[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