AHCPR OPPORTUNITY FOR COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTSAND OTHER PUBLIC-PRIVATE PARTNERSHIPS NIH GUIDE, Volume 26, Number 25, August 1, 1997 P.T. 34 Keywords: Health Services Delivery 0730021 0730023 Agency for Health Care Policy and Research I. Purpose The Agency for Health Care Policy and Research (AHCPR) is planning to enter into ~Cooperative Research and Development Agreements~ (CRADAs) and other public-private partnerships pursuant to the Federal Technology Transfer Act of 1986, as amended, and Executive Order 12591 of October 10, 1987. AHCPR is now seeking expressions of specific interest and general public comments regarding the Agency~s intention to develop additional public-private partnerships for research to enhance quality and access in the nation~s health care system. II. Background AHCPR is the Federal agency charged with supporting research to enhance the quality, appropriateness, and effectiveness of health care services and access to those services. AHCPR supports the development of scientific knowledge and disseminates information to strengthen consumer and clinical decisionmaking, and to improve the organization of public and private systems of health care delivery. AHCPR also has the lead for the special initiative of the Secretary of Health and Human Services (DHHS) on improving the quality of care throughout the nation's health care systems. AHCPR's strategic goals in research encompass projects designed to: o Help consumers make more informed choices. o Determine what works best in clinical practice. o Measure and improve quality of care. o Monitor and evaluate health care delivery. o Improve the cost-effective use of health care resources. o Assist health care policymakers. o Build and sustain the health services research infrastructure. AHCPR historically has used public-private partnerships to strengthen its dissemination activities, including the publication of clinical practice guidelines and co-sponsorship of conferences designed to expedite the translation of research findings into everyday health care practice. More recently, AHCPR has expanded its partnership roles with collaborations to support health services research projects through a variety of models, including the Cooperative Research and Development Agreement (CRADA). AHCPR~s interest in expanding its public-private partnerships is precipitated by three primary factors. First, demand for the products of health services research is growing beyond the Agency's ability to support it alone. Second, the rapid changes in health care markets and delivery systems create a need to re-examine the assumptions underlying the organization and delivery systems of health care. Third, some of the relevant data required to support health services research on health care innovations currently reside in the private sector. AHCPR believes that collaborations with the private sector will help to better target Federal resources, and ensure the relevance of AHCPR~s research to the emerging needs of the health care delivery systems and the growing demand for information. AHCPR is encouraging new public-private partnerships for collaborative research projects, with groups representing every segment of the health care community: o Patients and consumers. o Practitioners and organizations concerned with the delivery of clinical care. o Health plans and related organizations. o Purchasers of health care, including employers, labor unions, and other group purchasers. o Producers of health care products and equipment, including research-based manufacturers of pharmaceuticals, medical devices, and biotechnology products. o Researchers, policymakers, and research organizations. AHCPR will permit CRADA partners to negotiate with the Agency for a patent license, or similar license, to use or market (and develop further) any inventions, intellectual property, or copyrightable material created or developed through the collaboration. Partners will be expected to provide resources to facilitate the collaboration, including funds to support the costs of the research. The typical term of a CRADA will range from 2 to 5 years. Other Federal agencies, including the National Institutes of Health (NIH) and Health Care Financing Administration (HCFA) of the Department of Health and Human Services (DHHS), share AHCPR~s interest in conducting research projects, as well as in disseminating and utilizing the Agency~s research results, frequently leading to joint support and technical collaborations. For example, HCFA, as a purchaser of health care services for Medicare and Medicaid beneficiaries, shares AHCPR~s interest in the area of health care quality measurement and improvement. AHCPR and HCFA anticipate that it will often be effective and appropriate to cooperate in joint public-private partnerships for collaborative research endeavors. AHCPR's Role in Partnerships As a recognized leader in health services research, AHCPR has unique capabilities to bring to public-private partnerships, including: o Expertise in research methodology, including both quantitative and qualitative methods. o Demonstrated objectivity and recognized excellence in research. o Management of large national and state health care databases (including the Medical Expenditures Panel Surveys (MEPS), Health Care Cost and Utilization Project (HCUP), and HIV Cost and Services Utilization Study (HCSUS), as well as access to, and experience with, other major health-related national databases. o Expertise in evaluating cost-effectiveness, medical outcomes, and appropriateness of different clinical approaches and technologies for specific diseases or treatment regimes. o Expertise in working with policymakers and legislators to evaluate trends occurring in the health care market and to provide data to assist in decisionmaking. Recent AHCPR partnerships with nongovernmental organizations, leading toward important research initiatives, include: o Development of the Computerized Needs-Oriented Quality Measurement Evaluation System (CONQUEST), which enables health plans, practitioners, employers, and other users to identify and compare alternative quality of care measures in a meaningful way; and inauguration of the Quality Measurement Network (QMNet), which builds on the CONQUEST system and attempts to create a self-sufficient, comprehensive and publicly accessible quality measurement resource to improve the quality of care. These quality of care activities have involved AHCPR~s working with private-sector lead organizations in health care quality improvement and measurement, academia, and others. o Study of stroke prevention strategies in managed care organizations, particularly in ways to translate the findings of AHCPR's Patient Outcomes Research Team (PORT) into actual clinical practice across a variety of managed care models, using a three-way agreement involving AHCPR, PORT research institutions, and a major drug manufacturer. o Support for HCSUS, an HIV-related research project employing a cooperative agreement between AHCPR and RAND, in which investigators look at the delivery and cost of HIV/AIDS treatment. A partnership stemming from the HCSUS project, with funding from major pharmaceutical firms and technical assistance from AHCPR and other research partners, is enabling RAND to examine factors associated with initiating and adhering to combination therapies, which include protease inhibitors, for HIV/AIDS. AHCPR is now exploring new models for partnerships with other organizations. Areas for potential collaborations include, but are not limited to: o How the structure and organization of health care markets and the evolving managed care systems impact on cost, quality, and access; o Changes in the delivery of care such as clinical integration and new models of care, and how particular elements of managed care affect quality and outcomes; o Changes in financing mechanisms for health care coverage, including the impact of employer coalitions and value-based purchasing efforts; o Ways to use governmental and private sector health care databases for applying advanced data-analysis techniques to improve health care delivery; o Examining primary care delivery in terms of cost, quality, and patient outcomes; o The use of consumer satisfaction initiatives in the design of improved health care systems; o Development of syntheses of scientific evidence on specific clinical topics and technologies; o Disseminating evidence-based practice information to the clinical community; o Evaluating the relative impact (in terms of cost, quality, and outcomes) of new medical technologies, interventions, and innovations; and o Expanding efforts to explore and evaluate outcomes and effectiveness of various treatments for the same condition. Partners' Role The role of the private-sector partner in these research collaborations could include opportunities to: o Support research design and study through the provision of funding or other valuable research resources (such as data, research personnel, equipment). o Partner in the design, coordination, and conduct of research studies to evaluate the effectiveness and cost of health care delivery. o Provide clinical or other technical support for studies. o Improve consumer and practitioner access to research results through innovations in dissemination and evaluation. Submission of Proposals and Comments To receive immediate consideration, proposals or public comments must be received no later than September 23, 1997. However, proposals may be submitted at any time. Portions of proposals containing proprietary information may be labeled as confidential, if necessary. Proposals or comments may be sent directly to: Larry T. Patton Director, Office of Policy Analysis Agency for Health Care Policy and Research 2101 E. Jefferson Street, Suite 603 Rockville, MD 20852 Email: lpatton@ahcpr.gov INQUIRIES Questions or concerns regarding this notice may be directed to: Howard Cohen, J.D., 301-594-1321, ext.1016. .
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