[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.

                                  
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