Federal Register Notice

[Federal Register: February 14, 2002 (Volume 67, Number 31)]
[Notices]               
[Page 6933-6936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID: fr14fe02-80]                         

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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: The Agency for Healthcare Research and Quality (AHRQ), DHHS.

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, and 
November 13, 2000.

DATES: Topic nominations should be submitted by April 15, 2002, 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 through AHRQ 
press releases.

ADDRESSES: Topics 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, 540 
Gaither Road, Suite 6000, Rockville, MD 20850 

FOR FURTHER INFORMATION CONTACT: Jacqueline Besteman, J.D., M.A., 
Center for Practice and Technology Assessment, AHRQ, 540 Gaither Road, 
Suite 6000, Rockville, MD 20850; Phone: (301) 427-1617; Fax: (301) 
427-1639; E-mail: JBestema@ahrq.gov

Arrangement for Public Inspection: All nominations will be 
available for public inspections at the Center for Practice and 
Technology Assessment, 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) 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 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 takes order contracts to its 
Evidence-based Practice Centers (EPCs) to undertake scientific analysis 
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 organization and financing of health care 
grows, systematic review and analysis 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 2001, 
visit AHRQ's Web site at https://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 or 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 and 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 a 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. 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 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. 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 required 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 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; 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; and (d) process by which the nominating organization will 
measure the use of these products by their members, and impact of such 
use. Specifically, nomination information should include:

	o Defined condition and target population.
	o Three to five very focused questions to be answered.
	o 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.
	o 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).
	o Impact potential of the evidence report or technology 
assessment to decrease health care costs or to improve health status or 
clinical outcomes.
	o Availability of scientific data and bibliographies of 
studies on the topic.
	o References to significant differences in practice patterns 
and/or results; alternative therapies and controversies.
	o 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 about a particular technology or 
service).
	o Plans of the nominating organization for disseminating of 
these derivative products to its membership.
	o Process by which the nominating organization will measure 
members' use of the derivative products, and measure the impact of such 
use, on clinical practice.

(b) 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 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; and (9) 
submission of nominating organization's plan to disseminate derivative 
products to it members, and plan to measure members' use of these 
products, and the resultant impact of these products on clinical 
practice.

B. 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, supplemented 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 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, 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:

	o Defined organizational/financial arrangement or structure 
impacting quality, outcomes, cost, access or use.
	o Three to five focused questions to be answered.
	o 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).
	o Costs potentially affected by the organizational/financial 
arrangement, to the extent they can be quantified.
	o Impact potential of the evidence report to decrease health 
care costs or to improve health status or outcomes.
	o Availability of scientific and/or administrative data and 
bibliographies of studies on the topic.
	o References to significant variation in delivery and 
financing patterns and/or results, and related controversies.
	o Nominator's plan for use of an evidence report on the 
topic.
	o Nominator's plan for measuring the impact of the report on 
practice. 

(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 
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: February 8, 2002.
John M. Eisenberg,
Director.
[FR Doc. 02-3566 Filed 2-13-02; 8:45 am]
BILLING CODE 4160-90-M