration program regarding centers for education and research on therapeutics; and (2) the Office of the Forum for Quality and Effectiveness in Health Care.
Authorizes appropriations.
(Sec. 3) Directs the Secretary, acting through appropriate PHS agencies, to make grants to public or nonprofit private entities for the establishment and operation of regional centers to identify particular populations of patients and facilitate appropriate patient utilization of preventive health services through developing and disseminating strategies to improve the methods used by public and private health care programs and providers in interacting with such patients. Requires applicant entities to meet certain requirements with regard to quality management in order to be eligible to receive such a grant. Authorizes appropriations.
(Sec. 4) Requires the Secretary to make two payments, determined in accordance with a specified formula and guidelines, to each children's hospital for each of FY 2000 and 2001, one for the direct expenses and the other for indirect expenses associated with operating approved graduate medical residency training programs. Authorizes appropriations.
(Sec. 5) Directs the Secretary of Health and Human Services, acting through the appropriate PHS agencies, to study and report to Congress on whether and to what extent there is a shortage of licensed pharmacists.
(Sec. 6) Requires the Agency Director to report to Congress with regard to telemedicine services, care, and consultations.
(Sec. 7) Prohibits any funds authorized pursuant to this Act from being expended by an entity unless the entity complies with the Buy American Act. Expresses the sense of Congress that, in the case of any equipment or products that may be authorized to be purchased with financial assistance provided under this Act, the entities receiving such assistance should, in expending such assistance, purchase only American-made equipment and products. Directs the Secretary, in providing financial assistance under this Act, to provide to each assistance recipient a notice describing the congressional statement above.
[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2506 Introduced in House (IH)]
106th CONGRESS
1st Session
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 14, 1999
Mr. Bilirakis (for himself, Mr. Brown of Ohio, Mr. Greenwood, and Mrs.
Thurman) introduced the following bill; which was referred to the
Committee on Commerce
_______________________________________________________________________
A BILL
To amend title IX of the Public Health Service Act to revise and extend
the Agency for Health Care Policy and Research.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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, 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--
``(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 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, 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 clinical practice-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.''.
<all>
DEBATE - The Committee is debating the amendments offered by Ms. Jackson-Lee of Texas.
DEBATE - The Committee is debating the amendment offered by Mr. Davis of Illinois.
DEBATE - The Committee is debating the amendment offered by Mr. Davis of Illinois.
DEBATE - The Committee is debating the amendment offered by Mr. Thompson of California.
DEBATE - The Committee is debating the amendment offered by Mr. Pascrell.
DEBATE - The Committee is debating the amendment offered by Mr. Tierney.
DEBATE - The Committee is debating the amendment offered by Mr. Tierney.
DEBATE - The Committee is debating the amendment offered by Mr. Stearns.
DEBATE - The Committee is debating the amendment offered by Mrs. Johnson of Connecticut.
DEBATE - The Committee is debating the amendment offered by Mr. McGovern.
DEBATE - The Committee is debating the amendment offered by Mr. Thompson of California.
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DEBATE - The Committee is debating the amendment offered by Mr. Traficant.
The previous question was ordered pursuant to the rule.
The House rose from the Committee of the Whole House on the state of the Union to report H.R. 2506.
The House adopted the amendment in the nature of a substitute as agreed to by the Committee of the Whole House on the state of the Union.
Passed/agreed to in House: On passage Passed by the Yeas and Nays: 417 - 7 (Roll no. 457).
Roll Call #457 (House)On passage Passed by the Yeas and Nays: 417 - 7 (Roll no. 457).
Roll Call #457 (House)The Clerk was authorized to correct section numbers, punctuation, and cross references, and to make other necessary technical and conforming corrections in the engrossment of H.R. 2506.
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and read twice and referred to the Committee on HELP.