[Federal Register: January 28, 2003 (Volume 68, Number 18)]
[Notices]
[Page 4213-4216]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja03-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Nominations of Topics for Evidence-based Practice Centers (EPCs)
AGENCY: The Agency for Healthcare Research and Quality (AHRQ).
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 organization and financing of health care. AHRQ's
previous requests for topic nominations were published in the Federal
Register on December 23, 1996, November 28, 1997, May 4, 1999, November
13, 2000, and February 14, 2002.
DATES: Topic nominations should be submitted by March 31, 2003 in order
to be considered for the next group of evidence reports and technology
assessments to be funded in Fiscal Year 2003. In addition to timely
responses to this request for nominations, AHRQ also accepts topic
nominations on an ongoing basis. AHRQ is not able to reply to
individual responses, but will consider all nominations during the
selection process. Topics selected will be announced from time to time
in the Federal Register and through AHRQ press releases.
ADDRESSES: Topic nominations should be submitted to Jacqueline
Besteman, J.D., M.A., Director, Evidence-based Practice Centers (EPC)
Program, Center for Practice and Technology Assessment, AHRQ, 6010
Executive Boulevard, Suite 300, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jacqueline Besteman, J.D., M.A.,
Center for Practice and Technology Assessment, AHRQ, 6010 Executive
Blvd., Suite 300, Rockville, MD 20852; Phone: (301) 594-4017; Fax:
(301) 594-
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4017; Fax: (301) 594-4027; E-mail: jbestema@ahrq.gov.
Arrangement for Public Inspection: All nominations will be
available for public inspection at the Center for Practice and
Technology Assessment, telephone (301) 594-4015, 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) as amended by Pub. L. 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 promotion of improvements
in clinical practice and health systems practices including the
prevention of diseases and other health conditions.
2. Purpose
The purpose of 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. AHRQ awards task order contracts to its
Evidence-based Practice Centers (EPCs) to undertake scientific analyses
and evidence syntheses on high-priority topics. The EPCs produce
science syntheses--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.
In addition to clinical and behavioral research, as the body of
scientific studies related to the organization and financing of health
care expands, systematic review and analyses of these studies can
provide health system organizations with a scientific foundation for
developing system-wide policies and practices. These reports may
address and evaluate topics such as risk adjustment methodologies,
market performance measures, provider payment mechanisms, and insurance
purchasing tools, as well as provider integration of new scientific
findings regarding health care and delivery innovations. To review
topics that have been assigned to the EPCs between FY 1997 and FY 2002,
visit AHRQ's Web site at http://www.ahrq.gov/clinic/epc#centers.
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
include clinical recommendations or recommendations on 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 to AHRQ and
the EPCs, with defined roles and responsibilities. AHRQ places high
value on these relationships, and plans to review Partners' past
performance of these responsibilities at such time in subsequent years
when AHRQ is considering whether to accept additional topics nominated
by an organization. Specifically, Partners are expected to serve as
resources to EPCs as they develop the evidence reports and technology
assessments related to their nominated topic; serve as members of
external peer reviewers of relevant draft evidence report and
assessment; 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 to their membership. AHRQ also is interested in members' use
of these derivative products and the products' impact on enhanced
healthcare. 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.
The AHRQ will review topic nominations and supporting information
and determine final topics, seeking additional information as
appropriate. 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.
Section A: Clinical and Behavioral Topics
(a) 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 technoloy.
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. 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 technolgy 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, and completion of the
external peer review process. Topics selected will not duplicate
current and widely available research syntheses, unless new evidence is
available that
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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; and (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 to their
membership; (d) process by which the nominating organization will
measure the use of these products by their members, and impact of such
use; and (e) process by which the organization will measure the impact
of such use.
Specifically, nomination information should include:
[sbull] Defined condition and target population.
[sbull] Three to five very focused questions to be answered.
[sbull] 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.
[sbull] Costs associated with the clinical or behavioral condition,
including average reimbursed amounts for diagnostic 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).
[sbull] Impact potential of the evidence report or technology
assessment to decrease health care costs or to improve health status or
clinical outcomes.
[sbull] Availability of scientific data and bibliographies of
studies on the topic.
[sbull] References to significant differences in practice patterns
and/or results; alternative therapies and controversies.
[sbull] Plans of the nominating organization to incorporate the
report into its managerial or policy decision making (i.e., 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 policies about a particular
technology or service).
[sbull] Plans of the nominating organization for dissemination of
these derivative products to its membership.
[sbull] Process by which the nominating organization will measure
members' use of the derivative products.
[sbull] Process by which the nominating organization will measure
the impact of such use on clinical practice.
(b) Selection Criteria for Clinical and Behavioral Topics
Factors that will be considered in the selection of clinical and
behavioral topics for AHRQ evidence report and technology assessment
topics include: (1) 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; (2) significance for the needs of the Medicare,
Medicaid and other Federal health programs; (3) 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; (4) controversy or uncertainty about the effectiveness
or relative effectiveness of available clinical strategies or
technologies; (5) impact potential for informing and improving patient
or provider decision making; (6) 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; (7)
availability of scientific data to support the systematic review and
analysis of the topic; (8) submission of nominating organization's plan
to incorporate the report into its managerial or policy decision
making, as defined above; (9) submission of nominating organization's
plan to disseminate derivative products to its members; and (10)
submission of nominating organization's plan to measure members' use of
these products, and the resultant impact of these products on clinical
practice.
Section B: Organization and Financing Topics
(a) 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 systematically
reviewed, supplemental analyses performed, draft reports circulated for
external peer review, and final evidence reports produced. 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 for completion due to the complexity of the topic and
the volume of literature to be searched, abstracted, and 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 topics, nominators should provide a rationale and
supporting evidence on the importance and relevance of the topic.
Nominators must also state their plans for use of the evidence report
and indicate how the report could be used by public and private
decision makers. Nomination information should include:
[sbull] Defined organizational/financial arrangement or structure
impacting quality, outcomes, cost, access or use.
[sbull] Three to five focused questions to be answered.
[sbull] 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)
[sbull] Costs potentially affected by the organizational/financial
arrangement, to the extent they can be quantified.
[sbull] Impact potential of the evidence report to decrease health
care costs or to improve health status or outcomes.
[sbull] Availability of scientific and/or administrative data and
bibliographies of studies on the topic.
[sbull] References to significant variation in delivery and
financing patterns and/or results, and related controversies.
[sbull] Nominator's plan for use of an evidence report on this
topic.
[sbull] Nominator's plan for measuring the impact of the report on
organizational, financial, or delivery practices.
(b) 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: (1)
uncertainty about the impact of the subject organizational or financing
strategy; (2) potential for the subject organizational or financing
strategy or the proposed research synthesis to significantly impact
aggregate health care costs; (3) policy-relevant to Medicare, Medicaid,
and/or other Federal and State health programs; (4) relevant to
vulnerable
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populations, including racial and ethnic minorities, and particular
communities, such as rural markets; (5) available scientific data to
support systematic review and analysis of the topic; (6) plans of the
nominating organization to incorporate the report into its managerial
or policy decision-making; and (7) plans by the nominating organization
to measure the impact of the report on practice.
Dated: January 15, 2003.
Carolyn M. Clancy,
Acting Director.
[FR Doc. 03-1913 Filed 1-27-03; 8:45 am]
BILLING CODE 4160-90-M