[Federal Register Volume 64, Number 85 (Tuesday, May 4, 1999)]
[Notices]
[Pages 23836-23839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Health Care Policy and Research


Nomination of Topics for Evidence-based Practice Centers (EPCs)

    The Agency for Health Care Policy and Research (AHCPR) invites a 
third 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. AHCPR's 
first request for topic nominations was published in the Federal 
Register on December 23, 1996. AHCPR's second request was published in 
the Federal Register on November 28, 1997.
    With this third round of nominations, AHCPR is expanding the range 
of topics that may be submitted. In addition to nominations of topics 
for assessments and evidence reports on specific heath care 
technologies and medical

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procedures, including alternative or complementary therapies, AHCPR is, 
for the first time, inviting nominations of topics for assessments and 
evidence reports relating to organization and financing of health care. 
Section A of this announcement describes the nomination process and 
selection criteria for clinical topics. Section B of this announcement 
describes the nomination process and selection criteria for 
organizational and financial topics.
    AHCPR serves as a science partner with private-sector and other 
public organizations in their efforts to improve the quality, 
effectiveness, and appropriateness of health care delivery in the 
United States, and to speed the translation of evidence-based research 
findings into improved health care. AHCPR 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, and other strategies to improve the 
quality of health care and make decisions related to the effectiveness 
or appropriateness of specific health care technologies.
    As the body of scientific studies related to the organization and 
financing of health care grows, evidence reports and scientific 
syntheses of these studies can provide health system organizations with 
a scientific foundation for developing system-wide policies and 
practices. These reports might, for example, address and evaluate 
innovations in the delivery of care, the organization of health care 
systems, or provide payment mechanisms.
    As a result of nominations received in response to AHCPR's December 
1996 Federal Register notice, EPCs developed evidence reports or 
technology assessments on: (1) testosterone suppression treatment of 
prostatic cancer; (2) evaluation of cervical cytology; (3) diagnosis 
and treatment of dysphagia/swallowing problems in the elderly; (4) 
evaluation and treatment of new onset of atrial fibrillation in the 
elderly; (5) diagnosis of sleep apnea; (6) treatment of attention 
deficit and hyperactivity disorder; (7) diagnosis and treatment of 
acute sinusitis; (8) rehabilitation of persons with traumatic brain 
injury; (9) prevention and management of urinary tract infections in 
paralyzed persons; (10) pharmacotherapy for alcohol dependence; (11) 
management of stable angina; and, (12) treatment of depression with new 
drugs.
    As a result of nominations received in response to the November 
1997 Federal Register notice, the EPCs are developing evidence reports 
or technology assessments on: (1) use of erythropoietin in oncology and 
hematology; (2) management of chronic obstructive pulmonary disease; 
(3) criteria to determine disability for patients with chronic renal 
disease; (4) treatment of acne; (5) management of anesthesia during 
cataract surgery; (6) criteria for weaning from mechanical ventilation; 
(7) management of cancer pain; (8) evaluation of technologies for 
identifying acute cardiac ischemia in emergency departments; (9) 
management of hypertension during pregnancy; (10) management of acute 
otitis media; (11) management of pre-term labor; (12) prevention of 
venous thromboembolism after injury; (13) management of unstable 
angina; (14) criteria for referral of patients with epilepsy; and, (15) 
alternative and complementary medicine: use of garlic in prevention of 
cardiovascular disease and cancer; and use of silybum marianum in 
treatment of liver disease and cirrhosis.

Background

    Under Title IX of the Public Health Service Act, AHCPR is charged 
with enhancing the quality, appropriateness, and effectiveness of 
health care services and access to such services. AHCPR accomplishes 
these goals through scientific research and through promotion of 
improvements in clinical practice (including the prevention of diseases 
and other health conditions) and promotion of improvements in the 
organization, financing, and delivery of health care services (42 
U.S.C. 299-299c-6 and 1320b-12).

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, patient 
advocacy groups, and consumer 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 more 
commonly provided services, procedures, or technologies. Topics also 
may include issues related to the organization and financing of care. 
AHCPR widely disseminates the evidence reports and technology 
assessments produced by the EPCs, both electronically and in print.
    The AHCPR will review topic nominations and supporting information 
and determine final topics, seeking additional information as 
appropriate. Nominators of selected topics are expected to serve as 
resources to EPCs as they develop evidence reports and technology 
assessments. Nominators may also serve as peer reviewers of draft 
evidence reports and assessments.
    The processes that AHCPR employs to select topics nominated for 
analyses by the EPCs are described below. The topics selected will 
complement AHCPR's efforts to build a balanced portfolio of evidence 
reports. Section A addresses AHCPR's nomination process and selection 
criteria for clinical topics. Section B addresses AHCPR'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 AHCPR 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 within 12 months 
databases can be searched, the evidence reviewed, supplemental analyses 
performed, draft reports and assessments circulated for external peer 
review, and final evidence reports or technology assessments produced. 
Topics selected will not duplicate current and widely available 
clinical practice guidelines or technology assessments, 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 clinical relevance of the 
topic. Nominators also should indicate how the evidence report or 
technology assessment will be utilized by their professional practices 
or organizations. Nomination information should include:
     Defined condition, target population, and three to five 
specific questions to be answered.
     Incidence or prevalence, and indication of the disease 
burden (e.g., mortality, morbidity, functional impairment, diminution 
of quality of life) in the U.S. general population or in subpopulations 
(e.g., Medicare or

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Medicaid populations, minorities, women or children). For prevalence, 
the number of cases in the U.S. and the number affected 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 condition, procedure, 
treatment, or technology, including the number of people needing care, 
high unit cost of care, high indirect costs, or 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).
     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.
     Significant variations in practice patterns and/or 
results.
     Indication by nominator's organization and/or relevant 
professional organizations of intended use of the report or assessment 
(e.g., rapid use of the report or assessment to develop or update 
clinical practice guidelines, educational programs, and other quality 
improvement tools, or payment or coverage policies about a particular 
condition).

Selection Criteria for Clinical Topics

    Selection criteria for AHCPR evidence report and technology 
assessment topics include: (1) High incidence or prevalence in the 
general population or in subpopulations, including racial and ethnic 
minorities, as well as pediatric and elderly populations; (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) potential to inform 
and improve patient or provider decisionmaking; (6) potential to reduce 
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 study or analysis of 
the topic; (8) potential opportunities for rapid implementation; (9) 
complementarity to other evidence reports to support AHCPR's effort to 
build a balanced portfolio of evidence reports and technology 
assessments; and (10) indication that the nominating organization and/
or relevant professional organizations would use the report or 
assessment on the topic nominated to develop or update a clinical 
practice guideline, other quality improvement tools, or coverage 
decision policies.

Section B: Organization and Financing Topics

Nomination Process for Organization and Financing Topics

    Nominations of organization and financing topics for AHCPR research 
syntheses and evidence reports should focus on specific aspects of 
health care organization and finance, particularly with regard to their 
impact on health care outcomes and quality. Potential topics should be 
carefully defined and circumscribed so that within 12 months databases 
can be searched, the evidence reviewed, supplemental analyses 
performed, draft reports circulated for external peer review, and final 
evidence reports produced. 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 also should indicate how the evidence report could be used 
by public and private decision-makers to improve clinical care delivery 
and health outcomes. Nomination information should include:
     Defined organizational/financial arrangement or structure 
impacting quality, outcomes, cost, access or use, along with three to 
five specific questions to be answered.
     If appropriate, description of how the organizational or 
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 areas).
     Costs potentially affected by the organizational or 
financial arrangement, to the extent they can be quantified.
     Potential of the evidence report to decrease health care 
costs or to improve health status or outcomes.
     Availability of scientific data and bibliographies of 
studies on the topic.
     References to significant variation in delivery and 
financing patterns and/or results, and related controversies.
     Indication of why there is controversy or the need to 
evaluate outcomes and impact of the organizational or financing 
intervention.
     Indication by nominator's organization of intended use of 
an evidence report on this topic.

Selection Criteria for Organization and Financing Topics

    Topics for AHCPR evidence reports related to the organization and 
financing of care that will be of greatest interest are those that have 
one or more of the following characteristics: (1) Uncertainty about the 
impact of the subject organizational or financing strategy; (2) 
potential for the organizational or financing strategy or the proposed 
research synthesis to significantly affect aggregate health care costs, 
outcomes, or quality; (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 areas; (5) available scientific data to 
support the study or analysis of the topic; and, (6) potential for 
rapid incorporation into managerial or policy decisionmaking.
    Examples of topics related to the organization and financing of 
care include: (1) Use of formularies by hospitals and MCO's; (2) impact 
of pre-hospital care for coronary disease; (3) impact of gatekeeper 
systems; (4) effect of stepdown units on quality and cost of care; (5) 
effect of risk-sharing payment schemes for physicians; (6) effect of 
co-payment and deductibles on care sought and received.

Materials Submission and Deadline

    Nominations may be in the form of a letter. To be considered for 
the next group of evidence reports and technology assessments, topic 
nominations should be submitted by July 6, 1999 to: Douglas B. Kamerow, 
M.D., M.P.H., Director, Center for Practice and Technology Assessment, 
Agency for Health Care Policy and Research, 6010 Executive Boulevard, 
Suite 300, Rockville, Maryland 20852.
    AHCPR 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.
    In addition to publication of requests for topic nominations in the 
Federal Register, AHCPR also accepts nominations on an ongoing basis at 
the above address for EPC evidence reports and technology assessments.

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    All responses 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. AHCPR will not reply to 
individual responses, but will consider all nominations in selecting 
topics. Topics selected will be announced, from time to time, in the 
Federal Register and AHCPR press releases.

For Additional Information

    Additional information about topic nominations can be obtained by 
contacting: Jacqueline Besteman, EPC Project Officer, Center for 
Practice and Technology Assessment, Agency for Health Care Policy and 
Research, 6010 Executive Boulevard, Suite 300, Rockville, Maryland 
20852; telephone (301) 594-4017; E-mail address: [email protected].

    Dated: April 27, 1999.
John M. Eisenberg,
Administrator.
[FR Doc. 99-11127 Filed 5-3-99; 8:45 am]
BILLING CODE 4160-90-M