[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