[Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13464]


[[Page Unknown]]

[Federal Register: June 3, 1994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Health Care Policy and Research

 

Requests for Nominations of Members of Clinical Practice; 
Guideline Panel on Acute Myocardial Infarction

    The Agency for Health Care Policy and Research (AHCPR) has 
announced a request for proposals and intends to award a contract to a 
non-profit organization to develop a clinical practice guideline and to 
develop related medical review criteria, standards of quality, and 
performance measures for Acute Myocardial Infarction. The contractor 
will establish a panel of health care experts and consumers to assist 
in developing a clinical practice guideline on Acute Myocardial 
Infarction and to assist in developing medical review criteria, 
standards of quality, and performance measures. The AHCPR, on behalf of 
the contractor, invites nominations of qualified individuals to serve 
as chairperson(s) and members of the panel.

Background

    The Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) 
added a new title IX to the Public Health Service Act (the Act), which 
established the Agency for Health Care Policy and Research (AHCPR) to 
enhance the quality, appropriateness, and effectiveness of health care 
services, and access to such services. (See 42 U.S.C. 299-299c-6 and 
1320b-12.) The Agency for Health Care Policy and Research 
Reauthorization Act of 1992 (Pub. L. 102-410), enacted on October 13, 
1992, extended the authorization of AHCPR and amended certain 
provisions related to the development of clinical practice guidelines. 
In keeping with its legislative mandates, AHCPR is arranging for the 
development, periodic review, and updating of clinically relevant 
guidelines that may be used by physicians, other health care 
practitioners, educators, and consumers to assist in determining how 
diseases, disorders, and other health conditions can most effectively 
and appropriately be prevented, diagnosed, treated, and clinically 
managed. Medical review criteria, standards of quality, and performance 
measures are then developed based on the guidelines produced.
    Section 912 of the Act (42 U.S.C. 299b-1(b)), as amended by Public 
Law 102-410, requires that the guidelines:
    1. Be based on the best available research and professional 
judgment;
    2. Be presented in formats appropriate for use by physicians, other 
health care practitioners, medical educators, medical review 
organizations, and consumers;
    3. Be presented in treatment-specific or condition-specific forms 
appropriate for use in clinical practice, educational programs, and 
reviewing quality and appropriateness of medical care;
    4. Include information on the risks and benefits of alternative 
strategies for prevention, diagnosis, treatment, and management of the 
particular health condition(s); and
    5. Include information on the costs of alternative strategies for 
prevention, diagnosis, treatment, and management of the particular 
health condition(s), where cost information is available and reliable.
    Section 913 of the Act (42 U.S.C. 299b-2) describes two mechanisms 
through which AHCPR can arrange for development of guidelines: 1. 
Panels of qualified experts and health care consumers may be convened; 
and 2. Contracts may be awarded to public and private non-profit 
organizations. The AHCPR has elected to use the contract process for 
development of a clinical practice guideline on Acute Myocardial 
Infarction.
    Section 914 of the Act (42 U.S.C. 299b-3(a)), as amended by Public 
Law 102-410, identifies factors to be considered in establishing 
priorities for guidelines, including the extent to which the guidelines 
would:
    1. Improve methods for disease prevention;
    2. Improve methods of diagnosis, treatment, and clinical 
management, and thereby benefit a significant number of individuals;
    3. Reduce clinically significant variations among clinicians in the 
particular services and procedures utilized in making diagnoses and 
providing treatments; and
    4. Reduce clinically significant variations in the outcomes of 
health care services and procedures.
    Also, in accordance with title IX of the PHS Act and section 1142 
of the Social Security Act, the AHCPR Administrator is to assure that 
the needs and priorities of the Medicare program are reflected 
appropriately in the agenda and priorities for development of 
guidelines.

Panel Nominations

    The panel that will assist the contractor in developing the 
clinical practice guideline on Acute Myocardial Infarction will consist 
of two co-chairpersons and ten to fifteen other members. The work will 
be divided into two phases. Phase I is development of the clinical 
practice guideline. Phase II is development of medical review criteria, 
standards of quality, and performance measures based on the guideline.
    The role of the panel members is to assist the contractor to: 
develop a decisionmaking process; determine the focus of the guideline 
and the questions to be addressed; advise and monitor the review and 
analysis of the scientific literature; consider and advise on principal 
health care issues; monitor and provide counsel on development of 
medical review criteria, standards of quality, and performance 
measures; and review and approve the interim and final drafts of the 
different versions of the guideline. The co-chairpersons will provide 
leadership in carrying out these roles.
    To assist in identifying members for the panel, AHCPR is requesting 
recommendations from a broad range of interested individuals and 
organizations, including physicians representing primary care and 
relevant specialties, physicians' assistants, nurses, nurse 
practitioners, pharmacists, allied health and other health care 
practitioners, health care institutions, and consumers with pertinent 
experience or information. In making panel selections, AHCPR, will 
maintain, to the extent possible, a balance of individuals selected 
from academic settings and individuals selected without full-time 
academic appointments. At least two members of this panel shall be 
individuals who do not derive their primary source of revenue directly 
from the performance of procedures discussed in this guideline. Some 
participants in the guideline process (panel members, consultants, peer 
or pilot reviewers) should have expertise in epidemiology, health 
services research, or health economics, and familiarity with the 
clinical condition being studied. To the extent possible, the panel 
should have appropriate representation in terms of gender, minority 
populations, and geographic areas of the United States.
    The AHCPR is especially interested in receiving nominations of 
individuals with: (1) Experience in developing and/or commitment to 
developing clinical guidelines, medical review criteria, standards of 
quality, and performance measures; (2) relevant training and clinical 
experience; (3) relevant experience in basic and/or clinical research 
in acute myocardial infarction, including publication of relevant peer-
reviewed articles; (4) demonstrated interest in quality of care, 
medical outcomes, and medical effectiveness; (5) knowledge of the 
epidemiology of acute myocardial infarction; (6) experience in health 
services research or health economics, with expertise in the area of 
acute myocardial infarction; and (7) personal experience of acute 
myocardial infarction, either as a patient, family member, or friend of 
a patient, or as a person who actively works with consumer groups 
interested in acute myocardial infarction. The AHCPR encourages 
nominations of women and individuals who are members of minority 
population groups. Nominees should have no substantial financial 
interests or professional affiliations that would significantly 
jeopardize the integrity of the guideline development process or the 
final products.
    This notice requests nominations of qualified individuals to serve 
on the panel as members or as co-chairpersons. The functions of the 
panel co-chairpersons are critical to the process of developing 
guidelines. Co-chairpersons provide leadership regarding methodology, 
literature review, panel deliberations, and preparation of the final 
products. Nominations for co-chairpersons should take into 
consideration the criteria specified below, which AHCPR will use in 
approving final selections:
     Relevant training and clinical experience;
     Demonstrated interest in quality assurance and research on 
the clinical condition(s) under consideration and the related treatment 
of the condition(s), including publication of relevant peer-reviewed 
articles;
     Commitment to the need to produce clinical practice 
guidelines;
     Recognition in the field with a record of leadership in 
relevant activities;
     Broad public health view of the utility of particular 
procedures or clinical services;
     Demonstrated capacity to respond to consumer concerns;
     Prior experience in developing guidelines for the clinical 
condition in question; and
     No substantial financial interests or professional 
affiliations that would significantly impair the scientific integrity 
of the guidelines or final products.
    Subsequent to approval by AHCPR, the contractor will appoint the 
panel co-chairpersons. After the panel co-chairpersons have been 
appointed, nominations for members of the panel will be reviewed by the 
contractor and the co-chairpersons, prior to proposing panel members to 
AHCPR. Following AHCPR review and approval of proposed members' 
qualifications, review of the overall composition of the panel to 
ensure representation of a range of expertise and experience, and 
review of potential conflict of interest, the contractor will appoint 
panel members.
    Nominations should indicate whether the individual is being 
recommended to serve on the panel as a co-chairperson or as a member. 
Each nomination must include two copies of the individual's curriculum 
vitae or resume, and two copies of a letter of nomination with a 
statement of the rationale for the specific nomination.
    To be considered, nominations must be received by July 15, 1994 at 
the following address: Francis Chesley, Project Officer, Office of the 
Forum for Quality and Effectiveness in Health Care, Agency for Health 
Care Policy and Research, Willco Building, 6000 Executive Boulevard, 
Suite 310, Rockville, MD 20852, Phone: (301) 594-4015, Fax: (301) 594-
4027.

For Additional Information

    Additional information on the guideline development process is 
contained in the AHCPR Program Note, ``Clinical Practice Guideline 
Development,'' dated August 1993. This document describes AHCPR's 
activities with respect to clinical practice guidelines, including the 
process and criteria for selecting panels. This document may be 
obtained from the AHCPR Publications Clearinghouse, P.O. Box 8547, 
Silver Spring, MD 20907; or call Toll-Free: 1-800-358-9295.
    Information may also be obtained by contacting Carole Hudgings, 
Ph.D., Acting Director, Office of the Forum for Quality and 
Effectiveness in Health Care, Agency for Health Care Policy and 
Research, Willco Building, 6000 Executive Blvd, Suite 310, Rockville, 
MD. 20852. Information about this contract, RFP No. 282-94-2013, may be 
obtained from Patrick Joy, Division of Acquisition Management, 
Government Acquisition Branch, room 5-101, Parklawn Bldg., 5600 Fishers 
Lane, Rockville, MD 20857, (301)443-8826.
    Requests for copies of the contract solicitation may be transmitted 
by facsimile to 301-443-3238.
    Dated: May 24, 1994.
J. Jarrett Clinton,
Administrator.
[FR Doc. 94-13464 Filed 6-2-94; 8:45 am]
BILLING CODE 4160-90-P