DEPARTMENT OF HEALTH, EDUCATION, “REGIONAL MEDICAL PROGRAM SE! os Rockville, Maryland — - ; “ Tuesday, 9 November 1971 |]. ACE - FEDERAL REPORTERS, INC. -. — Official Reporters - : 415 Second Street, N.E. ee . Telephone: a Washington, D.C. 20002 s@ode 202) 547-6222 | | NATION-WIDECOVERAGE = Vea Aotdvity Discussion marks by. DE. Pahl . Pe Ohio Valley. ‘e *) gri-state . . ‘Connecticut, . _ North Dakota .— enarks by Dr.. ‘Baum . “Colorado/Wyoming . | Remarks. by Dr. ‘sinman ° »” ee - “CR-4157 GIBSON — cs Pox Frcdeal Reportar, Se 10 ou 12, "os 14 4 15 - 16 7 18 = py 19 20 Be 83 RA. 25 DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE © REGIONAL MEDICAL PROGRAM SERVICE COUNCIL MEETING - Conference Room GH Parklawn Building . 5600 Fishers Lane Rockville, Maryland Tuesday, November 9, 1971 “11/9/71. CR 4157" Gibson/ « Smith ~ | ArceFederal Reporters Gre — 20. 21. Be 2B». 5. du 10 Ll 12 13 14 15 16 17- 18 19 24 | his coming by having me remind you of the conflict of anterest PROCEEDINGS DR. MARGULIES: May I have your attention, please. Dr. Wilson is on his way down here, and since he is going to open the meeting, I thought we could prepare for and the ‘confidentiality of the meeting, the statement in the front of the books, to remind you of it, and to. take the opportunity while he is on his way here to introduce two new members of the Council who are here for the first time today, although one of them has been appointed for quite some time, Mrs. Audrey Mars of The Plains, Virginia, who is here on my right. Mrs. Mars has had a long experience with RMP in | Virginia and has been closely associated with cancer activities and other kinds of voluntary efforts for a number of years; and Mr, Robert Ogden, who is President and General counsel of the North Coast Life insurance Company of: ‘Spokane, and. has: served in a very distinguished manner as Chairman of the Regional | Advisory Group. Now, since the introductions are complete, Dr. Wilson, would you care to take over. oo | DR. WILSON: Thank you, Harold, and welcome to the new members of the Council. I don't have any long message for this morning. I do want to do two or three housekeeping types of things. Number one, although I haven't had word from Praca. Fe, adoral Reporters, Ge _ : 10 11 12 13 14 15 - 16 1? 18 19. 20 et 22 25 24 25 | 4 downtown yet, I think our new organizational structure has been approved. I talked to you, I think, about this at the last Council meeting, at least briefly, and it cleared the last hurdle -and was to have hit the Secretary's desk the last part of last week, Things never stay on his desk very long. I wish the same could be. said for a number of other desks in HEW North. But so far as I know, we are now functioning undey the new HSMHA organizational pattern. That, of course, brings me then to the direct introduction of someone with whom you may have had previous contact. Did you introduce Jerry earlier before I got here? DR. MARGULIES: No, just to a few people. DR. WILSON : I just did. Jerry Riso, many of you have known, was the Deputy Assistant Secretary for Health and seientitic Affairs with Roger Egeberg, and has been willing to come out to serve. with us wearing one hat here and then another hat within the Department as a whole. The hat he weays for us is Deputy Administrator for Development. This is the : organizational pattern qT. am now saying I think is cleared down- town, and in that Zple Jerry has the coordinating responsibili- ties for: ny. office for Regional Medical Programs, for Compre- hensive Health Planning which is now a separate program from Community Health: Services ‘and the other 314 programs» -—— it hag been moved ° over and is now: under this general direction -- for National Center for Health Services Research and Development, bo Pree- Pace Federal Reporters, Gre. 10 li 12. 13 14 15 16 17 18 19 20° 21 22 20 24 29 8 don't get involved-when a new issue comes up. We are strug- gling with two right now that have implications for national policy and we don't have a good way of getting councils in- volved in time-limited issues. We think that there must be a better way, whether it's an executive committee arrangement or whether there is some kind of a small task force kind of group. However that may be, we will be asking Jerry to work with that and come up with ways so that his office, as it provides extraordinary coordination for me, will have your advice and counsel not only at regular Council meetings but in interim periods as well. I repeat one statistic that always sort of amazes me. We do have about 2,000 people who give us advice through councils, committees, or consultant appointments. We have not | at all learned how to use that advice well, either from the point of view of the use of your time, or from the point of — view of solving ‘the problems in which we have a mutual inter- est, but we haven't given up and we solicit your suggestions and counsel. We do, have now about completed a paper on -- what do we call that -- talent banks, skills banks? MR, “RISO: Skills inventory. DR. WILSON: Skills inventory. We have used all kinds of titles. Nevertheless, we are working with our own staff to try out a-sort of a brief questionnaire. If it | Peo Federal Reporters, Gro. 10 11 12 13 14 15 16. 17. 18 19 20 21 22 24 a) ‘dines and will be a little more focused. 9 works out you will get it before too long, which is an attempt to see if one way or another we can kind of catalogue what people would like to do, a little bit of what their availa- bility is, and then when we have one of these ¢rash programs perhaps we can get you more purposely engaged in the conver- sation than just sheer memory allows. The only other thing that is quite different. that I would like to bring to you, there are a number of ~~ the Washington scene calls it new initiatives running around, I am not sure any of them are new, but the emphasis certainly has changed in the last period of time. The = one to which this Council will need to rather carefully address its thought and purposes, over the next year at least, and perhaps longer, is the issue of the extension of the physicians’ energies or the professionals’ energies. Now, that in the past has had a very heavy tendency to lean on auxiliary, allied professions, you know, physician assis- tant type of approach of one sort or another, and I see no evidence that the interest in that kind of activity is. going to wane. I think itt s beginning to crystalize. along ‘certain The one that is picking up and which needs very careful watching is one which Bland and I spent. a lot of time talking about as long as four or five years agos and that’ s the role of technology in the health care’ ‘field, and it turns BAacaFederal Reporters Gre. 10 li 12 130 14 15 (16° 17 18 19° 20 | nave a certain degree of technology. in it, that if it's to- 21 22 235 24 10 out that with the appointment of Mr. MaGruder, whom some of you know in science and technology in the White House ~-- he is the gentleman who worked with SST for a period of time and they didn't get the SST off the ground so now he is taking his talents to something else. We are now undergoing a great deal of review that I think is exploratory at the moment, but which should be in our minds as we look at our limited re- sources and attempt to decide how we can best get our job | done. The basic issue is one in which there are about six different panel groups under the general guidance of the Federal Council on Science and Technology, each of which is dealing with a service area, a service oriented area, personal services oriented area, like the building of houses, for in- stance, which uses an awful lot of manpower and a relatively low degree of automation, or like the health care field. “ks thay” are looking at these, what really is being said is that the economists feel that for a nation to continue to prosper from the point of view of economics, any field must tally personal services oriented it tends to level off and be- come self-defeating. You lose the growth potential and that becomes not an advantageous part of the program of building the economics of the country. Now, what is going on in these several groups -- 10 11 12 13 14 Peo Federal Reporters, Fro, . | 15 16 17 18 19- 21. 28x f Ll groups is a very vigorous search for an appropriate role for technology in the personal services oriented field. These are people of national stature who serve on the panels. The re- i port will go through the Federal Council on Science and Tech- nology. This igs not an HEW report. It's a general governmen- tal report. And my guess is that as each of the personal ser- vices oriented fields make their own case for the advantages for investment in technology in their field, that will finally be waived from the point of view of where would it be best to invest in technology from the point of view of economics, not from the point of view of the health field or the building of buildings or something else, but who can make the best use of an investment in technology . I never was one to feel that we ought to sit around and wait to see what happens. are in the newspapers and several panels and they are around. It's very clear, to me at least, and I hope to you, that if yq look at the cost of providing health care in its present mode and you look at. the number of people who cannot get health care, then you try to think about giving what we agree we must have in its present form that you can't get there from here, that 20 percent of our nation are under-served, and if about investment in the system, that we just can t. live up to I chair the one for health services -- what's going on in thes¢ It seems to me that the signals you take our present manpower and its increments then you talk Ua Paeo-Federal Reporters, Gro. 10 11 12 13 14 15 16 17 18 19 20 21 22 23° 24 25 12 the promises we've made. And I think it's equally. clear that there are a great many places where, without at all inter- fering with the physician or the professional patient inter- face, we still could do things a lot more effectively, and use the extender of our energy a lot better than we are at the current time, I won't debate thak:point at the moment. “I will be glad to, but I am making I think just the general overview statements at the moment. So as you look at the various kinds of opportuni- ties for sponsoring new activities with RMP, I think you need ‘to keep this issue very much in the back of your mind from a tactical point of view, since I have some considerable feeling that we are. going to see a substantial investment in the field and I do think it will be substantial when the.decision is made. Harold, that's about all I'd want to make as an opening statement. I'd be happy to try to clarify any con- fusion I've invoked. MR. OGDEN: Could I ask a question? DR. WILSON: Yes. MR. OGDEN : What input, if any, will your office have in this study being done by the ‘Office of Science and Technology? DR. WILSON : Well, I chair: the. committee. There is a group of -- the panel itself is a panel. of. twelve: -Palmer Pleo Federal Reporters, Gro, 10 il 12 13 14, 15 16 17 18 19 20 21 Re 20 24 20 13 sits on it, who is on the Board of Trustees, for instance, of the AMA. Max Berry, who is a practitioner in Kansas City, who has had a substantial interest in the Weid problem-oriented system, is on it. Ralph Berry, the economist from Harvard | who teaches medical economics, is on it. I can't give you the whole list. Wendel Musser is on it from the VA. There is someone on it from DOT, as I recall it, and from pop. There is a wide variety of people picked basically by the Council on Science and Technology. There are some physicians among them and of course people from the other fields as well. We will have pretty good input. We are staffing it. MR. OGDEN: Fine. DR. WILSON: And I think it would be perfectly appropriate to address anything through Harold or through Jerry that you want to that you think ought to be contemplated by the panel. Well, Harold, they all look either overwhelmed, not yet awake, or totally satisfied and I can't tell which. (Laughter . ) MRS. MARS: Let's say totally satisfied. DR. WILSON: Okay, then, I will turn it to Jerry, and I will be here for a little bit although, of all things, even the Administrator dissipates once in awhile. I have two meetings out in the Middle West in the next two days, and I looked that schedule over and decided this weekend was a A co- Federal Reporters, Ge 10 “i 12 13 14 15 16 17 18 19 21 22 wf B4 “ps | Ghallenge and a job that needed to be done, all the kinds of 14 good weekend to go goose hunting, so I will be leaving this afternoon, and I am in the process of attempting to get stuff cleared off the desk, so you will have to pardon me if I sneak out. It really is a dissipated life of an administrator. MR. RISO: Thank you, Vern. I am delighted to have joined HSMHA. Several months ago when Vern asked me to con- gider coming to HSMHA and wearing two hats, he promoted the idea on the basis of it being a very significant professional things Vern tells you when he is trying to promote an idea. But he never did tell me that part of the challenge would be to hold a position that has not yet been created, to head an organization that has not yet been established, and to coordi- nate subordinates who have not yet been appointed. But we have been operating this way for about six or seven weeks and it has been all of the challenge that Vern indicated to me that it would be, and I will cover some of that. There are some visible signs of progress, however, despite my having been here six or seven weeks. I found my way to this room without any help, and that I can tell you is progress in this building. I have spent the last six or seven weeks becoming acquainted with some of the programs and some of the in- dividuals within the programs. I really can't. give to you a direction in which we will go because I am still finding the - Poo Federal Reporters, Pre. 10 li “1e 13 14. ~15~ 16 17 18 19 20 21 22 25 24 25 Know that, and if our’ “guecess will be measured in terms of. 15 directions in which we are currently heading. I just give to you some. of the questions that I am asking with respect to the programs I am working with, and from these questions and the answers. I think you, will find the elements of our agenda during the next several months. I am basically raising questions on how can we im- prove our ability, our being for people within HSMHA, people who participate with HSMHA and other people within the health field -- our ability to recognize and define our health needs. How may we better relate our research activities within HSMHA to these needs? How may we better identify early in the game those concepts a practices which we consider at least to be of significant value, at least we think they will be of sig- nificant value, and therefore ought to be introduced to the field? How may we promote the introduction of these concepts to the field under appropriate kinds of safeguards, appro- priate testing? And finally, how can we improve the working relationships and the communications among our programs? And finally, to the extent that all of this results in two kinds of things: Ane clearly identified areas” in which change ought to be made and, secondly, rather comprehensive agreement on the: nature, of the changes and the way in which we would do it, how. may we. Ampement it. It's a rather tall order, I two things, ‘one, the time and energies of people around here, | Pree- get into it at the present time, but we can, or we can delay it until late in the day when I think we may have an executive session on two or three issues which will require that kind of attention. We have over some time been developing an updating of our regulations. These regulations in turn have gone to general counsel for their validation and for preparation for publication within the Federal Register, making them thereby official. This is an essential part of our activities. Since we operate in the public interest we should be viewed ‘publicly Some of the questions which are going to be. looked at there, and some of the decisions which are going to be made in those regulations, refer to such long-term sticky issues as the proper relationship between grantee agency, Regional Advisory Group, coordinator and core staff. . These have been defined, and I think with some clarify, ‘but as with all regulations there will remain room for interpretation which is going to be a responsibility ever time of the council. When these have ‘been moved from the early draft stage ‘to a point of finality, they will become something for yottr-de- liberations and certain sections of them. will certainly be. Ste: Proe-Federal Reporters, Gh 10 11 12 13 14. 15 16 17 18. 19 20 21 22. 23 24 25 36 familiar territory. Back again to the Council -- and I ee bouncing around; this is all part of the pattern -- council functions are clearly spelled out in the regulations which are being de- veloped as are the Regional Advisory Group functions and their interrelationships. The make-up of the Council, however, is not a part of regulation but a part of practice ot a part of Administra- tive preference. This Administration has a strong preference for the ladies, and that I must assume we all join. As a consequence, the two ladies who are here will over a period of time have company, and it is our hope that by the time we have filled vacancies which are occurring -- Bruce, this will be heartwarming to you -~ you will be replaced, I'm sure, ina manner which will be inadequate in one sense, but fully adequa in another. We don't think we can replace you. The best we thought we could do is to seek for someone of the opposite sex who could do through her special skills something which will compensate us for what we lose with the loss of your special skills. I don't know what I just said. (Laughter .) But in general, we are going to inctease the female we. complement on this Council. - I think you will also see some reflection of our hope to create a better balance both in terms of a minority Pee Federal Reporters; re. 10 11 12 13 15. 16 17 18 19 20 21° 22 20 B5 tu -AHEC for some months, and in fact when we reviewed the activi-~ 37 membership and in terms of a balance between the sexes by the present make-up of the review committee. It is now at full strength, and the new members, who are not here, of course, but whose names I would like to give to you, include Miss Dorothy Anderson, who is an assistant coordinator in Area 5 in Cali- fornia; Dr. Gladys Ancrum, who is Executive Director of the Community Health Board in Seattle; Mr. William Hilton from the Illinois State Scholarship Commission in Chicago; Mr. Jenus B. Parks, who was with the United Planning Organization in Washington; Dr. William Thurmon from the University of Virginii Mr. Robert Toomey , who is the Director of the Greenville Hospital System in Greenville, South Carolina. These are all pretty much in the nature of announcer ments, and I think now we will move into some issues which are going to remain of some concern to you. | one of them has already come up for some brief dis- cussion, and that is the current status of area health educa- tion centers. We have had under discussion the general concept of; ties of RMP since its origin, we found that we have been in the AHEC business for quite awhile. You will recall that at the last meeting of the Council there was a presentation of th activity in Watts Willowbrook, which represents many elements of what we are talking about in the AHEC. Pleo Federal Reporters, Gre. 10 li 13 14 es) 16 17 . 18 19 20 21 ‘ll ae BB aw >) 1 38 As with the HMO, no legislation has been passed to make the Area Health Education Center a newly defined legis- lative program. The Regional Medical Program legislation, however, contains all of the necessary substrates for AHEC ‘| development. Regardless of how the legislation comes out and the alternatives are primarily three -- one of them is that it won't come out, which is one alternative. The second is that it will be passed in the form that was introduced originally giving the primary responsibility to the Bureau of Education and Health Manpower Training at NIH; and the other one is that the primary responsibility would be under Title 9 and Regional Medical Programs. | Those issues are still being debated, and of course the outcome is unpredictable. In any case, it is quite clear that the RMP will be involved in AHEC's, working closely with the Bureau regardless of where primary responsibility is, and working closely with the Veterans Administration under any of these circumstances. ‘re ds also clear that whether we call it AHEC or something else, the RMP's are moving strongly in that direction, and the kind of ferment, Jerry, which you have described in the HMO area, is closely paralleled by. that which is in the AHEC area. a - qhere are some interesting differences, however, in perspective, and from my own parochial point of view, I think that the.RMP does represent an absolutely essential ingredient Peo Federal Reporters, Gho. 10 11 12 13 14 15 16 17 18 L9 20 21 22 23 24 25 39 in the development of at least one kind of AHEC. There may be several. Hecause one can regard the Area Health Education Center as an extension and an expansion of the educational activities dn the. University Health Sesence Center and else- where, or it can represent it as a kind of community-based activity, designed around service needs, which is so planned that the educational activities specifically serve those service requirements, which is the way I interpret it. Now, as a matter of experience and practicality, the Likelihood of developing a strong community base for an Area Health Education Center, by proceeding through the Regional Medical Program, with a balance between University Health Science Center and community, the possibility of doing that effectively I think is high. | The possibility of going through the University Health Science Center as the primary agent to the community to develop that relationship exists, but I think it is lower, be- cause the University Health Science Center has its own re- sponsibilities. It has grave financial problems. It has prior concepts of curriculum. And it is in fact bound to academic requirenents which: have been long developed. I have made no secret of ‘the fact ‘in moving around the country that I think that one of the. potential virtues of AHEC is to challenge Ehe institutional practices of University Health Science Centers, and to ‘in some ways assist them in their Pree-Pedoral Reporters, Gro. 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 | and the acquisition of a . diploma, certificate or degree. And degree will ‘become, secondary , and the effectivencss. or the 40 efforts to move out of their accustomed nesting place and into the community. I think many of them wish to make that move. They find it very difficult. And I think that RMP, and specifically RMP with the AHEC under the Veterans Adniinistra- tion collaborating, can make that move which ‘I think will eccur, move more rapidly and more effectively. Now, we are not in the position in RMP to put out a paper which describes what we think the AHEC ought to be. It would be inappropriate at a time when the whole subject is being debated and the resting place for lead responsibility is still uncertain. But we have shared these views with the Bureau, and the Bureau has been generally in accord with. them. Certainly Ken Endicott does not believe that the AHEC should be an extension of the University Health Science Center and a satellite thereof. On the contrary, he believes that there has to be devised a method of producing within the community ‘real competence for relating education, particularly education at the middle level, with service requirements, with the re- sults detexmaneS? evaluated, measured by the manner in which they improve ae delivery of services. Now, this jumps over the accustomed measurement of educational activities which is the completion es curriculum if it is done effectively enough, that certificate, diploma or : Pree Federal Reporters Gh 10 11 12. 218 14. 15 16 17 18 19 20 21 22 23 24 25 Al services being provided will become primary, and since I pre- sume that is our goal, I hope that we can be effective in pursuing that kind of an activity. This Council will, I am sure, begin to receive, either in partial or in complete form, applications for what represents that kind of an AHEC activity. We will also in RMPS be working very closely and in a more formal fashion with the Bureau to expand our activities so that we can do with the ll Bureau of Education and Manpower Training those combined in- vestments which up to the present time have been found diffi- cult to locate. The climate for it is good. There is little or no difference in our views of what needs to be done. So that I think, Jerry, we feel safe in saying that we are going to get on with the AHEC. To what degres we witl assume ste- wardship for it, and to what degree we will be cooperating witl someone else is as yét uncertain, but it will be an active program within the RMP. Would you like to add anything to that? MR. RISO: No, I would hope that I get that paper today. DR. MARGULIES : It was there last evening. MR. RESO: Good. This thing ought -to come to a head in rather short order. I am confident that it will come out, £OO; one, that it will. come out ina way that we can work with it; secondly, it will come out in a way in which RMP wd Peo-Faderal Reporters, Gne. 10 11 12 13 14 15) 16 17 18 19 20 21 22 24 BS an will take a significant leadership role in. the development of these. I am delighted with both. ws THE CHAIRMAN : Bland. DR. CANNON: Maybe you and Jerry will clarify Paul Sanazaro's department. I can't quite relate this -now in MMO's and AHEC's and sort of get the feel of where our Council | stands. | MR. RISO: That's one of the questions I'm raising. The proposed plan of organization of HSMHA places upon the National Center a distinct, and not necéssarily new but a much clearer role in terms of being part of a leadership activity here to bring about change in health care delivery. The question -- and I don't have an answer; let me jump. to that one and tell you that at the outset -- the ques- tions I am raising are essentially threefold: One, in looking at the Center, and in looking at the kinds of activities where it spends its money, looking at the amounts of a it spends the questions that I do propose to raise are: Are these the areas where money ought to be spent, is the program in which the programs that we support. through the National center, pro- grams that deserve the level of support that we are currently providing -~ ‘that is, with respect to priorities and such. Secondly, from an operating point of view, can we be satisfied that the results being developed by the National center are (1) clearly known, (2) are adequately reacted to by the.-RMP , Preo-Federal Reporters, Gre. 10 11 12 13 14 15 16 17 18 19: 20 21 22 23 24 | grammatic areas ,. and the areas we are interested in. _And 25. they are in terms of HMO's. 43 and other programs, and (3) do we have the management system for putting those particular findings, those particular pro- jects that we think are valuable,into ongoing programs? Intuitively I'd say that those systems do not exist and that there are major improvements necessary in working re- lationships and communications, and so the fact that you raised the question is perfectly understandable, because I work here and I can't answer those questions and I am raising them. MRS. WYCKOFF: We do need to know more about what MR. RISO: You are absolutely right. We all do. And it is an item, not for concern in a negative sense, but particularly with respect to the new plan of or- ganization, and particularly with respect to clustering five programs which together, and then working both independently and with other programs within HSMHA, are supposed to have a significant role in “institutional change." os Well, it is obvious and necessary that your re~- search arm has got to be an integral part of this activity, and this means that there have to be consistency between their objectives and the objectives of the group, and some -- I don't mean. duplication now but some consistency between the priorities in. areas they spend money, areas in terms of pro- ‘then finally some effective working relationships which ‘allow Aree Sederal Reporters, Ge. 10 il 12 13 14 15 16 17 18 19 21 22 25... 23° 44 ‘l communication in terms of where we stand, and think of it as a | series in terms of moving from research to field testing to evaluation to full-scale production, to go back into the world “I come out of, and those relationshinvs really -- I am not ‘confident -- I couldn't assure you those relationships, one, exist today, and that the current relationships will remain the same five months from now or less. DR. MARGULIES: Let me now bring you up to date on what we are doing with the Section 907 activity. For those of you who don't recall, Section 907 is that part of our legis- lation which requires us to provide through the Secretary a list of those hospitals which represent the most advanced skills for heart disease, cancer, stroke and kidney disease. We have made good progress, and we have reached a level of understanding by bringing together a very competent group of people from around the country who can accept the idea that we can do this effectively and usefully by depending heavily on the contracts which we have had in the past for developing guidelines, and modifying those in such a manner that we can set up institutional criteria. I believe even the cancer -contract produced enough data for institutional criteria so that we are going to be able to find it useful for that pur- pose. The heart guidelines and the stroke guidelines, of course, are effective for that purpose, and then we have, in : addition ‘to “that, put together a group of consultants for Prce-Fadoral Reporters Guo 10 ll 12 13 14 15 16 17 18° 19 20 21 22 20 24 25 45 kidney disease which is simpler because it is dealing pri- marily with dialysis and: transplants so that we can establish some criteria. | We will probably be working through contract with the Joint Commission on Accreditation of Hospitals, and we will try over a period of time to move through this process so that the level of skills which are identified and kept current will apply not only to the hospitals with me most advanced, \but also those which are of necessity related. to such insti- tutions, so that we , have a series of reports which will allow the profession and the public to make wide choices in how they seek help. I think it is moving along well, and since there are no more details than those, I think that we probably needn pursue it further. We will want your assistance, however, as we move into the final statement of criteria, and as the Joint Commission converts these into a method of inquiry which fits with their techniques, because you have to establish criteria first and then convert them into a useful form. Clark, unless you'd like to comment further on it I think that's probably as much as we need to do with it now. “Now to- some more , specifics about the RMP's and your prior: -reconmendations.. Over the last several meetings there | have. heen several Regional Medical Programs which have been the subject of particular attention, usually because DoF, ederal Retortor Sho. oe 10. oy 12 13 14. 15 16 uw 18 19 21 22 23. 24 25 46 there are problems. We have met with all of them in depth and there have been some results which may be of interest to you. I don't know that what has occurred ean be analyzed in full, but there are some symptoms which I think are worth noting. | In Central New York, Dr. Lyons has resigned as of November ist. | In Rochester, Dr. Parker is resigning January lst. In Susquehanna Valley, a coordinator who resigned, as I think you already knew, and a new one is being sought. — He will be an M.D. and they are close to a resolution and a selection there. In New Mexico, Reginald Fitz has been replaced by Dr. Jim Gay. He is a neurosurgeon. We will live with that | fact, but he appears to be all right anyway, Bland. We had an extremely direct meeting with Oklahoma, with Dale Groom and with Dr. Helio. The discussion was frank. We have no formal announcements of further alterations but they understand what kind of directions would be more appro- priate for them, and there may be further specific changes there in the very near future. 2 Greater Delaware Valley also has _ coordinator. Dr. Wollman has been confirmed as -- he was acting and he is now the regular coordinator of the Greater Delaware program. aan! Nebraska, which was in issue, has a new Coordinator PcoFederal LReportors, Gra . 10 ll 12. 13 14 15 16 17 18 19 z0 22 23 24 25 21 47 Dr. Marcie has replaced Dr. Morgan. South Dakota has also a new coordinator named Dr. ‘John Low. In Albany we had a meeting in depth, and I had the feeling that we left with both of us relatively unaltered. There was a possibility of some change, however, because among those who came down were some people who had some real fire in them, and I think we will have to pursue that one with a little more vigor. | We don't play games in this Council so we have to discuss things pretty openly, Jerry, so that one remains of some concern. However, Stu Bonderant, who is on the Regional Advisory Group up there, understands what needs to be done. We have put a very definite time limit on the program, which h most characterized the Albany program, and there is no questio that it will be phased out before the end of the year. So that they will perforce be seeking new directions. ~ We will be having a site visit with the metropolita D.C. RMP in the very near future, and that also may be an’ ex tremely difficult one for a number of reasons because there is not only the issue of the D.C. RMP, but there is also a ques- tion of a kidney proposal which Dr. Schreiner I think has. some faint knowledge of. In California, in Area 3, Dr. John Wilson, who was acting as coordinator, has been replaced by a full-time nm Paco Federal Reporters, Gre. 10 ll 12 13 14 15 16 17 18 19 20 21 22 23 24 25 48 coordinator, Dr. Faulks, who I think you are all familiar with who is an extremely good choice also. There are three RMP's where new coordinators are either being sought or have been selected and not announced. As you know, Al Eustice did resign from Michigan. It's no secret by now they tried very hard to get Bob Chambliss to ga out there as coordinator, and we gave him a very long rope which extended as far as 50 miles short of Michigan so that he could go as close to it as he wished, but we pulled him back and he's remained here as the Director of the Operations Divi- sion, and that set them back a little bit because they thought they could snatch him. They don't have a coordinator, but they are seeking one. Pete Doan is resigning from the Coloraéo/iyoming. Both of these resignations were time-based. They are both at the age of mandatory retirement. And I believe Al Hoffman will stay. So these are replacements which are based upon in- stitutional regulations on resignation. We have, as I indicated, met in depth with all of the programs: which have difficulties. I have not discussed Ohio. r have;not discussed Delaware. Both of these are special issties which z think we will preserve for the period of time when. we go into executive session. We will also be talking: at that, time about the new construction for a cancer center in the Seattle area. be gt e oO a ee Pee-Federal Reporters, Ge. ~~ oe - on im Hn 17 18 19 20 21 ® oe RR oe, BS BA 85 has emerged in new form as we have created a different kind of p= n pl a 49 Now, before coffee break I'd like to bring up one other issue, which is not a perennial one, but rather one which RMP review structure, and that has to do with the relationships between kidney activities and the RMP activities otherwise. We have been accused by the review committee, by people outside and inside RMPS, of being very inconsistent in the way we handle the kidney activities relative to the way we handle the Regional Medical Program review. That accusation is absolutely accurate. We are inconsistent, and we are de- liberately inconsistent, and we will probably perform better if we understand the reason for the inconsistency. The kidney activities, which are essentially, as we review them, concerned with end-stage treatment, with dialysis, transplant, and with all the necessary requirements for dialy- sis and transplant, is categorical, unblinkingly, plainly categorical in its approach. And as a consequence, and be- cause we wish to go about the management of that categorical activity through the creation of a national network with a minimum of unnecessary duplication, we do have to perform two kinds of acts which we hope we can perform with effectiveness.) One of them is a review as we in the past reviewed projects, technical review. That technical review has to take place in a special form. What we propose to do for technical review will be tied in with the way in which we are going to Boo ~laral Reporter Ga 10 ll 12 13 14 15 16 17. 18 19 20 21 ay 23 24 25 - 50 reorganize the kidney activities, about which I will speak in a moment. The nature of the technical review Dr. Hinman will describe to you either before coffee or immediately after. But the essence of the process is this: That we will under- stand that a technical review is necessary, that that technica review will be brought to the review committee as a project type of deliberation. It will also be brought to the Council where we now have kidney competence -~ well, we have always had kidney competence, but we have supplemented Mr. tyckof£ by having two more kidney experts on the Council, and. they will be in a position better than they were this time to re- ceive at an early date the technical review and consider it on the merits of its technical competence. Now, that does not separate us from the responsi- bility to consider this with two other issues in mind. One is how this relates to a Regional Medical Program, and the other is what it represents in the way of funding. So far as the RMP mechanism is concerned, it is necessary that we recognize the fact that a technically effective kidney activity may be proposed by a Regional Medical Program which has so many prob- lems and is having so. much difficulty functioning as an RMP that a serious question is raised about whether it is appro- priate that they take on this responsibility. This can be true for two very broad reasons. One of them, because it will divert their energies into something od Arco-Paderal Reporters Gre, 10 11 12 13 14 15 16 17 18 19 20 1 22 || 24 25 any of the other issues, I believe. . It becomes self-evident an RMP, that ‘a large kidney activity cannot be ‘approved for 51 which is less meaningful than it should be for total regionali gation. The other is because it will make them believe that — they are achieving something by having been awarded a fairly sizable grant when in fact they are achieving too little. But the underlying element is the fact that we are insisting that if we do approve something which is technically sound, that it be managed with regionalization, and that it serve the maximum public interest within that region. If the RMP has not achieved effective regionalization of provider ser- vices, then there faa very great Likelihood that it will have a sound kind of ari activity with little or no regionalization That issue will regularly come up and it will require delibera tion by this Council to resolve the differences. “When the kidney project is technically unsound there is no “issue. When it is technically sound and the RMP is sound, there is no issue, When the two are out of phase there is an issue. -The other question has to do with the way we look at the funding. of a kidney activity, vis-a-vis the basic funding of the Regional Medical Program. That is simpler. thay when you Look at the basic commitment which we may have to support if we limit the funds available to that activity to that which has already been awarded to that Regional Medical — } ; Pleo Federal Reporlors, Gro. - 10 ll 12 13 14 15 16 17 18 19 20 - 22 23 24 25 ‘total allocation’ is. 214, 52 Program. Sometimes. an RMP may be operating at a level, say, of $650, 000, and : it. gets approval for a kidney activity in the range of $200, 000. Clearly, this would be an award of an activity which is meaningless because it couldn't possibly support ite. - So we do, when we are able to do so and when we know enough about our budget, anticipate a level of funding, since this is still a categorical project type activity, which sets aside when we can do it, as I say, an amount of money — which will go into kidney programs, and we operate, as we understand our budget, within the constraints of the funds which are available. When you approve a kidney activity at whatever level it may be, we look separately at the total funds which we hope will be available for kidney activities and make at least some of our determination for final award on the basis of that total resource. Since this varies accor- ding to the allocation of funds to RMP and the other demands for funds within RMP, we are never sure until a little later in the year, and we are not sure at this moment what that In the past. fiscal year, through contracts and grants, we we were investing approximately $5 miliion per year in the kidney activities through RMPS. We hope, if we get a larger, final allotment ‘of funds in the RMPS, to increase that in accordance with the total amount available, and in accordan CE PlooFaderal Reporters Gre | 11 L2 13 14 15 . LT 18 “19 20 21. 22. 25 24 25 53 with what project activities come in. So that we have to also operate on a separate fiscal review, as well aS on a separate programmatic review basis. Now, I think that that’ is a reasonable enough ex~ plication of our inconsistency and I hope that we can live with it. I also hope that we can confine that kind of incon- sistency to the kidney activity and not acquire new categorical] programs which tend to move in the same direction, because all else that I can see which represents new interests, either | through Congress or through the Administration, can be devel- oped most effectively by having a sound delivery system rather than by having an isolated kind of project-related effort. DR. MERRILL: I wonder if I could ask you or Mr. Riso to respond to the following question: If kidney is to be treated as a technical review, and perhaps correctly sO, would this perhaps have any bearing on the discussion that you told us of new negotiations, the role of technology in the health field? Certainly a good many of the kidney activities depend for that efficacy upon advances in technology, and I think the new apparatus for dialysis, the production of anti- lymphocyte globulin, and a good many: others. Will this have an input into the technical review in a way. in which kidney funding is ; considered by the. RMP? | DR. MARGULIES: I think Tid have. to. answer no. to that, John, from what I understand. ‘T think-what vern was | / Bex Federal Reporters; re, 10 11 12 13 14 15. 16 17 18 19 20 | a1 22 23 54 talking about might be related to this, but he is essentially emphasizing new technology of the automated kind, the type of thing which was produced by space explorations out of NASA interests, the types of communication networks which’ can be established in rural health care delivery syetens, acme of the remarkable things that Washington/Alaska is doing with’ the use of the satellite, that kind of thing, rather than scientific technical development. DR. MERRILL: Perhaps the computer would fit better in this. DR. MARGULIES: Perhaps. DR. SCHREINER: Well, while I agree with your cau- tions, I'd just like to raise one additional aspect to what you mention. I think the problem of strong. kidney programs and weak RMP's is going to. be with us for a long time. While it is true you. have to be cautious, I would ask that you think in another direction, namely, that where there has been & prob- lem in coordination in RMP that has been difficult to solve over a period of time, it's just possible that because of the tight organized definitive way that kidney care is delivered that it might-be the means “by which you. inject the starter fuel into that particular program and get it moving: Te can By, remember several institutions where no surgeon talked “to an fnternist until they had to do a transplant ‘together. “And I don't think we should keep saying they" ve got. to talk , to each PArco-Federal Reporters, Gre. 10 1 12 13 14 15 16 18. 19 21 ee 23. 24 20 17 20. 55 other first in order to do that. It may be that the doing of it may be the means by which you get them to talk to each other. | DR. MARGULIES : I think you're quite right. There are ng absolutes in this and we have also considered that possibility, but these are the general kinds of ground rules. I do think it's time for a coffee break. I'd Like to say that when we come back I will bring to your attention some ques- tions which the review committee raised about kidney programs. I think that I have at least brought you up-to-date on our thinking, but you. will want to respond and you will want to go a little farther on the reorganization of the kidney activi- ties within the ‘RMPS. Let's see if we can be back in, say, twelve minutes (Whereupon, a short recess was taken.) “DR. MARGULIES: May we reconvene, please. We are still not through with the kidney issue. t wonder if we could get back on to the agenda, please. | | There are two issues which we wish to discuss further regarding kidney. One of them is broader than the ‘kianey issue alone that has to do with Section 910. and its potential usefulness. But first, I would like to have the ‘council ‘receive for their consideration the expressions of interest ‘from the review committee during their last. cycle, specifically ‘related to kidney disease. They asked ‘four Paes Federal Reperrs Gre. 10 ~o_l 12 13 14 ey oe : 15 16 17 18 19 21 22 23. 24 25 56 questions, and it seemed to me that some of them were of doubtful relevance to Council deliberations, but you can form your own judgments about that. I will give you all four of them, and then we can go back and consider them one at a time. Following consideration of the individual applica- tions, the committee passed the following motion regarding guidance from the Council: 1. Whether Council recommends that money appor- tioned for renal disease be considered in a proportional ratio to the total amount of money of the RMPS budget. 7 (2, Whether the total amount of money spent in a. given regiot: for renal disease should be in proportion to the total amount of dollars being spent in that region. I presume they 1 mean by that RMP dollars. 3. “whether ‘renal programs funded by the regions will come. out of. their. total budget or out ef a separate budge! re Whether renal programs should be considered outside of the total regional activities or not. Now, I attempted to address these issues in general jin what I said before the coffee break, and I wonder if we might not go back with any kinds of comments you care to make on those particular questions. The first one was whether the Council recommends that money apportioned for renal disease be considered in a | Pee Federal Reporters, Gro. 10 li 12 18 14 15 16 17 18 19 20. 21. 22 a5 2a-|| 25 || is a round-robin of activities. kidney cannot be arrived at on any basis of need, because it nal budgetary issue, and one decides that that's how much you |) education development or manpower utilization, or whatever may “be the competing elements within the program. really, as far as the review committee is concerned, just the “explanation you have given. 57 proportional ratio to the total amount of money in the RMPS budget. | DR. MILLIKAN: How was the dollars arrived at? Did that just sort of happen? You mentioned in your initial com- ments about $5 million. DR. MARGULIES : Actually, the final decision on budgetary dispersal is an administrative decision in which we only participate partially. If we get any sum of money, as it appears we will, above the level of last year's funding, this will be associated with a considerable amount of administra- tive negotiation. We will say what we want. HSMHA will say what it wants. HEW will participate, the OMB will, and there The figure of $5 million or any other level for clearly is inadequate for the needs. It's ‘strictly an inter- can afford relative ‘to RMP support, relative. to area health we DR. MILLIKAN : Then the answer to that question is DR. MARGULIES: They felt a little uneasy with it. They felt maybe the Council should decide it. DR, ‘ROTH: | This is prolsably asking the same question Peo-Federal Reporters, $hre 10 11 12 13 14, 15 16 ay 18 19) 6 22 23, 24 58 in a little different format, but when RMP assumed the mantle of guidance in the kidney effort, did it accumulate any speci- fic additional funds to do the job? DR. MARGULIES: “In the very initial stages it carried some contract activities from a prior time, but in fac! there have been no additional funds made available for kidney. DR. MILLIKAN: No earmarked funds? DR. MARGULIES: No earmarked funds. The legislatio: says you may spend up to $15 million, and then they immediatel: reduced the total amount available well below what it had been previously, so that regardless of what was recommended by Congress or by the appropriations process, we had even less for kidney than we had before the legislation was passed, if ~ you want to look at it that way. DR. SCHREINER: I wouldn't want to look at it that way, because what happened, they reduced the appropriation first, and after we went to the Appropriations Committee they added earmarked funds for kidney, and then the Bureau of the Budget froze it. And then in the conferences, since actually the kidney people who are working on this appropriation were not particularly pushing for earmarked funds, realizing the problem there is in administering eartiarked funds, but were using it to try to’ identify the interests of Congress and the interests of the Congressional committee. | So the earmarking was taken ‘off when the money was tr oe - Pee Fraderal Reporters, Gre. 10 il 12 13 14 in 18 19° 20 a1. ae | 23 24 | 25 15: }. 16 | 59 thawed. But I think the intentions -- and this was. by agree- ment -- the intentions of the Appropriations Committee were to increase the total appropriation. Of course we'd like to see it increased more, obviously, because it isn't meeting, the need. ) DR. MARGULIES: I think there is no question about it being the intent of Congress to increase the investment in kidney disease activities, and there is no question about our intent to do so. I really think what the review committee is asking the Council to do is to assume ani administrative re- sponsibility which it's in a poor position to carry out. We are not in a very good position ourselves because we only, as I say, enter into this discussion. You might ask the same question -- I hope you won't -- about the money for pulmonary pediatric centers. One could just as easily say that the amount of money should be equivalent to what you give for kidney disease. The needs exceed the funds available for both, so the decision is actually a fiscal decision, which is not related to total needs, but actually related to relative competition for funds. If we could do so, we would like to increase the kidney investment in the range of 50 percent over what it has been in the past, which would be in fact, out’ ‘of proportion to the increase in funds potentially evatlable. But it isn't on that kind of a basis the" decision has been made. It's really also determined by what ‘the a | Pleo Fedorl Reporters, Gre. 10 “li 12 13 14. 15. 16 17 18 19 20 21 20° 24 25° 69 potentialities are for good projects which can he supported and maintained over time, et cetera. DR. SCHREINER: I'd like to just comment so it's not misunderstood. It's so easy, I think, to keep kidney categorical, but the official position of the legislative committee in the National Kidney Foundation was against ear- marked funds. They simply were trying to point out that if you add a job to an already existing job, that you need to provide additional money, so on the one hand we are talking about additional appropriations for the added job. On the other hand, they were not in favor of putting bridles on “the money in terms of the way it should be spent administratively. So I think they are not thinking categorically in the implementation, but I think when you go and ask for a new task that there ought to be something to go with it and not | take away from the existing appropriations. | DR. MARGULIES : Perhaps I can clarify this first question by recounting to you the kind of logic which was generated for asking it. It went like this: The appropriations said that not more than $15 million should be spent on kidney disease. This meant $15 million. $15. miilion is such and such a percent of ‘the ‘total appropriation. Therefore, the percentage which should go int¢ kidney activities should be whatever percentage that presuned $15 million is of the total appropriation. eer Pho &, eral Reporters, Gre. 10 11 12 13 14 15 16 17 18 19 _ 20 21 ae 23 24 25 61 Now, unfortunately, there are a few flaws in that logic, one of which is no more than $15 million does not mean a minimum of $15 million, and it simply breaks down at that point; nor is in fact the budgetary process ever subject to that kind of percentage logic. DR. EVERIST: It seems to me we can give a mono- syllabic answer to the last two questions, and the first two are not appropriate to the Council. DR. MARGULIES: Would you care to do so? DR. EVERIST: DR. MARGULIES: What is the nonosyilable that you wish to use? | DR. MILLIKAN: No, yes, no, and so forth. “He's proposed we can answer the first two. I would suggest we say no, no, yes, and no, in the following sequence. MR. OGDEN: TI agree. DR. MARGULIES : You would have the renal programs funded by ‘the regions come out of their total budget? _That's a sort of meaningless question because it will have to be their total budget if you give them the money. DR, EVERIST: Right. DR. “MARGULIES : Rather than a separate budget. _So what you are proposing is that the answer be no no, yes, and no. DR. SCHREINER: The only provision I would like to Bac Federal Reporters Gre, 10 ll 12 13 14 15 16 17. 18 19 20 21 22 20. 24 25. 62 introduce on No. 4, it's conceivable that in the areas where there is little or no regional activity at the present time, that this could be the opening wedge. In that sense it could be outside of existing regional activities, because there even are regions that haven't formed yet in some of those areas and this may be a way of doing it. DR. MARGULIES: I wonder if we could have a second to this and then a discussion of it. The motion was that the answers in numerical order are no, no, yes, and no. | DR. ROTH: I'll second it. — imate, DR. MARGULIES: Okay, it has been moved and seconded. John, do you want to say anything? | DR. MERRILL: Well, only to comment again on ques- tion No. 4. Philosophically, at least, it might well be pos- sible that a renal program in and of itself might subgerve exactly the purposes for which RMP was created, and in so doing I should think we should fund it as any portion of RMP and not necessarily as a renal program in itself. Secondly, if we consider, as you have stated we will -- and I think it is probably true at least at present -~- that this is a technical activity related to dialysis trans- plantation, there are a limited number of people which can be served by this, and insofar as that is true, I would think that renal programs should not be a major drain on “he activity as a whole. But where they do serve the purposes, in Preo-Federal Reportors, ne. 10 11 12 13 44 15 16 17_ 18 19 20 21 22 23 24 25 63 many instances they have actually led the field in showing the way in serving these purposes, I would think that they should be considered on their own merits. | DR. McPHEDRAN: Dr. Margulies, do we really have to answer these questions? I mean if we really don't agéee with the premises from which the questions were derived in the first place, I mean that they are really significant ques- tions, which I think many people on the Council perhaps don't, since we don't have much regard for that percentage caloula- tion of the budget, and since that is the premise from which this is derived, maybe we don't have to answer the question. Maybe: Dr. Everist will correct me, but I think to some extent his answers are a little bit facetious because you can't just no, no, yes, and no these things. There are obvious qualifi- cations to each one. | | DR. MARGULIES : I welcome your thought, Alex, be- cause what is lying under this -- and it comes up regularly on the review committee -~ is a desire to move from review at their level and review and policy formation at your level, into administrative activities, which I can fully understand, but some members of the review committee would like to believe that there is a way in which the review process can actually determine budgetary allocations in a very specific sense and carry out the whole fiscal eanagement function, which in the days when Joe Murtog was on the review committee would usually Prce- grouped for your benefit -- regions were grouped in three groups with a range of ratings ingicated: I would note that in their first go- around, the average score given, to a region was 244. This was back in duly. We find ‘the second time around, I think not an un~ expected phenomena; that as they have greater familiarity with the system, and also. ‘as they look back and saw all kinds of scores, ‘and we disctissed this with them in much the same Poo Federal Reporters, Gre a 10 ll 12° 13 14 15. 16 17. 18 19° 99 "23 24 25 application of a weighted mean does not in any way alter that -initial series of groupings in terms of A, B, and C, upon | committee and anniversary panels particularly, but certainly 113 manner as we had with you last time, that there has been a significant increase in their average score, so that as a result of the October scores the average was 297, I might just add also, because Dr. Pahl has alluded to this, the staff anniversary panel is using the same criteria and doing the same kind of scoring. That panel came up with an average score of 306, which is fairly comparable, and 300 would sort of be the median conceptually. We have, and you will see this, because of the significant difference between the average score in July and the one in October, applied a weighted mean to in effect equalize the earlier scores with the subsequent round. This _ which certain selected funding decisions were made by Dr. Margulies subsequent to that. I think our own feeling as staff is now that we probably are in a position, with some possible slight modifi- cations still, to sort of freeze the system and let's see how it works for two or three more cycles before we do any more tinkering with it. I think quite apart from that, however, we do look forward-as staff to being more helpful to the review the Council also, in that to a far greater extent we would hope that we could be able to target and display information Pleo-Faderal Reporters, Gre. 10 11 12° 13. 14 15 16 17 18 19 20 a2 83 24 85 el jissue came up. more. wake reference to coordinators who appeared 114 that.is relevant to some of the criterion where that can be done in a fashion that will add to the judgmental as opposed to the intuitive process that is involved. The final thing I'd like to say, again -~ I think it can't be repeated too often -- is that the rating system, including the criteria and the scoring system, represents only a tool, and it's one device which the director and the Council needs to take into account in looking at regions, but it is not the answer, or the only answer, but it is an assist or a tool. DR. MILLIKEN : In our last review meeting several of the applications indicated that there was a great need for the coordinator to have a high level and very compe tent assis~ tant coordinator. to. be visible and to carry some of ‘the load, that some of the problem was a lack of such a person. | I have been thinking since that meeting that this if such a common thing, that it would not be well in the future to consider adding in the rating system some visibility for this. position sO that it does get attention. “DR. MARGULIES : I think that's a good point. . The to be getting along feebly and needed some propping up. The same thing is true, however, in regions in which there: is strong leadership ‘but in which there is obviously need. FOr | some back-up for that strong leadership, and I think it would Pea Fedoral Reporters, Gre. 10 11 12 13 14 15 16 17 18 19 20 21 22. 25 24 20 go over it, and unless we hear some evidence of a general 115 be a wise thing to identify, particularly ---well, this is true in nearly all circumstances. I have had some: of the better coordinators talk to me about this with great concern saying this is just fine, but I need to have someone who can take over at some point when I am not here and we need to be grooming him. I think it's a good idea. | DR. KOMAROFF: Have the coordinators or their staffs looked at this rating scheme and given their opinion to the steering committee or otherwise? DR. MARGULIES: They have had a full opportunity to dislike for it, which we have not up to the present time, we will consider this the process that we will continue to work with. We will not at any time reach the conclusion that it has to be just like this, but it has reached the point of a remarkable consensus as a working method, and unless we hear something which represents serious objection of a widespread kind, and unless you find that during the course of the de- liberations today and tomorrow in some way ineffective, we will use it as Pete ‘has indicated over a Long period of ‘time. MR. PETERSON: I failed to mention that, Tony. After we did discuss this matter with ' ‘the ‘council: dast: -time, we then nade a mailing to , the coordinators.‘oi the. review criteria with an explanation of how the syeten was being” Pree- : (Laughter .) DR. PAHL: No, sir; I was just asking. DR. CANNON: No icing on that cake. I think that Dr. Millikan was there, and I think Pree- Federal Reporters, Gro 10 11 12 13 14 15 16 17 18 19 20 au 23 “24 BB | 147 he has given you a pretty good rundown. I believe the review committee should hear his entire rebuttal. We've got it re- ‘corded. DR. MILLIKAN: It's really just a part of it. DR. PAHL: Dr. Schreiner. DR: SCHREINER: I don't know whether you want a completely total comment here or not. DR. PAHT:: On the kidney proposal aspect? ei ea, DR. SCHREINER: Yes. | DR. MERRILL: I have looked at that so I can com- ment'.on that, too. DR. PAHL: Fine, let's do the kidney one on this then. DR. SCHREINER: I was curious as to what Dr. Milli- kan's response was. I looked these over and I don't know all of the people who are on the Ad Hoc Panel on Renal Disease. Anse cence we pustines tea There is a lot of expertise on surgery and ‘organ ‘Srofusion, and I think their critique of the organ and tissue transfer program is generally correct, but I don't see anv sign of very much expertise in the realm of immunoflorescent and electronmicroscopy, because there are some statements made in the criticism here that are just plain not true, such as ten percent of kidney patient cases require EM or FM biopsy analysis. There is no such data in existence. It depends on whether you do prospective or retrospective analysis, and it A Alo-Federal Reporters, Gre. 10 ll 12 13 14 15 16 7 18 | 19 20 21° 22 25 24° 25 ‘and you can't get third-party payment because they don't con- _ other words, that group of people can then be phased out but 148 depends on what kind of patient material you are dealing with, if you are dealing with a loaded pediatric census with lympho-~ nephrosis, then maybe you don't need it in a large percentage of cases. But if you are dealing with adult hypersensitivity diseases which, for example, we encounter in a general hos- pital, you may need it in as much as a half or two-thirds. And I've seen some other comments by the panel to suggest there are some deep prejudices in this area, and I have looked over this scheme and it's an excellent one. This is one of the problems that falls through the cracks, and it's like any other technical achievement. You can't get research support for utilizing these new techniques on larger groups of people because it's not considered a pure research project sider it absolutely proven practice, and it's precisely the kind of thing that RMP ought to be addressing itself to, how you move it from the bench to the bedside. And to do this in any significant ature of people, to find its place, you are going to find three. kinds of. groups of people, one, in which you do it to discover that it's not going to be useful ~~ in we really don' t have that information now. you are going to find that there are a group of people in which it does add something, and you are going to find a group of people in which it is absolutely. necessary for proper treatment. Pleo Federal Reporters, Gre. 10 ll 12 13 14 15 16 17 18 19 20 22. 24 R5 149 And if it's not available and a medical school simply can't do this because of the expense involved, then there are some people that are going to he misdiagnosed and -there are going to be some people that are going to be mis- treated. It's like a lot of other technical things. You don't need it very often, but when you do you need it a. hun- dred percent. I think it's a very well-thought-out program. It has the strengths Dr. Millikan mentioned in that the material can actually get around from the various community hospitals to a center where it's going to be read because of the inter- change of personnel that they have, and I would Sasagres Ss nent ~ the Ad Hoc Re al Panel on that diagnostic one, and I would aie Elst params VUE SAE EEN AR ERS ini agree with them on the criticism of ‘the organ ‘and wee 05 SPREE yer et riba ee KIS bats transfer program. DR. PAHL: Dr. Merrill, do you have a comment? DR. MERRILL: Well, Ir cortesmly agree the organ and Theta l tissue transfer program has very Little merit, TL “aon' t ‘think / we ought to get into any technological discussion here, but my own opinion is that the renal regional diagnostic program ae nheantaah ee at a exsteaaguesgeet? Rast rons coca IRSA ISS N M RE n a ese " hag oan haan : Terenas Saar ett is a very valuable. one, but zt ust confess that. if rt were | wnt seseont ROPES LEE NARS PE ELIE OTP cp cepa segpincis running such a program myself - -~ and this | is | essentially what we do on almost all the patients we have; the yield in, terms of. making a difference between curing such a. patient. and not curing such a patient is almost minuscule, which is very | Paco Federal Reporters, Gre. 10 ll 12. 13 14 15 16. 17 ‘18 19 20 21 22 | 83 ea | 25 this can be interpreted as a function of RMP, then I would 150 disappointing, I think, to most of us. Perhaps Dr. Schreiner is an exception. So, for different reasons I would agree that the application be deferred. 1 don't think the yield in terms of number of people who might be helped, applying this gen- erally, at the present time: is going to be worthwhile. How- ever, eventually, in a prospective study over a period of five or ten years, we are going to learn something from this. If agree with Dr. Schreiner, but it's my impression that this is probably not the function of RMP. DR. PAHL: Is there further discussion before we phrase a motion? DR. OGDEN: I'd like to ask a question for purposes of information. If the site visitors had recommended $2 million, I assume that that includes $34,640 for the organ. and tissue transfer program, which you have now said you “don! t approve of. I. also assume that it includes the $133,533 for the kinetic kidney disease program, which you now tell us you do approve of. | If we look at the recommendation of our own review committee of ‘$i. 7 million, and’ add to it the $133,533 for the kinetic kidney disease program, we are up to $1,833,000. So I would like to know what figures are we dealing with, if we are déaling with the $2 million from the site visitors committee, $1. 7 million that has been recommended, Pee Federal Reporters, Gre. 10 11 12 13. 14 15 16 17 18 19 20 21 22. 23 24 | 25. 151 and then these other two kidney programs. I assume the kidney programs are not in the $1.7 million. DR. PAHL:. They are not in the $1.7 million. MR. COLBURN : The strategy for the $1.7 million was to not allow for additional funding for the new requested activity and to keep the funding level of the regional faculty at the present level and not at the requested increase. That came to $1.7 million. That was the strategy of the committee. MR, COLBURN: — What you are really talking about. here is $1.7 million, plus $133,533, if this regional kidney disease proposal is approved. MR. COLBURN: No. DR. EVERIST: No. DR. MARGULIES: The thing is there is .a difference, which isthe issue that Clark is getting at, between what the site visitors recommended and what the review committee recom— mended, and he is preferring the figure of the site. visitors which would come to what figure? DR. CANNON ¢ $2. 25 million on the second year § and cit ERC Shige $2. 50 on the third year. i EOE gre aspires spit MR ‘OGDEN: ‘He's talking about the $2 million. setae nga What I'm talking about ‘is the $1.7 million that our committee proposes, plus the: $133, 533 for this kinetic kidney disease program, which would come to $1,833,533. UURS . RYPPLE: Connecticut has an approved but | PAroo Federal Reporters, ro. 10 11 12 13 14 15 16 17. 18 19. 20 ; 21 23 . Ra ss, 25 152 unfunded Kidney activity | which is the aed 000 that you see on SNe sty {oe nr NT EE this chart. “It! s $97, 000 that | is the’ ‘proposed plan ‘that Dr. aaa REN hd HE gt 0 Ye meet “st SSRN Set REARS SPR gaan, reget EMT a Shc e Schreiner mentioned. MR, OGDEN: I stand corrected. Then what we are alee cree AL HEI oo “AN Pe iOS dea uate talking about here is Si. 7 histone plus SOT, 000. aoe snesoasie : self hag Rictieiteiy er MRS. KYTTLE: Right. DR. MILLIKAN: What I was really discussing was "wetiggar aa sas without ‘the inclusion of the kidney proposal , since those csr ORES there would be -- AER maging ent were not really gone into by this site visit team. Since we do have expert opinion about them here, I simply did not in- . paces Sieg Tense metre clude them in my discussion»... eminent SE Ea nailed IANS on acest MR; OGDEN: Dr. Millikan suggested $2 million plus $97,000. DR. MILLIKAN: I am not making any suggestions about: the kidney proposals at. all. dé think we should listen ont Le “to our experts on the subject. DR. PAHL: May the chair hear a motion, please. DR. MILLIKAN: I. move that we gO | on | record as Prensereng ea se ln ang be HE AMBRE tt insane RAE bie se approving their application, the feret year 32 ma1i+en —— this eg ed AA ail & maa oa al apenas th is not including funding of ‘the kidney activity —— second ee sine se pre deaOH ee eee year, $2, 250, 000, the third year 82, 500, 000. Cl eae spesemiissioeee OP IEP ett OE MR. OGDEN : Do you then recommend on top of that “DR. MILLIKAN: The way I'm phrasing my motion, that would be a separate motion. pomeaanegtin ft IREOTER ENT Hy mang 0 MO - rc trace ip seit E I PreoFaderal Reporters, Gra 10 el 12 13, 14, 15: 16 18° 19 20 21 22. 25 24 | 25 153 DR. PAHL: Is there a second to the motion? DR. CANNON : Second. ‘a: DR. PAHL: The motion has~ been ‘made and . seconded agus ' Pa tee, to accept the site visitors' recommended ‘levels of “support, Terese NER I a iiabas, LEAD re ge with the kidney consideration to be the subject of a second 17 I it Cees NE Bare motion. erernrsencgne SESE EDS ano Is there further discussion on this motion? If not, all in favor please say aye. (Chorus of ayes.) Opposed? MR. OGDEN: No. a DR. PAHL: The motion is carried. ri RRNA EIA MRS. KYTTLE: Dr. Millikan, can I ask a staff question right in front of you? DR. MILLIKAN: Sure. MRS. KYTTLE: Spence, do you feel that you have some material here that you could give committee feedback on the specifics for the reasons that Council overturned their recommendation? I don’ +t feel I do, but if you ae you do, then I will be comfortable with that, DR. MILLIKAN: I can draft them. It may bea ten- page document. | we : DR. MARGULIES: I think that would help. DR, PAHL: The concern here is’ that review com- mittee has expressed an interest at.its last meeting in all Pou Federal Reperton Sra. 10 au 12 13 14 15 16 17 - 18 i9 20 22 23 24 25 ‘be happy to draft it. | astic. 154 those instances where their recommendations are not accepted, to have as clear as possible an understanding of the basis on which the recommendations have been modified, and this is the basis for. this request that we as staff can convey the infor- mation back to them. DR. MILLIKAN: I think that's entirely fair. I'll DR. MARGULIES: I wonder if I could just shed a little light on this peculiar chain of events, because obvious something did alter the view of this program, Clark, as you saw. It was a most peculiar discussion by the review com- mittee. Those who presented it, who had been onthe site visit, did it extremely well and with considerable enthusiasm, and in this particular case there was the additicnal support of one of the site visitors, Dr. Hirschboeck, who is the co- ordinator of the Wisconsin program and was equally enthusi- Then the whole discussion sort of wound up in a lot of other issues, some of which were related and some of which were not. related, and there were some strong positions of advocacy and. antagonism, ‘and I" m | not sure that by the time we got through with it the Connecticut Regional Medical Pro- gram was what we were talking about. | DR. MILLTKAN:' I think that came through. “DR. _MARGULIES ¢ There was even a very strong motion PAce-Federal Reporters, Gre. . 10 11 12 13 14 15 16 17 18 19 20 21 | 22 235 24 25 155 at one point, in a manner which surprised me, which would suggest that what this program should do is conduct a plebi- scite of all the doctors in this State to find out if they liked what they were doing. Now, since this has hardly been a custom in the Regional Medical Program to have inhouse plebiscites on how well they like what's happening, it gave you some sense of the fact that the general review was not as objective at all times as it needed to be. And 1 would add to the reasons for that excepting that I don't understand » them. But there was something more afoot in that whole review process in looking at the Connecticut RMP, at least in my judgment. MISS SILSBEE: Dr. Margulies, nevertheless, the review committee 's expression reflected the con nuing, concernt that have been fee about a Connecticut program | since ‘its inception, and they ‘felt like the site team did not ‘come back | with an adequate appreciation of those continuing: concerns. The amount of money that they were requesting for the univer- sity. faculty which was rising over the three-year period with no notion of how the universities were going to take over some of this, if indeed they were -~ these were questions that have been inherent in the Connecticut program since its beginning, and I think that also was reflected in the committee discus— sion. DR. MARGULIES: Yes. isan SOIR ca Sig caseeeeat Pex Federal Reporter, Ine. 10 11. 12 13. — 14, 15. 16 17. 18 19. z0 21 eRe | ek 25° : concept that “they are willing to fund it themselves. 156 MRS. WYCKOFF: What do we do about the principle of phasing out programs after three years? We are supposed to recycle them. How do you get to that? DR. MARGULIES: As I understand it, the basic plan, so far as this additional staffing is concerned, is to have ‘this become the responsibility of the hospitals in which the additional personnel are located, and they seem to have moved in that direction. There was some question about the validity ; a of that, but. that appeared to be their purpose. And there was confusion, although there was a dis- cussion, about the status of the faculty at the universities, and I think valid discussion. There was also considerable TE confusion about what figures ye-wene..talking about, and the Hare MRR nc SCTE ee taiee review committee kept bouncing back and forth | between two eco ent ae levels of analysis, and it finally came down to a lower ‘figured than they had anticipated. tr think the questions they raised were valid, but the environment of the discussion became a little distorted. -pR. MILLIKAN: If you look.at the issue, for instance, of the full-tine chief, there is one hospital that has now opened. up positions of surgery and psyehiatry and 1 pediatrics requesting zero funds from RMP for those three new full-time chiefs. Why? They are so convinced via their ex- perience from the RMP sequenting of the validity of the I ‘think - Pleo Federal Petite Se 10 “a 12 13 14 15. 16 17 18 19 20 21 22 25 Ba 25 157 this is a fundamental idea of the whole RMP phenomenon. . Now, if one were to ask the question: Is the ynor- tion of this core staff, using the phrase in the large sense, at the University of Connecticut and at Yale, is it ever going to be completely self-supporting, I would venture a ‘guess on that that the answer is no. Now, where the support will come from remains for time to determine, but I think that's the problem of any core staff. MR. OGDEN: TI would like to ask some queatscne and also to make. a comment. “and I will preface this by saying I Wrest: ST ttt car ts an not a- great peliever in _this body or any Regional navisory Group abdicating its responsibilities to its staff, but at the sraengapisitB HOF) essasiicstiahanest mac iis AER CES oegy gene gaan eR fo same time 1 think we owe it to the staff to answer the ques~ tions that they present to us. ‘Now, . we have adopted a budget here a moment ago without actually addressing ourselves to some associated ques- tions which the staff has asked the Advisory Council. to anewex, and I think this. is the first of the triennial applications, looking back through them quickly that we have gone through today, on which specific questions have been asked by. the staff, and I really feel we should ancneee ourselves to those. We also have left unanswered an adopting this budget the question of whether this $2, 250, 000 and $2. 5, mill- Nec, ion also includes this kidney disease proposal, or whether peters TETAMNAN MN RR cn FT ido tee ‘ sen that will now be voted on as a ‘separate amount, “to be added to sys “remreenstennnyrese mee TE 4 Pree-Fadrral Reporters Bro. 10 11 12 | . 14, 15. 16 17 18 19 21. 22 20 24 25 158 those which have already been authorized. I should like to ash Dr. Pahl to lead a discussion about the three questions that appear on the blue sheet which the staff has ‘asked, the first of these being that CRMP at the end of its fourth year provide a statement on how vale and the University of Connecticut intend to eventually absorb the cost of the university-based faculty; the second that CRMP at the end of its fourth year provide a precise statement of the relationship to organized medicine in the State and what has been accomplished toward their improvement; and third, that the NAC render a policy guideline depending on the matter of support. of faculty physicians. | this is the reason I voted no a moment ago because noe I don't think these things have. ‘been. digcussed, rand I ‘don' t feel that adopting the budget is appropriate until they ‘have been. | | - DR: PAHL: Thank you, Mr. Ogden. Let me epen these questions for discussion. Perhaps we might turn to Dr. “Millikan for initial response beyond his previous comments. DR. MILLIKAN : I think it's entirely appropriate to ask any funding: gxoup to: tell us at a given point in time a what their intent. is as far as the future. That! s pAUBeE one, whet about Yale and Connecticut in the 04 year, what are 98 PRR tee . 1 their plans for absorbing these costs. I “think it! s “Shtirely legitimate to, ‘ask. ‘them that. | Proe- guidelines . groieate ERE DIS eae ec LPR ea Rg AR I Li cect to eg Therefore, L should like to move bail the cRMP be gE EE DE SECRETE ee uy ee ee AEN notified that. it is the desire of ‘the council that ways of nA ses 2 see SR RRO SY ea ne eet, vigaeenie all reducing the RMP share of these expenditures, these projected expenditures, be found. . I am not calling for the university to pay these expenditures. It's all right with me if they get it from the Hartford Trust, or something like that, but simply that they explore ways in conjunction with the hospitals and other funding sources, for seeing to it that this exemplary program is continued without quite so large a rate of growth as is projected at the bottom of this page. | “DR. EVERIST: Do you want to give that same admoni- tion for the community base? vo ; | DR. ‘BRENNAN: “No, because Tr understand the ‘communi based program is one which Ios all right, I will give - it for the community-based program, the whole works as a matter of fact. The only problem is it! sa little more difficult to Ly BPaee-Fadpral Reporters, Gre. 10 11 12 13 14 15 16 17 18 19 20 21 22. 24 B5 “IK 23... 181 handle this one. DR. PAHL: Is there a second? DR: SCHREINER: Second. DR. PAHL: ‘The motion has been mage and seconded, aga tT SMR RT At seamen ie Re NERS ees Is there further discussion by the council? seine TAPERS LONGER tir, Colburn. MR. COLBURN: ‘This could be confusing about the community based, because the community-based physicians do have a built-in phase-out mechanism, and it provides for only three years to a maact mum of $15, 000 per year. peisendemae Sa nae Kinng Aa ren are on DR. SCHREINER: The numbers still keep going up. MR. COLBURN: If you want to make some type of ‘judgment of what the saturation point is on the number .of. full-time chiefs in the State of Connecticut. DR. BRENNAN: All I want to do is put a shot across their bow, that's all. I don't intend to knock them down. DR, PAHL: The motion, however , includes Seite abaya PO isi eathaas a state- ape a Rta 1 aR ment as to the expectations. of the..totaL.growt h of the prograyt, fF aie — ones saad Base ES which would relate ‘therefore to the community-based activity, I would assume. _Is there further discussion? . —e ALL in favor of the motion please say aye. ‘(chorus of ayes.) Opposed? tio response. ) “Motion is carried. A Federal Reporters, Gre. 10 11 12 13 14 15 16 17. 18 19° 20 21 22 25 BA 25 ea OS | think we are in total agreement that this is a good procedure. 182 DR. PAHL: Now, if we may turn to Dr. Schreiner or watts a anole’: sais oa Sy aaa Dr. Merrill EOz a motion 3 relat pe kidney aspects of the Connecticut triennial application. erin oe ee ee a DR. MERRILL: Dr. Schreiner and I have had a little discussion during the coffee break, and I think we are essen- tially of me same opinion, although I think the implementation of that opinion is probably a matter for the board to decide. First of all, we both agree that the organ and tissue transfer program is probably, not worth funding. ‘We RAPER AIRE aaa agree also that one should do renal biopsies, and that cer- hie ina ROGET ERE NRE INS PSOE sii siebieNiOe ROTTS Fite, snot testy de om ea NOT Rati oa NS EOE a RIE tainly more than 10 percent of these do require EM or FM biopsies. Where. we perhaps disagree slightly is in whether or not this is critically important to the medical treatment of a Large number of patients. I do not feel so from our own experience. If, however, diagnosis as an end to itself is something the Regional Medical Program should fund, then I Is: that a fair statement, George? [orem nementiin TES St SINR, DR. “SCHREINER: Yes. qT ae part of our cheeee > SRS memes Prete agent ene encesof opinion. as we chatted were that we see a ‘little aif- ferent kind of material. John! s conclusions on glomerulo- nephritis, for example, are completely valid as far as our experience goes, but our material apparently is a little bit different. I think it has a little more utility than he does, 7 Peo Fadoral Reporters, Gre. 10 11 12 13 14- 15 : 16 17 18. “1g 20 | 21 22 23 24 £5 doesn't exist, and I think this is a valid thing. After all, | what' s the successful treatment for cancer if. you want to “183 but I also think that we did cardiac catheterizations long before there was cardiac surgery, and I think about three- quarters of what we do in medicine to establish diagnoses is” done without necessarily assuming that we are going to. follow immediately with successful treatment. There is always a point in making an accurate diagnosis even if successful treatment get down to it. We can do all kinds of diagnostic procedures, and rightly so, in order to characterize so that when the de- | velopments come along we will be able to put them in the right slots at the right time. DR. MARGULIES: Really, the issue is not so much a technical one-at this point as whether this represents the kind of an activity which RMP should reasonably support and which it is a segment of a health delivery system which at the present time ends at the point of diagnosis with no definitive treatment following, and I think we probably had enough experience that we could probably get a motion one way or another on whether this is worth supporting with RMP funds. | | | : DR. SCHREINER: Well, I would move that it be mevet e sei sc agit supported sor a. . three-year period, and I think it has ‘some teins SECON I cat eer eae SiR AS seas, interesting lessons to be learned from applying this. “There: aren't very many communities in which you can actually get op Pres-Fedoral Reporters Ge. 10 11. 12 13 14 15 16 1? 18 419. 20 21 23 24 BS 184 this material moved from the places where the tissue is being taken to the place where it can be adequately studied, and I think a small State with a big community hospital is a unique kind of situation. | e, DR. PAHL: Mrs. Kyttle reminds 1 me that this is a ect ORI acs REIT. spueeuneiiietinany See ARE oe 37 is required for the first spe sen EA AARNE ef two-year proposal in which $975 0 gongs TES SPN VEEN NESTE SITES ES A cae year, and $82,820 for the second year. DR. SCHREINER: I haven't critically gone over all aspects of the budget. If the staff feels that. this project can be done with a little bit less, I think that would be satisfactory as far as I am concerned, but I would like to move that the two-year project be approved. DR. PAHL: The motion has been made. Is there a second? DR. BRENNAN : Second. iigeigiocrmnmemnea taareae: St hasten ss DR. PAHL: The motion has been made and seconded «go rePneanicneemaanysr pe: Se jd EE NS ENE Se HER aetyaasgobsess ReREeS for. approval of the two-year period of project. 39. Is there SOREN... TES Hee NIT further discussion? DR. MERRILL: Could we have just a comment, per- nape” from staff, those two gentlemen at ‘the head table, as to whether there is any policy with regard to. funding this kind of approach? DR. MARGULIES : Well, so far as kidney activities are concerned -- and we are: now talking in categorical terms as you know, the previous policy of this. Council has been to eI PreoFederal Reporters, Gre. 10 ll 12 13 14 15 16 17 18 19 — BO 21 22 25 - 24 25 -eracks, and this is the problem; at least in most areas you ~ 185 concentrate the expenditure of funds in the development of complete centers for the management of patients with terminal kidney disease, and since ‘this is a separate kind of activity, my interpretation would be that it falls outside of that pre- viously established policy, and it will, of course, if passed, be in competition for other funds which we would elect to grant as a part of our general kidney effort. So one of the issues is: What else might be done with the same funds as a part of the total dialysis transplant facility? Now, I don't think we have any previous policy re- \ot a a garding this kind of expiration of diagnostic skills, but I do not believe that it has been a regular part of RMS, or fox the most part we have tried to concentrate on practice ready activities which are part of a continuum of diagnosis and treatment. DR. BRENNAN: Is this practice ready from that standpoint? DR. SCHREINER: Yes, but it falls between the. can't fund it with NIH funds and you can't fund it with Blue Cross or Blue Shield. One of them says it's research and the other one says it's care. DR. BRENNAN: So this.is developmental rather than research. There's a nice distinction but I think it's real. DR. PAHL: Is there further discussion by the PArco-