[Federal Register Volume 68, Number 18 (Tuesday, January 28, 2003)]
[Notices]
[Pages 4213-4216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1913]


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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: [email protected].
    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