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-.<ist between the
                                                                    affiliated unit and  the parent artificial kidney  complex
                                                                    shall be  fully documented as  part of  the  onooing  accredi-
                                                                    tation procedure.   This  affiliation should be  a matter  of
                                                                    public record.


                                                                                                   2 7

                          d.  An in-hospital dialys       o ram

                                (1)  General Considerations
                                     (a) An in-hospital dialysis program  should  be  located  in  a
                                          secondary or tertiary center  capable  of  evaluating  and
                                          treating patients with all types of renal disease.
                                     (b)  In-hospital dialysis should be provided in a special
                                          facility created for that purpose or  by  moving  the  hemo-
                                          dialysis equipment to the  bedside  of  the  patient  when

                                          considered medically necessary.
                                     (c)  An in-hospital dialysis program should function primarily
                                          as a supporting service to  the  transplant  program  and/or
                                          as a backup program for hospitalized patients who usually
                                          are dialyzing at home  or in a limited  care facility.

                       3.  Services of Programs and Facilities   for Hemodialysis
                           a. In order  to  maintain  the  highest standards  of  care  for  patients
                                undergoing  chronic  hemodialysis, the artificial kidney complex

                                shall provide the following:
                                (1)  The establishment of a formal review mechanism for the
                                     evaluation of suitable  candidates  for  chronic  hemodialysis,
                                     including primarily medical, but  also  social,  and  psychiatric
                                     evaluation, either directly or  from  patient  records,  and  a

                                     followup of patient experience.
                                (2)  The establishment of a formal review mechanism for t e
                                     evaluation of suitable  candidates   for   homotransplantation.
                                (3)  The artificial kidney  complex shall be responsible to
                                     clearly delineate the  commitment of this facility to t      con-

                                     tinued optimum care  of  the  patient  requiring  hemodialysis.


                                                                                              28

                                            guidelines in choosing patients for @,ermdialysis
                             (4)  Suagesled
                                  and transplantation should be available to all primary
                                  physicians as well as to rephrolog4sts and other members

                                  of the Fealth Care T4--am.
                              (5)  Approoriate outpatient facilities for followuo of patients
                                   on iimi,*ed care and home he!r@odialys4@s,
                              (6)  Const,-Itatiie seriices to affiliated liemodialysis programs
                                   in a broad scope of matters related 'Lo chronic dialysis,
                                   including equipment selection, operation and maintenance,
                                   patient management, and patient training and rehabilitation.
                              (7)  Treatment service capabilities shall inclu e:
                                   (a)  Blood access (cannulas or fistulas), sur-ery and recovery
                                   (b)   Mai-ptenance dialysis of patients who cannot dialyze
                                         thew-selves, and backup dialysis for patients at home or

                                         in limited care facilities
                                    (c)  HoTr-- dialysis training and supervision for patients and

                                         their families
                                    (d)  Followup of patients in affiliated proaram . limited
                                         care units, and home, as indicated
                                    (e)  Laboratory facilities with necessary tests to evaluate
                                         and @nage patients undergoing chronic ma ntenance
                                         hemodialysis including im=nological facilit es
                                    (f)  Vocational counseling and guidance for training,
                                         appropriate to the age and skills of the individual
                                    (g)  Education and training of medical and paramedical staff,
                                         and, when indicated, the patient and his family


                                                                                              29

                                    (h)  Collaboration and coordination with affiliated arti-

                                        ficial kidney programs
                                    (i) Affiliation with a renal homotransplantation program
                                        and its associated immunological laboratories

                          b.  A self-dialysis training program shall provide:
                               (1)  A training program that is capable,of providing the patient
                                    with the complete breadth and depth of knowledge and confi-
                                    dence.necessary for successful self-dialysis at home or in a

                                    limited care facility.
                               (2)  A program of periodic review and updating of the patient's

                                    competence.
                               (3)  The social and psychological supporting services which are
                                    essential to initial and long-term adjustrwnt to home dialysis.
                               (4)  Adequate capability for emergency servicing of equipment and
                                    'preventive maintenance to minimize breakdowns.
                               (5)  Up-to-date information on the best sources of hemodialysis
                                    supplies and drugs for self-dialysis.

                           c.  A limited care dialysis program shall provide:
                               (1)  The space and equipment for dialysis with the assistance of
                                    technical personnel or for self-dialysis with the assistance

                                    of family or friend.
                               (2)  Since the chief reason for the existence of a limited care
                                    facility is to provide an inex ensive substitute for home
                                                                  p
                                    hemodialysis, all other services should be provided through
                                    an artificial kidney complex.


                                                                                              30

                          d.  An affiliated hemodia          am shall provide only those
                               services for which it is accredited to provide.  All other
                               services shall be provided by the sponsoring artificial kidney

                               complex.

                          e.  in-hospital dialysis program should provide:
                               (1)  Hemodialysis to all patients who require hospitalization.
                                   Even though there may be a separate in-hospital dialysis
                                   facility for backup dialysis of patients on chronic dialysis,
                                   the program should have the capability of providing acute
                                   hemodialysis at the bedside in certain other designated
                                   areas of the hospital, such as the intensive care unit or

                                   a transplantation unit.
                               (2) The full gamut of diagnostic and therapeutic services that
                                   are required to diagnose and treat any hospitalized patient

                                   with renal disease.

                  B.  Pediatric Hemodialysis Resources

                      1.  General Considerations
                          a.  The incidence and problems of end-stage renal disease in the
                               Pediatric population is considerably different from those seen
                               in the adult population. Therefore, the hemodialysis resources
                               necessary for treatment are different and should be carefully
                               planned based upon the population to be served as well as existing
                               Pediatric treatment facilities within the region. On the basis
                               of present experience it can be estimated that one center providing
                               comprehensive care for end-stage renal disease in children could
                               effectively serve the needs of a population of 5-10 million.


                                                                                             31

                                        nt facility for children in renal failure should
                         b,  The treatme
                              ideally be located in a tertiary center which has an active
                                      for management of renal failu e in adults. Some progratm
                              program                             !7
                              have been developed or may be developed in the setting of a
                              children's hospital.  Strong working ties with proximate tertiary
                              centers with programs for adults and the provision of all of the
                              supportive departments and services described below are desirable.
                      2.  Classification of Programs           ties for Hemodialysis of Children

                          a.  General considerations
                              (1)  Although one comprehensive treatment facility could serve a
                                   described region, every effort should be made to develop
                                   integrated programs with secondary or satellite centers in
                                   physically separate medical centers in the region where spe-
                                   cial expertise in diagnosis and management of pediatric renal
                                   disease exists.  These secondary centers should possess the
                                   capability for diagnosis and management of chronic renal dis-
                                   ease in children, including peritoneal dialysis, but would not
                                   have the capability for chronic hemodialysis and transplants
                                   tion.  They should serve as feeder satellites to the tertiary
                                   center and participate in management and followup of the

                                   successful transplantation.

                          b.  TertialZ pediatric her          complex
                               (1) This center will have a similar description, as outlined in
                                   IV,A,2b(l) and 3a,  in addition, since this facility deals
                                   primarily with children, specific additional characteristics
                                   are mandatory, as outlined below.


                                                                                                32

                               (2)  The -,"illty to assess the physical and emotional growth  and
                                           .L
                                    development in the patient, and to evaluate the effects of the
                                    illness and its treatment on the family structure, and to
                                    develot) effective means of dealing with these complex  prob-

                               (3)  The ability to provide acute and chronic dialysis and general
                                    pediatric support to an affiliated  transplantation  program,
                                    and to assist in the evaluation and management  of  children
                                    after transplantation, with particular regard to  growth  and
                                    development, social, psychological, and educational problems.
                               (4)  The ability to provide consultative service  and  continuing
                                    education to referring physicians and secondary resources of

                                    the child's care.
                               (5)  The ability to serve as training resources for all levels of
                                    health personnel involved in the center's programs.
                               (6)  There should be ideally two or more  pediatric  nephrologists
                                    having 2 or more years' training in the diagnosis  and  care
                                    of children with renal disease who are responsible  for  the

                                    opera-lion of this facility.

                      3.  Services
                          in order to maintain the highest standards of care for children
                          undergoing chronic he.@dialysis, the  regional  pediatric  hemodialysis
                          center shall provide similar services as outlined under the artificial
                          kidney comple,- services /IV,-A,3a (105fl.


                                                                                              33

                 C.  Transplantation Resources

                     1.  General Considerations
                         a.  Renal transplantation is defined as transplantation of a kidney
                              from one individual to another.  The kidney to be transplanted
                              may be obtained from a living or cadaveric donor.  Insofar as
                              possible, transplantation should be effected on the basis of
                              histocompatibility and the matching of major blood groups, and
                              not performed when the crosshatch is positive.

                         bo   The major criterion for designating a kidney transplantation
                              center shall be its demonstration of potential ability to  attract
                              patients in sufficient numbers to maintain the competent expertise
                              demanded by a superior program.  A transplant center would qualify
                              if any one of the following situations existed:
                              (1) The center should have the capability within 1 to 2  years  of
                                   performing 50 or more.kidney transplants per year.  A  center
                                   that has performed more than 50 transplants in the  preceding
                                   year would be immediately designated as a transplant facility.
                                   If a center cannot demonstrate its potential of performing 50
                                   or more transplants'per year, it can qualify-if it  satisfies

                                   one of the following'additional criteria.
                              (2)  It must serve exclusively a population base of at least

                                   two million.
                              (3)  If located within 50 miles of another center, as defined under
                                   (1), above  it must serve exclusively a population base of at
                                   least two million, or the combined population of the metro-
       I     .                     politan area surrounding the two centers must exceed
   1.I..                           four million.


                                                                                              34
                                (4)  if a cent@@r has satisfactorily demonstrated an outstanding
                                                           I
                                   resea3:cb capability in the field of transplantation or
                                   would be located in a geographic isolated area (i.e., @waii),

                                   it could qualify as a transplant center.
                                (5)  if the transplantation program is part of a total program
                                   specifically caring for children Keith end-staoe renal dis-
                                   ease and serving a population base, as outlined.

                      2 .
                          a.  The renal transplant center shall be located in a general hospital,
                                providing all the diagnostic and treatwnt facilities for patients
                                with All forms of kidney disease, including general medical, both
                                adult and pediatric, immunological, anatomic and clinical pathology
                                surgical, urological, and radiological services, as needed.
                                operational integration or affiliation with a tertiary center or
                                its equivalent is necessary to assure the availability of the fu
                                gamut of required consultative services.
                          b.    Renal transplantation centers serving children shall have pediatric
                                facilities as previously described within Section B.  Stich
                                standards shall include the availability of a Board-certified
                                pediatrician trained and experienced in pediatric nephrology
                                assisted by a pediatric surgeon or urologist to supervise those

                                pediatric cases.
                           C.  Each renal transplantation center must have acute hemodialysis
                                facilities to assure that all patients requiring dialysis prior
                                to surgery or upon rejection of a donor kidney will have such

                                treatment available to them.


                                                                                                35

                                                                                       ties of
                                                                          the capabili
                                   renal transplantation center will have
                          d.  Each
                                                        ysis within the institution, or  have
                               providing chronic hemodial
                                                          chronic hemodialysis units, to assure
                               arrangements with qualified
                                                     epted for renal transplantation, who
                               that those patients acc
                                                                           ill have such treat-
                               subsequently require chronic hemodialysiss w

                               vent available to them.

                                          n of tertiary center by the Joint Commission on
                          e.   Accreditatio
                               Accreditation of Hospitals is necessary for approval of the  trans-

                               plant center.

                          f.   Each transplant center shall have two-way access to the informa-

                               tion/communications system.

                       3.   ervices
                           a.  The transplant center should have a committee with the chief of
                               the transplant service as its chairman to supervise all  renal
                               transplantation activities in the institution.

                           b.  Diagnostic and treatment facilities for chronic renal  disease,  as

                               outlined in previous sections.

                           C.  Consultative services to provide care for all  problem  related  to
                               transplantation and treatment of patients with end-stage renal
                               disease, as outlined in Section III,C,D,E,F.  In addition to the
                               Professional Services as outlined, a transplant center  should
                               have ready access to the following:
                               (1)  Tissue typing laboratory staffed by appropriately trained
                                    technician (supervised by a physician), with  appropriate


                                                                                             36
                                    space and resources to perform required histocompatibility

                                    testina and crossmatch.
                             (2)    An organ procuremen t system supervised by a surgeon capable
                                    of procuring adequate number of organs for the transplant

                                    program.
                             (3)    An organ preservation program.  The basic requirements shou
                                    include at least one pulsatile perfusion apparatus or other
                                    equipment of proven merit, and a technician capable of
                                    preparing a donor kidney for placement on the preservation
                                    apparatus.  In addition, appropriate space should be
                                    available for maintenance and storage of equipment required

                                    for this function.

                     4.

                          a.  YRdical
                              (1)  This department of transplantation should consist of a minimum
                                    of one full-time surgeon (he may be a general surgeon or
                                    urologist,) and another surgeon who is spending at least half
                                    time participating in the care of transplant patients.  They
                                    should be Board-certified in their respective specialties.
                                    They should provide evidence of special training and experi-
                                    ence in appropriate aspects of transplant surgery to insure
                                    high proficiency in renal transplantation.
                              (2)   The transplant surgeon should participate in both the short-
                                    term and long-term post transplant care of the patient.  The
                                    general long-term care of the patient should be in the hands
                                    of the patient's primary physician who, in most cases, will b
                                    an internist or a general practitioner, or a nephrologist.


                                                                                                       37

                                                                                early and late
                                      The'patient should be  cared  for,  during
                                    ..rejection, by a member of the team or    the transplant surgeon*
                                                                         ient, in  which  rejection   is
                                      Other problems involving the pat
                                      not a problem, may be cared for    by  the patient's primary

                                      physician.
                                 (3)  A nephrologist shall supervise the nephrology activities.
                                      For facilities serving children, a pediatric nephrologist or
                                      a pediatrician with experience and training in renal disease
                                      shall be on the staff, available to provide care for children
                                      with chronic  renal  disease,  to  participate  in  the  selection
                                      of children for renal transplantation, and to provide followup
                                      tare for patients treated by renal transplantation.
                                 (4)  A Board-certified urologist must be available to participate
                                      both in the  preoperative  and  postoperative   surgical   evalua-
                                      tion and management of the transplant patient.
                                 (5)  Pathologists and other laboratory scientists who are certified
                                      in  their  respective  specialties  should  supervise   laboratory
                                      operations and  coordinate  these  operations  so  that  they  may
                                      meet the  needs  of  the'clinical  services  promptly  and  effec-

                                      tively.
                                 (6)  Psychiatric  or  psychological  consultation  should  be   readily
                                      available for support and care of patients and families
                                      undergoing such treatment.  For the care of the pediatric
                                      patient,  a  child  psychiatrist  or  psychologist  is  essential.


                                                                                              38
                               (7) Each center @iust provide in-house physician coverage durin-,
                                                                hospital. Centers rnay  use  the
                                   the ti,-L-e patients are in the     I
                                   services of residents as part of a regular rotation system

                                   with other institutions.

                          b.  Nursina
                               (1)  Nurses participating in the care of patients undergoing renal
                                   transplantation shall have special training, with emphasis on
                                   the posl---transviant care of the patient. Nurses caring  for
                                   patients requiring hemodialysis post-transplantation will be
                                   required to be trained in hemodialysi-s procedures and  tech-
                                   niques.  Nurses caring for the pediatric patients, in addition
                                   to the above qualifications, should haie specific trainina in
                                   the care of the acutely ill pediatric patients.
                               (2) Professional nurses may be assisted by licensed practical

                                   nurses and nurses' aides.
                               .(3) in-service education must be an integral part of the operation
                                   of a transplantation unit.

                           c.  Technicians
                               Technicians are frequently required to assist in the operation of
                               the organ perfusion apparatus as well as in preparation and main-
                               tenance oz the artificial kidneys that may be used during  post-

                               transplantation periods.


                                                                                              39

                          d.  Social worker
                              Because of the intense social and emotional implications with

                                                               ervices from transplantation
                              patients and families requiring  8
                                                                                     during
                                                               e available to assist
                              centers, social services should  b

                              all stages of care.

                          e   Dietitians
                              Dietary aspects of patients post-transplantation shall be under
                              the direction and supervision of the primary physician working
                              with a professionally qualified dietitian meeting the American
                              Dietetic Association standards, with training and experience in

                              the management of therapeutic diets.

                           f. Vocational counseling
                              vocational counseling, or its equivalent services, shall be
                              provided by the Department of Rehabilitation.

                           g. Clinical and administrative personnel
                              Appropriate clinical and administrative personnel are required to
                              assure maintenance of records, keeping up the inventory,, handling
                              personnel, public relations, and to compile patient followup data.

                      5.  Physical Facilities
                           a. Operating room which shall be equipped with necessary equipment to
                              accomplish transplantation performed on adults or children,
                           b. Provision shall be made for an intensive care unit, or  an equiva ent
                              services thereof, for a minimal of 72 hours following  transplant

                              surgery,


                                                                                             40

                                                                          ing hemodialysis
                         c.  Dialysis facilities for those patients requir
                             post-transplantation.  The dialysis facilities should conform
                                                                          dealing with
                             to the requirements described in the section

                             hemodialysis.

                                          rvice shall be provided for the post-transplantation
                         d.  Outpatient se

                             patients.


                                               A P P E N D I C E S


                                                        APPENDIX I

                      CRITERIA FOR THE EVALUATION OF    THE SEVERITY OF ESTABIISHED RENAL DISEASE

                1.  CLASSIFICATION OF SIGNS AND SYMPTOM BY SEVERITY
                    This classification is designed to describe the severity of the clinical
                      nifestations of renal disease which are displayed by the patient.  The
                    ma
                    patient should be placed in the highest Class whose criteria are fulfilled.
                    Class     I:  Requires (a) plus one or more.of (b) through (f):
                            (a)   No symptoms directly  referable  to  renal  disease
                            (b)   Fixed proteinuria ( > 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


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                                                                    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
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                 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