[Federal Register Volume 69, Number 37 (Wednesday, February 25, 2004)]
[Notices]
[Pages 8663-8665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Nominations of Topics for Evidence-based Practice Centers

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Nominations of topics for evidence reports and technology 
assessments.

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SUMMARY: AHRQ invites nominations of topics for evidence reports and 
technology assessments relating to the prevention, diagnosis, treatment 
and management of common diseases and clinical conditions, as well as, 
topics relating to the organization and financing of health care. 
Previous evidence reports can be found at http://www.ahrq.gov/clinic/epcix.htm

DATES: Topic nominations should be submitted by April 16, 2004, in 
order to be considered for this fiscal year. In addition to timely 
responses to this request for nominations, AHRQ also accepts topic 
nominations on an ongoing basis for consideration for future years. 
AHRQ will not reply to individual responses, but will consider all 
nominations during the selection process.

ADDRESSES: Topics nominations should be submitted to Kenneth Fink, MD, 
MGA, MPH, Director, Evidence-based Practice Centers (EPC) Program, 
Center for Outcomes and Evidence, AHRQ, 540 Gaither Road, Rockville, MD 
20850. Electronic submissions are preferred. They may be sent to Dr. 
Fink at [email protected].

FOR FURTHER INFORMATION CONTACT: Kenneth Fink, MD, MGA, MPH, Center for 
Outcomes and Evidence, AHRQ, 540 Gaither Road, Rockville, MD 20850; 
Phone: (301) 427-1617; Fax: (301) 427-1640; E-mail: [email protected].
    Arrangement for Public Inspection: All nominations will be 
available for public inspections at the Center for Outcomes and 
Evidence, telephone (301) 427-1600, weekdays between 8:30 a.m. and 5 
p.m. (Eastern time).

SUPPLEMENTARY INFORMATION: 

1. Background

    Under Title IX of the Public Health Service Act (42 U.S.C. 299a-
299c-7) as amended by Public Law 106-129 (1999), AHRQ is charged with 
enhancing the quality, appropriateness, and effectiveness of health 
care services and access to such services. AHRQ accomplishes these 
goals through scientific research and through the promotion of 
improvements in clinical

[[Page 8664]]

practice and health systems practices, including the prevention of 
diseases and other health conditions.

2. Purpose

    The purpose of this Federal Register notice is to encourage 
participation and collaboration of professional societies, health 
systems, payors, and providers, with AHRQ as it carries out its mission 
to promote the practice of evidence-based health care. AHRQ serves as 
the science partner with private-sector and public organizations in 
their efforts to improve the quality, effectiveness, and 
appropriateness of health care delivery in the United States, and to 
expedite the translation of evidence-based research findings into 
improved health care services. In this context, AHRQ awards task order 
contracts to its Evidence-based Practice Centers (EPCs) to undertake 
scientific analysis and evidence syntheses on topics of high-priority 
to its public and private healthcare partners and the health care 
community generally. The EPCs produce science synthesis--evidence 
reports and technology assessments--that provide to public and private 
organizations the foundation for developing and implementing their own 
practice guidelines, performance measures, educational programs, and 
other strategies to improve the quality of health care and decision-
making related to the effectiveness and appropriateness of specific 
health care technologies and services.
    The evidence reports and technology assessments also may be used to 
inform coverage and reimbursement policies. As the body of scientific 
studies related to organization and financing of health care grows, 
systematic review and analysis of these studies, in addition to 
clinical and behavioral research, can provide health system 
organizations with a scientific foundation for developing or improving 
system-wide policies and practices. Thus, EPC reports may address and 
evaluate topics such as risk adjustment methodologies, market 
performance measures, provider payment mechanisms, and insurance 
purchasing tools, as well as measurement or evaluation of provider 
integration of new scientific findings regarding health care and 
delivery innovations.

3. Evidence-based Practice Centers (EPCs)

    The EPCs prepare evidence reports and technology assessments on 
topics for which there is significant demand for information by health 
care providers, insurers, purchasers, health-related societies, and 
patient advocacy organizations. Such topics may include the prevention, 
diagnosis and/or treatment of particular clinical and behavioral 
conditions, use of alternative or complementary therapies, and 
appropriate use of commonly provided services, procedures, or 
technologies. Topics also may include issues related to the 
organization and financing of care. AHRQ widely disseminates the EPC 
evidence reports and technology assessments, both electronically and in 
print. The EPC evidence reports and technology assessments do not make 
clinical recommendations or recommendations of reimbursement and 
coverage policies.

4. Role/Responsibilities of Partners

    Nominators of topics selected for development of an EPC evidence 
report or technology assessment assume the role of Partners of AHRQ and 
the EPCs. Partners have defined roles and responsibilities. AHRQ places 
high value on these relationships, and plans to review Partners' past 
performance of these responsibilities, at such time, as AHRQ is 
considering whether to accept additional topics nominated by an 
organization in subsequent years. Specifically, Partners are expected 
to serve as resources to EPCs as they develop the evidence reports and 
technology assessments related to the nominated topic; serve as 
external peer reviewers of relevant draft evidence reports and 
assessments; and commit to (a) timely translation of the EPC reports 
and assessments into their own quality improvement tools (e.g., 
clinical practice guidelines, performance measures), educational 
programs, and reimbursement policies; and (b) dissemination of these 
derivative products of their membership. AHRQ also is interested in 
members' use of these derivative products and the products' impact on 
enhanced health care. AHRQ will look to the Partners to provide these 
use and impact data on products that are based on EPC evidence reports 
and technology assessments.
    AHRQ will review topic nominations and supporting information 
including the need and the nominators' commitment to partnership roles 
described above; seeking additional information as appropriate to 
determine final topics. AHRQ is very interested in receiving topic 
nominations from professional societies and organizations comprised of 
members of minority populations, as well as nomination of topics that 
have significant impact on the health status of women, children, ethnic 
and racial populations.

5. Topic Nomination and Selection Process

    The processes that AHRQ employs to select topics nominated for 
analyses by the EPCs is described below. Section A addresses AHRQ's 
nomination process and selection criteria for clinical and behavioral 
topics. Section B addresses AHRQ's nomination process and selection 
criteria for organization and financing topics.

A. Clinical and Behavioral Topics

    1. Nomination Process for Clinical and Behavioral Topics. 
Nominations of clinical and behavioral topics for AHRQ evidence reports 
and technology assessments should focus on specific aspects of 
prevention, diagnosis, treatment and/or management of a particular 
condition, or on an individual procedure, treatment, or technology. 
Potential topics should be carefully defined and circumscribed so that 
the relevant published literature and other databases can be searched, 
evidence systematically reviewed, supplemental analyses performed, 
draft reports and assessments circulated for external peer review, and 
final evidence reports or technology assessments produced within a 
timely and reasonably responsive manner. Some reports and assessments 
can be completed within six months, if there is a small volume of 
literature to be systematically reviewed and analyzed. Other evidence 
reports and technology assessments may require up to 12 months for 
completion due to complexity of the topic, the volume of literature to 
be searched, abstracted, and analyzed, or completion of the external 
peer review process. Topics selected will not duplicate current and 
widely available syntheses, unless, new evidence is available that 
suggests the need for revisions or updates. For each topic, the 
nominating organization must provide the following information:
    a. Rationale and supporting evidence on the clinical relevance and 
importance of the topic;
    b. Plans for rapid translation of the evidence reports and 
technology assessments into clinical guidelines, performance measures, 
educational programs, or other strategies for strengthening the quality 
of health care services, or plans to inform development of 
reimbursement or coverage policies;
    c. Plans for dissemination of these derivative products, e.g., to 
membership; and
    d. Process by which the nominating organization will measure the 
use of these products, e.g., by their members,

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and impact of such use. Specifically, nomination information should 
include:
     Defined condition and target population.
     Incidence or prevalence, and indication of the 
disease burden (e.g., mortality, morbidity, functional impairment) in 
the U.S. general population or in subpopulations (e.g., Medicare and 
Medicaid populations). For prevalence, the number of cases in the U.S. 
and the number of affected persons per 1,000 persons in the general 
U.S. population should be provided. For incidence, the number of new 
cases per 100,000 a year should be provided.
     Costs associated with the clinical or behavioral 
condition, including average reimbursed amounts for diagnosis and 
therapeutic interventions (e.g., average U.S. costs and number of 
persons who receive care for diagnosis or treatment in a year, citing 
ICD9-CM and CPT codes, if possible).
     Impact potential of the evidence report or 
technology assessment to decrease health care costs or to improve 
health status or clinical outcomes.
     Availability of scientific data and 
bibliographies of studies on the topic.
     References to significant differences in 
practice patterns and/or results; alternative therapies and 
controversies.
     Plans of the nominating organization to 
incorporate the report into its managerial or policy decision making 
(e.g., rapid translation of the report or assessment into derivative 
products such as clinical practice guidelines or other quality 
improvement tools, or to inform reimbursement or coverage about a 
particular technology or service).
     Plans of the nominating organization for 
disseminating derivative products e.g., to its membership.
     Process by which the nominating organization 
will measure use of the derivative products, and measure the impact of 
such use, on clinical practice.
    2. Selection Criteria for Clinical Topics. Factors that will be 
considered in the selection of clinical topics for AHRQ evidence report 
and technology assessment topics include:
    a. High incidence or prevalence in the general population and in 
special populations, including women, racial and ethnic minorities, 
pediatric and elderly populations, and those of low socioeconomic 
status;
    b. Significance for the needs of the Medicare, Medicaid and other 
Federal health programs;
    c. High costs associated with a condition, procedure, treatment, or 
technology, whether due to the number of people needing care, high unit 
cost of care, or high indirect costs;
    d. Controversy or uncertainty about the effectiveness or relative 
effectiveness of available clinical strategies or technologies;
    e. Impact potential for informing and improving patient or provider 
decision making;
    f. impact potential for reducing clinically significant variations 
in the prevention, diagnosis, treatment, or management of a disease or 
condition, or in the use of a procedure or technology, or in the health 
outcomes achieved;
    g. Availability of scientific data to support the systematic review 
and analysis of the topic;
    h. Submission of nominating organization's plan to incorporate the 
report into its managerial or policy decision making, as defined above; 
and
    i. Submission of nominating organization's plan to disseminate 
derivative products, and plan to measure use of these products, and the 
resultant impact of these products on clinical practice.

B. Organization and Financing Topics

    1. Nomination Process for Organization and Financing Topics. 
Nominations of organization and financing topics for AHRQ evidence 
reports should focus on specific aspects of health care organization 
and finance. Topics should be carefully defined and circumscribed so 
that relevant databases may be searched, the evidence systematially 
reviewed, supplemented analyses performed, draft reports circulated for 
external peer review, and final evidence reports produced in a timely 
and reasonable manner. Reports can be completed within six months if 
there is a small volume of literature for systematic review and 
analysis. Some evidence reports may require up to 12 months to 
completion due to the complexity to the topic and the volume of 
literature to be searched, abstracted, analyzed. Topics selected will 
not duplicate current and widely available research syntheses, unless 
new evidence is available that suggests the need for revisions or 
updates. For each topic, nominations should provide:
    a. Rationale and supporting evidence on the importance and 
relevance of the topic including:
     Defined organizational/financial arrangement or 
structure impacting quality, outcomes, cost, access or use.
     Three to five focused questions to be answered.
     If appropriate, description of how the 
organizational/financial arrangement or structure is particularly 
relevant to delivery of care for specific vulnerable populations (e.g., 
children, persons with chronic disease) or certain communities (e.g., 
rural markets).
     Costs potentially affected by the 
organizational/financial arrangement, to the extent they can be 
quantified.
     Impact potential of the evidence report to 
decrease health care costs or to improve health status or outcomes.
     Availability of scientific and/or administrative 
data and bibliographies of studies on the topic.
     References to significant variation in delivery 
and financing patterns and/or results, and related controversies.
    b. Plans for use of the evidence report and indicate how the report 
could be used by public and private decisions makers including:
     Nominator's plan for use of an evidence report 
on the topic.
     Nominator's plan for measuring the impact of the 
report on practice.
    2. Selection Criteria for Organization and Financing Topics. 
Factors that will be considered in the selection of topics related to 
the organization and financing of care include the following:
    a. Uncertainty about the impact of the subject organizational or 
financing strategy;
    b. Potential for the subject organizational or financing strategy 
or the proposed research synthesis to significantly impact aggregate 
health care costs;
    c. Policy-relevance to Medicare, Medicaid, and/or other Federal and 
State health programs;
    d. Relevance to vulnerable populations, including racial and ethnic 
minorities, and particular communities, such as rural markets;
    e. Availability of scientific data to support systematic review and 
analysis of the topic;
    f. Plans of the nominating organization to incorporate the report 
into its managerial or policy decision making; and
    g. Plans by the nominating organization to measure the impact of 
the report on practice.

    Dated: February 17, 2004.
Carolyn M. Clancy,
Director.
[FR Doc. 04-4097 Filed 2-24-04; 8:45 am]
BILLING CODE 4160-90-M