I t w B&B INFORM^Irlom 300 Voodoo names R=uLxv Ulopcit M.%ItLoosto, od.% 040 Z0772 10 US^ 24@ 1 1 0 D E P A R T M E N T 0 P H E A L T Hs, E D U C A T I 0 N A N D W E L P A R E National Institutes of Health Division of Regional Medical Programs National Advisory Council on Regional Medical Programs Minutes of Meeting November @0-21, 1967 National Institutes of Health Conference Room "C" Sto-,ie House DEPARTMENT OF HEALTH, EDUCATION AND WELFARE PUBLIC HEALTH SERVICE NATIONAL ADVISORY COUNCIL ON REGIONAL MEDICAL PROGRAMS Minutes of Tenth Meeting 1/ 2/ November 20-21, 1967 The National Advisory Council on Regional Medical Programs convened for its tenth meeting at 8:45 a.m., on tionday, November 20, 1967, in Conference Room "C", Stone House, National Institutes of Health, Bethesda, Maryland. Dr* Robert Q. Marston, Associate Director, NIH, and Director@ Division of Regional Medical Programs, presided for Dr. William H. Stewart, Surgeon General, who was unable to be present at the meeting. The Council members present were: Dr* Leonidas H. Berry Dr. Clark H. Millikan Dr. Michael E. DeBakey Dr* Edmund D. Pellegrino Dr* Bruce W. Everist Dr. Alfred M. Popma Dr, John R. Hogness Dr. Mack 1. Shanholtz Dr. James T. Howell Dr. Cornelius H. Traeger The Council member absent was:; Dr, George E. Moore Public Health Service members attending some of the sessions included: Dr. Stuart M. Sessoms, Deputy Director, NIH Dr. S.M. Fox, National Center for Chronic Disease Control Bureau of Disease Prevention and Environmental Control Dr. Wilfred David, National Center for Chronic Disease Control Bureau of Disease Prevention and Environmental Control Dr,, Burnet Davis, National Library of Medicine Dr. E.P. Offutt, Office of the Surgeon General J/ 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/ For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications: (a) from their respective institutions, or (b) in which a conflict of interest might occur. This procedure does not, of course, apply to en bloc actions-- only when the application is under individual discussion. -2- Liaison tiembers attending: Dr, Sidney Farber, NCI Council Dr. A. Earl Walkert NINDB Council Others Attending: Dr. P.C. Anderson, NIH-OD Dr. Lionel M. Bemotdin,,Veterans Administration Dr. J.H.U. Brown, NIH-NIGMS Dr, Richard C , NIH-DRG II r. Frank Ehrlich, NIH@ Mr. John Francis, Bureau of the Budget Mr. James Gregg, NIH-OD Mr. Lawrence Maxey, NIH-OD Dr. Ian Mitchellt NIH-NCI DRNP Staff: Mr. Stephen Ackerman, Associate Director for Planning & Evaluation Mr. James Beattie, Chief, Grants Management Branch Mr. Edward Friedlander, Assistant to Director for Communications and Public Information Mrs. Eva M. Handal, Committee Management Officer Mr. James Lawrence, Financial Management Officer Dr. Richard G. Manegold, Associate Director for Program Development and Research Mr. Maurice E. Odoroff, Assistant to Director for Health Data Mr. Roland Peterson, Chief, Planning Branch Mrs. Martha Phillips, Chief, Grants Review Branch Dr. A. M. Schmidt, Chief, Continuing EOucation and Training Branch Dr. Margaret Sloan, Associate Director for Organizational Liaison Dr. Richa-id Steprwnson,, Assoc@e Director for Operations Mr. Karl Yordy, Deputy Director Miss Rhoda Abrams, Planning and Evaluation Branch Mr. Ira N. Alpert, Office for Operations Mr* Robert Anderson, Office for Operations Miss Sheila Beach, C ,-tttee Mana&ment Office Dr. Phyllis Carnes, Continuing Education Branch Mr. Peter Clepper, Grants Review Branch Miss Cecelia Conrath, Continuing Education Branch Dr. V.J. Corollo, Office for Operations Mr. A.E. Curry, Grants Management Branch Miss Judy Fleisher, Communication and Public Information Office Mr. Donald Fox, Grants Management Branch Mrs. Elizabeth Fuller, Office of the Director Mrs. M.V. Geisbert, Planning and Evaluation Branch LeRoy Goldman, Office of the Director Dr. John Hamilton, Office for Operations Mr. Arthur Hiatt, Planning and Evaluation Dr. Frank Husted, Continuing Education Branch Mr. Robert Jones, Grants Reveiw Branch Mr. Frank Karel# Communications and Public Information Office Dr. Philip Klieger, Office for Operations Mrs. Lorraine I(yttle, Grants Review Branch -3- Mr. Robert Lindee, Office of the Director Dr. H.O. Mathewson, Continuing Education Branch Mrs. Patricia McDonald, Grants Review Branch Mr. T.J. McNiff, Grants Management Branch Dr. Robert M. 01 @ an, Office for Operations Miss Leah Resnick, Statistics and Analysis Branch Mrs. Jessie P. Salazar, Grants Review Branch Mr. Joseph Simeone, Grants Management Branch Mr. Alphonse Strachocki, Office for Operations Mrs. Virginia Waller, Office for Operations Mr* Stephen Walsh, Planning and Evaluation 1. CALL TO ORDER AND OPENING REMARKS Doctor Marston called the meeting to order at 8:45 a.m. II. ANNOUNCEMENTS Doctor Marston made general announcements about the Service Desk, and called attention to the statements on, "Conflict of Interest," and "Confidentiality of Meetings." He announced that there would be an Executive Meeting of the Council and Liaison Council Members at noon today. Dr, Stuart M; Sessoms, Deputy Director, NIR, will attend the meeting. Mr. Charles J. Hitch, Vice President of the University for Administration,, University of California, has resigned as a member of the Council because of his appointment as President of the University of California, January 1, 1968. Dr. Edwin L. Crosby, Director, American Hospital Association, was,welcomed as an observer to the meeting. He will become a member of the Council effective December 10 1967. Dr. Sidney Farber, Director of Research,,Children's Cancer Research Foundation, is replacing Dr, Murray M. Copeland as the liaison metWoer from the National Advisory Cancer Council. Doctor Farber served in this capacity previously. III. CONSIDERATION OF FUTURE MEETING DATES The Council reaffirmed the following dates for future meetings: February 26-27, 1968 May 27-28, 1968 August 26-27, 1968 November 25-26, 1968 All of the above will be held in Conference Room 4, Building 31, beginning at 8:30 a.m. IV. CONSIDERATION OF MINUTES OF AUGUST 1967 MEETING The Council unanimously recommended approval of the Minutes of the August 28-29, 1967, meeting as written. -4- V. COMENTS FROM LIAISON MEMBERS Doctor Walker mentioned a discussion which was held by the National Advisory Council on Neurological Diseases and Blindness concerning the overlapping activities of the NINDB general program and the DRMP. The main discussion had to do with cerebrovascular diseases. For about ten years the NINDB has had a project program of clinical cerebrovascular research centers and at the present time there are approximately eighteen such centers around the country that are carrying out clinical investigations in this field. There have been a number of applications from other parts of the country for similar centers. It has become apparent to the NINDB Council that some of these centers which are now in operation are located in areas where DPXP has either planning or operational grants, but there has been no real contact between these centers and the RMP. It is believed that if the regional medical programs could utilize some of the background of these centers it would enable the regional medical program to disseminate to the community some of the research of the clinical centers and be used for some of the service activities of the regional medical program. In at least two areas of the country there are operational grants that do not include or have any real integration with clinical research centers in those areas. The NINDB Council believes that perhaps the DRMP project site visitors going into these areas might look into better integration between the clinical research center currently established and the We programs. VI. REPORT ON APPLICATION WHICH WERE CONSIDERED AT THE AUGUST 1967 COUNCIL MEETING AWARDED APPLICATION NMIBER REGION 3S02 R14 00003-02Sl Northern New England 3S02 R14 00006-02SlR North Carolina 3S02 Pd-I 00018-02Sl Tennessee Mid-South 3S02 RM 00019-02S3 California 3S02 Pll 00019-02S4 California 3S02 RM 00035-OlSl South Carolina 3S02 RM 00038-02Sl Washington-Alaska 3S03 R14 00037-OlSl Wisconsin PENDINC- IS02 RM 00024-OlR2 Florida 3S02 RM 00062-01R Tri-State VII. IEGISLATTVF, PRIPOSAL One of the major purposes of the Surgeon Generalls Report to the President and the Congress was to provide the basis for legislation extending this program and making whatever modifications seem to.be -5- necessary on the basis of the initial experience. A legislative proposal was submitted by the Division to implement the Report. The over-all outlines of that proposal are indicated in the specific recomendations of the Report. The specific recommendations concern the extension of the legislation and the need to authorize the use of RIIP giant funds for new construction of facilities to meet regional needs within specific constraints. New authority would also allow for direct support of activities meeting the needs of more than one region. .Two technical amendments were also proposed in the Report. The first is the addition of practicing dentists to that provision of the legislation which says that patients whose cost of care will be paid out of the RMP grant will have to be referred by a practicing physician. The oral surgeons have pressed for this amendment. The other technical amendment concerns modification of our legislation to permit the active involvement of Federal hospitals in REP activities. 'There is some question about this item because new legislation which provides that Public Health Service grants for research training or demonstration can be awarded to Federal hospitals. The General Counsel's Office has been asked for an opinion on the applicability of this new legislative provision to RMP grants. VITT. ANTICIPATED WORKLOAD FOR THE REVIEW OF GRANTS It is anticipated that the workload for future Council meetings will be so heavy, due to the increase in the number of operational applications, that it may become necessary to increase the time of the Council meetings to at least 2 1/2 days and continue to have at least four meetings a year. We are planning to increase the number of Committee members and may divide the Committee into sections A and B. ]X. EXECUTIVE SESSION The Council, Liaison Council members, Deputy Director, NIH, and certain DRMP staff members met in Executive session with Doctor Marston from 12:00-2:00 on November 20-21. Among the subjects discussed were, "Reorganization of the Division of Regional Medical Programs," and additional discussion of the, "Legislative Proposal." X. ANALYSIS OF THE CURRENT NATURE OF THE REGIONAL NEDICAL PROGRAMS Mr. Ackerman discussed the, "restatement of Regional Medical Programs," and indicated that it was needed because of the divergence of views and opinions at all levels concerning the scope and purposes of the program, and the lack of adequate attention to certain aspects of the program due to the early push to get RMP off the ground. Because of the above, there exists a need for increased Division guidance concerning the scope and purposes of the legislation within which the Regions may exercise their own initiative. -6- The followin- are policy issues which can be elaborated upmn: A. Focus on the Patient: 1, Quality versus quantity--"the evolution of a system that will make available to the bulk of the population medical services that are excellent in quality and adequate in quantity." 2. Program balance-- a. Categorical balance (heart I disease, cancer, stroke); b. Program function (research training, continuing education, demonstrations of patient care); c. Disease process (prevention, diagnosis, treatment and rehabilitation) d. Institutions and resources-(pr@6t icing physicians, university, hospital, public healths voluntary, consumer). B. Regionalization-. Cooperative Arrangements a. Local ane broadly-based decision making; b. Contributing to systems of health care. 2, Relationship of R14P to other govejL'omental programme, 3.@ Sub-regionalization'and interregional relationships. C. Other Issues: 1. Self-monitoring aspects Of the pro-gram, i.e., planning and evaluation as on-going activities. 2. The non-interference clause in P.L. 89-239. 3. Categorical nature of the' program vs. the need for comprehensive care. 4. The transmission of program priorities to the Regions. The following are proposed courses of action which are available to us: 1. The January meeting offers a national forum for spotlighting these issues. 2. The revision of the Guidelines,gives a timely opportunity for restatement and clarification of fundamental policies. 3. Special staff assistance can be given to regions particularly in connection with metropolitan programs and categorical emphasis areas. .7- 4. Special communications efforts can be undertaken with some pertinent areas including the development of monographs by appropriate experts and by regional or inter-re-ional workshops. 67 5. The review Process site visit and progress report @rotocols can be structured so as to assure that adequate attention is bein3 given to these fundamental policies. XI* DRMP GUIDELINES; ADM, THE JANUARY CONFERENCE-WORKSHOP ON REGIONAL HEDICAL PROGRAI-IS Mr. Robert Lindee, Assistant Dean, School of Medicine, Stanford University, has been working with the Division on a revision of the Guidelines. Mr, Lindeels contribution to this effort has enabled the revision to benefit from the perspective of the nonfederal institution that has to work with guidelines for Federal programs. The Division believes that a revision of the Guidelines is needed to benefit from base of experience that was not available at the time the original guidelines were drafted. This is a crucial time in the development of Regional Medical Programs because so many regions have reached the point when they are about to enter into the operational grant phase. It is important that the revised guidelines be available during this vital period. Therefore, the Division believes that revises guidelines should be issued in the near future even though new legislation will be proposed next year. (Subsequently, a Council Sub-Committee, consisting of Drs. Millikan, Chairman, Crosby, Everisto and Pellegrino, was appointed. As one of its first responsibilities the subcommittee will meet with the staff to review the revised Guideline Plans are proceeding for the Conference-Workshop on Regional Medical Programs, whicb will be held'at the Washington Hilton Hotels January 17-19, 1968. The theme far the Conference is, "Issues for Regional Medical Programs in the Improvement of Health Care." Mr. Lindee and Dr. John Gronvall,, Associate Diractor and Associate Dean, University of Mississippi Medical Centers are Co-Chairmen of the Conference. XII. RE. ON ACTIV3:TIES OF 'A-RFAIRS AND THE RELATIONSHIP TO C&TEGORIC&L PROGRAMS At the Executive Meeting of the-Council in August a discussion was held concerning the Regional Medical Programs with metropolitan areas and the related urban health problem. The Council issued a statement which recognized the complexities of the urban environment but stressed the responsibility of the RMP to contribute to health efforts there. It,also recommended that the Division of Regional Medical Programs call together appropriate National p leaders to consider how the attention of the RMP can best be focused on the urban health issues in metropolitan areas and their inner cities. Subsequentlyg on November 16,.a meeting was held to discuss ways -8- which the RMP can effectively contribute to the solution of these problems. The disucssion centered around the nature of Regional Medical Programs and their relevance to the problems, suggestions for types of action, and description of types of projects that might be developed in regions. The meeting was more diagnostic than therapeutic, but it should help orient future RMP activities in this vital area. The consumer group @ the community hospital need to have representation in the discussion of this important problem. XTTT. CONSIDERATION OF GRANT APPLICATIONS 1 G02 RM 00063-01, Northwestern Ohio (Toledo) The Council recommends approval in the amount and time requested of $274,450 first year, and $271,137, second year plus appropriate indirect costs. Council was satisfied that a vast amount of planning had preceded this application. The high level of cooperation achieved in the region was noted, with special mention that financial assistance had been provided by the Heart Association. Since the medical college with which the Region will be affiliated is a developing ones Council stated that this is a unique opportunity for the medical college and regional program to develop together. Information was provided that the Program Coordinator has recently arranged to work with the Program on a full-time basis. With that problem resolved, the Council was favorably impressed with the proposal. 1 G02 RM 00064-01, Northwastern Ohio (Cleveland) There was consensus that this planning proposal is reasonable in scope, size, and socioeconomic characteristics,, with the to be expected encumbent urban complexities. It shows great promise of success in that pre-planning has been underway for sufficient time to allow for the formulation of a well-organized plan, and also it comes from a region rich in talent and medical resources. The evidence of involvement of urban and suburban peripheral intere-,'K-,n to the Cleveland area could be stronger, but it was recognized that this is a common weakness of most planning applications. A strengthening of lay participation from the outlying areas would improve this aspect. The overlapping in state licensing practices was felt to be a potential strength for interregional cooperative efforts. The Council rec nds approval in.the amounts and time requested of $280,690 and $279#655 for an additional years plus appropriate indirect costs. -9- 2-GO2 RM 00035-02, South Carolina This is a competing application for a second year planning grant. The initial planning award was made for one year only. Discussion of the application was brief. Major concern was expressed about the absence of a permanent director. Reluctance of practicing physicians in the Region to cooperate was also mentioned. The possibility was suggested that the Regional Program has realized more progress than is evident in this application. The Council rec uds approval in the amounts and time requested of $316,675, first year, and $147,500 second year (six months),-plus appropriate indirect costs. 3 G02 RM 00013-02S lt WitaL e@ril. New York (Buffalo) The Council rec uds conditional approval in principle of all three components of this application subject to a Council sit* visit to (a) identify fundable planning aspects of each activity and (b) determine the amount to be awarded. The amounts requested were: $285,194 first year; $177,282 second year; and $180,243 third year, plus appropriate indirect-costs. 3 G02 RI,4 0 3-02Sl, Oklahoma The Council rec,lkends approval in the amounts and time requested of $112,849 first year (nine months), and $310,881 second year, plus appropriate indirect costs. Council expressed great interest in this application which will provide funds for supplementary planning activities for this Regional Medical Program. It defines needs which were not anticipated originally and proposes an imaginative approach to their solution. It also provides for the extension of the c-illl,ltted program period for one additional year* Some concern was expressed relative to the region's slowness in recruiting a permanent full-time coordinator. It was felt that although the present acting coordinator is dev*tt@ his full attention to the program, it is unlikely that the region will move smoothly into a full-fledged operational program until a permanent person is found. I G03 RM 00018, see Mid-South The Council recommends approval in the amount of $1.5-million direct costs for the first year, and at the same level, less nonrecurring costsp for the additional year of the program period. The final decision an the recommended dollar amount was based,, not only on the total of the "approved" projects, but on a general agreement that the $1.5-million will provide for an adequate program base upon which the Region may build. The Council was satisfied that the Region has the mechanisms available for an operation program. Special mention was made of -10- the intercommunity and interracial cooperation evident in the application. Shortcomings in the program are the absence of stroke projects and lack of full acceptance of the program on the part of the State Medical Society, which was apparent to the site visitors. Specific strengths of the program are the leadership; the degree of developed and developing cooperative arrangements among the health care facilities in the Region; and the personal c- itment of representatives of many health professions. The amounts requested were.: $2,6071,628 first year$ and $1,,5229601 second year, plus appropriate indirect costs, I C03'RM 00025-01, ochester, New York The Council recommends approval of $200,,857 first year; $149,498 second year; and $155,089 third year, plus appropriate indirect costs for four of the five components. The disapproved project requested support of the clinical application of diagnostic technique which, in the opinion of expert reviewers,, is not sufficiently developed for such application. The amounts requested were: $217,978 first year; $166,,619 second year; and $172,210 third year, plus appropriate indirect costs. I G03 RM OO33-OlR.3Lashington-Alaska The Council rec nds conditional approval for two years, direct costs of which shall not exceed $969,,904 in the first year and an equal amount in the second year,, exclusive of nonrecurring costs# to continue allowable activities presented in the application. The Council concurred in the Review Comittee's finding as to the viability of this regional medical program and -its readiness to mount an operational program, Final approval of this operational grant request is contingent upon the applicant's submission of an acceptable revised budget to the Division of Regional Medical Programs which reflects projected activities within the intent of the Councills rec ndation. The Council recommends approval of 13 of the 18 projects contained in'this application in the amounts indicated above. The amounts requested were: $@,180,716 first year. and $1,013,144 second year, plus appropriate indirect costs, Doctor Hogness absented himself* 3 G03 RM @ -09-OIS2. Missouri The Council recommends disapproval because this appears to be a thinly disguised request for immediate financial assistance for the Kansas City General Hospital with no clearly defined relevance of the request to the goals of Regional Medical Programs, G03 RH 00015-OlS2, -Intermmmtain The support of,two projects was requested; however,, the Council recommends approval only of project 2,, in the amounts of $3593,797 for each of three years. Project 2 will establish an endocrine metabolic laboratory as a regional resource for early detection of hypertension, and related services. Project 1 concerning control of chronic renal disease was disapproved. Although it was agreed that the disease is a "related" ones this particular project is not sufficiently within the purview of Regional, Medical Programs at present. It was agreed that if similar projects'--primarily for provisions of service to patients with this disease--were supported throughout the Nation,, they would require more than the total RMP allocation, The Council -also agreed that implementation of any such project should await further assessment of the studies recently reported by PHS @ BOB. The amounts requested were: $684.,369 first year,, $538,151 second year, and $660,775 third year, plus appropriate indirect costs. Doctors Millikan and Sha@itt opposed.- XIV, ADJO The meeting was adjourned at'3:00 p,m,'on November 21p 1967* .1 hereby certify that, to the best of my knowledge, the foregoing minutes and attachment are accurate and complete. Robert Q. Marston,, M.D. Associate Director, NIH,, and Director Division of Regional Medical Progr 8 Eva M.,Han@al,, Secretary National Advisory Council on Regional Medical Programs Division of Regional Medical Programs- NA,TIONAL ADVISORY COUNCIL ON REGIONAL MEDICAL PROGRAMS Edwin L. Crosby, M. D. (71) James T. Howell, M. D. (68) Director Executive Director American Hospital Association Henry Ford Hospital Chicago, Illinois 60611 Detroit,. Michigan 48202 Michael E. DeBakey, M. D. (68) Clark H. Millikan, M. D. (68) Professor and Chairman Consultant in Neurology Department of Surgery Mayo Clinic College of Medicine Rochester, Minnesota 55902 Baylor University Houston, Texas 77025 George E. Moore, M. D. (68) Director of Research Helen G. Edmonds, Ph.D. (71) New York State Health Department Dean, Graduate School Roswell Park Memorial Institute North Carolina College 666 Elm Street Durham, North Carolina 27707 Buffalo, New York 14203 MAILING ADDRESS Edmund D. Pellegrino, M. D. (70) Director of the Medical Center P.O. Box 432 State University of New York Durham, North Carolina 27707 Stony Brook, New York 11790 Bruce W, Everist, M. D. (71) Alfred M. Popma, M. D. (70) Chief of Pediatrics Regional Director Green Clinic Regional Medical Program 709 South Vienna Street 525 West Jefferson Street Ruston$ Louisiana 71270 Boise, Idaho 83702 John R. Hogness, M.D. (70) Mack 1. Shanholtz, M. D. (70) Dean, School of Medicine State Health C,ri,issioner University of Washington State Department of Health Seattle, Washington 98105 Richmond,, Virginia 23219 Ex Officio Member Dr. William'H. Stewart (Chairman) Surgeon General Public Health Service 9000 Rockville Pike Bethesda, Maryland 20014 Dece@r 1967