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###### Department of Health and Human Services

###### Agency for Healthcare Research and Quality

# AGENCY:

The Agency for Healthcare Research and Quality (AHRQ), formerly AHCPR.

# ACTION:

 Nominations of topics for evidence reports and technology assessments.

# 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: jbestema@ahrq.gov.

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