[Federal Register Volume 62, Number 143 (Friday, July 25, 1997)]
[Notices]
[Pages 40090-40092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19064]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Health Care Policy and Research


AHCPR Opportunity for Cooperative Research and Development 
Agreements and Other Public-Private Partnerships

AGENCY: Agency for Health Care Policy and Research, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Agency for Health Care Policy and Research (AHCPR) is 
seeking specific expressions of 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.

DATES: To receive immediate consideration, proposals or public comments 
must be received by September 23, 1997. However, proposals may be 
submitted at any time.

ADDRESSES: 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, Rockville, Md 20852. 
(Email: [email protected]). Portions of proposals containing 
proprietary information may be labeled as confidential, if necessary.

FOR FURTHER INFORMATION CONTACT: Howard Cohen, J.D., at 301-594-1321, 
ext. 1016.

SUPPLEMENTARY INFORMATION: 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, 
for collaboration on research projects as described below.

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 (HHS) on improving the quality of care throughout the 
nation's health systems.
    AHCPR's strategic goals in research encompass projects designed to:
     Help consumers make more informed choices.
     Determine what works best in clinical practice.
     Measure and improve quality of care.
     Monitor and evaluate health care delivery.
     Improve the cost-effective use of health care resources.
     Assist health care policymakers.
     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 
car 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

[[Page 40091]]

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 additional 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:
     Patients and consumers.
     Practitioners and organizations concerned with the 
delivery of clinical care.
     Health plans and related organizations.
     Purchasers of health care, including employers, labor 
unions, and other group purchasers.
     Producers of health care products and equipment, including 
research-based manufacturers of pharmaceuticals, medical devices, and 
biotechnology products.
 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 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. Responses proposing multi-agency 
action will receive a coordinated review.

AHCPR's Role in Partnerships

    As a recognized leader in health services research, AHCPR has 
unique capabilities to bring to public-private partnership, including:
     Expertise in research methodology, including both 
quantitative and qualitative methods.
     Demonstrated objectivity and recognized excellence in 
research.
     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.
     Expertise in evaluating cost-effectiveness, medical 
outcomes, and appropriateness of different clinical approaches and 
technologies for specific diseases or treatment regimes.
     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:
     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. 
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.
     Study of stroke prevention strategies in managed care 
organizations, particularly on 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.
     Support for HCSUS, an HIV-related research project 
employing a cooperative agreement between AHCPR and RAND, in which 
investigators look at the delivery and costs 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:
     How the structure and organization of health care markets 
and the evolving managed care systems impact on cost, quality, and 
access;
     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;
     Changes in financing mechanisms for health care coverage, 
including the impact of employer coalitions and value-based purchasing 
efforts;
     Ways to use governmental and private sector health care 
databases for applying advanced data-analysis techniques to improve in 
health care delivery;
    Examining primary care delivery in terms of cost, quality, and 
patient outcomes;
     The use of consumer satisfaction initiatives in the design 
of improved health care systems;
     Development of syntheses of scientific evidence on 
specific clinical topics and technologies;
     Disseminating evidence-based practice information to the 
clinical community;
     Evaluating the relative impact (in terms of cost, quality, 
and outcomes) of new medical technologies, interventions, and 
innovations; and
     Expanding efforts to explore and evaluate outcomes and 
effectiveness of various treatments for the same condition.

Partners' Role

    The role of the private partner in these research collaborations 
could include opportunities to:
     Support research design and study through the provision of 
funding or other valuable research resources (such as data, research 
personnel, equipment).
     Partner in the design, coordination, and conduct of 
research studies to evaluate the effectiveness and cost of health care 
delivery.
     Provide clinical or other technical support to studies.

[[Page 40092]]

     Improve consumer and practitioner access to research 
results through innovations in dissemination and evaluation.

    Dated: July 14, 1997.
John M. Eisenberg,
Administrator.
[FR Doc. 97-19064 Filed 7-24-97; 8:45 am]
BILLING CODE 4160-90-M