[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
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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]
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