Review Cycle: October 1972 #RMOOO AB R@IPS STAFF BRIEFING DOCU@IENT 910 APPLICATION Title: New York New Jersey Transplant Program Lplicant: The'Coimnunity Blood Council Director of of Greater New York, Inc. @O 'C@t: Louis N. Baker, Ph.tl). Funding Requested: Direct Indi rect Tota 01: 339,920 39,294 379,214 iO2: 288,038 38,155 .326,193 03: 177,725 27,270 204,995 Summary: Applicant propos-es a cadaver kidney organ procurement program to be developed in the Greater New York Metropolitan area, with full participa- of NYM/@T, New Jersey R@T, and Nassau-Suffolk RMP. The program is an outgrowth of several years' planning by NYM/RMP and with institutions- and a developmental grant given to the New York Blood Center for the period July 1, 1971 - December 31, 1972. Program objectives are: (1) to increase the supply of organs from the present 50/year to 400/year by the end of the third year; (2) provide a coordinating network for organ procurement, preservation, and distribution among 14 transplant hospitals, 5 org an preservation laboratories, 6 tissue- typing lab6ratiories, and other hospitals; (3) establish professional and public educational programs (4) develop third-party payment sources and, (5) develop complementary research programs to be supported by other than @RMP sources. The basic proposal complied with the review provisions of the Kidney Disease Guidelines, but was not fully responsive with regard to funding and cost elements, development of third-party support, and specification of committed cooperation. A program assistance visit was arranged and conducte on September 20 to discuss these factors. A supplement to the proposal was received on October 5, which proposed a funding period reduced from 5 years to 3 years, less total program grant cost, and a sharper decrement of RMPS . The Supplement also ed support provides a response to other issues rais by the staff visitors. DEPAI@TN4EN'I' OF fill@AL'FH, EDUCATION, AND WELFY@RE ivi'Li@iORANDUM 0 13Ul3f,lC] HEAL'I'l-I SF,"RVICE HEAI,'Fll AND NfENTAf I-IEALTH-AD,\]@INISTRATION TO Deputy Director, DOD -DATE: October 12, l@972 FROM Senior Health Consultant, PPTD SUBJECT: Staff Corm-aents on the 910 Application, New York - New Jersey Transplant Program Staff review of the original prorosal elicited a number of significant discrepancies with the Kidney Disease Guidelines. labile the review processes were complied with, we observed conflicts with policy stated and implied in R@MS guidelines. A program assistance visit was arranged on September 20, and on October @ a.Supplement to the application was received as d response to matters disciassed.at the meeting with staff. Partici ants in the meeting are listed in'the Supplement. p Major points of discussion at the program assistance meeting included: 1. The proposed 5-YeAr funding period and overall high cost. 2. Failure to reflect early development of support from third parties. 3. The strength of the commitments to the program by existing organ procurement groups. 4. Specific budget items such as the cost of organ procurement, the size of the educational program, and the inclusion of osts tems normally included in overhead. 5. Possible involvement with other organ procurement networks. 6. Involvement of other renal transplant and dialysis activities in those regions. The RMP participants generally accepted the criticisms with good grace, and expressed willingness to provide more specific information requested, including a reduction to 3-year M-TS support. Two items were not resolved to the full satisfaction of all: a) the cost of donor-organ re covery, which is double the amount recommended elsewhere; and, b) the efficacy of substituting educational efforts for direct Surgeon involvement in developing organ-donation and recovery sources. Deputy Director, DOD 910 Application Page 2 Statements made in the meetin@ were in direct opposition to previous tofoi-e obtained. As a part of experience and expertrenal advice here the discussion of these factors, staff were troubled by the fact that neither dates nor minutes could be produced regarding meetings of the Transplant Advisory Committee. 'The Supplemental document represents a significant realignment by the applicant, but is not entirely satisfactory to staff in the following ways: 1. The decrement of @S support is not as sharp as it'stiould be, being only 14% in Year 02 and 46% in Year 03. The@statements in the application may not accurately reflect-the early potentia for third-party support. Another New York @egion has reported that Medicaid has already agreed to reimburse for donor organs, and only the amount of such payments is to be established. Another &astern MQ has influenced the Hospital Insurance Council to advise its constituents-of its agreement with the concept of reimbursement for organ donatio-ft@. The Blood Center appears unnecessarily cautious with regard 'to the need for immediate intensive efforts to obtain third-party program support. 2. The program sponsors appear to be relying too heavily on educa- tional activitieslt6 increase the supply of organs. Their affir-- mation at the site visit, that the outside renal Consultants favored educational activities in preference to dedicated surgeon efforts in organ procurement, is'in contradiction to advice given heretofore. 3. The Blo od Center's interest in ultimately becoming a multi-organ source is not reflected in its refusal to accept developmental costs, such as renovations. At the same time, the Center is apparently asking full first-year support of its tissue-typing laboratory while it converts from research grants support to a service facility. 4. The Supplemental proposal has not clarified the intention, stated at the site visit, to reduce the number of service ti.ssue-typing laboratories once the Blood Center's laboratory is converted to a service operation. We are asked-to support a 6th tissue-typing laboratory which has not yet performed service activities, and with regard to which there is question regarding u ta te accep- tance as a major center by transplanters. As you know, in later,seeking to clarify some of the purported Consultant advice which appears to contradict previous tranplanter posture, we encountered potential problems which could affect successful implemen- tation of this proposal. Perhaps there will be opportunity to discuss this further in Council toward clarifications acceptable to all involved parties.