[Federal Register Volume 65, Number 219 (Monday, November 13, 2000)]
[Notices]
[Pages 67748-67750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28896]


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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), formerly 
AHCPR.

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

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SUMMARY: AHRQ invites a fourth round of 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, and May 4, 1999.

DATES: Topic nominations should be submitted by January 12, 2001 in 
order to be considered for the next group of evidence reports and 
technology assessments. In addition to timely responses to this request 
for nominations, AHRQ also accepts topic nominations on an ongoing 
basis. AHRQ will not 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 AHRQ press 
releases.

ADDRESSES: Topic nominations should be submitted to Douglas B. Kamerow, 
M.D., MPH, Director, 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) 594-4027; E-mail: <a href="/cdn-cgi/l/email-protection#ed878f889e9988808cad8c859f9cc38a829b"><span class="__cf_email__" data-cfemail="640e0601171001090524050c16154a030b12">[email protected]</span></a>.
    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 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. 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.
    As the body of scientific studies related to the organization and 
financing of health care grows, 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.

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

[[Page 67749]]

organizations. Such topics may include the prevention, diagnosis and/or 
treatment of particular diseases or health conditions including, where 
appropriate, the use of alternative/complementary therapies, as well as 
the 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.

Topic Nomination and Selection Process

    The AHRQ will review topic nominations and supporting information 
and determine final topics, seeking additional information as 
appropriate. AHRQ encourages 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. Nominators of selected topics assume the role of Partners 
to AHRQ and the EPCs. Partners are expected to serve as resources to 
EPCs as they develop evidence reports and technology assessments. 
Partners may also serve as peer reviewers of draft evidence reports and 
assessments.
    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 topics. Section 
B addresses AHRQ's nomination process and selection criteria for 
organization and financing topics.

Section A: Clinical Topics

Nomination Process for Clinical Topics

    Nominations of clinical 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. Reports and assessments can 
be completed in three to six months, if there is a small volume of 
literature to be systematically reviewed and analyzed. Some 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, 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 suggests the need for revisions or updates.
    For each topic, nominators should provide a rationale and 
supporting evidence on the clinical relevance and importance of the 
topic. Nominators also must state their plans are 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. 
Nomination information should include.
    <bullet> Defined condition and target population.
    <bullet> Three to five specific questions to be answered.
    <bullet> 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.
    <bullet> Costs associated with the clinical 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).
    <bullet> Impact potential of the evidence report or technology 
assessment to decrease health care costs or to improve health status or 
clinical outcomes.
    <bullet> Availability of scientific data and bibliographies of 
studies on the topic.
    <bullet> References to significant differences in practice patterns 
and/or results; alternative therapies and controversies.
    <bullet> Demonstrated commitment by nominating organization to 
incorporate the report into its managerial or policy decision making 
(i.e., rapid translation of the report or assessment into clinical 
practice guidelines or other quality improvement tools, or to inform 
reimbursement or coverage policies about a particular technology or 
service).
    <bullet> Plans by the nominating organization to measure the impact 
of the report on clinical practice.

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: (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 clinical 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) 
demonstrated commitment by the nominating organization to incorporate 
the report into its managerial or policy decision making; and (9) plans 
by the nominating organization to measure the impact of the report on 
clinical practice.

Section B: Organization and Financing Topics

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 in 
three to 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

[[Page 67750]]

duplicate current and widely available research syntheses, unless new 
evidence is available that suggests the need for revisions or updates.
    For each topic, 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:
    <bullet> Defined organizational/financial arrangement or structure 
impacting quality, outcomes, cost, access or use.
    <bullet> Three to five specific questions to be answered.
    <bullet> 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).
    <bullet> Costs potentially affected by the organizational/financial 
arrangement, to the extent they can be quantified.
    <bullet> Impact potential of the evidence report to decrease health 
care costs or to improve health status or outcomes.
    <bullet> Availability of scientific and/or administrative data and 
bibliographies of studies on the topic.
    <bullet> References to significant variation in delivery and 
financing patterns and/or results, and related controversies.
    <bullet> Nominator's plan for use of an evidence report on this 
topic.
    <bullet> Nominator's plan for measuring the impact of the report on 
practice.

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 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) 
demonstrated commitment by 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: November 2, 2000.
John M. Eisenberg,
Director.
[FR Doc. 00-28896 Filed 11-9-00; 8:45 am]
BILLING CODE 4160-90-M


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