Mr ll i stcareeaee ay SPECIAL ISSUE “FOR LIMITED DISTRIBUTION | enews. information A ‘éommiunication device _. _o designed to speed: | ror _ Ce , Py exchange of By - be ee Se we TES tg exelatize of Nees |. © CLARIFICATION OF KIDNEY DISEASE GUIDELINES 0 onal Medical Programs ©. oe a, TES De Sg, EE a ee and related activities. 3 September 14, 1972 - Vol. 6, Nos 16 “this. issue "presents clarification of the - "Kidney. Disease Guidelines - - ee ‘Guidelines and. Review Procedures Statement," issued in the May. 3, 1972. ep “dssue of News,” Information, and Data, Vol. 6, “No. 98.2 Three areas ae . are more fully, described in this issuance . m ‘ At “the request. of the Advisory ‘Council - at its meeting on Sune 5-6; 1972, a definition of full- time: transplantation surgeon is provided > Pediatric Ne shrology applications have been ‘refused by some RMP's | - ., «because of the wording in the Guidelines. A broader interpretation 7 4s proposed in. ‘this explanatory, statement. a — oe - Outside ‘Consultant Review of kidney programs is 5 required for anew | - Kidney disease proposal, and for subsequent years of its RMPS grant support. As a prototype for organized patient care delivery toa’. finite population, the kidney disease activity needs continued _ assessment with regard to progress made in treating identified - * patient population, program cost control, and achievement 7 increased financial independence . - Distribution: . Coordinators of Regional Medical Programs _ Members of National Advisory Council and Review Committee,on Regional Medical Programs . Staff of Regional Medical Programs Service . Regional Health Directors and Regional Medical Programs Service Representatives of Health, Education, and Welfare Regional Offices. . US _ DEPARTME NT OF HE PAL TH, EDU CATION, “AND WELFARE “Didic Hanlth Service © Health Services and Mental Health Administration ° Rockville, Maryland 20852 Continued Review of Kidney Disease Programs Technical Review of RMP Kidney Disease Programs After the First Application The kidney disease guidelines, "Kidney Disease Activities - Guidelines --and Review Procedures Statement" (News, Information, Data, May 3, 1972 - Vol. 6, No. 9S) require technical review of ,RMP renal programs by renal experts’ from outside the sponsoring Region.: The principal provisions are — contained in item 2, Technical Program Review, on page 3, under Review ‘Procedures. . , Questions have been raised by several Regions about the need to obtain | > ', this “outside technical review for kidney programs submitted as continuation . ~ applications. a a a i er ee The answer is, yes. Each application for RMP support’ for kidney disease program requires a peer.review by outside renal experts and the. incorporation of their:comments and subsequent Regional’ review actions asa part of the . “Region's submittals to RMPS. “The present state of development of end-stage kidney dialysis and transplantation therapies, and'the finite patient pop-- ulation involved, provides outstanding opportunity to establish a prototype for ‘delivery of sophisticated patient care. We believe that such a. prototype can have major implications in the overall pattern of delivery of other. advanced therapies. The requirement for continued technical review of. kidney — disease programs is a key factor to monitor the start-up, development and | coordination of renal programs carried out through all RMP's. As indicated in the Guidelines,’ critical. elements in the success of renal programs include . -costs through nonduplication of facilites. _ ‘patient access to care, control of >* Cand maximum utilization of resources, and the development of third-party sources for payment of patient care. 9 0 6 sg PD aseone The referral of outside technical consultants for kidney program progress _ assessment’ should be accomplished by, the same process as was followed in ~ ‘obtaining the initial outside review (see page-3, Kidney Guidelines). ° However, for these follow-up reviews only two (2) outside consultants are . : required. They will be selected, insofar as possible,’ from the reviewers. who performed the initial renal program technical review. These reviews usually | should be conducted on-site at the RMP, or grantee premises. Preparation for these anniversary technical reviews requires more than simply negotiating consulting time, place, and reimbursement. To adequately review program progress after the first and second. grant years,’ the technical re- viewers will need to be provided a statement of the program undertaken in the first year, the comments of the initial reviewers, a complete statement on program achievements (including numbers of patients treated, program staff development, costs of treatment services), and related information as is in- - dicated on page 2, May 3, 1972 Kidney Guidelines. The RMP submittal of the renal project report to RMPS should contain, in addition to the Form 15 summary statement and the RAG report, the review comments of the outside technical: consultants. | ee _ , Boe ay, : ok Le ~ hr. ee ee ety ere oR. | ao _SORTINENT, oN TE _DEVELORENT ¢ OF PEDIATRIC “NEPHROLOGY SERVICES ew guidelines. iy a disease programs were. Gssued. May’ 3, “i972, “which - lated to pediatric nephrology. cluded’ provision ‘for grant . applications re services: (News ,” Information, Data, ‘Kidney. ‘Disease Activities °-. ‘Guidelines * id Review" Procedures, Statement , UE 'May 53 1972, ‘Vols! 6; No. 198) 0 - The: ps ific. reference is. item di, on. age 7 , which states: eo NDediatric dialysis. and ‘transplantation services are. coordinated ith adult facilities: ‘to Provide optimal use | of . services. in some Regions. this statement has’ ‘been ee . reted:.to mean that: proposed pediatric nephrology services | must be. housed * jand_ extended. within adult nephrology. facilities. This-is an erroneous,» intrepretation and, we believe, one that could seriously circumscribe’ ‘the. ons xtraordinary | attention to. uniquely Pediatric problem eased end- stage. Pos al: care. to. children. requires. Se bt pas nyse te @ have ‘been advised that. i We: are not - prepared to offer a fixed definition of. “hat ‘eoordinated". iieans oe oS in*éach ‘situation. -Since, an estimated, total of only. 600 children.each year ~ T believed: to. be -good ‘candidates ‘for: dialysis and. kidney: transplantation, we. cannot - anticipate, ‘providing support. beyond. the development .of a,few.: Ve ehly. ‘centralized, pediatric nephrology units... The, ‘relation. of, these” services ° coe to. an adequate population base, and their reasonable coordination. with adult ~~ "nephrology. services, requires very judicious consideration. and should seldom ce be® addressed without “competent outside: counsel.” flare 4 agai lsg od ssible with established renal ee | vary (from pediatric: facilities physically adjacent ,: ‘spatially ,- ‘to adult - _ facilities, to. development of. services in a geographically separate. children’ S| = hospital: ‘The choice will: probably be deduced only after careful weighing. of needs and analytically relating service.costs to the special treatment a needs’ of pediatric. renal. patients, fora defined. service area. ree a ra “auniber: of carefully ‘structured applications ology services before we can ~ on 1 of services, to, The range of Ncoordinat ion" po ea We need opportunity to ‘conside: - for support of development. of pediatric. nephr .\ yprovide. clear answers” to. ‘the problems presented by: extens1t a this, patient. group. ime transplantation surgeon is a keystone to the for renal patients which we envision as both thin the existing state of the art. Without tive and efficient transplantation centers, — 11 stagnate at a level which emphasizes The concept of the full-t integrated system of care necessary and attainable wi conscious development of ‘ac care for terminal renal patients Wi closed-end dialysis care ‘at unnecessari -cost:to patients and with underutilization of available facilities... ly high psychological and. financial :, Definition of Full-Time Transplantation Surgeons | era the Kidney Guidelines issued May 3,:1972, included. the term "full TNC ne. Gplmegation surgeon." This, term is,clarified as, follows: A full time traps rGntation surgeon is defined as a surgeon who is comitted to the, oe “full-time, vocational conduct of pl iing, organizing and performing «. ee EO transplantation services. UND ne Re ret ae ae The phrase appears in item 6.b., page 2, of the "Kidney Disease Activities - 9 “Guidelines ‘and Review Procedures Statement," News, Information, Data, Bor aan “Vol..6,-No..9S, May: 3, 1972. "The full item, with imderscoring provided, . ig as follows: = ©"; ‘Transplantation facilities ‘are centralized-to: ~~. => a, limit duplication of high cost facilities and services. - “sb. assure maximum utilization of f 11l-time transplantation | >" Agurgeons. 0 CN Ue UN eo E ee C. “assure availability of complementary backup services © 0 0 Py -. required for special patient evaluations and treatment. 0 “3. d. provide the coordinating point’ for patient referral, as “Gonor-recipient matching, patient data exchange and organ Ssharing." The full item is repeated here because it reflects critical aspects of 0 3 _ the structure of end-stage kidney. disease service. programs which must be.~.: ‘satisfied before adequate patient access to care can be realized. Access“. to kidney transplantation already exists on the basis, that some surgeons can effect the kidney transplant procedure in a medically acceptable. manner. «There also exist sophisticated medical facilities in which a the necessary complementary, specialized departments and backup services. 2. are available to effectively support successful transplant operations.) © 00 The development of both of these components mist clearly be accelerated, =, - however, if we are to provide access «to transplantation of all of the medically. — - acceptable patients each year who suffer terminal uremia 0 ee Our experience with renal programs to date convinces us that without full-> - "time surgeon dedication to programs.of end-stage kidney patient care, the logistical and organizational problems of making available volume organ | Le .., grafts of high quality will not be surmounted in:the forseeable future. Many kidney grafts have been performed over the past 10 years. However, “in terms of annual institutional output, the events are typically in-. frequent and reflect an avocational approach which fails to address the - admitted shortage of transplantable organs, provides little input to .” organized research, presents no career incentive to students of surgery, “eludes effective contact by patient referral channels, and is incapable ~ -of routinizing the access to existing advanced clinical services or immu- - nology, pathology, psychiatry and others which the successful performance - of kindey transplantation therapy requires. . a a