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Pub.L. 106-130 To provide for the holding of court at Natchez, Mississippi, in the same manner as court is held at Vicksburg, Mississippi, and for other purposes. <> ...

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[[Page 113 STAT. 1653]]

Public Law 106-129
106th Congress

                                 An Act

To amend title IX of the Public Health Service Act to revise and extend 
     the Agency for Healthcare Policy and Research. <<NOTE: Dec. 6, 
                           1999 -  [S. 580]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Healthcare 
Research and Quality Act of 1999.>> 

SECTION <<NOTE: 42 USC 201 note.>>  1. SHORT TITLE.

    This Act may be cited as the ``Healthcare Research and Quality Act 
of 1999''.


    (a) In General.--Title IX of the Public Health Service Act (42 
U.S.C. 299 et seq.) is amended to read as follows:



``SEC. <<NOTE: 42 USC 299.>>  901. MISSION AND DUTIES.

    ``(a) In General.--There is established within the Public Health 
Service an agency to be known as the Agency for Healthcare 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 conducting and supporting--
            ``(1) research that develops and presents scientific 
        evidence regarding all aspects of health care, including--
                    ``(A) the development and assessment of methods for 
                enhancing patient participation in their own care and 
                for facilitating shared patient-physician decision-
                    ``(B) the outcomes, effectiveness, and cost-
                effectiveness of health care practices, including 
                preventive measures and long-term care;
                    ``(C) existing and innovative technologies;

[[Page 113 STAT. 1654]]

                    ``(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 
                    ``(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) the synthesis and dissemination of available 
        scientific evidence for use by patients, consumers, 
        practitioners, providers, purchasers, policy makers, and 
        educators; and
            ``(3) initiatives to advance private and public efforts to 
        improve health care quality.

    ``(c) Requirements With Respect to Rural and Inner-City Areas and 
Priority Populations.--
            ``(1) Research, evaluations and demonstration projects.--In 
        carrying out this title, the Director shall conduct and support 
        research and evaluations, and support demonstration projects, 
        with respect to--
                    ``(A) the delivery of health care in inner-city 
                areas, and in rural areas (including frontier areas); 
                    ``(B) health care for priority populations, which 
                shall include--
                          ``(i) low-income groups;
                          ``(ii) minority groups;
                          ``(iii) women;
                          ``(iv) children;
                          ``(v) the elderly; and
                          ``(vi) individuals with special health care 
                      needs, including individuals with disabilities and 
                      individuals who need chronic care or end-of-life 
                      health care.
            ``(2) Process to ensure appropriate research.--The Director 
        shall establish a process to ensure that the requirements of 
        paragraph (1) are reflected in the overall portfolio of research 
        conducted and supported by the Agency.
            ``(3) Office of priority populations.-- 
        <<NOTE: Establishment.>> The Director shall establish an Office 
        of Priority Populations to assist in carrying out the 
        requirements of paragraph (1).

``SEC. <<NOTE: 42 USC 299a.>>  902. GENERAL AUTHORITIES.

    ``(a) In General.--In carrying out section 901(b), the Director 
shall conduct and support research, evaluations, and training, support 
demonstration projects, research networks, and multidisciplinary 
centers, provide technical assistance, and disseminate 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;

[[Page 113 STAT. 1655]]

            ``(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(d)(3) as well as other 
        appropriated funds.
            ``(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 who are addressing health care issues for the 
        priority populations identified in section 901(c)(1)(B) and in 
        addition, shall take into consideration indications of long-term 
        commitment, amongst applicants for training funds, to addressing 
        health care needs of 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.
    ``(g) Annual Report.-- <<NOTE: Effective date.>> Beginning with 
fiscal year 2003, the Director shall annually submit to the Congress a 
report regarding prevailing disparities in health care delivery as it 
relates to racial factors and socioeconomic factors in priority 

[[Page 113 STAT. 1656]]



    ``(a) Evidence Rating Systems.--In collaboration with experts from 
the public and private sector, the Agency shall identify and disseminate 
methods or systems to assess health care research results, particularly 
methods or systems to rate the strength of the scientific evidence 
underlying 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 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 

    ``(a) Support for Efforts To Develop Information on Quality.--
            ``(1) Scientific and technical support.--In its role as the 
        principal agency for health care 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;

[[Page 113 STAT. 1657]]

                    ``(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) 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 
                          ``(ii) To provide objective clinical 
                      information to the following individuals and 
                                    ``(I) Health care practitioners and 
                                other providers of health care goods or 
                                    ``(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 

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