II

106TH CONGRESS

1ST SESSION S. 580

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

MARCH 10, 1999

Mr. FRIST (for himself, Mr. JEFFORDS, Mr. KENNEDY, Mr. NICKLES, Ms.

COLLINS, Mr. BREAUX, Mr. INOUYE, Mr. MACK, Mr. HAGEL, Mr.

SANTORUM, Ms. MIKULSKI, and Mr. BINGAMAN) introduced the following

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

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 Research

5 and Quality Act of 1999’’.
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1 SEC. 2. 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 RESEARCH

7 AND QUALITY

8 ‘‘PART A—ESTABLISHMENT AND GENERAL

9 DUTIES

10 ‘‘SEC. 901. MISSION AND DUTIES.

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

12 Public Health Service an agency to be known as the Agen13 cy for Healthcare Research and Quality. In carrying out

14 this subsection, the Secretary shall redesignate the Agency

15 for Health Care Policy and Research as the Agency for

16 Healthcare Research and Quality.

17 ‘‘(b) MISSION.—The purpose of the Agency is to en18 hance the quality, appropriateness, and effectiveness of

19 healthcare services, and access to such services, through

20 the establishment of a broad base of scientific research

21 and through the promotion of improvements in clinical

22 and health system practices, including the prevention of

23 diseases and other health conditions. The Agency shall

24 promote healthcare quality improvement by—
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1 ‘‘(1) conducting and supporting research that

2 develops and presents scientific evidence regarding

3 all aspects of Healthcare, including—

4 ‘‘(A) the development and assessment of

5 methods for enhancing patient participation in

6 their own care and for facilitating shared pa7 tient-physician decision-making;

8 ‘‘(B) the outcomes, effectiveness, and cost9 effectiveness of healthcare practices, including

10 preventive measures and long-term care;

11 ‘‘(C) existing and innovative technologies;

12 ‘‘(D) the costs and utilization of, and ac13 cess to healthcare;

14 ‘‘(E) the ways in which healthcare services

15 are organized, delivered, and financed and the

16 interaction and impact of these factors on the

17 quality of patient care;

18 ‘‘(F) methods for measuring quality and

19 strategies for improving quality; and

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

21 purchasers, and practitioners acquire new infor22 mation about best practices and health benefits,

23 the determinants and impact of their use of this

24 information;
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1 ‘‘(2) synthesizing and disseminating available

2 scientific evidence for use by patients, consumers,

3 practitioners, providers, purchasers, policy makers,

4 and educators; and

5 ‘‘(3) advancing private and public efforts to im6 prove healthcare quality.

7 ‘‘(c) REQUIREMENTS WITH RESPECT TO RURAL

8 AREAS AND PRIORITY POPULATIONS.—In carrying out

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

10 research, demonstration projects, and evaluations with re11 spect to—

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

13 areas (including frontier areas);

14 ‘‘(2) health services for low-income groups, and

15 minority groups;

16 ‘‘(3) the health of children;

17 ‘‘(4) the elderly; and

18 ‘‘(5) people with special healthcare needs, in19 cluding disabilities, chronic care and end-of-life

20 healthcare.

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

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

23 Director for Healthcare Research and Quality. The Direc24 tor shall be appointed by the Secretary. The Secretary,
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1 acting through the Director, shall carry out the authorities

2 and duties established in this title.

3 ‘‘SEC. 902. GENERAL AUTHORITIES.

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

5 the Director shall support demonstration projects, conduct

6 and support research, evaluations, training, research net7 works, multi-disciplinary centers, technical assistance, and

8 the dissemination of information, on healthcare, and on

9 systems for the delivery of such care, including activities

10 with respect to—

11 ‘‘(1) the quality, effectiveness, efficiency, appro12 priateness and value of healthcare services;

13 ‘‘(2) quality measurement and improvement;

14 ‘‘(3) the outcomes, cost, cost-effectiveness, and

15 use of healthcare services and access to such serv16 ices;

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

18 and practice-oriented research;

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

20 equipment;

21 ‘‘(6) healthcare costs, productivity, organiza22 tion, and market forces;

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

24 including clinical preventive services;
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1 ‘‘(8) health statistics, surveys, database devel2 opment, and epidemiology; and

3 ‘‘(9) medical liability.

4 ‘‘(b) HEALTH SERVICES TRAINING GRANTS.—

5 ‘‘(1) IN GENERAL.—The Director may provide

6 training grants in the field of health services re7 search related to activities authorized under sub8 section (a), to include pre- and post-doctoral fellow9 ships and training programs, young investigator

10 awards, and other programs and activities as appro11 priate. In carrying out this subsection, the Director

12 shall make use of funds made available under sec13 tion 487.

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

15 for the allocation of training funds under this sub16 section, the Director shall take into consideration

17 shortages in the number of trained researchers ad18 dressing the priority populations.

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

20 may provide financial assistance to assist in meeting the

21 costs of planning and establishing new centers, and oper22 ating existing and new centers, for multidisciplinary

23 health services research, demonstration projects, evalua24 tions, training, and policy analysis with respect to the mat25 ters referred to in subsection (a).
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1 ‘‘(d) RELATION TO CERTAIN AUTHORITIES REGARD2 ING SOCIAL SECURITY.—Activities authorized in this sec3 tion shall be appropriately coordinated with experiments,

4 demonstration projects, and other related activities au5 thorized by the Social Security Act and the Social Security

6 Amendments of 1967. Activities under subsection (a)(2)

7 of this section that affect the programs under titles XVIII,

8 XIX and XXI of the Social Security Act shall be carried

9 out consistent with section 1142 of such Act.

10 ‘‘(e) DISCLAIMER.—The Agency shall not mandate

11 national standards of clinical practice or quality

12 healthcare standards. Recommendations resulting from

13 projects funded and published by the Agency shall include

14 a corresponding disclaimer.

15 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec16 tion shall be construed to imply that the Agency’s role is

17 to mandate a national standard or specific approach to

18 quality measurement and reporting. In research and qual19 ity improvement activities, the Agency shall consider a

20 wide range of choices, providers, healthcare delivery sys21 tems, and individual preferences.
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1 ‘‘PART B—HEALTHCARE IMPROVEMENT

2 RESEARCH

3 ‘‘SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RE4 SEARCH.

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

6 with experts from the public and private sector, the Agen7 cy shall identify and disseminate methods or systems that

8 it uses to assess healthcare research results, particularly

9 methods or systems that it uses to rate the strength of

10 the scientific evidence behind healthcare practice, rec11 ommendations in the research literature, and technology

12 assessments. The Agency shall make methods or systems

13 for evidence rating widely available. Agency publications

14 containing healthcare recommendations shall indicate the

15 level of substantiating evidence using such methods or sys16 tems.

17 ‘‘(b) HEALTHCARE IMPROVEMENT RESEARCH CEN18 TERS AND PROVIDER-BASED RESEARCH NETWORKS.—

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

20 continuum of care and outcomes research, to link re21 search to practice improvement, and to speed the

22 dissemination of research findings to community

23 practice settings, the Agency shall employ research

24 strategies and mechanisms that will link research di25 rectly with clinical practice in geographically diverse

26 locations throughout the United States, including—
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1 ‘‘(A) Healthcare Improvement Research

2 Centers that combine demonstrated multidisci3 plinary expertise in outcomes or quality im4 provement research with linkages to relevant

5 sites of care;

6 ‘‘(B) Provider-based Research Networks,

7 including plan, facility, or delivery system sites

8 of care (especially primary care), that can

9 evaluate and promote quality improvement; and

10 ‘‘(C) other innovative mechanisms or strat11 egies to link research with clinical practice.

12 ‘‘(2) REQUIREMENTS.—The Director is author13 ized to establish the requirements for entities apply14 ing for grants under this subsection.

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

16 ORGANIZATION AND DELIVERY.

17 ‘‘(a) SUPPORT FOR EFFORTS TO DEVELOP INFOR18 MATION ON QUALITY.—

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

20 In its role as the principal agency for healthcare re21 search and quality, the Agency may provide sci22 entific and technical support for private and public

23 efforts to improve healthcare quality, including the

24 activities of accrediting organizations.
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1 ‘‘(2) ROLE OF THE AGENCY.—With respect to

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

3 ‘‘(A) the identification and assessment of

4 methods for the evaluation of the health of—

5 ‘‘(i) enrollees in health plans by type

6 of plan, provider, and provider arrange7 ments; and

8 ‘‘(ii) other populations, including

9 those receiving long-term care services;

10 ‘‘(B) the ongoing development, testing, and

11 dissemination of quality measures, including

12 measures of health and functional outcomes;

13 ‘‘(C) the compilation and dissemination of

14 healthcare quality measures developed in the

15 private and public sector;

16 ‘‘(D) assistance in the development of im17 proved healthcare information systems;

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

19 the purpose of measuring participant and bene20 ficiary assessments of their healthcare; and

21 ‘‘(F) identifying and disseminating infor22 mation on mechanisms for the integration of in23 formation on quality into purchaser and con24 sumer decision-making processes.
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1 ‘‘(b) CENTERS FOR EDUCATION AND RESEARCH ON

2 THERAPEUTICS.—

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

4 through the Director and in consultation with the

5 Commissioner of Food and Drugs, shall establish a

6 program for the purpose of making one or more

7 grants for the establishment and operation of one or

8 more centers to carry out the activities specified in

9 paragraph (2).

10 ‘‘(2) REQUIRED ACTIVITIES.—The activities re11 ferred to in this paragraph are the following:

12 ‘‘(A) The conduct of state-of-the-art clini13 cal research for the following purposes:

14 ‘‘(i) To increase awareness of—

15 ‘‘(I) new uses of drugs, biological

16 products, and devices;

17 ‘‘(II) ways to improve the effec18 tive use of drugs, biological products,

19 and devices; and

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

21 of combinations of drugs and biologi22 cal products.

23 ‘‘(ii) To provide objective clinical in24 formation to the following individuals and

25 entities:
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1 ‘‘(I) Healthcare practitioners and

2 other providers of healthcare goods or

3 services.

4 ‘‘(II) Pharmacists, pharmacy

5 benefit managers and purchasers.

6 ‘‘(III) Health maintenance orga7 nizations and other managed

8 healthcare organizations.

9 ‘‘(IV) Healthcare insurers and

10 governmental agencies.

11 ‘‘(V) Patients and consumers.

12 ‘‘(iii) To improve the quality of

13 healthcare while reducing the cost of

14 Healthcare through—

15 ‘‘(I) an increase in the appro16 priate use of drugs, biological prod17 ucts, or devices; and

18 ‘‘(II) the prevention of adverse

19 effects of drugs, biological products,

20 and devices and the consequences of

21 such effects, such as unnecessary hos22 pitalizations.

23 ‘‘(B) The conduct of research on the com24 parative effectiveness, cost-effectiveness, and

25 safety of drugs, biological products, and devices.
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1 ‘‘(C) Such other activities as the Secretary

2 determines to be appropriate, except that a

3 grant may not be expended to assist the Sec4 retary in the review of new drugs.

5 ‘‘(c) REDUCING ERRORS IN MEDICINE.—The Direc6 tor shall conduct and support research and build private7 public partnerships to—

8 ‘‘(1) identify the causes of preventable

9 healthcare errors and patient injury in healthcare

10 delivery;

11 ‘‘(2) develop, demonstrate, and evaluate strate12 gies for reducing errors and improving patient safe13 ty; and

14 ‘‘(3) promote the implementation of effective

15 strategies throughout the healthcare industry.

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

17 ‘‘(a) IN GENERAL.—In carrying out 902(a), the

18 Director shall—

19 ‘‘(1) conduct a survey to collect data on a

20 nationally representative sample of the population on

21 the cost, use and, for fiscal year 2001 and subse22 quent fiscal years, quality of healthcare, including

23 the types of healthcare services Americans use, their

24 access to healthcare services, frequency of use, how

25 much is paid for the services used, the source of
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1 those payments, the types and costs of private

2 health insurance, access, satisfaction, and quality of

3 care for the general population and also for popu4 lations identified in section 901(c); and

5 ‘‘(2) develop databases and tools that provide

6 information to States on the quality, access, and use

7 of healthcare services provided to their residents.

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

9 ‘‘(1) IN GENERAL.—Beginning in fiscal year

10 2001, the Director shall ensure that the survey con11 ducted under subsection (a)(1) will—

12 ‘‘(A) identify determinants of health out13 comes and functional status, the needs of spe14 cial populations in such variables as well as an

15 understanding of changes over time, relation16 ships to healthcare access and use, and monitor

17 the overall national impact of Federal and State

18 policy changes on healthcare;

19 ‘‘(B) provide information on the quality of

20 care and patient outcomes for frequently occur21 ring clinical conditions for a nationally rep22 resentative sample of the population; and

23 ‘‘(C) provide reliable national estimates for

24 children and persons with special healthcare
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1 needs through the use of supplements or peri2 odic expansions of the survey.

3 In expanding the Medical Expenditure Panel Survey,

4 as in existence on the date of enactment of this title)

5 in fiscal year 2001 to collect information on the

6 quality of care, the Director shall take into account

7 any outcomes measurements generally collected by

8 private sector accreditation organizations.

9 ‘‘(2) ANNUAL REPORT.—Beginning in fiscal

10 year 2003, the Secretary, acting through the Direc11 tor, shall submit to Congress an annual report on

12 national trends in the quality of healthcare provided

13 to the American people.

14 ‘‘SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE IM15 PROVEMENT.

16 ‘‘(a) IN GENERAL.—In order to foster a range of in17 novative approaches to the management and communica18 tion of health information, the Agency shall support re19 search, evaluations and initiatives to advance—

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

21 study of healthcare quality, including the generation

22 of both individual provider and plan-level compara23 tive performance data;

24 ‘‘(2) training for healthcare practitioners and

25 researchers in the use of information systems;
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1 ‘‘(3) the creation of effective linkages between

2 various sources of health information, including the

3 development of information networks;

4 ‘‘(4) the delivery and coordination of evidence5 based healthcare services, including the use of real6 time healthcare decision-support programs;

7 ‘‘(5) the structure, content, definition, and cod8 ing of health information data and medical vocabu9 laries in consultation with appropriate Federal enti10 ties and shall seek input from appropriate private

11 entities;

12 ‘‘(6) the use of computer-based health records

13 in outpatient and inpatient settings as a personal

14 health record for individual health assessment and

15 maintenance, and for monitoring public health and

16 outcomes of care within populations; and

17 ‘‘(7) the protection of individually identifiable

18 information in health services research and

19 healthcare quality improvement.

20 ‘‘(b) DEMONSTRATION.—The Agency shall support

21 demonstrations into the use of new information tools

22 aimed at improving shared decision-making between pa23 tients and their care-givers.
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1 ‘‘SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND

2 ACCESS IN UNDERSERVED AREAS.

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

4 ‘‘(1) PURPOSE.—The Agency shall provide on5 going administrative, research, and technical support

6 for the operation of the Preventive Services Task

7 Force. The Agency shall coordinate and support the

8 dissemination of the Preventive Services Task Force

9 recommendations.

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

11 Task Force shall review the scientific evidence relat12 ed to the effectiveness, appropriateness, and cost-ef13 fectiveness of clinical preventive services for the pur14 pose of developing recommendations for the

15 healthcare community, and updating previous rec16 ommendations, regarding their usefulness in daily

17 clinical practice. In carrying out its responsibilities

18 under paragraph (1), the Task Force shall not be

19 subject to the provisions of Appendix 2 of title 5,

20 United States Code.

21 ‘‘(b) PRIMARY CARE RESEARCH.—

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

23 the Agency a Center for Primary Care Research (re24 ferred to in this subsection as the ‘Center’) that

25 shall serve as the principal source of funding for pri26 mary care practice research in the Department of
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1 Health and Human Services. For purposes of this

2 paragraph, primary care research focuses on the

3 first contact when illness or health concerns arise,

4 the diagnosis, treatment or referral to specialty care,

5 preventive care, and the relationship between the cli6 nician and the patient in the context of the family

7 and community.

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

9 the Center shall conduct and support research

10 concerning—

11 ‘‘(A) the nature and characteristics of pri12 mary care practice;

13 ‘‘(B) the management of commonly occur14 ring clinical problems;

15 ‘‘(C) the management of undifferentiated

16 clinical problems; and

17 ‘‘(D) the continuity and coordination of

18 health services.

19 ‘‘SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVA20 TION.

21 ‘‘(a) IN GENERAL.—The Director shall promote inno22 vation in evidence-based clinical practice and healthcare

23 technologies by—
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1 ‘‘(1) conducting and supporting research on the

2 development, diffusion, and use of healthcare tech3 nology;

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

5 methodologies for assessments of healthcare prac6 tices and healthcare technologies;

7 ‘‘(3) conducting intramural and supporting ex8 tramural assessments of existing and new healthcare

9 practices and technologies;

10 ‘‘(4) promoting education, training, and provid11 ing technical assistance in the use of healthcare

12 practice and healthcare technology assessment meth13 odologies and results; and

14 ‘‘(5) working with the National Library of Med15 icine and the public and private sector to develop an

16 electronic clearinghouse of currently available assess17 ments and those in progress.

18 ‘‘(b) SPECIFICATION OF PROCESS.—

19 ‘‘(1) IN GENERAL.—Not later than December

20 31, 2000, the Director shall develop and publish a

21 description of the methods used by the Agency and

22 its contractors for practice and technology assess23 ment.

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

25 subsection, the Director shall cooperate and consult
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1 with the Assistant Secretary for Health, the Admin2 istrator of the Health Care Financing Administra3 tion, the Director of the National Institutes of

4 Health, the Commissioner of Food and Drugs, and

5 the heads of any other interested Federal depart6 ment or agency, and shall seek input, where appro7 priate, from professional societies and other private

8 and public entities.

9 ‘‘(3) METHODOLOGY.—The Director shall, in

10 developing the methods used under paragraph (1),

11 consider—

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

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

14 ‘‘(C) costs, benefits, and cost-effectiveness;

15 ‘‘(D) comparisons to alternate technologies

16 and practices; and

17 ‘‘(E) requirements of Food and Drug Ad18 ministration approval to avoid duplication.

19 ‘‘(c) SPECIFIC ASSESSMENTS.—

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

21 or support specific assessments of healthcare tech22 nologies and practices.

23 ‘‘(2) REQUESTS FOR ASSESSMENTS.—The Di24 rector is authorized to conduct or support assess25 ments, on a reimbursable basis, for the Health Care
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1 Financing Administration, the Department of De2 fense, the Department of Veterans Affairs, the Of3 fice of Personnel Management, and other public or

4 private entities.

5 ‘‘(3) GRANTS AND CONTRACTS.—In addition to

6 conducting assessments, the Director may make

7 grants to, or enter into cooperative agreements or

8 contracts with, entities described in paragraph (4)

9 for the purpose of conducting assessments of experi10 mental, emerging, existing, or potentially outmoded

11 healthcare technologies, and for related activities.

12 ‘‘(4) ELIGIBLE ENTITIES.—An entity described

13 in this paragraph is an entity that is determined to

14 be appropriate by the Director, including academic

15 medical centers, research institutions and organiza16 tions, professional organizations, third party payers,

17 governmental agencies, and consortia of appropriate

18 research entities established for the purpose of con19 ducting technology assessments.

20 ‘‘SEC. 917. COORDINATION OF FEDERAL GOVERNMENT

21 QUALITY IMPROVEMENT EFFORTS.

22 ‘‘(a) REQUIREMENT.—

23 ‘‘(1) IN GENERAL.—To avoid duplication and

24 ensure that Federal resources are used efficiently

25 and effectively, the Secretary, acting through the Di-
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1 rector, shall coordinate all research, evaluations, and

2 demonstrations related to health services research,

3 quality measurement and quality improvement ac4 tivities undertaken and supported by the Federal

5 Government.

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

7 collaboration with the appropriate Federal officials

8 representing all concerned executive agencies and de9 partments, shall develop and manage a process to—

10 ‘‘(A) improve interagency coordination, pri11 ority setting, and the use and sharing of re12 search findings and data pertaining to Federal

13 quality improvement programs, technology as14 sessment, and health services research;

15 ‘‘(B) strengthen the research information

16 infrastructure, including databases, pertaining

17 to Federal health services research and

18 healthcare quality improvement initiatives;

19 ‘‘(C) set specific goals for participating

20 agencies and departments to further health

21 services research and healthcare quality im22 provement; and

23 ‘‘(D) strengthen the management of Fed24 eral healthcare quality improvement programs.

25 ‘‘(b) STUDY BY THE INSTITUTE OF MEDICINE.—
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1 ‘‘(1) IN GENERAL.—To provide Congress, the

2 Department of Health and Human Services, and

3 other relevant departments with an independent, ex4 ternal review of their quality oversight, quality im5 provement and quality research programs, the Sec6 retary shall enter into a contract with the Institute

7 of Medicine—

8 ‘‘(A) to describe and evaluate current qual9 ity improvement, quality research and quality

10 monitoring processes through—

11 ‘‘(i) an overview of pertinent health

12 services research activities and quality im13 provement efforts conducted by all Federal

14 programs, with particular attention paid to

15 those under titles XVIII, XIX, and XXI of

16 the Social Security Act; and

17 ‘‘(ii) a summary of the partnerships

18 that the Department of Health and

19 Human Services has pursued with private

20 accreditation, quality measurement and

21 improvement organizations; and

22 ‘‘(B) to identify options and make rec23 ommendations to improve the efficiency and ef24 fectiveness of quality improvement programs

25 through—
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1 ‘‘(i) the improved coordination of ac2 tivities across the medicare, medicaid and

3 child health insurance programs under ti4 tles XVIII, XIX and XXI of the Social Se5 curity Act and health services research

6 programs;

7 ‘‘(ii) the strengthening of patient

8 choice and participation by incorporating

9 state-of-the-art quality monitoring tools

10 and making information on quality avail11 able; and

12 ‘‘(iii) the enhancement of the most ef13 fective programs, consolidation as appro14 priate, and elimination of duplicative ac15 tivities within various federal agencies.

16 ‘‘(2) REQUIREMENTS.—

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

18 enter into a contract with the Institute of Medi19 cine for the preparation—

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

21 the date of enactment of this title, of a re22 port providing an overview of the quality

23 improvement programs of the Department

24 of Health and Human Services for the

25 medicare, medicaid, and CHIP programs
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1 under titles XVIII, XIX, and XXI of the

2 Social Security Act; and

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

4 the date of enactment of this title, of a

5 final report containing recommendations.

6 ‘‘(B) REPORTS.—The Secretary shall sub7 mit the reports described in subparagraph (A)

8 to the Committee on Finance and the Commit9 tee on Health, Education, Labor, and Pensions

10 of the Senate and the Committee on Ways and

11 Means and the Committee on Commerce of the

12 House of Representatives.

13 ‘‘PART C—GENERAL PROVISIONS

14 ‘‘SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RE15 SEARCH AND QUALITY.

16 ‘‘(a) ESTABLISHMENT.—There is established an advi17 sory council to be known as the Advisory Council for

18 Healthcare Research and Quality.

19 ‘‘(b) DUTIES.—

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

21 advise the Secretary and the Director with respect

22 to activities proposed or undertaken to carry out the

23 purpose of the Agency under section 901(b).

24 ‘‘(2) CERTAIN RECOMMENDATIONS.—Activities

25 of the Advisory Council under paragraph (1) shall
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1 include making recommendations to the Director

2 regarding—

3 ‘‘(A) priorities regarding healthcare re4 search, especially studies related to quality, out5 comes, cost and the utilization of, and access

6 to, healthcare services;

7 ‘‘(B) the field of healthcare research and

8 related disciplines, especially issues related to

9 training needs, and dissemination of informa10 tion pertaining to healthcare quality; and

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

12 each of these areas in light of private sector ac13 tivity and identification of opportunities for

14 public-private sector partnerships.

15 ‘‘(c) MEMBERSHIP.—

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

17 in accordance with this subsection, be composed of

18 appointed members and ex officio members. All

19 members of the Advisory Council shall be voting

20 members other than the individuals designated

21 under paragraph (3)(B) as ex officio members.

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

23 shall appoint to the Advisory Council 21 appro24 priately qualified individuals. At least 17 members of

25 the Advisory Council shall be representatives of the
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1 public who are not officers or employees of the

2 United States. The Secretary shall ensure that the

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

4 representative of professions and entities concerned

5 with, or affected by, activities under this title and

6 under section 1142 of the Social Security Act. Of

7 such members—

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

9 the conduct of research, demonstration projects,

10 and evaluations with respect to healthcare;

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

12 the practice of medicine of which at least 1

13 shall be a primary care practitioner;

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

15 the other health professions;

16 ‘‘(D) 4 shall be individuals either rep17 resenting the private healthcare sector, includ18 ing health plans, providers, and purchasers or

19 individuals distinguished as administrators of

20 healthcare delivery systems;

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

22 the fields of healthcare quality improvement, ec23 onomics, information systems, law, ethics, busi24 ness, or public policy; and
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1 ‘‘(F) 2 shall be individuals representing the

2 interests of patients and consumers of

3 healthcare.

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

5 shall designate as ex officio members of the Advisory

6 Council—

7 ‘‘(A) the Assistant Secretary for Health,

8 the Director of the National Institutes of

9 Health, the Director of the Centers for Disease

10 Control and Prevention, the Administrator of

11 the Health Care Financing Administration, the

12 Assistant Secretary of Defense (Health Af13 fairs), and the Under Secretary for Health of

14 the Department of Veterans Affairs; and

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

16 Secretary may consider appropriate.

17 ‘‘(d) TERMS.—Members of the Advisory Council ap18 pointed under subsection (c)(2) shall serve for a term of

19 3 years. A member of the Council appointed under such

20 subsection may continue to serve after the expiration of

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

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

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

24 the full term applicable under subsection (d), the individ25 ual appointed to fill the resulting vacancy shall be ap-
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1 pointed for the remainder of the term of the predecessor

2 of the individual.

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

4 members of the Advisory Council appointed under sub5 section (c)(2), designate an individual to serve as the chair

6 of the Advisory Council.

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

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

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

10 chair.

11 ‘‘(h) COMPENSATION AND REIMBURSEMENT OF

12 EXPENSES.—

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

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

15 shall receive compensation for each day (including

16 travel time) engaged in carrying out the duties of

17 the Advisory Council unless declined by the member.

18 Such compensation may not be in an amount in ex19 cess of the maximum rate of basic pay payable for

20 GS–18 of the General Schedule.

21 ‘‘(2) EX OFFICIO MEMBERS.—Officials des22 ignated under subsection (c)(3) as ex officio mem23 bers of the Advisory Council may not receive com24 pensation for service on the Advisory Council in ad-
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1 dition to the compensation otherwise received for du2 ties carried out as officers of the United States.

3 ‘‘(i) STAFF.—The Director shall provide to the Advi4 sory Council such staff, information, and other assistance

5 as may be necessary to carry out the duties of the Council.

6 ‘‘SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND

7 CONTRACTS.

8 ‘‘(a) REQUIREMENT OF REVIEW.—

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

10 scientific peer review shall be conducted with respect

11 to each application for a grant, cooperative agree12 ment, or contract under this title.

13 ‘‘(2) REPORTS TO DIRECTOR.—Each peer re14 view group to which an application is submitted pur15 suant to paragraph (1) shall report its finding and

16 recommendations respecting the application to the

17 Director in such form and in such manner as the

18 Director shall require.

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

20 The Director may not approve an application described in

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

22 for approval by a peer review group established under sub23 section (c).

24 ‘‘(c) ESTABLISHMENT OF PEER REVIEW GROUPS.—
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1 ‘‘(1) IN GENERAL.—The Director shall establish

2 such technical and scientific peer review groups as

3 may be necessary to carry out this section. Such

4 groups shall be established without regard to the

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

6 appointments in the competitive service, and without

7 regard to the provisions of chapter 51, and sub8 chapter III of chapter 53, of such title that relate

9 to classification and pay rates under the General

10 Schedule.

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

12 review group established under this section shall be

13 appointed from among individuals who by virtue of

14 their training or experience are eminently qualified

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

16 Officers and employees of the United States may not

17 constitute more than 25 percent of the membership

18 of any such group. Such officers and employees may

19 not receive compensation for service on such groups

20 in addition to the compensation otherwise received

21 for these duties carried out as such officers and em22 ployees.

23 ‘‘(3) DURATION.—Notwithstanding section

24 14(a) of the Federal Advisory Committee Act, peer

25 review groups established under this section may
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1 continue in existence until otherwise provided by

2 law.

3 ‘‘(4) QUALIFICATIONS.—Members of any peer4 review group shall, at a minimum, meet the follow5 ing requirements:

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

7 to treat information received, pursuant to their

8 work for the group, as confidential information,

9 except that this subparagraph shall not apply to

10 public records and public information.

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

12 to recuse themselves from participation in the

13 peer-review of specific applications which

14 present a potential personal conflict of interest

15 or appearance of such conflict, including em16 ployment in a directly affected organization,

17 stock ownership, or any financial or other ar18 rangement that might introduce bias in the

19 process of peer-review.

20 ‘‘(d) AUTHORITY FOR PROCEDURAL ADJUSTMENTS

21 IN CERTAIN CASES.—In the case of applications for finan22 cial assistance whose direct costs will not exceed $100,000,

23 the Director may make appropriate adjustments in the

24 procedures otherwise established by the Director for the

25 conduct of peer review under this section. Such adjust-
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1 ments may be made for the purpose of encouraging the

2 entry of individuals into the field of research, for the pur3 pose of encouraging clinical practice-oriented or provider4 based research, and for such other purposes as the Direc5 tor may determine to be appropriate.

6 ‘‘(e) REGULATIONS.—The Director shall issue regula7 tions for the conduct of peer review under this section.

8 ‘‘SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVEL9 OPMENT, COLLECTION, AND DISSEMINATION

10 OF DATA.

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

12 DATA.—

13 ‘‘(1) IN GENERAL.—To ensure the utility, accu14 racy, and sufficiency of data collected by or for the

15 Agency for the purpose described in section 901(b),

16 the Director shall establish standard methods for de17 veloping and collecting such data, taking into

18 consideration—

19 ‘‘(A) other Federal health data collection

20 standards; and

21 ‘‘(B) the differences between types of

22 healthcare plans, delivery systems, healthcare

23 providers, and provider arrangements.

24 ‘‘(2) RELATIONSHIP WITH OTHER DEPARTMENT

25 PROGRAMS.—In any case where standards under
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1 paragraph (1) may affect the administration of other

2 programs carried out by the Department of Health

3 and Human Services, including the programs under

4 title XVIII, XIX or XXI of the Social Security Act,

5 or may affect health information that is subject to

6 a standard developed under part C of title XI of the

7 Social Security Act, they shall be in the form of rec8 ommendations to the Secretary for such program.

9 ‘‘(b) STATISTICS AND ANALYSES.—The Director

10 shall—

11 ‘‘(1) take appropriate action to ensure that sta12 tistics and analyses developed under this title are of

13 high quality, timely, and duly comprehensive, and

14 that the statistics are specific, standardized, and

15 adequately analyzed and indexed; and

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

17 such statistics and analyses on as wide a basis as is

18 practicable.

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

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

21 may conduct or support research or analyses otherwise au22 thorized by this title pursuant to arrangements under

23 which such entity will pay the cost of the services provided.

24 Amounts received by the Director under such arrange-
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1 ments shall be available to the Director for obligation until

2 expended.

3 ‘‘SEC. 924. DISSEMINATION OF INFORMATION.

4 ‘‘(a) IN GENERAL.—The Director shall—

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

6 United States Code, promptly publish, make avail7 able, and otherwise disseminate, in a form under8 standable and on as broad a basis as practicable so

9 as to maximize its use, the results of research, dem10 onstration projects, and evaluations conducted or

11 supported under this title;

12 ‘‘(2) ensure that information disseminated by

13 the Agency is science-based and objective and under14 takes consultation as necessary to assess the appro15 priateness and usefulness of the presentation of in16 formation that is targeted to specific audiences;

17 ‘‘(3) promptly make available to the public data

18 developed in such research, demonstration projects,

19 and evaluations;

20 ‘‘(4) provide, in collaboration with the National

21 Library of Medicine where appropriate, indexing, ab22 stracting, translating, publishing, and other services

23 leading to a more effective and timely dissemination

24 of information on research, demonstration projects,

25 and evaluations with respect to healthcare to public
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1 and private entities and individuals engaged in the

2 improvement of healthcare delivery and the general

3 public, and undertake programs to develop new or

4 improved methods for making such information

5 available; and

6 ‘‘(5) as appropriate, provide technical assistance

7 to State and local government and health agencies

8 and conduct liaison activities to such agencies to fos9 ter dissemination.

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

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

12 the publication or dissemination of data from, or the re13 sults of, projects conducted or supported under this title.

14 ‘‘(c) LIMITATION ON USE OF CERTAIN INFORMA15 TION.—No information, if an establishment or person sup16 plying the information or described in it is identifiable,

17 obtained in the course of activities undertaken or sup18 ported under this title may be used for any purpose other

19 than the purpose for which it was supplied unless such

20 establishment or person has consented (as determined

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

22 purpose. Such information may not be published or re23 leased in other form if the person who supplied the infor24 mation or who is described in it is identifiable unless such
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1 person has consented (as determined under regulations of

2 the Director) to its publication or release in other form.

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

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

5 than $10,000 for each such violation involved. Such pen6 alty shall be imposed and collected in the same manner

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

8 1128A of the Social Security Act are imposed and col9 lected.

10 ‘‘SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO

11 GRANTS AND CONTRACTS.

12 ‘‘(a) FINANCIAL CONFLICTS OF INTEREST.—With

13 respect to projects for which awards of grants, cooperative

14 agreements, or contracts are authorized to be made under

15 this title, the Director shall by regulation define—

16 ‘‘(1) the specific circumstances that constitute

17 financial interests in such projects that will, or may

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

19 obtaining results in the projects that are consistent

20 with such interests; and

21 ‘‘(2) the actions that will be taken by the Direc22 tor in response to any such interests identified by

23 the Director.

24 ‘‘(b) REQUIREMENT OF APPLICATION.—The Director

25 may not, with respect to any program under this title au-
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1 thorizing the provision of grants, cooperative agreements,

2 or contracts, provide any such financial assistance unless

3 an application for the assistance is submitted to the Sec4 retary and the application is in such form, is made in such

5 manner, and contains such agreements, assurances, and

6 information as the Director determines to be necessary to

7 carry out the program involved.

8 ‘‘(c) PROVISION OF SUPPLIES AND SERVICES IN

9 LIEU OF FUNDS.—

10 ‘‘(1) IN GENERAL.—Upon the request of an en11 tity receiving a grant, cooperative agreement, or con12 tract under this title, the Secretary may, subject to

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

14 services for the purpose of aiding the entity in carry15 ing out the project involved and, for such purpose,

16 may detail to the entity any officer or employee of

17 the Department of Health and Human Services.

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

19 With respect to a request described in paragraph

20 (1), the Secretary shall reduce the amount of the fi21 nancial assistance involved by an amount equal to

22 the costs of detailing personnel and the fair market

23 value of any supplies, equipment, or services pro24 vided by the Director. The Secretary shall, for the
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1 payment of expenses incurred in complying with

2 such request, expend the amounts withheld.

3 ‘‘(d) APPLICABILITY OF CERTAIN PROVISIONS WITH

4 RESPECT TO CONTRACTS.—Contracts may be entered into

5 under this part without regard to sections 3648 and 3709

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

7 ‘‘SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.

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

9 EMPLOYEES.—

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

11 appoint a deputy director for the Agency.

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

13 Director may appoint and fix the compensation of

14 such officers and employees as may be necessary to

15 carry out this title. Except as otherwise provided by

16 law, such officers and employees shall be appointed

17 in accordance with the civil service laws and their

18 compensation fixed in accordance with title 5,

19 United States Code.

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

21 this title—

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

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

24 through the Director of General Services, buildings

25 or portions of buildings in the District of Columbia
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1 or communities located adjacent to the District of

2 Columbia for use for a period not to exceed 10

3 years; and

4 ‘‘(2) may acquire, construct, improve, repair,

5 operate, and maintain laboratory, research, and

6 other necessary facilities and equipment, and such

7 other real or personal property (including patents)

8 as the Secretary deems necessary.

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

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

11 public and nonprofit entities and individuals, and may

12 enter into cooperative agreements or contracts with public

13 and private entities and individuals.

14 ‘‘(d) UTILIZATION OF CERTAIN PERSONNEL AND RE15 SOURCES.—

16 ‘‘(1) DEPARTMENT OF HEALTH AND HUMAN

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

18 may utilize personnel and equipment, facilities, and

19 other physical resources of the Department of

20 Health and Human Services, permit appropriate (as

21 determined by the Secretary) entities and individuals

22 to utilize the physical resources of such Department,

23 and provide technical assistance and advice.

24 ‘‘(2) OTHER AGENCIES.—The Director, in car25 rying out this title, may use, with their consent, the
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1 services, equipment, personnel, information, and fa2 cilities of other Federal, State, or local public agen3 cies, or of any foreign government, with or without

4 reimbursement of such agencies.

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

6 this title, may secure, from time to time and for such peri7 ods as the Director deems advisable but in accordance

8 with section 3109 of title 5, United States Code, the as9 sistance and advice of consultants from the United States

10 or abroad.

11 ‘‘(f) EXPERTS.—

12 ‘‘(1) IN GENERAL.—The Secretary may, in car13 rying out this title, obtain the services of not more

14 than 50 experts or consultants who have appropriate

15 scientific or professional qualifications. Such experts

16 or consultants shall be obtained in accordance with

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

18 that the limitation in such section on the duration

19 of service shall not apply.

20 ‘‘(2) TRAVEL EXPENSES.—

21 ‘‘(A) IN GENERAL.—Experts and consult22 ants whose services are obtained under para23 graph (1) shall be paid or reimbursed for their

24 expenses associated with traveling to and from

25 their assignment location in accordance with
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1 sections 5724, 5724a(a), 5724a(c), and

2 5726(C) of title 5, United States Code.

3 ‘‘(B) LIMITATION.—Expenses specified in

4 subparagraph (A) may not be allowed in con5 nection with the assignment of an expert or

6 consultant whose services are obtained under

7 paragraph (1) unless and until the expert

8 agrees in writing to complete the entire period

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

10 unless separated or reassigned for reasons that

11 are beyond the control of the expert or consult12 ant and that are acceptable to the Secretary. If

13 the expert or consultant violates the agreement,

14 the money spent by the United States for the

15 expenses specified in subparagraph (A) is recov16 erable from the expert or consultant as a statu17 tory obligation owed to the United States. The

18 Secretary may waive in whole or in part a right

19 of recovery under this subparagraph.

20 ‘‘(g) VOLUNTARY AND UNCOMPENSATED SERV21 ICES.—The Director, in carrying out this title, may accept

22 voluntary and uncompensated services.

23 ‘‘SEC. 927. FUNDING.

24 ‘‘(a) INTENT.—To ensure that the United States’s in25 vestment in biomedical research is rapidly translated into
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1 improvements in the quality of patient care, there must

2 be a corresponding investment in research on the most ef3 fective clinical and organizational strategies for use of

4 these findings in daily practice. The authorization levels

5 in subsections (b) and (c) provide for a proportionate in6 crease in healthcare research as the United State’s invest7 ment in biomedical research increases.

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

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

10 be appropriated $250,000,000 for fiscal year 2000, and

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

12 2001 through 2006.

13 ‘‘(c) EVALUATIONS.—In addition to amounts avail14 able pursuant to subsection (b) for carrying out this title,

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

16 amounts made available pursuant to section 241 (relating

17 to evaluations), an amount equal to 40 percent of the max18 imum amount authorized in such section 241 to be made

19 available for a fiscal year.

20 ‘‘SEC. 928. DEFINITIONS.

21 ‘‘In this title:

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

23 Council’ means the Advisory Council on Healthcare

24 Research and Quality established under section 921.
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1 ‘‘(2) AGENCY.—The term ‘Agency’ means the

2 Agency for Healthcare Research and Quality.

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

4 the Director for the Agency for Healthcare Research

5 and Quality.’’.

6 SEC. 3. REFERENCES.

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

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

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

10 ‘‘Agency for Healthcare Research and Quality’’.

Æ