THE OPTIMAL FACILITIES NECESSARY f o r DIAGNOSIS AND MANAGEMENT o f PATIENTS WITH END-STAGE RENAL DISEASE T a b 1 e o f C o n t e n t a I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II. DEFINITION AND IDENTIFICKTION OF 3 END-STAGE RENAL DISEASE . . . . . . . . . . . . . . . . . a . o III. RESOURCE CAPABILITIES DESIRED FOR END-STAGE RENAL DISEASE . . . . . . . . . . . . . . . . . . . . . o - . 4 A. Background . 0 . 0 . . & . . 0 0 0 . 0 a 0 . . . 0 . . 0 0 0 . 0 . . 0 4 B. Planning and Determination of Need . . . . . * 0 0 & a . & a . 0 # 0 6 5 C. Resources Desired for End-Stage Renal Disease . . . . . . . . . . . . 6 1. Primary Treatment and Diagnostic Centers . . 0 & . . . . 0 . . . . 6 2. Secondary Treatment and Diagnostic Centers . . . . . . . . . . . . 8 a. Yedical services . o - o * - - o . . . . . 8 8 b. Other health professionals . e . o . o . . * . . . * C. Special units or facilities . . . . . . . . . 0 . . . . . . . 9 3. Tertiary Treatment and Diagnostic Centers 0 . . . . . . . . . . . 9 a. Medical services . . . . . 6 0 a . . 0 . . * . . . . . . . . 0 10 b. Other health professionals . 6 * . . . . 0 . 0 . 0 . 0 . . 10 C. Special units or facilities . * * 0 0 . * . . . 0 . . . 0 . 11 D. Role of Professional Services . . . . . . 0 0 . . . . . . 9 . 0 . . 0 12 1. Department of Yedicine 0 0 a . 4 . 9 0 * 0 * * 0 . 0 . . . * 12 2. Department of Pediatrics With a Division of Nephrology . . * . 0 0 . 0 0 . . * 0 a . . . 0 0 0 . 13 3. Department of Transplantation . o 0 . 0 0 0 0 0 0 0 . * . . . . 0 14 4.. Department of Urology 14 - * * 0 0 * * - * 0 0 * # 0 0 * - * 5. Other Professional Servic;s*and Their Roles in the Tertiary Center . . . . . . . 0 . 0 6 0 # . . # 0 e .15 a. Department of Radiology With Capabilities in Nuclear Medicine . * . . . 9 . o . . . * o . . . o . . . 15 (1) Personnel . . . . . . 0 6 . . . 0 . 0 0 . # 0 . . . . . 9 15 (2) Facilities . . 0 0 . # 0 0 * . . * 0 . . . * * . 0 15 b. Department of Pathology . . . o . 0 . . 0 . 0 . . 0 e 0 . 0 t 16 (1) Personnel . . . . . . . . . & e 0 0 0 . 0 . . . . . . . . 16 (2) Facilities . . . . . . . . . 0 0 0 a * 0 0 0 . 0 # . 0 . 16 c. Department of Clinical Pathology or of Laboratory Medicine o 0 0 0 0 17 (1) Personnel . 0 0 0 0 . . . . . . 0 0 0 * 0 0 . . . e 0 . 0 17 (2) Facilities . . . . . . . . . . . . . . . . . . . . . . . 17 d. Dep!artment of Nursing . . . . . t . 0 . * . . . . 0 . 0 . . 0, 18 e. Supporting Resources . o . . o o . . o . * o . . & o . . . o * 18 E. Resource Coordination and Communication . o . o . . . . . . o o . . . 19 F. Evaluation of Quality of Care . * 0 # 0 . a . 0 * . . 0 0 0 20 Table of Contents -Page 2 --I END-S-AGE RENAL DISEASE . . . . . . . . . . . . 20 IV. THERAPEUTIC RESCURCEO F'-3. ,)O A. Adult Hemodialysis Resources . . . . . . . . . . . . . . . . 1. General Considerations . . . . . . . . . . . . . . . . . . . . . . 20 2. Classification of Progra@ and Facilities for Hemod'alvais . . . . . . . . . . . . o . . . . . . . . . . . . a. General coi@iderations . . . . . . o . . . . . . . . . . . . . 22 b. An artificial kidney complex . . . . . . . . . . . . . 0 . . . 23 (1) General Considerations . . . . . 4 . . . . . . . . . . . 2-@l (2) Functional Coirponents . . . . o . . . . . . . . . . . . . 24 c. An affiliated hemodialysis program . . . . . . . . . . . . . . 26 d. An in-hospil-al dialysis program . . . . . . . . . . . . . . . 27 3. Services of Programs and Facilities for Hemodialysis . . . . . . . . . . . . . . . . . . . . . . . . . . 27 a. Artificial kidney conTlex . * . . . . . . . . . . . . . . . . 27 b. A self-dialysis training program . . . . . . . . . . . . . . . 29 c. A limited care dialysis program . . . . . . . . . . .. . . . . 29 d. An affiliated hemodialysis pro-ram . . . . . . . . . . . . . . 30 e. in-hospital dialysis programs . . . . . . . . . . . . . . . . 30 B. Pediatric Heniodialysis Resources . . . . . . . . . . . . a . . . . . . 30 1. General Considerations . . . . . . . . . . . . . . . . . . . . . . 3" 2. Classification of Program and Facilities for Hemodialysis of Children . . . . . . . . . . . . . . . . . . 31 a. General.considerations . o . . o . o o . . . . . . . . . . . 31 b. Tertiary ped-,atric hemodialysis complex . . . . . . . . . . . 31 3. Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 C. Transplantation Resources . . . . . . . . . . . . . . . . . . . . . . 33 1. General Considerations . . . . . o . o o . . . . . . . . . . . . . 33 2. Essential Requirev*nts . . . . . . . . # . . . . . . . . . . . . . 34 3. Services . . . . . . . . . 0 . . . . . * 0 . . . . # 35 4. Staff Fequiret@nts . . . . # . . 0 . . 0 . . a . . . 36 a. Medical . . . . . . . . 0 . * 0 . . . . 0. . . . . . . . . 36 b. Nursing . . . * . . # . . . t 38 c. Technicians . . . . . . . . . 38 d. Social worker . . . . . . & . . . . . . . . . . . . . . 0 0 0 39 e. Dietitians . . . . . . * . 0 * * . # . . 39 f. Vocational counseling 0 a 0 0 0 0 a . . 39 g. Clinical and administrative personnel . . . . . . . . . . . . 39 5. Physicial Facilities . & 0 a 0 . 0 0 0 * . 0 * 0. . # 0 . . 0 . 39 V. APPENDICES . . . . . . . . . . . . . . . . . . . 9 o . . . o . & . . o 9 o 41 1. INTRODUCTION Uremia, or end-stage renal disease, is responsible for significant patient morbidity and mortality in the United States. Uremia respects neither age, sex, race, nor socioeconomic background. Although precise figures are not available, it is estimated that 10,000 patients die each year even with treatment modalities available. This lack of availability of care is not restricted to any specific geographic or economic group. This seems to be a deplorable situation when one considers the great advances made in the management of end-stage renal disease. Now we have two complementary thera- peutic approaches, i.e., renal transplantation and dialysis. Unfortunately, because of a lack of adequate resources as well as a unified plan to combat these diseases, there has been a great delay in.the develop- ment of centers for therapy, Therefore, it is essential that a plan be formulated for a concerted attack on chronic end-stage renal disease, and that technological advances be applied to all patients in need. Attainment of such a goal would result in the rehabilitation of the many patients who would otherwise be lost during their most productive years. The National Kidney Foundation, under contract from the Regional Z*dical Programs Service of the Department of I*alth, Education, and Welfare, convened a committee selected for their knowledge of the special problems related to renal disease. The names and affiliations of the members of this committee are listed in the appendix. In addition, a number of consultants were called upon to review the final draft of this document. This committee was charged with establishing the criteria for optimal care for patients with end-stage renal disease. 2 it became,immediately appa-ent that two inVortant concepts would pervade this document. First, the ultimate care for patients undergoing hemodialysis or renal transplantation requires highly developed medical facilities which are not as yet available in many regions of the country. It is appreciated that such facilities are not necessary for many patieits who are undergoing hemo- dialysis or who have a functioning transplanted kidney. This group of patients can and should be cared for by the primary physician working in concert with consultants who have expertise in the many and varied aspects of the management of patients with end-stage renal disease. Secondly, an equally itr@ortant concept deals with the integration and coordination of delivery of care in an organized wanner and to provide a mechanism for the primary physician to have available multidisciplinary con- sultation and assistance. Such a system integrates patient referral, patient registry, dialysis, organ procurement, transplantation, laboratory services, and continued patient supervision. With these concepts in mind, this report attempts to develop the guidelines for a coordinated regional system capable of delivering optimal care to all patients with end-gtage renal disease, and,furtherto promote an effective planning document for different communities and regions to assess their indi- vidual needs and effectively deliver high quality medical care. While this document describes the necessary framework for an effective system, it is not intended to explore in depth all the areas alluded to within the system. -Plans are being developed to further elaborate and expand these 3 guidelines to include other aspects of renal disease such as prevention, diagnosis,and therapy. In addition, with the advent of never knowledge and greater experience, significant advances will be'.made in our understand- ing of diagnosis and management of patients with renal disease. As these advances are made, more effective methods of caring for patients with renal disease will be developed so that these guidelines will, by necessity, be modified from time to time. In conclusion, I would like to express my gratitude to all the members of the committee and the consultants who gave so willingly of their expertise and contributed so much of their time to complete this project. II. DEFINITION AND IDENTIFICATION OF END-STAGE RENAL DISEASE Irreversible, far advanced renal.failure, or so-called end-stage renal disease, is defined as that stage of renal functional impairment which can no longer be favorably influenced by conservative management and which requires dialysis (hemo- or peritoneal) or transplantation to maintain life and health. The diagnosis of end-stage renal disease may need to be established or confirmed through: A. The distinction between acute reversible renal insufficiency'la'nd chronic renal disease. B. The exclusion of'certain chronic systemic or localized disorders of the extrarenal or intrarenal vasculature, renal parenchyma or urinary excretory system which might be corrected by medical or surgical treatment. 4 C. The observation nr,6 -,,@nitoring of the patient with progressive loss of renal function frcv. renal disease of known or unknown etiology, with demonstrated failu."e of the process to stabilize or improve despite all reasonable and apprcoriate therapy. To assist in a twre uniform description of patien@-s with chronic renal disease, attempts should be made to use ti-e criteria recently developed and subsequently modified by the Council on the Kidney in Cardiovascular Disease of The American Heart Association (Appendi:< 1). 111. RESOLJRCL' CAPABILIT7LES DESliED FC,R END-STAGE RENAL DISEASE A. Background The advances in r,;ed4-cal kncwledqe and the "hardware" of mdicine now permit utilization of renal transplantation and chronic intermittent hemodialysis as established therapy for chronic renal failure. It seems fundamental that Lhe organization of a system of health care delivery for patients with etid-3tage renal disease'rrust permit effective manage- ment of the patients problem, the best possible expenditure of medical resources, and the acct-nulation of as mch new information and knowledge as possible. Withir, any system designed to care for all patients with terminal renal disease, it is apparent that various factors Tmst be care- fully considered durir.,,7 planning and the early implementation phases. T e need for approor@ate public and professional awareness of the various aspects of this systeni is of areat inmortance to insure ease of access to the system for a variant, as well as to insure the availability o n7ultidiscipli,-,a@, consultation to the primary physician. In addition, to insure continued optimum care for these patients, a mechanism of review should be izTle@-nted so that the various components may be reevaluated and n C-oord' 017 'vie'w E%.aluatio 17IG,URE 1. Schematic representation of patient.flow in the health care system for end-stage renal disease described within this document 5 modifications are introduced. Finally, it replaced as-newer concepts and is important to realize that many patients undergoing dialysisor who have a well-functioning transplanted kidney generally, can be cared for by their primary physician, The in-depth expertise usually found in the tertiary centers are actually required by only a few dialysis patients and by those patients undergoing a renal transplantation. In the ensuing sections, these aspects of this health care system will be described. B. PlanniM and Determination of Need The importance of the developmental aspects of an effective system for diagnosis and treatment of patients with end-stage renal disease cannot be overemphasized. Paramount among the considerations made in the development of such a health care system should be: 1. The determination of the potential patient population and region to be served. 2. The evaluation and appraisal of those resources currently available to the renal team and the primary physician. 3. The determination of the number, type, and location of facilities needed for optimal patient care. 4. The effectiveness of treatment in terns of patient rehabilitation and restored productivity. 5. The development of an effective information and communications system to assist in accomplishing goals 1 through 4. A registry and use of common classification and data collecting system in selected areas of disease reporting will greatly improve disease classification and treatment evaluation. 6 C. Resources Desired -,@or End-Staae A- Renal Disease l. Primary Treatr@n,@ ai-,d Diagnostic @nte-.3 The primary treatment and diagnostic center will be the local physician whether he be a faraily practitioner, an internist, a pediatrician, a nephrologist, ,-tc. @ will be in mary instances the physician who was first consulted by the patient with end-staq.e renal disease. This physician wil'L be responsible for (1) the primary evaluation, (2) the initiation and the foll@o@p of all diagnostic procedures, and (3) the i-,ii-l-Lallicn of appropriate therapy. Howev2r, if it is the opinion of the P-rl@mary physician tiat adequate diagnostic and treatment facilities are -ct- Immediately available, he will be in a position to refer the patient to appropriate diagnostic and/or treatment facilities. Depending upon the individual situation, this may be the secondary or tertiary center. The development of the capacity to include the primary physic-'@-an ar, a member of the Pealth Care Team is most important. The two therapeutic modalities requiring more complex facilities are transplantation and @modialys-I.s. The forTrer, because of its nature, requires th.2 services of the full Health Team and as such should be confined to tertiary centers. The latter, however, ranges in com- plexity frGvi dialysis, in the immediate post-cransplant period requiring tertiarv facilities, to the stable, medically well, and sociop8vcholo-ically rehabilitated individual dialyzing himself at home with the assistance of a companion. 7 Certain general principles must govern the care of a dialysis patient as he becomes ill and requires hospitalization, moves in and out of a transplant program, or as his needs change from time to time for more or less complex facilities. At any one point in time the goal is to secure optimum care ci-, -nsurate with the patient's medical, pay- chological, sociological, and economic needs. Ideally, the least expensive most "normal" type of setting for treatment consistent with medical demands should be available. For this reason, multiple steps away from the most complex (most expensive and personally threat- ening to the patient) facility are required in his health care system in order to permit ready movement up and down the scale as his medical condition warrants. To facilitate patient movement, cooperation and communication between all components is mandatory. That is, every patient must have a 'clearly delineated course open to him which permits movement to the most complex medical capability as the need arises and insures his ability to move back. This requires one physician to be responsible for the general health care of the patient, who is knowledgeable enough concerning dialysis and transplantation to rec ognize the need of the patient for a more complex treatment facility if and when the need arises. In addition, the physician must be involved in the system to such an extent that he will be able to secure this care. in less populous areas, this physician must be the primary physician. in more populous areas, it is likely that the combined effort of a primary physician and nephrologist, or the latter alone, will assume this role. 8 2 t,@nt and diagnostic centers refers to the local The secondary t--ea 0 general hospital that will be in the position to provide more definitive diagnostic and treatment resources. T@.ase centers may also have the capabilities to provide conservative Management of the patient with ter-,n-,-nal renal disease wit',i appropriate nutritional and radical prcgram3. Furthermora, these centers way have the capabili- ties to provide the patient with chronic maintenance dialysis in a setting that will permit continued care bv the pri@ry physician as well as optimal rehabilitation. It should be anticipated that there exist commnicaticn ties between the secondary treatment center and the tertiary center for pu,@cses of providin- transplantation, as well as additional consultation if needed. The composition of secondary centers snould i-iclude an int--c,,rated Fealth Care Team, consisting of: a. Medical services (1) Prir.,.ary physician (2) Consultin- rephrologist (3) Consu'Ltiip, urologist (4) Consulting transplant surgeon (5) Consult-?i,-- radiologist (6) Consulting pathologist (7) Consulting psychiatrist or psychologist b. Other health professionals (1) Nursing service (2) Social service workers 9 (3) Vocat4.onal rehabilitation (4) Nutritionists (5) Technical personnel necessary to operate special units or facilities C. Special_units or facilities (1) Capabilities to perform chronic maintenance hemodialysis as needed to deliver optimal care to Datients with end- stage renal disease within a specific area. This my include capabilities in home or self-care hemodialysis training, limited care dialysis, and backup in-hospital dialysis for patients requiring hospitalization. (2) organ procurement and preservation facility in support of the regional procurement-preservation program is desirable. (3) An information and communications system linked to the regional system is necessary. 3. Tertiary Treatment and Diagnostic Centers The purposes of the tertiary center should be (1) to provide capabili- ties in transplantation, and (2) to be available for consultation, when necessary, to the primary physician and/or the secondary center to assist in the optimal management of the patient with end-stage renal disease. Since patients with end-stage renal disease may have couplex medical problems with multisystem involvement, the tertiary centers provi ing transplantation as well as consultation should have available broad 10 --s capabilities, i- 1 -@-f3iciiie, suraer,;, and related subspecialti COT,Iposition oz such a tertiary center might include: a. @dical services (1) Deoart@-@.nt of @dicine with a Division of Nephrology (2) De,,artx@e7it of Pediatrics with a Division of Nephrology (3) Dapa-rtm,-,ii- of Transplantation or Departrent of Surgery with a rjiv4.sion of Transplantation (4) Depart-,w-,it of Urology (5) Department of Radiology with an associated Division of Nuclear @diciiie (6) Depare--,ment of Pathology with special capabilities for interpreting kidney tissue by li-ht, fluorescence, and electror.mi-croscopy (7) Depa,-@-iT,--nt of Clinical Pathology or of Laboratory Y--dicine (or other-,i4-se structured) with capabilities in Clinical Pathology, Microbiology, Virology, lmmnology, Fematology ' Cos. any -ulation, Blood Banking, Chemistry, and other diagnostic laboratory services (8) Departu.,ent of Neurology (9) Depart@-nt of Psychiatry with an affiliated Clinica Psychology Service (10) of Physical @dicine b. Other health professionals (1) Department of Nursing (2) Scction of Social Service (3) Section of Vocational Rehabilitation (4) Section of Clinical Dietetics (5) Technician services in various diagnostic and laboratory areas C. Special units or facilities (1) Transplantation Unit and/or Intensive Care Ward (2) Transplantation Clinic (may be separate from, or part of, the Renal Clinic with a transplant-dialysis consulting group) (3) An In-Hospital Dialysis Program in association with, or as part of, the Transplant Unit (4) An Artificial Kidney Complex (5) Renal/Transplantation Clinic (6) Laboratory for special procedures relating to diagnosis of renal and electrolyte abnormalities (7) Renal Physiology and Nephrology Research Laboratory 8) Blood Bank, Tissue Typing, and Clinical Immunology Facility in support of Transplant Unit capable of measuring lymphocyte antibodies (tissue typing may be regional) (9) Organ Procurement and Preservation Facility and Service in support of Transplant Unit (This could be on a regional basis.) (10) An Information and Communications System with linkages to various dialysis facilities in its region 1 2 D . Role of the Professional Services Advances in the ir-anage..@nt of patients @4ith chronic renal disease have resulted primarily through application of fundamental knowledge gained in many disciplines including renal physiology, pathology, immunology, pharmacology, and biochemistry. Capabilities of professional services in a tertiary treatment center should include: a. Full-time clinician-te-achers with inpatient and outpatient facilities necessary for the care of patients with a wide variety of medical and surgical problems. b. A D4-vision of Nephrology with broad capabilities which might include in addition to the above: (1) The availability of a faculty trained in renal physiology, pharmacology, pathology, biochemistry, immunology, and water and electrolyte metabolism at clinical and laboratory levels (2) A neplirology research laboratory (3) A research training program in nephrology (4) Residency and fellowship program in nephrology (5) Laboratory for special procedures relating to diagnosis of renal and electrolyte abnormalities (6) A renal clinic for consultations and management of complex problems in renal and genitourinary medicine (7) An artificial kidney co!aplex 13 2. Department of Pediatrics With a Division of NephrolM Children who have end-stage renal disease face the following special problem: a. The diseasealeading to renal failure often stunt growth and impair development. For that reason, earlier detection of children who might develop renal'failure is important. b. Transplantation is a goal in therapy in the case of virtually all children. Following transplantation, however, both growth and development (social, not intellectual) may be modified. c. For these reasons, and because dialysis also is associated with less than optimal growth, dialysis and nutrition supervision in children must be especially comprehensive. d. Children are dependent members of a family, competing with other members of the family for resources of time, money, and energy. Their disease should have the least possible adverse effect on other members of the family. e. Because children, by definition, are affected prior to completion of their maturation, and because an increased life expectancy is a rational goal for all, the followup care into maturity must be continuous and comprehensive. f. The number of children so affected is probably limited to 400-600 new cases a year in the United States. For these reasons, the organization of centers for children under the care of a "renal failure" pediatric nephrologist will differ both in design and delivery system, and in the number required. Transplants- tion of children should be restricted to those transplant centers 14 having a Pediac-Ic Renal Failure Unit or to a center with a qualified . L pediatric nephrologist who can coordinate care with a Pediatric Renal Failure Unit aid its information system. 3. Department of, or Division of Tran-gi)iantation Centers performing transplantation should flave a separate Department or Division of 'Lransplantat4-on headed by a transplant suraeon. The transplant sur,,eon, whose basic sur-ical training may be in general sur-ery, uroio-y, vascular surgery, etc., rmst have special training and competence in transplantation medicine and surgery, as well as a full-ti--e Another surgeon, whose basic training may be in one of the areas enu@-ra'Led above, should be a member of the team on at least a 50-percent basis (see Section IV,C,4). in addition, the transplantation program mist have ready access to those various com- ponents, such as tissue typing, organ procurement, etc., as subse- quently outlined in the section on transplantation. 4. The participation of a urologist is necessary in the diagnostic evaluation and assessment of the patient and for the development of medical and surgical treatment regimens for renal and genitourinary problems . Pereover, the expertise of the urologist is necessary for the care of the patient who has a disorder of tie bladder or collecting and drainage system. 15 5. other Professional Services and Their Roles in the Tertiary Center The evaluation of patients with impaired renal function requires the expertise of the adult and pediatric nephrologist and urologist with strong support from colleagues in multiple disciplines in clinical and laboratory medicine. Complexities of techniques and technology alone require that many specialized facilities be developed in other departments. It is understood that any minimum criteria for specific services must be regularly reviewed so that any demands which are restrictive or archaic may be deleted. Accordingly, these professional services for end-stage renal disease patient care might include: a. Department of Radiology With Capabilities in Nuclear )*dicine (1) Personnel (a) Full-time coverage by Board-certified radiologists and specialists in nuclear medicine (b) Residency training program in radiology (c) Professional and technical personnel skilled in special procedure radiology and nuclear medicine, particularly as related to the renal and genitourinary systems, cardiovascular hemodynamics, and angiography (2) Facilities as required to accomplish: (a) Radiologic studies such as roentgenograms of the chest, abdomen, excretory urography, nephrotomography, and retrograde pyelography 16 (b) Mobile chest and abdominal roentgenogram (c) Laminagraphy (d) Visceral angiography (e) Cine cystourethrography and other procedures requiring cine capability (f) Fluoroscopic facilities to support percutaneous renal biopsy activities (g) Renal scans and rapid sequence scintiphotography (h) Isotope renography , (i) Radioisotope renal function testing b. Department of Pathology (1) Personnel (a) Full-time coverage by Board-certified pathologists with at least one member with special knowledge of renal diseases (b) Residency training program in pathology (c) Pro@@essional and technical personnel skilled in special procedure pathology, particularly as related to the renal and genitourinary systems (2) Facilities as required to accomplish: (a) Yiorphologic and histologic studies of renal tissues Electronmicroscopic examination of renal tissue, as indicated, must be availab e. (b) Necropsy examination of huiran and animal tissues (c) Experimental pathology laboratories sufficient to sup- port research studies on cells, tissues, or whole animals 17 c. Department of Clinical Pathology or of Laboratory Medicine (1) Personnel (a) Full-time coverage by a Board-certified clinical pathologist or other individuals) legally qualified to operate such a laboratory. The laboratories involved must meet qualifications of State and Federal licensing* (b) Full-time coverage by other specialists in clinical pathology or laboratory medicine including specialists in microbiology, virology, coagulation and special hematologic disorders, nuclear medicine, and other sub- specialty laboratory areas likely to be required in renal and genitourinary medicine. (c) Residency or graduate training programs or both in the various disciplines of clinical pathology or laboratory medicine. (2) Facilities as required to accomplish: (a) Routine hematology, urinalysis, serology, blood bank procedures, routine chemistries, and certain other laboratory procedures commonly required in a nephrology center (b) -Cultures for aerobic and anaerobic organisms and anti- biotic sensitivity testing (c) Radioi=mno assay (e.g., angiotensin and parathyroid hormone) 18 (d) Tigst-,.-- culture for routine viral studies, complement fix--tion test, and other related studies (e) Special coagulation studies and other aspects of specialized hematology (f) 14orphologic and histologic examination of tissue at a l'Aoht and electronmicroscopic level with im=nofluor- eseeiit studies (might preferably be acc @14-shed in the Depa.-t@nt of Pathology, as defined earlier) d. Deoartment of Nursing For an effecti-@ program, active in,,zolvemnt of nurses with specialty t@-a4-n4@ng in the care of adult and pediatric patients with end-sta,",e renal disease is essential. Nursing participation in dialysis and transplantation units is mandatory for effective operation of these units. e. S esources Institutional capabilities in neurology, ps chiatry, clinical y psychology, i,@nology, rheumatology, cardiology, genetics, nutrition, infectious diseases, physiology, pharmacology, ophthalmology, radiation therapy, and in the various surgical, pediatric, and medical subspecialty pro.-rams should be available. indeed, professional personnel and facilities for neurologic studies (to include electroencephalography and electromyography), psychiatric and psychological evaluation, and other aspects of overall patient investigation and tmnager..ent must be available to the medical and surgical renal team as part of the overall institu- tional commitment to a center for the care of patients with end-stage renal disease. 19 E. Resource Coordination and Communication Integr tion of the primary professional services in medicine, pediatrics a urology, and surgery with the primary physician and nephrologist will assure consultation in all instances where renal failure is to be managed by dialysis or transplantation. This will provide the beat therapeutic approach for the patient, as well as permit interdisciplinary planning for immediate and long-term management of the patient and appro- priate use of facilities and medical manpower in the secondary center and the tertiary end-s,tage renal disease center. In addition, because of the complexities of treatment programs, requirements for the processing of large volumes of data and the necessity of close and careful communication between the staff of the tertiary center, the secondary center, and the primary physician, each region should have available'a system for informa- tion storage and retrieval which might be a part of a national network. The development of such a renal registry for all patients with end-stage disease could assist in the daily management of the patient, in the monitoring of ongoing programs, in planning for new and developing pro- grams, and in more effective and rapid distribution of information and knowledge valuable in program development and operation. In addition'. this sys tem would be used as the source of information for patients awaiting transplantation within a region. Specific efforts shou e directed toward,the development of a national communications linkage as it relates to all patients with end-stage renal disease, in order to gain maximum utilization of medical information generated by these programs and to insure that patients awaiting transplants will receive matched kidneys. 20 F. Evaluation of Care The evaluation of a regional heal th care delivery system for patients with end-stage renal disease is necessary. A system of ongoing and/or periodic assessment of the various components of a regional program in terra of resources and performance must be established in order to disseminate to all regions, information concerning the highest standards in any region in the country. The mechanism employed to assess and review the resources and performance should be in the hands of a national kidney commission representative of both the academic and practice communities. IV. THE PEUTIC RESO SE A. Adult Hemodialvsis Resources 1. General Considerations a. The three major operating components of a complete hemodialysis program include: (1) A self-dialysis training program for training patients to dialyze themselves either in the home or in a limited care dialysis facility. (2) A facility to provide followup support for self-dialysis patients, including backup dialysis and source of supplies and equipment maintenance, and to provide maintenance dialy- sis for patients who are not trained in self-dialysis. (3) An in-hospital dialysis program to provide dialysis to any patient who requires hospitalization and must receive maintenance dialysis at the same time . 21 have the three major components b. Since a hemodialysis program must 31 a h component is expensive to establish and operate, it nd since eac is mandatory that hemodialysis programs be organized and operated on a regional basis and that the region to be served be adequate in population to provide enough patients to fully utilize the services of the program. Regionalized coordination of hemodialy- sis programs is essential in order to avoid both costly duplica- tion on the one hand and gaps in service on the ot er. Regulations for the licensing, certification, or approval of all hemodialysis facilities should be established and, further, should be subject to periodic review. c. The actual composition, organization, aid operation of a regional dialysis program will vary depending upon the region being served. Furthermore the type and scope of operation of the individual facilities which make up a regional program will be varied and evolving. indeed, new types of facilities are being created as dialysis technology continues to evolve and improve. d. In terms of cost, it is important to understand that the actual cost of a dialysis is far cheaper in the home than anywhere else. If the cost of a dialysis in the hove - X, then the cost of self- dialysis in a limited care facility 2X to 4X; in an affiliated hemodialysis program 4X to 6X; and the cost of a dialysis in-hospital 6X to 1OX or more. At the same time, a given patient, because of medical and/or social reasons, may require a certain type of dialysis and be harmed if forced to accept a less expensive type. Hence, the type of dialysis provided a given patient must be determined by the physician in charge. However, depending.on the 22 local situation, a larae ru.,@er of patients could be on horse n dialysis. A!3o, there is a substantial group of patients not on home dialysis @41,,o could be dialyzing themselves in a limited care facility. e. Because a routine he@mdia'vsis carried cut either in a limited care facility or in the ho@-,,e does not require the presence of a physician, cert;,-'Ln special problems exist relative to establishing equitable PI)75iciaii professional fees for maintenance hemodialysis. Physician 14ces for the supervision of patients undergoing mainten- ance dialysis should directly relate to the professional time expenditure. f. Techniques now l@ave been developed for using special for.@ of peritoneal dialysis for long-term maintenance of patients with end-stage kidney disease. However, since the techniques are no yet fully evaluated or generally available, the guidelines in this document are applicable only to hemodialysis. 2. Clas ification of Programs and Facilities for F@modialysis a. ( iderations (1) A cormlete hemodialysis program must provide a wide diversity of services which range from hemodialysis of a critically ill patient in an intensive care unit to the neintenance of hemo- dialysis equipment in the patient's home. (2) Since regular minte-iance dialysis does not require hospitali- zation, all hemadialysis facilities other than those required for iii-hospital dialysis should be located outside the 23 expensive, active bed area of a hospital and may be geographically separate. They should be administratively and financially independent of a parent hospital so that the high overhead of the hospital does not raise the cost of dialysis in the facility. (3) Since in-hospital dialysis is the most expensive and least frequently used type of dialysis, and since this type of dialysis must be available 24 hours a day, 7 days a week$ hospitals which can provide this service should serve large areas of population. Whenever possible, the regional kidney transplant program should be located in the same institution. b. An artificial kidpM complex (1) General Considerations (a) The organizational and operational complex of any complete hemodialysis program, as previously defined in Section IV,A,l, shall be designated as the artificial kidney complex. (b) An artificial kidney complex may be part of a secondary and/or tertiary center or an independent facility. However, in the latter situation, it must be closely associated with an in-hospital dialysis program so that its patients can be dialyzed in-hospital when necessary. (c) The various components that make up an artificial kidney complex may be located in geographically separate areas or even in geographically separate institutions, provided a clearly delineated plan of integrated operation of the various facilities is in existence. This plan should be a matter of public record. 24 (d) medical director oc an artificial @,idnev conTleK shal-l- be an experienced rephrologi3l--. An organizational structure of the center's program delineating the pro- 's and the proaram members' authorities gl--am director and responsibilities and 'heir places in the institu- ticnis organizational structure snoLild be provided. '.he other professional personnel necessary for function- in- oi the various components of the artificial kidney complex are described in their respective sections. (e) It should be the responsibility of the staff of an artificial kidney complex, in conjunction with the te--tiar,ky center, to develop a renal registry to record all patients with end-staae renal disease (see III,E, Resource Coordination and Comrunication). (f) The artificial kidney coLTlex shall be responsible to clearly delineate the commitmnt of this facility to the c3ntinued optimum care of the patient requiring hemod'@alysis. (2) Funct:Lonn.AAll Co=onents (a) @ i6,elf-ddiiaallysis trainn7- Pro ram 1. The purpose of such a proaran is to train patients and their companions in the technique of self-dialysis. After completion of training , the procedure would be performed either in the home or in a limited care facility. 2. Any self-di-alysis training program should be coordi- nated with and under the surveillance of the arti- ficial kidney conTlex to assure the highest standards 25 of care for these patients and to provide in-center -hospital dialysis when required. There should or in perative arrangements be documentation of the coo with the artificial kidney complex in the region.. 3. Self-dialysis training programs should be staffed by physicians, nurses* and technicians who are trained and/or experienced in dialysis techniques. (b) A limited care dia@sis program 1. The basic concept of limited care dialysis is to provide dialysis in a low-cost area, utilizing an absolute minimum of professional support. 2. The patient on limited care dialysis might be trained to dialyze himself without specific profes- sional support in this low-overhead unit. 3. Limited care dialysis provides an inexpensive substi- tut6 for home dialysis to be used by patients who cannot dialyze at home for one reason or another. 4. A.limited care dialysis facility can be located almost anywhere, including a vacated storefront or a trailer parked near a hospital. Mobile limited care units can move through rural areas servicing patients on a regular schedule. 50 A limited care dialysis program should be coordinated with the artificial kidney complex to assure the highest standards of care for these patients and to provide in-center or in-hospital dialysis when required. There should be documentation of the cooperative arrangements with the artificial kidney complex in 26 the region, and thi3 should be a Tratter Of Dublic record. 6. Staffing of a liriited care facility can be the themselves or with a -.iinimum of technical patients help, althouah supervised by a responsible neoh- rologist. (c) n @.-hosDital dial s-lq ro,,rap, An in-hospital dialysis program should function primarily as a supporting service to the transplant program and/or as a backuo program for hospitalized patients who usually are dilalyzing at home or in a limited care facility. c. An affilia d he!rodialvsis program (1) Gen6ral Considerations (a) Any hemodiaiysis program that does not offer the full gamut of facilities and services outlined for the artificial kidney comlex /(3)(a)-(c), above/ shall be designated an affiliated hemodialysis program. (b) An affiliated hemadialysis program shall be accredited to perform only those services for which it was estab- .Lished. (cl. The working relationship which must e-. 200 mg/24 hours) (c) Repeatedly abnormal urine sediment or bacteriuria in properly obtained urine specimens (d) Demonstrable radiographic abnormality of the upper GU tract (e) Hypertension attributable to past or active renal disease (f) Biopsy-proven parenchymal renal disease Class 11: Any two or more of the following: (a) Symptomatic because of symptoms directly refer- able to the kidney (e.g., hypoproteinemic edema, dysuria, flank pain, renal colic, nocturia) (b) Radiographic evidence of osteodystrophy (c) Stable anemia attributable to renal disease (d) Metabolic acidosis attributable to renal disease (e) Severe hypertension (diastolic BP> iio Hg) Class III: Any two or more of the following: (a) Symptomatic osteodystrophy @(b) Symptomatic peripheral neuropathy (c) Nausea and vomiting without primary GI cause .(d) Limited ability to conserve or excrete usual dietary load of sodium and water; tending to sodium dep e- tion, dehydration or congestive heart failure (e) Impaired mentation attributable to renal disease class IV: Any two or more of the following: (a) Uremic pericarditis (b) Uremic bleeding diathesis (c). Asterixis and severely impaired mentation, with or without convulsion (d) Hypocalcemic tetany Class V: Coma II. CLASSIFICATION OF RENAL FUNCTIONAL IMPAIRMENT Exact classification (primary criterion) should be based on measurement of the glov*rular filtration rate (commonly approximated by the creati- nine clearance) when possible, since the plasma creatinine concentration may vary in the presence of muscular wasting and decreased creatinine production. When clearance values are unavailable, the plasma creatinine concentration (secondary criterion) may be used, but the subscript "c" should.be added to the classification, eog., Class DC. PRIMARY SECONDARY Class A: GFR normal Serum creatinine normal Class B: GFR reduced Serum creatinine normal to 50% 2.4 mg% Class C: GFR 20-507. of Serum creatinine 2.5-4.9 mg% predicted normal Class D: GFR 10-20% of Serum creatinine 5.0-7.9 mg% predicted normal Class E: GFR 10% of Serum creatinine 8-12 trg% predicted normal Class F: GFR 57. of Serum creatinine 12 mg% predicted normal 111. PERFORMANCE CIASSIFICATION A description of what the patient thinks he is able to do and not what the physician thinks he should be able to do. Class 1: Capable of performing all his usual types of physical activity Class 2: Unable to perform the most strenuous of usual types of physical activity for that particular patient, e.g., sports activity, fast walking, running, shoveling, lawn mowing, etc. Class 3: Unable to perform all his usual daily physical activities on more than a part-time basis, e.g., household dutiesi employment, driving an automobile, playing with children, etc. Class 4: Severe limitation of usual physical activity. May need assistance for some facets of self-care, i.e., shaving, etc. Mentation may or may not be impaired. May be confined to bed. Class 5: Semi-coma or coma APPENDIX II s TO ESTABLIS ACILITIE Hoc COMKITTEE H CRITERIA FOR THE OPTMAL F THE AD NECESSARY FOR DIAGNOSIS AND MANAGEMENT OF PATIENTS WITH END-STAGE RENAL DISEASE E. Lovell Becker, M.D. (Chairman) Robert B. Jennings, M.D. Department of Meditine Department of Pathology New York Hospital - Cornell Medical Center Northwestern University New York, Now York Chicago, Illinois Early, M.D. Samuel L. Kountz, M.D. Lawrence Department of Medicine Department of Surgery University of California University of California San Francisco, California San Francisco, California Milton Elkin, M.D. Robert S. Post4-X.D. Department of Radiology Department of Medicine Albert Eiiistein College of Medicine University B6spitals of Cleveland Bronx, New York Cleveland, Ohio gli Arnold Friedman, M.D. Jorgen V. Schlegel, M.D Department of Medicine Department of Urology State University of New York Tulane Universit of Louisiana y Downstate Medical Center New Orleans, Louisiana Brooklyn New York William B. Schwartz, M.D. R. Earl Ginn, M.D. Department of Medic ne Department of Medicine Tufts University School of Medicine Vanderbilt University Boston, Massachusetts School of Medicine Nashville, Tennessee Belding H-. Scribner, M.D. Department of Medicine Ira Greifer, M.D. University of Washington Department of Pediatrics School of Medicine Albert Einstein College of Medicine Seattle, Washington Bronx, New York Wadi N. Suki, M.D. Paul F. Gulyassy, M.D. Department of Medicine Department of Medicine Baylor College of Medicine TSniveriity of California Houston, Texas San Francisco General Hospital San Francisco, California Robert L. Vernier, M.D. Department of Pediatrics Malcolm A. Holliday, M.D. University of Minnesota Medical School Department of Pediatrics Minneapolis, Minnesota University of California San Francisco General Hospital San Francisco, California James C. Hunt, M.D. Department of Medicine . . Mayo Clinic Rochester, Minnesota APPENDIX II (Cont'd) CONSULTANTS TO THE AD HOC COMMITTEE Jack H. Baur, M.D. Arnold Siemsen, M.D. Huntington Internal Medicine Group St. Francis Institute bf Renal Disease Huntington, West Virginia St. Francis Hospital Honolulu, Hawaii Richard T. Belinsky, M.D. Department of Medicine Margaret Sloan, M.D. Southern Illinois Medical School Regional Medical Programs Service Springfield, Illinois HS @ Rockville, Maryland Edward T. Blomquist, M.D. Regional Medical Programs Service HS,: Rockville, Maryland John W. Draper, M.D. Department of Urology New York Hospital-Cornell Medical Center New York, New York Edward J. Hinman, M.D. Regional Medical Programs Service HSIIHA Rockville, Maryland William J. Jones, M.D Childrents Hospital Detroit, Michigan William F. Keane, M.D. Regional Medical Programs Service HSMM Rockville, Maryland Thomas Marr, M.D. Department of Medicine Spokane, Washington Daniel P. Richman,@ M.D. Norwalk Hospital Norwalk, Connecticut Eugene Schupak, M.D. Department of Medicine Elmhurst General Hospital Elmhurst, New York Fred Shapiro, M.D. Department of Medicine Hennipen County General Hospital Minneapolis, Minnesota @,IPS POLICY STATE@IE!@TS The major thrusts of the health manpower efforts of @fPS are related to more effective utilization of existing manpower. Some of the ways of accomplishment are through linkages of educational and health care resources to make optimum use of limited resources and manpower; regionalization of resources and services; updating of knowledge and skills of health workers at all levels; redefinition of roles; expan- sion of functions of existing health manpower; development of inter- disciplinary programs; attitudinal learning to overcome obstacles to changes in health care practice s. In short, the manpower emphasis of RMPS is primarily on continuing education as a process to affect the manpower problem rather than on basic education to increase the man- power supply. DEFI'QITION OF CONTIIN'UING EDUCATION A@'D TRAI'41NC, As an operational definition of continuing education, the following has been accepted: "Those educational endeavors which are above and beyond those normally considered appropriate for qualification or entrance into a health profession or an occupation in a health related field." Continuing education activities must not be designed principally to qualify one for a degree, diploma or certification; therefore, internship and residency programs have been excluded from primary consideration. Continuing education and training activities should lead to the assumption of new responsibility in the already chosen career field, update knowledge and skills in the chosen career or add knowledge and skill in a different but basically related health field but not provide for career change. POSITION ON @ASIC EDUCATIOLN AND TR-KINING Cenerally speaking, other agencies exist whose primary efforts are aimed at supporting supply and training of health manpower at the basic and post-graduate levels. Ilowever, because of the critical need in regions for basic training support not usually available from other Federal and non-Federal sources, Regional liedical Programs Service has developed policy in three areas affecting support of basic training: (1) health careers recruitment; (2) basic training in established allied health professions; and (3) basic training for the development of new types of health personnel. (1) Health careers recruitment RMP grant funds are not to be used for direct operational grant support of health careers recruitment projects. Regions are encouraged however@ to use staff assistance to stimulate coopera- tive efforts between professional associations, clinical resources, .educational institutions and other appropriate agencies to provide new opportunities for recruitment into health careers. @IP funds may also be used in planning health careers recruitment activities a@ a part of and coordinated with the overall manpower strategy., for the region. (2) Basic training in established allied health Professions A health profession will be considered established if a Board of Schools of the AMA Council in Medical Education, or some similarly recognized mechanism, has been set up to approve schools, outline standards for admission, curriculum requirements and certific ation procedures, and/or if definitive formal educational programs in the particular health occupation have already been instituted in the educational and training systems of hospitals, technical schools, junior and senior colleges. No RMP grant funds may be used for the cost of providing basic education and training in established allied health professions as defined above. The use of professional staff assistance is encouraged as well as direct support of special planning studies to simulate educational institutions in conjunction with clinical r@sources:to provide new educational and training opportunities in established allied health disciplines and to add new disciplines. (3) 3asic training for the develoonent of n tvpes of health Personnel Grant funds maybe used for innovative training approaches and the development of new types of health personnel or new arrangements of health personnel to meet the Region's goal of improved patient care for those suffering from heart disease, cancer, stroke or related diseases. Some of these activities may fall into the category of basic education. Training of new types of health personnel is defined as that training which relates -Eo newly developing technologies of new modalities of diagnosis and treatment for which no standard iculum is yet recognized, no minimum national standards for curr certification or licensure are yet established and which is not generally part of the regular offerings of the health-related educational and training system of hospitals and/or technical schools, junior and senior colleges. NS OF SHORT AND LON,'G TERM TPAININC@ DEFINITIO (1) Training conferences and seminars Presentations which are planned full-time participation for periods from one full day to five consecutive days, or inter- mittently on a regular basis. (2) Short-term nin Activities which are planned for full-time participation for morelthan five consecutive days, but not more than a single academic session (quarter or semester). (3) Long-term trai@n Activities requiring full-time participation for more than a ,single academic session (quarter or semester). SPECIFIC POLICIES (1) Training for coron@r care unit Coronary care unit training projects are to disengage Regional Medical Program.funding at the end of their current project periods or within a reasonable time thereafter (no more than 18-24 months is considered as a "reasonable period of time (2) Cardiopulmonarv resuscitation training Regional Medical Program grant funding for projects in cardib- vascular resuscitation training must be limited to activities which are directed principally to medical and allied health personnel. Such personnel must be employed in hospitals and other in-patient facilities, or in.out-patient or emergency facilities operated by or directly related to-institutions which- ran provide immediate follow-up care. STIPEIIDS*, PER DIEM AND TRAVEL (1) Trainin@ conferences and seminars Stipends are not authorized for training conferences and seminars. 2) Short-term trainiin ipends, either Grant funds may not be used for the payment of st ectiy or on the "maintenance of income principle", to dir ontinuing education and training participants in short-term c projects. ercent of the- Grant funds may be requested and awarded 'for 50 p total amount budgeted for per them and travel for the trainees. The awarded funds may then be paid to the enrolled trainees as considered appropriate by the project personnel, depending on I provide these costs for themselves, the participants ability to gness of their employers to provide them. No and/or the willin single individual may receive per them or travel allowance at a rate higher than that prescribed by the present Addendum-Guidelines. r without the Grant funds may not be rebudgeted, from within o project budget, to increase Ithe total amount awarded for per them and travel above the 50 percent level-. -term train@ (3)L Long Payment of stipends and other participant costs for long-term port at the senior resident and post-resident post-doctoral sup levels, particularly in the clinical sub-specialties of impor- tance in patient management in the diseases targeted by Regional Medical Programs Service, may not be made from operational grant funds awarded under Section 904 of Title IX of the Public Health Service Act. *EXCEPTION Stipends tor training for new types of health personnel is an exception and may be supported with RNP funds. EDUCAT OLNAL TECHNOLOGY ing the planning, equipment require- An advice letter to the Regions cover ments, costs, utilization and evaluation of technology for educational purposes was sent to the Coordinators in January, 1971. The theme of the letter is guidance for effective use of technology within the context f Regional Medical Program operation. 0 A HEALTH AN ECONOMC MODEL AS IJECISION MAKING TOOL* lamentation of A National Kidney Program Hinman, Edward J. McDonald, Arthur K. Spear, Matthew H. Division of Professional and Technical Development Regional Medical Programs Service Health Services and Mental Health Administration Department of Health, Education, and Welfare Rockville, Maryland Presented at Annual Meeting of Southeastern Dialysis and Transplant Associ@tion, Biloxi, Mississippi. August 11, 1972 , I " .:.@- J. INTRODUCTION Nowhere in the health care industry does the same gap exist between 'the area of treatment of patients with technology and delivery as in end-stage renal disease. Technologic developments in the past ten years have made possible the rapid expansion of programs to provide patients with chronic dialysis therapy. The development of remark-. able innovations that allow self"dialysis by the patient or a member of his family in their home has been a major step in making this a practical approach. Techniques of organ harvesting, preservation, and transplantation have made renal homotransplantation a service entity and no longer a research tool. However, the funding mechanisms to develop the resources have lagged far behind. A conservative @'7 estimate is that. annually 7,000 ideal candidates for end-stage therapy will die of renal disease unless they receive either a successful transplant or chronic hemodialysis therapy. Hard data are lacking but f of the ideal candidates for best estimates indicate that one hal who would benefit from treatment are not treatment and many others receiving vital therapy. Severe restraints to development of necessary resources have been the high costs, particularly the costs of institutional dialysis. This paper presents a plan in which an integrated approach to end- stage therapy is proposed. Page 2 ents emphasized. Transplantation and home dialysis will be the treatm to care for all Americans The goal of the plan is to provide access suffering from end-stage renal disease who meet medical criteria for maintenance therapy. Details of this plan will be provided in h been devel- succeeding p The benefit-cost model described as ages. tation and evaluation of the 'llife plan"'o oped to help guide the'implemen criticisms of the'benefit-cost models are particularly welcome since stantly being modified and changes.pan quickly these models are con be analyzed. II. BACKGROUND Most past and current federal initiatives in the kidney disease area an oward research or demonstration. NIH funding have had orientation t ment of much has played-a prominent role in the develop of the tech-, ing applied in renal disease treatment, The Kidney nology currently be Disease Control Program of the Regional Medical Programs Service has funded a series'of demonstration projects to prove the feasibility of center dialysis, home dialysis, limited-care dialysis, and organ procurement systems, These demonstration projects are being completed and their success has been such that new federal initiatives are being directed toward the provision of these services to all Americans with end-stage renal disease. The Veterans Administration has an extensive' program which is expected to treat 400 new patients each year us ng Page 3 and Rehabi- equal mixes of dialysis.and transplantation, The Social litation Service of DHEW is providing funds to kidney disease patients ation. In many states, Medicare Medicaid, for vocational rehabilit and specific state legislation provide additional moneys for kidney disease. Local criteria determine the coverage and regional variation ,is extreme. The Division of Professional and Technical Development.of the Regional Medical Programs Service has assumed responsibility for development of a plan to be implemented through the local Regional Medical Programs to ensure the efficie t use of resources in a national endeavor to provide end-stage renal therapy (primarily transplantation and home dialysis training) in a limited number of tertiary treatment centers. A limited investment of $80 million over five years for developmental costs has been requested. Long-range, direct patient-care costs would be met by the usual medical payment mechanisms. III. THE "LIFE PLANII The goal of the proposed health initiative is the efficient provision of medical care to all suitable candidates for end-stage renal therapy. The initiative consists of a five-year program providing major thrusts in areas of prevention; public education; research; and, particularly, development of resources for patient care. The i'o'llowin'g'p'aragraphs will discuss each of these thrusts. Page 4 A. Prevention Research entially nonexistent* methods of primary prevention are ess e be pursued to develop methods. Secon- and development fforts will -Ltion is possible to a significant degree in the areas dary prevei of urinary tract infections and hypertension. The initiative would fund screening programs for high-risk groups with'those diseases and rely on regular patient-ca-re reimbursements to pay for treat- costs. Estimates are that 6% of the funds allocated would ment be u ed in.this field. s B. Public Education Emphasis would be placed on consumer education concerning the:, warning signs of renal disease, high-risk population groups, pre- available and importance of'.continuity ventive measures, services of care. A side benefit from this program should be an increase in or an donations so that cadaver kidne'.organ procurement would 9 y be facilitated. Some funds will be used to provide continuing education of primary physicians to acquaint them with the entire initiative. Plans are to use 6% of the funds available in this area C. Research and Development Efforts will be geared toward two major activities. The first@'; deals with etiology and prevention, and the second deals with the,-- Page' 5 fiend-stage" patients. research technology of 'maintaining d to Elucidate the mechanisms of development of is still neede chronic renal disease. As these are clarified, primary preventive measures can be developed. needed to maintain patients revolves Around-better The technology matching of do ors and recipients control of the rejection phen- n omenon, improved home and/or portable dialysis units, etc These activities will continue to be monitored by the National Institutes of Health. Twenty percent of the funds would be used in this research and development effort. D. Tertiary Treatment Centers Th tion made during this planning effort was that e first assump any patient with irreversible chronic renal disease in the United States, who met the medical criteria, should have access to care. This means that sufficient facilities should be available to accept all such patients and that these facilities should be reasonably accessible. Further, all patients should have care without regard to income or social status. It was especially felt that no family should have to become "pauperized" before financial assistance was available. In determining resources, it has been the feeling that every effort should be made to use renal transplantation as the treatment Page 6 lure. of choice for h irreversible chronic renal fai patients wit Home ho-modial sis would be utilized as a second choice for those y patients in, whom transplantation was not feasible or donor organs le. As a last resort, some form of chronic insti- were not availab tutional dialysis would be offered. It is our expectation that three-quarters of 411 newly referred cases will be candidates for transplantation and approximately three-quarters of the rema'l der will be candidates for home hemodialysis. Institutional facilities will have to be available for the remaining patients and those in whom rejection of the trans@@ant occurs. Specific objectives-are to develop tertiary treatment centers with facili- ties for renal homotransplantation and home dialysis training Iodated throughout the country at an average of approximately 1 per 3-4 million population. Transplant centers would be expected to perform a minimum'of 50 transplants per year with a goal of 75-100. Plans for the treatment of pediatric renal disease indi- cate a caseload of 60 new patients annually. Ten centers would need to be identified to treat this special group of patients. The De' artment. of Health, Education and Welfare, through the Health p Services and Mental Health Administration and the Regional Medical Programs Service, has already provided funds for start-up costs P age 7 for renal transplantation units and has selectively funded start- up costs for home dialysis training programs. ComL,'letion of this activity would utilize 62% of the projected program cost. E. -Referral Linkages The key to efficient utilization of the tertiary treatment centers lies in the development of effective patient referral patterns. Primary treatment will be provided by local physicians who will treat most of the acute events of kidney patients and provide local surveillance of home dialysis and post-trans-plant patients. Secondary care centers are represented by selected physician offices and designated community hospitals which are ordinarily within an hour's travel of the patients served. These secondary centers will provide specialized diagnostic evaluation and main- tain close linkage with tertiary centers for hemodialysis and homotransplantation. Tertiary care cent ers will be located in major medical facilities. These centers will initiate dialysis, provide home dialysis training, coordinate cadaver kidney organ tocurement, provide transplantation surgery and intensive care p services, and support research to improve end-stage kidney disease atient care. Physician education and the communication system p will be two tools used to strengthen relationships among the three level.-,' I-: i' ... Page 8 Comunication Svstem e activities of this life plan and to develop To coordinate th ational ment and sharing, a n information for better organ procure communication network has been proposed Information about all nal disease, whether or notthey have patients with end-stage re begun dialysis or have had a transplant, would be fed into this communication network. Six percent of the funds requested would be used to develo the Communications System. p IV. BENEFIT OST MDEL A Problem The central question addressed in the model can :be expressed as follows: Assuming all 7,000 candidates for end-stage t erapy are treated in a given year, what are the discounted costs and benefits.to society over a 20-yeat period. Once this question has been answered for a specific set of assumptions, the sensi- tivity of the model to variations in the assumptions will be examined and the effects of possible advances in the state of the art can be investigated. B. ethods All the benefits and costs were obtained by cohort analyses. the 7,000 The basic cohort studied in this paper consists of Page 9 eatment in a given year. Analy- ideal candidates for end-stage tr and benefits involves prediction of sis of long-range costs future events. Assumptions regarding the probabilities of signi- 'II be.pxplicitly ficant events form the heart of this model a-,id wi Table 1 --presents the assumptions used stated in every case. sic model. Many of'the in deriving the results in the ba assumptions listed in Table I are subject to dispute. We have some evidence, obtained from our contractors and the literature, to support all assumptions, but an important aspect of the model is an investigation of the effect of variations in the assumptions. A computer program has been written which carries out the entire analysis shown in this paper. It is thus a simple matter to consider any particular set of assumptions and derive a complete benefit-cost analysis. Tables 2, 3 and 4 reflect the assumptions detailed in Table 1. Table 2 shows the number of patients expected in each category during each year. Notice that we are considering- in this first model only the cohort of 7,000 patients presenting themselves in a given year. A more complete analysis will @follow in the dis- cussion section where a new cohort of 7,000 patients is analyzed each year over a ten-year period. It is assumed that 5,.OOO of the 7,000 patients will receive a transplant. Extensive use of Page 10 em for s will be required, and some national syst cadaveri@ kidney efficient utilization of potential donors will be necessary. Table 3 lists the costs and benefits discounted to the first 'n order to provide a common frame of ref6rence.* The assumed year i transplantation cost of $13,750 includes $3,750 for 6 months of maintenance dialysis before the operation and $10,000 for cost of the operation and follow-up. An annual cost of $1,000'@is assumed for each year after the transplant,to cover follow-up and any necessary treatment. The "average" dialysis cost of $7,500 assumes primary use of home dialysis, with moderate-cost training methods, secondary use of a lc4-overhead facility, and only very limited use of hospital dialysis. the data presented in Table 4 summarize the information contained in the model. A conservative approach has been adopted wherever the assumptions had the least validation. For example, no benefits are assumed for the first year, although certainly some uickly trained and rehabilitated, and dialysis patients can be q some transplant recipients will be working soon after the oppr- ation. The benefit-cost ratio is calculated by summing the total Discounted annual cost is computed b' ltiplying the transplantation mu discount factor by the sum of the product of the number of operations during ation and the product of the:'number of the year times the cost of an oper surviving transplant atients times the annual maintenance costi Total p transplantation cost is calculated by summing these discounted annual costs Other costs and benefits are calculated similarly* Page s and transplantation benef its and dividing by discounted d.ialysi scounted dialysis and transplantation the sum 'of the total di costs. Notice that, under this set of ass@tions, benefits out- weigh costs in the second and all subsequent years, but,-..the heavy load of costs in the first year is never balanced. C. Discussion The model.described in Section III has an obvious use in the immediate assessment of the economic benefits involved in a parti- cular medical expenditure pattern. Probably a more practical use of such a model is in the economic comparison of alternative approaches to disease treatment. A single benefit-cost ratio s limited information- a comparison of benefit-cost ratios provide for alternative programs can provide an'efficient tool 'for decision making. The following example illustrates one possible application of benefit-cost analysis. A change in the first year treatment pattern to 6,000 transplants and 1,000 dialysis patients substan- tially increases the benefit-cost ratio if other factors are nchanged. However, it is lil-.el that such a change in treat- u y ment pattern would raise transplant mortality and rejection rates. The assumption made here is that first year transplant mortality and rejection rates would increase from 20% @(>@-25%. Table 5 Page 12 pres nts beii fit-cost figures for these changes in treatment e n and mortality-rejection rates. Comparisons with Table 4 patter s, the increased number',.,of tion indicate that, under these assump transplants can be performed _only at the cost of a small drop in the benefit-cost ratio. A myriad of questions suggest themselves. Using the computer program, a numerical analysis can easily be performed providing a benefit-.cost ratio figure for any specific set of assumptions. Another approach to the investigation of sensitivity in the model uses an'@analytical expression for the benefit-cost ratio. Deri- vatives are calculated using methods of.elemeritary calculus. These derivatives provid roximation to the change in the e an app benefit-cost ratio per change in any independent variable. Table 6 shows the results of a sensitivity analysis performed using these 'methods for those independent variables where differen- tiation is practical. Note that results shown in Table 6 are on an absolute basis. The practical range of possible change in any assumption must be weighed in evaluating the results shown in Table 6.. Discussions to this point have been limited to the simplistic model of one cohort followed for 20 years. Planning a long-range Pa e 13 9 new cohort federal prog'am requires the use of models in which the r of patients presenting themselves each year' is analyzed. Results are based;on'examination,of,a series of cohorts. If each cohort is,followed. for the -same length of.time (for example 20 years) the benefit-cost ratio has the same.value for a single cohort as-it has'for,a.sdries of.cohorts. However, a different t,%.pe of -often asked by prqgram.administrators. At the end question is gram, what will be the realized benefits of,,ten years of this, pro te that patients first treated in the first year- and costs? -No will have nirie_years of possible benefits, whereas patients first treated in the tenth year will have no opportunity to accrue any benefits before the time of accounting. Obviously, ben6fit-cost ratios calculated under this cut-ofk method will be substantially lower than under the 20-year follow-up system. Table 7 contrasts BCR's Calculated using the two models with several sets of' .assumptions Criticisms of potential-earned income as a.measure of benefits have led to an alternative form of analysis. Cost-effectiveness analysis is.'a method-wherein costs of treatment are weighed against increased years of patient survival to provide, an estimate of cost per life year of treatment. Table 8 lists cost per life year for several sets of assumptions. Notice that the dialysis Page 14 cost per life year is calculated to-be less than the assumed annual dialysis cost because of the discounting procedure. The approach taken here is that estimated benefits are useful .enough to provide comparisons with estimated costs that can lead to bbnefit-cost ratios which may serve as one criterion in policy planning. Since'many benefit and cost elements may not be medsurable,,either because they Are indirect, or because they are not quantifiable with present techniques, policy decisions can never be made using benefit"cost criteria alone. V. CONCLUSION The state of the art in technology and medical care delivery have reached a point where a coordinated national kidney program would have maximum impact. Benefit-cost models show such a program to be feasible, The current level of RNPS spending for kidney disease pro- jects is'in excess of $8 million per year. These funds and future RNPS funds are being channeled into projects designed in accordance with the "life plan" concept. Renal specialists will continue to be used to review projects and evaluate progress in fulfilling the national program. TABLE SSUMPTTONS USED IN BASIC MODEL 15% .1. Annual Mortality Rate for Dialysis Patients $ 1,500 2. Average Annual Cost for-D@alysis 20% 3. Transplant Death Rate in First Year 10% Second Year 5% Subsequent Years 20% 4. Transpl ant Rejection Rate in First Year Second Year 10% 5 Subsequent Years tions receive another transplant within one year. 5 . One half of-transplant rej@c 6 months dialysis) $ 13,750 Cost of Transplant Operation (Include 6. 7 . Average Annual Maintenance Cost After Transplant $ 1,000 $ 8,000 8. Mean Annual Income (Member,of Labor Force) Transplant Rehabilitation Rate 80% ehabilitation Rate 10. Dialysis R 60% 4% 11. Discount Rate 12. No benefits are credited for first year. TABLE 2 PATIENT DISTRIBUTION Niimber Number of of Number of Transplants N=ber of Sur-4iving Perf rmed Transplant Recipients Dialysis patients Deaths Year o 0 2000 5000 0 2200 1300 500 3000 2 730 3 200 2700 2070 2520 1854 500 4 95 2313 1652 429 5 75 10 47 1498 936 250 546 152 15 30 970 628 327 93 20 20 296 85- 21 18 576 TABLE 3 s AND COSTS DISCOUNTED BOEFIT Transplant Dialysis Dialysis Transplant Benefits Costs Benefits Year Costs $ 14,000,000 0 1 $ 0 $ 71,000,000 18,000, 15,000. io,ooo,ooo 2 jo,ooo,ooo 000 'POOO 15,000,000 14,000,000 g,ooo,ooo 3 5,000.%OOO 12,000,000. 8,000,000 4 3,000,000 14,000,000 12,000,000 lo,ooo,000 7,000,000 5 3,000,000 6,500,000 4,800,000 3,000,000 10 1,5002000 800,000, 3,500,000 2,000,000 1,500,000 15 1,800,000 1,100,000 700,000 400,000 20 600,000 21 370,060 1,600,000 1,000,Iooo TABLE 4 RESULTS IN BASIC MODEL $ 122,000,000 Total Discounted Dialysis Costs ..Total Discounted Transplant Costs 109,000,000 Total Discounted Dialysis Benefits 69,000,000 Total Discounted Transplant Benefits 137,00 0,000 .89 Benefit-Cost Ratio $ 6,288 Dialysis Cost Per Life Year Life Year 3,515 Transplant Cost Per LE 5 TAB DIFIED* MODEL RESULTS IN MO 96,000,000 Total Discounted Dialysis Costs 128,000,000 Total Discounted Transplant Costs Total Discounted Dialysis Benefits 57,000,000 Total Discounted Transplant'Benefits 139,000,00 Benefit-Cost Ratio .87 Dialysis Cost Per Life Year $ 5,924 Transplant Cost Per Life Year 4,038 Change number of transplants in first year from 5,000 to 6,000 Change number of dialysis patients in first year from 2,000 to 1,000 Change first year transplant mortality rate to 25% Change first year transplant rejection rate to 25% TABLE 6 SENSITIVITY LYSIS ity Per Unit Increase Sensit Variable ooo dollars .024/1 Transplant Cost t Maintenance Cost -.11/1,000 dollars Annual Transplan .007/percentage point Dialysis Rehabilitation Rate .008/percentage point Transplant Rehabilitation Rate -.09/1,000 dollars Annual Dialysis Cost .13/1,000 dollars Mean Annual Income TABLE 7 BENEFIT-COST RATIO EYJMLES B.C.R. B.C.R. 20 Year Follow-Up 10 Year Cut-Off Basic Model .89 .59 odifications of Assumptions* m 6,000 Transplants in First Year .98 .62 Annual Income $10,000 1.11 .73 Cost of Transplant $7,500 1.06 .75 Annual Dialysis Death Rate 20% .92 .58 Dialysis Cost $5,000 1.08 .68 .74 .49 Transplant Rehabilitation 60% Dialysis Rehabilitation 40% .79 .52 Annu 1 Dialysis Death Rate 10% .86 .59 a Each example depicts a change in only one assumption. Multivariate comparisons of simultaneous variations have also been undertaken using the computer programs. Results are not tabulated here. TABLE 8 S PER LIFE YEAR COST Transplant Cost Dialysis Cost Per Life Year Per Life Year $ 6,288 3,515. Basic Model Modifications of AssumvtiOns* 5,880 3,515 6,000 Transplants in First Year Annual income $10,000 6,288 3,-515 2,317 6,288 cost of Transplant $7,500 3,515 6,702 Rate 20% Annual Dialysis Death 3,515 4,192 Dialysis Cost $5,000 3,515 6,288 ation 60% Transplant Rehabilit 6,288 3,515 ion 40% Dialysis Rehabilitat 3,515 1 Dialysis Death.Rate 10% 5,8 Annua e in only one assumption. Each example depicts a 6hang 'HEALTH INITIATIVE CONTROL OF THE RAVAGES OF KIDNEY DISEASE DEPAR@IENT OF HEALTH, EDUCATION, AND WELFARE Health Services and Mental Health Administration Regional Medical-Progiam Service February 14, 197-2 Table of Contents 1. Summary page 2. Introduction 3 3. Health Initiative ivery of Care 4. System for Del 9 5. Communication System 6. Current Related Programs 7. Rationale for Government Initiative 10 13 8. Management Plan 14 9. Project Schedule 15 10. Manpower Resources Plan 16 11. Desired Impact 16 12. Evaluation Plan 13. Management Review Procedure 17 APPENDICES Tab A Technologic SysteTf, Tab B Budget Tab C Incidence of Patients with Treatable End-Stage Renal Disease Tab D Current Expenditures Tab E Cost-Benefit Model' SUMMARY "Control of the The proposed federal health initiative Ravages of Kidney Disease" is a five-year program.totaling $80,000,000 of new investments that will provide a major thrust at prevention, pub,lic education, research and development for patients with kidney disease. The treatment phase would assure that an adequate number of tertiary renal treatment centers would be developed to.provide the resources for treatment of all patients with end-stage renal disease who were medically suitable as candidates for therapy. Th.. cost benefit model (Appendix E) describes how this investment would result in a net economic gain of $27.3,000,000 over ten years. INTRODUCTION The economic impact of diseases of the urinary tract was estimated to be $3,635,000,000 in 1965 for the United States. The.Kidney Disease Control Program of the United States Public Health 'Service estimated that durin- that fiscal year there was a prevalence of 7,847,000 cases of kidney disease leading to 139,939,000 days of restricted activity including 63,494,000 days of bed disability, 16,729,000 days of work loss in the United States, and nearly 50,000 deaths. It is estimated that on a National basis the death rate from primary renal diseases is 28 per 100,000. Deaths fron urinary tract disease are only exceeded by deaths due to heart disease,.@cancer, cerebral vascular accidents and accidents. It is estimated that 7,0'00 to 10,000 of the patients who die with chronic renal disease are suitable candidates for chronic hemodialysis and/or renal transplantation and that an additional 10,000 to'20,000 would benefit from such treatment but other systemic ill- nesses render them poor medical risks. This initiative would provide the sources to treat those 7,000 to 10,000 patients. At the present- time there re are approximately 5,000 patients on dialysis throughout the country. Between 1,000 and 3,000 of them are awaiting renal homotransplantation. The primary functions of the kidney are to: 1. regulate water balance, 2. regulate dissolved solute balance, 3. eliminate nitrogenous and other waste products, and 4. regulate blood pressure. The majority of patients with chronic renal disease come to the physician with an inability to regulate one or more of the above functions. There is little information concerning the -natural history of the vari- .ous renal diseases that lead to the patient with terminal renal disease. It is felt that many of the patients with chronic pyelonephritis (chronic infec- tion of the kidney) result from inadequately treated cases of.acute pyelo- nephritis. It is estimated that four to six million cases of unknown infec- tions of the urinary tract exist in the United States. Thus the prevalence of e may be much higher than the estimates listed above. Bacteri- renal disea5 uria in pregnancy is a forerunner of essentially all cases of acute pyelo- ephritis of pregnancy and ma of these Are thought, if inadequately treated-, n ny to become chronic pyelonephritis. It is known that with hypersensitivity diseases the majority of the patients with acute poststreptococcal glomerulo- nepbritis ("Bright's Disease") who survive the initial acute episode have complete recovery. Some investigators feel that essential hypertension is often associated with chronic pyelonephritis. Current knowledge allows no primary prevention of chronic renal disease with the exception of those patients: 1. i-7ho are detected to have abnormalities of the collecting and excre- tory system which may be surgically corrected, -2- 2. -those who have prompt treatment of cases of beta beinolytic strep- tococcal infections which in some patients may prevent.acute glomerulonephritis. Secondary prevention is possible in three areas: Bacteriuria and urinary tract infections. At the present time a large number of patients with bacteriura and/or acute urinary tract infections are receiving inadequate antibiotic therapy. @There is no.accepted length for antibiotic therapy but a minimum course should be fourteen days and possibly longer.@.There have been studies that suggest that a urinary antiseptic should be con- tinued for six months after the initial treatment. @,lany patients with bacteriuria and/or infection have anatomic abnormalities which should be carefully sought for and corrected whenever possible. Patients with indwelling urinary catheters are very likely to develop urinary tract infections unless scrupulous care and "closed system" drain-age are used. @ien with prostatic hypertrophy are prone to infection unless prostatic resection is performed, Children with bed-wetting problems are frequently found to ha-,,,- mild congenital anomalies and secondary infections. 2@ H@ersensitivity diseases. There are certain hypersensitivity diseases in which it is felt that prompt treatment with cortico- steroids may red ce the incidence of renal complications. These u include some cases of periarteritis nodosa and disseminated lupus erythematosus. 3. Hypertension. It has been demonstrated that control of sever, hypertension will prolong life and reduce morbid events. There is recent evidence to show that the treatment of mild to moderate hypertension will lower morbidity and/or mortality rate,-; thus, hypertension control will improve the outlook of thousands of patients. During the past 15 years the.technique of hemodialysis has been demon- strated to be practicable for the treatment of acute renal insufficiency and more recently for the maintenance of patients with chronic renal disease on a prolonged basis. Hemodialysis is the cleansing of blood" by passing it along semipermeable membranes with a specially prepared bath solution on the outside. The blood is then returned to the patient. Unwanted substances are removed during this process. Hemodialysis may be performed in hospitals or other centers on an inpatient or an outpatient basis and in selected candidates may be performed in the home by members of the family. This form of therapy has passed through the investigative phase and is currently accepted as a conventional form of therapy for those patients in whom it is indicated. More recently transplantation of kidneys from living donors or from cadaveric donors has proven to be an effective method of prolonging life for patients in whom it is indicated. over two-thirds - of these patients become rehabilitated to a level equivalent to their pre-illness state. -3- HEALTH INITIATIVE The health initiative is focused on 4 key elements: Prevention Public Education 41 Research and Development Tertiary Treatment Centers Over the course of 5 years the I-ederal Government can develop adequate resources to asEure access to health information and treatment for all citizens suffering from renal disease. The estimated total cost is $80,000,000 allocated as follows: Prevention $ 5,000,000 Public Education $ 5,000,000 Research and Development $15,000,000 Tertiary Treatment Centers $50,000,000 Communication System $ 5,000,000 The lead agency for implementation and evaluation would be the Regional Medical Programs Service. The National Institute of Health would assume responsibility for administering the Research and Development portions ($15,000,000) through the National Institute of Allergy and Infectious Diseases and the National Institute of Arthritis and Metabolic Diseases. Parts of the budget are detailed in Tab B. PREVENTION As mentioned previously, methods of primary prevention are essentially non- existent. Research and Development efforts will be pursued to develop methods. Secondary prevention is possible to a significant measure in two areas: Urinary Tract Infections Hypertension ilrinarv Tract Infections. Attention will be devoted to high-risk popula- tions (e.g., young girls, pregnant women, men over 45) for screening and refer- ral for acute treatment. The initiative will fund screening programs and rely INTRODUCTION diseases of the urinary tract was es,- iiiiaLec, tlz, Ti-ie economic impact of 0 in 1965 for the United States. The.Kidney Disease Control be $3,635,000,00 Program of the United States Public Health Service estimated tliit during a prevalence of 7,847,000 cases of kidney disease that fiscal year there was 39',OOO days of restricted activity including 63,494,000 days leading to 139,9 16,729,000 days of work loss in the United States, and of bed disability) 50,000 deaths. It is estimated that on a National basis the death nearly rate from primary renal diseases iq 28 per 100,000. Deaths from urinary tract disease are only exceeded by deaths due to heart disease,:cancer, cerebral vascular accidents and accidents. It is estimated that 7,0'00 to 10,000 of the patients who die with chronic renal disease are suitable candidates for chronic hemodialysis and/or renal transplantation and that an additional 10,000 to 20,000 would benefit from such treatment but other systemic ill- nesses render them poor medical risks. This initiative would provide the ces to treat those 7,000 to 10,000 patients. At the present time there -.resour are approximately 5,000 patients on dialysis throughout the country. Between 1,000 and 3,000 of them are awaiting ren al homotransplantation. The primary functions of the kidney are to: 1. regulate water balance, 2. regulate dissolved solute balance, 3. eliminate nitrogenous and other waste products, and 4. regulate blood pressure. The majority of patients with chronic renal disease come to the physician with an inability to regulate one or more of'the above functions. There is little information concerning the-natural history of the vari- -ous renal diseases that lead to the patient with terminal renal disease. It is felt that many of the patients with chronic pyelonephritis-(chronic infec- tion of the kidney) result from inadequately treated cases of.acute pyelo- nephritis. It is estimated that four to six million cases of unknown infec- tions of the urinary tract exist in the United States. Thus the prevalence of renal disease may be much higher than the estimates listed above. Bacteri- uria in -pregnancy is a forerunner of essentially all cases of acute pyelo- nephritis of pregnancy and many of these are thought, if inadequately treated., to become chronic pyelonephritis. It is known that with hypersensitivity diseases the majority of the patients with acute poststreptococcal glomerulo- nephritis ("Bright's Disease") who survive the initial acute episode have complete recovery. Some investigators feel that essential hypertension is often associated with chronic pyelonephritis. Current knowledge allows no primary prevention of chronic renal isease with the exception of those patients: 1. who are detected to have abnormalities of the collecting and excre- tory system which may be surgically corrected, nd choice for those patients in whom transplantation be utilized as a seco was not feasible or donor organs were not available. As a la,t resort, some form of chronic institutional dialysis would be offered. It is our expectation-that three-quarters of all newly referred cases will be candi- dates for transplantation and approximately three-quarters of @L-he remainder,. candidates'for home h&modialysis. Institutional facilities will have to be available for.the-'reriiaining.patients and for those in whom rejection of the transplant occurs. The paucity of information about the natural history of renal disease makes planning a difficult and imprecise tool. Figure 1. illustrates .. some of the "uncontrollable variables" which must be considered in establishing a regional plan. Technologic or other research advances will lessen the need for expansion of dialysis centers. The "controllable variables" repre- sent items that society in general and the medical profession in particular can alter. These two sets.of variables lead to "value variables" which are the out@come or effectiveness measures of the system. At this time, there is insufficient information to allow construction of a true "cost-effectiveness model." Figure 1. Factors Involved in Planning a Renal Disease Proarar, 'Uncontrollable Controllable Value Variables Variables :Var iab I-e s 1. Number of cases 1. Registry of all 1. Preventable deaths occurring cases 2. Decreased disability 2. Predilection for 2. Criteria for days race sex or socio- acceptance of economic factors patients into 3. Decreased 'hospitali- program zations for chronic 3. Geographic location renal disease patients of cases 3. Level of financing on treatment available 4;. Intetcurrent illness 4. Extended years of or other disease 4. Capacity of life developing centers for Dialysis and Transplantation 5. Rehabilitation 5. Technology and potential other research 5. Level of staffing advances available 6. Lack of welfare need for patient 6. Therapeutic method and/or family selected: Transplantation 7. Contribution to Dialysis, home economy (income Dialysis, tax etc.) institutional 8. Resource utilization (dollars, space, manpower) -6- A "Life@Plati" for the treatment of patients with end-stage renal disease is proposed. The goal of the plan is to provide tertiary treatment center resources for home dialysis training and renal homotransplantation so that all Americans who suffer from end-stage renal disease and meet the medical criteria for maintenance therapy will have access to care. Specific objec- tives are to develop a minitium of 50 tertiary treatment centers with facil- ities for renal homotransplantation and home dialysis training located throughout the country at an avera-e of approximately 1 per 3-4 million population. A second objective is to prevent duplication and under-utilization of services. The specific elements to achieve these objectives are that a Federal program, administered by the Health Services and Mental Ilealtli Admin- istration (through the Regional Medical Programs Service), will selectively fund medical centers which demonstrate the capacity to perform this service. A decremental funding pattern will be utilized. Continuation costs of these centers will be borne by patient care reimbursement mechanisms. The plan makes the following assumptions: 1. The average life extension will be seven years or more; 2. The rate of entry will be unchanging over the next five years; 3. Mechanisms for payment for direct patient services will develop-as the resources to provide the services become available (through Title XVIII, XIX, l@IIISAl Blue Plans, etc). There will be Federal-State cooperation in develop- ing these mechanisms. 4.-@ Acoordinated plan can be implemented with the voluntary cooperation of the health providers. This type of plan has already been enthusiastically endorsed by leading nephrologists. The special kidney elements to be developed in major medical centers so that they may be designated tertiary treatment centers are listed in figure 2, page 8. -7- for Deliverv of Care to Patients with Renal Disease Svstem Figure 2 is a schematic model of the proposed system. Three levels of care will be available. The primary treatment center will be the local physician whether generalist, internist, pediatrician$ urologist, etc. Essentially all cases of acute renal disease will be seen at this level. l@lith proper education during training years and a strong postgraduate continuing education program, these physicians will provide a high level of expertise and care to patients. It is expected that supervision of most of the atients in the p post-transplantation period and those on home dialysis will occur at this level. These physicians are already in practice and needs here are to provide continuing education and to strengthen the-referral mechanisms. The secondar care centers will involve physicians with specialty training y in dealing with patients with acute and chronic renal disease. Some will be physicians' offices, some will be clinics and some will be hospitals. These centers would also be referral centers for patients from both primary and tertiary dare centers. , They should be strategically located throughout the region ideally so that no patient would have to travel more than one hoi@@i to receive care (40-60 miles). ,The tertiary level of care will be centered in major medical centers. Services @-available-at this level are listed in Figure 2. Organ procurement and sharing and tissue typing must be coordinated with the other regions as well. Primary and secondary treatment centers are to be developed f rom existing resources. Tertiary treatment centers will be developed in existing major medical centers. The emphasis will be to develop this system as a subsystem of a comprehensive health care delivery system. Plan It was e@timated by the GottschAlk Report submitted in 1967 to the Bureau of the Budget that 7,000-to 10,000 patients are considered to be suitable candidates for supportive care and would be expected to achieve a 75% level of rehabilitation to their pre-terminal illness activities. Therefore, it would seem appropriate that a strategy be developed for the entrance of these 7,000 to 10,000 patients per-year into a coordinated plan of health care delivery. Tertiary Treatment Centers for Renal Disease Patients are to be developed for every three to four million residents. These Centers will combine the resources of hemodialysis and renal homotransplantation with conservative management as modalities of treatment for patients identified. As soon as a patient is diagnosed a he is to be entered into the registry as having chronic progressive renal disease and referred to the center for that region to be entered into the long-range "life plan." Emphasis in this "life plan" will be placed upon early homotrans- plantation. At the present time cadaveric transplantation seems to be the most practical. REGIONAL MEDICAL PROGRAMS SERVICE (To Fund and Evaluate) REGISTRY Centers: t Centers: Tertiary.Treatment Centers: fice al Health Major Medical Center (50 - 80 Primary Evaluation Specialty Eva-luation Specialty Evaluation Primary Treatment Specialty Treatment Specialty Treatment co Referral to Secondary outpatient Institutional Chronic Institutional and Tertiary Centers Dialysis Dialysis Home Dialysis Supervision Home Dialysis Supervision Home Dialysis Training ...Transplantation Followup (possibly training) Programs Participation in Continuing Shunt Replacement Shunt Placement Education Transplantation Followup Tissue Typing Prevention Continuing Education Organ Procurement and Consultation on: Preservation Diet Renal Transplantation Personal Services Training of Health'Personnel Rehnbilitation Ccatinuing Education irch Rese, Consultation on: Diet; Personal Services; Rehabilitation -9- s entering the program it is estimated that 60 to 80 percent of the patient will be suitable candidates for transplantation. Of the remaining 20 to 40 percent of patients, some form of long term hemadialysis is indicated. It is estimated that of the hemodialysis patients, three quarters will be entere,.l in a home dialysis training program for treatment in their homes or at lo\q cost satellite ambulatory care centers. The remaining will require institutional treatment because of the severity of their condition or for some other medical or social reason. The Department of Health Education and Welfare through the Health Services and Mental Health Administration and the Regional Medical Programs Service will fund the start-up costs for renal transplantation units and selectively fund start-up costs for home dialysis training programs. Communication System To coordinate the activities of this life plan and to develop information for better organ procurement and sharing, a national communication network will be established that will be operated centrally with one central computer system. Information will be fed into this communication network about all patients with end-stage renal disease whether or not they have begun dialysis or have had a transplant. 'Further Informati-on is contained in Tab A. Current Related Programs Currently there are 340 institutions in the country providing dialysis services to kidney patients and 95 hospitals providing kidney transplants, However, most of these are poorly utilized and not staffed with full time personnel. Until very recently all dialysis facilities were located in r affiliated with public and non-profit hospitals. During the past two 0 years.there has been a small number of privately owned dialysis facilities emerging in the largest metropolitan areas. Transplantation programs are all affiliated with medical schools including 12 programs located in Veterans Administration Hospitals and two programs in private foundations. By selective support of 50-80 tertiary treatment centers, DHEW would encourage their development and continuance. Most of the other cen'ters would be eypected to phase out. -10- At present there are several systems by which dialysis care is delivered. They are: (1) Training of the patient in' a hospital for routine- chronic care in the patient's home or in a low-overhead self-care facility both affiliated with a medical center, (2) Provision of total care in a low- ion of total care in a hospital. Each overhead facility or (3) Provis year a smaller proportion of patients are receiving all their care in a hospital setting. In-hospital dialysis care centers are continuin- to serve an important role as patient diagnostic and referral center,, and for treating emergency conditions which arise while patients are enrolled in the alternate delivery systems. HosDitals continue to be the main resource providing dialysis care immediately before and after transplant surgery. Tab D.lists the current expenditures for all tv es of renal lp disease. Rationale for Governmental Initiative The financial impact on the economy of kidney disease is in excess of $3,635,000,000. Estiiiates of the prevalence of kidney disease exceec 7,847,000 (or 3.7% of the total population). Thus a major initiative to decrease the morbidity and mortality rate is imperative. 'hloi4here in the health care industry does the same gap exist between technology and delivery as in the area of treatment of patients with end- stage renal disease. Technologic developments in the last few years have made possible the rapid expansion of programs to provide patients with hemodialysis, in an institutional settin-. The development of remarkable technologic innovations that allow self-dialysis by the patient or a member of his family at their home has been a major step in making this a practical approach. Techniques of organ harvesting, preservation, and transplantation have made renal hoinotransplantation a service entity and no longer a research tool. However, the funding mechanisms to develop the resources and provide patient care reimbursement have lagged far behind. A management plan to prevent duplication, establish a nationwide network, assure high quality, and assure access for all is necessary. Because of this disparity, and the need for a national network, it is an appropriate function of the Federal government to brid@e the gap by providing funds to develop the resources with the expectation that patient care reimburse- ment mechanisms such as Title XVIII, Title XVIX, the National Health Insurance Standards Act the Blue Plans, etc., will provide the payment of the direct services once the resources, are present. This program is a five-year funding effort that will be utilized as start-up costs to assist the health care industry to develop these additional resources. Two methods may be employed to prevent duplication of tertiary treatment centers. This is absolutely necessary to prevent a spiraling of costs to treat end-stage renal patients and further contribute to "health care inflation". The first method is a regulatory approach and consists of a system of franchising dialysis-transplaiitation centers through either the State Health Department or 314a agency. The-advantage of this systt--m is that it is an absolute prohibition against unnecessary services, the::dis- advantaoe is that this would require modification of existing State laws Fiat most areas. The second disincentive to unnecessar duplication of hemo- y dialysis and renal transplantation centers is the voluntary cooperation of four major health financing agencies with support of the National Kidney Foundation and the American Society of Nephrology. This approach would utilize third party reimbursement mechanisms as the disincentive. Specif- 'ically, if the Social Security Administration, Social and Rehabilitation Service, Health Insurance Association of America, and the Blue Plans werc to agree that they would only reimburse care given to patients in approval, certified centers, this would provide a mechanism for preventing duplicatory services. Several leading nephrologists have discussed elements of this plan with the Regional Medical Programs Service over the past several weeks. Their enthusiastic support of this approach would imply that it would be possible to receive essentially complete support of the members of the American Society of Nephrology and the National Kidney Foundation to back a Federally controlled program. This voluntary health agency and professional association support coupled with a funding decision by the third party payors would assure the success of the proposed plan. A question may be raised as to why the Federal Government should support a complete program for one specialized health problem such as end-sta-e renai'disease without insisting that it be part of a total comprehensive system. The answer lies in the fact that healthcare delivery must be comprehensive at a primary and secondary level but tertiary tare requires highly specialized skills and facilities on a regionalized basis. Dialysis- transplantation centers are a specialized form of tertiary care. The investment in training, technology, and other resources to provide tertiary levels of care is of such a magnitude and is so demanding on health manpower training facilities and resources that optimal utilization must be made of them. Not only are the resou rce requirements large but they cannot function in isolation from other tertiary levels of care. That is to say transplantation centers cannot exist without immunologists, good clinical pathology laboratories, good operating rooms, and recovery room; dialysis centers cannot function with- out blood banks,, nephrologists, psychiatrists, urologists and social workers. The aggregation and interdigitation of tertiary skills has a synergistic effect upon productivity. The climate that develops in a medical center is conducive to further testing and development of innovative technologies -12- Further, the skills are of such a high degree of specialization that a minimum level of activity is necessary to maintain quality. Coordinatioil is necessary to assure linl(ages of primary and secondary services to the tertiary services to prevent duplication. The second reason behind this special Federal program is that there is a finite group of patients with a predictable frequency thus the Supply of resources can be geared to the demand of the patients by effective centralized planning. There are few other health care deliverv problems that fit this category. The third answer is that this systematic approach to the delivery of one health care problem has proven to be successful on a regional basis in this country and on a National and International basis in other countries. Thus, the development of a National coordinated network, .that sets as its goal the provision of access to resources for all medically eligible citizens and the fulfillment.of this goal, establishes a systems model that can be applied to other health care problems as technology b@@ more advanced. During the past decade significant inroads have been made in the treat- ment of patients with end-stage renal disease. With demonstration that patients can be readily maintained for years by regular hemodialysis over a decade ago, efforts have been directed towards the development of low cost, practical and simple methods of treatment. These efforts have lead to the development of home hemodialvsls, a procedure that has -Der drastically reduced the cost of this therapy (from $200 inhospital dialysis to $25 per home dialysis). With the demonstration of the long term patient survival on hemoeialysis coupled with the advances in irnunosuppressive therapy, renal trans- plantation has become the acceptable @.ode of therapy. Significant strides have been made in organ-procurement and preservation, thereby, increasing the availability and improving the quality of donor kidneys. In conclusion, the technology necessary to treat patients with end-8tage renal disease is now a reality. Further investigative efforts are still being directed towards the improvement of existing techniques. A further discussion of technologic system is contained in Tab A. -13- Mana!ZE,n,. nt Plan lantation over the past decade The development of hemodialysis and transp as complementary modes of end-stage kidney disease patient care has indicated striking need to organize integrated systems of delivery. The efficient delivery of dialysis therapy requires concentration of ex- pensive dialyzers and dialyzate delivery systems at central points where scarce medical and paramedical manpower can be employed in treating large numbers of patients. Such centralization provides the patient with hiob quality services while he is being stabilized, and permits the medical center to fully classify the patient as a potential kidney transpla@-it@,- tion recipient. A comprehensive program that provides center, home trainint, and limited care dialysis treatment and transplantation can be responsive to the individual medical requirements and needs of each patient requiring treatment. It has been demonstrated that transplan- tation facilities with adequate dialysis (pre-and-post transplant) can serve large population groups. As the hub of a network of dialysis centers, transplantation offers patient egress from long-term dialysis. Thus the most'effective delivery system of end-stage kidney disease treatment requires aggregates of hospitals and other health facilities interrelated in an organized network which assures accessibility of care to the patient, and interdigitates patient referral, patient registry, dialysis, organ procurement, transplantation, laboratory services and continued patient follow-up. Such a system lends itself to a national program of coordinated dialysis- transplantation networks such as has been under development by the Regional Medical Programs Service, HSMM. The kidney disease control activity of the @fPs has intensively demonstrated dialysis and transplantation modalities in various settings, and the Regional Medical Programs across the country 'nave begun to organize regional kidney programs incorporating existing medical and health facilities, private patient care funding and ,manpower; they relate' to State and local planning agencies, and Veterans Administration, vocational rehabilitation and other Federal, State and local medical'and health pro-rams. RN11S authority to develop and coordinate interregional end-stage treatment delivery systems is contained in Section 910, Title IX, PHS Act. Inquiries and roposals for broad, interregional end-staae kidney disease programs p to coordinate dialysis, organ procurement, and transplantation activities for large sect4-ons of the country are being received. Such proarams C> typically propose cadaver organ procurement, and donor-recipient matching and registry facilities for a number of transplantation centers, which are related to supportin.- dialysis facilities. A broad program which provides contractual support for such "super regional" activities would assure coordination and monitoring capabilities at the national level to obtain efficient non-duplicating deployment of resources, and effective coordi- nation with related health programs at Regional, State, and local levels. Project Schedule 1. Fiscal Year 01: a. Grants to 's for Prevention and Public Education Prograii!. b. Contract for the development of the communications system. c. Fund 30 transplant centers - either completely new or supplementing existing incomplete centers. d. Fund 25 home dialysis training programs either completely new or supplementing existing incomplete centers. e. Grants and/or contracts for Research and Development. 2. Fiscal Year 02: a. Continue funding Prevention and Public Education. b. Continue fundin- the communication system. c. Continue funding 30 transplant centers. d. Start funding 20 additional transplant centers (as above). e. Start funding 25 home dialysis training programs (as above). f. Continue Research and Development funding. 3. Fiscal Years 03, 04, 05: a. Continue funding Prevention and Public Education. b. Continue funding the communication system. c. Continue decremental funding of 50 transplant cente rs d. Continue Research and Development fundili&. -15 - Manpower Resotii:ces Plan ovidin- The direct manpower required to fulfill the objective of pr full resources in the tertiary treatment centers includes the following: 1. For each Transplant Center a. Transplant Surgeon (full-time) b. Assistant Transplant Surgeon (at 50% time) c. Administrative Coordinator d. Secretary e. Perfusion Technician f. 3 Tissue-typing Teciinicians 2. For each-Home Dialysis Training Procram a. Physician b. Administrative Coordinator c. Secretary d. 2 RN's e. 2 LPN's f. 4 Dialysis Technicians 3. For the Center Communications System a. Coordinator b. 3 to 5 Computer Systems Technologists d. Also included here will be a significant but as yet undetermined number of personnel utilized in designing and implementing the system. These personnel will bc computer programmer and systems analyst specialists. If 50 centers are developed, this gives us a total of 925 direct personnel (exclusive of communications people) who will I;e supported with Federal funds. There are, however, other personnel who will be directly involved in the program, i.e., dieticians, social workers, .1 . this group of.per- psychiatrists and psychologists. In most cases sonnel will already be a part of the existing medical staff and will not require any recruitment. The availability of-trained medical and allied health personnel to fulfill these positions is adequate in most cases. However, 400 trained paramedical technical personnel are required, and it is anticipated that a shortage in this personnel areas may develop. To offset any shortage, discharged armed forces corpsmen and other 16- techn.ical specialists who have already been extensively trained in re and/or laboratory work, will be recruited general patient ca trained and employed in the appropriate center. Wherever possible, already existing hospital facilities -will be useA for the centers. -No new construction is anticipated but some -revio- vation of the existing facilities is expected. The initial source of funds for the establishment and operation of the centers will'come from the Federal government. Federal SUPP07-t for the first five years of the program will allow the centers to become firmly established and develop adequate direct patient reimbursement mechanisms, thus becoming self-sufficient. Desired Impact Renal disease is not a respecter of age, sex, race, or socioeconomic background. Lack-of access to care is not restricted to a specific geographic or economic group. It has been noted that there is a higher incidence of end-stage renal disease in minorities and in high density residential areas than in other portions of an urban community; renal disease secondary to hypertension is more prevalent in young and middle age Negro.males. The described program of pro- viding a national network of Tertiary Treatment Centers would provide access to all citizens with medical indications for hemodialysis and/or renal homotransplantations. At the end of five years the program goal of treatment resource availability for all citizens with this condition would have been reached. The impact upon the rest of the health care delivery system would be negligible as far as diversion of resources from other priority areas. Progress should have been made in research and development, prevention and public education which would begin to show a decreased number of disability days and other morbidity indices. This systematic approach to handling a major health issue will provide a model that may be emulated to solve other health care problems. Proper implementation of this program will strengthen the concept of regionaliza- tion and non-duplication of health care services. It will not be a perpetuation of further fragmentation of care. A cost benefit model is developed in Tab E. The total impact of the program cannot be accurately estimated as preventive methods are rudimentary as yet. Evaluation Plan It has been estimated that 7,000 to 10,000 lives are lost each year which are salvageable by the provision of proper treatment modalities. Not only are these lives salvageable but over 75% of them are rehabili- tatible to a level approaching their activities before the terminal 17 - illness began. Thus, the criteria for evaluation are: (1) access to care for those diagn@sed as having end-stage renal disease with medical indication for maintenance therapy., (2) degree of rehabilitation of those so treated; (3) acceptability of the care by the patient and his family; nt. With the present system the average annuili- (4) cost containme cost for patients in home dialysis, institutional dialysis and renal homotransplantation pr ograms, has been quite high. With a systematic approach, improved utilization of resources and coordination of repayment mechanisms, it is expected that the average annual cost will decrease (or remain stable).. No patient d care because of financial barriers; is to be deni-e (5) the quality of medical care delivered is to be evaluated b-v a national renal peer review mechanism. Standards of optim@1-1. will be developed and maintained for selection of patients, de- termination of medical management, degree of rehabilitation and end results. National optimal standards can assure the finest quality of care in each of the renal centers. m edure A kidney disease control program already exists in HSMHA in the Division of Professional and Technical Development of the Regional Medical Programs Service; procedures for the receipt, review, and approval of proposals for kidney disease.programs have been oper--- ti6nal for some years. An important element of this procedure is the requirement that applicant groups obtain State and Regional certifications of program need, evidence of non-duplication of exist- ing medical and health resources, and that plans provide effective linkage with other programs for planning, operations and patient referral. A Kidney Disease Advisory Committee will be established to advise the Administrator, HSIIHA, on the administration of the national kidney disease program. The committee should be comprised of out- standing individuals in the fields of nephrology and related medical specialties, health administration, consumers, and technological specialty areas,which are contributing to advanced medical delivery systems. The committee will evaluate the administration of the national kidney disease program, and advise the Administrator on matters of criteria, program performance, opportunities.for technical innovation, and organization and employment of appropriate health' resources. the selection of participating institutions Criteria applicable to are bein@ developed under the provisions of Section 907, Titl@- and will be available soon. Development and implementation of,tit-,,-, program will be monitored by the regional NT@edical Proarams in C> I.1'.I cooperation with comprehensive health planning agencies. EvaluaLi,,,,@--@i of program performance will be carried out by PBIPS thrOLlah estib- lished reQional and interregional reporting systems, and centralized registries of patients entering and being served by the national program. The Research and Development portion of the Initiative would be managed by NIH using present mechanisms. Proposals will be sought which fulfill the objectives of the program. SYS'ccrr@s Teclinoloc.,ic Comniuv.@t,-ations S@7sL:C,'m ),stc-m, coi,it@,ai.n@ii@ records of all cill-,.-O!'.ic' An ef-.icient conintililcatic)ns -s @ i- C i n; ti r@,! oi the renal disease patients must be an intec--, particular p@l@ient a di@,a(,,,,,-iosis O' The %ioul.d first list a irreversible chronic renal clil.seas-,-, is esta")'iislied. Data in the sy,"'-(,-m for allocation of end-ste.-e re-so-,lr(,ec would lie@.p in the ZD as well as in the selection of the most cc,,:i-,-,ati-bl.e recipient for each donor appear4-na, in the transplant The buC @tary allocation of 5 -Pill.i-on dollars for the s,,stc@ -,ncluces substantial start-up costs duri-n- the first year when deN7elopi7@@,iitel costs will predominate. Each of the 50-80 cooperating tcrti-arv trcitii,,c,,it centers x,.,ill have a terl:-,-,n ed to a - ra al linl, cent I- cc).-,,i),,iter ODerc.Li.-r.@, hours a day 7 days a N-7c!el@. The treatment centers would need no sp(-,ct.al te- e d t o -ell i nicians s4nce the terminals can be pro,7,ra operate in a con" mode. Costs for systems desian of both har,-4@.-are a-,-id sof t\,7are iliou'..cl be enormous clurii-ic, tiie first year, but costs should level. out in the second -year and 'Lie constant tlierca.-Lrte,@. Solicitation of bids for this proposal should r-@sult in a total cost of million dollars or I.,-,.ss. Prototypes of a co.7ipiiter match4-ii-, system already e@:i-stent are.: a) The 'national Co,-,-nun@..catio,,is l@et,,?orl- 07p<,,r,,ted by Dr. Paul 'J'erasa@.-.-L, Ti-ie UCLA, and supported I-.-- coiitrac -@.-itli D,,. orzan e@:chanc@e ?iid cocT)ea.-c,-@ive, L Util4ZO,t4oll 0-F CoMpute@izcd data for Vir@i,,iia, Georc@ia, ,.ia-@ylan'@, Carolina eii6 Dr. Terasa-[,.-i-'s no- -L C C,:-.-Ipt-l t:E@ ri zed c-,-,La on t!7,@ results, tissue-t,,-pin atus oi 4,C)OC) transplants performed and curre-nc st across the co-anl-r@, (7z, medical centers) .2@ %,.,ell as tissii@,-typi.ng data on 1,000 potential re-cip,4---ii@@s (ac,,ziin a,: 74 rn-@ical centers) @.,,ho are a@-7aiti.l),-, transplantation. l@,"iien a donor l@icllr.-cy and become avail- ab le at apv one o f th c-@ p art @ c ip @-@ t:-'@ cen,- &-: s the d atL@ --r or the s e 1 , OC6 0 re - cipicnts is available on a basis the best possible match can therefore be obtai-,qe'u. occasionally i-@iter-cen---er or-an c)2: -nt Ici-,ansi)c).@t. Tndc!ed, since ',-,"arc'n s (or paluiuiits) patic beti.)ee c P-1 have been transpo@ ri rfla il4Zill-, this co--,r,,,un-ca@@ions nc- tN,-orl,,. The. So@,itlictIsLe,:P. PrOCII17Cnl@Pt LI,--'n s,-Tpqi:t,@@'t -;@n @)prt by l@as utilized and 'eas7b-' 4 -,7 of a central co:,,puter of th n, at c 1) y s t or,, all-c, ino' 21,,-',iour av- r)otcll.tial the r 1) :n states. --@f-cd the Both of these pilot efforts value of a computerized nati,lii,7@). Platcl-iii-,@c' Althc)u--,Ii ill the questions DI.-,'IgTnatic use Of tisst@,c@-t@7 'ing P for Cada\7eric transplants are yet to I)(-- Lns@7,,@rcd, for til;sLle,- typi,-ic, for liviiic, related dc@iors., -nd the -,tiperi-or -.cc@slilts of -Li@Lilizin- "A" r@,,atc',Ics in cadaveric is N.!@ll !-'f for no L) t 1-1 than these reasc)is alone, a national of and exchanc,L@ 0 is desirE@le. II. Trends in Current Technolo(,,,y of Kidv..?y i)is,-,asc Re-l-at.--d Equj.l)inent O@, aci\,ancc@s In the field of dialysis there are a n,,im,)r-:-r of p to liardi,@cr@ that equipment, if found clinically r.,.@y si(-,-,:.ifica-.@-itly m,-)d- improve the present dial@rs-'-Is r,', a 1 @'L ties. Sub s c q uc n- t o t li c d ev e I oT)mcn t o f tli e c a p -i I ary ki-LI n c 4 @n i c t .@L nt er e s t has becii generated .o-t.,,ard the use of ul,-,ca-thin cellulose acetate flat membranes. This type of men,@brane appears Lo be su-,)erior to the e,:istinc, membranes for of "urciilc The -Li,-c,, )f this t\lne of r,-.,embranc- may s can t ly t c-n t,ic, p er@L od c a paL i eyiy. may oe d-ialyzc@ per day, thereby n t i oi-L, s i @n i f -1@ c a i-i trials a e just undcrxTa@, stri.e@es are E- in the prolonc,ati-on of C"L C a n,-JL:, !Es. B-v of an appropriate tissue si;bptalce, --s @@7c-11 as minimal "lirom'L)ogen surfaces, c.-,:tcrnal ca-,nulas eniov r a L c I-litli recard to the of ne-,,7 C,@Lalysis syLtei,-,s, there are t@,7c) promis@Ln-, avenues presently unclcr-oiia,,, clinical tr,'@,.ls. The first is the -%@o lur - -s) sor,@ent C-'@ r i C 11 t'l" p Cl 1 ( -L - 2 1 i t,@,, I w being constantly recirculated cs "-t 'i),-2 r c-, g. a t c c aid of Et -@; of selected adsorbents. This Cle-\7C-lopiie-pt alonc-- is spectru @l@@ly valuable b2causr-- for !--he first time lie-:i@di-al@,sis becorie 2-IndeDen@-le-,it of the the toilet C-'i:aii-@" in dial-@s@l-s. This C--rastic 4 reductio i, t'i u-@,t of d@-alysaf--e reai-,i2-ed also promises to sol-,e a N.!hole Fei-4--s of prc@blc--7@-,,,s b@c-c-',: ii.alyc-is, 11-lic- c,-L: a I- -'@ t), of aL@ I (-@ T- c,, r a I v s i s P. n d t I @ C. p r c- 1) a -L a t i c@ V, c, LI 1 L L r c,@ c- 7 C) tapi,lat-c,,r a--a 1:-lT-,es Of d i a 'I@ 3, s c A i 2L -L- I i t li c 6 c, f c, T) ) r t -L c) n, i-p- o s a n a c o - c c-@ r a t e s c, i u !-- I' 0 ri S The, sacc)@,. e-rals sister c@ii.Ic--u ', i rL- - a i 1 o ii x@,71i 41-cli ha s n t L C) e, s yet prc--Lcst'- -3 - tl,@erc has been the introduction of r@i-cro-c-,nc@-@pstilated particles i.-Ii-i-ch arc in,(,rested by tii(-@ patient a,-,d tl,eorecic,,illy adsorb t the j.11 a,,, -,mount ,,,,ifficieiit c;ii@u,i-i to rc,,j-,ic:e the of dialysis. Finally, per:Ltc@neal dialysis has rcc,?,@,'-ved interc,F@u ililh the I development of q.n dc-livc- Ftem. s systc;: c@iroves inDst r-@ sy of the complications -tss,,)ciated N-.Ti-tll pcritoi a r-r enables on, to perform the procedure quite readily. In concli-,sio-,,i, there are a number of sicni,fic,@-..-@t advances that are- c)-ri the horizon that have the-, I)ote-ntial,of si-,c,,nLficantly alterin.@ the completion of diaivs.'Ls. I Ctirrent Status of Home Dialysis Tccl-iiiolo-.Y Home liemodialysis was initiated in Boston in 1963 and in S&&'.tle and ' e:,:perimen London in 196L,. Initially, home treatment was a tal endeavor but has evolved rapidly into a practical an(i succ(-ss-,,il me--,.i:. of trea-lin,, end-sta-e rer-al. disease. 1,@ainterai-Lcc- dialysis now can be made available to almost @nyc7nr-- @.?"Ao is capa,)!-e of leariii-:ia to trea,: Ili,-isel--F ill his C)V"-l FurthE@.rmqi--c-, treatment -I.ii the rather ttiai- the center can prc)vide an opportunity for r,,jl-e therefore, better control of the ezc)tcmic state and at less than the cost. At tile Di--eseut time. in a treatment designed for 7 for ho-:c- d al@ s, a i)ericd of six t@:) ei-lit i-7eel-,s oi instr-L,,c- tioil serves to train L, patient trained for home dialysis primarily used !--he ii4.1-ti,pe dialyzc-r i@,ith a simple 1-i-vOraulic dial-,-satc- delivery svstc-ni. rapid advances du@@-i-,io tile ensuing iia-,.Tc lead to @he introduction of more sophisticated and safer dialysa4 these advances cc4-l- d-' - at Pir)rc,. of a reality tlio,,-i in the pasL. l-i7L Lhe ciuctic,n ol such dialyzers as the capillary Ir@i(Iney' has an acccp-Lablc@ ait,--rnati.-,.7c to the usual dial-@zers. Presently, significant in@-zoac:s are bei.n@ made into the eevel.opmc-iit of compact disposable di-aly- zers. In --ddit@-on, the uQe of small and co=acll- dial),sate delivery s-ystej,-@s are. Presently unia-r(,oing clinical. tri-a',-c,. The potentials for the future arc Tndeel c i @7.-,Dr es s -Lv e it @,@ot-,Id --,early appear -hat o. patient i,,ith renal 'Lail,-ire 1.14 1 1only have t-, e@@e.lyz-@- 1-iii@isc-l' one two hours a day a system that co-ild readily fit a si-,itc--sc--. and Prcscrvati,,)n of T)o-riL)r The basic principal of p,@.-ovidin@ tranST-lai-it recipient with the best .possible donor orcan would be @reat:ly enhanced by the. ability to effec- c; C, tively assay potential donor o,-r;,ins for viability and transplantability prior to the actual surgery. Presently,.ti,)o preservation methods are available @.,,hicli have been used extensively in clinical or-an transplants 1) simple hypotliermic storace with or without brief initial cold perfusion and 2) prolonged pulsatile perfusio,,i. Stora,@,,e by simple hypothermia has been used extensively and appears., to be a procedure for less than ten hours. On the other hand, the P.,,@thod of pulsatile p@-rfusion of the l@idney allows for considerably @reater advantages 1) adequate preserva- tion for at least thirty hours, 2) assessment of viability of donor kidn6y, 3) removes transplant surccry from that of an emergency procedure to that of an elective one, 4) allows for potential sharing of a l@idney with the best matched recipient wherever tic- ii,,ay be, 5) allows for pre- surgery reassessment of potential recipients. Presentl@,, devices have been developed which can be easily transported in a small van or even an airplane seat. This then allows for the transportation of orcahs from region to region -and potentially from,country to country. Currently, the scarcity of availa'DI.e cadaver organs is probably the most important factor in limiting the nLLTber of transplants beina performed. Hence, it is of utmost importance that an aggressive organ procurement pro-ram be established as part of the public education program. In addi- tion, the support of local legislation to mal@e it easier to obtain organs is of vital concern. B ted to T,ie federal e:@-,-,cndittire c)-,Ic!r a five-year period of tire is es'ui_.ma for tertiar,T treatment centers, 15 million for R & D, be 50 million -,illion for prevention, blic education and 5 million 5 r 5 million for pu for co.@@-ani-ce.-Lio-,is ,ietwork or a total ol' 80 million dollars over five years (which avc-ra@,es 16 million dollars per @,ear.) It should be noted that there are -@iread\y in E-@:,@istence -,everal transplantation centers that would not need additional support to become self-sufficie@-iL (approximate-L.@ 7-10). It should also be noted that there are already in e-:istence @orfle di.alysis trainin- programs that would not need further support to become self-sufficieat. At this time an e:.,act estimate of the number of these is not available, but X,74 @ll be developed shortly. The funds saved by not having to support the full quota of transplant centers or home dialysis centers wi.11 be utilized to fill the gap where additional tertiary treat- ment centers or satellite, low cost, hemodialysis centers are needed to provide for the patients who can not cire for themselves at home or re- ceive a renal ho,-@.otransplant. Several States have already established State-wide funding mechanisms to pay for the direct patient care costs. This national plan will be coordi- nated with these States. Federal-State cooperation in this network approach to a priority health issue is a model that can be followed by other programs. The direct economic impact of this proposal upon equipment manufacturers is: 1. Perfusion and dialysis equipment $2,000,000 2. Computer systems $5,000,000 The direct full-time employment impact of this program in tertiary treat- ment centers il- 1. Physicians 125 2. Nursing personnel (RN and LPN) 200 3. Technicians (Perfusion, Dialysis, Tissue 400 Typing) 4. Administrative staff- 100 @5. Clerical 100 Total 925 Transplantation Centers Transplantation Centers will be funded at an average,-, c;.,-. three to four million people per center for 50 to 80 transp'iantatior- centers. These will be supported at medical centers in :areas in which there Health Plannir,-@@ expected that a tot I Aaencies have determined that a need c)@ists. It is of 5,000 to 7,000 transplants will be performed annually by the fi.Zth year. enter will be planned in a re(,ion until any existing No new transplantation cc, center is approachiiic, 75. transplants per year. The desired level of --s per year per center. The Federal activity will be 75-100 transplant Goveriur,ent will fund'6ft adccre-,rental basis (up to 100 percent year one and two, 75 percent year.,three, 50 percent year four and 25 percent year five) the follo@qin- categories provided that they do not currently exist in that region. If one,or more of these budget items are available, the center Hill be funded for the remaining portions. Transplant Surgeon $35,000 Assistant Surgeon (50% of the time) Administrative Coordinator 15,000 Secretary 8,000 Perfusioii Equipment 20,000 Perfusion Technician 10,000 Supplies 5 000 Hospital expenses for cadaveric 75,000 organ.-liarvesting Typing Lab 3 technicians 30,000 Supplies 5,000 Sub-Total $218,000 Overhead 60,000 Total $278,000 The procram being considered would provide funds to support transplantation suraeons at the various medical centers. 'Ihe critical importance of this stems from consideration of several factors. First, most University- affiliated hospitals cannot find funds for the sole support of a surgeon who only does transplantation surgery as a separate categorical activity, as opposed to general surgery or vascular surgery with part-time activities in transplantation. Yet, it has been clearly demonstrated that the suc- cess and progressive -rowth of a renal transplantation program is critically dependent upon the presence of a full-tin@e suraeon devoted exclusively to transplantation and probably requires a rii-nimu--i equivalent of l-;! full-time surgeons. It has further been demonstrated that in most instances, the -3 - initial support of such individuals, once a pro-ram has developed, no lonaer requires outside financial support for the salary of the surgeon, this being subsequently obtainable throuch funds -athered via 3td party payment mechanisms. Alternatively, funds often become available through the hospital administration, as it sees the source of increasing incoming funds generated by the transplantit-.on ser-,7iCCI. Home Dialysis Training Pro@rarns leaking the assumption that each Home Dialysis Training Program will operate two shifts per day, two cycles per week (Monday, I-lednesday and Friday -,nd Tuesday, Thursday and Saturday) and will have a minimum of four beds, this will allow at least 12 patients per training cycle and at least 6 cycles per year; thus each unit will be expected to train 72 patients per year. As the total number expected would be between 700 and 3,000 per year, 50 home dialysis trainin- programs can support this national end-stage renal disease life plan. DHEW would fund one home training pro-ram per tertiir@- treatment center with the above assumptions and with any necessary elements of the following budget (provided that they do not previously exist): 1 Physician $30,000 2 RI\"s 30,000 2 LPN's 18,000 4 Technicians 32,000 1 Administrative Coordinator 15,000 1 Secretar)i 6,0(@@ Equipment, Supplies and RenoNration 5,000 Sub-Total 166,000 Overhead 65.0,'jO Total $231,000 This would be funded for one time onl@ with the expectation that revenue from patient care reiT@nbursf--iiien,- mechanisms would be adequate by the second operational year to bear the continuing expenses of salaries. Incidence of Patients with Treatable E-tid-Stage Renal Diseases In 1967, the Gottschalk Report was submitted to the Bureau of the Budo,et. This report concerned itse lf with the problem of developing programs to c'are for persons with chronic kidney disease. Special note was made of the incidence in the United States of chronic kidney disease. At the same time, a study from the National- Institute of Ilealth addressed itself to the same question. These two reports are in remarkably close agreement and have accurately defined the problem when examined against recent statistical analysis. These reports estimated that approximately 50,000 persons die each year from chronic renal disease. This works out to 35 patients per million per year who are treatable. Of those with kidney failure 7,000 to 1 000 are suitable candidates for prolonged 0 medical treatment. liedical treatment consists of conservative therapy, chronic dialysis, and transplantation. 'This prediction has been borne out by the experience of the majority of physicians who care for persons with chronic kidney disease. Indeed, the incidence of 35 suitable patients per one million popu- lation per year has stood the test of four years time. A National Plan for Establishing Patient Referral Patterns one of the factors.that limits care for patients with chronic kidney disease is the lack of a system for patients to enter a well-defined referral pattern. A system of this nature has been proven effectiv in the United Kingdom; Scandia-Transplant which serves Benelux, Germany, Austria, and Switzerland. From their experience we feel this type of procram could be planned and adopted in the United States. The patient referral pattern is best established at a national level. The program which is proposed establishes close knit cooperation between facilities. The activities of these facilities include prevention of kidney disease, education case detection and treat- ment, organ procurement, tissue-typin-, dialysis networks, and trans- plantation. Information between the various facilities will be -2- 11 information on a particular coordinated by a national reaistry. A 0 patient must be exchaii,,ed between the centers of excellence and those primarily concerned with a patient's care. The overriding purpose of this system is to care for a greater number of patients,27cfer patients to the optimum level of medical treatment needed and to return them to useful lives as quickly as possible. In order to not overload the centers, it is planned to return the patient to the primary physician. The primary physician, therefore,-, must have continued training. Continuing education will also be made available to nurses,, dietitians., technicians and other para- medical persoraiel who are involved'x@ith the patient's care. The flow of patient referral is outlined diagra.Tiatically in the introduction. This system is not unlike the pattern of referral that is used today in some areas of the United States. However, the development of a more organized national program will allow -i the quality of care that is necessa for more patients to reacl ry Expected Case Loads and Growth Rates I. Transplantation Information from the National Dialysis Registry suggests that there are approximately 5,000 patients on dialysis in the United States today. Dr. Paul Tcrasalci has data indicating that there are approximately 1,000 patients awaitin- transplantation across the country. His data are not complete, however, and an estimate of the actual current backlog of patients who are candidates for transplantation would be somewhere between 2,000 and 3,000. Data from the Gottschalk Committee Report suggests that approximately 35 patients per million population per year are candidates for transplant or dialysis therapy -- this works out to be approximately, 7,000 patients iii,the United States each year. The program f6r end-stage renal disease would be expected to progressively increase the national capacity for transplantation over a five-year period and over a someiqhat@long-er period, result in a stabilization of transplantation capacity such that a steady state would be reached. Assuming that 80% of all patients with end-stage renal disease who are treatable will be transplanted, then the rate of new transplant candidates for the nation per year will be approximately 5,000 per year. If the rate of expansion of transplantation case load capability averages 30 patients per center per year during year 1, 40 pet year for year 2, 60 per year 3 80 per year for year 4, 100 per year for year 5, and finally, r;aching 150 per year by year 6, then the following predictions can be made: At the end of five years such a transplantation -3 - -ram will have reached a capability of handlinc, the subsequent pro yearly rate of entry of transplant candidates into the system. In ail additional three years (a total of.eiglit years after the i-ilcep- am) the backlog of patients encountered in the tion of the progr system (the initial backlog plus the yearly backlog resultin- from progressive increase in transplant capability) will also have been transplanted. Therefore, it is predicted that a total of eight years is required for a steady state to be achieved with respect to transplantation, and thereafter, transplantation capability will be fully adequate to meet the yearly need. This projection does not include second and third transplantation due to rejection. If this remains a problem, md-re than 50 centers will be needed;a total of 80 centers should take care of this eventuality. Anot:l),-@, assumption tTiat is made in these calculations is that all of the 35 patients per million that are potential candidates will be identified in the proposed program and therefore treated. The -tence to date is that there is initially a significant lag exper in identifying all of these potential candidates so that the pre- dicted case load in the first few years is probably excessive. TATith proper emphasis by the program to further public and physician education, it is anticipated that all or nearly all potential candidates for therapy will be identified. This will not signifi- cantly alter the predictions for the.time required for the system to reach a steady state. The predictions regarding the expected rate of transplantation are realistic in view of the present data showing that in 1969, 900 transplants were done in the United States; in 1970, 1,000 were done and by the end of 197i between 1,100 and 1,500 will be done. The expectations for the proposed proaram of transplanting 1,500 patients in year 1 and progressively increasing to 5,000 patients transplanted in year 5, is attainable. II. Si Dialysis supportive aspects of the life-plan will reach a steady state earlier because of the progressively decreasing case load as transplantation capability increases. 'It is predicted that the dialysis case load will begin at a proximately 5,500 patients p ely 2,000 -patients for year 5 for year I and decrease to approxinat and all subsequent years. The proposed program entails supporting current home dialysis training programs by providin- increase home dialysis training capacity to each of the 50 centers, and adding an additional four home training beds to each of the centers (operatin- on a three dialysis per week, two shifts per day schedule). It is proposed that such a system allows for the handling of the dialysis load and achieves full capacity to do so by as early as year 3, and thereafter, a progressive decrease in dialysis need and capacity could be effected. Existing Kidney Transplant Centers OK@014A Hawaii: 1 Source: Kidney Transplant Registry Terasaki, Caaaver Kidney Communications N Number of Transplantation Centers for which-each State is Eligible* 3 5 -L2 3/4 @4 3/ 3 Puerto Ric6 based on ratio: 1 center p-er-4 million population t@,liF,,ibic for less than center CURRENT E)'PEi,',DITURES of patients i,:ith. A. Hemodialysis: Total number of patients treatpd 42500 .Annual number of dialyses per patient 156 Average cost per dialysis $150 Total current annual expenditure for dialysis $105,300,000 B. Transplantation- Totai number of patients treated annually 1,000 t per patient $10,000 Total cos Total current annual expenditure for $ 10,000,000 transplant II. Av expenditures for therapy A. Hemodialysis in-hospital dialysis Low-overhead facility 125 Home self-dialysis 25 B. Transplant 2 Ttoal average cost per patient $10,000 NOTES: I From financial reports of Federal contracts monitored by Re-ional 14edical ProaraT,-,. 2 This figure is an estimate The rat-ige of costs extends from $5 000 to $50,000. III. Distribution endittires A. Hemodialysis Total Source Amount Percent of Patient out-of-pocket 12,600,000 12% Patient insurance 46,300)000 44% Public and other 46)400,000 44% 2 B. Transplants Source Amount Percent of Total Patient out-of-pocket 1,000$000 10% Public and other 9..Iooo,ooo 90% IV. Estimated Total'Cost of Kidney Disease (National) ti) item Indirect costs,-annual $2,875,000@ 000 Morbidity 1,173@000,000 1 Mortality .1702,000,000 (2) Direct costs, annual 1,458,000,000 Estimated annual total: @4,333,000,000 NOTES: I - Telephone survey February 1970 of 1.7 dialysis ce@-iters. Selection of patients significantly affects these ratios: data from 12 home trainin- dialysis centers under contract show lower out-of-pocket costs due to greater selection of indigent patients. 2 Estimated. were developed in 1968. (1) Data presented The renal disease data was developed from 1964 census data and are adjusted for 1971 prices. (2) Includes hospital, nursing home care, physician, dentists, nurses, other health professional personnel. disease 'in,;ura,lce coverage trc@-tids V. A. enefits - No coherent data is now available. Through individual physician efforts during the 1960s, and more x.7ith major health insurance recent RYIPS staff discussions carrie-rs, insurance support,is rapidly increasing. Blue Cross/Bltie Shield, for instance, administers 74 autonomous plans and coverage varies widely from total to none. Blue Cross/BlL,.e Shield has surveyed its plans, and may have data analyzed.by February or Ilarch 1972. B. Current premium costs are those charoed.for coverage selected. Actuarial estimates based on the experience of Blue Cross/Blue Shield indicate a potential premium levy for renal disease coverage at between $1.00 and $2.00 per year. Informal estimates of preiftium required for national coverage for renal disease are below $1.00 per year. C. Insurance carrier expenditures for chronic renal disease; Unknown. Initial information from the Blue Cross/Blue Shield survey mentioned above indicates that of 70 plans reporting, 66 provide inpatient coveraae (Dialysis overnight). 54 provide outpatient coverage (Dialysis during the day). 44 provide home self-dialysis coverage. No information has been provided on transplantation, although costs have been covered in some areas. The 70 reporting plans encompass 9,643,000 members with coverage complementary to Medicare, while 132,100,000 members are under age 65. At an end-sta-e disease incidence of 35 per 1,000 000 an estimated kidney disease population of 4,600 is projected in the latter figure, D. No Social Security Administration or Social and Rehabilitation Service expenditures for,chronic renal disease are available. Coverage is determined locally. SRS reports that program covering only Counselina and Training provide only $250 pet year, per patient. Where full coverage for end-stage renal disease is provided, a range of $12,000 $25,000 per patient per year is provided. California and New York are examples of States with essentially full covera-e for their end-stage renal.disease populations. it should be noted that more than 25 States have enacted legislation to develop renal disease control programs and/or to help tient care. Funds appropriated vary from support pa none to $1,000,000. End Stage Kidney Disease ltcosE-Beii--fit" @iodel (10 Years) Costs A. Assumptions 1. 7000 ideal patients will be identif ied and treatal year 2. Equilibrium will be reached with 5000 of those ideal patients receiving a transplan;- 3. Transplant capacity will grow from current level of 1500 to 5000 within 4 years. Iteanwhile, dialysis facilities will treat all other ideal candidates. 4. Constant mortality rate of 15% per year on dialysis 5. First year graft failure 25%, and mortality rate of 25%, subsequent yearly mortality of 5% following trans- plant operation. 6. Cost of transplant is $10,000 in first year and $1000 per year thereafter.. 7. Cost of Dialysis is $15,000 per year (combining honc@, low cost satellite and hospital-based dialysis). i B. Case]-oads DX Tx N eLT DX D 4Li Backloo Backlog DxB TxB Dx D Year 1 5000 1000 5000 2000 2050 3000 2798 9000 1950 40C)O 2, 3 11800 3353 3000 4000 3388 2000 5000 3 8 4 13580 5185 5 14493 7426 2000 5000 4095 2000 5000 4318 6 15269 9554 7 15929 11576 2000 5000 4518 2000 5000 4698 8 16490 13497 16967 15322 2000 5000 4861@ 9 10 17372 17056 2000 5000 5009 17716 18703 .85 DxB + .8 DxB k + 1 k 5 Ih-k' .25Txk TxB 95 TxB + .5OTx k + 1 k k D .15 DxB + .05TYB .15Dxk + .25 Txk k + 1 k k C. Yearly Costs Dx Tx New L)x @e@,7 L% Year Backlog Backlog 1 75M $ l@l $75@i $20M $ 17 l@l 2 135M 2M 6OiNi 30@i 3 8 0,111 3@l 45@l 4 0'211 268@l 4 2 0 4 511 30M 50M 289@l 5 218@l 7M 30M 50M 30511 6 23011 iom 30M 50M 320M 7 2391-1 1214 30M 50M 331M 8 248M 13@f 30M 50@l 34DI 9 255M 15M 30M 501@i 350',,l 10 2611.1 17M 3 O@l 50M 3-r Total 2045i\l 85M 390M 440M 2 9 TOTAL COST $2,960,000,000 fits Assumptions 1. Av@r.age annual 'inco-ic for fully re;,iabi-'L.4 is $3000 2. Transplant patients will achieve 80% rehabilitation after the first year 3. Dialysis patients will achieve 60% rehabilitation. Social Benefits (cumul,@ti'k'e over 10 years) 1. Years of Life on dialysis 148,616 2. Years of Life after transplant 103,622 3. Future lives of 17,716 persons undergoing dialysis at end of teh-yeat period 4. Future lives of 18,703 transplant recipients living at the end of ten-year period. Economic Benefits 1. Dialysis: (10 years) 148,616 patient years x $8000 x 60%/patient year@= $71')@l 2. Transplantation: (10 years) 103,622 patient years x $8000 x 80%/Patient year 3. Future earnings of dialysis patients 0 4. Future earnings of transplant,recipients Average'life expectancy is'15 years 15 years x(income minus treatment cost) 6400-1000/patient year x 18,703 patients $151511 TOTAL ECONO!Ilic BENEFIT $2,891@000,000 Cost-Benefit Analysis A. We estimate the total cost of tni-s prooram to be Of this total, $80,000,000 would be government "seea, the remainder would be provided through the u,,-,ual medical p ay- ment mechanisms. B. The 76,000 patients treated under this program can be estimated to earn $2,891,000,000 as a result of receiving this end stage therapy. C. Our cost figures should be weighed against an average cost of death of $4500/patient (assumption of 30-day terminal hospitaii- zation at $150/day). If the ideal end stage kidney disease patients were not treated during the next ten years, death of ttiose.76,000 patients would be expected to co,-L.$342,000,'-,:'.. D. Combining the results shown in paragraphs A, B,-and C, we have an expected economic gain (B + C A) gain): $2891M + $342M - $2960,11 $273@l Gain $273,000,000 E. No assumptions or projections are made for improvements in rehabilitation rates, breakthrough in treatment modalit-;-- improved preventive techniques. The indirect gains of re- duced "disability days increased employment (of rehabilitated patients), increased by revenue and decreased "welfare" ncu(I@@ are likewise not included. These factors should substant4,-.,I"-,.- increase the expected economic gain of this program. F. Codifying our model to include the following more optimistic assumptions gives even better 10-year results. 1. 116dified Assumptions a. Average dialysis cost will fall from present level of $15,000 per year to $7500 per year at the ei-id of 10 years. We will use a figure of $10 000 per year as a representative cost for 10-year period. b. Transplantation capability will increas@ beyond levels necessary to treat new patients in order to reduce pool of long-term dialysis patients. @iaximum level will be 7500 transplants per year. c. Graft survival will average 60% in first N,-ear and 9-@,% each year thereafter following transplant operation. Patient survival will ave age 80% in first vear An,,! r coincide with graft survival each year thereafter 2. Caseloads Dialysis Transplant New New Deaths Badklog I'@acklog Dialysis T ranE. u-f a-n Dx Year DxB TxB 5000 1000 5000 2000 195,r, 2 8900 2150 4000 30-00 6 3 9 4000 31 7 3 11565 3843 3000 4 13180 6051 2000 5000 3580 5 13903 8748 2000 6000 3872 6 13868 11911 2000 7000 7 13188 15515 2000 7500 4179 8 12285 19239 2000 7500 4230 9 11517 22777 2000 7500 4292 10 10864 26138 2000 7500 10309 29331 + .85 Dx + .20 Tx DxB .85 DxB f(Tx-5000' k .1 E k TxB 95 TxB .60 Tx .k + I k k D 15 DxB (Tx-5000)\/ .05 TxB + .15 Dx + .2DTx k k k k k 3 Yearly Cost6 .Total Dx Tx New Dx New Tx Year Backlog Backlog $50@l 1 $' 5bm im 2 891.1 2M 3 116M 4M 3011 -.190@j 4 132M 6M 20M 50M 208M 5 139M 9m 20M 60M 22811 6 139M 12M 20M @70M 241@l 7 132M 16M 20@L 7 5@@@ 8 123M 19M 20M 75M 237M 233M 9 115M 23@f 20M 7511 230M 10 109M 26M 20M 75M. f Total 1144M 118M 260M 570M 209?1@l TOTAL COST .$2,092,'OOO,ODO I Benefits (1.0 Years) a. Years of life on dialysis Economic bene@ 119,579 years b. Years of life after transplant 145,703 years Economic benefit $932M c. -Future lives of patients on dialysis at end oi pt!@iod 10,309 patients Economic benefit 0 d. Future lives of transplant recipients living-a,t end of period 29,331 patients Economic benefit $2,376@l TOTAL ECONO@II,C BEL@@'EFIT $3,954,000,000 5. Cost-benefit comparison $4500 ner -ntipnt, As before, we assume cost of death of which gives us cost of $342M if we allow 76,0'lk-; patients to die Hence Economic Gain 3954@l + 3421-i 2092,Nl '$2,204,000,000 DRAFT Kidney Disease Position Paper Division of Professional and Technical Development Regional Medical Programs Service January 7, 1972 Lt has been generally accepted that access prehensive to com health services of high quality must be available to all Americans. Comprehensive systems of care must be developed throughout the Country. One of the components of this system is a method of prompt detection., diagnosis and treatment of patients with renal this e d a series of primary, secondary, and tertiary disease. To n centers with renal treatment capability and effective linkages should be pro'vided on a planned basis. The primary centers will revolve around practicing physicians' offices, public health clinics, and other facili- ties. Upon detection of a recurring or chronic problem, referral should be made to a secondary or tertiary center. Secondary centers will exist in multispecialty clinics, hospitals,, clinics, and community medical centers. Sophisticated specialized diagnostic skills should be provided. Tertiary centers will usually be located in a university health science center and should have a full range of kidney services available. This would include the usual diagnostic and therapeutic services as well as training facilities for medical and ancillary personnel. Specialized resources will include hemodialysis and renal homotransplantation facilities. These centers should be dispersed in such a way that all sections will have adequate medical coverage but without duplication. This is 2 per 4 million residents. approximately one center For patients with end-stage renal disease, the disparity greater than any other phase between technology and delivery,is he health care industry. During the Past fifteen years in t nd dependent th rapies have evolved in two mutually supportive a e the treatment of kidney failure: hemodialysis and renal homo- transplantation. Due to the lack of adequate patient care reimbursement mechanisms, sufficient resources have not developed to match patient needs. With both techniques becoming widely accepted, it is important to develop coordinated plans indicating the proper relationship between dialysis and trans- plantation, and develop the financial support needed to bridge the gap. A system for patients to enter a well-defined referral pattern is to be established, with national coordination. Once established, this centrally operated communication network would feed information back to the practicing physician about their patients with end-stage renal disease. The patient would be entered into the renal center's long-range "life-plan." Tertiary treatment centers should establish a life-plan for each patient identified as having end-stage renal disease. This plan should provide for conservative medical management 3. as soon indicat ed. When th patient begins to develop e complications of his disease, adecision to transplant should be the treatment of choice. If, however, the patient is not medically suitable for transplant, or an organ is not avail- able, or the patient declines, training should be initiated for home dialysis. If circumstances do not permit this therapeutic modality, treatment at a satellite, low-cost ambulatory care center or hospital dialysis center should be provided. city of available cadaver organs is probably The scar the most important factor in limiting the number of transplants being performed. An aggressive organ procurement prog ram to increase the national capacity for transplantation is necessary. Support of local legislation And education of the public to make them aware of the use of cadaver kidneys is necessary to make it easier to obtain organs. Another major deficiency is the lack of full-time center-based trans- plantation surgeons. As a further step, improvements in the techniques of organ harvesting, preservation, transplantation and a com- puter matching system could be developed. Other programs to further public and physician education, support current home dialysis training programs, provide increasing home 4 ose knit cooperation between dialysis training, and develop a cl facilities would prevent duplication of efforts. The development of a national coordinated network can ap lied to other health care problems as technology be p becomes more advanced. The development of a communication tem, funding of transplant centers, funding of home@ Sys dialysis training programs and other continuing education programs, will make the management of end-stage kidney disease dly in the immediate futur In the next ten progress rapi years, the goal of adequate dialysis and transplantation resources can be met. Guidelines are being developed for @S support of Regional Medical Programs to assist them in providing the resources necessary to develop comprehensive treatment plans and dialysis and transplantation centers. medical SPECIAL ISSUE programs FOR LIMITED DISTRIBUTION service iL ii j: ni @at iL 1 odata A ct)niiiitiiii(,atioti (](,vice (lesi.,Ile(i it) Si)(-C(l the exch,'In,,e of lieivs, KIDNEY DISEASE ACF@'ITIES information tti(I flata on Policy Statement and Guidelines lt(!(,ional Iletli(-al 1'ro,,rams am[ related activities. November 27, 1970 - Vol. 4, No. S3S Included in this issue is the policy endorsed for kidney disease activities by the National Advisory Council on Regional Medical Programs. Also included are Guidelines for Planning a Comprehensive Regional (or Inter- Regional) Kidney Disease Program. For guidance in developing and submitting grant applications incorporating kidney disease activities, please refer to . . . Guidelines for Regional Medical Programs , revised May 1968. Addendum to Guidelines for Regicnal Medical Programs - February 1970. Guidelines for Multi-Program Services Project Grants - Regional Medical Programs Service - August 1970. 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. U.S. DEPARTMENT OF HEALTH, EDIJCATION, AND WELFARE Ptil)lic Health Service * Health Services and Mental Health Administration a Rockville, Nlarylati4l 20@i.-i,2 ."LIFE-PLAN" for END STA-GE PENAL DISF-B@SE Department of Health, Education, and UTelfare Health Services and Frontal Health Adzinistration Regional l@'-,edical Prograzas Service Decer.ber 10, 1971 December 10, 1971 Program Summary Nowhere in the health care industry is the disparity between technology and delivery as great as it is for the patients with end-stage renal disease. Over 50,000 Americans die each year from some form of renal disease. Of these, 7,000 to 10,000 have medical indications for mainte- nance therapy by hemodialysis or renal homotransplantation. A "Life-Plan" for the treatment of patients with end-stage renal disease is proposed. The goal of the plan is to provide the resources for home dialysis train- ing and renal homotransplantation so that all Americans who suffer from end-gtage renal disease that meet the medical criteria for maintenance therapy will have access to care. Specific objectives are to establish a minimum of 50 "Life-Plan" Renal Centers with facilities for renal homotransplantation and home dialysis training located throughout the country on an average of approximately I per 4 million popu at2on, a total of 50 centers A second objective is to prevent duplication and under utilization of services The specific elements to achieve these objectives are that a Federal program, administered by the Health Services and Mental Health Administration (through the Regional Medical Programs Service), will selectively fund medical centers which demonstrate the capacity to perform this service. A decremental funding pattern will be utilized with 100% funding for the first 2 years, 75% the third, 50% the fourth and 25% the fifth year. Continuation costs of these centers will be borne by patient care reimbursement mechanisms. The plan makes the following assumptions: 1. The average life extension will be seven years or more; 2. The rate of entry will be unchanging over the next five years; 3. Mechanisms for payment for direct patient services will develop as the resources to provide the services become available (through Title XVIII, XIX, N'HISA, Blue Plans, etc.). There will be Federal-State cooperation in develop- ing these mechanisms. 4. A coordinated plan can be implemented with the voluntary cooperation of the health providers. This type of plan has already been enthusiactically endorsed by leading nephrologists. -2- Plan The following Federal strategy is recommended for development of a "Life Plan" for the treatment of end-stage renal disease patients by selective funding of dialysis and transplantation centers. It has been estimated that approximated 50,000 Americans die each year of some form of chronic renal disease. Of these, it was estimated by the Gottschalk Report submitted in 1967 to the Bureau of the Budget that 7,000 to 10,,OOO are considered to be good candidates for supportive care and would be expected to achieve a 75% level of rehabilitation to their pre-terminal illness activities. Therefore, it would seem appropriate that a strategy be developed for the entrance of these 7,000 to 10,000 patients per year into a coordinated plan health care delivery. An end-stage Renal Disease Center is to be developed for every four million residents, a total of 50 centers. This Center will combine the resources of hemodialysis and renal homotransplantation as modalities of treatment for patients identified. As soon as a patient is diagnosed as having chronic progressive renal disease he is to be referred to the center for that region to be entered into the long-range life-plan. Emphasis in this life-plan will be placed upon early liomotransplantation. At the present time cadaveric transplantation seems to be the most practical. It is estimated that 60 to 80 percent of the patients entering the pro- gram will be suitable candidates for transplantation. Of the remaining 20 to 40 percent of patients, some form of long term hemodialysis is indicated. It is estimated that of the hemodialysis patients, 10 to 30 percent will be entered in a home dialysis training program for treat- ment in their homes or at low cost satellite ambulatory care centers. The remaining 10 percent will require institutional treatment because of the severity of their condition or for some other medical or social reason. The Department of Health, Education and I%Telfare through the Health Services and Mental Health Administration and the Regional Medical Programs Service will fund the start-up costs for renal transplantation units and selectively fund start-up costs for home dialysis training programs. Conununicati stem To coordinate the activities of this life plan and to develop information for better organ procurement and sharing, a national communication network will be established that will be operated centrally with one central com- puter syste.-,i. Information will be fed into this communication network about all patients with end-staae renal disease whether or not they have begun dialysis or have had a transplant. -3 - Current Related Pro,,rLms Currently there are 340 institutions in the country providing dialysis services to kidney patients and 95 hospitals providing kidney transplants. However most of these are poorly utilized and not staffed with full time personnel. Until very recently all dialysis facilities were located in or affiliated with public and non-profit hospitals. During the past two years there has been a small number of privately owned dialysis facilities emerging in the largest metropolitan areas. Transplantation programs are all affiliated with medical schools including 12 programs located in Veterans Administration Hospitals and two programs in private foundations. To-day there are several systems by which dialysis care is delivered. They are: (1) Training of the patient in a hospital for routine, chronic care in the patient's home or in a low-overhead self-care facility both affiliated with a medical center,, (2) Provision of total care in a low- overhead facility or (3) Provision of total care in a hospital. Each year a smaller proportion of patients are receiving all their care n a hospital setting. In-hospital dialysis care centers are continuing to serve an important role as patient diagnostic and referral centers and for treating emergency conditions which arise while patients are enrolled in the alternate delivery systems. Hospitals continue to be the main resource providing dialysis care immediately before and after transplant surgery. Rationale for Governmental Innitiative As previously stated, nowhere in the health care industry does'.the same gap exist between technology and delivery as in the area of treatment of patients with end-stage renal disease. Technologic developments in the last few years have made possible the rapid expansion of programs to enter patients in hemodialysis, in an institutional setting. The develop- ment of remarkable technologic innovations that allow self dialysis by the patient or a member of his family at their home has been a major step in making this a practical approach. Techniques of organ harvesting, preservation, and transplantation have made renal homotransplantation a service entity and no longer a research tool. However, the funding mechanisms to develop the resources and provide patient care reimburse- ment have laaaed far behind. A management plan to prevent duplication, and establish a nationwide network and high quality to assure total coverage is necessary. Because of this disparity, and the need for a national network it is an appro riate function of the Federal government p to by providing funds to develop the resources with the ion that patient care reimbursement mechanisms such as Title 18, expectat Title 19, the National Health Insurance Standards Act, the Blue Plans, etc.,, will provide the payment of the direct services once the resource is present and to coordinate the program. This program is a five-year funding effort that will be utilized as startup costs to assist the medical centers to develop these additional resources. -3a- revent duplication of services. This is Two methods may be employed to p absolutely necessary to prevent a spiraling of costs to treat end-stage renal patients and further contribute to "health care inflation". The first method is a regulatory approach and consists of a system of frati- C> chising dialysis-traiisplantation centers through either the State Ilealth Department or 314a agency. The advantage of this system is that it is an absolute prohibition against unnecessary services, the disadvantage is that this would require modification of existing State laws in most areas. The second disincentive to unnecessary duplication of hemodialysis and renal transplantation centers is the voluntary cooperation of four major health financing agencies with -support of the National Kidney Foundation and the American Society of Neplirology. This approach would utilize third party reimbursement mechanisms as the disincentive. Specifically, if the Social security Administration, Social and Rehabilitation Service, Ilealth Insurance Association of America, and the Blue Plans were to agree that they would only reimburse care given to patients in approved, certified centers, this would provide a mechanism for preventing duplicatory services. Several leading nephrologists have discussed elements of this plan with the Regional @ledical Programs Service over the past several weeks. Their enthusiastic support of this approach would imply that it would be possible to receive essentially complete support of the members of the American Society of Nephrology and the National Kidney Foundation to back a Federally controlled program. This voluntary health agency and professional association support coupled with a funding decision by the third party payors would assure the success of the proposed plan. A question may be raised as to why the Federal Government should support a complete program for one specialized health problem such as end-stage renal disease without insisting that it be part of a total comprehensive system. The answer lies in the fact that health care delivery must be comprehensive at a primary and secondary level but tertiary care requires highly specialized skills and facilities on a regionalized basis. Dialysis- transplantation centers are a specialized form of tertiary care. The investment in training, technology, and other resources to provide tertiary levels of care is of such a magnitude and is so demanding on health manpower training facilities and other resources that optimal utilization must be made of them. Not only are the resource requirements large but also they cannot function in isolation from other tertiary levels of care. That is to say transplantation centers cannot exist without immunologists, good clinical pathology laboratories, good operating rooms, and recovery room; dialysis centers cannot function without blood banks, nephrologists, psychiatrists, urologists and social workers. The aggregation and interdigitation of tertiary skills has a synergistic effect upon productivity. The climate that develops in a medical center is conducive to further testing and development of innovative technologies. -3b- Further, the skills are of such a high degree of specialization that a minimum level of activity is necessary to maintain quality. Coordination is necessary to assure linkages of primary and secondary services to the tertiary services to prevent duplication. The second reason behind this special Federal procral-n is that there is a finite group of patients with a predictable frequency thus the supply of resources can be geared to the demand of the patients by effective centralized planning. There are few other health care delivery problems that fit this category. The third answer is that this systematic approach to the delivery of one health care problem has proven to be successful on a regional basis inthis country and on a National and International basis in other countries. Thus, the development of a National coordinated network, that sets as its goal the provision of access to resources for all medically eligible citizens and the fulfillment of this goal, establishes a systems model that can be applied to other health care problems as technology becomes more advanced. -4- Technological Plan During the past decade significant inroads have been made in the'treat- ment of patients with end-stage renal disease. With demonstration that patients can be readily maintained for years by regular hemodialysis over a dccade ago, efforts have been directed to,,,7ards the development of low cost, practical and simple methods of.treatment. These efforts a procedure that has have lead to the development of home hemodialysis) drastically reduced the cost of this therapy. ith the demonstration of the long term patient su w rvival on hemodialysis coupled with the advances in immunosuppressive therapy, renal trans- plantation has become the acceptable mode of therapy. Significant strides have been made in organ procurement and preservation,thereby, increasing the availability and improving the quality of donor kidneys. With the recent introduction of anti-lymphocyte globulin to bolster the already existing immuno-suppressive drugs, further improvement in cadaver kidney survival may be on the horizon. In conclusion, the technology necessary to treat patients with end-stage renal disease is now a reality. Further investigative efforts are still c being directed towards the improvement of existing techniques. Management Plan The development of hemodialysis and transplantation over the past decase as complementary modes of end-stage kidney disease patient care has indicated striking need to organize integrated systems of delivery. The efficient delivery of dialysis therapy requires concentration of ex- pensive dialyzers and dialyzate delivery systems at central points where scarce medical and paramedical manpower can be employed in treating larae numbers of patients. Such centralization provides the patient with high quality services while he is being stablized, and permits the medical center to fully classify the patient as a potential kidney transplanta- tion recipient. Acomprehensive program that provides center, home training and limited care dialysis treatment and transplantation can be responsive to the individual medical requirements and needs of each patient requiring treatment. it has been demonstrated that transplan- tation facilities with adequate dialysis (pre-and-post transplant) can serve lar-e population groups. As the hub of a network of dialysis centers transplantation offers patient e-ress from long-term dialysis. m of end-stage kidney disease Thus, the most effective delivery syste treatment requires aggregates of hospitals and other health facilities interrelated in an organized network which assures accessibility of care to the patient, and interdigitates patient referral, patient registry, dialysis, organ procurement, transplantation, laboratory services and continued atient follow-up p -5- stem lends itself to a national program of coordinated dialysis- Such a sy transplantation networks such as has been under development by the Regional Medical Programs Service, HSMHA. The kidney disease control activity of the RYIPS has intensively demonstrated dialysis and trans- plantation modalities in various settings, and the Regional Medical Programs across the country have begun to organize regional end- grams incorporating existing medical and health facilities, stage pro private patient care funding and manpower; they relate to State and local, planning agencies, and Veterans Administration vocational rehabilita- tion and other Federal, State and local medical and health programs. RMPS authority to develop and coordinate interregional end-stage treatment delivery systems is contained in Section 910, Title IX, PHS Act. Inquiries and proposals for broad, interregional end-stage kidney disease programs to coordinate dialysis, organ procurement, and transplantation activities for large section of the country are being received. Such programs typically propose cadaver organ procre- ment and donor-recipient matching and registry facilities for a number of transplantation centers, which are related to supporting dialysis facilities. A broad Program which provides contractual support for such "super regional" activities would assure coordination and monitoring capabilities at the national level to obtain efficient, non-duplicating employment of resources, and effective coordination with related health programs at Regional, State, and local levels. Project Schedule 1. Fiscal Year 01: a. Contract for the development of the communications system. b. Fund 30 transplant centers - either completely new or supplementing existing incomplete centers. c. Fund 25 home dialysis training programs either completely new or supplementing existing incomplete centers. 2. Fiscal Year 02: a. Continue funding the communication system. b. Continue funding 30 transplant centers. c. Start funding 20 additional transplant centers (as above). d. Start funding 25 home dialysis trainina programs (as above). cl 3. Fiscal Years 03,104,05: a. Continue funding the communication system. b. Continue decremental funding of 50 transplant centers. -6- Resources Plan ives of the "Life-Plan" The direct manpower required to fulfill the object for End-State Renal Disease includes the following: 1. For the Transplant Center a. Transplant Surgeon b. Assistant Transplant Surgeon (at 50% time) c. Administrative Coordinator d. Secretary e. Perfusion Technician f. 3 Tissue-typing Technicians 2. For the Home Dialysis Training Pro-ram a. Physician b. Administrative Coordinator c. Secretary d. 2 RN's e. 2 LPN's f. 4 Dialysis Technicians 3. For the Communications System a. Coordinator b. 3 to 5 Computer Systems Technologists c. Also included here will be a significant but as yet undetermined number of personnel utilized in designing and implementing the system. These personnel will be computer prograramer and systems analyst specialists. For the entire program, this gives us a total of 925 direct personnel (exclusive of communications people) who will be supported with Federal funds. These are, however other personnel who will be directly in- volved in the program, i.e., dieticians, social workers, psychiatrists, and psychologists. In most cases, this group of personnel will already be a part of the existing medical staff and will not require any re- cruitment. The availability of trained medical and allied health personnel to fulfill these positions is adequate in most cases. However, 400 trained para- medical technical personnel are required, and it is anticipated that a shortage in this personnel areas may develop. To offset any shortage, discharged armed forces corpsmen and other technical specialists who have already been extensively trained in general patient care and/or laboratory work, will be recruited, trained and employed in the approp- riate center. 7- Wherever possible, already existing hospital facilities will be used for the centers. No new construction is anticipated but some renovation of the existing facilities is expected. The initial source of funds for the establishment and operation of the centers will come from the Federal government. Federal support for the first five years of the program will allow the centers to become firmly established and develop adequate direct patient reimbursement mechanisms, thus becoming self-sufficient. Desired Impact tor of age, sex, race, or socio- End-stage renal disease is not a respec economic background. Lack of access to care is not restricted to a specific geographic or economic group. It has been noted that there is a higher incidence of end-stage renal disease in minorities and in high density residential areas than in other portions of an urban community. The described program of providing a national network of Life-Plan Renal Treatment Centers would provide access to all citizens with medical indications for hemodialysis and/or renal homotrans- plantations. At the end of five years the program goal of treatment resource availability for all citizens with this condition would have been reached. The impact upon the rest of the health care delivery system would be negligible as far as diversion of resources from other priority areas. This systematic approach to handling a major health issue will provide a model that may be emulated to solve other health care problems. Proper implementation of this pro,-,ram will strengthen the concept of regionalization and non-duplication of health care services. It will not be a perpetuation of further fragmentation of care. Evaluation Plan It has been estimated that 7,000 to 10,000 lives are lost each year that are salvageable by the provision of proper treatment modalities. Not only are these lives salvageable but over 75% of them are rehabilitatible to a level approaching their activities before the terminal illness began. Thus, the criteria for evaluation are: (1) access to care for those diagnosed as having end-stage renal disease with medical indication for maintenance therapy; (2) degree of rehabilitation of those so treated; (3) acceptability of the care by the patient and his family; (4).Cost containment. With the present system the averaae annual cost for patients in home dialysis, institutional dialysis and renal homo- transplantation programs, has been quite high. With a systematic approach, improved utilization of resources and coordination of re- payment mechanisms, it is expected that the average annual cost will decrease (or remain stable). No patient is to be denied care because of financial barriers; (5) the quality of medical care delivered is to be evaluated by a national renal peer review mechanism. Standards of optimal care will be developed and maintained for selection of patients, determination of medical management, degree of rehabilitation and end results. National optimal standards can assure the finest quality of care in each of the renal centers. Management Review Procedure A kidney disease control program already exists in HSMHA in the Division of Professional and Technical Development of the Regional Medical Programs Service; procedures for the receipt, review, and approval of proposals for kidney disease programs have been operational for some years. An important element of this procedure is the requirement that applicant groups obtain State and Regional certifications of program need, evidence of non-duplication of existing medical and health resources, and that plans provide effective linkage with other proarams for planning, operations and patient referral. A Kidney Diseae Advisory Committee will be established to advise the Administrator, HSMHA,on the administration of the national kidney disease program. The committee should be comprised of outstandin- individuals in the fields of nephrology and related medical specialties, health administration, consumer and technological specialty areas which are contributing to advanced medical delivery systems. The committee will evaluate the administration of the national kidney disease program, and advise the Administrator on matters of criteria program performance, opportunities for technical innovation, and organization and employment of appropriate health resources. Criteria applicable to the selection of participating institutions are being developed under the provisions of Section 907, Title IX, and will be available soon. Development and implementation of the program will be monitored by the Regional Medical Programs in cooperation with compre- hensive health planning agencies. Evaluation of program performance will be carried out by @TS through established regional and inter- regional reporting systems, and centralized registries of patients entering and being served by the national program. Tct,6 December 10, 1971 et ive-year period of time is estimated to The federal expenditure over a f be 35 million for transplantation centers, 10 million for home dialysis training centers and 5 million for communications network or a total of 50 million dollars over five years (which averages 10 million dollars per year.) It should be noted that there are already in existence several transplantation centers that would not need additional support to become self-sufficient (approximately 7-10). It should also be noted that there are already in existence home dialysis training programs that would not need further support to become self-sufficient. At this time an exact estimate of the number of these is not available, but will be developed shortly. The funds saved by not having to support the full quota of transplant centers or home dialysis centers will be utilized to fill the gap where satellite, low cost, hemodialysis centers are needed to provide for the patients who can not care for themselves at home or receive a renal homotransplant. Several States have already established State-wide funding mechanisms to pay for the direct patient care costs. This national plan will be coordinated with these States. Federal-State cooperation in this network approach to a priority health issue is a model that can be followed by other programs. The economic input of this proposal upon equipment manufacturers is: 1. Perfusion and dialysis equipment $2,000,000 2. Computer systems $5,000,000 The employment impact of this program is: 1. Physicians 125 2. Nursing personnel (RN and LPN) 200 3. Technicians (Perfusion, Dialysis, Tissue 400 Typing) 4. Administrative staff 100 5. Clerical 100 Total 925 Transplantation Centers Transplantation Centers will be funded at an average of four million people per center for up to 50 transplantation centers. These will be supported at medical centers in areas in which the Health Planning 2- Agencies have determined that a need exists. It is expected that a total of 5,000 to 7,000 transplants will be performed annually by the fifth year. No new transplantation center will be planned in a region until any existing center is approaching 150 transplants per year. The desired level of activity will be 100 transplants per year per center. The Federal Government will fund on a decremental basis (up to 100 percent year one and two, 75 percent year three, 50 percent year four and 25 percent year five) the following categories provided that they do not currently exist in that region. If one or more of these budget items are available, the center will be funded for the remaining portions. Transplant Surgeon $35,000 Assistant Surgeon 15,000 (50% of the time) Administrative Coordinator 15,000 Secretary 8,000 Perfusion Equipment 20,000 Perfusion Technician 10$000 Supplies 5,000 Hospital expenses for cadaveric 75,000 organ-harvesting Typing Lab 3 technicians 30,000 Supplies 5,000 Sub-Total $218,000 Overhead 60pooo Total $278$000 The program being considered would provide funds to support transplantation surgeons at the various medical centers. The critical'importance of this stems from consideration of several factors. First, most University- affiliated hospitals cannot find funds for the sole support of a transplant surgeon (who only does transplantation surgery), as a separate categorical activity as opposed to general surgery or vascular surgery with part-time activities in transplantation. Yet, it has been clearly demonstrated that the success and progressive growth of a renal transplantation program is critically dependent upon the presence of a full-time surgeon devoted -3- exclusively to transplantation and probably requires a minimum equivalent of I-, full-time surgeons. It has further been demonstrated that in most instances, the initial support of such individuals, once a program has developed, no longer requires outside financial.slipport for the salary of the surgeon, this being subsequently obtainable through funds gathered via 3rd party payment mechanisms. Alternatively, funds often become available through the hospital administration, as it sees the source of increasing incoming funds generated by the transplantation service. Home Dialysis Tra- ams Making the assumption that each Home Dialysis Training Program will operate two shifts per day, two cycles per week (Monday, Wednesday and Friday and Tuesday and Saturday) and will have a minimum of four beds, this will allow at least 12 patients per training cycle and at least 6 cycles per year; thus each unit will be expected to train 72 patients per year. As the total number expected would be between 700 and 3,000 per year, 50 home dialysis training programs can support this national end-staae renal disease life 0 plan. DHLI%7 would fund one home training program per transplant center with the above assumptions and with any necessary elements of the following budget (provided that they do not previously exist): I Physician $30,000 2 RN's 30,000 2 LPN's 18,000 4 Technicians 32,000 I Administrative Coordinator 15,000 I Secretary 6,000 Equipm6nt, Supplies and Renovation 35,000 Sub-Total 166,000 Overhead 65,000 Total $231,000 This would be funded for one time only with the expectation that revenue from patient care reimbursement mechanisms would be adequate by the second operational year to bear the continuing expenses of salaries. Technologic Systems December' 10, 1971 Communications System An efficient communications system containing records of all end-stage patients must be an integral part of the life-plan system. The system would first list a particular patient whenever a diagnosis of irreversible chronic renal disease is established. Data in the system would help in the general planning for allocation of end-stage resources as well as in the selection of the most compatible recipient for each donor kidney appearing in the transplant system. The bud-etary allocation of 5 million dollars for the system includes substantial start-up costs during the first year when developmental costs will predominate. Each of the 50 cooperating transplant centers will have a terminal linked to a central computer operating 24 hours a day 7 days a week. The treatment centers would need no special computer technicians since the terminals can be programmed to operate in a conversational mode. Costs for systems design of both hardware and software would be enormous during the first year, but costs should level out in the second year and be constant thereafter. Solicitation of bids for this proposal should result in a total cost of 5 million dollars or less. Prototypes of a computer matching system already existent are: a) The National Communications Network currently operated by Dr. Paul Terasaki, UCLA, and supported by contract with RITS, and b) The Southeastern Organ Procurement and coordinated activity of organ exclian-e and cooperative utilization of computerized tissue-typing data for Virginia, Georgia, Maryland, North Carolina and New Jersey I I I Dr. Terasaki's computerized information system houses data on the clinical results, tissue-typing, and current status of 4,000 transplants performed across the country (74 medical centers) as well as tissue-typing data on 1,000 potential recipients (a-ain at 74 medical centers) who are awaiting transplantation. When a donor kidney and his tissue-typing become avail- able at any one of the participating centers, the data for these 1,000 re- cipients is available on a 24-hour basis and the best possible match can therefore be obtained . occasionally involving inter-center organ or patient transport. indeed, since ifarch 1969, 408 kidneys (or patients) have been transported between medical centers utilizing this communications network. The Southeastern Oraan Procurement Program also supported in part by R@TS has a-ain utilized and demonstrated the feasibility of a central computer -2- matching system, allowing 24-hour availability of matching of donors with potential recipients, and utilizing organ exchanae within the participating states. Both of these pilot efforts have demonstrated the feasibility and potential value of a computerized national matching system. Although all the questions regarding the pragmatic'use of tissue-typ ing for cadaveric transplants are yet to be answered, the need for tissue- typing for living related donors, and the superior results of utilizing "A" matches in cadaveric transplants is well established. If for no other than these reasons alone, a national system of matching and or-an exchange is highly desirable. II. Trends in Current Technology of Kidney Disease Related Equipment In the field of dialysis there are a number of potential advances relating to hardware that are currently receiving intense clinical evaluation. This equipment if found,clinically applicable, may significantly modify and improve the present dialysis treatment modalities. Subsequent to the development of the capillary kidney, significant interest has been generated toward the use of ultra-thin cellulose acetate flat membranes. This type of membrane appears to be superior to the existing membranes for removal of "uremic toxins". The use of this type of membrane may significantly shorten the period of time a patient may be required to dialyze per day, thereby increasing potential for rehabilitation. Clinical trials are just underway. In addition, significant strides are being made in the prolongation of function of cannulas. By the development of an appropriate tissue interfacing substance, as well as minimal thrombogenic surfaces, external cannulas may enjoy significant improvement in survival rates. With regard to the development of new dialysis systems, there are two promising avenues presently undergoing clinical trials. The first is the low volume (1-2 liters) sorbent dialysis system, in which the dialysate is being constantly recirculated as it is being regenerated with the aid of a spectrum of selected adsorbents. This development alone is extremely valuable because for the first time hemodialysis may become independent of the "kitchen sink and the toilet drain" in home dialysis. This drastic reduction in the amount of dialysate required also promises to solve a whole series of problems which have beset dialysis, namely, the quality of tapwater available for dialysis and the preparation of large volumes of dialysate with the aid of proportioning pumps and concentrate solutions. The second deals with a system called liemodiafiltration which has not as yet undergone sufficient clinical pre-testing. -3- sulated In addition, there has been the introduction of micro-encap particles which are ingested by the patient and theoretically adsorb the 'uremic toxins' in an amount sufficient enough to reduce the frequency of dialysis. Finally, peritoneal dialysis has received renewed interest with the development of an automatic delivery system. This system removes most of the complications associated with peritoneal dialysis and enables one to perform the procedure quite readily. In conclusion, there are a number of significant advances that are on the horizon that have the potential,of significantly altering the complexion of dialysis. Ill. Current Status of Home Dialysis Technoloa oy Home hemodialysis was initiated in Boston in 1963 and in Seattle and London in 1964. Initially, home treatment was a cumbersome experimental endeavor but has evolved rapidly into a practical and successful means of treating end-stage renal disease. Maintenance dialysis now can be made available to almost anyone who is capable of learning to treat himself in his own home. Furthermore, treatment in the home rather than the center can provide an opportunity for more dialysis and, therefore, better control of the azotemic state and at less than half the cost. At the present time, in a treatment program designed for training patients for home dialysis, a period of approximately six to eight weeks of instruc- tion serves to train a patient a@uately. Initially, patients trained for home dialysis primarily used the Kiil-type dialyzer with a simple hydraulic dialysate delivery system. Rapid advances durin- the ensuing years have lead to the introduction of more sophisticated and safer dialysate delivery systems. 14ith these advances coil dialysis at home became more of a reality than in the past. In recent years, the intro- duction of such dialyzers as the 'capillary kidney' has offered an acceptable alternative to the usual dialyzers. Presently, significant inroads are being made into the Jevelopment of compact disposable dialy- zers. In addition, the use of small and compact recirculating dialysate delivery systems are presently undergoing clinical trials. The potentials these @-dvances hold for the future are impressive. Indeed it would realistically appear that a patient with renal failure will only have tb dialyze himself one - two hours a day with a system that could readily fit within a suitcase. IV. Procurement and Preservation of Donor Kidneys The basic principal of providing each transplant recipient with the best -4- possible donor organ would be greatly enhanced by the ability to effec- tively assay potential donor organs for viability and transplantability prior to the actual surgery. Presently, two preservation methods are available which have been used extensively in clinical organ transplant: 1) simple hypothermic storage with or without brief initial cold perfusion and 2) prolonged pulsatile perfusion. Storage by simple hypothermia has been used extensively and appears to be a safe procedure for less than ten hours. On the other hand, the method of pulsatile perfusion of the kidney allows for considerably greater advantages: 1) adequate preserva- tion for at least thirty hours, 2) assessment of viability of donor kidney 3) removes transplant suraery from that of an emergency procedure to that of an elective one 4) allows for potential sharing of a kidney with the best matched recipient wherever he may be, 5) allows for pre- surgery reassessment of potential recipients. Presently, devices have been developed which can be easily transported in a small van or even an airplane seat. This then allows for the transportation of organs from region to region and potentially from country to country. Currently, the scarcity of available cadaver organs is probably the most important factor in limiting the number of transplants being performed. Hence it is of utmost importance that an aggressive organ procurement program be established. The importance of public and physician education, so that the pool of potential donors will be increased, is absolutely vital to the future of cadav)er organ procurement. In addition, the support of local legislation to make it easier to obtain organs is of vital concern. In conclusion, or,-,an procurement relies heavily on public education and acceptance of organ transplantation. December 10, 1971 Patients with Incidence of Treatable End Stage Renal Diseases In 1967, the Gottschalk Report was submitted to the Bureau of the Budget. This report concerned itself with the problem of developing pro-rams to care for persons with chronic kidney disease. Special note was made of the in- cidence in the U.S. of chronic kidney disease. At the same time, a study from the National Institute of Health addressed itself to the same question. These two reports are in remarkably close agreement and have accurately defined the problem when examined against recent statistical analysis. These reports estimated that approximately 50,000 persons die each year from chronic renal disease. This works out to 35 patients per million per year who are treatable. of those with kidney failure 7,000 to 10,000 are suitable candidates for prolonged medical treatment. Medical treatment consists of conservative therapy, chronic dialysis, and transplantation. This prediction has been borne out by the experience of the majority of hysicians who care for persons with chronic kidney disease. Indeed the p .1 incidence of 35 suitable patients per one million population per year has stood the test of four years time. A National Plan for Establishing Patient Referral Patterns One of the factors that limits care for patients with chronic kidney disease is the lack of a system for patients to enter a well defined referral pattern. A system of this nature has been proven effective in the United Kingdom; Scandia-Trdnsplant which serves Sweden, Finland, Norway, Denmark and Northern Germany,4 and Euro-Transplant which serves Benelux, Germany, Austria, and Switzerland. From their experience we feel this type of program could be planned and adopted in the United States. The patient referral pattern is best established at a national level. The program which is proposed establishes close knit cooperation between facilities within 50 dialysis-transplant centers. The activities of these facilities include prevention of kidney disease, education, case detection and treatment, organ procurement, tissue typing, dialysis networks, and trans- plantation. Information between the various facilities will be coordinated by a national registry. All information on a particular patient must be exchanged between the centers of excellence and those primarily concered with a patient's care. "I -- 7 - - 2 e of this system is to care for a greater number of The overriding purpos patients, refer patients to the most sophisticated source of medical treat- ment and to return them to useful lives as quickly as possible. in order to not overload the centers of excellence it is planned to return the patient to the primary physician. The primary physician, therefore, must have continued training from the centers of excellence. Continuing education will also be made available to nurses, dietitians, technicians and other paramedical personnel who are involved with the patient's care. The flow of patient referral is outlined diagramatically below. This system is not unlike the pattern of referral that is used today in some areas of the United States. However, the-development of a more organized national program will allow for more patients to reach the quality of care that is resently available. p Expected Case Loads and Growth Rates of the Life-Plan Renal System I. Transplantation Information from the National Dialysis Registry suggests that there are approximately 5,000 patients on dialysis in the United States today. Dr. Paul Terasaki has data indicating that there are approximately 1,000 patients awaiting transplantation across the country. His data are not complete and an estimate of the actual current backlog of patients who are however candidates for transplantation would be somewhere between 2,000 and 3,000. Data from the Gottschalk Committee Report suggests that approximately 35 patients per million population per year are candidates for transplant or dialysis therapy -- this works out to be approximately 7,000 patients in the 'United States each year. The life plan program for end-stage renal disease would be expected to progressively increase the national capacity for transplantation over a five-year period and over a somewhat longer period, result in a stabiliza- tion of transplantation capacity such that a steady state would be reached. Assuming that 80% of all patients with end-stage renal disease who are treatable will be transplanted, then the rate of new transplant candidates for the nation per year will be approximately 5,000 per year4 If the rate of expansion of transplantation case load capability averages 30 patients per center per year during year 1, 40 per year for year 2 60 per year for year 3, 80 per year for year 4, 100 per year for year 5, ear by year 6, then the following predic- and finally reaching 150 per y tions can be made: At the end of five years such a transplantation program will have reached a capabilit of handling the subsequent yearly y rate of entry of transplant candidates into the system. In an additional 3 three years (a total of eiaht years after the inception of the program) the backlog of patients encountered in the system (the initial backlog plus the yearly backlog resulting from progressive increase in transplant capa- bility) will also have been transplanted. Therefore, it is predicted that a total of eight years is required for a steady state to be achieved with respect to transplantation and thereafter, transplantation capability will be fully adequate to meet the yearly need. Another assumption that is made in these calculations is that all of the 35 patients per million that are potential candidates will be identified in the proposed program and therefore treated. The experience to date is that there is initially a significant lag in identifying all of these potential candidates so that the predicted case load in the first few years is probably excessive. With proper emphasis by the program to further public and physician education, it is anticipated that all or nearly all potential candidates for therapy will be identified. This will not significantly alter the predictions for the time required for the system to reach a steady state. The predictions regarding the expected rate of transplanta- tion are realistic in view of the present data showing that in 1969, 900 transplants were done in the United States;in 1970, 1000 were done and by the end of 1971 between 1100 and 1500 will be done. The expectations for the proposed program of transplanting 1500 patients in year 1, and pro- gressively increasing to 5000 patients transplanted in year 5, is attainable. Dialysis supportive aspects of the life-plan will reach a steady state earlier because of the progressively decreasing case load as transplanta- tion capability increases. It is predicted that the dialysis case load will begin at approximately 5500 patients for year I and decrease to approximately 2000 patients for year 5 and all subsequent years. The pro- posed program entails supporting current home dialysis training programs by providing increased home dialysis training capacity to each of the 50 centers, and adding an additional four home training beds to each of the centers (operating on a three dialysis per week, two shifts per day schedule). It is proposed that such a system allows for the handling of the dialysis load and achieves full capacity to do so by as early as year 3, and thereafter, a progressive decrease in dialysis need and capacity could be effected. A @,TATT.O",'@T, PT,Al@' Life Plan Center OR@-ITI Procil and Preser,, PI,Nrs@l c 1cp@.'rol o@i.s Uni t7 Transplartati.o,-, U",i it@t r) i i I t e,i,.i I t- i. o ii T) i s 0 c t@, V r oi are t T' (-2 F c. r 37 Ol 1:0 Ile').,)roli"i.st Oi,ii:i@it@4ei-it itisf7itil- PI.-)ii Center ll,)r,ie Di.elysis 'Di-,.pervi-sion ll()me dialyses sitT)crvi.sLon Specialty ENTaltiqf-.ion Trnrisplani:atior, follow-up (possi@l.y Specialtv tre@it-Tr@ent Coiit@ziuln- edLicll,-.i.on SliiinL Cl-,roni.c institutional dialyses Trinsplant-. follow-up lioine dialysis trai.iiir,- education Shunt placement Cotisiilf-.ation on: diet, personal services, O@--an procurement and reliabili.tni@ion pi.-eser,7atio@i Tl\e;i.41 rrans,,)Iant-,3t,'Ion Trainin,, of health personnel If.ey: Patient-. referral and exclian-e Conf:initin- education of inforiiiatioa Consultation on: diet, personal Exchan@,e of information only services, rehabilitation Number of Transplantation Centers for which each State is Eligible* X2 CZ Hawaii: 1 Puerto Ric6 based on ratio: I center per 4 million population Elipible for less than center Existing Kidney Transplant Centers Hawaii: 1 Source: Kidney Transplant Registry Terasaki, Cadaver Kidney Communications Ne reEzi-o i@i a I- medical SPECIAL ISSUE @-programs FOR LIMITED DISTRIBUTION service 0 ILI q,u NV n ri r" na I u, 11 0 kaata ,@k coiiiiiiunication (leltlice (lesi,,zieil to si)e(@d the c-,cliaii@,t@ of news, KIDNA DISEASE ACFIVITIES itiforinatioii an(] t[ala on Guidelines and Revieiv Procedures Statement ]it,,,ional Me(lical I-rt),,rzitns atiti related activities. May 3, 1972 - Vol. 6, No. 9S This issue presents revised guidelines and local and national review procedures for kidney disease activities. These guidelines supersede all previous @S materials relative to the submission of kidney disease applications, specifically including those appearing in the News Information Data, "Policy Statement and Guidelines" published on November 27, 1970, Vol. 4, ,No. 53S, and the "InteiWetation of Guidelines." published on March 1, 1971, Vol. 5, No. SS.- Distribution: Coordinators of Regional Medical Programs Members of National Advisory Council and Review Committee on Regional Medical Program Staff of Regional Medical Programs Service Regional Health Directors and Regional Medical Programs Service Representatives of Health, Education and Welfare Regional Offices. U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Pijl)lic Health Service * Health Services and Mental Health Administration 0 Rockville, Marviaii(i 208;'v2 GUIDELINES AND REVIEW PROCEDURES STATE@'@ENT Kidney Disease BACY,GROIJI\'D Nowhere in medicine does the same gap exist between technology and delivery as in the area of treatment of patients with end-stage renal disease. Tech- nological developments in recent years have made possible the rapid expansion of programs to provide patients with heniodialysis in institutional settings. Innovations which allow self-dialysis by the patient in his home, or in a low overhead facility, vastly extend the utilization of delivery resources, and reduce the cost to the patient. Techniques of organ harvesting, pre- servation, and transplantation have made renal homotransplantatioii a service entity, no longer a researtq tool. It is estimated that of the approximately 50,000 persons who die each year from kidney disease, 7,000 to 10,000 are suitable candiates for chronic hemodialysis and/or renal transplantation, and that an additional 10,000 to 20,000 might berie'L'It from each treatment. At present, the annual increment of new patients being offered treatment for terminal kidney disease is pro- bably riot more than 3,000. CURRENT R@'L?S PROG@'I EljPPASIS FOR KIDNEY DISEASE PROPOSALS Although national priorities for kidney disease proarams will be established a-,id modified over time as appropriate by a panel of renal authorities, for the present it is necessary to focus on improvement and expansion of the delivery of care to end-stage kidney disease patients. @TS is primarily concerned with the development and implementation of kidney disease programs which will provide the therapeutic tertiary care services of dialysis and transplantation to patients who do not now have access to such lifesaving care. The substance of such programs includes: 1. Procedures to assure early identification of patients in, or approaching a terminal stage of renal failure. 2. Rapid referral of such patients from the level of primary care (private physician) to tertiary care facilities for dialysis and transplantation. 3. Early patient classification with regard to tissue type, and other per- tinent factors. 4. Dialysis and transplantation facilities which assure treatment alter- natives to both the patient and physician. 2. 5. Effective cadaver kidney procurement operations, coupled with rapid kidney donor-recipient matcliin(,. 6. Selective training to meet the specific needs of the above program. The characteristics of such programs include: 1. The patient has access to conservative management before kidney function has ceased. 2. The patient is registered in shared recipient rosters to assure optimum ti@sue matching, and maximum utilization of harvested cadaver kidneys. 3. The patient can be trained to carry out dialysis at home, or if not eligible for this mode of care delivery, has access to satellite dialysis, or in-center care. 4. Dialysis facilities encompassing all three'of the above modes of dialytic treatment will serve, or be an integrated part of a system which serves a population of no less than 500,000. 5. The patient can gain access to transplantation if such therapy is his choice, with his physician's concurrence. 6. Transplantation facilities are centralized to: a. limit duplication of hiah cost facilities and services. b. assure maximum utilization of full-time transplantation surgeons. C. assure availability of complementary backup services required for special patient evaluations and treatment. d. provide the coordinating point for patient referral, donor- recipient matching, patient data exchange, and organ sharing. 7. Transplantation centers will serve populations of 3-4-million persons. 8. Maximum utilization is made of services and facilities for kidney disease patients. 9. Continued development of third-party payment meclianis ms is pursued to support expanding kidney patient care services. 10. Integration of renal disease patient services with other patient services and facilities is organized at all levels. 11. Pediatric dialysis and transplantation services are coordinated with adult facilities to provide optimal use of services. 3. REVIEW PROCEDURES kidney disease activities, and The openly categorical nature of end-stage the need to effectively coordinate integrated dialysis and transplantation systems indicate the need for continued central direction for development of a national program. Thus, applications for kidney activities will be handled in a manner different from other Re-ional Medical Program applica- tioiis, but modified from the procedures followed heretofore. 1. Policy Preclearance - immediately upon an indication of interest in the submission of a kidney proposal by a source within an R@T, the P3T should contact the appropriate R,-Na)S Branch in the Division of Operations and Development (DOD). It is suo-ested that a brief abstract or letter CID of intent be submitted which outlines the nature of the prospective activity, the probable role the proposal would play in the Regional program, and the need which will be satisfied within the overall renal disease procram of the Region. The Branch which serves the Region will utilize the Reaion's written inquiry to confer with staff of the Divi- C, sion of Professional and Technical Development (DPTD). RMPS will advise the Region whether it is desirable to proceed further. The RIT, of course, may accept or reject this advice. 2. Technical Program Review - prior'to submitting application for a renal disease prooram, the R-.-NIP is expected to obtain a technical review of the proposal by a group which has not participated in the program's development. The technical review group must.be comprised of at least 3 renal authorities from outside the geographic area served by the Region. Payment of the costs of such consultant services will be made by the requesting RMP. The Region may obtain the names of consulting renal experts by calling the appropriate Operations Branch for assistance. The Division of Professional and Technical Development maintains a list of renal consul- tants, and is responsible for coordinating their assignment. Should the @T desire to choose its own review panel, the names and curriculum 'tae of prospective consultants must be cleared with the DPTD. vi Technical reviews of renal proarams need not always be made by consultant 0 site visits, but may be accomplished by mail when appropriate. The @IP will negotiate any compromise needed should conflicting technical advice be given by the technical reviewers. 3. Fori4arding proposals - only those proposals which are recommended favor- ably by t@e local Technical Review Group (para@raph 2., above) shall be eligible for consideration by R@IPS. In addition, an opportunity must be provided prior to consideration of the proposal by the RAG for review and comment by the appropriate CHP agency(ies) as required by Section 904(b) of the Act. 4 The RAG shall consider any CIIP comments and comment on the ability of the R@IP to manacye the kidney project without hindering the development C> of the overall RMP program, and the reasonableness and adequacy.of the kidney budget proposed. The RAG is responsible also for indicating how major issues raised by the local technical review group will be re-solved. Since kidney proposals are reviewed separately at the national level, the RAG need not give priority rankina to kidney proposals in relation to other 'non-kidney KiT operational activities. Kidney proposals shall be considered by RIIPS in relation to national priorities. The complete comments of the members of the Technical Review Committee, and any CHP aaency comments, must be included in the forwarded proposal. C, 4. @iPS Staff Review - the initial review at R@IPS shall include: a. the contribution of the project toward kidney pro-ram objectives. b. the completeness and nature of the comments of the RAG (point 3., above). C. comments of CBP aaencies. d. the preferred method of funding. 5. r@1,TS Review Committee - RITS staff will summarize for the RIUS Review Committee available information as to how each kidney proposal proposes to support the National Kidney Program objectives, and the substantive points developed through local review processes by the Technical Review committee, the RAG, and the CHP Agency. For those applications for which the RAG; CHP Agency; Director, PLNTS, or IUTS Review Committee has indicated a concern apart-from the technical merits of the project, the IUTS Review Committee will be asked to make a recommendation to the National Advisory Council. The P-7,TS Review Committee specifically will not review on a technical basis the merit of the proposal, or establish formal numerical ratings for individual proposals. 6. Council Review - all kidney proposals shall be submitted to the National Advisory Council for final recommendation. In keeping with the cateuori- cal nature of the kidney disease proaram within RNIPS, the Council will review and recommend fundina levels for kidney proposals separately from the funding level of the specific MT. Kidney pro-ram funding will be in addition to other R@T program funding. 5. PREPARATION OF APPLICATIONS Effective July 1, 1973, all.kidney proposals must be submitted as part of the @IP's regular annual application in accordance with the Region's assigned anniversary date. Prior to July 1, 1973, kidney proposals may be submitted in accordance with the document "Procedures for Requesting supplements to PIJTS Grants, April 7, 1972". Sponsors of applications for support of kidney disease projects should submit them to the appropriate MQ in the format which the R@IP prescribes. An application involving 2 or more Pi@IP's may be submitted where appropriate. In such cases, one RMP should be designated to act as "applicant" and submit a single application. Such applications must be approved by each RAG and shall include a description of mutually agreed upon arrangements for administration of the project. In view of the preliminary clearances which are called for in these guidelines, it may be helpful to develop and submit a letter of intent to the appropriate R@IP's before an applica- tion is prepared. In addition to the summary information to be provided on the forms speci- ficd for a plications, narrative should address in detail the program p elements specified below. Descriptions which are comprised only of aenera- lized narrative will not be acceptable; disease control needs and the applicability of the proposed program must be presented on the basis of solid data relatino to patient populations and distribution, specification of existing services and resources, and clearly documented commitments of cooperation and participation from key persons and institutions. Assistance can be obtained from the proaram staff of the M2. Program elements to be addressed are: 1. the magnitude of the renal disease problem. 2. facilities and programs currently in operation and the needs they are meeting. 3. the needs which the new proposal will meet and how the proaram will integrate with existing programs to improve patient care services without duplication of existing services or facilities. 4. existing and potential sources of third-party payment for care and how these resources will be developed. 5. the commitment of cooperating institutions, groups and health prac- titioners whose collaboration is essential to insure the success of the program. 6. training, when pertinent to the plan, which is directly related to the projects comprising the plan, or judicious expansion of existing programs. 6. employed. 7. the system or method of program evaluation which will be 8. a decremental rate or proportion of Federal (@IPS)contribution to the program over time. 9. the program's phase-out as an RMP-supported activity. Program costs related to the Federal share of support should normallyb-- identified with personnel and equipment requirements in tertiary care facilities. R@IPS will not fund ALG-related activities. Such funding may be included in the future if standardized production and testing is achieved and its efficacy is demonstrated. The I\IIH is sponsoring research in ALG through a contract. Al@AP,DS' Awards for kidney projects will be issued as a part of the total award to the Regional Medical Program. The amount allocated for the kidney activity will be specified in Item 14, under "Remarks", of the Notice of Grant Award, Iorm HSM-457. Funds awarded for kidney activities must be spent for such activities, except that unexpended balances may be rebud- geted in certain cases provided that prior approval for such reprogramming is first obtained from R@U?S. In some cases 'a kidney proposal may be approved by P31PS but unfunded. An RIIP may fund such a kidney project through rebudgeting other PIIP funds to the kidney activity. Rebudgeting of this nature should be undertaken only after the RAG has carefully considered the effect of such action on the remainder of the RIEP program. Likewise, a kidney project may be expanded as determined by the RAG by rebudgeting of funds to the kidney activity in addition to those specifically earmarked for kidney in the Notice of Grant Award. OTHER A glossary of kidney disease terms is enclosed for your information. GLOSSARY OF KIDNEY TERMS l@ ALC ATS Abbreviations for AntiLyi-.iphocyte Globulin; AntiLymphocyte Serum. Both are products of animal serum used to prevent rejection of transplanted organs, especially kidneys. 2. Artificial Kidney - Total system used for hemodialysis consisting of di-alyzer and dialysate delivery system. 3. Belzer Niachi-ie Special type of perfusion equipment developed by Dr. F. Belzer. There are others, some devised by local hospitals. Perfusion machines preserve harvested cadaver kidneys in a viable condition, sometimes for periods of up to 48 hours. 4. Backup Di@lsis - Dialysis civen patients trained for self care who, 0 under special circumstances, are unable to perform dialysis without additional assistance. Also, pre- and postoperative dialysis provided transplantation patients, particularly when the newly grafted organ is unable to assume its full function immediately. 5. Canntila - Surgically prepared, exposed connection made between an artery and a vein. The exposed connection between artery and vein is made with plastic tubin-. 6. Care Facilities Primary - The initial facility to which a patient seeks medical advice and care; may be the physician's office. Secondary - A general hospital or equivalent capable of rendering definitive diagnosis and treatment. Also, a satellite dialysis facility. Tert - Sophisticated medical center. In the case of kidney end-stage disease, it is a facility capable of performing trans- plantation, supportive dialysis therapy, and consultation to primary and secondary facilities. 7. Decremental Funding - System of phased reduction of the Federal share of the costs of an activity, usually by increased assumption of costs through earned income and local third-party payments. 8. Dialysate - The solution used in an artificial kidney to rid the body of accumulated waste products in the blood. 9. Dialysate Delivery System - That part of the artificial kidney which supplies the dialysate and regulates such critical items as rate of flow, temperature, and concentration of dialysate. -2- 10. Process by which waste products are removed from the blood by diffusion from one fluid compartment to another across a semiper- meable membrane. In the case of kidney dialysis, blood is one of the fluids and the bath solution or dialysate is the other. 11. Dial,,,zer - That part of the artificial kidney through which waste products pass from the blood to the bath solution or dialysate. 12. End-Stage (Renal) Disease - That stage of renal impairment which cannot be favorably influenced by conservative management and which requires dialysis and/or kidney transplantation to maintain life and health. 13. End-Stage (Renal) Treatment - Refers to either dialysis or kidney transplantation or both forms of therapy. 14. Fistula - Surgically prepared unexposed connection made directly between an artery and a vein to allow repeated and ready access to the blood stream. Dialysis access to the blood stream is obtained with large hollow needles, creation of a fistula is an alternative to surgical insertion of a cannula. 15. Functions of the Kidnev - The @rmal kidney's work includes 1) control of electrolyte concentration in the body, 2) maintenance of proper water balance, 3) maintenance of the body buffer system, 4) excretion of the by-products of cellular metabolism (urea, creatinine, and uric acid). 16. Kidney Disease Spectrum of ailments which directly or indirectly affect the kidneys and compromise their function. (Frequently involves the entire urinary tract.) 17. Low Overhead Facility - Any kind of a building where the expensive operating costs of a general hospital can be avoided. Such facilities are used for dialysis services, makinc, minimal use of physician time in staff required. 18. organ Preservation - Maintenance of the kidney after it has been removed from the donor and until it has been transplanted into a recipient. Oraan preservation is an intearal part of a kidney transplantation program. 19. Organ Procurement The identification of a prospective donor; the surgical removal and transportation of a donor kidney. 20. Peritoneal Dial@,sis - An alternative to hemodialysis - the process by the dialysate is introduced into the abdominal cavity using the peritoneum as the semipermeable membrane. -3- A resource providin- limited, specific services 21. Satellite Facility 0 under the general direction of a secondary or tertiary care facility. 22. Self-Dialysis - Dialysis performed by a trained patient at home or in a special facility with or without the assistance of a family mem- ber or friend. 23. Shunt (noun) -,Tl-ie means by which blood is passed through other than the usual channels. There are two types of shunts used in dialysis 1) the cannula, 2) the fistula. 24. Tissue Typing - Laboratory procedure used to determine the de-ree of coinpatability between the donor oraan and the recipient of a kidney transplant. 25. LTrinary Tract - Collective term referrin- to the kidneys, ureters, bladder, and urethra. INDEX Tabs A. Consultant Guide in ev'ew)@ 1 es (RL4PS R I B. RMPS Public Law 91-515, Amended and Extended,,and Review Information. C. Kidney Guidelines (2'.Issues)@, May 3-and Sept. 14, 191;2 D. The Optimal Facilities Necessziry for Diagnosis and Management of Patients With End-Stage Renal nisease E. RMPS Training Policy F. An Economic Model As A Health- Decision Making tool G. RMPS Fact Sheet KIDNEY PROGIIM@ REVIEW Program Review Guidelines for Technical Consultation BACKGROUND has developed a program aimed at addressing the service RMPS delivery problems of Kidney Disease. This program is based on documented needs and the existence of technically sound treat- ment modalities which currently are not available to a large number of patients with end stage renal disease. It recognizes the fact that a finite amount of funds are available for at- tacking this problem. This pro-ram evolved from the activities of non-government and governmental professionals who identified the resources that are necessary for such an attack on the prob- lems. This program, which has been termed the RMPS kidney disease "Life Plan" is the result of previous kidney program -developments, and it is generally in concert with such documents as the "Optimal Facilities, Necessary for Diagnosis and Manage- ment of Patients with End State Renal Disease" which was recently prepared by the National Kidney Foundation. The framework of this program is based upon a comprehensive regional plan covering the multiple aspects of renal disease. The matrix of the system requires the establishment of primary, secondary, and tertiary care mechanisms for the identification, referral, and treatment of the patient with kidney disease. The realities of currently available treatment for end stage renal disease necessitate the establishment of a limited number of tertiary kidney disease centers with the technical expertise and service capabilities to provide comprehensive care to a large number of patients on a regional basis. Studies indicating physical resources and available monies, compared with projected costs and cost effectiveness data, show that any effort aimed at treating end stage kidney patients must be linked with such tertiary centers in order to provide a complete spectrum of high quality care at a reasonable price. We believe that @IPS can.-provide adequate "seed money" support in a decremental fashion to develop such programs in a manner such that they are on,,,oing and self sustaining. As an aid in instituting this program, RMPS has developed guidelines for the regions use in creating programs to meet their regional needs. I 4 , I I Page 2-Kidney Program Review eview Procedures Statement were distribu- These Guidelines and R May 1972, and a Clarification statement ted to the regions in idelines was issued in early concerning certain aspects of gu September 1972. ROLE OF THE RENAL TECHNICAL CONSULTANT renal program review by peer professionals from outside the RMP applicant Region is required by the Kidney Disease Guidelines issued in May 1972. Because KiP functions on a decentralized basis, technical review is done at the regional level prior to submission to P@IPS for funding. The use of expert consultants from outside the region is aimed at giving a particular Region an objective evaluation and critique of regional kidney programs. IOIPS supplies the Regions with the names of Renal Technical Con- sultants on request from the Regions. The outside Renal Technical Consultant services are official services provided to the Regional Advisory Group (RAG) of a particular Region. The renal consultant is a private agent responsible for conducting his own negotiation on fee, time and site of consultation with the RMP which requests ..bis.services. The negotiated agreements reached between the consultant and the RMP represent a contractual arrangement between the two parties for consultant personal services. The payment for the consultants services cannot be part of the renal program grant budget, nor can it be contingent upon successful project funding. There are three (3) basic circumstances when outside consultation will be requested two (2) of which are required of renal program sponsors by the guidelines: 1. Renal program planning. Before a specific proposal has been developed a region may wish assistance in planning its regional program. (Not required by guidelines, but frequently desirable). 2* A specific project or program has been developed and requires technical review so that the RAG is provided objective infor- mation to support its-decision concerning approval or dis- approval of the proposal. (Required by Guidelines). I -Kidney Program Review Page 3 3. A project (s) or program will be reviewed progress. (Required by Guidelines). onsultants who assist a region in planning a c projects should not participate in the technic assessments. Consultants who review the initi ject proposals should normally participate in assessment. A minimum of three (3) consultant in the initial technical review; two (2) consu the progress assessments. Since the consultant's official relationship i written report of the consultant's program rev for the RAG and presented to the Coordinat who is the RAG's aaent. The reviewers' report parameters which are considered in the technic should have a recommendation section which cle suggested action, such as approval/disapproval and changes or modifications necessary to meri Dialogue with the project/program sponsoring i- individual should make clear the consultants' and recommendations but the con sultant has di. whether he will provide the sponsor a copy of1 RAG. TECM-IICAL RE-VINT - GENERAL Technical review of kidney grant programs requ4 assessment of all the substantiative activities ments concerning the qualifications of the majc specific goals; and efficiency of the program E We believe that the Kidney Disease Program prov opportunity to establish a prototype for delive patient care. For this reason, a Regional Kidn should be aimed at having the following impacts 1. improvement of the availability'of care to 2. enhancement of t'@ie capability of health an resources to provide-patient care-; 3. assurance of high quality of the care prove 4. establishment of linkages between primary, and tertiary care providers; and 5. establishment of collaborative and cooperat ments among institutions. Page 4-Kidney Program Review patient need, Regional kidney programs must address factors of program site, organization, staffing, avoidance of duplication of expensive resources, financing and the overall relationship of the program with the care programs and institutions of the region. The technical reviewers should attempt to ascertain the sponsors' past collaborative performance and commitment concerning these factors which contribute to the future develop- ment of viable patient services. The review should also verify that the sponsors have indicated how they will seek out data for use in evaluation. A. PROGRAM DEVELOM@NT The project (s) under review should have been preceded by, or be a part of, a comprehensive renal plan. The comprehensive regional renal plan should not be confused with the 'grant appli- cation for RMP support of specific projects. The plan provides the objectives and overall system; the projects represent suc- cessive steps over time to realize the comprehensive program based on the plan. The comprehensive renal plan should identify and describe the: 1. geographic area to be served. 2. population area to be served. 3. estimated or established number of renal patients. a. If only estimated; how will accurate confirmation of this estimate be achieved? b. How will patients gain entrance into the program? Are there any factors concerning minorities or patients with cultural, economic or environmental uniqueness effecting entrance into this system which must be considered? UThat are the selection criteria of the institutions within the region? 4. existing personnel and facilities providing care, and the quantity and physical characteristics of the care being delivered by these facilities, such as, in-center dialysis, home training proarams, low overhead limited care dialysis, transplantation, etc. 5. the proposed resources which are necessary to meet the regional needs identified by the parameters above. 'The proposed'(or operational) program or project should indicate: 1. the unmet needs which it is designed to resolve. 2. how the activity relates to the overall framework of the regional plan for end stage renal disease. Page 5-Kidney Program Review B. ORGANIZATIONAL SETTI Efforts should be taken to ascertain the readiness of renal pro- gram sponsors to undertake an operation which will be viable and become self sustaining within a finite period of time. Several areas which should be assessed are as follows: 1. Does the RAG consider kidney needs as having relatively high priority? 2. '6,hat are the attitudes of officials in institutions and groups whose cooperation in implementing such a program is necessary? 3. Has a regional renal committee been established to provide guidance for the continued development, evaluation and in- tegration of the renal program as a service program in the@ overall health care delivery program? Is there strong kidney leadership? 4. To what extent have other hospitals, clinics, etc., who are involved with delivery of care to kidney patients been in- vited to participate in the renal program, and what is the extent of their pledged support in terms of real delivery of care to patients now, or in the future? 5. What are the regulatory statutes and mechanisms concerning kidney disease within the region? C. PROGRAM OR PROJECT PROPOSAL The proposed'program/project should include: 1. Specific objectives that are appropriate, clearly defined, quantifiable, and achievable by the proposed activity. Details concerning limitation of chronic institutional dialysis and attempts to assure that all acceptable patients will receive appropriate therapies such as transplantation and low cost maintenance dialysis should be presented. 2. Details concerning measurement of progress for each project period should be presented and expressed in terms of cap- abilities established, services initiated, problems en- countered, and number of patients served. 3. How the evaluation of services proposed will indicate acceptable quality of care. The individual/individuals responsible for evaluating the program should be identified as well as to whom the results of the evaluation will be reported. I z; '-: @I -'.@rogram Review --on of Resources: -,,I(s) and size(s) of facilities to be used. of facilities to accomplish project. @@it should be identified by kind and number, Acquisition plan set forth. @.ianism of the funding of consumable equip- -,plies necessary to carry out the program also be identified. and staff acquisition should be carefully on a progressive pattern that reasonably the development and implementation of ser- .-.on and alteration of facilities should be .-efully scrutinized, and all non-RMPS support RNPS is very reluctant to provide scarce funds for this purpose beyond the barest necessary to help activate the program. renovation and alteration expenditure from sources are acceptable as the institutions' .-!r commitment to the program. -.,on-RNPS funds to meet patient care costs should Problems faced in achieving availability @.is, and specific actions and time table planned third-party sources of support should be enu- :@articipating institutions should be advised that ready to cover unreimbursed costs of care. -ant of the plan should address the applicants .1iieving project or program independence rom by the end of the third project year. Its must reflect assumption of successive year s funded by RMPS. The individuals carrying out of the program should be named, as well as the :,-)r office which will exercise direct review and of funding source development activities. and meaning of decremental '.RMP funding must be :@@amined, as many applicants do not fully under- Decremental funding means that, generally, -,,rant year-of a specific project should require that the first year, and the third year -re less than the second. This does not mean renal funding will necessarily cease. if successive projects which are part of a com- :)lan may maintain a comparable level of RNP excremental funding underscores the need for 2nt service programs to be built into the ongoing program, including the billin Dractices of ogram Review Page 7-Kidney Pr hospitals and Dhvsicians. The identification of appropriate third party payments, and the initiation and increased billing over time should occur as early as possible to offset the reduction of @iP support in successive years. This will help assure continued program viability when KIP support ter- minates after the third project year. 6. Regional Medical Programs are not the appropriate source for support of degree oriented programs, such as A.A., R.N., and M.D. programs. Other basic training necessary for certifi- cation such as internships, residencies, and fellowships are also not available for R.@fP support. However, FIIT will support, when it is appropriate to the goals of a comprehen- sive renal program, trainina in continuing education of physicians (excluding fellowships), post graduate renal nurses, and other health professionals. As is the case with other MT programs, the training program must achieve independence from @ support by the end of the grant period. 7. Relative staffing and cost patterns are helpful in judging whether or not a program or project is being executed effectively and efficiently. RIEPS is only interested in reimbursing that portion of the staff member s time which is required to execute specific renal program duties (or such renal program duties which are in excess of those being other- wise continued for the institution or other programs). Renal programs require a relatively wide range of medical and allied health personnel. However, many of these people will con- tinue their other established duties on behalf of the in- stitution, and such work should not be charged against the renal grant program. D. FOLLOlq-UP REVIEW PERFO@NIANCE There will be annual review during the period of program perfor- mance. The purpose of the annual follow-up review will be to evaluate the accomplishment of program objectives. The follow-up reviews of programs/projects should consider the items mentioned above in the proper time frame so that accomplishments are com- pared to the original program goals. If the original goals of the program are not being met, the reason/reasons for this should be sought. It should also be determined whether or not the sponsors' initiative and actions have been appropriate to attemp to rectify the program's poor performance. Page 8- Yidney Program Review pared for the RAG in the same The folloTi-up report will be pre review. If a fashion as specified for the original program eeting its goals, successfully and m program is not functioning o bring the he options necessary t the report should detail t ith the guidelines. program into conformance w E. STANDARDS ASSESSMENT To help analyze and provide counsel on these matters) consultants will need to draw on their own knowledge and experience. In addition, we are providing some very general guidelines as follows: 1. Home Dialysis Training: a. Patient Load: A home dialysis training facility should run 6 shift days per week and should train a minimum of 12 patients per year per bed. b. Suggested Staffing Patterns: --I-.-ere should be 1 physician technician per bed per 24 patients trained; 1 nurse or per shift; 1 social worker per 24 pts; and 1/2 full time equivalent (FTE) dietician per 24 patients. Psychiatrists and psychologists should be utilized on a fee basis, and a surgeon should be utilized on a fee basis for fistulae and cannulae work. C. Equipment: Initially, a new delivery system must be acquired for each patient trained. Delivery systems should be kept in the training center.at all times to provide backup and acute treatments. The cost of a coil delivery system plus ancil ary equipment (alarms, blood pupp,, etc.) is $3,000 to $3,500. The kiil delivery system plus ancillary equipment (artificial kidney, alarms, etc.) is $4,700 to $5,200. It should be noted that it is not always necessary to purchase all machines in that Vocational Rehabilitation and the "bluell plans in many states have leasing arrangements. Capital equipment cost would not be expected to be projected beyond the first year. d. Supplies: Consumable supply costs in the training center and the home will--be virtually the same. For the coil, the costs per dialysis would be $25 to $30. This includes the coil, tubing, dialysate, heparin, saline, etc. For the kiil the costs per dialysis would be $15 to $20 including the membranes, dialysate, tubing, saline, heparin, etc. These items are-costs which can reasonably be expected to be reimbursed b third party sources. y Page 9-Kidney Program Review e. Laboratory: Direct patient care mechanisms should support the costs of laboratory services. f. Travel: Some staff travel to patients homes should be indicated. Follow-up visits after training and occasional maintenance will be necessary. 2. Transplantation: A Transplantation Prog a. ,ram has one or more hospitals doing transplantation surgery, one (1) tissue typing facility or contractural agreement, one (1) organ procurement and sharing program linkages to dialysis services (backup and home dialysis training), and is characterized by strong leadership. Such a program should do a minimum of 25 transplants per unit per year and should aim ulti- mately at 50-100 transplants per year and meeting the Region's needs. b. The patient hospitalization runs, generally, 14 to 21 days for uncomplicated identical living related donor transplants, and may run up to 30 to 90 days for non- identical ELA transplants, with several rejection episodes. Thus, an accurate cost analysis of transplanta- tion is difficult. Charges should be cost-accountable on the basis of physicians' fees, operating room expenses, patient care daily charges, lab fees, etc., and should be analyzed in the framework of 3 year decremental funding, with a strong emphasis on getting continuing support from third-party collections. RMPs cannot pay direct hospi- talization costs. Its support is indirect, and usually in the form of staff salaries and/or equipment costs. A number of existing transplant programs have now success- fully shifted the major portion of their funding to third-party carriers. C. Staffing: At least one full-time transplant surgeon and a part-time transplant surgeon are highly desirable; a nurse coordinator is highly desirable; a dietician is usually a 1/2 FTE; and a social worker as needed. Again psychiatrists and psychologists are utilized on a fee basis. d. Laboratory: Laboratory services for transplant patients should be available through existing hospital facilities which must be of a standard required for caring for transplant patients. Again, these services are generally reimbursable by tliird-party sources. 3. organ Procurement: A program should show capability of harvesting sufficient kidneys so that at least 50 transplants can be performed each year. Generally, about one-third of the kidneys harvested are unusable. Aaain, cost of organ procurement is b6--@.(@.oTnin- imminently recoverable fron third- party carriers. Page 10-Kidney Program Review 4. Histocompatibility Testing: Ulherever possible, a transplanta- tion program should utilize a tissue typing lab already in existence, especially where geographic proximity permits this. The tissue typing director must be a qualified immunologic leader, and the lab should serve a geographic region performing 50 to 75 transplants per year in order to maintain a full-time technical staff with 24-hour on-call capabilities. Third-party carriers have indicated willingness to assume tissue-typing costs, and funding should be directed towards their takeover of payment. 5. Limited Care Dialysis: A limited care center maybe considered as an integral part of a regional program dependent upon a region's needs. Kidnev Disease Activities Eligible for Separate P-NIPS Funding_ The program activities of the "Life Plan" for Kidney Disease which are eligible to compete for I*IPS kidney funds generally fall into the category of service resources for end-stage renal disease. These activities will eive RMPS support in the form of "separate" decremental funding which rec provides less @IPS funding each subsequent year of program operation as developed third-party sources of funds support an increasing share of the program cost. Kidney disease programs are expected to be fully operations independently from IUIPS support after the third year of grant support. Separate funds are available for the following program areas: 1. Transplantation - PIEPS funds will be provided on a decremental basis for establishing programs in transplantation in areas of need. Direct patient-c7are costs are not appropriate for support. 2. Organ Procurement Activities - RNIS will finance the start-up of a region's organ-procurement activities in the framework of decremental KT funding with assumption of costs by other sources over time. 3. Tissue Typing - RMPS will pay for start-up costs in this activity provided that the tissue-typing labs are not redundant and duplicative. Tissue-typin- costs also must be assumed by other sources of funds. 4. Organ Procurement and Communication Activities - These are designed to provide optimal use of harvested organs shared among many transplant centers over several regions. These activities should also become self-sufficient by the time IUTS seed money is withdrawn. It is, however, more difficult for these activities to be financed by third-party carriers and the costs of managing the organ-procurement network may be added to the individual cost per organ harvested. 5. Home Dialysis Training - RMPS will provide seed money for the develop- ment of home dialysis-training programs where the need has been demonstrate Such programs must be affiliated with a transplantation program and provide or have access to acute medical resources. 6. Low Overhead Limit.ed Care Dialysis - Where documented regional needs exist, RNPS will support the development of low-c6st limited-cate programs having access to acute medical care resources and affiliated with a tertiary- care program. 7. Satellite Dialysis Facilities - Where appropriate, RIPS may support the development of satellite-dialysis resources to serve the backup needs of patients who are geographically removed from the tertiary-care facilities. -2- and Transplantation Programs for Children @NTS will provide 8. Dialysis the start-up costs for pediatric end-stage renal activities in selected areas of need. Since an estimated total of only 600 children each year are believed to be good candidates for dialysis and transplantation, we oviding support for only a few highly centralized pediatric anticipate pr nephrology units. As with adult facilities, pediatric nephrolog3, units must be based on a decremental PIIP funding sequence, with assumption of costs by non-@IPS sources in time. 9. Education - RI-TS will support, when appropriate to the goals of a comprehensive renal proaram, training in continuing education of physicians (excluding fellowships), postgraduate renal nurses, and other allied health professionals aimed at improving care for patients with end-stage renal disease. IUTS is not the appropriate source for support of degree or certificate-oriented programs, such as A.A., R.N., and M.D. pro,-:>rams; internships, residencies, and fellowships also are not suitable for KT support. 10. Public Education - RMPS will provide limited support for appropriate public education activities which are clearly related to specific output of the end-stage renal program. re@ioyi.al @ -V . m e (:i iLcal SPECIAL ISSUE program,-, FOR LIMITED DISTRIBUTION servi-c- e 1011 II f IL in t OC[ata A (-oiiiititiiii(-,itioti (I(@sigil(@ll to SI)CC(I LEGISLATION E\-iF-'\DED I,\D @IENDED FOR Regional Nlodical til(. of 11(@%s, ijif4)riiiatiopit a'ti(l (lata ori Programs - Pub!-ic Law 91-515 lti-,,ii)llltl Pr4)llraiii.,i aii(I relatt-41 activiti(@s. November 20, 1970 Vol. 4, No. 51S On October 30, 1970, the President sioiie(I Ilublic Law 91-SI.5 which extends and amends the Regional Medical Progran,, legislation, is well as that of Comprehensive Health Planning and Services, the National Center for Health Services IZosearch and Development and the Natiojiil Center for fic@.il.th Statistics. To reflect the details of this action, a copy of Title I of the new law (P.L. 91-SlS) referring to Regional Medical Programs specifically, and parts of certain other titles relevant to Regional Medical Programs, are reproduced in the first part of this issue. I To indicate how the total Regional Medical Programs law now reads as part of the Public Stealth Service Act, all changes have been interpolated into the original law (Public Law 89-239, as @nonded by Public Law 90-S74) on the pa@es that follow. Deletions in the previous law are shown in tbrack-t-s Qc is underscored. 0 while the now I.egi.slative langtia., Distrit)ution: Coordinators of Regional Medical 11-rogrwiis Nled)crs of National j@dvisory Council. and IZeview Conunittee on Regional Medical Programs Staff of R6gional Nledical Progr@ Service Regional Ifealth Directors and Regional Medical. PrograNLs Service Representatives of Health, Education, and Welfare Regional Offices f@'I)tj(!A'I'ION, ANI) Wl,,I,FARI,', If.S. I)EII'Alt'l')IEN'I' ()F lfi@, I 11(@allit Servi(-(t lit@aitli Sf-.rvif-4-s Haiti NI(@ntal llealiti A(iiiiiiiistratioii 201t.-i,2 regiLonal medical SP'E-CIAL ISSU;@T programs FOR LIMITED DIST;IIBUTION service @ ia ei/v s 0 0 Ila ornaat'ioii 0c) oda'a A coinniuitication device designed to speed KIDNEY DISF-ASE ACFIVITIES the exchange of news, information and data on Guidelines and Review Procedures Statement Regional Medical Programs and related activities. M2x 3, 1972 - Vol. 6, No. 9S This issue presents revised guidelines and local and national review procedures for kidney disease activities. These guidelines supersede all previous @S materials relative to the submission of kidney disease applications, specifically including those appearing in the News Information Data, Policy Statement and Guidelines" published on November 27, 1970, Vol. 4, No. 53S, and the "Interpretation of Guidelines." published on March 1, 1971, Vol. 5, No. SS. Distributim: . Coordinators of Regional Medical Programs . Members of National Advisory Council and Review Committee on Regional Medical Program . Staff of Regional Medical Programs Service . Regional Health Directors and Regional Medical Programs Service RepresentativL-s of Health, Education, and Welfare Regional Offices. U.S. DEPARTMENT OF, HEALTH, EDUCATION, AND WELFARE Public Health Service a Health Services.and Mental Health Administration 0 Rockville, ]VI,-ryltiiii 208;-@2 revional m-edical SPECIAL ISSUE @-)rograrns FOR LIMITED DISTRIBUTION service -vv s e 0 C90 1 11 f n-i at 'I 0 *data A colililiti[iicatioii (](,VIC(, flit, ex(.Ilzill"(. of ll(!@vs, r- CLARIFICATION OF KIDNEY DISF-@SE GUIDELI,\TES ilifol-ill,itit@it aii4i (iita t)ti Pro,,raiii.4 aii(I rt,late(I activiti(@s. September 14, lL72_- Vol. 6,-No. 16S This issue presents clarification of the "Kidney Disease Guidelines - Guidelines and Review Procedures Statement," issued in th 72 issue of News, Information, and Data, Vol. 6, No. 9S., Three areas are more fully described in this issuance. 1. At the reque st of the Advisory Council at its meeting on June 5-6, 1972 a definition of full-time transplantat is provided. .1 2.. Pediatric Nephrology applications have been refused by some RNIP's ecause of the wor ing in the Guidelines. A broader interpretation is proposed in this explanatory statement. 3. Outside Consultant Review of kidney programs is required for a new kidney disease proposal, and for subsequent years of its RMPS grant support. As a prototype for organized patient care delivery to a finite population, the kidney disease activity needs continued assessment with regard to progress made in treating identified patient population, program cost control, and achievement of increased financial independence. Distribution: Coordinators of Regional Nle ical rograms Nlembers of National Advisory Council and Review Committee on Regional Nledical Programs Staff of Regional @ledical Programs Service Regional Health Directors and Regional @ledical -Programs Service Representatives of Health, Education and IVelfare Regional Offices. U.S. DEPARTIIEN-l' OF IIEALTII, EDIJCATION, AND WELFARE I'til)lit- licaiiii Service 9 flealilt Services aii(I Meii tal ficaiiii Adiiiinistration 9 Rockville, Nlar,,-Iziii(I 20it.-i,2