II

105TH CONGRESS

2D SESSION S. 2208

To amend title IX of the Public Health Service Act to revise and extend

the Agency for Healthcare Policy and Research.

IN THE SENATE OF THE UNITED STATES

JUNE 23, 1998

Mr. FRIST introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

A BILL

To amend title IX of the Public Health Service Act to

revise and extend the Agency for Healthcare Policy and

Research.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Healthcare Quality

5 Enhancement Act of 1998’’.

6 SEC. 2. TABLE OF CONTENTS.

7 The table of contents for this Act is as follows:

Sec. 1. Short title.

Sec. 2. Table of contents.

Sec. 3. Amendment to the Public Health Service Act.

‘‘TITLE IX—AGENCY FOR HEALTHCARE QUALITY
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‘‘PART A—ESTABLISHMENT AND GENERAL DUTIES

‘‘Sec. 901. Mission and duties.

‘‘Sec. 902. General authorities.

‘‘PART B—HEALTHCARE IMPROVEMENT RESEARCH

‘‘Sec. 911. Healthcare outcome improvement research.

‘‘Sec. 912. Private-public partnerships to improve organization and delivery.

‘‘Sec. 913. Information on quality and cost of care.

‘‘Sec. 914. Information systems for healthcare improvement.

‘‘Sec. 915. Research supporting primary care and access in underserved

areas.

‘‘Sec. 916. Clinical practice and technology innovation.

‘‘Sec. 917. Coordination of Federal Government quality improvement efforts.

‘‘PART C—GENERAL PROVISIONS

‘‘Sec. 921. Advisory Council for Healthcare Quality.

‘‘Sec. 922. Foundation for Healthcare Research.

‘‘Sec. 923. Peer review with respect to grants and contracts.

‘‘Sec. 924. Certain provisions with respect to development, collection, and

dissemination of data.

‘‘Sec. 925. Dissemination of information.

‘‘Sec. 926. Additional provisions with respect to grants and contracts.

‘‘Sec. 927. Certain administrative authorities.

‘‘Sec. 928. Funding.

‘‘Sec. 929. Definitions.

Sec. 4. References.

1 SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE

2 ACT.

3 Title IX of the Public Health Service Act (42 U.S.C.

4 299 et seq.) is amended to read as follows:

5 ‘‘TITLE IX—AGENCY FOR

6 HEALTHCARE QUALITY

7 ‘‘PART A—ESTABLISHMENT AND GENERAL

8 DUTIES

9 ‘‘SEC. 901. MISSION AND DUTIES.

10 ‘‘(a) IN GENERAL.—There is established within the

11 Public Health Service an agency to be known as the Agen-
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1 cy for Healthcare Quality. In carrying out this subsection,

2 the Secretary shall redesignate the Agency for Healthcare

3 Policy and Research as the Agency for Healthcare Quality.

4 ‘‘(b) MISSION.—The purpose of the Agency is to en5 hance the quality, appropriateness, and effectiveness of

6 healthcare services, and access to such services, through

7 the establishment of a broad base of scientific research

8 and through the promotion of improvements in clinical

9 practice, including the prevention of diseases and other

10 health conditions. The Agency shall promote healthcare

11 quality improvement by—

12 ‘‘(1) conducting and supporting research that

13 develops and presents scientific evidence regarding

14 all aspects of healthcare, including—

15 ‘‘(A) the development and assessment of

16 methods for the purposes of enhancing patient

17 participation in their own care and for facilitat18 ing shared patient-physician decision-making;

19 ‘‘(B) the outcomes, effectiveness, and cost20 effectiveness of healthcare practices, including

21 preventive measures and primary care;

22 ‘‘(C) existing and innovative technologies;

23 ‘‘(D) the costs and utilization of, and ac24 cess to healthcare;
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1 ‘‘(E) the ways in which healthcare services

2 are organized, delivered, and financed and the

3 interaction and impact of these factors on the

4 quality of patient care;

5 ‘‘(F) methods for measuring quality and

6 strategies for improving quality; and

7 ‘‘(G) ways in which patients, consumers,

8 and practitioners acquire new information

9 about best practices and health benefits, and

10 the determinants of their use of this informa11 tion;

12 ‘‘(2) synthesizing and disseminating available

13 scientific evidence for use by patients, consumers,

14 practitioners, providers, purchasers, policy makers,

15 and educators; and

16 ‘‘(3) advancing private and public efforts to im17 prove healthcare quality.

18 ‘‘(c) REQUIREMENTS WITH RESPECT TO RURAL

19 AREAS AND PRIORITY POPULATIONS.—In carrying out

20 subsection (b), the Director shall undertake and support

21 research, demonstration projects, and evaluations with re22 spect to—

23 ‘‘(1) the delivery of health services in rural

24 areas (including frontier areas);
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1 ‘‘(2) health services for low-income groups, and

2 minority groups;

3 ‘‘(3) the health of children;

4 ‘‘(4) the elderly; and

5 ‘‘(5) people with special healthcare needs, in6 cluding chronic care and end-of-life healthcare.

7 ‘‘(d) APPOINTMENT OF DIRECTOR.—There shall be

8 at the head of the Agency an official to be known as the

9 Director for Healthcare Quality. The Director shall be ap10 pointed by the Secretary. The Secretary, acting through

11 the Director, shall carry out the authorities and duties es12 tablished in this title.

13 ‘‘SEC. 902. GENERAL AUTHORITIES.

14 ‘‘(a) IN GENERAL.—In carrying out section 901(b),

15 the Director shall support demonstration projects, conduct

16 and support research, evaluations, training, research net17 works, multi-disciplinary centers, technical assistance, and

18 the dissemination of information, on healthcare, and on

19 systems for the delivery of such care, including activities

20 with respect to—

21 ‘‘(1) the quality, effectiveness, efficiency, appro22 priateness and value of healthcare services;

23 ‘‘(2) quality measurement and improvement;
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1 ‘‘(3) the outcomes, cost, cost-effectiveness, and

2 use of healthcare services and access to such serv3 ices;

4 ‘‘(4) clinical practice, including primary care

5 and practice-oriented research;

6 ‘‘(5) healthcare technologies, facilities, and

7 equipment;

8 ‘‘(6) healthcare costs, productivity, and market

9 forces;

10 ‘‘(7) health promotion and disease prevention,

11 including clinical preventive services;

12 ‘‘(8) health statistics, surveys, database devel13 opment, and epidemiology; and

14 ‘‘(9) medical liability.

15 ‘‘(b) HEALTH SERVICES TRAINING GRANTS.—The

16 Director may provide training grants in the field of health

17 services research related to activities authorized under

18 subsection (a), to include pre- and post-doctoral fellow19 ships and training programs, young investigator awards,

20 and other programs and activities as appropriate. In car21 rying out this subsection, the Director shall make use of

22 funds made available under section 478.

23 ‘‘(c) MULTIDISCIPLINARY CENTERS.—The Director

24 may provide financial assistance to assist in meeting the

25 costs of planning and establishing new centers, and oper-
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1 ating existing and new centers, for multidisciplinary

2 health services research, demonstration projects, evalua3 tions, training, and policy analysis with respect to the mat4 ters referred to in subsection (a).

5 ‘‘(d) RELATION TO CERTAIN AUTHORITIES REGARD6 ING SOCIAL SECURITY.—Activities authorized in this sec7 tion may include, and shall be appropriately coordinated

8 with experiments, demonstration projects, and other relat9 ed activities authorized by the Social Security Act and the

10 Social Security Amendments of 1967. Activities under

11 subsection (a)(2) of this section that affect the programs

12 under titles XVIII and XIX of the Social Security Act

13 shall be carried out consistent with section 1142 of such

14 Act.

15 ‘‘(e) DISCLAIMER.—Nothing in this title shall be con16 strued to imply that the Agency’s role is to mandate na17 tional standards of clinical practice or quality healthcare

18 standards. Recommendations resulting from projects

19 funded and published by the Agency shall include a cor20 responding disclaimer.

21 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec22 tion shall be construed to imply that the Agency’s role is

23 to mandate a national standard or specific approach to

24 quality measurement and reporting. In research and qual25 ity improvement activities, the Agency shall consider a
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1 wide range of choices, providers, healthcare delivery sys2 tems, and individual preferences.

3 ‘‘PART B—HEALTHCARE IMPROVEMENT

4 RESEARCH

5 ‘‘SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RE6 SEARCH.

7 ‘‘(a) EVIDENCE RATING SYSTEMS.—In collaboration

8 with experts from the public and private sector, the Agen9 cy shall identify and disseminate methods or systems used

10 to assess healthcare research results, particularly—

11 ‘‘(1) to rate the strength of the scientific evi12 dence behind healthcare practice and technology rec13 ommendations in the research literature; and

14 ‘‘(2) to assess the quality and currency of

15 health related information available on the Internet

16 and other electronic media.

17 The Agency shall make methods or systems for evidence

18 rating widely available. Agency publications containing

19 healthcare recommendations shall indicate the level of sub20 stantiating evidence using such methods or systems.

21 ‘‘(b) HEALTHCARE IMPROVEMENT RESEARCH CEN22 TERS AND PROVIDER-BASED RESEARCH NETWORKS.—

23 ‘‘(1) IN GENERAL.—In order to address the full

24 continuum of care and outcomes research, to link re25 search to practice improvement, and to speed the
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1 dissemination of research findings to community

2 practice settings, the Agency shall employ research

3 strategies and mechanisms that will link research di4 rectly with clinical practice in geographically diverse

5 locations throughout the United States, including—

6 ‘‘(A) Healthcare Improvement Research

7 Centers that combine demonstrated multidisci8 plinary expertise in outcomes or quality im9 provement research with linkages to relevant

10 sites of care;

11 ‘‘(B) Practice-based Research Networks,

12 including plan, facility, or delivery system sites

13 of care (especially primary care), that can

14 evaluate and promote quality improvement; and

15 ‘‘(C) other innovative mechanisms or strat16 egies.

17 ‘‘(2) REQUIREMENTS.—The Director is author18 ized to establish the requirements for entities apply19 ing for grants under this subsection.

20 ‘‘(c) EXPANSION OF THE HEALTH SERVICES RE21 SEARCH WORKFORCE.—

22 ‘‘(1) GRANTS.—The Agency shall, through the

23 awarding of grants, support eligible entities at geo24 graphically diverse locations throughout the United

25 States to enable such entities to carry out research
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1 training programs that are dedicated to health serv2 ices research training at the doctoral, post-doctoral,

3 and junior faculty levels.

4 ‘‘(2) REQUIREMENTS.—In developing priorities

5 for the allocation of training funds under this sub6 section, the Director shall take into consideration

7 shortages in the number of trained researchers ad8 dressing the priority populations.

9 ‘‘SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE

10 ORGANIZATION AND DELIVERY.

11 ‘‘(a) SUPPORT FOR EFFORTS TO DEVELOP INFOR12 MATION ON QUALITY.—

13 ‘‘(1) SCIENTIFIC AND TECHNICAL SUPPORT.—

14 In its role as the principal agency for healthcare

15 quality research, the Agency shall provide scientific

16 and technical support for private and public efforts

17 to improve healthcare quality, including accrediting

18 organizations.

19 ‘‘(2) ROLE OF THE AGENCY.—With respect to

20 paragraph (1), the role of the Agency shall include—

21 ‘‘(A) the identification and assessment of

22 methods for the evaluation of the health of en23 rollees in health plans by type of plan, provider,

24 and provider arrangements;
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1 ‘‘(B) the ongoing development, testing, and

2 dissemination of quality measures, including

3 measures of health and functional outcomes,

4 that take into account appropriate variations in

5 individual preferences;

6 ‘‘(C) the compilation and dissemination of

7 healthcare quality measures developed in the

8 private and public sector;

9 ‘‘(D) assistance in the development of im10 proved healthcare information systems;

11 ‘‘(E) the development of survey tools for

12 the purpose of measuring participant and bene13 ficiary assessments of their healthcare; and

14 ‘‘(F) the integration of information on

15 quality into purchaser and consumer decision16 making processes.

17 ‘‘(b) DEMONSTRATION PROGRAM REGARDING CEN18 TERS FOR EDUCATION AND RESEARCH ON THERA19 PEUTICS.—

20 ‘‘(1) IN GENERAL.—The Secretary, acting

21 through the Director and in consultation with the

22 Commissioner of Food and Drugs, shall establish a

23 demonstration program for the purpose of making

24 one or more grants for the establishment and oper-
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1 ation of one or more centers to carry out the activi2 ties specified in paragraph (2).

3 ‘‘(2) REQUIRED ACTIVITIES.—The activities re4 ferred to in this paragraph are the following:

5 ‘‘(A) The conduct of state-of-the-art clini6 cal research for the following purposes:

7 ‘‘(i) To increase awareness of—

8 ‘‘(I) new uses of drugs, biological

9 products, and devices;

10 ‘‘(II) ways to improve the effec11 tive use of drugs, biological products,

12 and devices; and

13 ‘‘(III) risks of new uses and risks

14 of combinations of drugs and biologi15 cal products.

16 ‘‘(ii) To provide objective clinical in17 formation to the following individuals and

18 entities:

19 ‘‘(I) Healthcare practitioners and

20 other providers of Healthcare goods or

21 services.

22 ‘‘(II) Pharmacy benefit managers

23 and purchasers.
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1 ‘‘(III) Health maintenance orga2 nizations and other managed

3 healthcare organizations.

4 ‘‘(IV) Healthcare insurers and

5 governmental agencies.

6 ‘‘(V) Patients and consumers.

7 ‘‘(iii) To improve the quality of

8 healthcare while reducing the cost of

9 Healthcare through—

10 ‘‘(I) the appropriate use of drugs,

11 biological products, or devices; and

12 ‘‘(II) the prevention of adverse

13 effects of drugs, biological products,

14 and devices and the consequences of

15 such effects, such as unnecessary hos16 pitalizations.

17 ‘‘(B) The conduct of research on the com18 parative effectiveness, cost-effectiveness, and

19 safety of drugs, biological products, and devices.

20 ‘‘(C) Such other activities as the Secretary

21 determines to be appropriate, except that a

22 grant may not be expended to assist the Sec23 retary in the review of new drugs.

24 ‘‘(3) APPLICATION FOR GRANT.—A grant under

25 paragraph (1) may be made only if an application
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1 for the grant is submitted to the Secretary and the

2 application is in such form, is made in such manner,

3 and contains such agreements, assurances, and in4 formation as the Secretary determines to be nec5 essary to carry out this section.

6 ‘‘(4) PEER REVIEW.—A grant under paragraph

7 (1) may be made only if the application for the

8 grant has undergone appropriate technical and sci9 entific peer review.

10 ‘‘(c) RESEARCH ON HEALTHCARE BENEFITS.—

11 ‘‘(1) PURPOSE.—The Director is authorized to

12 conduct and support research to evaluate the impact

13 of changes in healthcare benefits.

14 ‘‘(2) CONSIDERATIONS.—In carrying out para15 graph (1), the Director shall build partnerships with

16 appropriate public and private sector entities to re17 view available scientific evidence and undertake such

18 evaluations. As appropriate and to the extent that

19 data are available, the evaluation shall consider—

20 ‘‘(A) safety and effectiveness, including

21 health and functional outcomes of patients;

22 ‘‘(B) costs, benefits, and cost-effectiveness;

23 and

24 ‘‘(C) comparisons with alternative clinical

25 approaches.
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1 ‘‘(d) REDUCING ERRORS IN MEDICINE.—The Direc2 tor shall conduct and support research and build private3 public partnerships to—

4 ‘‘(1) identify the causes of preventable

5 healthcare errors and patient injury in healthcare

6 delivery systems;

7 ‘‘(2) develop, demonstrate, and evaluate strate8 gies for reducing errors and improving patient safe9 ty; and

10 ‘‘(3) promote the implementation of effective

11 strategies throughout the healthcare industry.

12 ‘‘SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.

13 ‘‘(a) IN GENERAL.—In carrying out 902(a), the Di14 rector shall—

15 ‘‘(1) collect data from a nationally representa16 tive sample of the population on the cost and use of

17 healthcare, including the types of healthcare services

18 Americans use, their access to healthcare services,

19 frequency of use, how much is paid for the services

20 used, the source of those payments, the types and

21 costs of private health insurance, access, satisfac22 tion, and quality of care for the general population

23 and also for children, uninsured persons, poor and

24 near-poor individuals, and persons with special

25 healthcare needs, including end-of-life healthcare;
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1 ‘‘(2) develop databases and tools that enable

2 States to track the quality, access, and use of

3 healthcare services provided to their residents; and

4 ‘‘(3) enter into agreements with public or pri5 vate entities to use, link, or acquire databases for re6 search authorized under this title.

7 ‘‘(b) QUALITY AND OUTCOMES INFORMATION.—

8 ‘‘(1) IN GENERAL.—To enhance the under9 standing of the quality of care, the determinants of

10 health outcomes and functional status, the needs of

11 special populations as well as an understanding of

12 these changes over time, their relationship to

13 healthcare access and use, and to monitor the overall

14 national impact of Federal and State policy changes

15 on healthcare, the Director, beginning in fiscal year

16 2000, shall ensure that the survey conducted under

17 subsection (a)(1) will—

18 ‘‘(A) provide information on the quality of

19 care and patient outcomes for frequently occur20 ring clinical conditions for a nationally rep21 resentative sample of the population; and

22 ‘‘(B) provide reliable national estimates for

23 children and persons with special healthcare

24 needs through the use of supplements or peri25 odic expansions of the survey.
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1 ‘‘(2) ANNUAL REPORT.—Beginning in fiscal

2 year 2002, the Secretary, acting through the Direc3 tor, shall submit to Congress an annual report on

4 national trends in the quality of healthcare provided

5 to the American people.

6 ‘‘SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE IM7 PROVEMENT.

8 ‘‘In order to foster a range of innovative approaches

9 to the management and communication of health informa10 tion, the Agency shall support research to evaluate and

11 initiatives to advance—

12 ‘‘(1) the use of information systems for the

13 study of healthcare quality, including the generation

14 of both individual provider and plan-level compara15 tive performance measures;

16 ‘‘(2) training for healthcare practitioners and

17 researchers in the use of information systems;

18 ‘‘(3) the creation of effective linkages between

19 various sources of health information, including the

20 development of information networks;

21 ‘‘(4) the delivery and coordination of evidence22 based healthcare services, using real-time decision23 support programs;
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1 ‘‘(5) the structure, content, definition, and cod2 ing of health information data and medical vocabu3 laries and shall consult with other Federal entities;

4 ‘‘(6) the evaluation and use of computer-based

5 health records in outpatient and inpatient settings

6 as a personal health record for individual health as7 sessment and maintenance, and for monitoring pub8 lic health and outcomes of care within populations;

9 and

10 ‘‘(7) the protection of individually identifiable

11 information in health services research and

12 healthcare quality improvement.

13 ‘‘SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND

14 ACCESS IN UNDERSERVED AREAS.

15 ‘‘(a) PREVENTIVE SERVICES TASK FORCE.—

16 ‘‘(1) PURPOSE.—The Agency shall provide on17 going administrative, research, and technical support

18 for the operation of the Preventive Services Task

19 Force. The Agency shall coordinate and support the

20 dissemination of the Preventive Services Task Force

21 recommendations.

22 ‘‘(2) OPERATION.—The Preventive Services

23 Task Force shall review the scientific evidence relat24 ed to the effectiveness, appropriateness, and cost-ef25 fectiveness of clinical preventive services for the pur-
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1 pose of developing recommendations, and updating

2 previous recommendations, regarding their useful3 ness in daily clinical practice. In carrying out its re4 sponsibilities under paragraph (1), the Task Force

5 shall not be subject to the provisions of Appendix 2

6 of title 5, United States Code.

7 ‘‘(b) PRIMARY CARE RESEARCH.—

8 ‘‘(1) IN GENERAL.—There is established within

9 the Agency a Center for Primary Care Research (re10 ferred to in this subsection as the ‘Center’) that

11 shall serve as the principal source of funding for pri12 mary care research in the Department of Health and

13 Human Services. For purposes of this paragraph,

14 primary care research focuses on the first contact

15 when illness or health concerns arise, the diagnosis,

16 treatment or referral to specialty care, preventive

17 care, and the relationship between the clinician and

18 the patient in the context of the family and commu19 nity.

20 ‘‘(2) RESEARCH.—In carrying out this section,

21 the Center shall conduct and support research on—

22 ‘‘(A) the nature and characteristics of pri23 mary care practice;

24 ‘‘(B) producing evidence for the manage25 ment of commonly occurring clinical problems;
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1 ‘‘(C) the management of undifferentiated

2 clinical problems; and

3 ‘‘(D) the continuity and coordination of

4 health services.

5 ‘‘(3) DEMONSTRATION.—The Agency shall sup6 port demonstrations into the use of new information

7 tools aimed at improving shared decision-making be8 tween patients and their care-givers.

9 ‘‘SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVA10 TION.

11 ‘‘(a) IN GENERAL.—The Director shall promote inno12 vation in evidence-based clinical practice and healthcare

13 technologies by—

14 ‘‘(1) conducting and supporting research on the

15 development, diffusion, and use of healthcare tech16 nology;

17 ‘‘(2) developing, evaluating, and disseminating

18 methodologies for healthcare practice and technology

19 assessment;

20 ‘‘(3) conducting intramural and supporting ex21 tramural assessments of existing and new healthcare

22 practices and technologies;

23 ‘‘(4) promoting education, training, and provid24 ing technical assistance in the use of healthcare
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1 practice and healthcare technology assessment meth2 odologies and results; and

3 ‘‘(5) working with the National Library of Med4 icine and the public and private sector to develop an

5 electronic clearinghouse of currently available assess6 ments and those in progress.

7 ‘‘(b) SPECIFICATION OF PROCESS.—

8 ‘‘(1) IN GENERAL.—Not later than June 1,

9 1999, the Director shall develop and publish a de10 scription of the methods used by the Agency and its

11 contractors for practice and technology assessment.

12 ‘‘(2) CONSULTATIONS.—In carrying out this

13 subsection, the Director shall cooperate and consult

14 with the Administrator of the Health Care Financ15 ing Administration, the Director of the National In16 stitutes of Health, the Commissioner of Food and

17 Drugs, and the heads of any other interested Fed18 eral department or agency, professional societies,

19 and other private and public entities.

20 ‘‘(3) METHODOLOGY.—The methods employed

21 in practice and technology assessments under para22 graph (1) shall consider—

23 ‘‘(A) safety, efficacy, and effectiveness;

24 ‘‘(B) legal, social, and ethical implications;

25 ‘‘(C) costs, benefits, and cost-effectiveness;
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1 ‘‘(D) comparisons to alternative tech2 nologies and practices; and

3 ‘‘(E) requirements of Food and Drug Ad4 ministration approval to avoid duplication.

5 ‘‘(c) SPECIFIC ASSESSMENTS.—

6 ‘‘(1) IN GENERAL.—The Director shall conduct

7 and support specific assessments of healthcare tech8 nologies and practices.

9 ‘‘(2) GRANTS AND CONTRACTS.—The Director

10 may make grants to, or enter into cooperative agree11 ments or contracts with, entities described in para12 graph (3) for the establishment of collaborative ar13 rangements for the purpose of conducting assess14 ments of experimental, emerging, existing, or poten15 tially outmoded healthcare technologies, and for re16 lated activities.

17 ‘‘(3) ELIGIBLE ENTITIES.—An entity described

18 in this paragraph is an entity that is determined to

19 be appropriate by the Director, including academic

20 medical centers, research institutions, professional

21 organizations, third party payers, other govern22 mental agencies, and consortia of appropriate re23 search entities established for the purpose of con24 ducting technology assessments.
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1 ‘‘SEC. 917. COORDINATION OF FEDERAL GOVERNMENT

2 QUALITY IMPROVEMENT EFFORTS.

3 ‘‘(a) REQUIREMENT.—

4 ‘‘(1) IN GENERAL.—The Secretary, acting

5 through the Director, shall coordinate all research,

6 evaluations, and demonstrations related to health

7 services research and quality measurement and im8 provement activities undertaken and supported by

9 the Federal Government.

10 ‘‘(2) SPECIFIC ACTIVITIES.—The Director, in

11 collaboration with the appropriate Federal officials

12 representing all concerned executive agencies and de13 partments, shall develop and manage a process to—

14 ‘‘(A) improve interagency coordination, pri15 ority setting, and the use and sharing of re16 search findings and data pertaining to Federal

17 quality improvement programs and health serv18 ices research;

19 ‘‘(B) strengthen the research information

20 infrastructure, including databases, pertaining

21 to Federal health services research and

22 healthcare quality improvement initiatives;

23 ‘‘(C) set specific goals for participating

24 agencies and departments to further health

25 services research and healthcare quality im26 provement; and
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1 ‘‘(D) strengthen the management of Fed2 eral healthcare quality improvement programs.

3 ‘‘(b) STUDY BY THE INSTITUTE OF MEDICINE.—

4 ‘‘(1) IN GENERAL.—To provide the Department

5 of Health and Human Services with independent, ex6 pert advice in redesigning its quality oversight func7 tions, and pertinent research programs, the Sec8 retary shall enter into a contract with the Institute

9 of Medicine—

10 ‘‘(A) to describe and evaluate current qual11 ity improvement research and monitoring proc12 esses through—

13 ‘‘(i) an overview of pertinent health

14 services research activities and quality im15 provement efforts with particular attention

16 paid to those performed by the peer review

17 organizations;

18 ‘‘(ii) an analysis of the various part19 nership activities that the Department of

20 Health and Human Services has pursued

21 with private sector accreditation and other

22 quality measurement organizations;

23 ‘‘(iii) the exploration of programmatic

24 areas where partnership activities could be

25 pursued to improve quality oversight of the
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1 medicare and medicaid programs under ti2 tles XVIII and XIX of the Social Security

3 Act; and

4 ‘‘(iv) an identification of opportunities

5 for enhancing health system efficiency

6 through simplification and reduction in re7 dundancy of public and private sector qual8 ity improvement efforts; and

9 ‘‘(B) to identify options and make rec10 ommendations to improve the efficiency and ef11 fectiveness of such quality improvement pro12 grams and to optimize public/private sector ac13 creditation bodies through—

14 ‘‘(i) the improved coordination of ac15 tivities across the medicare and medicaid

16 programs under titles XVIII and XIX of

17 the Social Security Act and various health

18 services research programs;

19 ‘‘(ii) greater consistency and stand20 ardization of oversight activities across tra21 ditional fee-for-service and managed care

22 components of these programs;

23 ‘‘(iii) the strengthening of patient

24 choice and participation by incorporating

25 state-of-the-art quality monitoring tools
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1 and making information on quality avail2 able; and

3 ‘‘(iv) the enhancement of the most ef4 fective programs, consolidation as appro5 priate, and elimination of duplicative ac6 tivities within various federal agencies.

7 ‘‘(2) REQUIREMENTS.—

8 ‘‘(A) IN GENERAL.—The Secretary shall

9 enter into a contract with the Institute of Medi10 cine for the preparation—

11 ‘‘(i) not later than 12 months after

12 the date of enactment of this title, of a re13 port providing an overview of the quality

14 improvement programs of the Department

15 of Health and Human Services for the

16 medicare, medicaid, and CHIP programs

17 under titles XVIII, XIX, and XXI of the

18 Social Security Act; and

19 ‘‘(ii) not later than 24 months after

20 the date of enactment of this title, of a

21 final report containing recommendations

22 for a comprehensive system and public-pri23 vate partnerships for healthcare quality

24 improvement.
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1 ‘‘(B) REPORTS.—The Secretary shall sub2 mit the reports described in subparagraph (A)

3 to the Committee on Finance and the Commit4 tee on Labor and Human Resources of the Sen5 ate and the Committee on Ways and Means and

6 the Committee on Commerce of the House of

7 Representatives.

8 ‘‘PART C—GENERAL PROVISIONS

9 ‘‘SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE QUALITY.

10 ‘‘(a) ESTABLISHMENT.—There is established an advi11 sory council to be known as the Advisory Council for

12 Healthcare Quality.

13 ‘‘(b) DUTIES.—

14 ‘‘(1) IN GENERAL.—The Advisory Council shall

15 advise the Secretary and the Director with respect

16 to activities to carry out the purpose of the Agency

17 under section 901(b).

18 ‘‘(2) CERTAIN RECOMMENDATIONS.—Activities

19 of the Advisory Council under paragraph (1) shall

20 include making recommendations to the Director re21 garding—

22 ‘‘(A) priorities regarding healthcare re23 search, especially studies related to quality, out24 comes, cost and the utilization of, and access

25 to, healthcare services;
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1 ‘‘(B) the field of healthcare research and

2 related disciplines, especially issues related to

3 training needs, and dissemination of informa4 tion on quality; and

5 ‘‘(C) the appropriate role of the Agency in

6 each of these areas in light of private sector ac7 tivity and identification of opportunities for

8 public-private sector partnerships.

9 ‘‘(c) MEMBERSHIP.—

10 ‘‘(1) IN GENERAL.—The Advisory Council shall,

11 in accordance with this subsection, be composed of

12 appointed members and ex officio members. All

13 members of the Advisory Council shall be voting

14 members other than the individuals designated

15 under paragraph (3)(B) who shall be ex officio mem16 bers of the Advisory Council.

17 ‘‘(2) APPOINTED MEMBERS.—The Secretary

18 shall appoint to the Advisory Council 21 appro19 priately qualified individuals. At least 17 members of

20 the Advisory Council shall be representatives of the

21 public who are not officers or employees of the

22 United States. The Secretary shall ensure that the

23 appointed members of the Council, as a group, are

24 representative of professions and entities concerned

25 with, or affected by, activities under this title and
29

•S 2208 IS

1 under section 1142 of the Social Security Act. Of

2 such members—

3 ‘‘(A) 4 shall be individuals distinguished in

4 the conduct of research, demonstration projects,

5 and evaluations with respect to healthcare;

6 ‘‘(B) 4 shall be individuals distinguished in

7 the practice of medicine of which at least 1

8 shall be a primary care practitioner;

9 ‘‘(C) 3 shall be individuals distinguished in

10 the health professions;

11 ‘‘(D) 4 shall be individuals either rep12 resenting the private healthcare sector, includ13 ing health plans, providers, and purchasers or

14 individuals distinguished as administrators of

15 healthcare delivery systems;

16 ‘‘(E) 4 shall be individuals distinguished in

17 the fields of healthcare quality improvement, ec18 onomics, information systems, law, ethics, busi19 ness, or public policy; and

20 ‘‘(F) 2 shall be individuals representing the

21 interests of patients and consumers of

22 healthcare.

23 ‘‘(3) EX OFFICIO MEMBERS.—The Secretary

24 shall designate as ex officio members of the Advisory

25 Council—
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•S 2208 IS

1 ‘‘(A) the Director of the National Insti2 tutes of Health, the Director of the Centers for

3 Disease Control and Prevention, the Adminis4 trator of the Health Care Financing Adminis5 tration, the Assistant Secretary of Defense

6 (Health Affairs), and the Chief Medical Officer

7 of the Department of Veterans Affairs; and

8 ‘‘(B) such other Federal officials as the

9 Secretary may consider appropriate.

10 ‘‘(d) TERMS.—Members of the Advisory Council ap11 pointed under subsection (c)(2) shall serve for a term of

12 3 years. A member of the Council appointed under such

13 subsection may continue to serve after the expiration of

14 the term of the members until a successor is appointed.

15 ‘‘(e) VACANCIES.—If a member of the Advisory

16 Council appointed under subsection (c)(2) does not serve

17 the full term applicable under subsection (d), the individ18 ual appointed to fill the resulting vacancy shall be ap19 pointed for the remainder of the term of the predecessor

20 of the individual.

21 ‘‘(f) CHAIR.—The Director shall, from among the

22 members of the Advisory Council appointed under sub23 section (c)(2), designate an individual to serve as the chair

24 of the Advisory Council.
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•S 2208 IS

1 ‘‘(g) MEETINGS.—The Advisory Council shall meet

2 not less than once during each discrete 4-month period

3 and shall otherwise meet at the call of the Director or the

4 chair.

5 ‘‘(h) COMPENSATION AND REIMBURSEMENT OF EX6 PENSES.—

7 ‘‘(1) APPOINTED MEMBERS.—Members of the

8 Advisory Council appointed under subsection (c)(2)

9 shall receive compensation for each day (including

10 travel time) engaged in carrying out the duties of

11 the Advisory Council unless declined by the member.

12 Such compensation may not be in an amount in ex13 cess of the maximum rate of basic pay payable for

14 GS–18 of the General Schedule.

15 ‘‘(2) EX OFFICIO MEMBERS.—Officials des16 ignated under subsection (c)(3) as ex officio mem17 bers of the Advisory Council may not receive com18 pensation for service on the Advisory Council in ad19 dition to the compensation otherwise received for du20 ties carried out as officers of the United States.

21 ‘‘(i) STAFF.—The Director shall provide to the Advi22 sory Council such staff, information, and other assistance

23 as may be necessary to carry out the duties of the Council.
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1 ‘‘SEC. 922. FOUNDATION FOR HEALTHCARE RESEARCH.

2 ‘‘(a) IN GENERAL.—The Secretary shall, acting

3 through the Director of the Agency for Healthcare Qual4 ity, establish a nonprofit corporation to be known as the

5 Foundation for Healthcare Research (hereafter in this sec6 tion referred to as the ‘Foundation’). The Foundation

7 shall not be an agency or instrumentality of the United

8 States Government.

9 ‘‘(b) PURPOSE OF FOUNDATION.—The purpose of

10 the Foundation shall be to—

11 ‘‘(1) support the Agency for Healthcare Quality

12 in its mission;

13 ‘‘(2) foster public-private partnerships to sup14 port the programs and activities of the Agency;

15 ‘‘(3) advance collaboration with healthcare re16 searchers from universities, industry, and nonprofit

17 organizations; and

18 ‘‘(4) develop linkages with users of healthcare

19 and quality research, including patients, consumers,

20 practitioners and other healthcare providers, health

21 plans and insurers, large private or public sector

22 purchasers of healthcare, healthcare policy makers,

23 and healthcare educators.

24 ‘‘(c) CERTAIN ACTIVITIES OF FOUNDATION.—In car25 rying out subsection (b), the Foundation may solicit and

26 accept gifts, grants, and other donations, establish ac-
33

•S 2208 IS

1 counts, and invest and expend funds in support of a broad

2 range of research, training, dissemination, and other ac3 tivities with respect to the purpose described in such sub4 section. In addition, the Foundation is authorized to sup5 port the following:

6 ‘‘(1) A program to provide and administer en7 dowed positions that are associated with the re8 search program of the Agency for Healthcare Qual9 ity. Such endowments may be expended for the com10 pensation of individuals holding the positions, for

11 staff, equipment, quarters, travel, and other expendi12 tures that are appropriate in supporting the en13 dowed positions.

14 ‘‘(2) A program to provide and administer fel15 lowships and grants to research personnel in order

16 to work and study in association with the Agency for

17 Healthcare Quality. Such fellowships and grants

18 may include stipends, travel, health insurance bene19 fits, and other appropriate expenses. The recipients

20 of fellowships shall be selected by the donors and the

21 Foundation upon the recommendation of the Agency

22 for Healthcare Quality, and shall be subject to the

23 agreement of the Director of the Agency for

24 Healthcare Quality and the Executive Director of

25 the Foundation.
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•S 2208 IS

1 ‘‘(d) GENERAL STRUCTURE OF FOUNDATION; NON2 PROFIT STATUS.—

3 ‘‘(1) BOARD OF DIRECTORS.—The Foundation

4 shall have a Board of Directors (in this section re5 ferred to as the Board), which shall be established

6 and conducted in accordance with subsection (e).

7 The Board shall establish the general policies of the

8 Foundation for carrying out subsection (b), includ9 ing the establishment of the bylaws of the Founda10 tion.

11 ‘‘(2) EXECUTIVE DIRECTOR.—The Foundation

12 shall have an executive director (in this section re13 ferred to as the ‘Director’), who shall be appointed

14 by the Board, who shall serve at the pleasure of the

15 Board, and for whom the Board shall establish the

16 rate of compensation. Subject to compliance with the

17 policies and bylaws established by the Board pursu18 ant to paragraph (1), the Director shall be respon19 sible for the daily operations of the Foundation in

20 carrying out subsection (b).

21 ‘‘(3) NONPROFIT STATUS.—In carrying out

22 subsection (b), the Board shall establish such poli23 cies and bylaws under paragraph (1), and the Direc24 tor shall carry out such activities under paragraph
35

•S 2208 IS

1 (2), as may be necessary to ensure that the Founda2 tion maintains status as an organization that—

3 ‘‘(A) is described in subsection (c)(3) of

4 section 501 of the Internal Revenue Code of

5 1986; and

6 ‘‘(B) is, under subsection (a) of such sec7 tion, exempt from taxation.

8 ‘‘(e) BOARD OF DIRECTORS.—

9 ‘‘(1) CERTAIN BYLAWS.—

10 ‘‘(A) IN GENERAL.—The Board shall en11 sure that bylaws established under subsection

12 (a)(1) include bylaws for the following:

13 ‘‘(i) Policies for the selection of the

14 officers, employees, agents, and contractors

15 of the Foundation.

16 ‘‘(ii) Policies, including ethical stand17 ards, for the acceptance and disposition of

18 donations to the Foundation and for the

19 disposition of the assets of the Foundation.

20 ‘‘(iii) Policies for the conduct of the

21 general operations of the Foundation.

22 ‘‘(iv) Policies for writing, editing,

23 printing, and publishing of books and other

24 materials, and the acquisition of patents
36

•S 2208 IS

1 and licenses for devices and procedures de2 veloped by the Foundation.

3 ‘‘(B) REQUIREMENTS.—The Board shall

4 ensure that the bylaws established under sub5 section (d)(1) (and activities carried out under

6 such bylaws) do not—

7 ‘‘(i) reflect unfavorably upon the abil8 ity of the Foundation, or the Agency for

9 Healthcare Quality, to carry out its re10 sponsibilities or official duties in a fair and

11 objective manner; or

12 ‘‘(ii) compromise, or appear to com13 promise, the integrity of any governmental

14 program or any officer or employee in15 volved in such program.

16 ‘‘(2) COMPOSITION.—

17 ‘‘(A) IN GENERAL.—Subject to subpara18 graph (B), the Board shall be composed of 7 in19 dividuals, appointed in accordance with para20 graph (4), who collectively possess education or

21 experience appropriate for representing the con22 stituencies described in subsection (b). Each

23 such individual shall be a voting member of the

24 Board.
37

•S 2208 IS

1 ‘‘(B) ADDITIONAL MEMBERS.—The Board

2 may, through amendments to the bylaws of the

3 Foundation, provide that the number of mem4 bers of the Board shall be a greater number

5 than the number specified in subparagraph (A).

6 ‘‘(3) CHAIR.—The Board shall, from among the

7 members of the Board, designate an individual to

8 serve as the chair of the Board (in this subsection

9 referred to as the ‘Chair’).

10 ‘‘(4) APPOINTMENTS, VACANCIES, AND

11 TERMS.—The following shall apply to the Board:

12 ‘‘(A) Any vacancy in the membership of

13 the Board shall be filled by appointment by the

14 Board, after consideration of suggestions made

15 by the Chair and the Director regarding the ap16 pointments. Any such vacancy shall be filled not

17 later than the expiration of the 180-day period

18 beginning on the date on which the vacancy oc19 curs.

20 ‘‘(B) The term of office of each member of

21 the Board appointed under subparagraph (A)

22 shall be 5 years. A member of the Board may

23 continue to serve after the expiration of the

24 term of the member until the expiration of the
38

•S 2208 IS

1 180-day period beginning on the date on which

2 the term of the member expires.

3 ‘‘(C) A vacancy in the membership of the

4 Board shall not affect the power of the Board

5 to carry out the duties of the Board. If a mem6 ber of the Board does not serve the full term

7 applicable under subparagraph (B), the individ8 ual appointed to fill the resulting vacancy shall

9 be appointed for the remainder of the term of

10 the predecessor of the individual.

11 ‘‘(5) COMPENSATION.—Members of the Board

12 may not receive compensation for service on the

13 Board. The members may be reimbursed for travel,

14 subsistence, and other necessary expenses incurred

15 in carrying out the duties of the Board.

16 ‘‘(f) CERTAIN RESPONSIBILITIES OF EXECUTIVE DI17 RECTOR.—In carrying out subsection (d)(2), the Director

18 shall carry out the following functions:

19 ‘‘(1) Hire, promote, compensate, and discharge

20 officers and employees of the Foundation, and define

21 the duties of the officers and employees.

22 ‘‘(2) Accept and administer donations to the

23 Foundation, and administer the assets of the Foun24 dation.
39

•S 2208 IS

1 ‘‘(3) Establish a process for the selection of

2 candidates for holding endowed positions under sub3 section (c).

4 ‘‘(4) Enter into such financial agreements as

5 are appropriate in carrying out the activities of the

6 Foundation.

7 ‘‘(5) Take such action as may be necessary to

8 acquire patents and licenses for devices and proce9 dures developed by the Foundation and the employ10 ees of the Foundation.

11 ‘‘(6) Adopt, alter, and use a corporate seal,

12 which shall be judicially noticed.

13 ‘‘(7) Commence and respond to judicial pro14 ceedings in the name of the Foundation.

15 ‘‘(8) Other functions that are appropriate in the

16 determination of the Director.

17 ‘‘(g) GENERAL PROVISIONS.—

18 ‘‘(1) AUTHORITY FOR ACCEPTING FUNDS.—The

19 Director of the Agency for Healthcare Quality may

20 accept and utilize, on behalf of the Federal Govern21 ment, any gift, donation, bequest, or devise of real

22 or personal property from the Foundation for the

23 purpose of aiding or facilitating the work of such

24 Agency. Funds may be accepted and utilized by such

25 Director under the preceding sentence without re-
40

•S 2208 IS

1 gard to whether the funds are designated as general2 purpose funds or special-purpose funds. Any funds

3 transferred under this paragraph shall be subject to

4 all Federal limitations relating to federally funded

5 research.

6 ‘‘(2) AUTHORITY FOR ACCEPTANCE OF VOL7 UNTARY SERVICES.—

8 ‘‘(A) IN GENERAL.—The Director of the

9 Agency for Healthcare Quality may accept, on

10 behalf of the Federal Government, any vol11 untary services provided to such Agency by the

12 Foundation for the purpose of aiding or facili13 tating the work of such Agency. In the case of

14 an individual, such Director may accept the

15 services provided under the preceding sentence

16 by the individual for not more than 2 years.

17 ‘‘(B) LIMITATION.—The limitation estab18 lished in subparagraph (A) regarding the period

19 of time in which services may be accepted ap20 plies to each individual who is not an employee

21 of the Federal Government and who serves in

22 association with the Agency for Healthcare

23 Quality pursuant to financial support from the

24 Foundation.
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•S 2208 IS

1 ‘‘(3) ADMINISTRATIVE CONTROL.—No officer,

2 employee, or member of the Board of the Founda3 tion may exercise any administrative or managerial

4 control over any Federal employee.

5 ‘‘(4) APPLICABILITY OF CERTAIN STANDARDS

6 TO NON-FEDERAL EMPLOYEES.—In the case of any

7 individual who is not an employee of the Federal

8 Government and who serves in association with the

9 Agency for Healthcare Quality pursuant to financial

10 support from the Foundation, the Foundation shall

11 negotiate a memorandum of understanding with the

12 individual and the Director of the Agency for

13 Healthcare Quality specifying that the individual—

14 ‘‘(A) shall be subject to the ethical and

15 procedural standards regulating Federal em16 ployment, scientific investigation, and research

17 findings (including publications and patents)

18 that are required of individuals employed by the

19 Agency for Healthcare Quality, including stand20 ards under this Act, the Ethics in Government

21 Act, and the Technology Transfer Act; and

22 ‘‘(B) shall be subject to such ethical and

23 procedural standards under chapter 11 of title

24 18, United States Code (relating to conflicts of

25 interest), as the Director of such Agency deter-
42

•S 2208 IS

1 mines is appropriate, except such memorandum

2 may not provide that the individual shall be

3 subject to the standards of section 209 of such

4 chapter.

5 ‘‘(5) FINANCIAL CONFLICTS OF INTEREST.—

6 Any individual who is an officer, employee, or mem7 ber of the Board of the Foundation may not directly

8 or indirectly participate in the consideration or de9 termination by the Foundation of any question af10 fecting—

11 ‘‘(A) any direct or indirect financial inter12 est of the individual; or

13 ‘‘(B) any direct or indirect financial inter14 est of any business organization or other entity

15 of which the individual is an officer or employee

16 or in which the individual has a direct or indi17 rect financial interest.

18 ‘‘(6) AUDITS; AVAILABILITY OF RECORDS.—The

19 Foundation shall—

20 ‘‘(A) provide for biennial audits of the fi21 nancial condition of the Foundation; and

22 ‘‘(B) make such audits, and all other

23 records, documents, and other papers of the

24 Foundation, available to the Secretary and the
43

•S 2208 IS

1 Comptroller General of the United States for

2 examination or audit.

3 ‘‘(7) REPORTS.—

4 ‘‘(A) IN GENERAL.—Not later than Feb5 ruary 1 of each fiscal year, the Foundation

6 shall publish a report describing the activities of

7 the Foundation during the preceding fiscal

8 year. Each such report shall include for the fis9 cal year involved a comprehensive statement of

10 the operations, activities, financial condition,

11 and accomplishments of the Foundation.

12 ‘‘(B) FINANCIAL REQUIREMENT.—With re13 spect to the financial condition of the Founda14 tion, each report under subparagraph (A) shall

15 include the source, and a description of, all gifts

16 to the Foundation of real or personal property,

17 and the source and amount of all gifts to the

18 Foundation of money. Each such report shall

19 include a specification of any restrictions on the

20 purposes for which gifts to the Foundation may

21 be used.

22 ‘‘(C) PUBLIC INSPECTION.—The Founda23 tion shall make copies of each report submitted

24 under subparagraph (A) available for public in25 spection, and shall upon request provide a copy
44

•S 2208 IS

1 of the report to any individual for a charge not

2 exceeding the cost of providing the copy.

3 ‘‘(8) LIAISON FROM THE AGENCY FOR

4 HEALTHCARE QUALITY.—The Director of the Agen5 cy for Healthcare Quality shall serve as the liaison

6 representative of such Agency and the Foundation.

7 ‘‘(h) FEDERAL FUNDING.—

8 ‘‘(1) AUTHORITY FOR FINANCIAL SUPPORT.—

9 ‘‘(A) IN GENERAL.—The Secretary, acting

10 through the Director of the Agency for

11 Healthcare Quality, shall—

12 ‘‘(i) for fiscal year 1999, support the

13 work of the Committee, established pursu14 ant to subsection (i); and

15 ‘‘(ii) for fiscal year 2000 and each

16 subsequent fiscal year, make a grant to the

17 Foundation.

18 ‘‘(B) LIMITATIONS.—Financial support

19 under subparagraph (A) may be expended—

20 ‘‘(i) in the case of the Committee,

21 only for the purpose of carrying out the

22 duties established in subsection (i); and

23 ‘‘(ii) in the case of the Foundation,

24 only for the purpose of the administrative

25 expenses of the Foundation.
45

•S 2208 IS

1 ‘‘(C) REMAINING FUNDS.—For the pur2 poses described in subparagraph (B), any por3 tion of the financial support provided to the

4 Committee under subparagraph (A)(i) for fiscal

5 year 1999 that remains unobligated after the

6 Committee completes the duties established in

7 subsection (i) shall be available to the Founda8 tion.

9 ‘‘(2) FUNDS.—

10 ‘‘(A) AUTHORIZATION OF APPROPRIA11 TIONS.—For the purpose of providing financial

12 support under paragraph (1), there is author13 ized to be appropriated for the Foundation

14 $500,000 for each fiscal year.

15 ‘‘(B) GRANTS.—For the purpose of grants

16 under paragraph (1), the Secretary may for

17 each fiscal year make available not more than

18 $500,000 from the amounts appropriated for

19 the fiscal year for the programs of the Depart20 ment of Health and Human Services. Such

21 amounts may be made available without regard

22 to whether amounts have been appropriated

23 under subparagraph (A).

24 ‘‘(3) CERTAIN RESTRICTION.—If the Founda25 tion receives Federal funds for the purpose of serv-
46

•S 2208 IS

1 ing as a fiscal intermediary between Federal agen2 cies, the Foundation may not receive such funds for

3 the indirect costs of carrying out such purpose in an

4 amount exceeding 10 percent of the direct costs of

5 carrying out such purpose. The preceding sentence

6 may not be construed as authorizing the expenditure

7 of any grant under paragraph (1) for such purpose.

8 ‘‘(i) ESTABLISHMENT OF COMMITTEE.—

9 ‘‘(1) IN GENERAL.—The Secretary shall estab10 lish in accordance with this subsection a committee

11 (referred to in this subsection as the ‘Committee’) to

12 carry out the functions described in paragraph (2).

13 ‘‘(2) FUNCTIONS.—The functions referred to in

14 paragraph (1) for the Committee are as follows:

15 ‘‘(A) To carry out such activities as may

16 be necessary to incorporate the Foundation

17 under the laws of the State involved, including

18 serving as incorporators for the Foundation.

19 Such activities shall include ensuring that the

20 articles of incorporation for the Foundation re21 quire that the Foundation be established and

22 operated in accordance with the applicable pro23 visions of this part (or any successor to this

24 part), including such provisions as may be in

25 effect pursuant to amendments enacted after
47

•S 2208 IS

1 the date of the enactment of the Healthcare

2 Quality Enhancement Act of 1998.

3 ‘‘(B) To ensure that the Foundation quali4 fies for and maintains the status described in

5 subsection (d)(3) (regarding taxation).

6 ‘‘(C) To establish the general policies and

7 initial bylaws of the Foundation, which bylaws

8 shall include the bylaws described in subsections

9 (d)(3) and (e)(1).

10 ‘‘(D) To provide for the initial operation of

11 the Foundation, including providing for quar12 ters, equipment, and staff.

13 ‘‘(E) To appoint the initial members of the

14 Board in accordance with the requirements es15 tablished in subsection (e)(2)(A) for the com16 position of the Board and establish their respec17 tive terms, and other such qualifications as the

18 Committee may determine to be appropriate.

19 ‘‘(3) COMPLETION OF FUNCTIONS OF COMMIT20 TEE; INITIAL MEETING OF BOARD.—

21 ‘‘(A) IN GENERAL.—The Committee shall

22 complete the functions required in paragraph

23 (1) not later than 1 year following the appoint24 ment of the last member of the Committee. The

25 Committee shall terminate upon the expiration
48

•S 2208 IS

1 of the 30-day period beginning on the date on

2 which the Secretary determines that the func3 tions have been completed.

4 ‘‘(B) INITIAL MEETING.—The initial meet5 ing of the Board shall be held not later than 90

6 days after the Committee has completed its

7 functions.

8 ‘‘(4) COMPOSITION.—The Committee shall be

9 composed of 7 members, each of whom shall be a

10 voting member. Of the members of the Committee—

11 ‘‘(A) not fewer than 2 members shall have

12 broad, general experience in healthcare; and

13 ‘‘(B) not fewer than 2 members shall have

14 broad, general experience in the creation of a

15 nonprofit private organization, one of whom

16 shall have expertise in the legal structuring of

17 nonprofit organizations (without regard to

18 whether the individuals have experience in

19 healthcare).

20 ‘‘(5) CHAIR.—The Committee shall, from

21 among the members of the Committee, designate an

22 individual to serve as the chair of the Committee.

23 ‘‘(6) TERMS; VACANCIES.—The term of mem24 bers of the Committee shall be for the duration of

25 the Committee. A vacancy in the membership of the
49

•S 2208 IS

1 Committee shall not affect the power of the Commit2 tee to carry out the duties of the Committee. If a

3 member of the Committee does not serve the full

4 term, the individual appointed to fill the resulting

5 vacancy shall be appointed for the remainder of the

6 term of the predecessor of the individual.

7 ‘‘(7) COMPENSATION.—Members of the Com8 mittee may not receive compensation for service on

9 the Committee. Members of the Committee may be

10 reimbursed for travel, subsistence, and other nec11 essary expenses incurred in carrying out the duties

12 of the Committee.

13 ‘‘(8) COMMITTEE SUPPORT.—The Director of

14 the Agency for Healthcare Quality may, from

15 amounts available to the Director for the general ad16 ministration of such Agency, provide staff and finan17 cial support to assist the Committee with carrying

18 out the functions described in paragraph (2). In pro19 viding such staff and support, the Director may both

20 detail employees and contract for assistance.

21 ‘‘SEC. 923. PEER REVIEW WITH RESPECT TO GRANTS AND

22 CONTRACTS.

23 ‘‘(a) REQUIREMENT OF REVIEW.—

24 ‘‘(1) IN GENERAL.—Appropriate technical and

25 scientific peer review shall be conducted with respect
50

•S 2208 IS

1 to each application for a grant, cooperative agree2 ment, or contract under this title.

3 ‘‘(2) REPORTS TO DIRECTOR.—Each peer re4 view group to which an application is submitted pur5 suant to paragraph (1) shall report its finding and

6 recommendations respecting the application to the

7 Director in such form and in such manner as the

8 Director shall require.

9 ‘‘(b) APPROVAL AS PRECONDITION OF AWARDS.—

10 The Director may not approve an application described in

11 subsection (a)(1) unless the application is recommended

12 for approval by a peer review group established under sub13 section (c).

14 ‘‘(c) ESTABLISHMENT OF PEER REVIEW GROUPS.—

15 ‘‘(1) IN GENERAL.—The Director shall establish

16 such technical and scientific peer review groups as

17 may be necessary to carry out this section. Such

18 groups shall be established without regard to the

19 provisions of title 5, United States Code, that govern

20 appointments in the competitive service, and without

21 regard to the provisions of chapter 51, and sub22 chapter III of chapter 53, of such title that relate

23 to classification and pay rates under the General

24 Schedule.
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•S 2208 IS

1 ‘‘(2) MEMBERSHIP.—The members of any peer

2 review group established under this section shall be

3 appointed from among individuals who by virtue of

4 their training or experience are eminently qualified

5 to carry out the duties of such peer review group.

6 Officers and employees of the United States may not

7 constitute more than 25 percent of the membership

8 of any such group. Such officers and employees may

9 not receive compensation for service on such groups

10 in addition to the compensation otherwise received

11 for duties carried out as such officers and employ12 ees.

13 ‘‘(3) DURATION.—Notwithstanding section

14 14(a) of the Federal Advisory Committee Act, peer

15 review groups established under this section shall

16 continue in existence until otherwise provided by

17 law.

18 ‘‘(4) QUALIFICATIONS.—Members of any peer19 review group shall, at a minimum, meet the follow20 ing requirements:

21 ‘‘(A) Such members shall agree in writing

22 to treat information received, records, reports,

23 and recommendations as confidential informa24 tion.
52

•S 2208 IS

1 ‘‘(B) Such members shall agree in writing

2 to recuse themselves from participation in the

3 peer-review of specific applications which

4 present a potential personal conflict of interest

5 or appearance of such conflict, including em6 ployment in the applicant organization, stock

7 ownership, or any financial or other arrange8 ment that might introduce bias in the process

9 of peer-review.

10 ‘‘(d) AUTHORITY FOR PROCEDURAL ADJUSTMENTS

11 IN CERTAIN CASES.—In the case of applications described

12 in subsection (a)(1) for financial assistance whose direct

13 costs will not exceed $100,000, the Director may make

14 appropriate adjustments in the procedures otherwise es15 tablished by the Director for the conduct of peer review

16 under this section. Such adjustments may be made for the

17 purpose of encouraging the entry of individuals into the

18 field of research, for the purpose of encouraging clinical

19 practice-oriented research, and for such other purposes as

20 the Director may determine to be appropriate.

21 ‘‘(e) REGULATIONS.—The Secretary shall issue regu22 lations for the conduct of peer review under this section.
53

•S 2208 IS

1 ‘‘SEC. 924. CERTAIN PROVISIONS WITH RESPECT TO DEVEL2 OPMENT, COLLECTION, AND DISSEMINATION

3 OF DATA.

4 ‘‘(a) STANDARDS WITH RESPECT TO UTILITY OF

5 DATA.—

6 ‘‘(1) IN GENERAL.—With respect to data devel7 oped or collected by any entity for the purpose de8 scribed in section 901(b), the Director shall, in order

9 to assure that utility, accuracy, and sufficiency of

10 such data for all interested entities, establish rec11 ommendations for methods of developing and collect12 ing such data. Such recommendations shall include

13 recommendations for the development and collection

14 of data on the outcomes of healthcare services and

15 procedures. Such recommendations shall recognize

16 the differences between types of healthcare plans,

17 delivery systems, healthcare providers, and provider

18 arrangements.

19 ‘‘(2) RELATIONSHIP WITH MEDICARE PRO20 GRAM.—In any case where recommendations under

21 paragraph (1) may affect the administration of the

22 program under title XVIII of the Social Security

23 Act, they shall be in the form of recommendations

24 to the Secretary for such program.

25 ‘‘(b) STATISTICS.—The Director shall—
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•S 2208 IS

1 ‘‘(1) take such action as may be necessary to

2 assure that statistics developed under this title are

3 of high quality, timely, and comprehensive, as well

4 as specific, standardized, and adequately analyzed

5 and indexed; and

6 ‘‘(2) publish, make available, and disseminate

7 such statistics on as wide a basis as is practicable.

8 ‘‘(c) AUTHORITY REGARDING CERTAIN REQUESTS.—

9 Upon request of a public or private entity, the Director

10 may undertake research or analyses otherwise authorized

11 by this title pursuant to arrangements under which such

12 entity will pay the cost of the services provided. Amounts

13 received by the Director under such arrangements shall

14 be available to the Director for obligation until expended.

15 ‘‘SEC. 925. DISSEMINATION OF INFORMATION.

16 ‘‘(a) IN GENERAL.—The Administrator shall—

17 ‘‘(1) without regard to section 501 of title 44,

18 United States Code, promptly publish, make avail19 able, and otherwise disseminate, in a form under20 standable and on as broad a basis as practicable so

21 as to maximize its use, the results of research, dem22 onstration projects, and evaluations conducted or

23 supported under this title;
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1 ‘‘(2) promptly make available to the public data

2 developed in such research, demonstration projects,

3 and evaluations;

4 ‘‘(3) building upon information services pro5 vided by the National Library of Medicine and con6 sidering applicable interagency agreements, provide

7 indexing, abstracting, translating, publishing, and

8 other services leading to a more effective and timely

9 dissemination of information on research, dem10 onstration projects, and evaluations with respect to

11 healthcare to public and private entities and individ12 uals engaged in the improvement of healthcare deliv13 ery and the general public, and undertake programs

14 to develop new or improved methods for making

15 such information available; and

16 ‘‘(4) as appropriate, provide technical assistance

17 to State and local government and health agencies

18 and conduct liaison activities to such agencies to fos19 ter dissemination.

20 ‘‘(b) PROHIBITION AGAINST RESTRICTIONS.—Except

21 as provided in subsection (c), the Director may not restrict

22 the publication or dissemination of data from, or the re23 sults of, projects conducted or supported under this title.

24 ‘‘(c) LIMITATION ON USE OF CERTAIN INFORMA25 TION.—No information, if an establishment or person sup-
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1 plying the information or described in it is identifiable,

2 obtained in the course of activities undertaken or sup3 ported under this title may be used for any purpose other

4 than the purpose for which it was supplied unless such

5 establishment or person has consented (as determined

6 under regulations of the Director) to its use for such other

7 purpose. Such information may not be published or re8 leased in other form if the person who supplied the infor9 mation or who is described in it is identifiable unless such

10 person has consented (as determined regulations of the

11 Director) to its publication or release in other form.

12 ‘‘(d) PENALTY.—Any person who violates subsection

13 (c) shall be subject to a civil monetary penalty of not more

14 than $10,000 for each such violation involved. Such pen15 alty shall be imposed and collected in the same manner

16 as civil money penalties under subsection (a) of section

17 1128A of the Social Security Act are imposed and col18 lected under that section.

19 ‘‘SEC. 926. ADDITIONAL PROVISIONS WITH RESPECT TO

20 GRANTS AND CONTRACTS.

21 ‘‘(a) PRIORITIES.—In establishing priorities to carry

22 out this title, subject to the availability of funds, the Di23 rector shall consider—
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1 ‘‘(1) the needs and priorities of healthcare pro2 grams that are operated by or supported, in whole

3 or in part, by Federal agencies;

4 ‘‘(2) the healthcare needs of low-income groups,

5 minority groups, children, the elderly, and persons

6 with special healthcare needs and issues related to

7 the delivery of healthcare services in rural areas (in8 cluding frontier areas).

9 ‘‘(b) FINANCIAL CONFLICTS OF INTEREST.—With

10 respect to projects for which awards of grants, cooperative

11 agreements, or contracts are authorized to be made under

12 this title, the Director shall by regulation define—

13 ‘‘(1) the specific circumstances that constitute

14 financial interests in such projects that will, or may

15 be reasonably expected to, create a bias in favor of

16 obtaining results in the projects that are consistent

17 with such interests; and

18 ‘‘(2) the actions that will be taken by the Direc19 tor in response to any such interests identified by

20 the Director.

21 ‘‘(c) REQUIREMENT OF APPLICATION.—The Director

22 may not, with respect to any program under this title au23 thorizing the provision of grants, cooperative agreements,

24 or contracts, provide any such financial assistance unless

25 an application for the assistance is submitted to the Sec-
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1 retary and the application is in such form, is made in such

2 manner, and contains such agreements, assurances, and

3 information as the Director determines to be necessary to

4 carry out the program in involved.

5 ‘‘(d) PROVISION OF SUPPLIES AND SERVICES IN

6 LIEU OF FUNDS.—

7 ‘‘(1) IN GENERAL.—Upon the request of an en8 tity receiving a grant, cooperative agreement, or con9 tract under this title, the Secretary may, subject to

10 paragraph (2), provide supplies, equipment, and

11 services for the purpose of aiding the entity in carry12 ing out the project involved and, for such purpose,

13 may detail to the entity any officer or employee of

14 the Department of Health and Human Services.

15 ‘‘(2) CORRESPONDING REDUCTION IN FUNDS.—

16 With respect to a request described in paragraph

17 (1), the Secretary shall reduce the amount of the fi18 nancial assistance involved by an amount equal to

19 the costs of detailing personnel and the fair market

20 value of any supplies, equipment, or services pro21 vided by the Director. The Secretary shall, for the

22 payment of expenses incurred in complying with

23 such request, expend the amounts withheld.

24 ‘‘(e) APPLICABILITY OF CERTAIN PROVISIONS WITH

25 RESPECT TO CONTRACTS.—Contracts may be entered into
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1 under this part without regard to sections 3648 and 3709

2 of the Revised Statutes (31 U.S.C. 529; 41 U.S.C. 5).

3 ‘‘SEC. 927. CERTAIN ADMINISTRATIVE AUTHORITIES.

4 ‘‘(a) DEPUTY DIRECTOR AND OTHER OFFICERS AND

5 EMPLOYEES.—

6 ‘‘(1) DEPUTY DIRECTOR.—The Director may

7 appoint a deputy director for the Agency.

8 ‘‘(2) OTHER OFFICERS AND EMPLOYEES.—The

9 Director may appoint and fix the compensation of

10 such officers and employees as may be necessary to

11 carry out this title. Except as otherwise provided by

12 law, such officers and employees shall be appointed

13 in accordance with the civil service laws and their

14 compensation fixed in accordance with title 5,

15 United States Code.

16 ‘‘(b) FACILITIES.—The Secretary, in carrying out

17 this title—

18 ‘‘(1) may acquire, without regard to the Act of

19 March 3, 1877 (40 U.S.C. 34), by lease or otherwise

20 through the Director of General Services, buildings

21 or portions of buildings in the District of Columbia

22 or communities located adjacent to the District of

23 Columbia for use for a period not to exceed 10

24 years; and
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1 ‘‘(2) may acquire, construct, improve, repair,

2 operate, and maintain laboratory, research, and

3 other necessary facilities and equipment, and such

4 other real or personal property (including patents)

5 as the Secretary deems necessary.

6 ‘‘(c) PROVISION OF FINANCIAL ASSISTANCE.—The

7 Director, in carrying out this title, may make grants to

8 public and nonprofit entities and individuals, and may

9 enter into cooperative agreements or contracts with public

10 and private entities and individuals.

11 ‘‘(d) UTILIZATION OF CERTAIN PERSONNEL AND RE12 SOURCES.—

13 ‘‘(1) DEPARTMENT OF HEALTH AND HUMAN

14 SERVICES.—The Director, in carrying out this title,

15 may utilize personnel and equipment, facilities, and

16 other physical resources of the Department of

17 Health and Human Services, permit appropriate (as

18 determined by the Secretary) entities and individuals

19 to utilize the physical resources of such Department,

20 and provide technical assistance and advice.

21 ‘‘(2) OTHER AGENCIES.—The Director, in car22 rying out this title, may use, with their consent, the

23 services, equipment, personnel, information, and fa24 cilities of other Federal, State, or local public agen-
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1 cies, or of any foreign government, with or without

2 reimbursement of such agencies.

3 ‘‘(e) CONSULTANTS.—The Secretary, in carrying out

4 this title, may secure, from time to time and for such peri5 ods as the Director deems advisable but in accordance

6 with section 3109 of title 5, United States Code, the as7 sistance and advice of consultants from the United States

8 or abroad.

9 ‘‘(f) EXPERTS.—

10 ‘‘(1) IN GENERAL.—The Secretary may, in car11 rying out this title, obtain the services of not more

12 than 50 experts or consultants who have appropriate

13 scientific or professional qualifications. Such experts

14 or consultants shall be obtained in accordance with

15 section 3109 of title 5, United States Code, except

16 that the limitation in such section on the duration

17 of service shall not apply.

18 ‘‘(2) TRAVEL EXPENSES.—

19 ‘‘(A) IN GENERAL.—Experts and consult20 ants whose services are obtained under para21 graph (1) shall be paid or reimbursed for their

22 expenses associated with traveling to and from

23 their assignment location in accordance with

24 sections 5724, 5724a(a), 5724a(c), and

25 5726(C) of title 5, United States Code.
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1 ‘‘(B) LIMITATION.—Expenses specified in

2 subparagraph (A) may not be allowed in con3 nection with the assignment of an expert or

4 consultant whose services are obtained under

5 paragraph (1) unless and until the expert

6 agrees in writing to complete the entire period

7 of assignment, or 1 year, whichever is shorter,

8 unless separated or reassigned for reasons that

9 are beyond the control of the expert or consult10 ant and that are acceptable to the Secretary. If

11 the expert or consultant violates the agreement,

12 the money spent by the United States for the

13 expenses specified in subparagraph (A) is recov14 erable from the expert or consultant as a debt

15 of the United States. The Secretary may waive

16 in whole or in part a right of recovery under

17 this subparagraph.

18 ‘‘(g) VOLUNTARY AND UNCOMPENSATED SERV19 ICES.—The Director, in carrying out this title, may accept

20 voluntary and uncompensated services.

21 ‘‘SEC. 928. FUNDING.

22 ‘‘(a) INTENT.—To ensure that the United States’s in23 vestment in biomedical research is rapidly translated into

24 improvements in the quality of patient care, there must

25 be a corresponding investment in research on the most ef-
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1 fective clinical and organizational strategies for use of

2 these findings in daily practice. The authorization levels

3 in subsections (b) and (c) provide for a proportionate in4 crease in healthcare research as the United State’s invest5 ment in biomedical research increases.

6 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the

7 purpose of carrying out this title, there are authorized to

8 be appropriated $180,000,000 for fiscal year 1999, and

9 such sums as may be necessary for each of the fiscal years

10 2000 through 2003.

11 ‘‘(c) EVALUATIONS.—In addition to amounts avail12 able pursuant to subsection (b) for carrying out this title,

13 there shall be made available for such purpose, from the

14 amounts made available pursuant to section 241 (relating

15 to evaluations), an amount equal to 40 percent of the max16 imum amount authorized in such section 241 to be made

17 available for a fiscal year.

18 ‘‘(d) CENTERS FOR EDUCATION AND RESEARCH ON

19 THERAPEUTICS.—For the purpose of carrying out the

20 demonstration program regarding centers for education

21 and research on therapeutics under section 912(b), there

22 are authorized to be appropriated $2,000,000 for fiscal

23 year 1998, and $3,000,000 for fiscal year 1999, and such

24 sums as may be necessary for each of the fiscal years 2000

25 through 2003.
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1 ‘‘SEC. 929. DEFINITIONS.

2 ‘‘In this title:

3 ‘‘(1) ADVISORY COUNCIL.—The term ‘Advisory

4 Council’ means the Advisory Council on Healthcare

5 Quality established under section 921.

6 ‘‘(2) AGENCY.—The term ‘Agency’ means the

7 Agency for Healthcare Quality.

8 ‘‘(3) DIRECTOR.—The term ‘Director’ means

9 the Director for the Agency for Healthcare Qual10 ity.’’.

11 SEC. 4. REFERENCES.

12 Effective upon the date of enactment of this Act, any

13 reference in law to the ‘‘Agency for Health Care Policy

14 and Research’’ shall be deemed to be a reference to the

15 ‘‘Agency for Healthcare Quality’’.

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