[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]
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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
