E001293* D E P A R T M E N T 0 F H E A L T H, E D U C A T I 0 A N D W E L F A R E PUBLIC HEALTH SERVICE National Institutes of Health Division of Regional Medical Programs National Advisory Council on Regional Medical Programs Minutes of Meeting February 24-25, 1966 National Institutes of Health Conference Room "All Stone House DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE NATIONAL ADVISORY COUNCIL-ON REGIONAL MEDICAL PROGRAMS Minutes of Second Meetingll February 24-25, 1966 The National Advisory Council. on Regional Medical Programs convened for its second meeting at 9:05 a.m., Thursday, February 24, 1966, in Conference Room A, Stone House, National Institutes of Health, Bethesda, Maryland. Dr. Robert Q. Marston, Associate Director, NIH, and Chief, Division of Regional Medical Programs, presided. The Council members present were: Dr. Mary I. Bunting (2/24 only) Dr. Clark H. Millikan Dr. Leonidas H. Berry Dr. George E. Moore (2/24 only) Dr. Michael E. DeBakey Dr. William J. Peeples (2/24 only) Dr. Bruce W. Everist Dr. Robert J. Slater Dr. James T. Howell Dr. Cornelius H. Traeger Dr. John W. Hurst (2/24 only) The Council member absent was: Mr. Gordon R. Cumming Public Health Service members attending some of the sessions'included: Dr. Ernest M. Allen, Grants Policy Officer, OSG, PHS Mrs. Esther H. Deel, Committee Management Officer, PHS Liaison members: Dr. A. B. Baker, NINDB Council Dr. Edward W. Dempsey, NIGMS Council Dr. John B. Hitkam, NHI Council (Dr. Sidney Farber, NCI Council--absent) Proceedings of meetings are restricted unless cleared by the Office of the Surgeon General. The restriction relates to all material submitted for discussion at the meetings, the agenda for the meetings, the supplemental material, and all other official documents. 2 Others present were: Mr. Karl D. Yordy, Assistant Chief, DRMP Mr. Stephen J. Ackerman, Chief, Planning and Evaluation Branch, DRMP Dr. Carl li. Brewer, Chief, Program Review Branch, DRMP Mr. Charles Hilsenroth, Executive Officer, DRMP Dr. Kenneth M. Endicott, Director.- NCI ' Dr. William J. Zukel, Acting Director, NHI Dr. Eugene A. Confrey, Chief, DRG Dr. J. H. U. Brown, NIGMS Dr. Jerome G. Green, NIII- Dr. Malcolm 0. Ray, NINDB Dr. R. B. Stephenson, OD-NIH Mr. Daniel Zwick, DRMP Dr. Samuel Fox, BSS Dr. Wilfred D. David, BSS Dr. Benjamin B. Wells, VA Liaison-Observer Dr. Henry T. Clark, Jr., Consultant, OD-NIH Dr. William D. Mayer, Consultant, DRMP Mr. True Steffenhagen, DRFR I. CALL TO ORDER AND OPENING REMARKS Dr. Marston called the meeting to order at 9:05 a.m. He introduced Dr. Bunting, who was unable to attend the first Council meeting, and the Public Health Service and NIH staff members. Dr. Marston stated that the purpose and goals of this meeting were two-fold: (1) To inform the Council of progress in several areas, such as the regulations, the guidelines, and the progress in various areas of the country in the development of programs; and (2) to discuss procedures and activities which will assist the Council in preparing itself.for its role in the review and Approval process. II. ANNOUNCEMENTS Dr. Marston made general announcements about the Service Desk and luncheon. He also read the statements on, "Conflict of Interest,, and "Confidentiality of Meetings." III. CONSIDERATION OF FUTURE MEETING DATES At the time of the first Council meeting the Regulations were expected to be published in the Federal Register in January. This did not occur, but publication is still expected shortly. Dr. Marston proposed that the meeting scheduled for April 8-9 might be more useful at a later date after regulations and application forms are 3 available to potential applicants. The Council agreed on the following dates: April 29-30, 1966 (instead of April 8-9) June - 1966 (tentatively) IV. CONSIDERATION OF MINUTES OF DECEMBER 1965 MEETING The Council unanimously recommended approva 1 of the Minutes of the December 21-22, 1965, meeting as written. V. PROGRESS REPORT ON REGULATIONS--Mr. Yordy The Regulations are in the process of being transmitted to the Surgeon General and to the Secretary for approval for publication in the Federal Register. Some changes have been made is a result of several discussions with the Office of the General Counsel, and as a result of some comments which were submitted by'the national health organizations which had considered the first draft of the Regulations in December. Essentially, the Regulations retain the flexible approach of the earlier drafts. Howeveri they contain the following changes: 1. Under Section 66.2,, (g) "Definitions"'the term, "Practicing Physician" is that which was recommended by phe Council at the December meeting; 2. Section 66.2 (k) is a definition which has been added concerning ligeographic area." The Law says that the Surgeon General shall determine whether the geographic area fits the purposes of the Law in accordance with the Regulations. The terms, "region" @and rlgeographic area" are synonymous; 3. Section 66.4 (e) "Advisory group; membership; descriptions has added "dentists, nurses, and representatives of other health professions.11 This is not a mandatory requirement for inclusion, but states that the applicant shall describe the selection and membership of the designated advisory group, showing the extent of inclusion of these health professions in addition to the categories listed in the Act. 4. Section 66.5 (f), "Responsible official." This is the responsible official who is listed on the grant application 4 as the point of contact for the Public Health Service. If there is a change in this designation, the Public Health Service'has to be notified. 5. Section 66.6 (d) contains new wording, It adds as a factor in considering a grant award, "The population to be served by the regional medical program and relationships to adjacent or other regional medical Programs." This change was suggested by the experiences around the country in the preliminary planning. 6. Section 6646 (f) carries out the statement that is made in the Law that these funds shall n ot replace non-Federal funds. If someone receives a grant under this program, they are to e encouraged to continue to seek funds.from other sources for the activities related to the program. Section 66.6 (g), "The geographic distribution of grants throughout the Nation", has been moved to the end of the list of factors considered in making an award since the Applicant does not have control over this factor. The Council recommended that Section 66.4 (e) include general mention of other members of the health professions, but that dentists and nurses not be specifically mentioned. If they are mentioned it might be interpreted as a requirement that each.lo,cal advisory group include these professions, and it might lead to pressures to specifically include representatives of additional health professions. The question was raised about the relationship between the activities under this program and those conducted by the Bureau of State Services which relate to this program. These relationships are to be handled through memoranda of agreement between Dr. Marston and his counterpart in the other Bureaus. Dr. Clark suggested that project site visitors for this program should be broad-gauged and quite knowledgeable of total planning activities. The project site visitors should have a breadth of understanding of Federal programs because they will need to know not only this Law but what is going on in other types of planning activities. VI. REPORTS FROM LIAISON MEMBERS--Dr. A. B. Baker for NINDB Council; Dr. Dempsey for NIGMS Council; Dr. Endicott for Dr. Farber, NCI Council; and Dr. Hickam for Heart Council. Dr. Hickam--The Heart Council has not met since the first meeting of the Council on Regional Medical Programsl buL the Planning 5 Committee has met and has discussed the implications of this new activity fo-e the programs of the Heart Council. The Planning Committee is concerned about the relationship between activities in the Heart Institute and the Regional Medical Programs. The matters for consideration by the Heart Council will be simplified when it is possible to understand where the lines will be drawn. There is a complex overlapping of areas of'interest of these two groups, and it will be very helpful to have this overlap clarified as soon as possible. Dr. Endicott--The Cancer Council has not met since the first meeting of this Council, but the Policies Sub-Committee, which was set up specifically to interact with this program, has had one meet g and a joint meeting with representatives of virtually every major cancer research group in the country. They are beginning to arrive at some understanding of what may be in the process of evolving and an appreciation of how the programs of the Cancer Institute and National Advisory Cancer Council can be'interdigitated with the regional programs to their mutual benefit. Three major programs being supported by the Cancer Institute at the present time inevitably will be closely tied in with almost all of the regional medical programs. The first is a new program this year--the Clinical Training Grant Program--which is aimed at clinical training. This is, in effect, an institutional grant for the development of the institutional approach toward improving the quality of training of medical students, house officers, and practicing physicians. The second program is one which was launched about five years ago for the development of radiation therapists. The third program relates to the clinical research centers."' About 25 cancer clinical research centers are being funded now, but the distribution is bad from the standpoint of the Council on Regional Medical Programs, which is aiming at the whole country. The Cancer Institute has been attempting to identify promising locations for the development of cancer centers in gap areas. There are a number of places which have a potential for rapid development, and between the Cancer Council and the Regional Medical Programs Council much can be accomplished to develop strengths where they are not now in existence. The Cancer Council has concern because the budget has been cut back for the coming year for operating funds. Because of the lack of funds, the NCI is terminating support to many activities 6 which have been supported for some years. The NCI is concerned about the loss of key personnel as the need may develop to shift people from research budgets to the new budgets, and with the Regional Medical Programs 'going through a period of several years in which it will be involv2d primarily in planning rather than operational grants. They are disturbed about what may happen to people whose salaries have been derived from grant support. The Cancer Council and the medical schools are also concerned about those investigators whose orientation is not,clinical but more basic. There is worry that the increased attention and support to clinical aspects, with perhaps a diminution of support to the more @'basic side, may result in much stress and strain. The Policy Subcommittee reviewed some possible mechanisms whereby an effective liaison might be developed. They perceived that the categorical Institute should develop a capability of interacting with an institution or institutions as well as with individuals in the institution if there are ever to be meaningful management decisions at the Council level. The NCI has made substantial progress in consolidating support to an institution, i.e., contracts, grants, and awards from the NIH into one single cost-sharing grant. There Are arguments for and against this, but from the management standpoint it meant that if the Regional Medical Programs Council becomes involved in a regional activity, it will be possible to negotiate and include it with the other support. The Policy Subcommittee also discussed the desirability of making available to the management of a regional medical program a substantial sum of money with which to encourage and develop cancer research and the training of cancer research personnel within that regional system. This would not be a device to replace project grants, but an additional means for encouraging and developing the research front which the Cancer Council feels must be an essential part of any meaningful medical center. The Cancer Council wants to know, as soon as possible, what kinds of things are going to be developed by the Regional Medical Programs Council so it can provide full information as to what on-going things are supported by NCI in that region, what the assessment-of resources may be, etc. Drs. Baker and Dempsey did not have a report from their Councils. VII. REPORT ON LIAISON WITH OTHER GROUPS--Dr. Marston The staff of the Division of Regional Medical Programs has been working with other Public Health Service programs and groups 7 throughout the country, and have had discussions with the following groups: Thirteen national organizations concerning the regulations; Association of State and Territorial Health Officers; Associate Regional Medical Directors of the Public Health Service; Executive Committee of the Association of State Chronic Disease Directors; National Committee of the American Heart Association; American Medical Association; American Hospital Association; National Library of Medicine. The staff is scheduled to attend many out -of-town meetings within the next few months to discuss the program. The Division will soon have a staff man who will be responsible for maintaining contact with outside organizations. VIII. USE OF AD HOC ADVISORY GROUPS--Dr. Marston The Division is starting to call together small groups of individuals with expert knowledge in one of the fields covered by the Regional Medical Programs to help outline the pitfalls and opportunities in these particular fields, and to make suggestions concerning the developments of criteria. A group of consultants is coming in soon for a meeting to discuss the continuing education as an integral part of regional-medical programs, and to identify.larger problems in the area of continuing education about which the Council may need to have information. A meeting will also be set up to discuss the hospital aspects of Regional Medical Programs and to identify special policy and administrative problems. Other groups will be convened to discuss problem areas as the needs arise. The use of ad hoc advisory committees for the initial review is being considered, with plans to use existing strengths of NIH such as the Councils, the staff, the Study Section and committee mechan sm. IX. REPORT OF ACTIVITIES BY STATES--Mr. Ackerman Reports were made concerning, "Participation in Pre-Planning for Regional Medical Programs," and "Different Conditions of Regioiial Medical Programs." It was emphasized that this information does not represent a balanced, accurate picture, because there has not been an opportunity to elicit this type of information. The Division will ultimately have an organized reporting system that will show what is happening around the country. 8 X. REPORT 01.1 STATIUS OF GUIDELINES Ai4D APPLICATION FORMS--Dr.Brewer Tentative program guidelines for planning grants were developed on the assumption that the proposed regulations on which they are based will be implemented substantially unchanged from the present votding. The guidelines are intended to amplify and clarify the regulations, and to guide the applicants in preparing effective applications. Because of the urgency of planning activities, the Division has not yet developed program guidelines for the operational programs. It is anticipated that there will be a single set of program guidelines to cover both the planning grants and the operational grants. The application is still in draft form. The staff believes that this form should be relatively unstructured, that it should leave ,to the applicant the maximum opportunity to describe local conditions and plans that are most appropriate for those conditions. The application will be distributed as soon as it has received appropriate clearances. The Council expressed.-general agreement with the approaches taken on the tentative guidelines. XI. DISCUSSION OF CRITERIA TO BE USED IN REVIEWING APPLICATIONS FOR (1) PLANNING GRANTS. AND OPE @TIONAL GRANTS The Council was invited to make comments regarding these two types of grants. The Council wanted assurance that sound planning had occurred prior to the award of an operational grant even if the planning is not financed under this program. Review of both types of applications will be done through the use of ad hoc groups of consultants prior to review by the Council. The Council was asked for comments about particular areas that would be useful in the writing of operational guidelines, and there was a lengthy discussion concerning this subjecti This discussion covered the role of Regional Medical Programs in providing support for training and the relationship of that support to training support provided through other Federal programs4 The Council agreed that training was one of the most vital objectives of the Regional Medical Programs, and that there needed to be close collaboration with other programs in meeting the over-all manpower problem. Also considered were the support of full-time staff -tn the hospital for education and service purposes, the training of new types of medical manpower, the attraction of personnel to be trained, the emphasis to be placed on determining the feasibility of communication systems before embarking on full-scale'support, and the need to work with other programs in the development and support of communication systems. XII. ADJOURNMENT The meeting was adjourned at 12:00 noon, February 25, 1966. I hereby certify that, to the best of my knowledge, the foregoing minutes and attachments are accurate and complete.. Robert Q. Marston, M.D. Associate Director, NIH, And Chief, Division of Regional Medical Progr s Eva M. Handal, Recording Secretary Council Assistant, DRMP REGIONAL MEDICAL PROGRAMS COUNCIL MENERS 1/7/66 Dr. Leonidas H. Berry Dr. 'John Willis Hurst Professor, Cook County Graduate Professor and Chairman, School of Medicine, and Department of Medicine, Senior Attending Physician, Emory University School Michael Reese Hospital of Medicine 412 E. 47th Street Atlanta, Georgia 30303 Chicago, Illinois 60653 Dr. Clark H. Millikan Dr. Mary I. Bunting Consultant in Neurology President, Mayo Clinic Radcliffe College Rochester, Minnesota Cambridge, Massachusetts Dr. George E. Moore Mr. Gordon R. Cumming Director, Administrator, Roswell Park Memorial Institute acramento County Hospital 666 Elm Street 2315 Stockton Boulevard Buffalo 3, New York Sacramento, California es Dr. William J. Peeples Dr. Michael E. DeBakey Commissioner of Health Professor and Chairman State Department of Health Department of Surgery State Office Building college of Medicine 301 West Preston Street Baylor University Baltimore, Maryland 21201 Houston, Texas 77025 Dr. Robert J. Slater Dr. Bruce W. Everist Dean., College of Medicine Green Clinic University of Vermoni 709 South Vienna Street Burlington, Vermont Ruston, Louisiana 71270 Dr. Cornelius H. Traeger Dr. James T. Howell 799 Park Avenue Executive Director, New York, New York Henry Ford Hospital Detroit, Michigan Ex Officio Member Dr. William H. Stewart (Chairman) Surgeon General Public Health Service Washington, D. C. 20201