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HEALTH RESEARCH AND QUALITY ACT OF 1999
(House of Representatives - September 28, 1999)

Text of this article available as: TXT PDF [Pages H8910-H8941] HEALTH RESEARCH AND QUALITY ACT OF 1999 Mr. GOSS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 299 and ask for its immediate consideration. The Clerk read the resolution, as follows: H. Res. 299 Resolved, That at any time after the adoption of this resolution the Speaker may, pursuant to clause 2(b) of rule XVIII, declare the House resolved into the Committee of the Whole House on the state of the Union for consideration of the bill (H.R. 2506) to amend title IX of the Public Health Service Act to revise and extend the Agency for Health Care Policy and Research. The first reading of the bill shall be dispensed with. General debate shall be confined to the bill and shall not exceed one hour equally divided and controlled by the chairman and ranking minority member of the Committee on Commerce. After general debate the bill shall be considered for amendment under the five-minute rule. It shall be in order to consider as an original bill for the purpose of amendment under the five-minute rule the amendment in the nature of a substitute recommended by the Committee on Commerce now printed in the bill. Each section of the committee amendment in the nature of a substitute shall be considered as read. No amendment to the committee amendment in the nature of a substitute shall be in order except those printed in the portion of the Congressional Record designated for that purpose in clause 8 of rule XVIII and except pro forma amendments for the purpose of debate. Each amendment so printed may be offered only by the Member who caused it to be printed or his designee and shall be considered as read. The Chairman of the Committee of the Whole may: (1) postpone until a time during further consideration in the Committee of the Whole a request for a recorded vote on any amendment; and (2) reduce to five minutes the minimum time for electronic voting on any postponed question that follows another electronic vote without intervening business, provided that the minimum time for electronic voting on the first in any series of questions shall be 15 minutes. At the conclusion of consideration of the bill for amendment the Committee shall rise and report the bill to the House with such amendments as may have been adopted. Any Member may demand a separate vote in the House on any amendment adopted in the Committee of the Whole to the bill or to the committee amendment in the nature of a substitute. The previous question shall be considered as ordered on the bill and amendments thereto to final passage without intervening motion except one motion to recommit with or without instructions. {time} 1445 The SPEAKER pro tempore (Mr. Pease). The gentleman from Florida (Mr. Goss) is recognized for 1 hour. Mr. GOSS. Mr. Speaker, for purposes of debate only, I yield the customary 30 minutes to the distinguished gentlewoman from Rochester, NY (Ms. Slaughter) pending which I yield myself such time as I may consume. During consideration of this resolution, Mr. Speaker, all time yielded is for the purpose of debate only. Mr. Speaker, this is a fair and appropriate rule for this particular legislation. In fact, had it not been for the amount of money H.R. 2506 authorizes, doubling the current authorization level to $900 million, the bill would have been considered under the suspension process. The bill was voted out of the Committee on Commerce by a voice vote and the Committee on Rules reported a modified open rule to ensure that no extraneous amendments to the Public Health Service Act would be considered. The rule allows any Member who has preprinted an amendment in the Congressional Record to offer that amendment. This will ensure a full and open, yet targeted debate on the merits of this particular agency covered by this legislation. When the Agency for Health Care Policy and Research, AHCPR as it is known in its acronym, was created in 1989, the health care universe looked far different than it does today. Traditional fee for service plans still dominated the market and managed care was still very much in its infancy period. Utilization review, peer review, these were largely unknown concepts, at least fully tried or tested. H.R. 2506 modernizes the agency to reflect these and other changes and provides resources to enable more effective collection of data. Many Americans sitting at home watching may be wondering why we need yet another Federal agency involved in health care quality. Well, health care quality is a critical issue these days. As someone who has always believed that Congress too often stands in the way of true health care quality, I share concern with the people at home who are worried about this. To the extent that this ``reformed'' agency can promote better research and encourage successful partnerships between the public and private sectors with limited Federal red tape, it can be a worthy investment. And, of course, that is the goal. But we must retain vigorous oversight and maintain high expectations to ensure that these precious taxpayer dollars are indeed put [[Page H8911]] to good use. Again, we think that is the reason for this legislation and we congratulate its authors for this effort. As I stated before, this is an eminently fair rule that should engender no controversy as far as I know. Mr. Speaker, I reserve the balance of my time. Ms. SLAUGHTER. Mr. Speaker, I thank my distinguished colleague from Florida for yielding me the 30 minutes, and I yield myself such time as I may consume. (Ms. SLAUGHTER asked and was given permission to revise and extend her remarks.) Ms. SLAUGHTER. Mr. Speaker, this is an ``almost open'' rule, for the majority has again relied on a preprinting requirement for amendments which may affect some Members of the House. But I rise in support of the rule and in support of H.R. 2506, the Health Research and Quality Act of 1999. The bill is being brought to the floor by the gentleman from Florida (Mr. Bilirakis) for the majority and the gentleman from Ohio (Mr. Brown) for the minority. This bipartisan legislation reauthorizes the Agency for Health Care Policy and Research and renames the agency as the Agency for Health Research and Quality, AHRQ, pronounced ``arc.'' This agency promotes health care quality through research, synthesizing and consolidating medical information, and disseminating scientific evidence. Building on its current initiatives, the agency will play a key role in partnering with the private sector to improve the quality of health care in the United States. As a longtime supporter of health care research, I believe this piece of legislation will benefit patients, care-givers and insurance providers with vital information and statistics on how to improve the Nation's health care system. The agency's research and information consolidation will play a key role in extending quality care and improving health service delivery throughout the country. This agency provides vital information and resources that foster improvement in health care systems from America's smallest rural townships to its most populous inner cities. The agency's mission includes fostering the extension of quality health care systems to those Americans left behind as our Nation continues its economic growth. The agency's work is especially important as health care delivery in our country evolves. When the AHCPR was established a little over 10 years ago, the health care system was vastly different from what we know today. More people now receive their care through managed plans and HMOs. The growing complexity of health plans bewilderers many patients and contributes to the growing tensions between patients and insurers. This legislation directs AHRQ to address the public's growing concern for the quality of patient care and the number of medical errors that continue to grow each day. Their research helps hospitals and clinics around the country to reduce the injuries arising from mismanagement of cases. A recent study examined the records of more than 30,000 hospital patients in my home State of New York. The study found that nearly 4 percent of patients suffered serious injuries that were related to the management of their illnesses rather than the illnesses themselves. This is a vital area of research for the agency and another reason why the reauthorization of funding for this agency and the redirection of its mission is important. The legislation does more than merely change the name of the agency. It directs the agency to develop new public-private partnerships in the health care arena. This will bring new perspectives to improving the dissemination of health information and the development of health care systems that better serve our neighborhoods, towns and cities. These partnerships will also leverage greater private investment and commitment to creating improved health care service systems throughout the Nation. In the process, AHRQ will also support increased efficiency and quality of Federal program management. According to testimony provided to the committee during a recent hearing, nine out of 10 people surveyed supported health research as well as the amount of Federal money spent on our Nation's health care. Mr. Speaker, this agency costs just one one-hundredth of one percent of the total funds spent by the government on health care and is a sound investment in our Nation's future health. I support this initiative even though it is only a modest step toward guaranteeing that all our citizens have access to the finest medical care in the world. Citizens across the United States are crying out for more. We need comprehensive health care reform that includes a provision to ban genetic discrimination in insurance. We need a true Patients' Bill of Rights. Mr. Speaker, I yield back the balance of my time. Mr. GOSS. Mr. Speaker, I yield back the balance of my time, and I prove the previous question on the resolution. The previous question was ordered. The resolution was agreed to. A motion to reconsider was laid on the table. The SPEAKER pro tempore (Mr. Knollenberg). Pursuant to House Resolution 299 and rule XVIII, the Chair declares the House in the Committee of the Whole House on the State of the Union for the consideration of the bill, H.R. 2506. {time} 1454 In the Committee of the Whole Accordingly, the House resolved itself into the Committee of the Whole House on the State of the Union for the consideration of the bill (H.R. 2506) to amend title IX of the Public Health Service Act to revise and extend the Agency for Health Care Policy and Research, with Mr. Pease in the chair. The Clerk read the title of the bill. The CHAIRMAN. Pursuant to the rule, the bill is considered as having been read the first time. Under the rule, the gentleman from Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each will control 30 minutes. The Chair recognizes the gentleman from Florida (Mr. Bilirakis). Mr. BILIRAKIS. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I am pleased to bring H.R. 2506, the Health Research and Quality Act of 1999, to the floor today. This widely supported bipartisan bill was approved by voice vote in the Committee on Commerce and the Subcommittee on Health and Environment. In April, experts from both the public and private sector testified about the critical function of this agency at a hearing before the subcommittee. I introduced this measure jointly with the gentleman from Ohio (Mr. Brown), the ranking member of the House Commerce Subcommittee on Health and Environment, to reauthorize the Agency for Health Care Policy and Research and redefine its mission. Our bill renames it as the Agency for Health Research and Quality, or, one of those famous Washington acronyms, AHRQ. The purpose of this new name, and the reauthorization, is to foster comprehensive improvements in our health care system. Our bill refocuses the efforts of this critical agency to support private sector initiatives. Building on its current activities, the new agency will become a key partner to the private sector in improving the quality of health care in America. The bill specifically prohibits the agency from mandating national standards of clinical practice or quality health care standards. Instead, it emphasizes the agency's nonregulatory role in building the science of health care quality. The bill also includes provisions to overcome barriers to access to preventive health care through a public-private partnership. It authorizes grants for the establishment of regional centers to improve and increase access to preventive health care services. By approving the legislation before us, we can ensure the continued availability of the objective, science-based information this agency provides. I urge Members to join us in supporting passage of H.R. 2506, the Health Research and Quality Act of 1999. Mr. Chairman, I reserve the balance of my time. Mr. BROWN of Ohio. Mr. Chairman, I yield myself such time as I may consume. I am pleased that the gentleman from Florida (Mr. Bilirakis) and I [[Page H8912]] could work together to introduce the Health Research and Quality Act and pass it out of the Committee on Commerce. We hold similar views on why this issue is important. It is important because research is important. The U.S. health care system is far from transparent. In fact, in many ways it is not even a system. It is a complex set of relationships influenced by science, demographics, politics, money and cultural trends. Whether the focus is on health care financing or health care delivery, common sense alone rarely explains what is going on. In fact, it often throws policymakers off track. If we want to improve on the status quo in health care, we have to get a realistic picture of what the status quo is. By conducting and supporting health services research, AHCPR helps paint that picture for us. If we want to improve on the status quo in health care, we have got to find out what improvement actually means. By conducting and supporting outcomes, effectiveness and cost effectiveness research, AHCPR helps us determine the best way to spend the limited health care dollars that we do have. And if we want to improve on the status quo in health care, we need to get the word out to the people in the institutions, in the agencies and the industries that somehow keep the whole thing running. By disseminating research and data broadly, AHCPR helps ensure that our investment in data collection, health services research and biomedical research pays off. This reauthorization makes research and broad dissemination of information AHCPR's main focus. We could definitely use more of both. I urge support of this important legislation. Mr. Chairman, I reserve the balance of my time. Mr. BILIRAKIS. Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Gary Miller). (Mr. GARY MILLER of California asked and was given permission to revise and extend his remarks.) Mr. GARY MILLER of California. Mr. Chairman, I rise today in support of H.R. 2506, the Health Research and Quality Act. First I want to thank the bill's author the gentleman from Florida (Mr. Bilirakis) and the cosponsors for all their hard work on this issue. H.R. 2506 is an important piece of legislation which will improve the quality of health care by directing the Agency for Health Care Policy and Research to emphasize medical research, synthesizing and disseminating scientific evidence, and advancing public and private efforts to improve health care quality. With the explosion of medical research and information being produced, medical practitioners face the increasingly difficult task of keeping current with medical literature and putting the latest scientific findings into perspective. As one study indicated, even if a doctor read two peer-reviewed journals each night for a year, he or she would still be 800 years behind in their reading. Access to up-to-date, quality research will improve the care that patients obtain from all levels of the health care system. H.R. 2506 will provide a means whereby medical group practices can obtain and contribute to such a body of information. This legislation frees the Agency for Health Care Policy and Research from the difficult task of providing guidelines and standards of care and allows it to focus on providing unbiased, science-based research to the health care community. H.R. 2506 will help health care professionals and policymakers better understand the future demands on the Nation's health care system. Again, I lend my strong support to this measure and urge my colleagues to join me in voting in favor of the Health Research and Quality Act of 1999. {time} 1500 Mr. BILIRAKIS. Mr. Chairman, I yield such time as he may consume to another gentleman from California (Mr. Bilbray). Mr. BILBRAY. Mr. Chairman, I rise to strongly support H.R. 2506, and let me just say as someone who has the privilege of representing the 49th District of California, one of the capitals of both public and private research, I want to commend the chairman and the ranking member for a cooperative effort here at really serving the American people. The concept of reform and change sometimes scares people in these chambers and they worry about what could go wrong, and I think we have to remind ourselves again and again that reform and change is also an essential step to improvement. And this bill will allow us to take that step towards an improvement of not only the cost effectiveness, the cost efficiency, but also the effectiveness of our total health care system through the information age. Mr. Chairman, 2506 will be that kind of step. And I hope that in the future we will be able to look back at H.R. 2506 and look back at the cooperative effort between the chairman of the subcommittee and the ranking member of this subcommittee and say this was the beginning of a very productive relationship between both sides of the aisle and a productive relationship with the American people and their health care system. Mr. Chairman, I would ask all of us to support this bill and support the attitude that is behind this bill and to support the entire concept that Democrats and Republicans can work together for the good of the safety and the health of the American people. Mr. BLILEY. Mr. Chairman, I commend the gentlemen from Florida and Ohio for bringing H.R. 2506, the Health Research and Quality Act of 1999, to the floor. This legislation, introduced by Representatives Bilirakis and Brown, represents an important commitment to provide the science-based evidence that we need to improve health care quality. We need sound and reliable information to help patients make informed decisions, to help health care providers make sense of new discoveries, to help purchasers get value for their health care dollar, and to help avoid medical errors. Today's legislation builds on the progress the Agency for Health Care Policy and Research has already made. It will enable us to benefit from our investment in biomedical research, to improve the health care delivery programs under our jurisdiction, and to build the science of quality measurement and improvement. This emphasis on quality measurement and improvement is important. The focus on health outcomes is critical. If we are unable to determine the long-term effect of the care patients receive today, we will be unable to improve upon that care tomorrow. To address the full continuum of care and outcomes research, and to link research directly with clinical practice in geographically diverse locations throughout the United States, this bill stresses the importance of health care improvement research centers and provider-based research networks. Since the science of outcomes research is complex, this bill requires the agency to support research and evaluation to advance the use of information systems for the study of health care quality and outcomes. The importance of outcomes research and information dissemination in the continuous improvement of patient care cannot be overstated. For example, in the area of cancer care, the ability to chart patient outcomes from a variety of interventions and communicate these outcomes effectively among practitioners will allow significant improvement in the treatment of all types of cancer. In summary, Mr. Chairman, the Health Research and Quality Act of 1999 is a sound investment in the future; it is legislation that both sides of the aisle can support. The Commerce Committee gave unanimous approval to this legislation and I hope it will enjoy similar support on the floor today. Mr. BALDACCI. Mr. Chairman, I commend the Chairman, Mr. Bilirakis, and the Ranking Member, Mr. Brown, for introducing this valuable legislation. I particularly want to thank the Members for the special attention given to rural health care in the bill. Access and quality of health care in rural America is of particular importance to me. I represent the largest geographic district east of the Mississippi. Recently, compounding changes in Medicare reimbursement and regulations have had a devastating impact on my district, and have endangered a very vulnerable population of my state. People in rural areas do not have the same choices available to those in urban areas. I am concerned that the rate of the uninsured in Maine continues to grow. Maine citizens rely heavily on community care, and we ought to promote research into enhancing quality of and access to health care in these areas. Careful studies of the delivery of health services in rural America will allow us to make better public policy, and I thank the Chairman and Ranking Member for their attention to this issue. I am also pleased to see the legislation address the critical issue of health insurance. Section 913 requires that there must be surveys on, among other factors, the types and [[Page H8913]] costs of private health insurance. As we know, there is a growing trend to consolidation among health insurance companies, and I am particularly concerned about the ability of these large companies to direct costs and types of care offered when they buy out smaller local insurers. It is my hope that with this component of the bill, we will gain a better understanding of what effect the consolidation in the health insurance market is having on quality, access, and cost of insurance to rural Americans. Again, I thank the Chairman and Ranking Member for addressing this issue. Mr. BILIRAKIS. Mr. Chairman, we have no further requests for time. Mr. BROWN of Ohio. Mr. Chairman, I yield back the balance of my time. Mr. BILIRAKIS. Mr. Chairman, I yield back the balance of my time. The CHAIRMAN. All time for general debate has expired. Pursuant to the rule, the committee amendment in the nature of a substitute printed in the bill shall be considered by sections as an original bill for the purpose of amendment, and each section is considered read. No amendment to that amendment shall be in order except those printed in the portion of the Congressional Record designated for that purpose and pro forma amendments for the purpose of debate. Amendments printed in the Record may be offered only by the Member who caused it to be printed or his designee and shall be considered read. The Chairman of the Committee of the Whole may postpone a request for a recorded vote on any amendment and may reduce to a minimum of 5 minutes the time for voting on any postponed question that immediately follows another vote, provided that the time for voting on the first question shall be a minimum of 15 minutes. The Clerk will designate section 1. The text of section 1 is as follows: Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Health Research and Quality Act of 1999''. The CHAIRMAN. Are there any amendments to section 1? The Clerk will designate section 2. The text of section 2 is as follows: SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT. (a) In General.--Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is amended to read as follows: ``TITLE IX--AGENCY FOR HEALTH RESEARCH AND QUALITY ``PART A--ESTABLISHMENT AND GENERAL DUTIES ``SEC. 901. MISSION AND DUTIES. ``(a) In General.--There is established within the Public Health Service an agency to be known as the Agency for Health Research and Quality, which shall be headed by a director appointed by the Secretary. The Secretary shall carry out this title acting through the Director. ``(b) Mission.--The purpose of the Agency is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health system practices, including the prevention of diseases and other health conditions. The Agency shall promote health care quality improvement by-- ``(1) conducting and supporting research that develops and presents scientific evidence regarding all aspects of health, including-- ``(A) the development and assessment of methods for enhancing patient participation in their own care and for facilitating shared patient-physician decision-making; ``(B) the outcomes, effectiveness, and cost-effectiveness of health care practices, including preventive measures and long-term care; ``(C) existing and innovative technologies; ``(D) the costs and utilization of, and access to health care; ``(E) the ways in which health care services are organized, delivered, and financed and the interaction and impact of these factors on the quality of patient care; ``(F) methods for measuring quality and strategies for improving quality; and ``(G) ways in which patients, consumers, purchasers, and practitioners acquire new information about best practices and health benefits, the determinants and impact of their use of this information; ``(2) synthesizing and disseminating available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, policy makers, and educators; and ``(3) advancing private and public efforts to improve health care quality. ``(c) Requirements With Respect to Rural Areas and Priority Populations.--In carrying out subsection (b), the Director shall undertake and support research, demonstration projects, and evaluations with respect to-- ``(1) the delivery of health services in rural areas (including frontier areas); ``(2) health services for low-income groups, and minority groups; ``(3) the health of children; ``(4) the elderly; and ``(5) people with special health care needs, including disabilities, chronic care and end-of-life health care. ``SEC. 902. GENERAL AUTHORITIES. ``(a) In General.--In carrying out section 901(b), the Director shall support demonstration projects, conduct and support research, evaluations, training, research networks, multi-disciplinary centers, technical assistance, and the dissemination of information, on health care, and on systems for the delivery of such care, including activities with respect to-- ``(1) the quality, effectiveness, efficiency, appropriateness and value of health care services; ``(2) quality measurement and improvement; ``(3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services; ``(4) clinical practice, including primary care and practice-oriented research; ``(5) health care technologies, facilities, and equipment; ``(6) health care costs, productivity, organization, and market forces; ``(7) health promotion and disease prevention, including clinical preventive services; ``(8) health statistics, surveys, database development, and epidemiology; and ``(9) medical liability. ``(b) Health Services Training Grants.-- ``(1) In general.--The Director may provide training grants in the field of health services research related to activities authorized under subsection (a), to include pre- and post-doctoral fellowships and training programs, young investigator awards, and other programs and activities as appropriate. In carrying out this subsection, the Director shall make use of funds made available under section 487. ``(2) Requirements.--In developing priorities for the allocation of training funds under this subsection, the Director shall take into consideration shortages in the number of trained researchers addressing the priority populations. ``(c) Multidisciplinary Centers.--The Director may provide financial assistance to assist in meeting the costs of planning and establishing new centers, and operating existing and new centers, for multidisciplinary health services research, demonstration projects, evaluations, training, and policy analysis with respect to the matters referred to in subsection (a). ``(d) Relation to Certain Authorities Regarding Social Security.--Activities authorized in this section shall be appropriately coordinated with experiments, demonstration projects, and other related activities authorized by the Social Security Act and the Social Security Amendments of 1967. Activities under subsection (a)(2) of this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act shall be carried out consistent with section 1142 of such Act. ``(e) Disclaimer.--The Agency shall not mandate national standards of clinical practice or quality health care standards. Recommendations resulting from projects funded and published by the Agency shall include a corresponding disclaimer. ``(f) Rule of Construction.--Nothing in this section shall be construed to imply that the Agency's role is to mandate a national standard or specific approach to quality measurement and reporting. In research and quality improvement activities, the Agency shall consider a wide range of choices, providers, health care delivery systems, and individual preferences. ``PART B--HEALTH CARE IMPROVEMENT RESEARCH ``SEC. 911. HEALTH CARE OUTCOME IMPROVEMENT RESEARCH. ``(a) Evidence Rating Systems.--In collaboration with experts from the public and private sector, the Agency shall identify and disseminate methods or systems that it uses to assess health care research results, particularly methods or systems that it uses to rate the strength of the scientific evidence behind health care practice, recommendations in the research literature, and technology assessments. The Agency shall make methods or systems for evidence rating widely available. Agency publications containing health care recommendations shall indicate the level of substantiating evidence using such methods or systems. ``(b) Health Care Improvement Research Centers and Provider-Based Research Networks.-- ``(1) In general.--In order to address the full continuum of care and outcomes research, to link research to practice improvement, and to speed the dissemination of research findings to community practice settings, the Agency shall employ research strategies and mechanisms that will link research directly with clinical practice in geographically diverse locations throughout the United States, including-- ``(A) Health Care Improvement Research Centers that combine demonstrated multidisciplinary expertise in outcomes or quality improvement research with linkages to relevant sites of care; ``(B) Provider-based Research Networks, including plan, facility, or delivery system sites of care (especially primary care), that can evaluate outcomes and promote quality improvement; and ``(C) other innovative mechanisms or strategies to link research with clinical practice. ``(2) Requirements.--The Director is authorized to establish the requirements for entities applying for grants under this subsection. ``SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND DELIVERY. ``(a) Support for Efforts To Develop Information on Quality.-- ``(1) Scientific and technical support.--In its role as the principal agency for health research and quality, the Agency may provide scientific and technical support for private and [[Page H8914]] public efforts to improve health care quality, including the activities of accrediting organizations. ``(2) Role of the agency.--With respect to paragraph (1), the role of the Agency shall include-- ``(A) the identification and assessment of methods for the evaluation of the health of-- ``(i) enrollees in health plans by type of plan, provider, and provider arrangements; and ``(ii) other populations, including those receiving long- term care services; ``(B) the ongoing development, testing, and dissemination of quality measures, including measures of health and functional outcomes; ``(C) the compilation and dissemination of health care quality measures developed in the private and public sector; ``(D) assistance in the development of improved health care information systems; ``(E) the development of survey tools for the purpose of measuring participant and beneficiary assessments of their health care; and ``(F) identifying and disseminating information on mechanisms for the integration of information on quality into purchaser and consumer decision-making processes. ``(b) Centers for Education and Research on Therapeutics.-- ``(1) In general.--The Secretary, acting through the Director and in consultation with the Commissioner of Food and Drugs, shall establish a program for the purpose of making one or more grants for the establishment and operation of one or more centers to carry out the activities specified in paragraph (2). ``(2) Required activities.--The activities referred to in this paragraph are the following: ``(A) The conduct of state-of-the-art research for the following purposes: ``(i) To increase awareness of-- ``(I) new uses of drugs, biological products, and devices; ``(II) ways to improve the effective use of drugs, biological products, and devices; and ``(III) risks of new uses and risks of combinations of drugs and biological products. ``(ii) To provide objective clinical information to the following individuals and entities: ``(I) Health care practitioners and other providers of health care goods or services. ``(II) Pharmacists, pharmacy benefit managers and purchasers. ``(III) Health maintenance organizations and other managed health care organizations. ``(IV) Health care insurers and governmental agencies. ``(V) Patients and consumers. ``(iii) To improve the quality of health care while reducing the cost of health care through-- ``(I) an increase in the appropriate use of drugs, biological products, or devices; and ``(II) the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations. ``(B) The conduct of research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices. ``(C) Such other activities as the Secretary determines to be appropriate, except that a grant may not be expended to assist the Secretary in the review of new drugs. ``(c) Reducing Errors in Medicine.--The Director shall conduct and support research and build private-public partnerships to-- ``(1) identify the causes of preventable health care errors and patient injury in health care delivery; ``(2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and ``(3) promote the implementation of effective strategies throughout the health care industry. ``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE. ``(a) In General.--In carrying out 902(a), the Director shall-- ``(1) conduct a survey to collect data on a nationally representative sample of the population on the cost, use and, for fiscal year 2001 and subsequent fiscal years, quality of health care, including the types of health care services Americans use, their access to health care services, frequency of use, how much is paid for the services used, the source of those payments, the types and costs of private health insurance, access, satisfaction, and quality of care for the general population and also for populations identified in section 901(c); and ``(2) develop databases and tools that provide information to States on the quality, access, and use of health care services provided to their residents. ``(b) Quality and Outcomes Information.-- ``(1) In general.--Beginning in fiscal year 2001, the Director shall ensure that the survey conducted under subsection (a)(1) will-- ``(A) identify determinants of health outcomes and functional status, the needs of special populations in such variables as well as an understanding of changes over time, relationships to health care access and use, and monitor the overall national impact of Federal and State policy changes on health care; ``(B) provide information on the quality of care and patient outcomes for frequently occurring clinical conditions for a nationally representative sample of the population; and ``(C) provide reliable national estimates for children and persons with special health care needs through the use of supplements or periodic expansions of the survey. In expanding the Medical Expenditure Panel Survey, as in existence on the date of enactment of this title in fiscal year 2001 to collect information on the quality of care, the Director shall take into account any outcomes measurements generally collected by private sector accreditation organizations. ``(2) Annual report.--Beginning in fiscal year 2003, the Secretary, acting through the Director, shall submit to Congress an annual report on national trends in the quality of health care provided to the American people. ``SEC. 914. INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT. ``(a) In General.--In order to foster a range of innovative approaches to the management and communication of health information, the Agency shall support research, evaluations and initiatives to advance-- ``(1) the use of information systems for the study of health care quality and outcomes, including the generation of both individual provider and plan-level comparative performance data; ``(2) training for health care practitioners and researchers in the use of information systems; ``(3) the creation of effective linkages between various sources of health information, including the development of information networks; ``(4) the delivery and coordination of evidence-based health care services, including the use of real-time health care decision-support programs; ``(5) the structure, content, definition, and coding of health information data and medical vocabularies in consultation with appropriate Federal entities and shall seek input from appropriate private entities; ``(6) the use of computer-based health records in outpatient and inpatient settings as a personal health record for individual health assessment and maintenance, and for monitoring public health and outcomes of care within populations; and ``(7) the protection of individually identifiable information in health services research and health care quality improvement. ``(b) Demonstration.--The Agency shall support demonstrations into the use of new information tools aimed at improving shared decision-making between patients and their care-givers. ``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN UNDERSERVED AREAS. ``(a) Preventive Services Task Force.-- ``(1) Purpose.--The Agency shall provide ongoing administrative, research, and technical support for the operation of the Preventive Services Task Force. The Agency shall coordinate and support the dissemination of the Preventive Services Task Force recommendations. ``(2) Operation.--The Preventive Services Task Force shall review the scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care community, and updating previous recommendations, regarding their usefulness in daily clinical practice. In carrying out its responsibilities under paragraph (1), the Task Force shall not be subject to the provisions of Appendix 2 of title 5, United States Code. ``(b) Primary Care Research.-- ``(1) In general.--There is established within the Agency a Center for Primary Care Research (referred to in this subsection as the `Center') that shall serve as the principal source of funding for primary care practice research in the Department of Health and Human Services. For purposes of this paragraph, primary care research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral to specialty care, preventive care, and the relationship between the clinician and the patient in the context of the family and community. ``(2) Research.--In carrying out this section, the Center shall conduct and support research concerning-- ``(A) the nature and characteristics of primary care practice; ``(B) the management of commonly occurring clinical problems; ``(C) the management of undifferentiated clinical problems; and ``(D) the continuity and coordination of health services. ``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION. ``(a) In General.--The Director shall promote innovation in evidence-based clinical practice and health care technologies by-- ``(1) conducting and supporting research on the development, diffusion, and use of health care technology; ``(2) developing, evaluating, and disseminating methodologies for assessments of health care practices and health care technologies; ``(3) conducting intramural and supporting extramural assessments of existing and new health care practices and technologies; ``(4) promoting education, training, and providing technical assistance in the use of health care practice and health care technology assessment methodologies and results; and ``(5) working with the National Library of Medicine and the public and private sector to develop an electronic clearinghouse of currently available assessments and those in progress. ``(b) Specification of Process.-- ``(1) In general.--Not later than December 31, 2000, the Director shall develop and publish a description of the methods used by the Agency and its contractors for practice and technology assessment. ``(2) Consultations.--In carrying out this subsection, the Director shall cooperate and consult with the Assistant Secretary for Health, the Administrator of the Health Care Financing Administration, the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the heads of any other interested Federal department or agency, and shall seek input, where appropriate, from professional societies and other private and public entities. ``(3) Methodology.--The Director shall, in developing the methods used under paragraph (1), consider-- ``(A) safety, efficacy, and effectiveness; [[Page H8915]] ``(B) legal, social, and ethical implications; ``(C) costs, benefits, and cost-effectiveness; ``(D) comparisons to alternate technologies and practices; and ``(E) requirements of Food and Drug Administration approval to avoid duplication. ``(c) Specific Assessments.-- ``(1) In general.--The Director shall conduct or support specific assessments of health care technologies and practices. ``(2) Requests for assessments.--The Director is authorized to conduct or support assessments, on a reimbursable basis, for the Health Care Financing Administration, the Department of Defense, the Department of Veterans Affairs, the Office of Personnel Management, and other public or private entities. ``(3) Grants and contracts.--In addition to conducting assessments, the Director may make grants to, or enter into cooperative agreements or contracts with, entities described in paragraph (4) for the purpose of conducting assessments of experimental, emerging, existing, or potentially outmoded health care technologies, and for related activities. ``(4) Eligible entities.--An entity described in this paragraph is an entity that is determined to be appropriate by the Director, including academic medical centers, research institutions and organizations, professional organizations, third party payers, governmental agencies, and consortia of appropriate research entities established for the purpose of conducting technology assessments. ``SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY IMPROVEMENT EFFORTS. ``(a) Requirement.-- ``(1) In general.--To avoid duplication and ensure that Federal resources are used efficiently and effectively, the Secretary, acting through the Director, shall coordinate all research, evaluations, and demonstrations related to health services research, quality measurement and quality improvement activities undertaken and supported by the Federal Government. ``(2) Specific activities.--The Director, in collaboration with the appropriate Federal officials representing all concerned executive agencies and departments, shall develop and manage a process to-- ``(A) improve interagency coordination, priority setting, and the use and sharing of research findings and data pertaining to Federal quality improvement programs, technology assessment, and health services research; ``(B) strengthen the research information infrastructure, including databases, pertaining to Federal health services research and health care quality improvement initiatives; ``(C) set specific goals for participating agencies and departments to further health services research and health care quality improvement; and ``(D) strengthen the management of Federal health care quality improvement programs. ``(b) Study by the Institute of Medicine.-- ``(1) In general.--To provide Congress, the Department of Health and Human Services, and other relevant departments with an independent, external review of their quality oversight, quality improvement and quality research programs, the Secretary shall enter into a contract with the Institute of Medicine-- ``(A) to describe and evaluate current quality improvement, quality research and quality monitoring processes through-- ``(i) an overview of pertinent health services research activities and quality improvement efforts conducted by all Federal programs, with particular attention paid to those under titles XVIII, XIX, and XXI of the Social Security Act; and ``(ii) a summary of the partnerships that the Department of Health and Human Services has pursued with private accreditation, quality measurement and improvement organizations; and ``(B) to identify options and make recommendations to improve the efficiency and effectiveness of quality improvement programs through-- ``(i) the improved coordination of activities across the medicare, medicaid and child health insurance programs under titles XVIII, XIX and XXI of the Social Security Act and health services research programs; ``(ii) the strengthening of patient choice and participation by incorporating state-of-the-art quality monitoring tools and making information on quality available; and ``(iii) the enhancement of the most effective programs, consolidation as appropriate, and elimination of duplicative activities within various federal agencies. ``(2) Requirements.-- ``(A) In general.--The Secretary shall enter into a contract with the Institute of Medicine for the preparation-- ``(i) not later than 12 months after the date of enactment of this title, of a report providing an overview of the quality improvement programs of the Department of Health and Human Services for the medicare, medicaid, and CHIP programs under titles XVIII, XIX, and XXI of the Social Security Act; and ``(ii) not later than 24 months after the date of enactment of this title, of a final report containing recommendations. ``(B) Reports.--The Secretary shall submit the reports described in subparagraph (A) to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Ways and Means and the Committee on Commerce of the House of Representatives. ``PART C--GENERAL PROVISIONS ``SEC. 921. ADVISORY COUNCIL FOR HEALTH CARE RESEARCH AND QUALITY. ``(a) Establishment.--There is established an advisory council to be known as the Advisory Council for Health Care Research and Quality. ``(b) Duties.-- ``(1) In general.--The Advisory Council shall advise the Secretary and the Director with respect to activities proposed or undertaken to carry out the purpose of the Agency under section 901(b). ``(2) Certain recommendations.--Activities of the Advisory Council under paragraph (1) shall include making recommendations to the Director regarding-- ``(A) priorities regarding health care research, especially studies related to quality, outcomes, cost and the utilization of, and access to, health care services; ``(B) the field of health care research and related disciplines, especially issues related to training needs, and dissemination of information pertaining to health care quality; and ``(C) the appropriate role of the Agency in each of these areas in light of private sector activity and identification of opportunities for public-private sector partnerships. ``(c) Membership.-- ``(1) In general.--The Advisory Council shall, in accordance with this subsection, be composed of appointed members and ex officio members. All members of the Advisory Council shall be voting members other than the individuals designated under paragraph (3)(B) as ex officio members. ``(2) Appointed members.--The Secretary shall appoint to the Advisory Council 18 appropriately qualified individuals. At least 14 members of the Advisory Council shall be representatives of the public who are not officers or employees of the United States. The Secretary shall ensure that the appointed members of the Council, as a group, are representative of professions and entities concerned with, or affected by, activities under this title and under section 1142 of the Social Security Act. Of such members-- ``(A) 3 shall be individuals distinguished in the conduct of research, demonstration projects, and evaluations with respect to health care; ``(B) 3 shall be individuals distinguished in the practice of medicine of which at least 1 shall be a primary care practitioner; ``(C) 3 shall be individuals distinguished in the other health professions; ``(D) 3 shall be individuals either representing the private health care sector, including health plans, providers, and purchasers or individuals distinguished as administrators of health care delivery systems; ``(E) 3 shall be individuals distinguished in the fields of health care quality improvement, economics, information systems, law, ethics, business, or public policy; and ``(F) 3 shall be individuals representing the interests of patients and consumers of health care. ``(3) Ex officio members.--The Secretary shall designate as ex officio members of the Advisory Council-- ``(A) the Assistant Secretary for Health, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Care Financing Administration, the Assistant Secretary of Defense (Health Affairs), and the Under Secretary for Health of the Department of Veterans Affairs; and ``(B) such other Federal officials as the Secretary may consider appropriate. ``(d) Terms.--Members of the Advisory Council appointed under subsection (c)(2) shall serve for a term of 3 years. A member of the Council appointed under such subsection may continue to serve after the expiration of the term of the members until a successor is appointed. ``(e) Vacancies.--If a member of the Advisory Council appointed under subsection (c)(2) does not serve the full term applicable under subsection (d), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual. ``(f) Chair.--The Director shall, from among the members of the Advisory Council appointed under subsection (c)(2), designate an individual to serve as the chair of the Advisory Council. ``(g) Meetings.--The Advisory Council shall meet not less than once during each discrete 4-month period and shall otherwise meet at the call of the Director or the chair. ``(h) Compensation and Reimbursement of Expenses.-- ``(1) Appointed members.--Members of the Advisory Council appointed under subsection (c)(2) shall receive compensation for each day (including travel time) engaged in carrying out the duties of the Advisory Council unless declined by the member. Such compensation may not be in an amount in excess of the maximum rate of basic pay payable for GS-18 of the General Schedule. ``(2) Ex officio members.--Officials designated under subsection (c)(3) as ex officio members of the Advisory Council may not receive compensation for service on the Advisory Council in addition to the compensation otherwise received for duties carried out as officers of the United States. ``(i) Staff.--The Director shall provide to the Advisory Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council. ``SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS. ``(a) Requirement of Review.-- ``(1) In general.--Appropriate technical and scientific peer review shall be conducted with respect to each application for a grant, cooperative agreement, or contract under this title. ``(2) Reports to director.--Each peer review group to which an application is submitted pursuant to paragraph (1) shall report its finding and recommendations respecting the application to the Director in such form and in such manner as the Director shall require. ``(b) Approval as Precondition of Awards.--The Director may not approve an application described in subsection (a)(1) unless [[Page H8916]] the application is recommended for approval by a peer review group established under subsection (c). ``(c) Establishment of Peer Review Groups.-- ``(1) In general.--The Director shall establish such technical and scientific peer review groups as may be necessary to carry out this section. Such groups shall be established without regard to the provisions of title 5, United States Code, that govern appointments in the competitive service, and without regard to the provisions of chapter 51, and subchapter III of chapter 53, of such title that relate to classification and pay rates under the General Schedule. ``(2) Membership.--The members of any peer review group established under this section shall be appointed from among individuals who by virtue of their training or experience are eminently qualified to carry out the duties of such peer review group. Officers and employees of the United States may not constitute more than 25 percent of the membership of any such group. Such officers and employees may not receive compensation for service on such groups in addition to the compensation otherwise received for these duties carried out as such officers and employees. ``(3) Duration.--Notwithstanding section 14(a) of the Federal Advisory Committee Act, peer review groups established under this section may continue in existence until otherwise provided by law. ``(4) Qualifications.--Members of any peer-review group shall, at a minimum, meet the following requirements: ``(A) Such members shall agree in writing to treat information received, pursuant to their work for the group, as confidential information, except that this subparagraph shall not apply to public records and public information. ``(B) Such members shall agree in writing to recuse themselves from participation in the peer-review of specific applications which present a potential personal conflict of interest or appearance of such conflict, including employment in a directly affected organization, stock ownership, or any financial or other arrangement that might introduce bias in the process of peer-review. ``(d) Authority for Procedural Adjustments in Certain Cases.--In the case of applications for financial assistance whose direct costs will not exceed $100,000, the Director may make appropriate adjustments in the procedures otherwise established by the Director for the conduct of peer review under this section. Such adjustments may be made for the purpose of encouraging the entry of individuals into the field of research, for the purpose of encouraging clinical practice-oriented or provider-based research, and for such other purposes as the Director may determine to be appropriate. ``(e) Regulations.--The Director shall issue regulations for the conduct of peer review under this section. ``SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION, AND DISSEMINATION OF DATA. ``(a) Standards With Respect to Utility of Data.-- ``(1) In general.--To ensure the utility, accuracy, and sufficiency of data collected by or for the Agency for the purpose described in section 901(b), the Director shall establish standard methods for developing and collecting such data, taking into consideration-- ``(A) other Federal health data collection standards; and ``(B) the differences between types of health care plans, delivery systems, health care providers, and provider arrangements. ``(2) Relationship with other department programs.--In any case where standards under paragraph (1) may affect the administration of other programs carried out by the Department of Health and Human Services, includ

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HEALTH RESEARCH AND QUALITY ACT OF 1999
(House of Representatives - September 28, 1999)

Text of this article available as: TXT PDF [Pages H8910-H8941] HEALTH RESEARCH AND QUALITY ACT OF 1999 Mr. GOSS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 299 and ask for its immediate consideration. The Clerk read the resolution, as follows: H. Res. 299 Resolved, That at any time after the adoption of this resolution the Speaker may, pursuant to clause 2(b) of rule XVIII, declare the House resolved into the Committee of the Whole House on the state of the Union for consideration of the bill (H.R. 2506) to amend title IX of the Public Health Service Act to revise and extend the Agency for Health Care Policy and Research. The first reading of the bill shall be dispensed with. General debate shall be confined to the bill and shall not exceed one hour equally divided and controlled by the chairman and ranking minority member of the Committee on Commerce. After general debate the bill shall be considered for amendment under the five-minute rule. It shall be in order to consider as an original bill for the purpose of amendment under the five-minute rule the amendment in the nature of a substitute recommended by the Committee on Commerce now printed in the bill. Each section of the committee amendment in the nature of a substitute shall be considered as read. No amendment to the committee amendment in the nature of a substitute shall be in order except those printed in the portion of the Congressional Record designated for that purpose in clause 8 of rule XVIII and except pro forma amendments for the purpose of debate. Each amendment so printed may be offered only by the Member who caused it to be printed or his designee and shall be considered as read. The Chairman of the Committee of the Whole may: (1) postpone until a time during further consideration in the Committee of the Whole a request for a recorded vote on any amendment; and (2) reduce to five minutes the minimum time for electronic voting on any postponed question that follows another electronic vote without intervening business, provided that the minimum time for electronic voting on the first in any series of questions shall be 15 minutes. At the conclusion of consideration of the bill for amendment the Committee shall rise and report the bill to the House with such amendments as may have been adopted. Any Member may demand a separate vote in the House on any amendment adopted in the Committee of the Whole to the bill or to the committee amendment in the nature of a substitute. The previous question shall be considered as ordered on the bill and amendments thereto to final passage without intervening motion except one motion to recommit with or without instructions. {time} 1445 The SPEAKER pro tempore (Mr. Pease). The gentleman from Florida (Mr. Goss) is recognized for 1 hour. Mr. GOSS. Mr. Speaker, for purposes of debate only, I yield the customary 30 minutes to the distinguished gentlewoman from Rochester, NY (Ms. Slaughter) pending which I yield myself such time as I may consume. During consideration of this resolution, Mr. Speaker, all time yielded is for the purpose of debate only. Mr. Speaker, this is a fair and appropriate rule for this particular legislation. In fact, had it not been for the amount of money H.R. 2506 authorizes, doubling the current authorization level to $900 million, the bill would have been considered under the suspension process. The bill was voted out of the Committee on Commerce by a voice vote and the Committee on Rules reported a modified open rule to ensure that no extraneous amendments to the Public Health Service Act would be considered. The rule allows any Member who has preprinted an amendment in the Congressional Record to offer that amendment. This will ensure a full and open, yet targeted debate on the merits of this particular agency covered by this legislation. When the Agency for Health Care Policy and Research, AHCPR as it is known in its acronym, was created in 1989, the health care universe looked far different than it does today. Traditional fee for service plans still dominated the market and managed care was still very much in its infancy period. Utilization review, peer review, these were largely unknown concepts, at least fully tried or tested. H.R. 2506 modernizes the agency to reflect these and other changes and provides resources to enable more effective collection of data. Many Americans sitting at home watching may be wondering why we need yet another Federal agency involved in health care quality. Well, health care quality is a critical issue these days. As someone who has always believed that Congress too often stands in the way of true health care quality, I share concern with the people at home who are worried about this. To the extent that this ``reformed'' agency can promote better research and encourage successful partnerships between the public and private sectors with limited Federal red tape, it can be a worthy investment. And, of course, that is the goal. But we must retain vigorous oversight and maintain high expectations to ensure that these precious taxpayer dollars are indeed put [[Page H8911]] to good use. Again, we think that is the reason for this legislation and we congratulate its authors for this effort. As I stated before, this is an eminently fair rule that should engender no controversy as far as I know. Mr. Speaker, I reserve the balance of my time. Ms. SLAUGHTER. Mr. Speaker, I thank my distinguished colleague from Florida for yielding me the 30 minutes, and I yield myself such time as I may consume. (Ms. SLAUGHTER asked and was given permission to revise and extend her remarks.) Ms. SLAUGHTER. Mr. Speaker, this is an ``almost open'' rule, for the majority has again relied on a preprinting requirement for amendments which may affect some Members of the House. But I rise in support of the rule and in support of H.R. 2506, the Health Research and Quality Act of 1999. The bill is being brought to the floor by the gentleman from Florida (Mr. Bilirakis) for the majority and the gentleman from Ohio (Mr. Brown) for the minority. This bipartisan legislation reauthorizes the Agency for Health Care Policy and Research and renames the agency as the Agency for Health Research and Quality, AHRQ, pronounced ``arc.'' This agency promotes health care quality through research, synthesizing and consolidating medical information, and disseminating scientific evidence. Building on its current initiatives, the agency will play a key role in partnering with the private sector to improve the quality of health care in the United States. As a longtime supporter of health care research, I believe this piece of legislation will benefit patients, care-givers and insurance providers with vital information and statistics on how to improve the Nation's health care system. The agency's research and information consolidation will play a key role in extending quality care and improving health service delivery throughout the country. This agency provides vital information and resources that foster improvement in health care systems from America's smallest rural townships to its most populous inner cities. The agency's mission includes fostering the extension of quality health care systems to those Americans left behind as our Nation continues its economic growth. The agency's work is especially important as health care delivery in our country evolves. When the AHCPR was established a little over 10 years ago, the health care system was vastly different from what we know today. More people now receive their care through managed plans and HMOs. The growing complexity of health plans bewilderers many patients and contributes to the growing tensions between patients and insurers. This legislation directs AHRQ to address the public's growing concern for the quality of patient care and the number of medical errors that continue to grow each day. Their research helps hospitals and clinics around the country to reduce the injuries arising from mismanagement of cases. A recent study examined the records of more than 30,000 hospital patients in my home State of New York. The study found that nearly 4 percent of patients suffered serious injuries that were related to the management of their illnesses rather than the illnesses themselves. This is a vital area of research for the agency and another reason why the reauthorization of funding for this agency and the redirection of its mission is important. The legislation does more than merely change the name of the agency. It directs the agency to develop new public-private partnerships in the health care arena. This will bring new perspectives to improving the dissemination of health information and the development of health care systems that better serve our neighborhoods, towns and cities. These partnerships will also leverage greater private investment and commitment to creating improved health care service systems throughout the Nation. In the process, AHRQ will also support increased efficiency and quality of Federal program management. According to testimony provided to the committee during a recent hearing, nine out of 10 people surveyed supported health research as well as the amount of Federal money spent on our Nation's health care. Mr. Speaker, this agency costs just one one-hundredth of one percent of the total funds spent by the government on health care and is a sound investment in our Nation's future health. I support this initiative even though it is only a modest step toward guaranteeing that all our citizens have access to the finest medical care in the world. Citizens across the United States are crying out for more. We need comprehensive health care reform that includes a provision to ban genetic discrimination in insurance. We need a true Patients' Bill of Rights. Mr. Speaker, I yield back the balance of my time. Mr. GOSS. Mr. Speaker, I yield back the balance of my time, and I prove the previous question on the resolution. The previous question was ordered. The resolution was agreed to. A motion to reconsider was laid on the table. The SPEAKER pro tempore (Mr. Knollenberg). Pursuant to House Resolution 299 and rule XVIII, the Chair declares the House in the Committee of the Whole House on the State of the Union for the consideration of the bill, H.R. 2506. {time} 1454 In the Committee of the Whole Accordingly, the House resolved itself into the Committee of the Whole House on the State of the Union for the consideration of the bill (H.R. 2506) to amend title IX of the Public Health Service Act to revise and extend the Agency for Health Care Policy and Research, with Mr. Pease in the chair. The Clerk read the title of the bill. The CHAIRMAN. Pursuant to the rule, the bill is considered as having been read the first time. Under the rule, the gentleman from Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each will control 30 minutes. The Chair recognizes the gentleman from Florida (Mr. Bilirakis). Mr. BILIRAKIS. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I am pleased to bring H.R. 2506, the Health Research and Quality Act of 1999, to the floor today. This widely supported bipartisan bill was approved by voice vote in the Committee on Commerce and the Subcommittee on Health and Environment. In April, experts from both the public and private sector testified about the critical function of this agency at a hearing before the subcommittee. I introduced this measure jointly with the gentleman from Ohio (Mr. Brown), the ranking member of the House Commerce Subcommittee on Health and Environment, to reauthorize the Agency for Health Care Policy and Research and redefine its mission. Our bill renames it as the Agency for Health Research and Quality, or, one of those famous Washington acronyms, AHRQ. The purpose of this new name, and the reauthorization, is to foster comprehensive improvements in our health care system. Our bill refocuses the efforts of this critical agency to support private sector initiatives. Building on its current activities, the new agency will become a key partner to the private sector in improving the quality of health care in America. The bill specifically prohibits the agency from mandating national standards of clinical practice or quality health care standards. Instead, it emphasizes the agency's nonregulatory role in building the science of health care quality. The bill also includes provisions to overcome barriers to access to preventive health care through a public-private partnership. It authorizes grants for the establishment of regional centers to improve and increase access to preventive health care services. By approving the legislation before us, we can ensure the continued availability of the objective, science-based information this agency provides. I urge Members to join us in supporting passage of H.R. 2506, the Health Research and Quality Act of 1999. Mr. Chairman, I reserve the balance of my time. Mr. BROWN of Ohio. Mr. Chairman, I yield myself such time as I may consume. I am pleased that the gentleman from Florida (Mr. Bilirakis) and I [[Page H8912]] could work together to introduce the Health Research and Quality Act and pass it out of the Committee on Commerce. We hold similar views on why this issue is important. It is important because research is important. The U.S. health care system is far from transparent. In fact, in many ways it is not even a system. It is a complex set of relationships influenced by science, demographics, politics, money and cultural trends. Whether the focus is on health care financing or health care delivery, common sense alone rarely explains what is going on. In fact, it often throws policymakers off track. If we want to improve on the status quo in health care, we have to get a realistic picture of what the status quo is. By conducting and supporting health services research, AHCPR helps paint that picture for us. If we want to improve on the status quo in health care, we have got to find out what improvement actually means. By conducting and supporting outcomes, effectiveness and cost effectiveness research, AHCPR helps us determine the best way to spend the limited health care dollars that we do have. And if we want to improve on the status quo in health care, we need to get the word out to the people in the institutions, in the agencies and the industries that somehow keep the whole thing running. By disseminating research and data broadly, AHCPR helps ensure that our investment in data collection, health services research and biomedical research pays off. This reauthorization makes research and broad dissemination of information AHCPR's main focus. We could definitely use more of both. I urge support of this important legislation. Mr. Chairman, I reserve the balance of my time. Mr. BILIRAKIS. Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Gary Miller). (Mr. GARY MILLER of California asked and was given permission to revise and extend his remarks.) Mr. GARY MILLER of California. Mr. Chairman, I rise today in support of H.R. 2506, the Health Research and Quality Act. First I want to thank the bill's author the gentleman from Florida (Mr. Bilirakis) and the cosponsors for all their hard work on this issue. H.R. 2506 is an important piece of legislation which will improve the quality of health care by directing the Agency for Health Care Policy and Research to emphasize medical research, synthesizing and disseminating scientific evidence, and advancing public and private efforts to improve health care quality. With the explosion of medical research and information being produced, medical practitioners face the increasingly difficult task of keeping current with medical literature and putting the latest scientific findings into perspective. As one study indicated, even if a doctor read two peer-reviewed journals each night for a year, he or she would still be 800 years behind in their reading. Access to up-to-date, quality research will improve the care that patients obtain from all levels of the health care system. H.R. 2506 will provide a means whereby medical group practices can obtain and contribute to such a body of information. This legislation frees the Agency for Health Care Policy and Research from the difficult task of providing guidelines and standards of care and allows it to focus on providing unbiased, science-based research to the health care community. H.R. 2506 will help health care professionals and policymakers better understand the future demands on the Nation's health care system. Again, I lend my strong support to this measure and urge my colleagues to join me in voting in favor of the Health Research and Quality Act of 1999. {time} 1500 Mr. BILIRAKIS. Mr. Chairman, I yield such time as he may consume to another gentleman from California (Mr. Bilbray). Mr. BILBRAY. Mr. Chairman, I rise to strongly support H.R. 2506, and let me just say as someone who has the privilege of representing the 49th District of California, one of the capitals of both public and private research, I want to commend the chairman and the ranking member for a cooperative effort here at really serving the American people. The concept of reform and change sometimes scares people in these chambers and they worry about what could go wrong, and I think we have to remind ourselves again and again that reform and change is also an essential step to improvement. And this bill will allow us to take that step towards an improvement of not only the cost effectiveness, the cost efficiency, but also the effectiveness of our total health care system through the information age. Mr. Chairman, 2506 will be that kind of step. And I hope that in the future we will be able to look back at H.R. 2506 and look back at the cooperative effort between the chairman of the subcommittee and the ranking member of this subcommittee and say this was the beginning of a very productive relationship between both sides of the aisle and a productive relationship with the American people and their health care system. Mr. Chairman, I would ask all of us to support this bill and support the attitude that is behind this bill and to support the entire concept that Democrats and Republicans can work together for the good of the safety and the health of the American people. Mr. BLILEY. Mr. Chairman, I commend the gentlemen from Florida and Ohio for bringing H.R. 2506, the Health Research and Quality Act of 1999, to the floor. This legislation, introduced by Representatives Bilirakis and Brown, represents an important commitment to provide the science-based evidence that we need to improve health care quality. We need sound and reliable information to help patients make informed decisions, to help health care providers make sense of new discoveries, to help purchasers get value for their health care dollar, and to help avoid medical errors. Today's legislation builds on the progress the Agency for Health Care Policy and Research has already made. It will enable us to benefit from our investment in biomedical research, to improve the health care delivery programs under our jurisdiction, and to build the science of quality measurement and improvement. This emphasis on quality measurement and improvement is important. The focus on health outcomes is critical. If we are unable to determine the long-term effect of the care patients receive today, we will be unable to improve upon that care tomorrow. To address the full continuum of care and outcomes research, and to link research directly with clinical practice in geographically diverse locations throughout the United States, this bill stresses the importance of health care improvement research centers and provider-based research networks. Since the science of outcomes research is complex, this bill requires the agency to support research and evaluation to advance the use of information systems for the study of health care quality and outcomes. The importance of outcomes research and information dissemination in the continuous improvement of patient care cannot be overstated. For example, in the area of cancer care, the ability to chart patient outcomes from a variety of interventions and communicate these outcomes effectively among practitioners will allow significant improvement in the treatment of all types of cancer. In summary, Mr. Chairman, the Health Research and Quality Act of 1999 is a sound investment in the future; it is legislation that both sides of the aisle can support. The Commerce Committee gave unanimous approval to this legislation and I hope it will enjoy similar support on the floor today. Mr. BALDACCI. Mr. Chairman, I commend the Chairman, Mr. Bilirakis, and the Ranking Member, Mr. Brown, for introducing this valuable legislation. I particularly want to thank the Members for the special attention given to rural health care in the bill. Access and quality of health care in rural America is of particular importance to me. I represent the largest geographic district east of the Mississippi. Recently, compounding changes in Medicare reimbursement and regulations have had a devastating impact on my district, and have endangered a very vulnerable population of my state. People in rural areas do not have the same choices available to those in urban areas. I am concerned that the rate of the uninsured in Maine continues to grow. Maine citizens rely heavily on community care, and we ought to promote research into enhancing quality of and access to health care in these areas. Careful studies of the delivery of health services in rural America will allow us to make better public policy, and I thank the Chairman and Ranking Member for their attention to this issue. I am also pleased to see the legislation address the critical issue of health insurance. Section 913 requires that there must be surveys on, among other factors, the types and [[Page H8913]] costs of private health insurance. As we know, there is a growing trend to consolidation among health insurance companies, and I am particularly concerned about the ability of these large companies to direct costs and types of care offered when they buy out smaller local insurers. It is my hope that with this component of the bill, we will gain a better understanding of what effect the consolidation in the health insurance market is having on quality, access, and cost of insurance to rural Americans. Again, I thank the Chairman and Ranking Member for addressing this issue. Mr. BILIRAKIS. Mr. Chairman, we have no further requests for time. Mr. BROWN of Ohio. Mr. Chairman, I yield back the balance of my time. Mr. BILIRAKIS. Mr. Chairman, I yield back the balance of my time. The CHAIRMAN. All time for general debate has expired. Pursuant to the rule, the committee amendment in the nature of a substitute printed in the bill shall be considered by sections as an original bill for the purpose of amendment, and each section is considered read. No amendment to that amendment shall be in order except those printed in the portion of the Congressional Record designated for that purpose and pro forma amendments for the purpose of debate. Amendments printed in the Record may be offered only by the Member who caused it to be printed or his designee and shall be considered read. The Chairman of the Committee of the Whole may postpone a request for a recorded vote on any amendment and may reduce to a minimum of 5 minutes the time for voting on any postponed question that immediately follows another vote, provided that the time for voting on the first question shall be a minimum of 15 minutes. The Clerk will designate section 1. The text of section 1 is as follows: Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Health Research and Quality Act of 1999''. The CHAIRMAN. Are there any amendments to section 1? The Clerk will designate section 2. The text of section 2 is as follows: SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT. (a) In General.--Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is amended to read as follows: ``TITLE IX--AGENCY FOR HEALTH RESEARCH AND QUALITY ``PART A--ESTABLISHMENT AND GENERAL DUTIES ``SEC. 901. MISSION AND DUTIES. ``(a) In General.--There is established within the Public Health Service an agency to be known as the Agency for Health Research and Quality, which shall be headed by a director appointed by the Secretary. The Secretary shall carry out this title acting through the Director. ``(b) Mission.--The purpose of the Agency is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health system practices, including the prevention of diseases and other health conditions. The Agency shall promote health care quality improvement by-- ``(1) conducting and supporting research that develops and presents scientific evidence regarding all aspects of health, including-- ``(A) the development and assessment of methods for enhancing patient participation in their own care and for facilitating shared patient-physician decision-making; ``(B) the outcomes, effectiveness, and cost-effectiveness of health care practices, including preventive measures and long-term care; ``(C) existing and innovative technologies; ``(D) the costs and utilization of, and access to health care; ``(E) the ways in which health care services are organized, delivered, and financed and the interaction and impact of these factors on the quality of patient care; ``(F) methods for measuring quality and strategies for improving quality; and ``(G) ways in which patients, consumers, purchasers, and practitioners acquire new information about best practices and health benefits, the determinants and impact of their use of this information; ``(2) synthesizing and disseminating available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, policy makers, and educators; and ``(3) advancing private and public efforts to improve health care quality. ``(c) Requirements With Respect to Rural Areas and Priority Populations.--In carrying out subsection (b), the Director shall undertake and support research, demonstration projects, and evaluations with respect to-- ``(1) the delivery of health services in rural areas (including frontier areas); ``(2) health services for low-income groups, and minority groups; ``(3) the health of children; ``(4) the elderly; and ``(5) people with special health care needs, including disabilities, chronic care and end-of-life health care. ``SEC. 902. GENERAL AUTHORITIES. ``(a) In General.--In carrying out section 901(b), the Director shall support demonstration projects, conduct and support research, evaluations, training, research networks, multi-disciplinary centers, technical assistance, and the dissemination of information, on health care, and on systems for the delivery of such care, including activities with respect to-- ``(1) the quality, effectiveness, efficiency, appropriateness and value of health care services; ``(2) quality measurement and improvement; ``(3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services; ``(4) clinical practice, including primary care and practice-oriented research; ``(5) health care technologies, facilities, and equipment; ``(6) health care costs, productivity, organization, and market forces; ``(7) health promotion and disease prevention, including clinical preventive services; ``(8) health statistics, surveys, database development, and epidemiology; and ``(9) medical liability. ``(b) Health Services Training Grants.-- ``(1) In general.--The Director may provide training grants in the field of health services research related to activities authorized under subsection (a), to include pre- and post-doctoral fellowships and training programs, young investigator awards, and other programs and activities as appropriate. In carrying out this subsection, the Director shall make use of funds made available under section 487. ``(2) Requirements.--In developing priorities for the allocation of training funds under this subsection, the Director shall take into consideration shortages in the number of trained researchers addressing the priority populations. ``(c) Multidisciplinary Centers.--The Director may provide financial assistance to assist in meeting the costs of planning and establishing new centers, and operating existing and new centers, for multidisciplinary health services research, demonstration projects, evaluations, training, and policy analysis with respect to the matters referred to in subsection (a). ``(d) Relation to Certain Authorities Regarding Social Security.--Activities authorized in this section shall be appropriately coordinated with experiments, demonstration projects, and other related activities authorized by the Social Security Act and the Social Security Amendments of 1967. Activities under subsection (a)(2) of this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act shall be carried out consistent with section 1142 of such Act. ``(e) Disclaimer.--The Agency shall not mandate national standards of clinical practice or quality health care standards. Recommendations resulting from projects funded and published by the Agency shall include a corresponding disclaimer. ``(f) Rule of Construction.--Nothing in this section shall be construed to imply that the Agency's role is to mandate a national standard or specific approach to quality measurement and reporting. In research and quality improvement activities, the Agency shall consider a wide range of choices, providers, health care delivery systems, and individual preferences. ``PART B--HEALTH CARE IMPROVEMENT RESEARCH ``SEC. 911. HEALTH CARE OUTCOME IMPROVEMENT RESEARCH. ``(a) Evidence Rating Systems.--In collaboration with experts from the public and private sector, the Agency shall identify and disseminate methods or systems that it uses to assess health care research results, particularly methods or systems that it uses to rate the strength of the scientific evidence behind health care practice, recommendations in the research literature, and technology assessments. The Agency shall make methods or systems for evidence rating widely available. Agency publications containing health care recommendations shall indicate the level of substantiating evidence using such methods or systems. ``(b) Health Care Improvement Research Centers and Provider-Based Research Networks.-- ``(1) In general.--In order to address the full continuum of care and outcomes research, to link research to practice improvement, and to speed the dissemination of research findings to community practice settings, the Agency shall employ research strategies and mechanisms that will link research directly with clinical practice in geographically diverse locations throughout the United States, including-- ``(A) Health Care Improvement Research Centers that combine demonstrated multidisciplinary expertise in outcomes or quality improvement research with linkages to relevant sites of care; ``(B) Provider-based Research Networks, including plan, facility, or delivery system sites of care (especially primary care), that can evaluate outcomes and promote quality improvement; and ``(C) other innovative mechanisms or strategies to link research with clinical practice. ``(2) Requirements.--The Director is authorized to establish the requirements for entities applying for grants under this subsection. ``SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND DELIVERY. ``(a) Support for Efforts To Develop Information on Quality.-- ``(1) Scientific and technical support.--In its role as the principal agency for health research and quality, the Agency may provide scientific and technical support for private and [[Page H8914]] public efforts to improve health care quality, including the activities of accrediting organizations. ``(2) Role of the agency.--With respect to paragraph (1), the role of the Agency shall include-- ``(A) the identification and assessment of methods for the evaluation of the health of-- ``(i) enrollees in health plans by type of plan, provider, and provider arrangements; and ``(ii) other populations, including those receiving long- term care services; ``(B) the ongoing development, testing, and dissemination of quality measures, including measures of health and functional outcomes; ``(C) the compilation and dissemination of health care quality measures developed in the private and public sector; ``(D) assistance in the development of improved health care information systems; ``(E) the development of survey tools for the purpose of measuring participant and beneficiary assessments of their health care; and ``(F) identifying and disseminating information on mechanisms for the integration of information on quality into purchaser and consumer decision-making processes. ``(b) Centers for Education and Research on Therapeutics.-- ``(1) In general.--The Secretary, acting through the Director and in consultation with the Commissioner of Food and Drugs, shall establish a program for the purpose of making one or more grants for the establishment and operation of one or more centers to carry out the activities specified in paragraph (2). ``(2) Required activities.--The activities referred to in this paragraph are the following: ``(A) The conduct of state-of-the-art research for the following purposes: ``(i) To increase awareness of-- ``(I) new uses of drugs, biological products, and devices; ``(II) ways to improve the effective use of drugs, biological products, and devices; and ``(III) risks of new uses and risks of combinations of drugs and biological products. ``(ii) To provide objective clinical information to the following individuals and entities: ``(I) Health care practitioners and other providers of health care goods or services. ``(II) Pharmacists, pharmacy benefit managers and purchasers. ``(III) Health maintenance organizations and other managed health care organizations. ``(IV) Health care insurers and governmental agencies. ``(V) Patients and consumers. ``(iii) To improve the quality of health care while reducing the cost of health care through-- ``(I) an increase in the appropriate use of drugs, biological products, or devices; and ``(II) the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations. ``(B) The conduct of research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices. ``(C) Such other activities as the Secretary determines to be appropriate, except that a grant may not be expended to assist the Secretary in the review of new drugs. ``(c) Reducing Errors in Medicine.--The Director shall conduct and support research and build private-public partnerships to-- ``(1) identify the causes of preventable health care errors and patient injury in health care delivery; ``(2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and ``(3) promote the implementation of effective strategies throughout the health care industry. ``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE. ``(a) In General.--In carrying out 902(a), the Director shall-- ``(1) conduct a survey to collect data on a nationally representative sample of the population on the cost, use and, for fiscal year 2001 and subsequent fiscal years, quality of health care, including the types of health care services Americans use, their access to health care services, frequency of use, how much is paid for the services used, the source of those payments, the types and costs of private health insurance, access, satisfaction, and quality of care for the general population and also for populations identified in section 901(c); and ``(2) develop databases and tools that provide information to States on the quality, access, and use of health care services provided to their residents. ``(b) Quality and Outcomes Information.-- ``(1) In general.--Beginning in fiscal year 2001, the Director shall ensure that the survey conducted under subsection (a)(1) will-- ``(A) identify determinants of health outcomes and functional status, the needs of special populations in such variables as well as an understanding of changes over time, relationships to health care access and use, and monitor the overall national impact of Federal and State policy changes on health care; ``(B) provide information on the quality of care and patient outcomes for frequently occurring clinical conditions for a nationally representative sample of the population; and ``(C) provide reliable national estimates for children and persons with special health care needs through the use of supplements or periodic expansions of the survey. In expanding the Medical Expenditure Panel Survey, as in existence on the date of enactment of this title in fiscal year 2001 to collect information on the quality of care, the Director shall take into account any outcomes measurements generally collected by private sector accreditation organizations. ``(2) Annual report.--Beginning in fiscal year 2003, the Secretary, acting through the Director, shall submit to Congress an annual report on national trends in the quality of health care provided to the American people. ``SEC. 914. INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT. ``(a) In General.--In order to foster a range of innovative approaches to the management and communication of health information, the Agency shall support research, evaluations and initiatives to advance-- ``(1) the use of information systems for the study of health care quality and outcomes, including the generation of both individual provider and plan-level comparative performance data; ``(2) training for health care practitioners and researchers in the use of information systems; ``(3) the creation of effective linkages between various sources of health information, including the development of information networks; ``(4) the delivery and coordination of evidence-based health care services, including the use of real-time health care decision-support programs; ``(5) the structure, content, definition, and coding of health information data and medical vocabularies in consultation with appropriate Federal entities and shall seek input from appropriate private entities; ``(6) the use of computer-based health records in outpatient and inpatient settings as a personal health record for individual health assessment and maintenance, and for monitoring public health and outcomes of care within populations; and ``(7) the protection of individually identifiable information in health services research and health care quality improvement. ``(b) Demonstration.--The Agency shall support demonstrations into the use of new information tools aimed at improving shared decision-making between patients and their care-givers. ``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN UNDERSERVED AREAS. ``(a) Preventive Services Task Force.-- ``(1) Purpose.--The Agency shall provide ongoing administrative, research, and technical support for the operation of the Preventive Services Task Force. The Agency shall coordinate and support the dissemination of the Preventive Services Task Force recommendations. ``(2) Operation.--The Preventive Services Task Force shall review the scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care community, and updating previous recommendations, regarding their usefulness in daily clinical practice. In carrying out its responsibilities under paragraph (1), the Task Force shall not be subject to the provisions of Appendix 2 of title 5, United States Code. ``(b) Primary Care Research.-- ``(1) In general.--There is established within the Agency a Center for Primary Care Research (referred to in this subsection as the `Center') that shall serve as the principal source of funding for primary care practice research in the Department of Health and Human Services. For purposes of this paragraph, primary care research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral to specialty care, preventive care, and the relationship between the clinician and the patient in the context of the family and community. ``(2) Research.--In carrying out this section, the Center shall conduct and support research concerning-- ``(A) the nature and characteristics of primary care practice; ``(B) the management of commonly occurring clinical problems; ``(C) the management of undifferentiated clinical problems; and ``(D) the continuity and coordination of health services. ``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION. ``(a) In General.--The Director shall promote innovation in evidence-based clinical practice and health care technologies by-- ``(1) conducting and supporting research on the development, diffusion, and use of health care technology; ``(2) developing, evaluating, and disseminating methodologies for assessments of health care practices and health care technologies; ``(3) conducting intramural and supporting extramural assessments of existing and new health care practices and technologies; ``(4) promoting education, training, and providing technical assistance in the use of health care practice and health care technology assessment methodologies and results; and ``(5) working with the National Library of Medicine and the public and private sector to develop an electronic clearinghouse of currently available assessments and those in progress. ``(b) Specification of Process.-- ``(1) In general.--Not later than December 31, 2000, the Director shall develop and publish a description of the methods used by the Agency and its contractors for practice and technology assessment. ``(2) Consultations.--In carrying out this subsection, the Director shall cooperate and consult with the Assistant Secretary for Health, the Administrator of the Health Care Financing Administration, the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the heads of any other interested Federal department or agency, and shall seek input, where appropriate, from professional societies and other private and public entities. ``(3) Methodology.--The Director shall, in developing the methods used under paragraph (1), consider-- ``(A) safety, efficacy, and effectiveness; [[Page H8915]] ``(B) legal, social, and ethical implications; ``(C) costs, benefits, and cost-effectiveness; ``(D) comparisons to alternate technologies and practices; and ``(E) requirements of Food and Drug Administration approval to avoid duplication. ``(c) Specific Assessments.-- ``(1) In general.--The Director shall conduct or support specific assessments of health care technologies and practices. ``(2) Requests for assessments.--The Director is authorized to conduct or support assessments, on a reimbursable basis, for the Health Care Financing Administration, the Department of Defense, the Department of Veterans Affairs, the Office of Personnel Management, and other public or private entities. ``(3) Grants and contracts.--In addition to conducting assessments, the Director may make grants to, or enter into cooperative agreements or contracts with, entities described in paragraph (4) for the purpose of conducting assessments of experimental, emerging, existing, or potentially outmoded health care technologies, and for related activities. ``(4) Eligible entities.--An entity described in this paragraph is an entity that is determined to be appropriate by the Director, including academic medical centers, research institutions and organizations, professional organizations, third party payers, governmental agencies, and consortia of appropriate research entities established for the purpose of conducting technology assessments. ``SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY IMPROVEMENT EFFORTS. ``(a) Requirement.-- ``(1) In general.--To avoid duplication and ensure that Federal resources are used efficiently and effectively, the Secretary, acting through the Director, shall coordinate all research, evaluations, and demonstrations related to health services research, quality measurement and quality improvement activities undertaken and supported by the Federal Government. ``(2) Specific activities.--The Director, in collaboration with the appropriate Federal officials representing all concerned executive agencies and departments, shall develop and manage a process to-- ``(A) improve interagency coordination, priority setting, and the use and sharing of research findings and data pertaining to Federal quality improvement programs, technology assessment, and health services research; ``(B) strengthen the research information infrastructure, including databases, pertaining to Federal health services research and health care quality improvement initiatives; ``(C) set specific goals for participating agencies and departments to further health services research and health care quality improvement; and ``(D) strengthen the management of Federal health care quality improvement programs. ``(b) Study by the Institute of Medicine.-- ``(1) In general.--To provide Congress, the Department of Health and Human Services, and other relevant departments with an independent, external review of their quality oversight, quality improvement and quality research programs, the Secretary shall enter into a contract with the Institute of Medicine-- ``(A) to describe and evaluate current quality improvement, quality research and quality monitoring processes through-- ``(i) an overview of pertinent health services research activities and quality improvement efforts conducted by all Federal programs, with particular attention paid to those under titles XVIII, XIX, and XXI of the Social Security Act; and ``(ii) a summary of the partnerships that the Department of Health and Human Services has pursued with private accreditation, quality measurement and improvement organizations; and ``(B) to identify options and make recommendations to improve the efficiency and effectiveness of quality improvement programs through-- ``(i) the improved coordination of activities across the medicare, medicaid and child health insurance programs under titles XVIII, XIX and XXI of the Social Security Act and health services research programs; ``(ii) the strengthening of patient choice and participation by incorporating state-of-the-art quality monitoring tools and making information on quality available; and ``(iii) the enhancement of the most effective programs, consolidation as appropriate, and elimination of duplicative activities within various federal agencies. ``(2) Requirements.-- ``(A) In general.--The Secretary shall enter into a contract with the Institute of Medicine for the preparation-- ``(i) not later than 12 months after the date of enactment of this title, of a report providing an overview of the quality improvement programs of the Department of Health and Human Services for the medicare, medicaid, and CHIP programs under titles XVIII, XIX, and XXI of the Social Security Act; and ``(ii) not later than 24 months after the date of enactment of this title, of a final report containing recommendations. ``(B) Reports.--The Secretary shall submit the reports described in subparagraph (A) to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Ways and Means and the Committee on Commerce of the House of Representatives. ``PART C--GENERAL PROVISIONS ``SEC. 921. ADVISORY COUNCIL FOR HEALTH CARE RESEARCH AND QUALITY. ``(a) Establishment.--There is established an advisory council to be known as the Advisory Council for Health Care Research and Quality. ``(b) Duties.-- ``(1) In general.--The Advisory Council shall advise the Secretary and the Director with respect to activities proposed or undertaken to carry out the purpose of the Agency under section 901(b). ``(2) Certain recommendations.--Activities of the Advisory Council under paragraph (1) shall include making recommendations to the Director regarding-- ``(A) priorities regarding health care research, especially studies related to quality, outcomes, cost and the utilization of, and access to, health care services; ``(B) the field of health care research and related disciplines, especially issues related to training needs, and dissemination of information pertaining to health care quality; and ``(C) the appropriate role of the Agency in each of these areas in light of private sector activity and identification of opportunities for public-private sector partnerships. ``(c) Membership.-- ``(1) In general.--The Advisory Council shall, in accordance with this subsection, be composed of appointed members and ex officio members. All members of the Advisory Council shall be voting members other than the individuals designated under paragraph (3)(B) as ex officio members. ``(2) Appointed members.--The Secretary shall appoint to the Advisory Council 18 appropriately qualified individuals. At least 14 members of the Advisory Council shall be representatives of the public who are not officers or employees of the United States. The Secretary shall ensure that the appointed members of the Council, as a group, are representative of professions and entities concerned with, or affected by, activities under this title and under section 1142 of the Social Security Act. Of such members-- ``(A) 3 shall be individuals distinguished in the conduct of research, demonstration projects, and evaluations with respect to health care; ``(B) 3 shall be individuals distinguished in the practice of medicine of which at least 1 shall be a primary care practitioner; ``(C) 3 shall be individuals distinguished in the other health professions; ``(D) 3 shall be individuals either representing the private health care sector, including health plans, providers, and purchasers or individuals distinguished as administrators of health care delivery systems; ``(E) 3 shall be individuals distinguished in the fields of health care quality improvement, economics, information systems, law, ethics, business, or public policy; and ``(F) 3 shall be individuals representing the interests of patients and consumers of health care. ``(3) Ex officio members.--The Secretary shall designate as ex officio members of the Advisory Council-- ``(A) the Assistant Secretary for Health, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Care Financing Administration, the Assistant Secretary of Defense (Health Affairs), and the Under Secretary for Health of the Department of Veterans Affairs; and ``(B) such other Federal officials as the Secretary may consider appropriate. ``(d) Terms.--Members of the Advisory Council appointed under subsection (c)(2) shall serve for a term of 3 years. A member of the Council appointed under such subsection may continue to serve after the expiration of the term of the members until a successor is appointed. ``(e) Vacancies.--If a member of the Advisory Council appointed under subsection (c)(2) does not serve the full term applicable under subsection (d), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual. ``(f) Chair.--The Director shall, from among the members of the Advisory Council appointed under subsection (c)(2), designate an individual to serve as the chair of the Advisory Council. ``(g) Meetings.--The Advisory Council shall meet not less than once during each discrete 4-month period and shall otherwise meet at the call of the Director or the chair. ``(h) Compensation and Reimbursement of Expenses.-- ``(1) Appointed members.--Members of the Advisory Council appointed under subsection (c)(2) shall receive compensation for each day (including travel time) engaged in carrying out the duties of the Advisory Council unless declined by the member. Such compensation may not be in an amount in excess of the maximum rate of basic pay payable for GS-18 of the General Schedule. ``(2) Ex officio members.--Officials designated under subsection (c)(3) as ex officio members of the Advisory Council may not receive compensation for service on the Advisory Council in addition to the compensation otherwise received for duties carried out as officers of the United States. ``(i) Staff.--The Director shall provide to the Advisory Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council. ``SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS. ``(a) Requirement of Review.-- ``(1) In general.--Appropriate technical and scientific peer review shall be conducted with respect to each application for a grant, cooperative agreement, or contract under this title. ``(2) Reports to director.--Each peer review group to which an application is submitted pursuant to paragraph (1) shall report its finding and recommendations respecting the application to the Director in such form and in such manner as the Director shall require. ``(b) Approval as Precondition of Awards.--The Director may not approve an application described in subsection (a)(1) unless [[Page H8916]] the application is recommended for approval by a peer review group established under subsection (c). ``(c) Establishment of Peer Review Groups.-- ``(1) In general.--The Director shall establish such technical and scientific peer review groups as may be necessary to carry out this section. Such groups shall be established without regard to the provisions of title 5, United States Code, that govern appointments in the competitive service, and without regard to the provisions of chapter 51, and subchapter III of chapter 53, of such title that relate to classification and pay rates under the General Schedule. ``(2) Membership.--The members of any peer review group established under this section shall be appointed from among individuals who by virtue of their training or experience are eminently qualified to carry out the duties of such peer review group. Officers and employees of the United States may not constitute more than 25 percent of the membership of any such group. Such officers and employees may not receive compensation for service on such groups in addition to the compensation otherwise received for these duties carried out as such officers and employees. ``(3) Duration.--Notwithstanding section 14(a) of the Federal Advisory Committee Act, peer review groups established under this section may continue in existence until otherwise provided by law. ``(4) Qualifications.--Members of any peer-review group shall, at a minimum, meet the following requirements: ``(A) Such members shall agree in writing to treat information received, pursuant to their work for the group, as confidential information, except that this subparagraph shall not apply to public records and public information. ``(B) Such members shall agree in writing to recuse themselves from participation in the peer-review of specific applications which present a potential personal conflict of interest or appearance of such conflict, including employment in a directly affected organization, stock ownership, or any financial or other arrangement that might introduce bias in the process of peer-review. ``(d) Authority for Procedural Adjustments in Certain Cases.--In the case of applications for financial assistance whose direct costs will not exceed $100,000, the Director may make appropriate adjustments in the procedures otherwise established by the Director for the conduct of peer review under this section. Such adjustments may be made for the purpose of encouraging the entry of individuals into the field of research, for the purpose of encouraging clinical practice-oriented or provider-based research, and for such other purposes as the Director may determine to be appropriate. ``(e) Regulations.--The Director shall issue regulations for the conduct of peer review under this section. ``SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION, AND DISSEMINATION OF DATA. ``(a) Standards With Respect to Utility of Data.-- ``(1) In general.--To ensure the utility, accuracy, and sufficiency of data collected by or for the Agency for the purpose described in section 901(b), the Director shall establish standard methods for developing and collecting such data, taking into consideration-- ``(A) other Federal health data collection standards; and ``(B) the differences between types of health care plans, delivery systems, health care providers, and provider arrangements. ``(2) Relationship with other department programs.--In any case where standards under paragraph (1) may affect the administration of other programs carried out by the Department of Health and Human Servic

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HEALTH RESEARCH AND QUALITY ACT OF 1999
(House of Representatives - September 28, 1999)

Text of this article available as: TXT PDF [Pages H8910-H8941] HEALTH RESEARCH AND QUALITY ACT OF 1999 Mr. GOSS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 299 and ask for its immediate consideration. The Clerk read the resolution, as follows: H. Res. 299 Resolved, That at any time after the adoption of this resolution the Speaker may, pursuant to clause 2(b) of rule XVIII, declare the House resolved into the Committee of the Whole House on the state of the Union for consideration of the bill (H.R. 2506) to amend title IX of the Public Health Service Act to revise and extend the Agency for Health Care Policy and Research. The first reading of the bill shall be dispensed with. General debate shall be confined to the bill and shall not exceed one hour equally divided and controlled by the chairman and ranking minority member of the Committee on Commerce. After general debate the bill shall be considered for amendment under the five-minute rule. It shall be in order to consider as an original bill for the purpose of amendment under the five-minute rule the amendment in the nature of a substitute recommended by the Committee on Commerce now printed in the bill. Each section of the committee amendment in the nature of a substitute shall be considered as read. No amendment to the committee amendment in the nature of a substitute shall be in order except those printed in the portion of the Congressional Record designated for that purpose in clause 8 of rule XVIII and except pro forma amendments for the purpose of debate. Each amendment so printed may be offered only by the Member who caused it to be printed or his designee and shall be considered as read. The Chairman of the Committee of the Whole may: (1) postpone until a time during further consideration in the Committee of the Whole a request for a recorded vote on any amendment; and (2) reduce to five minutes the minimum time for electronic voting on any postponed question that follows another electronic vote without intervening business, provided that the minimum time for electronic voting on the first in any series of questions shall be 15 minutes. At the conclusion of consideration of the bill for amendment the Committee shall rise and report the bill to the House with such amendments as may have been adopted. Any Member may demand a separate vote in the House on any amendment adopted in the Committee of the Whole to the bill or to the committee amendment in the nature of a substitute. The previous question shall be considered as ordered on the bill and amendments thereto to final passage without intervening motion except one motion to recommit with or without instructions. {time} 1445 The SPEAKER pro tempore (Mr. Pease). The gentleman from Florida (Mr. Goss) is recognized for 1 hour. Mr. GOSS. Mr. Speaker, for purposes of debate only, I yield the customary 30 minutes to the distinguished gentlewoman from Rochester, NY (Ms. Slaughter) pending which I yield myself such time as I may consume. During consideration of this resolution, Mr. Speaker, all time yielded is for the purpose of debate only. Mr. Speaker, this is a fair and appropriate rule for this particular legislation. In fact, had it not been for the amount of money H.R. 2506 authorizes, doubling the current authorization level to $900 million, the bill would have been considered under the suspension process. The bill was voted out of the Committee on Commerce by a voice vote and the Committee on Rules reported a modified open rule to ensure that no extraneous amendments to the Public Health Service Act would be considered. The rule allows any Member who has preprinted an amendment in the Congressional Record to offer that amendment. This will ensure a full and open, yet targeted debate on the merits of this particular agency covered by this legislation. When the Agency for Health Care Policy and Research, AHCPR as it is known in its acronym, was created in 1989, the health care universe looked far different than it does today. Traditional fee for service plans still dominated the market and managed care was still very much in its infancy period. Utilization review, peer review, these were largely unknown concepts, at least fully tried or tested. H.R. 2506 modernizes the agency to reflect these and other changes and provides resources to enable more effective collection of data. Many Americans sitting at home watching may be wondering why we need yet another Federal agency involved in health care quality. Well, health care quality is a critical issue these days. As someone who has always believed that Congress too often stands in the way of true health care quality, I share concern with the people at home who are worried about this. To the extent that this ``reformed'' agency can promote better research and encourage successful partnerships between the public and private sectors with limited Federal red tape, it can be a worthy investment. And, of course, that is the goal. But we must retain vigorous oversight and maintain high expectations to ensure that these precious taxpayer dollars are indeed put [[Page H8911]] to good use. Again, we think that is the reason for this legislation and we congratulate its authors for this effort. As I stated before, this is an eminently fair rule that should engender no controversy as far as I know. Mr. Speaker, I reserve the balance of my time. Ms. SLAUGHTER. Mr. Speaker, I thank my distinguished colleague from Florida for yielding me the 30 minutes, and I yield myself such time as I may consume. (Ms. SLAUGHTER asked and was given permission to revise and extend her remarks.) Ms. SLAUGHTER. Mr. Speaker, this is an ``almost open'' rule, for the majority has again relied on a preprinting requirement for amendments which may affect some Members of the House. But I rise in support of the rule and in support of H.R. 2506, the Health Research and Quality Act of 1999. The bill is being brought to the floor by the gentleman from Florida (Mr. Bilirakis) for the majority and the gentleman from Ohio (Mr. Brown) for the minority. This bipartisan legislation reauthorizes the Agency for Health Care Policy and Research and renames the agency as the Agency for Health Research and Quality, AHRQ, pronounced ``arc.'' This agency promotes health care quality through research, synthesizing and consolidating medical information, and disseminating scientific evidence. Building on its current initiatives, the agency will play a key role in partnering with the private sector to improve the quality of health care in the United States. As a longtime supporter of health care research, I believe this piece of legislation will benefit patients, care-givers and insurance providers with vital information and statistics on how to improve the Nation's health care system. The agency's research and information consolidation will play a key role in extending quality care and improving health service delivery throughout the country. This agency provides vital information and resources that foster improvement in health care systems from America's smallest rural townships to its most populous inner cities. The agency's mission includes fostering the extension of quality health care systems to those Americans left behind as our Nation continues its economic growth. The agency's work is especially important as health care delivery in our country evolves. When the AHCPR was established a little over 10 years ago, the health care system was vastly different from what we know today. More people now receive their care through managed plans and HMOs. The growing complexity of health plans bewilderers many patients and contributes to the growing tensions between patients and insurers. This legislation directs AHRQ to address the public's growing concern for the quality of patient care and the number of medical errors that continue to grow each day. Their research helps hospitals and clinics around the country to reduce the injuries arising from mismanagement of cases. A recent study examined the records of more than 30,000 hospital patients in my home State of New York. The study found that nearly 4 percent of patients suffered serious injuries that were related to the management of their illnesses rather than the illnesses themselves. This is a vital area of research for the agency and another reason why the reauthorization of funding for this agency and the redirection of its mission is important. The legislation does more than merely change the name of the agency. It directs the agency to develop new public-private partnerships in the health care arena. This will bring new perspectives to improving the dissemination of health information and the development of health care systems that better serve our neighborhoods, towns and cities. These partnerships will also leverage greater private investment and commitment to creating improved health care service systems throughout the Nation. In the process, AHRQ will also support increased efficiency and quality of Federal program management. According to testimony provided to the committee during a recent hearing, nine out of 10 people surveyed supported health research as well as the amount of Federal money spent on our Nation's health care. Mr. Speaker, this agency costs just one one-hundredth of one percent of the total funds spent by the government on health care and is a sound investment in our Nation's future health. I support this initiative even though it is only a modest step toward guaranteeing that all our citizens have access to the finest medical care in the world. Citizens across the United States are crying out for more. We need comprehensive health care reform that includes a provision to ban genetic discrimination in insurance. We need a true Patients' Bill of Rights. Mr. Speaker, I yield back the balance of my time. Mr. GOSS. Mr. Speaker, I yield back the balance of my time, and I prove the previous question on the resolution. The previous question was ordered. The resolution was agreed to. A motion to reconsider was laid on the table. The SPEAKER pro tempore (Mr. Knollenberg). Pursuant to House Resolution 299 and rule XVIII, the Chair declares the House in the Committee of the Whole House on the State of the Union for the consideration of the bill, H.R. 2506. {time} 1454 In the Committee of the Whole Accordingly, the House resolved itself into the Committee of the Whole House on the State of the Union for the consideration of the bill (H.R. 2506) to amend title IX of the Public Health Service Act to revise and extend the Agency for Health Care Policy and Research, with Mr. Pease in the chair. The Clerk read the title of the bill. The CHAIRMAN. Pursuant to the rule, the bill is considered as having been read the first time. Under the rule, the gentleman from Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each will control 30 minutes. The Chair recognizes the gentleman from Florida (Mr. Bilirakis). Mr. BILIRAKIS. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I am pleased to bring H.R. 2506, the Health Research and Quality Act of 1999, to the floor today. This widely supported bipartisan bill was approved by voice vote in the Committee on Commerce and the Subcommittee on Health and Environment. In April, experts from both the public and private sector testified about the critical function of this agency at a hearing before the subcommittee. I introduced this measure jointly with the gentleman from Ohio (Mr. Brown), the ranking member of the House Commerce Subcommittee on Health and Environment, to reauthorize the Agency for Health Care Policy and Research and redefine its mission. Our bill renames it as the Agency for Health Research and Quality, or, one of those famous Washington acronyms, AHRQ. The purpose of this new name, and the reauthorization, is to foster comprehensive improvements in our health care system. Our bill refocuses the efforts of this critical agency to support private sector initiatives. Building on its current activities, the new agency will become a key partner to the private sector in improving the quality of health care in America. The bill specifically prohibits the agency from mandating national standards of clinical practice or quality health care standards. Instead, it emphasizes the agency's nonregulatory role in building the science of health care quality. The bill also includes provisions to overcome barriers to access to preventive health care through a public-private partnership. It authorizes grants for the establishment of regional centers to improve and increase access to preventive health care services. By approving the legislation before us, we can ensure the continued availability of the objective, science-based information this agency provides. I urge Members to join us in supporting passage of H.R. 2506, the Health Research and Quality Act of 1999. Mr. Chairman, I reserve the balance of my time. Mr. BROWN of Ohio. Mr. Chairman, I yield myself such time as I may consume. I am pleased that the gentleman from Florida (Mr. Bilirakis) and I [[Page H8912]] could work together to introduce the Health Research and Quality Act and pass it out of the Committee on Commerce. We hold similar views on why this issue is important. It is important because research is important. The U.S. health care system is far from transparent. In fact, in many ways it is not even a system. It is a complex set of relationships influenced by science, demographics, politics, money and cultural trends. Whether the focus is on health care financing or health care delivery, common sense alone rarely explains what is going on. In fact, it often throws policymakers off track. If we want to improve on the status quo in health care, we have to get a realistic picture of what the status quo is. By conducting and supporting health services research, AHCPR helps paint that picture for us. If we want to improve on the status quo in health care, we have got to find out what improvement actually means. By conducting and supporting outcomes, effectiveness and cost effectiveness research, AHCPR helps us determine the best way to spend the limited health care dollars that we do have. And if we want to improve on the status quo in health care, we need to get the word out to the people in the institutions, in the agencies and the industries that somehow keep the whole thing running. By disseminating research and data broadly, AHCPR helps ensure that our investment in data collection, health services research and biomedical research pays off. This reauthorization makes research and broad dissemination of information AHCPR's main focus. We could definitely use more of both. I urge support of this important legislation. Mr. Chairman, I reserve the balance of my time. Mr. BILIRAKIS. Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Gary Miller). (Mr. GARY MILLER of California asked and was given permission to revise and extend his remarks.) Mr. GARY MILLER of California. Mr. Chairman, I rise today in support of H.R. 2506, the Health Research and Quality Act. First I want to thank the bill's author the gentleman from Florida (Mr. Bilirakis) and the cosponsors for all their hard work on this issue. H.R. 2506 is an important piece of legislation which will improve the quality of health care by directing the Agency for Health Care Policy and Research to emphasize medical research, synthesizing and disseminating scientific evidence, and advancing public and private efforts to improve health care quality. With the explosion of medical research and information being produced, medical practitioners face the increasingly difficult task of keeping current with medical literature and putting the latest scientific findings into perspective. As one study indicated, even if a doctor read two peer-reviewed journals each night for a year, he or she would still be 800 years behind in their reading. Access to up-to-date, quality research will improve the care that patients obtain from all levels of the health care system. H.R. 2506 will provide a means whereby medical group practices can obtain and contribute to such a body of information. This legislation frees the Agency for Health Care Policy and Research from the difficult task of providing guidelines and standards of care and allows it to focus on providing unbiased, science-based research to the health care community. H.R. 2506 will help health care professionals and policymakers better understand the future demands on the Nation's health care system. Again, I lend my strong support to this measure and urge my colleagues to join me in voting in favor of the Health Research and Quality Act of 1999. {time} 1500 Mr. BILIRAKIS. Mr. Chairman, I yield such time as he may consume to another gentleman from California (Mr. Bilbray). Mr. BILBRAY. Mr. Chairman, I rise to strongly support H.R. 2506, and let me just say as someone who has the privilege of representing the 49th District of California, one of the capitals of both public and private research, I want to commend the chairman and the ranking member for a cooperative effort here at really serving the American people. The concept of reform and change sometimes scares people in these chambers and they worry about what could go wrong, and I think we have to remind ourselves again and again that reform and change is also an essential step to improvement. And this bill will allow us to take that step towards an improvement of not only the cost effectiveness, the cost efficiency, but also the effectiveness of our total health care system through the information age. Mr. Chairman, 2506 will be that kind of step. And I hope that in the future we will be able to look back at H.R. 2506 and look back at the cooperative effort between the chairman of the subcommittee and the ranking member of this subcommittee and say this was the beginning of a very productive relationship between both sides of the aisle and a productive relationship with the American people and their health care system. Mr. Chairman, I would ask all of us to support this bill and support the attitude that is behind this bill and to support the entire concept that Democrats and Republicans can work together for the good of the safety and the health of the American people. Mr. BLILEY. Mr. Chairman, I commend the gentlemen from Florida and Ohio for bringing H.R. 2506, the Health Research and Quality Act of 1999, to the floor. This legislation, introduced by Representatives Bilirakis and Brown, represents an important commitment to provide the science-based evidence that we need to improve health care quality. We need sound and reliable information to help patients make informed decisions, to help health care providers make sense of new discoveries, to help purchasers get value for their health care dollar, and to help avoid medical errors. Today's legislation builds on the progress the Agency for Health Care Policy and Research has already made. It will enable us to benefit from our investment in biomedical research, to improve the health care delivery programs under our jurisdiction, and to build the science of quality measurement and improvement. This emphasis on quality measurement and improvement is important. The focus on health outcomes is critical. If we are unable to determine the long-term effect of the care patients receive today, we will be unable to improve upon that care tomorrow. To address the full continuum of care and outcomes research, and to link research directly with clinical practice in geographically diverse locations throughout the United States, this bill stresses the importance of health care improvement research centers and provider-based research networks. Since the science of outcomes research is complex, this bill requires the agency to support research and evaluation to advance the use of information systems for the study of health care quality and outcomes. The importance of outcomes research and information dissemination in the continuous improvement of patient care cannot be overstated. For example, in the area of cancer care, the ability to chart patient outcomes from a variety of interventions and communicate these outcomes effectively among practitioners will allow significant improvement in the treatment of all types of cancer. In summary, Mr. Chairman, the Health Research and Quality Act of 1999 is a sound investment in the future; it is legislation that both sides of the aisle can support. The Commerce Committee gave unanimous approval to this legislation and I hope it will enjoy similar support on the floor today. Mr. BALDACCI. Mr. Chairman, I commend the Chairman, Mr. Bilirakis, and the Ranking Member, Mr. Brown, for introducing this valuable legislation. I particularly want to thank the Members for the special attention given to rural health care in the bill. Access and quality of health care in rural America is of particular importance to me. I represent the largest geographic district east of the Mississippi. Recently, compounding changes in Medicare reimbursement and regulations have had a devastating impact on my district, and have endangered a very vulnerable population of my state. People in rural areas do not have the same choices available to those in urban areas. I am concerned that the rate of the uninsured in Maine continues to grow. Maine citizens rely heavily on community care, and we ought to promote research into enhancing quality of and access to health care in these areas. Careful studies of the delivery of health services in rural America will allow us to make better public policy, and I thank the Chairman and Ranking Member for their attention to this issue. I am also pleased to see the legislation address the critical issue of health insurance. Section 913 requires that there must be surveys on, among other factors, the types and [[Page H8913]] costs of private health insurance. As we know, there is a growing trend to consolidation among health insurance companies, and I am particularly concerned about the ability of these large companies to direct costs and types of care offered when they buy out smaller local insurers. It is my hope that with this component of the bill, we will gain a better understanding of what effect the consolidation in the health insurance market is having on quality, access, and cost of insurance to rural Americans. Again, I thank the Chairman and Ranking Member for addressing this issue. Mr. BILIRAKIS. Mr. Chairman, we have no further requests for time. Mr. BROWN of Ohio. Mr. Chairman, I yield back the balance of my time. Mr. BILIRAKIS. Mr. Chairman, I yield back the balance of my time. The CHAIRMAN. All time for general debate has expired. Pursuant to the rule, the committee amendment in the nature of a substitute printed in the bill shall be considered by sections as an original bill for the purpose of amendment, and each section is considered read. No amendment to that amendment shall be in order except those printed in the portion of the Congressional Record designated for that purpose and pro forma amendments for the purpose of debate. Amendments printed in the Record may be offered only by the Member who caused it to be printed or his designee and shall be considered read. The Chairman of the Committee of the Whole may postpone a request for a recorded vote on any amendment and may reduce to a minimum of 5 minutes the time for voting on any postponed question that immediately follows another vote, provided that the time for voting on the first question shall be a minimum of 15 minutes. The Clerk will designate section 1. The text of section 1 is as follows: Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Health Research and Quality Act of 1999''. The CHAIRMAN. Are there any amendments to section 1? The Clerk will designate section 2. The text of section 2 is as follows: SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT. (a) In General.--Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is amended to read as follows: ``TITLE IX--AGENCY FOR HEALTH RESEARCH AND QUALITY ``PART A--ESTABLISHMENT AND GENERAL DUTIES ``SEC. 901. MISSION AND DUTIES. ``(a) In General.--There is established within the Public Health Service an agency to be known as the Agency for Health Research and Quality, which shall be headed by a director appointed by the Secretary. The Secretary shall carry out this title acting through the Director. ``(b) Mission.--The purpose of the Agency is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health system practices, including the prevention of diseases and other health conditions. The Agency shall promote health care quality improvement by-- ``(1) conducting and supporting research that develops and presents scientific evidence regarding all aspects of health, including-- ``(A) the development and assessment of methods for enhancing patient participation in their own care and for facilitating shared patient-physician decision-making; ``(B) the outcomes, effectiveness, and cost-effectiveness of health care practices, including preventive measures and long-term care; ``(C) existing and innovative technologies; ``(D) the costs and utilization of, and access to health care; ``(E) the ways in which health care services are organized, delivered, and financed and the interaction and impact of these factors on the quality of patient care; ``(F) methods for measuring quality and strategies for improving quality; and ``(G) ways in which patients, consumers, purchasers, and practitioners acquire new information about best practices and health benefits, the determinants and impact of their use of this information; ``(2) synthesizing and disseminating available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, policy makers, and educators; and ``(3) advancing private and public efforts to improve health care quality. ``(c) Requirements With Respect to Rural Areas and Priority Populations.--In carrying out subsection (b), the Director shall undertake and support research, demonstration projects, and evaluations with respect to-- ``(1) the delivery of health services in rural areas (including frontier areas); ``(2) health services for low-income groups, and minority groups; ``(3) the health of children; ``(4) the elderly; and ``(5) people with special health care needs, including disabilities, chronic care and end-of-life health care. ``SEC. 902. GENERAL AUTHORITIES. ``(a) In General.--In carrying out section 901(b), the Director shall support demonstration projects, conduct and support research, evaluations, training, research networks, multi-disciplinary centers, technical assistance, and the dissemination of information, on health care, and on systems for the delivery of such care, including activities with respect to-- ``(1) the quality, effectiveness, efficiency, appropriateness and value of health care services; ``(2) quality measurement and improvement; ``(3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services; ``(4) clinical practice, including primary care and practice-oriented research; ``(5) health care technologies, facilities, and equipment; ``(6) health care costs, productivity, organization, and market forces; ``(7) health promotion and disease prevention, including clinical preventive services; ``(8) health statistics, surveys, database development, and epidemiology; and ``(9) medical liability. ``(b) Health Services Training Grants.-- ``(1) In general.--The Director may provide training grants in the field of health services research related to activities authorized under subsection (a), to include pre- and post-doctoral fellowships and training programs, young investigator awards, and other programs and activities as appropriate. In carrying out this subsection, the Director shall make use of funds made available under section 487. ``(2) Requirements.--In developing priorities for the allocation of training funds under this subsection, the Director shall take into consideration shortages in the number of trained researchers addressing the priority populations. ``(c) Multidisciplinary Centers.--The Director may provide financial assistance to assist in meeting the costs of planning and establishing new centers, and operating existing and new centers, for multidisciplinary health services research, demonstration projects, evaluations, training, and policy analysis with respect to the matters referred to in subsection (a). ``(d) Relation to Certain Authorities Regarding Social Security.--Activities authorized in this section shall be appropriately coordinated with experiments, demonstration projects, and other related activities authorized by the Social Security Act and the Social Security Amendments of 1967. Activities under subsection (a)(2) of this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act shall be carried out consistent with section 1142 of such Act. ``(e) Disclaimer.--The Agency shall not mandate national standards of clinical practice or quality health care standards. Recommendations resulting from projects funded and published by the Agency shall include a corresponding disclaimer. ``(f) Rule of Construction.--Nothing in this section shall be construed to imply that the Agency's role is to mandate a national standard or specific approach to quality measurement and reporting. In research and quality improvement activities, the Agency shall consider a wide range of choices, providers, health care delivery systems, and individual preferences. ``PART B--HEALTH CARE IMPROVEMENT RESEARCH ``SEC. 911. HEALTH CARE OUTCOME IMPROVEMENT RESEARCH. ``(a) Evidence Rating Systems.--In collaboration with experts from the public and private sector, the Agency shall identify and disseminate methods or systems that it uses to assess health care research results, particularly methods or systems that it uses to rate the strength of the scientific evidence behind health care practice, recommendations in the research literature, and technology assessments. The Agency shall make methods or systems for evidence rating widely available. Agency publications containing health care recommendations shall indicate the level of substantiating evidence using such methods or systems. ``(b) Health Care Improvement Research Centers and Provider-Based Research Networks.-- ``(1) In general.--In order to address the full continuum of care and outcomes research, to link research to practice improvement, and to speed the dissemination of research findings to community practice settings, the Agency shall employ research strategies and mechanisms that will link research directly with clinical practice in geographically diverse locations throughout the United States, including-- ``(A) Health Care Improvement Research Centers that combine demonstrated multidisciplinary expertise in outcomes or quality improvement research with linkages to relevant sites of care; ``(B) Provider-based Research Networks, including plan, facility, or delivery system sites of care (especially primary care), that can evaluate outcomes and promote quality improvement; and ``(C) other innovative mechanisms or strategies to link research with clinical practice. ``(2) Requirements.--The Director is authorized to establish the requirements for entities applying for grants under this subsection. ``SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND DELIVERY. ``(a) Support for Efforts To Develop Information on Quality.-- ``(1) Scientific and technical support.--In its role as the principal agency for health research and quality, the Agency may provide scientific and technical support for private and [[Page H8914]] public efforts to improve health care quality, including the activities of accrediting organizations. ``(2) Role of the agency.--With respect to paragraph (1), the role of the Agency shall include-- ``(A) the identification and assessment of methods for the evaluation of the health of-- ``(i) enrollees in health plans by type of plan, provider, and provider arrangements; and ``(ii) other populations, including those receiving long- term care services; ``(B) the ongoing development, testing, and dissemination of quality measures, including measures of health and functional outcomes; ``(C) the compilation and dissemination of health care quality measures developed in the private and public sector; ``(D) assistance in the development of improved health care information systems; ``(E) the development of survey tools for the purpose of measuring participant and beneficiary assessments of their health care; and ``(F) identifying and disseminating information on mechanisms for the integration of information on quality into purchaser and consumer decision-making processes. ``(b) Centers for Education and Research on Therapeutics.-- ``(1) In general.--The Secretary, acting through the Director and in consultation with the Commissioner of Food and Drugs, shall establish a program for the purpose of making one or more grants for the establishment and operation of one or more centers to carry out the activities specified in paragraph (2). ``(2) Required activities.--The activities referred to in this paragraph are the following: ``(A) The conduct of state-of-the-art research for the following purposes: ``(i) To increase awareness of-- ``(I) new uses of drugs, biological products, and devices; ``(II) ways to improve the effective use of drugs, biological products, and devices; and ``(III) risks of new uses and risks of combinations of drugs and biological products. ``(ii) To provide objective clinical information to the following individuals and entities: ``(I) Health care practitioners and other providers of health care goods or services. ``(II) Pharmacists, pharmacy benefit managers and purchasers. ``(III) Health maintenance organizations and other managed health care organizations. ``(IV) Health care insurers and governmental agencies. ``(V) Patients and consumers. ``(iii) To improve the quality of health care while reducing the cost of health care through-- ``(I) an increase in the appropriate use of drugs, biological products, or devices; and ``(II) the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations. ``(B) The conduct of research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices. ``(C) Such other activities as the Secretary determines to be appropriate, except that a grant may not be expended to assist the Secretary in the review of new drugs. ``(c) Reducing Errors in Medicine.--The Director shall conduct and support research and build private-public partnerships to-- ``(1) identify the causes of preventable health care errors and patient injury in health care delivery; ``(2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and ``(3) promote the implementation of effective strategies throughout the health care industry. ``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE. ``(a) In General.--In carrying out 902(a), the Director shall-- ``(1) conduct a survey to collect data on a nationally representative sample of the population on the cost, use and, for fiscal year 2001 and subsequent fiscal years, quality of health care, including the types of health care services Americans use, their access to health care services, frequency of use, how much is paid for the services used, the source of those payments, the types and costs of private health insurance, access, satisfaction, and quality of care for the general population and also for populations identified in section 901(c); and ``(2) develop databases and tools that provide information to States on the quality, access, and use of health care services provided to their residents. ``(b) Quality and Outcomes Information.-- ``(1) In general.--Beginning in fiscal year 2001, the Director shall ensure that the survey conducted under subsection (a)(1) will-- ``(A) identify determinants of health outcomes and functional status, the needs of special populations in such variables as well as an understanding of changes over time, relationships to health care access and use, and monitor the overall national impact of Federal and State policy changes on health care; ``(B) provide information on the quality of care and patient outcomes for frequently occurring clinical conditions for a nationally representative sample of the population; and ``(C) provide reliable national estimates for children and persons with special health care needs through the use of supplements or periodic expansions of the survey. In expanding the Medical Expenditure Panel Survey, as in existence on the date of enactment of this title in fiscal year 2001 to collect information on the quality of care, the Director shall take into account any outcomes measurements generally collected by private sector accreditation organizations. ``(2) Annual report.--Beginning in fiscal year 2003, the Secretary, acting through the Director, shall submit to Congress an annual report on national trends in the quality of health care provided to the American people. ``SEC. 914. INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT. ``(a) In General.--In order to foster a range of innovative approaches to the management and communication of health information, the Agency shall support research, evaluations and initiatives to advance-- ``(1) the use of information systems for the study of health care quality and outcomes, including the generation of both individual provider and plan-level comparative performance data; ``(2) training for health care practitioners and researchers in the use of information systems; ``(3) the creation of effective linkages between various sources of health information, including the development of information networks; ``(4) the delivery and coordination of evidence-based health care services, including the use of real-time health care decision-support programs; ``(5) the structure, content, definition, and coding of health information data and medical vocabularies in consultation with appropriate Federal entities and shall seek input from appropriate private entities; ``(6) the use of computer-based health records in outpatient and inpatient settings as a personal health record for individual health assessment and maintenance, and for monitoring public health and outcomes of care within populations; and ``(7) the protection of individually identifiable information in health services research and health care quality improvement. ``(b) Demonstration.--The Agency shall support demonstrations into the use of new information tools aimed at improving shared decision-making between patients and their care-givers. ``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN UNDERSERVED AREAS. ``(a) Preventive Services Task Force.-- ``(1) Purpose.--The Agency shall provide ongoing administrative, research, and technical support for the operation of the Preventive Services Task Force. The Agency shall coordinate and support the dissemination of the Preventive Services Task Force recommendations. ``(2) Operation.--The Preventive Services Task Force shall review the scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care community, and updating previous recommendations, regarding their usefulness in daily clinical practice. In carrying out its responsibilities under paragraph (1), the Task Force shall not be subject to the provisions of Appendix 2 of title 5, United States Code. ``(b) Primary Care Research.-- ``(1) In general.--There is established within the Agency a Center for Primary Care Research (referred to in this subsection as the `Center') that shall serve as the principal source of funding for primary care practice research in the Department of Health and Human Services. For purposes of this paragraph, primary care research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral to specialty care, preventive care, and the relationship between the clinician and the patient in the context of the family and community. ``(2) Research.--In carrying out this section, the Center shall conduct and support research concerning-- ``(A) the nature and characteristics of primary care practice; ``(B) the management of commonly occurring clinical problems; ``(C) the management of undifferentiated clinical problems; and ``(D) the continuity and coordination of health services. ``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION. ``(a) In General.--The Director shall promote innovation in evidence-based clinical practice and health care technologies by-- ``(1) conducting and supporting research on the development, diffusion, and use of health care technology; ``(2) developing, evaluating, and disseminating methodologies for assessments of health care practices and health care technologies; ``(3) conducting intramural and supporting extramural assessments of existing and new health care practices and technologies; ``(4) promoting education, training, and providing technical assistance in the use of health care practice and health care technology assessment methodologies and results; and ``(5) working with the National Library of Medicine and the public and private sector to develop an electronic clearinghouse of currently available assessments and those in progress. ``(b) Specification of Process.-- ``(1) In general.--Not later than December 31, 2000, the Director shall develop and publish a description of the methods used by the Agency and its contractors for practice and technology assessment. ``(2) Consultations.--In carrying out this subsection, the Director shall cooperate and consult with the Assistant Secretary for Health, the Administrator of the Health Care Financing Administration, the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the heads of any other interested Federal department or agency, and shall seek input, where appropriate, from professional societies and other private and public entities. ``(3) Methodology.--The Director shall, in developing the methods used under paragraph (1), consider-- ``(A) safety, efficacy, and effectiveness; [[Page H8915]] ``(B) legal, social, and ethical implications; ``(C) costs, benefits, and cost-effectiveness; ``(D) comparisons to alternate technologies and practices; and ``(E) requirements of Food and Drug Administration approval to avoid duplication. ``(c) Specific Assessments.-- ``(1) In general.--The Director shall conduct or support specific assessments of health care technologies and practices. ``(2) Requests for assessments.--The Director is authorized to conduct or support assessments, on a reimbursable basis, for the Health Care Financing Administration, the Department of Defense, the Department of Veterans Affairs, the Office of Personnel Management, and other public or private entities. ``(3) Grants and contracts.--In addition to conducting assessments, the Director may make grants to, or enter into cooperative agreements or contracts with, entities described in paragraph (4) for the purpose of conducting assessments of experimental, emerging, existing, or potentially outmoded health care technologies, and for related activities. ``(4) Eligible entities.--An entity described in this paragraph is an entity that is determined to be appropriate by the Director, including academic medical centers, research institutions and organizations, professional organizations, third party payers, governmental agencies, and consortia of appropriate research entities established for the purpose of conducting technology assessments. ``SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY IMPROVEMENT EFFORTS. ``(a) Requirement.-- ``(1) In general.--To avoid duplication and ensure that Federal resources are used efficiently and effectively, the Secretary, acting through the Director, shall coordinate all research, evaluations, and demonstrations related to health services research, quality measurement and quality improvement activities undertaken and supported by the Federal Government. ``(2) Specific activities.--The Director, in collaboration with the appropriate Federal officials representing all concerned executive agencies and departments, shall develop and manage a process to-- ``(A) improve interagency coordination, priority setting, and the use and sharing of research findings and data pertaining to Federal quality improvement programs, technology assessment, and health services research; ``(B) strengthen the research information infrastructure, including databases, pertaining to Federal health services research and health care quality improvement initiatives; ``(C) set specific goals for participating agencies and departments to further health services research and health care quality improvement; and ``(D) strengthen the management of Federal health care quality improvement programs. ``(b) Study by the Institute of Medicine.-- ``(1) In general.--To provide Congress, the Department of Health and Human Services, and other relevant departments with an independent, external review of their quality oversight, quality improvement and quality research programs, the Secretary shall enter into a contract with the Institute of Medicine-- ``(A) to describe and evaluate current quality improvement, quality research and quality monitoring processes through-- ``(i) an overview of pertinent health services research activities and quality improvement efforts conducted by all Federal programs, with particular attention paid to those under titles XVIII, XIX, and XXI of the Social Security Act; and ``(ii) a summary of the partnerships that the Department of Health and Human Services has pursued with private accreditation, quality measurement and improvement organizations; and ``(B) to identify options and make recommendations to improve the efficiency and effectiveness of quality improvement programs through-- ``(i) the improved coordination of activities across the medicare, medicaid and child health insurance programs under titles XVIII, XIX and XXI of the Social Security Act and health services research programs; ``(ii) the strengthening of patient choice and participation by incorporating state-of-the-art quality monitoring tools and making information on quality available; and ``(iii) the enhancement of the most effective programs, consolidation as appropriate, and elimination of duplicative activities within various federal agencies. ``(2) Requirements.-- ``(A) In general.--The Secretary shall enter into a contract with the Institute of Medicine for the preparation-- ``(i) not later than 12 months after the date of enactment of this title, of a report providing an overview of the quality improvement programs of the Department of Health and Human Services for the medicare, medicaid, and CHIP programs under titles XVIII, XIX, and XXI of the Social Security Act; and ``(ii) not later than 24 months after the date of enactment of this title, of a final report containing recommendations. ``(B) Reports.--The Secretary shall submit the reports described in subparagraph (A) to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Ways and Means and the Committee on Commerce of the House of Representatives. ``PART C--GENERAL PROVISIONS ``SEC. 921. ADVISORY COUNCIL FOR HEALTH CARE RESEARCH AND QUALITY. ``(a) Establishment.--There is established an advisory council to be known as the Advisory Council for Health Care Research and Quality. ``(b) Duties.-- ``(1) In general.--The Advisory Council shall advise the Secretary and the Director with respect to activities proposed or undertaken to carry out the purpose of the Agency under section 901(b). ``(2) Certain recommendations.--Activities of the Advisory Council under paragraph (1) shall include making recommendations to the Director regarding-- ``(A) priorities regarding health care research, especially studies related to quality, outcomes, cost and the utilization of, and access to, health care services; ``(B) the field of health care research and related disciplines, especially issues related to training needs, and dissemination of information pertaining to health care quality; and ``(C) the appropriate role of the Agency in each of these areas in light of private sector activity and identification of opportunities for public-private sector partnerships. ``(c) Membership.-- ``(1) In general.--The Advisory Council shall, in accordance with this subsection, be composed of appointed members and ex officio members. All members of the Advisory Council shall be voting members other than the individuals designated under paragraph (3)(B) as ex officio members. ``(2) Appointed members.--The Secretary shall appoint to the Advisory Council 18 appropriately qualified individuals. At least 14 members of the Advisory Council shall be representatives of the public who are not officers or employees of the United States. The Secretary shall ensure that the appointed members of the Council, as a group, are representative of professions and entities concerned with, or affected by, activities under this title and under section 1142 of the Social Security Act. Of such members-- ``(A) 3 shall be individuals distinguished in the conduct of research, demonstration projects, and evaluations with respect to health care; ``(B) 3 shall be individuals distinguished in the practice of medicine of which at least 1 shall be a primary care practitioner; ``(C) 3 shall be individuals distinguished in the other health professions; ``(D) 3 shall be individuals either representing the private health care sector, including health plans, providers, and purchasers or individuals distinguished as administrators of health care delivery systems; ``(E) 3 shall be individuals distinguished in the fields of health care quality improvement, economics, information systems, law, ethics, business, or public policy; and ``(F) 3 shall be individuals representing the interests of patients and consumers of health care. ``(3) Ex officio members.--The Secretary shall designate as ex officio members of the Advisory Council-- ``(A) the Assistant Secretary for Health, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Care Financing Administration, the Assistant Secretary of Defense (Health Affairs), and the Under Secretary for Health of the Department of Veterans Affairs; and ``(B) such other Federal officials as the Secretary may consider appropriate. ``(d) Terms.--Members of the Advisory Council appointed under subsection (c)(2) shall serve for a term of 3 years. A member of the Council appointed under such subsection may continue to serve after the expiration of the term of the members until a successor is appointed. ``(e) Vacancies.--If a member of the Advisory Council appointed under subsection (c)(2) does not serve the full term applicable under subsection (d), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual. ``(f) Chair.--The Director shall, from among the members of the Advisory Council appointed under subsection (c)(2), designate an individual to serve as the chair of the Advisory Council. ``(g) Meetings.--The Advisory Council shall meet not less than once during each discrete 4-month period and shall otherwise meet at the call of the Director or the chair. ``(h) Compensation and Reimbursement of Expenses.-- ``(1) Appointed members.--Members of the Advisory Council appointed under subsection (c)(2) shall receive compensation for each day (including travel time) engaged in carrying out the duties of the Advisory Council unless declined by the member. Such compensation may not be in an amount in excess of the maximum rate of basic pay payable for GS-18 of the General Schedule. ``(2) Ex officio members.--Officials designated under subsection (c)(3) as ex officio members of the Advisory Council may not receive compensation for service on the Advisory Council in addition to the compensation otherwise received for duties carried out as officers of the United States. ``(i) Staff.--The Director shall provide to the Advisory Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council. ``SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS. ``(a) Requirement of Review.-- ``(1) In general.--Appropriate technical and scientific peer review shall be conducted with respect to each application for a grant, cooperative agreement, or contract under this title. ``(2) Reports to director.--Each peer review group to which an application is submitted pursuant to paragraph (1) shall report its finding and recommendations respecting the application to the Director in such form and in such manner as the Director shall require. ``(b) Approval as Precondition of Awards.--The Director may not approve an application described in subsection (a)(1) unless [[Page H8916]] the application is recommended for approval by a peer review group established under subsection (c). ``(c) Establishment of Peer Review Groups.-- ``(1) In general.--The Director shall establish such technical and scientific peer review groups as may be necessary to carry out this section. Such groups shall be established without regard to the provisions of title 5, United States Code, that govern appointments in the competitive service, and without regard to the provisions of chapter 51, and subchapter III of chapter 53, of such title that relate to classification and pay rates under the General Schedule. ``(2) Membership.--The members of any peer review group established under this section shall be appointed from among individuals who by virtue of their training or experience are eminently qualified to carry out the duties of such peer review group. Officers and employees of the United States may not constitute more than 25 percent of the membership of any such group. Such officers and employees may not receive compensation for service on such groups in addition to the compensation otherwise received for these duties carried out as such officers and employees. ``(3) Duration.--Notwithstanding section 14(a) of the Federal Advisory Committee Act, peer review groups established under this section may continue in existence until otherwise provided by law. ``(4) Qualifications.--Members of any peer-review group shall, at a minimum, meet the following requirements: ``(A) Such members shall agree in writing to treat information received, pursuant to their work for the group, as confidential information, except that this subparagraph shall not apply to public records and public information. ``(B) Such members shall agree in writing to recuse themselves from participation in the peer-review of specific applications which present a potential personal conflict of interest or appearance of such conflict, including employment in a directly affected organization, stock ownership, or any financial or other arrangement that might introduce bias in the process of peer-review. ``(d) Authority for Procedural Adjustments in Certain Cases.--In the case of applications for financial assistance whose direct costs will not exceed $100,000, the Director may make appropriate adjustments in the procedures otherwise established by the Director for the conduct of peer review under this section. Such adjustments may be made for the purpose of encouraging the entry of individuals into the field of research, for the purpose of encouraging clinical practice-oriented or provider-based research, and for such other purposes as the Director may determine to be appropriate. ``(e) Regulations.--The Director shall issue regulations for the conduct of peer review under this section. ``SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION, AND DISSEMINATION OF DATA. ``(a) Standards With Respect to Utility of Data.-- ``(1) In general.--To ensure the utility, accuracy, and sufficiency of data collected by or for the Agency for the purpose described in section 901(b), the Director shall establish standard methods for developing and collecting such data, taking into consideration-- ``(A) other Federal health data collection standards; and ``(B) the differences between types of health care plans, delivery systems, health care providers, and provider arrangements. ``(2) Relationship with other department programs.--In any case where standards under paragraph (1) may affect the administration of other programs carried out by the Department of Health and Human Services, includ

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HEALTH RESEARCH AND QUALITY ACT OF 1999
(House of Representatives - September 28, 1999)

Text of this article available as: TXT PDF [Pages H8910-H8941] HEALTH RESEARCH AND QUALITY ACT OF 1999 Mr. GOSS. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 299 and ask for its immediate consideration. The Clerk read the resolution, as follows: H. Res. 299 Resolved, That at any time after the adoption of this resolution the Speaker may, pursuant to clause 2(b) of rule XVIII, declare the House resolved into the Committee of the Whole House on the state of the Union for consideration of the bill (H.R. 2506) to amend title IX of the Public Health Service Act to revise and extend the Agency for Health Care Policy and Research. The first reading of the bill shall be dispensed with. General debate shall be confined to the bill and shall not exceed one hour equally divided and controlled by the chairman and ranking minority member of the Committee on Commerce. After general debate the bill shall be considered for amendment under the five-minute rule. It shall be in order to consider as an original bill for the purpose of amendment under the five-minute rule the amendment in the nature of a substitute recommended by the Committee on Commerce now printed in the bill. Each section of the committee amendment in the nature of a substitute shall be considered as read. No amendment to the committee amendment in the nature of a substitute shall be in order except those printed in the portion of the Congressional Record designated for that purpose in clause 8 of rule XVIII and except pro forma amendments for the purpose of debate. Each amendment so printed may be offered only by the Member who caused it to be printed or his designee and shall be considered as read. The Chairman of the Committee of the Whole may: (1) postpone until a time during further consideration in the Committee of the Whole a request for a recorded vote on any amendment; and (2) reduce to five minutes the minimum time for electronic voting on any postponed question that follows another electronic vote without intervening business, provided that the minimum time for electronic voting on the first in any series of questions shall be 15 minutes. At the conclusion of consideration of the bill for amendment the Committee shall rise and report the bill to the House with such amendments as may have been adopted. Any Member may demand a separate vote in the House on any amendment adopted in the Committee of the Whole to the bill or to the committee amendment in the nature of a substitute. The previous question shall be considered as ordered on the bill and amendments thereto to final passage without intervening motion except one motion to recommit with or without instructions. {time} 1445 The SPEAKER pro tempore (Mr. Pease). The gentleman from Florida (Mr. Goss) is recognized for 1 hour. Mr. GOSS. Mr. Speaker, for purposes of debate only, I yield the customary 30 minutes to the distinguished gentlewoman from Rochester, NY (Ms. Slaughter) pending which I yield myself such time as I may consume. During consideration of this resolution, Mr. Speaker, all time yielded is for the purpose of debate only. Mr. Speaker, this is a fair and appropriate rule for this particular legislation. In fact, had it not been for the amount of money H.R. 2506 authorizes, doubling the current authorization level to $900 million, the bill would have been considered under the suspension process. The bill was voted out of the Committee on Commerce by a voice vote and the Committee on Rules reported a modified open rule to ensure that no extraneous amendments to the Public Health Service Act would be considered. The rule allows any Member who has preprinted an amendment in the Congressional Record to offer that amendment. This will ensure a full and open, yet targeted debate on the merits of this particular agency covered by this legislation. When the Agency for Health Care Policy and Research, AHCPR as it is known in its acronym, was created in 1989, the health care universe looked far different than it does today. Traditional fee for service plans still dominated the market and managed care was still very much in its infancy period. Utilization review, peer review, these were largely unknown concepts, at least fully tried or tested. H.R. 2506 modernizes the agency to reflect these and other changes and provides resources to enable more effective collection of data. Many Americans sitting at home watching may be wondering why we need yet another Federal agency involved in health care quality. Well, health care quality is a critical issue these days. As someone who has always believed that Congress too often stands in the way of true health care quality, I share concern with the people at home who are worried about this. To the extent that this ``reformed'' agency can promote better research and encourage successful partnerships between the public and private sectors with limited Federal red tape, it can be a worthy investment. And, of course, that is the goal. But we must retain vigorous oversight and maintain high expectations to ensure that these precious taxpayer dollars are indeed put [[Page H8911]] to good use. Again, we think that is the reason for this legislation and we congratulate its authors for this effort. As I stated before, this is an eminently fair rule that should engender no controversy as far as I know. Mr. Speaker, I reserve the balance of my time. Ms. SLAUGHTER. Mr. Speaker, I thank my distinguished colleague from Florida for yielding me the 30 minutes, and I yield myself such time as I may consume. (Ms. SLAUGHTER asked and was given permission to revise and extend her remarks.) Ms. SLAUGHTER. Mr. Speaker, this is an ``almost open'' rule, for the majority has again relied on a preprinting requirement for amendments which may affect some Members of the House. But I rise in support of the rule and in support of H.R. 2506, the Health Research and Quality Act of 1999. The bill is being brought to the floor by the gentleman from Florida (Mr. Bilirakis) for the majority and the gentleman from Ohio (Mr. Brown) for the minority. This bipartisan legislation reauthorizes the Agency for Health Care Policy and Research and renames the agency as the Agency for Health Research and Quality, AHRQ, pronounced ``arc.'' This agency promotes health care quality through research, synthesizing and consolidating medical information, and disseminating scientific evidence. Building on its current initiatives, the agency will play a key role in partnering with the private sector to improve the quality of health care in the United States. As a longtime supporter of health care research, I believe this piece of legislation will benefit patients, care-givers and insurance providers with vital information and statistics on how to improve the Nation's health care system. The agency's research and information consolidation will play a key role in extending quality care and improving health service delivery throughout the country. This agency provides vital information and resources that foster improvement in health care systems from America's smallest rural townships to its most populous inner cities. The agency's mission includes fostering the extension of quality health care systems to those Americans left behind as our Nation continues its economic growth. The agency's work is especially important as health care delivery in our country evolves. When the AHCPR was established a little over 10 years ago, the health care system was vastly different from what we know today. More people now receive their care through managed plans and HMOs. The growing complexity of health plans bewilderers many patients and contributes to the growing tensions between patients and insurers. This legislation directs AHRQ to address the public's growing concern for the quality of patient care and the number of medical errors that continue to grow each day. Their research helps hospitals and clinics around the country to reduce the injuries arising from mismanagement of cases. A recent study examined the records of more than 30,000 hospital patients in my home State of New York. The study found that nearly 4 percent of patients suffered serious injuries that were related to the management of their illnesses rather than the illnesses themselves. This is a vital area of research for the agency and another reason why the reauthorization of funding for this agency and the redirection of its mission is important. The legislation does more than merely change the name of the agency. It directs the agency to develop new public-private partnerships in the health care arena. This will bring new perspectives to improving the dissemination of health information and the development of health care systems that better serve our neighborhoods, towns and cities. These partnerships will also leverage greater private investment and commitment to creating improved health care service systems throughout the Nation. In the process, AHRQ will also support increased efficiency and quality of Federal program management. According to testimony provided to the committee during a recent hearing, nine out of 10 people surveyed supported health research as well as the amount of Federal money spent on our Nation's health care. Mr. Speaker, this agency costs just one one-hundredth of one percent of the total funds spent by the government on health care and is a sound investment in our Nation's future health. I support this initiative even though it is only a modest step toward guaranteeing that all our citizens have access to the finest medical care in the world. Citizens across the United States are crying out for more. We need comprehensive health care reform that includes a provision to ban genetic discrimination in insurance. We need a true Patients' Bill of Rights. Mr. Speaker, I yield back the balance of my time. Mr. GOSS. Mr. Speaker, I yield back the balance of my time, and I prove the previous question on the resolution. The previous question was ordered. The resolution was agreed to. A motion to reconsider was laid on the table. The SPEAKER pro tempore (Mr. Knollenberg). Pursuant to House Resolution 299 and rule XVIII, the Chair declares the House in the Committee of the Whole House on the State of the Union for the consideration of the bill, H.R. 2506. {time} 1454 In the Committee of the Whole Accordingly, the House resolved itself into the Committee of the Whole House on the State of the Union for the consideration of the bill (H.R. 2506) to amend title IX of the Public Health Service Act to revise and extend the Agency for Health Care Policy and Research, with Mr. Pease in the chair. The Clerk read the title of the bill. The CHAIRMAN. Pursuant to the rule, the bill is considered as having been read the first time. Under the rule, the gentleman from Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each will control 30 minutes. The Chair recognizes the gentleman from Florida (Mr. Bilirakis). Mr. BILIRAKIS. Mr. Chairman, I yield myself such time as I may consume. Mr. Chairman, I am pleased to bring H.R. 2506, the Health Research and Quality Act of 1999, to the floor today. This widely supported bipartisan bill was approved by voice vote in the Committee on Commerce and the Subcommittee on Health and Environment. In April, experts from both the public and private sector testified about the critical function of this agency at a hearing before the subcommittee. I introduced this measure jointly with the gentleman from Ohio (Mr. Brown), the ranking member of the House Commerce Subcommittee on Health and Environment, to reauthorize the Agency for Health Care Policy and Research and redefine its mission. Our bill renames it as the Agency for Health Research and Quality, or, one of those famous Washington acronyms, AHRQ. The purpose of this new name, and the reauthorization, is to foster comprehensive improvements in our health care system. Our bill refocuses the efforts of this critical agency to support private sector initiatives. Building on its current activities, the new agency will become a key partner to the private sector in improving the quality of health care in America. The bill specifically prohibits the agency from mandating national standards of clinical practice or quality health care standards. Instead, it emphasizes the agency's nonregulatory role in building the science of health care quality. The bill also includes provisions to overcome barriers to access to preventive health care through a public-private partnership. It authorizes grants for the establishment of regional centers to improve and increase access to preventive health care services. By approving the legislation before us, we can ensure the continued availability of the objective, science-based information this agency provides. I urge Members to join us in supporting passage of H.R. 2506, the Health Research and Quality Act of 1999. Mr. Chairman, I reserve the balance of my time. Mr. BROWN of Ohio. Mr. Chairman, I yield myself such time as I may consume. I am pleased that the gentleman from Florida (Mr. Bilirakis) and I [[Page H8912]] could work together to introduce the Health Research and Quality Act and pass it out of the Committee on Commerce. We hold similar views on why this issue is important. It is important because research is important. The U.S. health care system is far from transparent. In fact, in many ways it is not even a system. It is a complex set of relationships influenced by science, demographics, politics, money and cultural trends. Whether the focus is on health care financing or health care delivery, common sense alone rarely explains what is going on. In fact, it often throws policymakers off track. If we want to improve on the status quo in health care, we have to get a realistic picture of what the status quo is. By conducting and supporting health services research, AHCPR helps paint that picture for us. If we want to improve on the status quo in health care, we have got to find out what improvement actually means. By conducting and supporting outcomes, effectiveness and cost effectiveness research, AHCPR helps us determine the best way to spend the limited health care dollars that we do have. And if we want to improve on the status quo in health care, we need to get the word out to the people in the institutions, in the agencies and the industries that somehow keep the whole thing running. By disseminating research and data broadly, AHCPR helps ensure that our investment in data collection, health services research and biomedical research pays off. This reauthorization makes research and broad dissemination of information AHCPR's main focus. We could definitely use more of both. I urge support of this important legislation. Mr. Chairman, I reserve the balance of my time. Mr. BILIRAKIS. Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Gary Miller). (Mr. GARY MILLER of California asked and was given permission to revise and extend his remarks.) Mr. GARY MILLER of California. Mr. Chairman, I rise today in support of H.R. 2506, the Health Research and Quality Act. First I want to thank the bill's author the gentleman from Florida (Mr. Bilirakis) and the cosponsors for all their hard work on this issue. H.R. 2506 is an important piece of legislation which will improve the quality of health care by directing the Agency for Health Care Policy and Research to emphasize medical research, synthesizing and disseminating scientific evidence, and advancing public and private efforts to improve health care quality. With the explosion of medical research and information being produced, medical practitioners face the increasingly difficult task of keeping current with medical literature and putting the latest scientific findings into perspective. As one study indicated, even if a doctor read two peer-reviewed journals each night for a year, he or she would still be 800 years behind in their reading. Access to up-to-date, quality research will improve the care that patients obtain from all levels of the health care system. H.R. 2506 will provide a means whereby medical group practices can obtain and contribute to such a body of information. This legislation frees the Agency for Health Care Policy and Research from the difficult task of providing guidelines and standards of care and allows it to focus on providing unbiased, science-based research to the health care community. H.R. 2506 will help health care professionals and policymakers better understand the future demands on the Nation's health care system. Again, I lend my strong support to this measure and urge my colleagues to join me in voting in favor of the Health Research and Quality Act of 1999. {time} 1500 Mr. BILIRAKIS. Mr. Chairman, I yield such time as he may consume to another gentleman from California (Mr. Bilbray). Mr. BILBRAY. Mr. Chairman, I rise to strongly support H.R. 2506, and let me just say as someone who has the privilege of representing the 49th District of California, one of the capitals of both public and private research, I want to commend the chairman and the ranking member for a cooperative effort here at really serving the American people. The concept of reform and change sometimes scares people in these chambers and they worry about what could go wrong, and I think we have to remind ourselves again and again that reform and change is also an essential step to improvement. And this bill will allow us to take that step towards an improvement of not only the cost effectiveness, the cost efficiency, but also the effectiveness of our total health care system through the information age. Mr. Chairman, 2506 will be that kind of step. And I hope that in the future we will be able to look back at H.R. 2506 and look back at the cooperative effort between the chairman of the subcommittee and the ranking member of this subcommittee and say this was the beginning of a very productive relationship between both sides of the aisle and a productive relationship with the American people and their health care system. Mr. Chairman, I would ask all of us to support this bill and support the attitude that is behind this bill and to support the entire concept that Democrats and Republicans can work together for the good of the safety and the health of the American people. Mr. BLILEY. Mr. Chairman, I commend the gentlemen from Florida and Ohio for bringing H.R. 2506, the Health Research and Quality Act of 1999, to the floor. This legislation, introduced by Representatives Bilirakis and Brown, represents an important commitment to provide the science-based evidence that we need to improve health care quality. We need sound and reliable information to help patients make informed decisions, to help health care providers make sense of new discoveries, to help purchasers get value for their health care dollar, and to help avoid medical errors. Today's legislation builds on the progress the Agency for Health Care Policy and Research has already made. It will enable us to benefit from our investment in biomedical research, to improve the health care delivery programs under our jurisdiction, and to build the science of quality measurement and improvement. This emphasis on quality measurement and improvement is important. The focus on health outcomes is critical. If we are unable to determine the long-term effect of the care patients receive today, we will be unable to improve upon that care tomorrow. To address the full continuum of care and outcomes research, and to link research directly with clinical practice in geographically diverse locations throughout the United States, this bill stresses the importance of health care improvement research centers and provider-based research networks. Since the science of outcomes research is complex, this bill requires the agency to support research and evaluation to advance the use of information systems for the study of health care quality and outcomes. The importance of outcomes research and information dissemination in the continuous improvement of patient care cannot be overstated. For example, in the area of cancer care, the ability to chart patient outcomes from a variety of interventions and communicate these outcomes effectively among practitioners will allow significant improvement in the treatment of all types of cancer. In summary, Mr. Chairman, the Health Research and Quality Act of 1999 is a sound investment in the future; it is legislation that both sides of the aisle can support. The Commerce Committee gave unanimous approval to this legislation and I hope it will enjoy similar support on the floor today. Mr. BALDACCI. Mr. Chairman, I commend the Chairman, Mr. Bilirakis, and the Ranking Member, Mr. Brown, for introducing this valuable legislation. I particularly want to thank the Members for the special attention given to rural health care in the bill. Access and quality of health care in rural America is of particular importance to me. I represent the largest geographic district east of the Mississippi. Recently, compounding changes in Medicare reimbursement and regulations have had a devastating impact on my district, and have endangered a very vulnerable population of my state. People in rural areas do not have the same choices available to those in urban areas. I am concerned that the rate of the uninsured in Maine continues to grow. Maine citizens rely heavily on community care, and we ought to promote research into enhancing quality of and access to health care in these areas. Careful studies of the delivery of health services in rural America will allow us to make better public policy, and I thank the Chairman and Ranking Member for their attention to this issue. I am also pleased to see the legislation address the critical issue of health insurance. Section 913 requires that there must be surveys on, among other factors, the types and [[Page H8913]] costs of private health insurance. As we know, there is a growing trend to consolidation among health insurance companies, and I am particularly concerned about the ability of these large companies to direct costs and types of care offered when they buy out smaller local insurers. It is my hope that with this component of the bill, we will gain a better understanding of what effect the consolidation in the health insurance market is having on quality, access, and cost of insurance to rural Americans. Again, I thank the Chairman and Ranking Member for addressing this issue. Mr. BILIRAKIS. Mr. Chairman, we have no further requests for time. Mr. BROWN of Ohio. Mr. Chairman, I yield back the balance of my time. Mr. BILIRAKIS. Mr. Chairman, I yield back the balance of my time. The CHAIRMAN. All time for general debate has expired. Pursuant to the rule, the committee amendment in the nature of a substitute printed in the bill shall be considered by sections as an original bill for the purpose of amendment, and each section is considered read. No amendment to that amendment shall be in order except those printed in the portion of the Congressional Record designated for that purpose and pro forma amendments for the purpose of debate. Amendments printed in the Record may be offered only by the Member who caused it to be printed or his designee and shall be considered read. The Chairman of the Committee of the Whole may postpone a request for a recorded vote on any amendment and may reduce to a minimum of 5 minutes the time for voting on any postponed question that immediately follows another vote, provided that the time for voting on the first question shall be a minimum of 15 minutes. The Clerk will designate section 1. The text of section 1 is as follows: Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Health Research and Quality Act of 1999''. The CHAIRMAN. Are there any amendments to section 1? The Clerk will designate section 2. The text of section 2 is as follows: SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT. (a) In General.--Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is amended to read as follows: ``TITLE IX--AGENCY FOR HEALTH RESEARCH AND QUALITY ``PART A--ESTABLISHMENT AND GENERAL DUTIES ``SEC. 901. MISSION AND DUTIES. ``(a) In General.--There is established within the Public Health Service an agency to be known as the Agency for Health Research and Quality, which shall be headed by a director appointed by the Secretary. The Secretary shall carry out this title acting through the Director. ``(b) Mission.--The purpose of the Agency is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of scientific research and through the promotion of improvements in clinical and health system practices, including the prevention of diseases and other health conditions. The Agency shall promote health care quality improvement by-- ``(1) conducting and supporting research that develops and presents scientific evidence regarding all aspects of health, including-- ``(A) the development and assessment of methods for enhancing patient participation in their own care and for facilitating shared patient-physician decision-making; ``(B) the outcomes, effectiveness, and cost-effectiveness of health care practices, including preventive measures and long-term care; ``(C) existing and innovative technologies; ``(D) the costs and utilization of, and access to health care; ``(E) the ways in which health care services are organized, delivered, and financed and the interaction and impact of these factors on the quality of patient care; ``(F) methods for measuring quality and strategies for improving quality; and ``(G) ways in which patients, consumers, purchasers, and practitioners acquire new information about best practices and health benefits, the determinants and impact of their use of this information; ``(2) synthesizing and disseminating available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, policy makers, and educators; and ``(3) advancing private and public efforts to improve health care quality. ``(c) Requirements With Respect to Rural Areas and Priority Populations.--In carrying out subsection (b), the Director shall undertake and support research, demonstration projects, and evaluations with respect to-- ``(1) the delivery of health services in rural areas (including frontier areas); ``(2) health services for low-income groups, and minority groups; ``(3) the health of children; ``(4) the elderly; and ``(5) people with special health care needs, including disabilities, chronic care and end-of-life health care. ``SEC. 902. GENERAL AUTHORITIES. ``(a) In General.--In carrying out section 901(b), the Director shall support demonstration projects, conduct and support research, evaluations, training, research networks, multi-disciplinary centers, technical assistance, and the dissemination of information, on health care, and on systems for the delivery of such care, including activities with respect to-- ``(1) the quality, effectiveness, efficiency, appropriateness and value of health care services; ``(2) quality measurement and improvement; ``(3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services; ``(4) clinical practice, including primary care and practice-oriented research; ``(5) health care technologies, facilities, and equipment; ``(6) health care costs, productivity, organization, and market forces; ``(7) health promotion and disease prevention, including clinical preventive services; ``(8) health statistics, surveys, database development, and epidemiology; and ``(9) medical liability. ``(b) Health Services Training Grants.-- ``(1) In general.--The Director may provide training grants in the field of health services research related to activities authorized under subsection (a), to include pre- and post-doctoral fellowships and training programs, young investigator awards, and other programs and activities as appropriate. In carrying out this subsection, the Director shall make use of funds made available under section 487. ``(2) Requirements.--In developing priorities for the allocation of training funds under this subsection, the Director shall take into consideration shortages in the number of trained researchers addressing the priority populations. ``(c) Multidisciplinary Centers.--The Director may provide financial assistance to assist in meeting the costs of planning and establishing new centers, and operating existing and new centers, for multidisciplinary health services research, demonstration projects, evaluations, training, and policy analysis with respect to the matters referred to in subsection (a). ``(d) Relation to Certain Authorities Regarding Social Security.--Activities authorized in this section shall be appropriately coordinated with experiments, demonstration projects, and other related activities authorized by the Social Security Act and the Social Security Amendments of 1967. Activities under subsection (a)(2) of this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act shall be carried out consistent with section 1142 of such Act. ``(e) Disclaimer.--The Agency shall not mandate national standards of clinical practice or quality health care standards. Recommendations resulting from projects funded and published by the Agency shall include a corresponding disclaimer. ``(f) Rule of Construction.--Nothing in this section shall be construed to imply that the Agency's role is to mandate a national standard or specific approach to quality measurement and reporting. In research and quality improvement activities, the Agency shall consider a wide range of choices, providers, health care delivery systems, and individual preferences. ``PART B--HEALTH CARE IMPROVEMENT RESEARCH ``SEC. 911. HEALTH CARE OUTCOME IMPROVEMENT RESEARCH. ``(a) Evidence Rating Systems.--In collaboration with experts from the public and private sector, the Agency shall identify and disseminate methods or systems that it uses to assess health care research results, particularly methods or systems that it uses to rate the strength of the scientific evidence behind health care practice, recommendations in the research literature, and technology assessments. The Agency shall make methods or systems for evidence rating widely available. Agency publications containing health care recommendations shall indicate the level of substantiating evidence using such methods or systems. ``(b) Health Care Improvement Research Centers and Provider-Based Research Networks.-- ``(1) In general.--In order to address the full continuum of care and outcomes research, to link research to practice improvement, and to speed the dissemination of research findings to community practice settings, the Agency shall employ research strategies and mechanisms that will link research directly with clinical practice in geographically diverse locations throughout the United States, including-- ``(A) Health Care Improvement Research Centers that combine demonstrated multidisciplinary expertise in outcomes or quality improvement research with linkages to relevant sites of care; ``(B) Provider-based Research Networks, including plan, facility, or delivery system sites of care (especially primary care), that can evaluate outcomes and promote quality improvement; and ``(C) other innovative mechanisms or strategies to link research with clinical practice. ``(2) Requirements.--The Director is authorized to establish the requirements for entities applying for grants under this subsection. ``SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND DELIVERY. ``(a) Support for Efforts To Develop Information on Quality.-- ``(1) Scientific and technical support.--In its role as the principal agency for health research and quality, the Agency may provide scientific and technical support for private and [[Page H8914]] public efforts to improve health care quality, including the activities of accrediting organizations. ``(2) Role of the agency.--With respect to paragraph (1), the role of the Agency shall include-- ``(A) the identification and assessment of methods for the evaluation of the health of-- ``(i) enrollees in health plans by type of plan, provider, and provider arrangements; and ``(ii) other populations, including those receiving long- term care services; ``(B) the ongoing development, testing, and dissemination of quality measures, including measures of health and functional outcomes; ``(C) the compilation and dissemination of health care quality measures developed in the private and public sector; ``(D) assistance in the development of improved health care information systems; ``(E) the development of survey tools for the purpose of measuring participant and beneficiary assessments of their health care; and ``(F) identifying and disseminating information on mechanisms for the integration of information on quality into purchaser and consumer decision-making processes. ``(b) Centers for Education and Research on Therapeutics.-- ``(1) In general.--The Secretary, acting through the Director and in consultation with the Commissioner of Food and Drugs, shall establish a program for the purpose of making one or more grants for the establishment and operation of one or more centers to carry out the activities specified in paragraph (2). ``(2) Required activities.--The activities referred to in this paragraph are the following: ``(A) The conduct of state-of-the-art research for the following purposes: ``(i) To increase awareness of-- ``(I) new uses of drugs, biological products, and devices; ``(II) ways to improve the effective use of drugs, biological products, and devices; and ``(III) risks of new uses and risks of combinations of drugs and biological products. ``(ii) To provide objective clinical information to the following individuals and entities: ``(I) Health care practitioners and other providers of health care goods or services. ``(II) Pharmacists, pharmacy benefit managers and purchasers. ``(III) Health maintenance organizations and other managed health care organizations. ``(IV) Health care insurers and governmental agencies. ``(V) Patients and consumers. ``(iii) To improve the quality of health care while reducing the cost of health care through-- ``(I) an increase in the appropriate use of drugs, biological products, or devices; and ``(II) the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations. ``(B) The conduct of research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices. ``(C) Such other activities as the Secretary determines to be appropriate, except that a grant may not be expended to assist the Secretary in the review of new drugs. ``(c) Reducing Errors in Medicine.--The Director shall conduct and support research and build private-public partnerships to-- ``(1) identify the causes of preventable health care errors and patient injury in health care delivery; ``(2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and ``(3) promote the implementation of effective strategies throughout the health care industry. ``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE. ``(a) In General.--In carrying out 902(a), the Director shall-- ``(1) conduct a survey to collect data on a nationally representative sample of the population on the cost, use and, for fiscal year 2001 and subsequent fiscal years, quality of health care, including the types of health care services Americans use, their access to health care services, frequency of use, how much is paid for the services used, the source of those payments, the types and costs of private health insurance, access, satisfaction, and quality of care for the general population and also for populations identified in section 901(c); and ``(2) develop databases and tools that provide information to States on the quality, access, and use of health care services provided to their residents. ``(b) Quality and Outcomes Information.-- ``(1) In general.--Beginning in fiscal year 2001, the Director shall ensure that the survey conducted under subsection (a)(1) will-- ``(A) identify determinants of health outcomes and functional status, the needs of special populations in such variables as well as an understanding of changes over time, relationships to health care access and use, and monitor the overall national impact of Federal and State policy changes on health care; ``(B) provide information on the quality of care and patient outcomes for frequently occurring clinical conditions for a nationally representative sample of the population; and ``(C) provide reliable national estimates for children and persons with special health care needs through the use of supplements or periodic expansions of the survey. In expanding the Medical Expenditure Panel Survey, as in existence on the date of enactment of this title in fiscal year 2001 to collect information on the quality of care, the Director shall take into account any outcomes measurements generally collected by private sector accreditation organizations. ``(2) Annual report.--Beginning in fiscal year 2003, the Secretary, acting through the Director, shall submit to Congress an annual report on national trends in the quality of health care provided to the American people. ``SEC. 914. INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT. ``(a) In General.--In order to foster a range of innovative approaches to the management and communication of health information, the Agency shall support research, evaluations and initiatives to advance-- ``(1) the use of information systems for the study of health care quality and outcomes, including the generation of both individual provider and plan-level comparative performance data; ``(2) training for health care practitioners and researchers in the use of information systems; ``(3) the creation of effective linkages between various sources of health information, including the development of information networks; ``(4) the delivery and coordination of evidence-based health care services, including the use of real-time health care decision-support programs; ``(5) the structure, content, definition, and coding of health information data and medical vocabularies in consultation with appropriate Federal entities and shall seek input from appropriate private entities; ``(6) the use of computer-based health records in outpatient and inpatient settings as a personal health record for individual health assessment and maintenance, and for monitoring public health and outcomes of care within populations; and ``(7) the protection of individually identifiable information in health services research and health care quality improvement. ``(b) Demonstration.--The Agency shall support demonstrations into the use of new information tools aimed at improving shared decision-making between patients and their care-givers. ``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN UNDERSERVED AREAS. ``(a) Preventive Services Task Force.-- ``(1) Purpose.--The Agency shall provide ongoing administrative, research, and technical support for the operation of the Preventive Services Task Force. The Agency shall coordinate and support the dissemination of the Preventive Services Task Force recommendations. ``(2) Operation.--The Preventive Services Task Force shall review the scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care community, and updating previous recommendations, regarding their usefulness in daily clinical practice. In carrying out its responsibilities under paragraph (1), the Task Force shall not be subject to the provisions of Appendix 2 of title 5, United States Code. ``(b) Primary Care Research.-- ``(1) In general.--There is established within the Agency a Center for Primary Care Research (referred to in this subsection as the `Center') that shall serve as the principal source of funding for primary care practice research in the Department of Health and Human Services. For purposes of this paragraph, primary care research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral to specialty care, preventive care, and the relationship between the clinician and the patient in the context of the family and community. ``(2) Research.--In carrying out this section, the Center shall conduct and support research concerning-- ``(A) the nature and characteristics of primary care practice; ``(B) the management of commonly occurring clinical problems; ``(C) the management of undifferentiated clinical problems; and ``(D) the continuity and coordination of health services. ``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION. ``(a) In General.--The Director shall promote innovation in evidence-based clinical practice and health care technologies by-- ``(1) conducting and supporting research on the development, diffusion, and use of health care technology; ``(2) developing, evaluating, and disseminating methodologies for assessments of health care practices and health care technologies; ``(3) conducting intramural and supporting extramural assessments of existing and new health care practices and technologies; ``(4) promoting education, training, and providing technical assistance in the use of health care practice and health care technology assessment methodologies and results; and ``(5) working with the National Library of Medicine and the public and private sector to develop an electronic clearinghouse of currently available assessments and those in progress. ``(b) Specification of Process.-- ``(1) In general.--Not later than December 31, 2000, the Director shall develop and publish a description of the methods used by the Agency and its contractors for practice and technology assessment. ``(2) Consultations.--In carrying out this subsection, the Director shall cooperate and consult with the Assistant Secretary for Health, the Administrator of the Health Care Financing Administration, the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the heads of any other interested Federal department or agency, and shall seek input, where appropriate, from professional societies and other private and public entities. ``(3) Methodology.--The Director shall, in developing the methods used under paragraph (1), consider-- ``(A) safety, efficacy, and effectiveness; [[Page H8915]] ``(B) legal, social, and ethical implications; ``(C) costs, benefits, and cost-effectiveness; ``(D) comparisons to alternate technologies and practices; and ``(E) requirements of Food and Drug Administration approval to avoid duplication. ``(c) Specific Assessments.-- ``(1) In general.--The Director shall conduct or support specific assessments of health care technologies and practices. ``(2) Requests for assessments.--The Director is authorized to conduct or support assessments, on a reimbursable basis, for the Health Care Financing Administration, the Department of Defense, the Department of Veterans Affairs, the Office of Personnel Management, and other public or private entities. ``(3) Grants and contracts.--In addition to conducting assessments, the Director may make grants to, or enter into cooperative agreements or contracts with, entities described in paragraph (4) for the purpose of conducting assessments of experimental, emerging, existing, or potentially outmoded health care technologies, and for related activities. ``(4) Eligible entities.--An entity described in this paragraph is an entity that is determined to be appropriate by the Director, including academic medical centers, research institutions and organizations, professional organizations, third party payers, governmental agencies, and consortia of appropriate research entities established for the purpose of conducting technology assessments. ``SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY IMPROVEMENT EFFORTS. ``(a) Requirement.-- ``(1) In general.--To avoid duplication and ensure that Federal resources are used efficiently and effectively, the Secretary, acting through the Director, shall coordinate all research, evaluations, and demonstrations related to health services research, quality measurement and quality improvement activities undertaken and supported by the Federal Government. ``(2) Specific activities.--The Director, in collaboration with the appropriate Federal officials representing all concerned executive agencies and departments, shall develop and manage a process to-- ``(A) improve interagency coordination, priority setting, and the use and sharing of research findings and data pertaining to Federal quality improvement programs, technology assessment, and health services research; ``(B) strengthen the research information infrastructure, including databases, pertaining to Federal health services research and health care quality improvement initiatives; ``(C) set specific goals for participating agencies and departments to further health services research and health care quality improvement; and ``(D) strengthen the management of Federal health care quality improvement programs. ``(b) Study by the Institute of Medicine.-- ``(1) In general.--To provide Congress, the Department of Health and Human Services, and other relevant departments with an independent, external review of their quality oversight, quality improvement and quality research programs, the Secretary shall enter into a contract with the Institute of Medicine-- ``(A) to describe and evaluate current quality improvement, quality research and quality monitoring processes through-- ``(i) an overview of pertinent health services research activities and quality improvement efforts conducted by all Federal programs, with particular attention paid to those under titles XVIII, XIX, and XXI of the Social Security Act; and ``(ii) a summary of the partnerships that the Department of Health and Human Services has pursued with private accreditation, quality measurement and improvement organizations; and ``(B) to identify options and make recommendations to improve the efficiency and effectiveness of quality improvement programs through-- ``(i) the improved coordination of activities across the medicare, medicaid and child health insurance programs under titles XVIII, XIX and XXI of the Social Security Act and health services research programs; ``(ii) the strengthening of patient choice and participation by incorporating state-of-the-art quality monitoring tools and making information on quality available; and ``(iii) the enhancement of the most effective programs, consolidation as appropriate, and elimination of duplicative activities within various federal agencies. ``(2) Requirements.-- ``(A) In general.--The Secretary shall enter into a contract with the Institute of Medicine for the preparation-- ``(i) not later than 12 months after the date of enactment of this title, of a report providing an overview of the quality improvement programs of the Department of Health and Human Services for the medicare, medicaid, and CHIP programs under titles XVIII, XIX, and XXI of the Social Security Act; and ``(ii) not later than 24 months after the date of enactment of this title, of a final report containing recommendations. ``(B) Reports.--The Secretary shall submit the reports described in subparagraph (A) to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Ways and Means and the Committee on Commerce of the House of Representatives. ``PART C--GENERAL PROVISIONS ``SEC. 921. ADVISORY COUNCIL FOR HEALTH CARE RESEARCH AND QUALITY. ``(a) Establishment.--There is established an advisory council to be known as the Advisory Council for Health Care Research and Quality. ``(b) Duties.-- ``(1) In general.--The Advisory Council shall advise the Secretary and the Director with respect to activities proposed or undertaken to carry out the purpose of the Agency under section 901(b). ``(2) Certain recommendations.--Activities of the Advisory Council under paragraph (1) shall include making recommendations to the Director regarding-- ``(A) priorities regarding health care research, especially studies related to quality, outcomes, cost and the utilization of, and access to, health care services; ``(B) the field of health care research and related disciplines, especially issues related to training needs, and dissemination of information pertaining to health care quality; and ``(C) the appropriate role of the Agency in each of these areas in light of private sector activity and identification of opportunities for public-private sector partnerships. ``(c) Membership.-- ``(1) In general.--The Advisory Council shall, in accordance with this subsection, be composed of appointed members and ex officio members. All members of the Advisory Council shall be voting members other than the individuals designated under paragraph (3)(B) as ex officio members. ``(2) Appointed members.--The Secretary shall appoint to the Advisory Council 18 appropriately qualified individuals. At least 14 members of the Advisory Council shall be representatives of the public who are not officers or employees of the United States. The Secretary shall ensure that the appointed members of the Council, as a group, are representative of professions and entities concerned with, or affected by, activities under this title and under section 1142 of the Social Security Act. Of such members-- ``(A) 3 shall be individuals distinguished in the conduct of research, demonstration projects, and evaluations with respect to health care; ``(B) 3 shall be individuals distinguished in the practice of medicine of which at least 1 shall be a primary care practitioner; ``(C) 3 shall be individuals distinguished in the other health professions; ``(D) 3 shall be individuals either representing the private health care sector, including health plans, providers, and purchasers or individuals distinguished as administrators of health care delivery systems; ``(E) 3 shall be individuals distinguished in the fields of health care quality improvement, economics, information systems, law, ethics, business, or public policy; and ``(F) 3 shall be individuals representing the interests of patients and consumers of health care. ``(3) Ex officio members.--The Secretary shall designate as ex officio members of the Advisory Council-- ``(A) the Assistant Secretary for Health, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Administrator of the Health Care Financing Administration, the Assistant Secretary of Defense (Health Affairs), and the Under Secretary for Health of the Department of Veterans Affairs; and ``(B) such other Federal officials as the Secretary may consider appropriate. ``(d) Terms.--Members of the Advisory Council appointed under subsection (c)(2) shall serve for a term of 3 years. A member of the Council appointed under such subsection may continue to serve after the expiration of the term of the members until a successor is appointed. ``(e) Vacancies.--If a member of the Advisory Council appointed under subsection (c)(2) does not serve the full term applicable under subsection (d), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual. ``(f) Chair.--The Director shall, from among the members of the Advisory Council appointed under subsection (c)(2), designate an individual to serve as the chair of the Advisory Council. ``(g) Meetings.--The Advisory Council shall meet not less than once during each discrete 4-month period and shall otherwise meet at the call of the Director or the chair. ``(h) Compensation and Reimbursement of Expenses.-- ``(1) Appointed members.--Members of the Advisory Council appointed under subsection (c)(2) shall receive compensation for each day (including travel time) engaged in carrying out the duties of the Advisory Council unless declined by the member. Such compensation may not be in an amount in excess of the maximum rate of basic pay payable for GS-18 of the General Schedule. ``(2) Ex officio members.--Officials designated under subsection (c)(3) as ex officio members of the Advisory Council may not receive compensation for service on the Advisory Council in addition to the compensation otherwise received for duties carried out as officers of the United States. ``(i) Staff.--The Director shall provide to the Advisory Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council. ``SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS. ``(a) Requirement of Review.-- ``(1) In general.--Appropriate technical and scientific peer review shall be conducted with respect to each application for a grant, cooperative agreement, or contract under this title. ``(2) Reports to director.--Each peer review group to which an application is submitted pursuant to paragraph (1) shall report its finding and recommendations respecting the application to the Director in such form and in such manner as the Director shall require. ``(b) Approval as Precondition of Awards.--The Director may not approve an application described in subsection (a)(1) unless [[Page H8916]] the application is recommended for approval by a peer review group established under subsection (c). ``(c) Establishment of Peer Review Groups.-- ``(1) In general.--The Director shall establish such technical and scientific peer review groups as may be necessary to carry out this section. Such groups shall be established without regard to the provisions of title 5, United States Code, that govern appointments in the competitive service, and without regard to the provisions of chapter 51, and subchapter III of chapter 53, of such title that relate to classification and pay rates under the General Schedule. ``(2) Membership.--The members of any peer review group established under this section shall be appointed from among individuals who by virtue of their training or experience are eminently qualified to carry out the duties of such peer review group. Officers and employees of the United States may not constitute more than 25 percent of the membership of any such group. Such officers and employees may not receive compensation for service on such groups in addition to the compensation otherwise received for these duties carried out as such officers and employees. ``(3) Duration.--Notwithstanding section 14(a) of the Federal Advisory Committee Act, peer review groups established under this section may continue in existence until otherwise provided by law. ``(4) Qualifications.--Members of any peer-review group shall, at a minimum, meet the following requirements: ``(A) Such members shall agree in writing to treat information received, pursuant to their work for the group, as confidential information, except that this subparagraph shall not apply to public records and public information. ``(B) Such members shall agree in writing to recuse themselves from participation in the peer-review of specific applications which present a potential personal conflict of interest or appearance of such conflict, including employment in a directly affected organization, stock ownership, or any financial or other arrangement that might introduce bias in the process of peer-review. ``(d) Authority for Procedural Adjustments in Certain Cases.--In the case of applications for financial assistance whose direct costs will not exceed $100,000, the Director may make appropriate adjustments in the procedures otherwise established by the Director for the conduct of peer review under this section. Such adjustments may be made for the purpose of encouraging the entry of individuals into the field of research, for the purpose of encouraging clinical practice-oriented or provider-based research, and for such other purposes as the Director may determine to be appropriate. ``(e) Regulations.--The Director shall issue regulations for the conduct of peer review under this section. ``SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION, AND DISSEMINATION OF DATA. ``(a) Standards With Respect to Utility of Data.-- ``(1) In general.--To ensure the utility, accuracy, and sufficiency of data collected by or for the Agency for the purpose described in section 901(b), the Director shall establish standard methods for developing and collecting such data, taking into consideration-- ``(A) other Federal health data collection standards; and ``(B) the differences between types of health care plans, delivery systems, health care providers, and provider arrangements. ``(2) Relationship with other department programs.--In any case where standards under paragraph (1) may affect the administration of other programs carried out by the Department of Health and Human Servic