1'4 H @E I A:R HEALTII@ SERV @c ALTI-I SERVICES. IIEALTH@@ADMIIQISTRAT REG: MEDICAL@PROGRAf4 COMMITIREE:@ Rockville. Mlirylan :Thuksday 4 May 1972 ACE - FEDERAL REPORTERS, INC.,@ Official RepQrters, 415 Second Street, N.E. Telephone: as W hingt6n, D. C. 20002. (Code 202) 547-6222 NATION-WIDE COVERAGE @ra-@t/Renzi I DEPA.RTI,'X-,NT OF HEALTH,, EDY,@CAI-rION PND T,@TELFAPE CR "D876 2 PUBLIC HEALTli 'O'ElIN7ICE 0 3 HEALTH SERVICES AND MENTAL HEALTH ADM@T-NISTRTTION 4 REGIONAL MEDICAli PROGRAMS 5 6 Review Committee 7 8 9 Conference Room GH 10@ Parklawn Building 11 Rockville, Maryland Thursday, May 4, 1972 12 The meeting convened at 8:45 o'clock a.m., Dr. 13 William Mayer presiding. 14 Council Members Present: 15 Dr. Gladys Ancrum 16 Miss Dorothy Anderson Sister Ann Josephine 17 Dr. Gerald Besson Dr. G@ V. Brindl.ey 181 Dr. Effie 0. Ellis Dr. Joseph Hess 19 Mr. William Hilton Dr. John Kralewski 20 Dr. William Mayer Mr. Jeanus Parks 21 Dr. Leonard Scherlis Dr. Alexander M. Schmidt 22 Dr. Mitchell Spellman Dr. William Thurman 23 Dr. Philip White 24 -e-Federal Reporters, Inc. 25 2 C 0 N T E N T S 2 nda I a@e 3 Coriments by Harold May,,.-yi:i -"Les . . . . . . .0 . . 0 0 * . .3 4 Future Meeting Da tes . . . . . . . . . . . . . . . . * 0 37 5 Comments by Dr. Herb Pahl . . . . . . . . . . . . . . . 39 6Peral Program - Dr. ilinman . . . . . . . . 4 . . 0 0 . 69 7Consideration of'Appli--ations: 8 Oregon . . 94 9 Ohio . . . . . . . . . . . . . . . . . . . . . . . 137 10 Northeast Ohio . . . . . . . . . . . . . . . . . . 167 11 Nassau-Suffolk . . . . . . 0 * . . 0 *I . a * * 209 12 14ebraska . . . . . . . . . . 242 13 14 15 16 17 18 19 20 21 22 23 24 A,ce- Federal Repoiters, Inc. 25 3 P R 0 C E E D I N G S 2 DR. MAYER: I think we might begin. As some of you 3 are aware, there are four of us who will not be with you at 4 the next meeting. And I note that all four of us are rigorously 5 in attendance and on time. And as a consequence of that, I 6 thought we might commence and pick up the others as we go 7 along. 8 Hopefully, because of the changes that are here and 9 that we have laboriously worked at and staff has laboriously 10 worked at, maybe we might be able to get through without workinc 11 all night tonight and without starting at 7 or so in the 12 morning but at a reasonable time. ' 13 A great deal has happened since the last meeting of 14 this committee. Harold kindly did send us an interim report and 15 try to keep us up to date on it. I would have to say that MY 16 grapevine suggests that even since that interim report, a 17 heck of a lot has happened. And I thought I understood what 18 a rapid rate of change was. Harold, but I must admit that I 19 am developing a now perspective on how rapid that change is 20 and the degree of that slope. 21 With that, let me turn it over to Harold.Margulies 22 for comments. 23 Harold. 24 DR. 14ARGULI"@S: Thank you very much. Ace --Federal Reporters, Inc. 25 The title of this presentation is "Present Shock.' 4 I There are a number of things I would like to go over with you, 2 but before I do and at the risk of saying the obvious, I would 3 like to comment on the fact that the end of the period of 4 activity of the 'Lour,people who have been serving on the 5 review committee is a point of real concern for all of us. 6 I was just talking to Bill who confessed to something like, 7 six years and six months with the Regional Medical Program 8 which should represent some kind of a badge of honor, purple 9 heart, or something of that kind or purple heart for each 10 year, but it is going to make a big change. And it is going 11 to be a notable loss when we see these very,, very effective 12 people leave the coiami-Ltee. 13 And it does not-.xnean,of course, that we won't 14 anticipate being able to call on them regularly as we have 15 with others who have served on both committee and Council. 16 And we don't expect to let them leave the program that 17 effectively. 18 I would like to bring you up to date on a series of 19 events which are not necessarily related, but all of which 201 have a heavy impact on our activities and on the Regional 21 Medical Programs. 22 First, let's start with the current legislative 23 interest which suddenly built into a point of great concern 24 and people realized that the Regional Medical Program Ace-Federal Reporters, Inc. 25 legislation along with just abotit every major legislative 5 I program, legislative act, which siippor4,--s progr@-us in Health 2 Services;and Mental. Health Aclrainistra-tioii was up for extension is 3 during the coming fiscal year. I think there are at least 4 14 major health legislative acts which have to be renewed by 5 June 30 of 1973. Pj4P is one of them. 6 1 don't believe that the Administration has estab- 7 lished a clear position on the wl-iole range of them, but it has 8 made it clear in the first response to Senator Kennedy's 9 bill that it hoped to address the legislation this time in a 10 much more inter-related fashion rather than having a separate 11 extension of Acts which have come to have a relationship with 12 one another, but were created at a different point in tiiii-3 13 without that relationship clearly spelled out. 14 What did happen is that when Senator Kennedy intro- 15 duced his bill on Health Maintenance Organizations, he added 16 to it for purposes of opening the discussion the extension of 17 several of the legislative Acts. And Title IX for Regional 18 Medical Programs was one of them. 19 I believe that hearings are already underway and 20 will continue. I don't know the format in which they will be 21 carried out. There have been discussions inside HEW simply 22 leading up to what the legislative form of the RMP should be. 23 The coordinators independently have suggested certain legislative 24 bases for Regional Medical Programs so that this will have a Ace -Federal Reporters, Inc. 25 very clear-cut influence on wha..@ we do in the future. 6 The issues are all those which you have discussed 2 here in the review co,-mtittee. They raise the questions of 3 how RMP relateds to comprehensive health planning. They 4 raise the question of the relationship of the National Medical 5 Programs to educational activities, to the implementation of 6 planning, to the categorical devices which have been a part 7 of P14P since its-beginning, and to a number of other organiza- 8 tional issues which will probably carry-the debate until well 9 after the election. I would be surprised if there is any 10 final action on our legislation until sometime after the next 11 Congress meets. But, of course, it is conceivable it could 12 be done in the present Congress. It is conceivable, but very 13 doubtful. 14 I also don't know how much the House and Senate 15 committees are going to call on other people to provide 16 testimony. And it is perfectly possible that if they have 17 not already, they may ask menibers,of this committee to testify 181 regarding their recommendation on Regional Medical Programs. 19 While all that is going on, of course, there are 20 appropriation acts. Ile have had hearings before both the 21 House and the Senate Appropriations Subcommittees. They have 22 made every effort this year to complete the appropriations 23 actions prior to June. I don't know where the Senate stands 24 at this point, but the House has completed its actions. Ace-Federal Reporters, Inc. 251 What now is necessary is for the two chambers separately to I 7 It I reach an agreement on what they believ,-- the appropriations 2 shouldhe to get those through the Fiouse and the Senate,, then 3 to reconcile any differences'. 4 The request on the part of the Administration for 5 PIIP was, as I think we have already indicated at the last 6 meeting, one which would allow the Regional Medical Programs 7 to maintain their present level of grant support which is 8 in the general range of about $98 million. They indicated 9 during the testimony before both chambers that there would be 10 no special funds set aside in the coming fiscal year for 11 health maintenance-organizations out of the RMP budget and 12 made it quite plain that the funds used this year for HMOs 13 were all that they had expected to use out of the RMP 14 appropriations. 15 They also indicated that the construction funds which- 16 we will talk about in a moment for a cancer facility were one- 17 time funds in the Regional Medical Programs. And there would 18 be no further request for construction funds. They prefer to 19 keep those under other kinds of administrative authorities, 20 especially Hill-Burton. And I would assume some under the new 21 cancer authority and possibly some under the educational 22 institution support programs in the NIH. 23 There was an indication also by the Administration 24 that they wanted to raise the level of support for emergency 4ce- Federal Reporters, Inc. 25 medical services from the current $8 million to $15 million in 8 I the next fiscal year and that this would be all that would 2 be requested for special demonstration purposes which I will 3 refer to again in a moment. 4 There was no real discussion of the Area Health 5 Education Center concept during the appropriations deliberation!, 6 but we will talk about that in a moment also. So that I would 7 anticipate some'final action on our appropriation level in 8 the relatively near future which means one would guess by 9 midsummer which is far better than we had been doing during 10 the past several years. 11 Now, there is a word of warning on that. Although 12 the appropriations action was completed last year by August#, 13 there was no final disbursement of funds until well into the 14 well, it wash't-until after the beginning of the next fiscal 15 year. So completing appropriations action in Congress is not 16 enough to assure us that we will ]-,now our actual level of 17 funding. And as you will be hearing, this has produced some 18, specific problems for us during the present fiscal year, 19 Now, I have got several other items, but if there 20 are some questions about that, perhaps I should stop. That is 21 really fairly mechanical up to this point. 22 DR. MYER: Harold, would you translate the appropria- 23 tions into dollars for RMP grants? 24 DR. 14ARGUL). S: What has happened this year is that ,ce- Federal Repoftefs, Inc. 25 with the final resolved ion of caryyover and so forth, we ended 9 up at about $98.3 million for PAP grant support. And that is what we anticipate for the next fiscal year. 3 DR. I&YER: other questions? 4 DR. SPELLMAN: You said the emergency medical 5 services grant funds are being increased to $10 million? 6 DR. MARGULIES: The emergency medical funds are going 7 to be increased -from the $8 million of this year to $15 million 8 next year, but that gets a little bit more uncertain because 9 during the discussions of budgetary process, since that money is 10 being utilized not as an RMP activity but rather as a 11 HSMHA-wide activity in the current fiscal year and probably will 12 be next fiscal year, it will very likely drop (3ut of our 13 budget and become a separate item. So it will not be carried 14 as a part of the RMP budgett but this will not affect the 15 basic level of grant support for RMPs which will remain at least 16 constant. This is on the assumption that the Administration 17 recommendations are the same as Congress'. In the past, they 18 have not been. Congress has regularly increased the level. 19 DR. BESSON: To what extent does that apply to the 20 current $8 million, that same suggestion that you just 21 raised about the $15 million being HSMHA funds for emergency 22 medical services. 23 DR. @IARGULIES: I will get to that in a moment. 24 But the question that is raised is how the current $8 million %ce- Federal Reporters, Inc. 25 for emergency medical services is being handled. And that is 10 I being managed as a HSMIiA-wide emergency medical service 2 activity with contracts out of the office of the Administrator. 3 It is not being managed by the Regional Medical Program.. 4 DR. BESSON: Is PLAPS then not allocating money 5 separately for EMS activity? 6 DR. MARGULIES: I have that on my agenda to discuss. 7 This is as good a time as any if there are no otlier questions 8 about that. 9 All rightt let's talk about the emergency medical 10 systems activities. 11 When the President indicated in the state of the 12 Union message and subsequently that he wanted to raise the' 13 level of investment in emergency medical systems, there was 14 at the same time a decision made to do this in basically two 15 ways in HS1411A. 16 one of them was to develop some major emergency 17 medical systems demonstration activities with the emphasis 1 8on it being a total system and to do this in such a manner 19 that the various emergency activities which are fairly 20 widespread in IISMIIA could be well coordinated at one point. 21 There is, for example, in NIMli suicide prevention and 22 crises intervention emergency activities, maternal and child 23 health services, general pediatric and poison control centers. iThere is a Division of Emergency Medical Services in HSMHA, 24 Ace-Fedetal Reportets, Inc. etc., a whole range of emergency activities. In order to bring 25 I the full effectiveness of these together and to produce some 2@ major demonstrations, what was established was a central 3 coordinating group which includes Regional Medical Programs. 4 And I sit on the general group and on the small executive 5 body which decides the basic management and contract processes 6 for these activities. 7 The determination, thent was that there should be 8 in this fiscal year five major demonstration activities which 9 would be funded by contract. And these contracts were invited 10 in a request for a proposal which went out sometime ago which 11 had an initial deadline of April 15, then extended to April 21. 12 So that all of the proposals arc@, now in and are Linder review. 13 That is a discrete separate a,ctivitv. 14 I would assume that next fiscal year, if there is 15 another $15 million added to the funds available that it would 16 be carried out in essentially this fashion, but would allow 17 us to also at the same time establish a centralized data 18 gathering and evaluation activity which the initial investment 19 is probably only going to gtt started rather than fully go develop, At the same time,, it was felt that all of the existinc 21 22 emergency activities in RMP and in the other proSrams should 23 be continued, but in such a way that they were consistent with 24 and whenever convenient supplementary to the major contract Ace-Federal Reporters, Inc. demonstration programs so that we did in RMP, to make sure 25 12 It 1 that these demonstrations did not simply be demonstrations 2 with no effect, which is too often the case, initiate and 3 encourage the development of emergency medical activities 4 to the RMPs as a ser-.@arate grant activity eligible for 5 supplementary grant award. And we have done that. And so the Regional 14edical Programs have received and are responding 7 to a description of a well-coordinated total emergency medical 8 service to be supported by grants vihich,is complementary to 9 the contract activity. And in fact, we exchange day to day,, 10 data between what we are doing in grants and what we are doing 11 in contracts with the hope that when the whole thing has been 12 completed, we will have a total body of knowledge and of 13 action which is effective in order to carry out that emergency 14 medical activity. As I think-you know, we have set up a 15 separate special review body which is going to look at the 6 responses to our invitation to submit supplementary grant 7 requests. 18 DR. MAYER: This is within RMP? 19 DR. MARGULIES-. This is within RMP. 20 DR. MAYER: And separate from the contract? 21 DR. MARGULIES: Quite distinct and separate from the 22 contract. The contract activity is another issue entirely. 23 In order to give enough time to the RMPs to 241 respond and to develop something %,Yhich is meaningful, we have 4ce-Federat Reporters, Inc. 25 given them a fairly tight, but reasonably broad period of time 13 I in which to work. The grant requests, applications, are 2 at the present time all in. They reach a fairly formidable 3 level, and they will have to be reviewed on may 15. 4 hhat we have done, in order to set up an effective 5 review mechanism for a kind of special action, was to ask 6 Dr. Besson, Dr. Toomey, Dr. Scherlis, who will act as 7 chairman from the review committee, Dr. MdPhedran and Dr.'Roth 8 from the Council to act together for these two bodies and 'for 9 the RMPS in making a review of the E,,nergency Medical 10 Systems grants requests. When that occurs, we will g ve 11 them full information regarding the status of the contract 12 proposals so there is no confusionIbetween the --wo. And He 13 will try to keep then, as discrete as possible. 14 We would anticipate that the Emergency Medical 15 systems activities would continue beyond this year. We have 16 not set aside a specific sum for that purpose, and I will get 17 into the funding aspects a little bit later. But you might 18 want to ask further questions about the Emergency Medical 19 Systems. 20 DR. SPEI,Ll4AN: When you say that the grant awards 21 will complement 22 DR. MAYER: Mitch, could you use the speaker? 23 DR. SPELLMAN: My qnestion is in making one of'the 24 qualifications of grant awards for Emergency Medical Services %ce- Federal Reporters, Inc. 25 projects funded by RMPS, does this mean then that the grant 14 It I awards are in effect supplements of cont-actse or does the 2 coaplerentary process occur in a way in which the contract 3 and grant awards are two different things, different 4 institutions or entities? 5 DR, MARGULIES: It is complementary in a conceptual 6 sense. What we are saying is we don't want to develop 7 contract activity which would represent a total approach to 8 a system and have some grant awards which have a piece of 9 equipment here and training program there. We want both of 10 them to represent an effective approach to organizing a total 11 emergency system. But with the RMP activities, I think we 12 have some laterality which may not be true of the contracts 13 because we are dealing with a Regional @ledical Program in that 14 case, 15 Being very specific, if a contract is awarded, 16 contract this time is awarded, for an Emergency Medical System 17 to a unit of government in a community, it will be with the 18 understanding that this is a very time-limited and emergency- 19 related activity. It has to do with the moment at which an 20 emergency is identified until the point of resolution of what 21 you do with that emergency in the emergency room or whatever. 22 And beyond thatl the contract activity doesn't apply. 23 It doesn't. for example, go to in-hospital 24 emergencies, to referral activities. It has to be that kce- Federal Reporters, Inc. discrete. 25 15 We will be interested in @,e Regional Medical 2 Programs in this being more tlii n an EMS carryout effectively, 3 but in addition to that being something which has an 4 influence on the rest of what that RMP does and on the rest of 5 the system which is around it such as the other ambulatory 6 care, the referral services. And, of course, with our special 7 interests in heart disease and in stroke, we would be 8 particularly sensitive to how effectively they include competence 9 to deal with acute infections, acute strokes and so on. 10 DR. 14AYER: Two questions, Harold. One is you are 11 talking next year in terms of that move from $8 to'$15 million 12 of the operation being there to start to develop centralized 13 information. Is it the intent to expand on those original 14 five contracts, to extend it to more or to expand on those 15 original five? What is the intent in terms of next year? 16 DR. 14ARGULZES: It is to expand it to more new 17 contracts, I am quite sure, because I believe what we will do 181 -- and this depends in part on the demand -- I just looked@at 19 some of the contract reports, submissions, yesterday -- is 20 contract in such a way that we obligate funds which will carry 21 them over the full period of the tliree-year contract so that 22 they will be full funded contracts and the ones which we 23 would be looking at in the next round, therefore, would be 24 new contracts. %ce -Federal Repoi ters, Inc. 25 DR. 14AYER: Jercy. 16 DR. BES-C)N: Yiaybe I can ask any question in a 2@ different way. How much ,noney would you anticipate would be 3 allowed for the five contracts? 4 DR. MARGULIES: The five contracts will for the most 5 part consume the $8 million. 6 DR. BESSON: Thent the moneys pertinent for RMPS-EMS 7 are outside of anything in -- 8 DR. MARGULIES: Yes, they are separate. 9 DR. BESSON: And the only reason they are not being 10 considered by this committee is because of the lateness of 11 submission of the grant proposals. 12 DR. IIARGULIES: We have the same problem with those 13 and with the community education activities which I can get to 14 in a moment also. DR. BESSON: You previously have spoken of RMPS 151 16 money as maybe not being allocated, but somewhat sequestered 17 for kidney activities or other activities. Is there any 18 thought in RMPS about how much of the -- 19 DR. MAYER: Can you hear him in the back? 20 They can't hear you, Jerry. 21 DR. BESSON: Is there any thought in RMPS as to how much money would be allotted from RMPS funds for other 22 23 activities? 24 DR. MARGULIES: There is some thought about it, and ,%ce-Federal Reporters, Inc. I will get back to that, Jerry, but it is wrapped up in several 25 17 I things in our final 4'undi.ng level and the change in our 2 review cycle which is not too complex, but it is interlaced. 3 And I would rather go over it all at one tine, I think it 4 would be clearer. 5 DR. BESSON: Well, perhaps I can indicate why I am 6 a@king the question. In describing the five contracts vihi.ch 7 are going to be let for what you refer to as broad systems 8 for Bmergency Medical Services contracts, the way RMPS would 9 approach it, the implication is that we are interested in 10 finding out on a demonstration basis how to organize geographic 11 areas for the provision of a total system. But IOIPS has 12 served a somewhat different functio@i historically in relating 13 to the various health institutions in a community. And I am 14 wondering whether it might not be a more appropriate stance for 15 RMPS's interest in EMS, rather than fund:-demonstration 16 programs to fund what I might call seedlings and spread 4-ts 17 moneys as wide as possible rather than concentrating them on 18 single large, grandiose activities. 19 This is peripheral to the review coimittee's 20 activities, but since I have been immersed in the 60 pounds of 21 reading material I received the other day, I have become very 22 much aware of PJAPS's emerging role in EMS. And I wondered whether it might not be appropriate that we give consideration 23 24 to being very lenient in funding some of these 35 proposals A,ce-Federal Reporters, Inc. that are being received from the point of view of encouraging 25 18 the development of E14S thinking and development of F14S 2 activities without necessarily following the straight criteria 3 that we have laid out in the past for grant requests, hewing 4 very closely to a certain set of criteria and either being very 5 meritorious and therefore having priority or being somewhat 6 lower merit and therefore being passed over. 7 I am just wondering as to how we can most effectively 8 spend whatever dollars P14PS considers they are going to allot 9 to this aspect of their new activity. 10 DR. 14AYER: Harold, would you care to comment on that' 11 DR. 14ARGULIES: Well, I don't think you need feel 12 bound by the size, the scale, the specific requirements of the 13 contract activities, Jerry. We would anticipate- there would 14 be a fair range of potentialities in the grant requests. And 15 what we are really talking about is the avoidance of funds 16 expended for unifocal interests like training 16 ambulance 17 drivers when there isn't anything for them to drive or heavy 181 investments in radio equipment when there isn't anybody at 19 the other end. That is really what I am talking about. 20 1 think in looking at requests for grant awards in 21 the PJ4P, one merely needs to make sure there is quality or 22 potential for quality. And it doesn't have the same kind of 23 rigidity that the demonstration does. But at the same time, 24 we are hoping it represents a method of pulling the system kce- Federal Reporters, Inc. together rather than dealing with only one segment of it. And 25 19 I that is really the only issue. 2 DR. YJAYER: Additional comments on EMS? 3 (No response.) 4 Vihat would be the intent next year in terms of MAP 5 activity in EMS? 6 DR. MARGULIES: I think this is going to depend 7 pretty much on the total influence of the current round. 8 And there are really three things involved. 9 one is our general appropriation level. 10 The second is the f@,nal decision on what will be 11 done with the additional emergency medical activities in the 12 $15 million zone. 13 And the third will be some judgment about how ready 14 we are to do more emergency activities. 15 1 told you I thought the $15 million would go in 16 that direction, Bill, but it really hasn't been formalized yet. 17 It is perfectly psssible the role of P14P in the EMS activity 18 will be redefined either by legislation or by something else 19 during the coming year. But assuming everything I have said 20 is true, I would anticipate we would continue to show a high 21 level of interest in the support of Bmergency Medical System 22 activities in the next fiscal year as well. 23 DR. MAYER: Under RMP? 24 DR.MARGULIES: Yes. Nce -Federal Repoitefs, Inc. 25 DR. MAYER: Under separate kind of review effort? 20 1 DR. MARGULIES: Not we wouldn't do it separately 2 because this was a matter of duress. At that point, we could 3 enfold it into the regular review system. is an importan@ concept for 4 DR. MAYER: I think that 5 this committee because it is the bits and pieces issue. 61 Slowly but surely you dissect everything off. 7 DR. MA:RGULIES: Well, let me deal with that issue now, 8 DR. MAYER: Before you do, let me make a comment@as 9 someone who is absolutely and irrevocably addicted to 10 nicotine that as all of you are aware, the Secretary of this 11 superb organization known as HEW has indicated a mandate which 12 has come on down through t,',iiz-. T think everyone is on tl-iej.Lr 13 own in relationship to wheth(zr,they feel the lightning bolt 14 coming down from downtown or not in regard to that issue. 15 I say that in preface to I have already made by 16 decision. I want to leave tomorrow, not today. 17 DR. MARGULIES: That statement is part of the 18 confidentiality of the meeting. 19 I think it might be easier for us to deal with the 20 budgetary issues because they keep coming up rather than with 21 such things as the area health education center concept. What 22 has happened in this fiscal year has been the appearance of 231 a funding pattern which might have embarrassed us badly, having 24 us reach the end of the fiscal ,rear with more money than we had %ce-Fedefat Repoftets, Inc. anticipated and no way to spend it or the appearance of that 25 21 I amount of money with us very well ready to spend it as we are 2 or no additional money whatsoever which might yet occur. 3 Now, in that range of possibilities here is about 4 what happened: We did not get a clear statement about our 5 total funds for this current fiscal year until after the end 6 of January. Even when we had received that information, there 7 was uncertainty about the funds which would be spent for Health 8 Maintenance organizations,, some $16.2 million, and the funds 9 which were set aside for Area Health Education %--enters, some 10 $7.5 million. 11 Furthermore, the $8 million which had been identified 12 for Emergency Medical Services Systems had not yet been set li aside as they are now as I described to you for contract 14 activities. And so we had this range of uncertainties. 15 There was from the preceding fiscal year, you may 16 recall, approximately $44.5 million which was not released in 17 that fiscal year which we had been promised would be released 18 in this fiscal year. It was released, but only in part. 19 So we got to about.March knowing that there were several 20 possibilities which gave us a range of difference in the month 21 of JUne which is turning out to be true of about $22.5 million 22 uncertainty. 23 Well, with $22.5 million uncertainty and the 24 desire to be able to use it effectively, you have to develop @ce- Federal Reporters, Inc. some footwork. And so we developed some footwork. This 25 22 It I included the decision to support Emergency Medical Systems, 2 decided on rather late when it became clear how the other 3 EMS activities would be, that we would decide educational 4 activities which were like, but not the same-as, an Area 5 Health Education Center which had to be decided late for other 6 reasons which I will get back to, and we would at the same 7 time to cover our potentialities decide now to change the 8 review cycle from 4 to 3 a year. That became the pivotal@- 9 point in the whole budgetary romance because ;what we had to 10 do was to make a decision to go from 4 to 3 a year, thereby 11 change fiscal yearsf and thereby give us the opportunity to 12 use funds either in fiscal '72 or 173 according to what we 13 had available and in the process of doing that anticipate the 141 level of commitment for fiscal 173 and 174 so we didn't over- 15 extend ourselves. 16 Added to that was the uncertainty of whether the HMO 17 funds would actually be totally used. And as time goes ono it 18 appears to me personally more and more likely that they will 19 not be totally used. So this adds some more potential fLunds 20 to the program. 21 While all this was going on, the $7.5 million which 22 had been set aside for Area Health Education Centers was 23 kept back and remains back. So we still have the uncertainty 24 of whether we will have available $7.5 million for educational %ce-Fedecal Reporters, Inc. 25 activities, whether some of the HMO money will be returned to u 23 and whether we will have funds available at varying levels, depending upon the grant requests from the Regional Medical 3 Programs in fiscal 172. 4 What we decided on is a rather simple maneuver to 5 give ourselves maximum flexibility. And the way it is going to 6 work out, we will be able -to expand all our funds no matter 7 what the decisions are. We extended the fiscal years of each 8 of the programs in this review cycle, but we did not give 9 them grant awards to cover the whole period of time. So if 10 an Rmp went from 12 months to 16 months, the grant award was 11 for 12 months. And what we told them was, "Show us what your 12 rquirements are for the full 16 months. And if you require 13 X level, you can be assured of getting that if that is an 14 appropriate level. But we can decide with you whether you 15 need it this fiscal year or next fiscal year." That meant that 16 in the majority of the program 17 DR. MAYER: In terms of release, Harold. 18 DR. 14ARGULIES: In terms of release, yes.- 19 It covers the same period of time, but this meant 20 that up to June 30, we had a liability just in grant award 21 for basic RMPs of something in the range of $8 million which 22 could go in one fiscal year or the other and produce the same 23 result. This is the only year we will ever be able to do that, 24 but it is also the year in which the uncertainties appear to Ace -Federal Reporters, Inc. 25 be maximal. I 2 4. That last statement, don't believe that for a mor@tent, 2 but the flexibility is maximal. 3 (Laughter.) 4 So we are really trying to play these varying kinds 5 of games. 6 If you say in the middle of that, "Exactly how much 7 is it you are going to have for EMS and how much for educational 8 activities," I can just add to the fringe of interest by 9 telling you about what we are thinking about. We hope that we 10 can talk-in the educational activities in the general range 11 of about $3 million. And in the EMS, we have had a greater 12 level of uncertainty because it has been awfully hard to 13 predict what might actually come in. But I would not be 14 surprised to see us working in the same general range for the 15 Emergency Medical Systems. 16 Now, this depends on an action which may be taking 17 place today, I am not sure. Part of it does. And that is that 181 we have gone through, and I will have to complete this, Bill -- 19 I am sorry that this gets complex, but, damn it, all of it is 20 complex. It has been like that. We have gone through an- 21 interesting tango -- you can't tango with four partners 22 we have gone through an interesting square dance on the Area 23 Health Education Center activity trying to decide who does 24 what. And it has at least reached a point of some definition. Ace - Federal Reporters, Inc. 25 And that is that in the opinion of the office of Management and 25 budget and of the Office of the Secretary, something called 2 an Area Health Education Cento-i: is related to the Carnegie 3 Commission model which is essentially an activity conducted 4 primarily under the auspices of a university health science 5 center with the Area Health Ed,-ication Center a satellite 6 thereof. And this with some embellishments is the concept. 7 The essential ingredient is the extension of the 8 energies and interests of the university health science 9 center. That is not exactly what the Carnegie Commission report 10 said. It has become the general concept in the JWIA and the 11 article by Margaret Gordon and in the office of the Secretary. 12 ODIB and I believe the Office of the Secretary feel that that 13 is fit for NIH Bureau of Education and 14anpower Training to do, 14 not for HSYIIA RMP. 15 There was in the middle of this discussion of Area 16 Health Education circulated in among other places what is 17 known as the blue sheet a statement which said that General 18 Counsel opinion deleted RMP from educational activities. That 19 was in error. There had been at that time no General Coiinsel 20 opinion submitted to anybody. There had been some grants which 21 were incomplete and which we asked them to complete at a 22 later date. 23 The General Counsel opinion on educational activities 24 for R-?4P is quite clear-cut. it says that under 910(c), we kce -Federal Reporters, Inc. 25 can indeed conduct educational activities which need not be I 26 1 confined to the categories v@,liich are concerned with improving 2 the utilization of manpower,, expanding their capacityf but they 3 added the comment that they fel.t clear that RI,4P should not be 4 involved through 910(c) in the support of training activities 5 iihich essentially changed the unskilled into skilled. 6 And to be definite about it, they said such as 7 training a high school graduate to be an RN, paying for that 8 or paying for the stipends or faculty for medical students and 9 so on, and that we were concerned with tl-ie community activity 10 which linked education to service. And they are quite com- 11 fortable with that differentiation. 12 Since that is basically the policy under vthich IUIP 13 has been operating for some time and causes us no concern -- 14 DR. MAYER: Since the beginning, Harold. CC and I 15 wrote those exact same guidelines five years ago. 16 DR. MARGULIES: This is buttressed, then, by the 17 General Counsel opinion, so we have no problems over it. 18 So what we had done without any of these decisions having been 19 made and without any General Counsel opinion is to run the risk 20 of circulating to the Regional Medical Programs the description 21 of a program community based education activity to which we 22 invited their attention and for which we are going to provide 23 supplementary grant awards. This is parallel to the Emergency 24 Medical System activity. @ce-Fedefal Repofters, Inc. 25 We could not put this out with any term. that said 27 I "Area Health l@,ducation Center.ft lqe were not even sure at 21 that point anyone would allovi us to do it because this fall's 3 draft opinion was floating around. But anyway, we did it. 4 And this meant we had to wait until the last minute, hoping to 5 get some clarification. We got no clarification so we went 6 ahead and circulated throughout the country a description of vihzt 7 we meant by some-kind of a community-based educational and 8 service consortium. This has led to a careful review by the 9 RMPS. 10 Ile do now have in hand a number of submissions for 11 grant awards. They will be reviewed on May 20 to 21 because 12 some of them are still coming in from both Emergencies and 13 Area Health Education Centers. And the ones involved in that 14 review process which will be carried out at the same time as 15 the Allied Health Conference from the review committee will be 16 Hilton, Anderson, Kerr, and Hess, with Perry as chairman, 17 and from the Council Tony Komaroff and Bob Ogden. And we have 18 asked Al Popma formerly on the Council, former RMP coordinator, 19 to join the group so that we will be taking a review action 20 en bloc on these educational activities at that time. 21 There was justno mechanism by which we could conduct 22 this under an orderly review process. And as one more feature 23 to it, it is likely -- Well, let me stop at this point because 24 the additional feature gets complicated. The rest of it has been kce -Federal Reporters, Inc. 251@ easy. 2 8 Leonard. 2 DR. SCliERLIS: Have yo u distributed to the members 3 of this committee the same information you sent out to the 4 various regions as far as their coming in for EMS or these 5 educational centers? 6 DR. MARGULIES: Yes. 7 DR. SCQERLIS: We had that? 8 DR. MAYER: No. 9 DR. MARGULIES: Didn't this go to review committee? 10 I am sorry, it should have gone to review committee. 11 I thought it went to review committee and Council. That was 12 an error on ou-- pa--t, then. 13 DR. SCHERLIS: Perhaps we can have those. 14 DR. MARGULIES: We can get them to you today. 15 DR. SCHERLIS: Fine. 16 DR. MARGULIES: Let me add one more feature to it 17 which gives you an idea of some of the special procedures we 18 have to carry out regarding these two categories of interest, 19 the Area Education Service one and the EMS. If we get funds 20 released yet this fiscal year, and I think it is likely, which 21 the office of Management and Budget does not intend to have 22 in continuing appropriations, we will have to provide evidence 23 that that money can be spent to support activities in RMP 24 without raising the level of commitment to individual programs. kce-Fedeial Reportefs, Inc. 25 Now, that can be done, It can be done if we handle 29 I for one clioice the EMS activity as a discrete activity in a 2 program. If the program coires in and says,, "We have a well 3 knit Emergency Medical System activitity, it will take three 4 years to complete, it will cost X amount of money,," we can 5 award a grant based upon their total needs for three years 6 and reach an agreement for them to carry that as a separate 7 item in their budget. At the end of those three years, that 8 activity will-have been completed and will not be part of 9 their basic commitment. 10 I think that the Office of Management and Budget will 11 accept that procedure. 12 DR. tl).AYER: WI-&th the convaitment, how,@ver, for the 13 three years coining out of -- let us assume $3 million -- that 14 original $3 million. 15 DR. MARGULIES-. That's right. It is essentially 16 forward funding for the line item in their own budget. 17 DR. MAYER: In other words, the corrlmitment that would ]Bi be made, let us say. 19 DR. M,-kRGULIES: We would release all the funds now. 20 DR. MAYER: There would be only a million dollars of 21 annualized commitment that would be made at this time, is that 22 what you are saying? 23 DR. MARGULIES: Yes, we would release the $3 million, 24 but at the end of that pe.-iod. @ce - Fedefat Repofters, Inc., 25 DR. MAYER: It would be spread over three years. 30 DR. tIARGUI,TES: 'rt would be spread out over three .L. 2 years. If they were smart, they would probably handle it 3 through some kind of a contract to keep it separate. At the 4 end of the three years, their commitment level would be whatever 5 it had reached at that time exclusive of that $3 million which 6 then disappeared. 7 DR. SPELLI-,IAD!: You would make the three-year award 8 at one time, one sum? 9 DR. MARGULIES: To get the funds obligated... 10 DR. SPELL@IAN: 014B will commit them? 11 DR. MARGULIES: We don't know yet. That is our plan. 12 DR. SPELUIAN: it is extraordinary. 13 DR. 14ARGULIES: It is not so extraordinary. 14 DR. MAYER: They have been doing that in construction 15 for years. 16 DR. MARGUTJIES: The reason they have to do that is 17 ibecause they are committed to releasing all funds. It is 18 their -- their being downtown, whoever is downtown, it is always 19 they, all those people downtown with responsibility -- so the 20 fund was not released, and tl,aey have to @evise a method of 21 releasing it and making it effective. I think they had 22 assumed we would not be in a position to respond as effectively 23 as we can. And we can do it because we will have reviewed 24 and approved and identified actions on that kind of a base Ace-Fedetal Repotters, Inc. 25 because I guess it was staff wisdom 8 months ago this is exactl 3 1what would happen now. 21 DR. MAYER: O.K.0 otl-ier questions. 3 (No response.) 4 That was the easy part. Have you got the hard 5part, Harold? 6 DR. MARGULIES: Let me just run over two or three 7other things quite quickly because they might take some further 8time. We can come back to them because this gets to be quite 9a long unifocal dialogue. 10 DR. IAAYER: We are listening. 11 DR. MARGULIES: The Cancer Center proposal which was 12 reviewed by Council last time represents for your recollection 13 the investment based upon Congressional action of $5 million 14 struction center in the Northeast part of for a cancer con 15 United States. That was reviewed, and there has been favorable 16 action with certain requirements attached to it by the Council 17 for a cancer center in Seattle called the Fred Hutchinson 18 Cancer Research Center. 19 There were specific requirements by the Council and 20 some that we imposed which had to do with such regulations 21 as are in the legislation in State regulation, certificate of 22 need and so on. They appear to be moving quite well to 23 complete their requirements. 24 We said that we would release the funds only when Ace-Federal Repoitefs, Inc. 25 all of these requirements were met. So that the award was made 32 I by Councilt but we will not make the aaa-d a formal award 2 until all of these requirements are not. And Council will have 3 an opportunity to look at it again at least informally to see 4 if it satisfies their needs. 5 Probably the key issue for some members of the 6 Council was the plan to have patient beds in the research 7 center which is-connec-@ted with Swedish Hospital by a tunnel, 8 but which is not a part of the building itself. And some 9 members of the Council felt very strongly that this might 10 produce a good research environment, but they worried about the 11 adequacy of regular, around-the-clock medical care in that 12 circumstance. 13 DR. MAYER: it is going to be physically linked 14 to Swedish, is that it? 15 DR. MARGULIES: Yes. And they have responded showing 16 us ways in which they are going to give assurance of good 17 medical care. @.d it is going to be up to the Council to judge whether that assurance is adequate. 18 DR. SPELLMAN: Those would be the only beds, I take 19 20 21 DR. MARGULIES: For research purposes, yes. I don't really know how much to get into this next 22 23 issue because we could spend a lot of time speculating on it. 24 I would be glad to speculate with you, and it is an election Ace - Federal Reporters, Inc. year, and that is the popular thing to do, but this has to do 251 33 I with the iieaiiing of the emergence of the now cancer 2 authority and of the now heart disease push in the form of 3 two major forms of legislation. You may recall that there was 4 new cancer authority passed to produce a special center for 5 cancer research and control. And there is a parallel bill for 6 management of heart disease. 7 This, -of course, raises the question immediately of 8 what relationship either of these activities may have to the 9 Regional Medical Programs which are identified with the same 101 diseases. 11 It also raises the question of whether there will be 12 a continuation of @iis kind of special interest and special 13 disease categories, perhaps rejuvenation of interest in 14 neurological diseases or some of the others. I don't know 15 about that. 16 What has happened, however, has been a desire certainly 17 in the cancer bill to produce a consistent pathway from the 18 cancer laboratory research area to the delivery of good care 19 tothe public with prevention, diagnosis, treatment, rehabilita- 20 tion. 21 This could be done by establishing or re-establishing 22 the control programs which were carried under the Di-vision of 23 Chronic Diseases in the past. It could be done by other 24 mechanisms. It could be done by the National, Cancer Institute kce -Federal Reporters, Inc. 25 managing the whole thing from ttie research end to the delivery I I 3 4 I end. Or it coul,d b- done by which they work 2 out with programs like the Pegional Medical Progr,-tln-,. 3 There has not been a decision made at present about 4 what our actual working relationship will be either with the 5 National Cancer Institute or the National Heart and Lung 6 Institute. Tomorrow I am to go over and talk with a group of 7 people in the National lbart and Lung Institute about heart 8 and stroke activities which we might be able to carry out in 9 common. But I think the negotiations are taking place 10 currently between the office of the Administrator and with 11 Bob Marston at NIH to decide how best we can work this out. 12 What I hope for is v. union of the special cancer 13 interests and special heart and lung interests which represent 14 NIH's major interest and constituency with those in the Regional 15 Medical Programs. And what nany of us hope for would be if 16 there is a re-emergence of the control program that this be 17 designed in such a way that it improves the delivery system 18 rather than operating in isolated segments thereof. 19 But we will probably have a clearer answer to 20 that at some time in the future. 21 in the meantime, interestingly enough, just to 22 add to the confusion of the picture, when .@anator Kennedy 23 extended our legislation, he dropped the categorical designation 24 out entirely and put his total emphasis on education, manpower, kce-Federat Reporters, Inc.Iand the improvement of delivery of health services. So we are 25i 35 I in a continuing Period of ti.me of struggle between these 2 issues which, if you had thougl,.t would disappear with anticipat.,nc 3 events is not likely to occur in the next few years. I do not 4 know what final arrangements will be carried out. 5 In the meantime, it has caused us to look again 6 more sharply at how much of our activities are dealing with 7 heart disease, cancer, stroke, and kidney disease. And they 8 still remain a preponderant part of Regional Medical Programs. 9 W-iat we have difficulty with, and it is distressing 10 that we do, is the idea thatyou can by improving -- well, 11 we talked about it earlier -- total emergency medical services 12 Liiake a contributioi-i *-,o tlio cor.-I@-zol of li@zart dise That 13 never emerges from the kind of data which are put together. 14 If you are talking about a categorical disease activity in the 15 way most of the people looking at it at the budget end like 16 to look at it, it has to be exclusively for a specific disease 17 within that category. If not, they can't recognize it. 18 If you improve basic primary care services iln a rural area, 19 the assumption is,.l guess,, that somehow you do that and 20 exclude heart disease, cancer, stroke, and kidney disease and 21 related diseases when in fact that is an absurdity. 22 If you try to tote up what you ve doing in some kind 23 of dollar terms to improve management of these diseases, it is 24 very difficult to do.. And we are in that kind of a dialogue. kce -Federal Repof ters, Inc. 25 I have no answers for you, 36 1 DR. IVIAYER: O.K. con,,-teiitse Harold? 2 DR. MARGULIES: one other, and some of these others 3 will come up again. 4 We have issued the new kidney guidelines very recentl,), 5 and they are available to you. And I think rather than go 6 into detail at the present time, since we have been over qu3te 7 abit of ground already this morning, that we will bring up the 8 details of that at a point where you are actually going to 9 deal with the subject. Or we can do it now if you prefer, 10 Bill. It is up to you. 11 I have a more significant issue to deal with, though, 12 for the tire being. And that -is the nonpayment of consultants. 13 All I can do is read you the note. 14 What happened was that the central payroll converted 15 to a new system. An old consultant timekeeper number was 16 used which resulted in many consultant checks not being written. 17 Research has been conducted to double check on the consultants 18 not Paid and to clear up other errors. Hopefully, all work 19@ will be completed-and checks written for the May 23, 1972, pay., 2o day. 21 in other words, we operate our pay system when we 22 change from an old system to a new system just as others do -- 23 ineffectively. So that those who have not been paid have not 24 been paid because they had wrong addresses, wrong numbers Ace -Federal Reporters, Inc. 25 which the switchover managed to produce. And we will, if we 37 1 can get the machine to listen to us, make sure evc,,,,:ybody gets 2 paid as he should have. 3 Some people are in arrears clear back to last 4 October. 5 DR. SCHE@TIS: It has been speculated that is a 6 source of funding for your expanding EMS.programs. 7 DR. MA RGULIES: As a matter of fact, we linked it up 8 to another failure in another subscriber system. And if you 9 don't get paid, you are going to get a 10-year subscription to 10 the National Geographic. I 1 (Laughter.) 12 DR. MAYER: Otlier conui@ents? 13 (No response.) 14 Thank you very much, Harold. 15 At the risk early in the meeting of fixing dates, 16 I would like to turn to the calendars wh4Lch are contained in 17 your notebooks under the first tab which is labeled simply 18 "Calendar" in an attemot to get the link with Council or closer 19 link to Council at least temporally if not philosophically, 20 we need to pick two dates out of the following three weeks 21 in the subsequent year. 22 If you will put a circle around the September 17-23 23 week, a circle around the January 15-19 week and a circle 24 around the May 14-1-9 week, what vi-e need to do is pick two Ace -Federai Repo@tets, Inc. 25 days in that period of time, ca,,-h of those weeks, that you 3 8 I would like to schedule for m@,eti.n(-T. And this is part of that 2 goi.ng from four cycles to three cy6l,e year. 3 Preference is in Sept@er? We are now on a 4 Thursday-Friday go. Is that good, bad, indifferent? 5 How about the 21st and 22nd of Septainber as 6 possibilities? 7 Going -once, twice,, all right, gone. 8 In January, is the 18-19 appropriate? 9 All rights other time during that week? 10 DR. AN-CRUM: Any day except that Friday. I have 11 to be back in Seattle. 12 DR. MAYER: O.K., 13 DR. ANCRUI@lo. That would be fine. 14 DR. MLAYFR: How is that, O.K.? 15 17-18, then, of January. 16 And in May 17-18 of may? 17 DR. ANCRUM: The third Friday is out for me. 18 DR. MAYER: Then what about the 16-17? 19 DR. ANCRUM: Am I the only one that has this 20 conflict? 21 DR. MAYER: I don't hear anybody moaning about the 22 other cycle. There is no magic about Thursday-Friday. 23 O.K., then the 16-17 of May. 24 O.K.,, then what we have said is 21-22 September, Ace-Federal Reporters, Inc. 17-18 January, and 3.6-17 May, as the next three gols. 25 would like to turn now to sol,-te other additional 2comients which I think are very pertinent to the review 3process itself as we go through the review process from Dr. 4Pahl. 5 Herb. 6 DR. PAHL: Thank you, Bill. 7 First'of al'L, I would like to mention for you that 8there is the dinner this evening at the Flagship Restaurant 9close by here to the Parklawn Building. 10 And, Bob, perhaps you can give detail arrangements 11 later. But this is something that we are looking forward to 12 because we do have several of -the members of the coiuaittee 13 leaving. And we believe that the other members of the cogLmittec 14 together with-staff would like to meet together informally and 15 have an opportunity to socialize and wish those who are 16 departing well, althouch we do hope we have close and continuing 17 relationships with each and every one. 18 I have just a very few comments because I think Dr. 19 Margulies has indicated the complexities that we have been 20 going through. And you will again obviously have a very full 21 agenda of information items in September because the program 22 does continue to change. However, my remarks are much more 23 mundane and specific. 24 Specifically, I would like to indicate that the Ace -Federal Reporters, Inc. 25@ staff anniversary review panel is continuing to function very 40 I well and that this time they had an tuiusually heavy task 2 before there. because the appli,ca-ions tllztt came before them 3 had not received initial priority ratings. Ther,eforet there 4 was in this period along with all of the other specialized 5 activities the need to review in depth these particular 6 programs and assign priorities. These priorities are indicated 7 to you in the applications in the book. 8 There are some few programs which are behind the 9 blue tab in the book where you are not required to take action. 10 Those applications are being brought before this committee 11 for information purposes only. The other applications for 12 one reason or ano--her do require certain kinds of action. 13 liov7ever, I do want to make it clear that the committee 141 does have the opportunity and privilege of raising a question 15 about any priority on any application that the staff anniversary 16 review panel assigned regardless of whether that application 17 is before you for action or for information only. And we 181 will be asking you to formally concur in those priority ratings 19 or to mod,-&fy th,--m,as you see fit. 20 Should you have questions about any priority rating, 21 we will have the chief of the operational branch responsible 22 for that region prepared to present to you the basis on which 23 those ratings were assigned. And you should know in this 24 connection that the branch chief for that region was not a Ace-Federal Reporters, Inc. 25 member of the voting team for that application so that he I 41 1 would be p--esenting a su@tary, if you will, of what the staff 2@ anniversary review panel concluded relative to the application 3 to reach that assigned priority. 4 You will also note that we have introduced certain 5 new formats in the paper work which has come to you both at the 6 time of site visits and in terms of primary and secondary 7 review of the applications. And I believe you will see very 8 readily that the purpose of this has been to try to tie into 9 our analysis of the application in question the review criteria 10 which have been developed and are increasingly being used not 11 only by RMPS, but by the RmPs themselves as they view the 12 p-Logress of their programs. 13 There will be an opportunity provided to this 14 committee at the end of this meeting tomorrow to comment upon 15 and make constructive suggestions for modifications in these 16 new kinds of forms and so forth which we are using. We hope 17 that the information is being organized perhaps somewhat better 18 for you, particularly for comparison purposes between and 19 among programs-since by having the items organized along the 20 lines of the review criteria it is more possible now to review 21 one program in comparison to another and look at the similar 22 items of information. 23 Internally, there certainly is not complete agreement 24 that this is the ultimate way to present information. We do Ace -Federal Reporters, Inc. 25 feel,, however, that there is an opportunity here to improve 42 I matters. At the same time, we feel eiat the information as 2 we are now reco@ving it and prsenting it to you does contain 3 perhaps less narrative and more pithy substance on the particular 4 points in question. However, we do look fonTard to your 5 comments at the end of the meeting as you have had an 6 opportunity to use these new forms. 7 DR. MAYER: I might just interject, Herb, each of 8 you, I think, at your desk had a long sheet which does have 9 the May-June review cycle, SARP recommendations on it which you 10 need to have for referral as we go through. 11 DR. PAHL: And it is the five applications at the 12 bottorA of the sliect Viich are being brought -,,;o you for infor1rat4on purposes only and are included behind that blue 13 14 tab in the back of your book. 15 In terms of the NIS printouts, in just a moment I 16 would like to ask Mr. lettinoviski to present very briefly for 17 you what the printouts are designed to do. And he has 18 distributed these large binders for you. 19 There is no intent to have you try to look at or 20 absorb any such information here at the table. Rather, those 21 Of You who have been assigned primary and secondary review 22 of applications have already received the appropriate printout 23 packages. And this merely represents a compilation for 24 each application before you today so that you will have some Ace -Federal Reporters, Inc. 25, appreciation of how the NI.S, National Information Systemo is 11.3 I being utilized more and more to bring information to your 2 site visitors, and the National Pdvisoril Council, and to be 3 used more effectively by our oAn staff as we go through the 4 review process and analysis of regions. 5 I would indicate again that we look to this committee 6 and to our non-committee site visitors for constructive 7 suggestions as to how to bring to you those kinds of 8 information and present them to you in some organized fashion 9 that will be more effective in accomplishing both site visits 10 and the anlaysis and discussions of the regions' programs. 11 Now, with that slight introduction I would like to 12 ask 1-ir. Ichinowski to take a fGw minutes and rev,.e-a for you 13 not any specific numbers within these pr2.ntouts, but rather 14 what the nature of the format of each printout is designed to 15 do for you. 16 And,, again, I will appreciate as well, particularly 17 at the end of tomorrow's meeting or at any time, of course, 18 that you so desire suggestions as to how this kind of 19 activity can be improved to se-eve your purposes better. 20 Frank. 21 MR. ICHINOWSKI: Thank you, Dr. Pahl. 22 We put together a number of printouts on each 23 region that is going to be discussed here today and tomorrow. 24 And these packages were previously sent to the primary and Ace -Federal Reporters, Inc. ,- those regions that they ha 25 econdary reviewers for d =der their I responsibility. So maybe they are not completely new to you. 2 We have, thenr all 14 regions here with the excerption 3 of the new Ohio RMP. we have six printouts for each WIP. 4 And if you would be so kind as just to take your big black 5 binder, maybe we could run through for a minute or two the 6 kinds of things we have there and perhaps how you could use 7 them in your determinations. 8 First of all, they cxe all alphabetical, the ILMP, 9 starting with Kansas, Missouri, and so forth. We have 10 reduced the printouts, as you know, from the large size which 11 we found somewhat unwieldy to this reduced version that you 12 bee in front of you. 13 If we could use perhaps the Ya-Tisas P2,IP as an example 14 and run through the printouts, maybe that would be of assistance. 15 The first printout is a funding history list which 16 identifies for you for each RMP all of the projects that 17 were ever supported by RI,4PS funds and then in each column by 18 year the moneys that were put into that activity. 19 For example, in the Kansasp you see there they have 20 it awarded for five years. So the first five columns are the 21 moneys that were awarded in each project and total at the bottom 22 for each of those five years. 23 To the right of the asterisk column are those ,Ttoneys that they are requesting at thi s time for subsequent 24 Ace-Federal Reporters, Inc. years, In the case of Kansas for years 06, 07, and 08. Again, 251 45 at tl-ie bottoirp the totals that are bei.ng requested. 2 O.K. For the ne,,ct printout, you flip over behind 3 the number one tab. The breakout of request which identifies 4 for each RMP by type of support being requested, whether it is 5 continuation within approved period of support, which is the 6 first column, continues beyond the approved period of support 7 whichis the second column, and so forth, those moneys that are 8 being requested for a particular year. , 9 Each page is a program period. The first page for 10 Kansas is their 06 year of request. The second page will be 07, 11 At the right of the page, you not only have the 12 direct cost being requested, but also the indirect and total 13 dollars. 14 Now, behind the nu@er 4 tab, under Kansas, we have 15 an identification of the PNY).PS funds that. are being requested 16 as a percentage of other sources of support. 17 Now, in the financial data record that the RMP 18, submits to us on each project, they identify if they are going 19 to be getting other sources of support for that activity. 20 And we have displayed this in terms of identifying in the first 21 column after the title the RMPS funds that are requested. 22 The second one is those funds that they have indicated will be 23 coming from other sources, with the total then in the third 24 column. And in the fourth column is that percentage of money Ace-Fedefal Reporters, Inc. 25 that RMPS would be contributing. ik ri In the case of Kansas, as you can see, they have 2 not indicated any other sources of support for any of their 3 activities. 4 We can go, then, behind the number 9 tab of Kansas, 5 And these are printouts that come from the descriptor summaries 6 that had been submitted to us by the IU4P. We have this 7 broken down into,three major groupings. 8 The first groupings are operational components. 9 in the case of Kanasa, on the top left-hand corner, you can 101 see that they are requesting 12 operational components which 11 total $693,243. within each of the 12 major groupings of 12 descriptor categories, we have brok-c-ii tl-iose dean to identify 13 for you tlic- number of componei).ts that relate to that specific 14 element, the dollars that are related and then the percentage 15 of those dollars that that money identifies of the amount that 16 they are requesting. 17 There are four pages for that particular printout. 18 And then right behind the little yellow @ , we have a similar 19 type of display for the ple-xxning studies that they have 20 identified in their application which runs the same pattern, -- 211 the number of programs that they are requesting and the amount 22 @of dollars. 23 And the third batch are the program feasibility 241 studies and central services again in a similar arrangements (kce-Fedetat Reporters, Inc. 95 and array. 47 The next printout Londer Tab No. 11 is a repeat 2 of their page 7 of their application which identifies equal 3 employment opportunity data they have submitted to us. There 4 are four major columns, the first being core staff, again 5 broken down into professionals technical and secretarial 6 and clerical the same breakdown for project staff. 7 The th."&rd major column is the regional advisory 8 group, 9 And the fourth one other committees. 10 The rows, I believe, are self-explanatory. The top 11 row is total which are members. Then you have the breakdown 12 bet@7een male and femF.-.1e. Thr@ii you h,--t@re the breakdo,@ under 13 minority groups, total minority, and those that are 14 appropriate to blacks, Indians, Spanish, oriental and others. 15 This is a direct take-off from page 7 of their application. 16 The lst printout we have provided for each RMP 17 behind Tab 14 has been derived from the financial data 18 records where we have identified for those objecf@-s of expenditua 19 that are on page 16, moneys in each component that have been 20 reported to us. Each coliLnin is a particular component, the 0 21 first being core, the second one developmental, and then the 22 component numbers. The total in each object of expenditure 23 for each PIIP would be the furthermost right-hand row of the 24 last page. In the case of Xansas, the last colunun on page 2. Ace-Fedetat Reporters, Inc. 25 Now, there is one other set of printouts that we have I prov4-ded which is helpful for those of you who want to do some 2 analysis. And that is at the veL-Y back of the book, there is 3 a tab that is identified as miseell,@ieous printouts, if we can 4 flip back there under the No. 10 tab, there are four different 5 printouts in this series. And what these printouts identify 6 are those RMPs that are in this revielvi cycle broken down accord-@ 7 ing to the number of years that they are operational. So you 8 can see that there are four RmPs that are in their first year 9 of operational, one in the second and so forth. 10 If we can use the Kansas e@ca,.,nple which is the second 11 line from the bottom that we have been following through, you 12 can see that Kansas has been operational. for five years. 13 Nowe what we have attempted to display on this 14 printout is a comparison of the moneys that they are requesting 15 in column 3, $1.7 million, as a percentage of their currently 16 budgeted dollars in column 2, $1.3 million. 17 In the third coliznm request is the percent change fro 18 current. You can see they are requesting 19.9 percent more 19 moneys in total direct cost than thay are currently being 20 funded for. 21 In the subsequent columns in that page, we have also 22 given you a comparison for you to see in terms of the history 23 of that FLMP, the percentage change that occurred in that RMP 24 between years 1 and 2 -- in this case 177.7 percent. And then Ace-Fedeial Repotteis, Inc. the second column would be between years 2 and 3, a plus 27 25 49 percent and so forth down th.@,@ lirAe. Now, there are four printouts to this series. The first page 'chat we have gone over is total direct cost. The 4 second page has to do for core contpoients, the third one for 5 project and the fourth for those that apply developmental 6 components. 7 Yes, Sister. 8 SISTER ANN JOSEPHINE: I am interested in this five 9 years. 10 DR. MAYER: Sister, could you use the microphone? 11 SISTER ANN JOSEPHINE: in this five-year operational, 12 as you look at Kansas and Missouri, and you look at the current 13 budget and requested, immediately the question comes up what 14 is changing there? Because it is changing very rapidly. 15 MR. ICHINOWSKI: In the case of Kansas, they are 16 requesting $1.7 million. And they are currently being supported 171 at the $1.3 million level. 18 SISTER ANN JOSEPHINE: I am talking about Missouri. 19 As I look at these two, they are being funded at $1.9, and 20 they are requesting $4.4. There are some significant changes 21 taking place here. 22 MR. ICHINOWSKI: In Missouri? I believe you will 231 discuss that at the time the Missouri application is to be 24 presented. Ace-Fedetal Reporters, itic. 25 SISTER ANN JOSEPHINE: This could highlight these I 50 of things I suppose one would l,ool,, ;;,,t. MR. ICIIINOWSKI: That is the intent of my covering 3 this. 4 SISTER ANN JOSEPHINE: I keep hoping vie ask the right 5 questions because if we don't, we work on the wrong answers. 6 MR. ICHINOWSKI: Are there any other questions? 7 MR. HILTON: Yes. 8 DR. MAYER: Yes, Mr. Hilton. 9 MR. HILTON: Is the current plan to have these 10 printouts replace much of the reading material we have in the 11 other book? Is this the idea? 12 ViR. ICIITIIO;,JSKI: Yo 13 MR. HILTON: Is there some way to make this printout 14 clearer7 Some of these figures are -- 15 MR. ICHINOWSKI: Yes. We have just in this last cycle 16 made the decision to go from the large printout to the reduced 17 printout. It is an internal problem with the use of a Xarox 18 7000 machine in the building here. And if we can get #to use 19 the Brun!.ng or one of the other machines which we are negotiating 20 for right now and get it perhaps printed rather than xeroxed, 21 we can improve the quality significantly. And I believe by 22 the next tire these printouts are presented to you, you will 23 note the difference in the quality. 24 DR. MAYER: That is extremely helpful data. When I Ace-Fedetat Repoitets, Inc. 251tried to dissect out that "new" Ohio program, I would have 5% my eye teeth for this data. Arid I have just asked to try to 2 get some comparable data for that one because there is literally 3 no way you can view the thing in a total picture over time 4 without some feeling of this kind of data displayed. There is 5 just no way if you haven't been involved, at least that I can 6 capture, without this kind of information. It is absolutely 7@ essential. 8 MR. HILTON: Perhaps this is a question for Dr. Pahl. 9 I notice some new colors in the form. Is there a color coding 10 formula somewhere? Does it mean anything? or are we just 11 more decorative, surplus paper? 12 DR. PAHL: Well, to answer your question, I wil@l try 13 to go through it with Lorraine Kyttle here. I am sure she 14 will check my accuracy. 15 The Staff Anniversary Review-Panel acts on only 16 certain types of applications, you will recall. And when they 17 do, the report of that panel is given on sort of this pink 18 sheet. 19 DR. MARGULIES: It i-s good you asked him. I am 201 color blind. 21 DR. PAHL: A yellow sheet indicates that this is a 22 cument for use by the committee and the Sta.F4' staff do 23 Anniversary Review Panel has not acted. Therefore, this kind 24 of staff summary is coming to you as an initial consideration A,ce-Fedetal Repofters, Inc. 25 without prior review by an iiite-&nal staff panel. 52 I And the whites are generally the back-tip information. 11 And Lorraine, do we have another color? 3 MRS. XYTT.TJE: No, sir, only one little thing that 4 jarred us, and that is that tl,,e printer contracted out and, 5 therefore, we have several shades of the same color. A pink 6 is a pink, no matter what its shade is. It depends on what 7 contractor printed it, 8 MR. HILTON: V7hat is a salmon'. 9 MRS. KYTTLE: Mr. Hilton, the salmon indicates materi@.l@ 10 generated by staff or the initial review of the Staff Anni%rer- 11 sary Review Panel. 12 DR. IIA@RER: that is the link. 13 MRS. KYTTLE: We are a.11 swixring upstream. 14 DR. MAYER: other comments 15 DR. PAHL: I do have one or two points of information 16 for you, And then I have something to state about the kidney 17 proposals. So let me take up the first two point@.3 relative 18 to information at this time. There has been over many months now an increasing 19 20 need by Pd4Ps for a clear statement from RMPs relative to the 21 responsibilities and relationships of the grantee, the RAG and the coordinator. And ri,.any months of staff work have now gone 22 23 into a statement which has been looked at by the steering 24 committee of the coordinators and has received the approval Ace -Federal Reporters, Inc. of the HSMHA grants office. And we will be getting out 25 53 It I hopefully within the next week or two weeks a statr-,-tnent on 2 0- IIAG, grantee and responsibilities and relati.onshi@)s 3 coordinator. 4 Now, we are aware thal- by making this statement 5 and it will be policy, there will have to be some modifications 6 in some of the RMP regions' by-liN,.,Ys and relationships. But 3-n 7 general this is 'what the director and HSM.HA and the steering 8 committee of the coordinator believe is appropriate. And 9 since it is rather lengthy, I won't read it into the record. 10 We do not have it for you today. We have been 11 working intensively to make such a deadline, but have been 12 unable to get the HSMIIA clearance in ordex, to do so. 13 The value of this, I will@ be that for once 14 there will be an opportunity for both the regions and their 15 organizational groups and ours to have a common document to 16 look at as we discuss problems which do arise in the various 17 regions. 181 In general, the key statement which has been itself 19 so easy to read and has taken so long to get clearance on, I 20 would like to read into the record because I think the rest of 21 it amplifies this statement. 22 The grantee organization shall manage the grant of 23 the Regional medical Program in a manner which will implement 241 the program established '--Jy the Regional Advisory Group in 4,ce-Federat Reportets, Inc. 25 accordance with Federal regulations and policies. 54 And then there are a of it@.oz describing in 2@ detail the role and responsibilities of the grantee, the 3 Regional Advisory Group and the coordinator who in this document 4 is also identified as the chief executive officer. And it 5 represents, I think, a major step fonTard. And there will be 6 some specific, isolated problems, but most of the problems 7 which have arisei are because of misunderstandings and lack 8 of agreement as to a common theme.. 9 So we do,hope that this results in better unders4.--andin@,s 10 and relationships. And over the course of the year, I am sure 11 the few specific problems will be able to be worked out on a 12 negotiable basis. 13 MISS @4DERSON: Pre you going to include the make-up 14 of the RAG and definitions of what consumer is? 15 DR. PPJIL: Not in this document. As we have- brought 16 before you at earlier times, there is a requirement by the 17 Department that more aspects of all HEW programs be put into 18 regulations. This is a mandate by the Secretary's office, 19 and we are proceeding as we develop these documents to tlen 20 couch them in broader, more general language in terms of 21 regulations. We are tnring to kecp the formal regulations 22 as broad as possible to provide maximum flexibility to both the 23 regions and ourselves and to use these statements to make 24 explicit what is understood and Intended and IISMIIA policy. Ace-Federal Reporters, Inc. 25 But the points you ,mentioned are not in this 11 5 r, I documi2@-rit and prc)l)r@@ly will be the! ':;LPb-iect of @@urther Work. 2 These take quite a while to get everybody to come to some 3 agreement on. 4 DR. 14AYER: When will these be released, Herb? 5 DR. PR-XL: It has been cleared by HSMHA. I would 6 expect in the next two weeks we would be able to begin 7 mechanically getting them printed and out. 8 The second point I would mention is that HSMHA has 9 now established a policy effective April 11 -- and this is only 10 for your information -- which now makes it a requirement, 11 places it as a requirement, on all IISIAHA programs to inform 12 the appropriate regional health director of anv proposed gravity 13 or contract to be r,@ie@de by L@IMSIIA in that II-RW region and to give 14 to that regional health director the opportunity to comment 15 upon prior to the final decision either grant or contract. 16 He is not required to submit comment, but he trust be provided 17 the opportunity to make comment. 18 It also is a requirement that once the disposition 19 has been made, either approval or disapproval and award level, 201 this information must be given back to the regional health 21 director. Obviously, this is in the interest of keeping him 22 better informed about all activities, whether they are managed Iin his office or not, but which come from HS@IHA. And we have 23 24 already implemented this relative to our grant activity in that ce- Federal Reporters, Inc. we are soliciting for current applications to go to the June 25@ 56 I Council, EIls apr@licaticn, the corc,,@,tiinity-ba-:.;ed educational 2 applications, mid also the ones before you. if there have 3 not been comments, we are so not.4.fy4-ng the regional health 4 director in providing him that opportunity to submit them 5 prior to this Jime Council. 6 And then we will be implementing this in an effective 7 way for the contract activities which the office of the 8 Director of PZIPS does engage in. 9 Now, I would like to turn to the last item. And 10 I am sorry there are so many things, but this is relatively 11 important. And with your permission, I would like to read to 12 you the importe-Tit aspec-tri because has not bc--@-n given to 13 You- And it is difficult for you to select out those 14 important paragraphs. 15 As Dr. Margulies indicated, we have now issued the 16 revised guidelines and local and national review procedures 17 for the kidney disease activities of RMPS. Dr. Hinman will 18 pick up where I leave off and will then lead into a general 19 discussion of these guidelines. But I would like to go over 201 the review process with you and as a matter of information for 21 you and also as part of our record read to you those parts which are pertinent to the review process and leave to Dr. 22 23 Hinman to then discuss the more general statement about the 24 kidney program objectives and specifics relative to th4-s Ace-Federal Reporters, Inc. meeting and kidney applications. 25 57 I There bc-on a xvel-y grca@,t z@,-notxn,@- of effort in 2 trying to develop this issuance and without going into that, 3 let me read to you, then, what the siimaary of the review 4 process at the local and the national level is which is 5 effective now and, therefore, pertains to the activities of 6 the meeting of this committee. 7 StartiAg off with the technical review process at 8 the local level and forgetting about initial discussions which 9 may occur between the region and MIPS staff as a concept for lo a kidney proposal develops, but starting with the technical 11 review process at the local level, the issuance reads: 12 Prior i-o st2.bm3-tti-.ng applicc3.tion for a renal 13 disease program, the W4P is expected to obtain a technical 14 review of the proposal by a group which has not participated in 15 the program's development. The technical review group must 16 be comprised of at least three renal authorities from outside 17 the geographic area served by the region. Payment of the costs 18,1 of such consultant services will be made by the requesting MAP. 19 The region may obtain the names of consulting renal 20 experts by calling the appropriate Operations Branch for 21 assistance. The Division of Professional and Technical Development maintains a list of renal consultants, and is 22 responsible for coordinating their assignments Should the RI,4P 23 24 desire to choose its own review panel, the names and curriculum Ace-Federal Reporters, Inc. vitae of prospective consultants must be cleared with the 25 I Division of Prolless4Lonal and Technical, 2 Technical reviews of renal px,ograNts need not 3 always be made by consultant site visits,, but may be accomplish d 4 by mail when appropriate. The RYX will negotiate any compromise 5 needed should conflicting technical advice be given by the 6 technical reviewers. 7 Forviarding Froposals - only those proposals which arE 8 recommended favorably by the local technical review group 9 shall be eligible for consideration by P.MPS. In addition, 10 an opportunity must be provided prior to consideration of the 11 proposal by the RAG for review and comment by the appropriate 12 CIIP @,genc@,, or agencies as reqi-,.,4,red by Section 904(b) of the 13 Act. 14 The RAG shall consider any CHP comments and comment 15 on the ability of the IULD to manage the kidney project without 16 hindering the development of the overall MIP program, and the 17 reasonableness and adequacy of the kidney budget proposed. 181 The RAG is responsible also for indicating how major issues 19 raised by the local technical review group will be resolved. Since kidney proposals are reviewed separately at the 20 21 national level, the RAG need not give priority ranking to 22 kidney proposals in relation to other nori-kidney PIIP operational 23 activities. Kidney proposals shall be considered by RMPS in 24 relation to national priorities. kce - Federal Reporters, Inc. The complete comments of the members of the technical 25 59 I review col,rl.,,rtittee,azid any CI-IP @c;c@ncy com@nc-,nts, must be included 2 in the forwarded proposal. 3 R,:4PS Staff Review - the initial review z;t RMPS shall 4 include: 5 a. The contribution of the project toward kidney 6 program objectives. 7 b. The completeness and nature of the comments of 8 the RAG. 9 c. Comments of CHP agencies. 10 d. The preferred met-.hod of fiLnding. 11 Pj4PS Review Committee - PLAPS staff will summarize for 12 the PU@,PS review coriun-I.-tt,,ze avc,4.1ab e information as to how -each 13 kidney proposal- proposes to support the National Kidney Program 14 objectives, and the substantive points developed through local 15 review processes by the Technical Review Committee, the RZTG, anc 16 the CHP agency. For those applications for which the RAG; 17 CHP a @ cy; director, RMPS, or RMPS Review Committee has 18 indicated a concern apart from the technical merits of the 19 project, the RMPS-Roview Conutiittee will be asked to make a 20 recommendation to the National Adviso271 Council. The R14PS Review Cor 'fically will not 21 .@r-ittee speci. 22 review on a technical basis the merit of the proposal, or 23 establish formal numerical ratings for individual proposals. 24 And, finally, section 6, Council Review - all kidney Ace-Federal Reporters, Inc. 25 proposals shall be submitted to the National Advisory Council 6 0 I for f;-nal recom,.itendition, in keeping with the categorical 2 nature of the kidney disease pro@ra,.@,t within Ri@iPS, the Council 3 will review and recommend funding levels for kidney proposals 4 separately from the funding level of the specific RMP. Kidney 5 program funding will be in addition to other PMP program fundin(,,, 0 Now, those are pages 3 and 4 of this issuance. And 7 I would like before we entertain discussion, because I think 81 this is not in the complete framework, to have Dr. Hinman 9 have distributed to you these which were just issued and perhaps,, 10 comment on some of the other features of this -- namely, the 11 framework of kidney program objectives. 12 DR. PJAYER-. Before we do that, cov.,3.d we talk about 13 the specific ..ro"&a of this ;,-aview committee 14 DR. PAHL: Of course. 15 DR. MAYER: -- to make sure we have got that under- 16 stood? 17 DR. PAHL: Of course, Bill. 18 Perhaps what I should do is indicate to you that the ig review co@mmttee responsibilities are on page 4, item 5, and 20@ if we can have Dr. Hinman come up perhaps the two of us 21 can try to respond together with Dr. Margulies to the questions that may be raised. 22 23 DR. I-IAYER: I guess my problem relates to how we 24 deal with this. We are not dealing with the technical aspects @ce-Fedeial Repofteis, Inc. of it. lie are dealing with its presumed relationship to the 25 6 1 tlia-@- col7r,-@ct@? 1 rest of the regional act 2 I am trying to get a, feel for wha,@- is our role 3 vis-a-vis the kidney projects. 4 DR. Pr-iHL: Wellp this issuance came about as a result 5 of the extended discussion at @ last committee meeting and 6 at the Council subsequent to that meeting. And perhaps in 7 order to abbreviate it, Dr. Margulies can reiterate, I think, 8 what was a statement to the committee that afternoon of the 9 second day and which has been embodied in the principles 10 enunciated here. 11 So let me ask Harold 12 DR. PI-IYER: I need to have a positive statement, 13 perhaps with examples of concerns apart from technical merits 14 which is what it defines as this and what kind of range is that 15 DR. MARGULIES: I think the most important issue here 16 is the one that we wrestled with over quite a period of time. 17 And that is the relationship betueen a proposed kidney activity 18 which may be technically satisfactory and a Regional Medical 19 Program which may have some problems with it. 20 At one time, we had been operating with, at least, 21 the iniplici4@- assumption that an PJ4P which was in real trouble 22 was probably not a very good site for the establishment of an 23 effective categorical kidney program. That appeared in many 24 ways to be as a general principle unacceptable ,aid unworkable. Ace-Fedeial Reportefs, Inc. 25 So what we would ask the revieNq conmittee to do with that kind 62 I of a question is essentially to opT.@rcite on review of kidney 2 activities by exception .-- by mF--anirig when you see 3 a kidney proposal which has gone through technical review and 4 is acceptable, but it is in a Regional iledical Program about 5 which you have some doubts, review committee should on that 6 occasion raise those doubts and make some kind of decision 7 about whether it is appropriate for that r@P and not ask itself 8 to carry out a technical review, to second the technical review 9 which has already been completed. So it really is action by 10 exception in those circumstances. 11 DR. MAYER: I guess my problem is I can conceive of 12 a Y,)oor IL@IP, if I can use that ter,-fl, having a superb, not only 13 technical, but superbly organized kidney effort. % I have 141 got that problem. And I am going to comment that that is a 15 miserable RM.0, and they have got a great kidney proposal in it. 16 And the PI-,IP ought to grow up to be as good a cooperative 17 arrangement as that kidney proposal. 18 Now, what have I done? I am having a tough time 19 dealing with what.is the role of this review committee in that 20 process and how do we get ahold of the data to deal with that 21 role? 0 DR. 14ARGULIES: I tl-Aink it is an extremely difficult 22 23 problem. We have gone at it two ways. In both instances, we 24 have felt uncomfortable with izhe result. There are at least 4ce-Fedetal Reporters, Inc. in our experience to date two possibilities in those circumstan c 25 63 I And that is exactly the kind of sitt@atic)n we are talking about. 21 one of them is a possibility -that the kidney program 3 will be the only thing in the activity which is any good. 4 it will be relatively large, it will not involve the Regional 5 medical Program in any kind of regionalizing activity and 6 under some circumstances, based upon your judgment of those 7 circumstances, might serve as an excuse for the P14P to go on 8 doing a bad job because they are doing something good with the 9 kidney activity, in which case you might decide no matter how 10 good the kidney activity is,the total result for the whole 11 region will be made worse rather than better. 12 The alternative probe,-bil2'.ty is that % kidney program 13@ which is put together which is truly regionalized and which is 14 designed to meet the needs of the population in the best 15 possible way may p@-ove a good vehicle in a weak program for 16 learning how to do things in c-m integrated, effective fashion, 17 and might be an additive stimulus to it. 18 There aren't any specific rules on that, Those are 19 the kinds of events you have to examine cn an individual 20 basis. And it is exactly that kind of dilemma which the review 21 committee, I am afraid, is going to have to deal with. I don't 22 know any sharp rules for it. 23 DR. MI@YER: Sister Ann Josephine. 24 SISTER %,NN JOStv,@DHINE: I call anticipate another Problc- @ce-Federat Repofters, Inc. 25 l@ where the consultants do not have to examine the project on 64 I site on a site visit, but can jl-;e con@,tiltc-d by I.,,i-ione or mail 2 or however. And I am becor.,@ing more exid more avia--e of the 3 fact that sometimes what is i,@,ritten and what actually 4 is quite different. And I c@,iii .,ee that the validity of a 5 technical review could be in question inder those conditions. 6 land I can even visualize the conditions. 7 DR. MARGULIES: These consultant visits will have to 8 be on site visits. We are act going to accept the paper 9 review'. 10 DR. HIN14AN: Harold, that is not what it says. 11 DR. MARGULIES: It doesn't? 12 SISTER P@ill 13 DR. MAPGULIES: WI-,Il, in that case, we have to reach 14 full agreement because I can't see just a paper review of it 15 either. There has got to be some site visit involved in this. 16 DR. HINI,@N: As the committee can tell, there has 17 been considerable amount of discussion, both within RIAPS and 18 between various committee mei-Lbers,, Council members, RMPS, 19 and various people in the field. And it was not until 20 Tuesday there was a final decision on most of these things, 21 the thought being on the ability to have a mail vote. And we 22 have in hand some technical reviews in which in Seattle at the 23 ASAIO meeting which was convened, a review committee on a 24 proposal for five members that were present there, and they kce-Fedefat Repofters, Inc. 25 discussed it thoroughly, but they had not site visited the I 65 I the region, whel.:ber this would suL'fice or not. It is very similar in the anniversary applications. 3 This body gits in review without hearing physically gone to the 4 region to site visit. 5 DR. PAHL: Sister Pnnl I believe that both of the 6 questions that have already been raised and those that will 7 come up, you really have the answer couched in this statement 8 by exception which is as broad as we could conceive it to be 9 and yet be helpful. And that is, %.:here the RAG, where the 10 CHP agency, where the Director and his staff, or where the 11 review committee has a concern apart from the actual technical 12 iftf--r-Lt of the prop,-salo then this rc,.r-'"evi corun.4.ttee is asked to 13 review the data and to mal@ a reccwm---Yidzition, 14 Now, the concern can be on any point. We felt there 15 were occasions when it would not be necessary to make a full 16 site visit because of recent actions by staff or Knowledge. 171 And we were trying not to bind every applicant into a specific. 18 We would imagine that most activities would involve site 19 visits, but we wanted to be free on that. But if there were 20 1a concern by any party to this review process that it weren't 21 an adequate, valid review, this committee is given the full 22 responsibility for raising that concern, having full information 23 from the staff, and making whatever recommendation it so 24 desires to the Council. Ace - Fedetal Reportets, Inc'I 251 It doesn't solve it poin.t by point, but that is the I 66 1 heart of the @,jhole i@sue in safeguax,diiig cit the national level 21 abuses that inadvertently may arise through local actions end 3 not seeing the total picture as the review corariittee might 4 here. 5 DR. SCIIERLIS: I am curious as to why the device is 6 used permitting the region submitting the kicL-tey project to 7 select its own technical review members. I would think that 8 if we carry that to the extreme, we should allow RMPs to 9 select their own site visitors. I think this gets t,,Ie 10 national Pj4PS in a position if they don't like a technical 11 review member to be in an embarrassing position to say no. 12 @vhy cc-ai't you just maintain your @,?n techriic4,a reviews? 131 I would think a local group could Utilize this 14 mechanism in ways which I think should not be part of the 15 national policy. I don't see the reason for...havi-ng them 16 initiate their own technical review when it should be done, I 17 think, through R-T-@,PS, Isn't that the responsibility of Pd4PS? 18 DR. 14AYER: Harold, before you answer, let me 191 amplify the question as I read it and as I heard it. 201 It is my underst nding that the major component of 21 the burden of technical review belongs to those local technical 22 reviewers who are brought in by the region from the outside. 23 Is thatnot correct? 24 DR. DL@RGULIES: That is right. Ace-Federal Reporters, Inc. 25 DR. MAYER: Then I think Loonard's question is a very 67 1 pertinent one. 21 DR. MPRGUL'L'ES: I thin k i4l-- is a pertinent one. 3 The difficulty we find ourselves in in following your 4 suggestion is that we are still trying to maintain some reasonallc 5 balance even in the categorical activities between a centrally 6 controlled activity and one whicti is locally developed. 7 You might raise the same question about technical 8 review for all activities in a Regional Medical Program. 9 The basic plan for non-kidney activities is the technical 10 review is carried out under the purview of the local Regional 11 Medical Programs selecting its own specialists and its own 12 con@ul,4-,ants, its own advisers,. 13 The -eason we have iRz-tdo an exception in the ki(Liev 14 activity is no more complicated than the fact it is almost 15 impossible to get technical review by people within the RIIP 16 without involving those who will be in fact in the project. 17 And all we are really aiming for is to make sure that those 18 who are not actively personally interested are involved in the 19 review. And so long as they select competent people, the 20 individual selection, it would seem to us, is reasonably 21 left in the region as it is with all other technical review. 22 DR. SCIIERLIS: Then you are particularly exempting 23 any technical review by this committee, are you not? 24i DR. 14ARGTILIES: That's right. Ace-Federal Reporters, Inc. 25 DR. SCHL.RLIS: I gLess I have to wrestle with that 6 8 It 1as our cha-i2--m@ doer,, 2 DR. 1,14YER: Let re M