RFA-HS-00-001: HEALTH CARE MARKETS AND MANAGED CARE

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

HEALTH CARE MARKETS AND MANAGED CARE Release Date: June 22, 1999 RFA: HS-00-001 Agency for Health Care Policy and Research Letter of Intent Receipt Date: September 2, 1999 Application Receipt Date: November 10, 1999 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for research program project grants to support, conduct, and disseminate health services research about the roles that managed care and other market forces play in the organization, financing, and delivery of health care. Research results are intended to provide rigorous evidence critical to the formulation of public policy affecting health care costs, utilization, access, and quality. Each research program project grant will support a broad, integrated, interdisciplinary, multi-project health services research program --a center of excellence-- that will bring together strong teams of experienced and new researchers to share essential facilities, services, knowledge, and other resources in purchasing and developing data sources, developing new methodologies, and generating analytic measures appropriate across supported projects. Central research questions to be addressed by applicants concern: (1) the nature, extent, and effects of competition among and within increasingly complex organizations in health care markets, including the effects of competition-driven consolidation among physicians into networks, and the effects of recent mergers in many markets among and across health plans, hospitals, and other health care organizations, (2) the increased and varied role that managed care plays in health care markets and in the proliferation of new organizational types --many of which are based not on ownership but on purely contractual relationships, (3) the role and consequences of the behavior of employers and other purchasers in health care markets, including their role in incorporating quality considerations into their health coverage buying decisions, i.e., value-based purchasing, and (4) the effects of all of these factors and other recent changes in health care markets on health care delivery, utilization, access, outcomes, quality, and costs --which recent evidence suggests will start to rise again. In addition to projects focused on the central issues above, applicants are strongly encouraged to incorporate related cross-cutting research projects that provide policy-relevant evidence (1) about the role of market forces and managed care in rural settings, and (2) about the effects of changing markets and organizations on access to health care for minorities. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting health improvement priorities for the United States. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign, public or private nonprofit organizations, including universities, clinics, units of State and local governments, and eligible agencies of the Federal government. AHCPR, by statute, can make grants only to non-profit organizations, however, for-profit organizations may participate in grant projects as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHCPR encourages investigators who are women, members of minority groups and persons with disabilities to apply as principal investigators. MECHANISM OF SUPPORT Projects supported under this initiative will use the Research Program Project Grant (P01) mechanism. Responsibility for the planning, direction, and execution of the proposed Research Program Project Grant (henceforth, P01) will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. The earliest possible award date is May 1, 2000. AHCPR"s Guidelines for the Research Program Project Grant are available on AHCPR"s Website at http://www.ahcpr.gov (under Funding Opportunities) and from Ms. Dawn French at the address listed below under Letter of Intent. The P01 mechanism is designed to support multiple, interacting discrete projects focused on a central theme, involving a number of independent investigators who share knowledge, data, and common resources. Under this initiative, each P01 application must have a minimum of four discrete projects and a maximum of six-- and are strongly encouraged to include cores. A core is a separately budgeted component of a P01 that provides essential facilities or services to two or more of the proposed research projects. For example, in addition to an administrative core, a P01 may include a technical core to facilitate across-institution and across-project sharing of resources in purchasing, developing and using data sources. A core may not count as one of the four discrete research projects. A P01 may support projects that are performed at multiple sites but coordinated by a single principal investigator (PI) at the grantee institution. The PI will be responsible for the planning, direction and execution of the proposed project. An award will be made only to the PI"s institution. Applicants are encouraged to coordinate most activities at other institutions through an administrative core located at the PI"s institution. Note that the scope of this initiative and the capacity-building aspects of the P01 allow new investigators and institutions to be drawn together to work collaboratively with a team of experienced researchers. AHCPR particularly encourages collaboration with researchers from Historically Black Colleges and Universities, Hispanic Serving Institutions, and other minority and minority serving institutions. This RFA is a one-time solicitation. AHCPR has not determined whether or how this solicitation will be continued beyond this present initiative. FUNDS AVAILABLE AHCPR expects to award up to $2.205 million in total costs (i.e., including indirect costs) in fiscal year 2000 to support the first year of two or three P01s selected under this RFA. Thus, each selected P01 can expect to be awarded about $750,000 to $1 million in the first year. At the time of this solicitation, the anticipated level of continuation funding across the several awarded P01s for second, third, fourth, and fifth years is at an equivalent level (i.e., about $2 million per year for total costs for the entire initiative). The actual number of applications funded is dependent on the number of high quality applications and their individual budget requirements. It is not the intent of AHCPR that the awards be equal in size. Although the financial plans of AHCPR provides for this program, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. RESEARCH OBJECTIVES Background AHCPR has always focused on public policy issues dealing with the role of markets in organizational behavior and in the cost and financing of health care (Eisenberg, 1998). In recent years, particularly through RFA HS-95-005 (Market Forces in a Changing Health Care System, 1995), AHCPR has looked at both cost and financing issues in health care reform and the effects of managed care on market behavior. However, over the past few years, the organizational behavior in all health care markets has become increasingly complex. Salient characteristics of health care markets now include: (1) Horizontal integration and consolidation occurring at record rates in certain parts of the health care sector. For example, the number of Health Maintenance Organization (HMO) mergers and acquisitions more than doubled between 1995 and 1996 (see Gaynor and Haas-Wilson, 1999). This horizontal integration has resulted in complex multi-product, multi-market health plans and diversified provider networks. (2) A proliferation of new organizational types. Very recently, the vertical integration of the early 1990"s has appeared to unravel, resulting in vertical "dis-integration:" a shift from ownership to contractual relationships between providers and plans (Robinson, 1999). The regulatory and legislative environment --notably the Employment and Retirement Income Security Act of 1974-- often blur distinctions among previously discrete functions of insurance, hospital care, ambulatory care, supply of pharmaceuticals, administrative services, and employer purchasing of healthcare. Conversions of not-for-profit health care institutions continue, adding to the increased presence of for-profit ownership in all markets. (3) Increasingly widespread penetration of many new types of managed care. In fact, the proportion of individuals with employer-provided health insurance who were in some form of managed care increased from 51 percent in 1993 to 73 percent in 1995 (Jensen et al., 1997). (4) Increased purchaser power. Much of this organizational change in healthcare markets has been fueled by the increased power of purchasers under the rise of managed care. Since managed care is often marketed directly to employers, this increased managed care penetration has resulted in buyer-driven price competition in all health care markets. Moreover, a few large employers have also engaged in "value-based" purchasing: buying health care on the basis of quality as well as cost (Meyer, 1998). (5) Fragmentation, diminished access, and disparities. Despite undeniable consolidation among some health care organizations, other parts of the health care sector now antithetically exhibit a much greater degree of fragmentation than ever before. For example, many HMOs have recently withdrawn from the Medicaid and Medicare programs. In addition, rural health care markets still remain isolated from managed care competition. Racial and ethnic minorities still face limited access, less than half of all Hispanics and blacks had private health insurance, compared to three-fourths of whites in 1996. Racial and ethnic disparities in health outcomes still persist. For example, blacks are 40 percent more likely to die of heart disease than whites. Cancer death rates among blacks are 35 percent higher (DHHS, 1999). (6) A resurgence in health care costs. Despite all the organizational restructuring in markets, national health care spending is projected to double between 1996 and 2007, growing from 13.6 percent of Gross Domestic Product (GDP) in 1996 to 16.6 percent of GDP by 2007 (Smith et al., 1998). Objectives and Scope This strategic environment provides both new demands and opportunities for policy-relevant research on the role of market forces. Participants in the formulation of public policy -- and decision makers at all levels and in all parts of the health care sector as well -- require new rigorous evidence about the extent and nature of recent health care market and organizational changes and about the consequences of such changes for health care delivery, utilization, access, outcomes, quality, and costs. The goal of projects supported under this RFA is the generation of knowledge that policy makers can use to address the myriad of issues that emerge from the increased organizational complexity of the U.S. health care markets, as well as renewed cost pressures and potential threats to access for poor and minority populations. To achieve a full analysis of these types of public policy issues, each P01 grant will consist of at least 4 and no more than 6 inter-related individual projects that all revolve around one general program theme conceived by the principal investigator (e.g., provider networks, or effects of recent changes in health care markets on health care outcomes, or measuring and assessing effects of competition in complex health care markets, or the role of quality in health care markets). Within the main program theme, the individual discrete projects will address specific topics chosen from the following four areas. The distribution of projects across the topic are given below in "Special Requirements." (1) Provider and Health Plan Behavior. Providers may be any organized provider (or network of providers) of medical care, such as hospitals, medical groups, HMOs, integrated delivery systems, nursing homes, home health care companies, subacute care and rehabilitation facilities, disease management programs, carve- outs, and pharmaceutical suppliers. Health plans refer to any organization that provides health insurance, such as HMOs, Preferred Provider Organizations (PPOs), and fee-for-service carriers. A study of behavior may involve (a) a description of the structural and behavioral complexity within provider organizations and within health plans, and/or (b) an analysis of the public policy implications of the strategic behavior between providers and health plans. For example: What are the market and community-level impacts of organizational change and market complexity on consumer prices, consumer quality, cost efficiency, risk bearing, competition, market structure, and patient care? How should competition and managed care penetration in these complex markets be defined? How has regulation affected market dynamics and patient care? AHCPR is also interested in how market complexity affects consumer quality and consumer health outcomes. For example: Which types of market changes are associated with improved health outcomes? Does organizational complexity lead to greater variation in health outcomes? In particular, AHCPR is interested in analysis that provides information to public policymakers concerned about reducing disparity of outcomes for minorities in any of the six outcome areas formulated in the Department of Health and Human Services" Initiative on Race (also referenced below in topic 3). (2) Purchaser Behavior. Purchasers refer to any organized buyer of health care and insurance, such as employers, coalitions, and public purchasers (Medicare, Medicaid, S-CHIP). A study of behavior may involve (a) a description of the structural complexity among purchasers, and/or (b) an analysis of the public policy implications of the strategic behavior among purchasers, providers, and health plans. For example: How has purchaser behavior and coalition formation influenced the changes observed in the market? How has the level of market complexity affected the employer"s benefit package and selection of plans? Under what market conditions do buyers engage in value-based purchasing? Value-base purchasing is selection of coverage options for employees by large employers, coalitions and government purchasers incorporating information on the quality of health care, plan/provider processes, population and patient outcomes, as well as information on price. In order to provide employers with tools to enhance their ability to buy value and to encourage the adoption of best practices by large employers, employer coalitions and government purchasers, AHCPR seeks to better understand the potential and the limitations of various value-based purchasing strategies to improve quality. (3) Minority Access. Ethnic and racial minorities are of particular interest as subjects for study under this RFA. A description of the Department of Health and Human Services" Initiative to Eliminate Racial and Ethnic Disparities in Health can be found at http://raceandhealth.hhs.gov/over-txt.htm. In this RFA, AHCPR is particularly interested in the link between market forces and the public policy issues reflected in the Departmental initiative. For example, what financial and geographical barriers to health insurance and to particular sets of providers are minorities more likely to face than non-minorities? Understanding whether and how features of delivery systems differentially affect minority access to health care and the quality of care they receive is an essential first step to redressing these disparities. Research proposed under this RFA, however, should go beyond merely documenting the existence of disparities, and identify the market-level and organizational causes of disparities and suggest strategies that will lead to better health care access and quality for minorities. (4) Rural Markets. AHCPR has an interest in research relevant to increasing consumer access to health care and health insurance in rural areas. For example, how can the implementation of managed care be improved in rural areas? Do rural employers use different purchasing strategies than urban employers? Many of the recent important antitrust cases in exclusive contracting have occurred in rural areas. Is there evidence that particular strategies in urban markets may be anti- competitive (i.e., not motivated by greater efficiency) but that, in contrast, such behavior may be quite efficient in rural areas? For example, are exclusionary provider networks cost-efficient in rural markets? Methods Individual projects may use a combination of rigorous qualitative and quantitative methods among the P01"s individual projects. Qualitative methods may be especially useful in studying rapidly changing environments and can be used on their own to deepen understanding of the transformation of health care delivery systems or to complement quantitative methods and thereby strengthen the research design. For example, rigorous qualitative research may detail the exact characteristics of the organizations and markets under study (and not merely a classification or typology of the organizations). Quantitative methods should be rigorous and use state-of-the-art methodologies. Projects using such methods should be grounded in appropriate theoretical frameworks. Hypotheses-testing projects should present competing hypotheses clearly. Applied and new quantitative methods are expected to address endogeneity, selection bias, and other statistical problems often associated with the use of secondary data sources to conduct research on the topics describe within this initiative. Technical Cores Within this initiative, each P01 is expected to have one or more technical cores. For example, a technical core may be a separately budgeted facility that processes and analyzes data for several projects within the P01, allowing projects to link data sets and share variables. Development of large new surveys is not encouraged. It is expected that research supported under this initiative will use existing data for good reasons: (1) Such data are usually quite appropriate for such research, given that they are is often connected to reimbursement and thus track market transactions, (2) Use of such data is efficient and expedient, since they do not require collection and are relatively available, (3) Given rapid changes in health care markets and commensurate changes in the legislative and regulatory environments, both the research questions and the policy context for research on health care markets make relatively high demands for timeliness in conducting such research and on the reporting of results, thus making existing data sources attractive, (4) Application of rigorous statistical techniques can be used to address certain inherent weaknesses in the use of existing data. Thus, investigators are expected to acquire, process, and use existing data from multiple sources to capture complex interactions between organizations and within markets. For example, a quantitative analysis of HMO and hospital costs may control for demand-side changes in the market (e.g., purchaser behavior) by linking to purchaser data from a P01"s individual project on employer behavior. Development of a state level data set detailing states" regulatory structure for providers, health plans, and purchasers (e.g., PPO regulation) may provide another focus for a P01"s technical core, potentially useful across a number of the inter-related P01 projects. Also, AHCPR encourages research using data from the Medical Expenditure Panel Survey (MEPS), developed by AHCPR with collaboration by the National Center for Health Statistics, and other AHCPR-supported data bases such as the Healthcare Cost and Utilization Project (HCUP). For assistance with AHCPR data sets, see the Inquiry section below. Policy Relevance and Dissemination Studies under this RFA are expected not only to contribute to our basic understanding of recent changes in health care markets and organizations but also to build capacity --tools, talent, and teams-- to answer associated questions of policy relevance and to produce information in formats useful to participants in the formulation of public policy. Applicants should be concrete in describing (1) the public policy and other audiences most interested in the supported research and (2) how applicants anticipate their results being used for public policy purposes. Dissemination strategies should not be limited to publication in peer-reviewed journals but may encompass a variety of approaches, such as translating results into nontechnical monographs and distributing them through associations of private and public officials, educating legislators, public administrators, health plan executives, employers, and others in seminars, and outreach to the mass media. Consistent with the purpose of this initiative to provide rigorous evidence critical to the formulation of public policy affecting health care costs, utilization, access, and quality, applicants should plan to attend an annual conference of awardees supported under this RFA in order to (1) make visible the research capacity developed under the grant to a public policy audience, (2) discuss public policy issues relevant to supported projects, and (3) share results when available with public policy audiences, with researchers supported under other P01s funded under this initiative, and with AHCPR program staff. AHCPR program staff will bear the responsibility for coordination and timing of such conferences. SPECIAL REQUIREMENTS Special Terms of Award indicated below are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grants administration regulations, 45 CFR Parts 74 and 92, and other HHS and PHS grants administrative policies. Applicants should be familiar with the Agency"s grant regulation, 42 CFR Part 67 Subpart A, and particularly 76.18-67.22. Consistent with AHCPR"s Guidelines for the Research Program Project Grant, supported projects will most likely require assembly of inter-disciplinary teams to include investigators from more than one institution. "Letters of intent to collaborate with the applicant organization" signed by the appropriate institutional official from each participating organization must be included in the application. Submission of formal collaborative documents can be delayed until time of award. Each P01 must have a minimum of four individual projects, with a maximum of six individual projects. At least two of the individual projects in a P01 must respond to topic area 1 -- Provider and Health Plan Behavior. At least one of the individual projects in a P01 must respond to topic area 2 -- Purchaser Behavior. At least one individual project must cover either topic area 3 or topic area 4. Individual projects may address multiple topic areas. Rural and minority issues, for example, may be addressed across all projects. Applicants should be extremely clear --project-by-project-- about which topic areas are addressed. Individual projects within the P01 must all be inter-related and pertain to one general, overall program theme selected, titled, and presented as such in the application by the principal investigator. As indicated, applicants should plan to attend an annual conference of awardees supported under this RFA for dissemination purposes. For budgetary purposes, applicants for each P01 may plan for two representatives to travel to the Washington, DC, area for conference presentations that will be timed with annual submission of applications for continued funding. To this end, applicants should present a relevant plan, to include involved personnel, budget justifications, and timetables appropriate to participating in such conferences. Data Privacy Pursuant to section 903(c) of the Public Health Service Act (42 USC 299a-1(c)), information obtained in the course of any AHCPR-study that identifies an individual or entity must be treated as confidential in accordance with any promises made or implied regarding the use and purposes of the data collection. Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of such identifying information. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be safeguarded. The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Offices of Management and Budget (OMB) in OMB circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standard and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST handbook, Generally Accepted Principle and Practices for Securing Information Technology Systems, and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://www.whitehouse.gov/OMB/circulars/a130/a130.html, http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf, http://csrc.nist.gov/publications/nistbul/csl96-10.txt, http://csrc.nist.gov/publications/nistbul/itl99-04.txt, respectively. Rights in Data AHCPR grantees may copyright or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHCPR funds. Such copyrights and patents are subject to a Federal government license to use and permit others to use these products and materials for AHCPR purposes. In accordance with its legislative dissemination mandate, AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers, and subject to AHCPR budget constraints, final products maybe made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publicizes research findings but relies on grantees to publish in peer-reviewed journals and to market grant-supported products. Important legal rights and requirements applicable to AHCPR grantees are set out or referenced in the AHCPR"s grants regulation at 42 CFR Part 67, Subpart A. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS It is the policy of AHCPR that women and members of minority groups be included in all AHCPR-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 and in the NIH Guide for Grants and Contracts of March 18, 1994. To the extent possible, AHCPR requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHCPR contractor, listed under INQUIRIES, or from the NIH Guide Website http://www.nih.gov/grants/guide/index.html. AHCPR also encourages investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide of May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. This Notice is available through the AHCPR Website http://www.ahcpr.gov (Funding Opportunities) and InstantFAX (see instructions under INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by September 2, 1999, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHCPR staff to estimate the potential review workload and avoid conflict of interest in the review. AHCPR will not provide responses to letters of intent. The letter of intent is to be sent to: Dawn French Center for Organization and Delivery Studies Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone (301) 594-6768 FAX: (301) 594-2314 Email: [email protected] APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. State and local government applicants may use PHS 5161-1, Application for Federal Assistance (5/96), and follow those requirements for copy submission. Applications kits are available at most institutional offices of sponsored research. They may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: [email protected]. AHCPR applicants may also obtain application materials from the AHCPR contractor (see INQUIRIES). In addition to the above, application procedures should conform to AHCPR"s Guidelines for the Research Program Project Grant. Applications for a P01 must include (1) an overall organizational plan, (2) an overarching research plan, and (3) detailed plans for the research projects. For purposes of the page limitations of section 1 through 4 of the PHS 398 form, the P01 organizational plan (including the administrative, technical, and other cores) and the overarching research plan should be considered as one component with a 25 page limit. A maximum of 5 additional pages may be used to describe each discrete research project that the P01 will undertake. The P01 mechanism under the RFA involves at least four and no more than six inter-related individual projects bundled together under one program theme. The characteristics of the P01 are expected to facilitate data sharing, variable sharing, and data processing among researchers, and across projects and institutions. Each P01 has three main types of leadership: the principal investigator, project leaders, and core directors. The principal investigator is in charge of the entire P01 and sets the general over-arching theme of all the projects in the P01. Each individual project in the P01 is directed by a project leader. In addition, individual projects in the P01 may share one or more "cores." Led by a core director, a core is a separately budgeted component of the P01 that provides essential facilities, administrative staff, or services for two or more of the P01"s individual projects. The cores are to create synergies among the various projects, researchers, and institutions in the program. For a detailed description of the design of the P01, please see AHCPR"s Guidelines for the Research Program Project Grant. The RFA label available in the PHS 398 (4/98) must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. The sample RFA label available at http://www.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The PHS 398 type size requirements (p. 6) will be enforced rigorously, and non- compliant applications returned. Applicants are encouraged to review current instructions prior to preparing their application. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application, labeled "Advanced Copy(s)" must also be sent to: Dawn French Center for Organization and Delivery Studies Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone (301) 594-6768 FAX: (301) 594-2314 Email: [email protected] Applications must be received by November 10, 1999. If an application is received after that date, it will be returned to the applicant without review. Application Preparation (including use of HCFA Data) For applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form PHS 398) the specific files, time periods, and cohorts proposed for the research. In consultation with the Health Care Financing Administration (HCFA), AHCPR will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. Applicants should be aware that for individually identifiable Medicare and Medicaid data, principal investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with HCFA to protect the confidentiality of data in accordance with standards set out in OMB Circular A- 130, Appendix III Security of Federal Automated Information Systems. The use of the data is restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee is required to return the data to HCFA or certify that the data have been destroyed. Grantees must also comply with the confidentiality requirements of Section 903(c) of the PHS Act. See the Data Privacy Section for details on these requirement as well as references for Circular A-130 and its implementation guides from the National Institute of Standards and Technology. In developing research plans, applicants should allow time for refining, providing, and processing their data requests. Requests may take 6 months from the time they are submitted to completion. Applications proposing to contact beneficiaries or their providers require the approval of the HCFA Administrator and may require meeting with HCFA staff. HCFA data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats. Questions regarding HCFA should be directed to the AHCPR program official listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by AHCPR in accordance with the review criteria stated below. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria The goals of AHCPR-supported research are to enhance the quality, appropriateness, and effectiveness of health care services, and access to such services. The reviewers will be asked to discuss the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Are the proposed data sources appropriate and adequate? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Is the project (or work plan) well organized? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 6. Policy Relevance. Is the project designed to be applicable to future decision-making by public and private policy makers? Will the project provide Federal and State policymakers, and others participating in the formulation of such policy, with the evidence-based information they need to improve quality and outcomes, control costs, and assure access to needed services? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Special Review Criteria Special P01 review criteria will also be used in the review of these applications. Peer review of the overall scientific and technical merit emphasizes a synthesis of two major aspects: 1) review of the P01 as an integrated effort focused on a central theme and 2) review of the merit of individual research projects and core components in the context of the proposed P01. Applicants are encouraged to study the evaluation criteria cited in the AHCPR"s Guidelines for the Research Program Project Grant before preparing their applications. The following sections from the Guidelines will apply to the review of this RFA: review criteria for the overall P01, review criteria for the program as an integrated effort, review criteria for projects, and review criteria for cores. AWARD CRITERIA Applications will compete for available funds with all other P01 applications under this RFA. The following will be considered in making funding decisions: 1) quality of the proposed P01 as determined by peer review, 2) availability of funds, 3) responsiveness to the goals and objectives of the RFA, 4) relevance to the formulation of public policy, and 5) portfolio balance. INQUIRIES Copies of the RFA are available from the AHCPR contractor: Equals Three Communication, Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone (301) 656-3100 FAX (301) 652-5264 This RFA is also available on AHCPR"s Web site, http://www.ahcpr.gov, and through AHCPR InstantFAX at (301) 594-2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the RFA number). The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR"s Division of Communications at (301) 594-6344. AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants who have obtained and read the RFA. Written and telephone inquiries concerning this RFA are encouraged. Inquiries regarding programmatic issues, including issues related to the inclusion of women, minorities, and children in study populations, should be addressed to: Michael Hagan Center for Organization and Delivery Studies Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone (301) 594-6768 FAX: (301) 594-2314 Email: [email protected] Bill Encinosa, PhD Center for Organization and Delivery Studies Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone (301) 594-6768 FAX: (301) 594-2314 Email: [email protected] For technical assistance on HCUP, direct inquiries to: Kelly Carper Center for Cost and Financing Studies Agency for Health Care Policy and Research 2101 E. Jefferson St., Suite 502 Rockville, MD 20852 Telephone: (301) 301-3075 Email: [email protected] For technical assistance on MEPS, direct inquiries to: Nancy Krauss Center for Cost and Financing Studies Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 502 Rockville, MD 20852-4908 Telephone: (301) 594-0846 Email: [email protected] Direct inquiries regarding fiscal and eligibility matters to: George (Skip) Moyer Grants Management Specialist Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1842 FAX: (301) 594-3210 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 USC 299-299c-6) and Section 1142 of the Social Security Act (42 USC 1320b-12) as applicable. Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Eisenberg, John M., 1998. "Health Services Research In A Market-Oriented Health Care System." Health Affairs. January/February 17:1, pp. 97-108. Jensen, Gail A., Michael A. Morrisey, Shannon Gaffney, and Derek K. Liston. 1997. "The New Dominance of Managed Care: Insurance Trends in the 1990s." Health Affairs. January/February, 16:1, pp. 125-136. Gaynor, Martin, and Deborah Haas-Wilson.1999. " Change, Consolidation, and Competition in Health Care Markets." The Journal of Economic Perspectives. Winter, 13:1, pp.141-164 Meyer, Jack A. 1997. "Theory and Reality of Value-Based Purchasing: Lessons From The Pioneers" AHCPR Research Report. November, Publication No. 98-0004, pp. 1-55. Robinson, James E. 1999. "The Future Of Managed Care Organization." Health Affairs. March/April, 18:2, pp. 7-24. Smith, Sheila, Mark Freeland, Stephen Heffler, David McKusick, and the Health Expenditures Projection Team. 1998. "The Next Ten Years Of Health Spending: What Does The Future Hold." Health Affairs. September/October, 17:5.129-140. U.S. Department of Health and Human Services, "The Initiative to Eliminate Racial and Ethnic Disparities in Health," 1999.

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