The Effectiveness and Costs of Continuous

Ambulatory Peritoneal Dialysis (CAPD)

September 1985

NTIS order #PB87-148939
HEALTH TECHNOLOGY CASE STUDY 35

The Effectiveness and Costs of

Continuous Ambulatory Peritoneal

Dialysis (CAPD)

SEPTEMBER 1985

This case study was performed as part of OTA’s Assessment of

Medical Technology and Costs of the Medicare Program

Prepared for OTA by:

William B. Stason, M. D., M.S.

Associate Professor, Harvard School of Public Health

Chief, Health Services Research

West Roxbury, VA Medical Center

Benjamin A. Barnes, M.D.

Associate Professor of Surgery, Harvard Medical School

Director, New England Organ Bank

OTA Case Studies are documents containing information on a specific medical

technology or area of application that supplements formal OTA assessments. The

material is not normally of as immediate policy interest as that in an OTA Report,

nor does it present options for Congress to consider.
Recommended Citation:

Stason, William B., and Barnes, Benjamin A., The Effectiveness and Costs of Continuous

Ambulatory Peritoneal Dialysis (CAPD) (Health Technology Case Study 35), OTA-HCS-35

(Washington, DC: U.S. Congress, Office of Technology Assessment, July 1985). This case

study was performed as part of OTA’s assessment of Medical Technology and Costs of

the Medicare Program.

Library of Congress Catalog Card Number 85-600554

For sale by the Superintendent of Documents

U.S. Government Printing Office, Washington, DC 20402
Preface

The Effectiveness and Costs of Continuous Ambulatory Peritoneal Dialysis (CAPD) is Case

Study 35 in OTA’s Health Technology Case Study

Series. This case study, which was requested by

the Senate Committee on Finance and its Subcommittee on Health, has been prepared in connection with OTA’s project on Medical Technology

and Costs of the Medicare Program, which was

requested by the House Committee on Energy and

Commerce and its Subcommittee on Health and

the Environment and the Senate Committee on

Finance, Subcommittee on Health. A listing of

other case studies in the series is included at the

end of this preface.

OTA case studies are designed to fulfill two

functions. The primary purpose is to provide

OTA with specific information that can be used

in forming general conclusions regarding broader

policy issues. The first 19 cases in the Health Technology Case Study Series, for example, were conducted in conjunction with OTA’s overall project

on The Implications of Cost-Effectiveness Analysis of Medical Technology. By examining the 19

cases as a group and looking for common problems or strengths in the techniques of cost-effectiveness or cost-benefit analysis, OTA was able

to better analyze the potential contribution that

those techniques might make to the management

of medical technology and health care costs and

quality.

The second function of the case studies is to

provide useful information on the specific technologies covered. The design and the funding levels of most of the case studies are such that they

should be read primarily in the context of the associated overall OTA projects, Nevertheless, in

many instances, the case studies do represent extensive reviews of the literature on the efficacy,

safety, and costs of the specific technologies and

as such can stand on their own as a useful contribution to the field.

Case studies are prepared in some instances because they have been specifically requested by

congressional committees and in others because

they have been selected through an extensive review process involving OTA staff and consultations with the congressional staffs, advisory panel

to the associated overall project, the Health Program Advisory Committee, and other experts in

various fields. Selection criteria were developed

to ensure that case studies provide the following:

●

●

●

●

●

Ž

●

●

examples of types of technologies by function (preventive, diagnostic, therapeutic, and

rehabilitative);

examples of types of technologies by physical nature (drugs, devices, and procedures);

examples of technologies in different stages

of development and diffusion (new, emerging, and established);

examples from different areas of medicine

(e.g., general medical practice, pediatrics,

radiology, and surgery);

examples addressing medical problems that

are important because of their high frequency or significant impacts (e. g., cost);

examples of technologies with associated high

costs either because of high volume (for lowcost technologies) or high individual costs;

examples that could provide information material relating to the broader policy and methodological issues being examined in the

particular overall project; and

examples with sufficient scientific literature.

Case studies are either prepared by OTA staff,

commissioned by OTA and performed under contract by experts (generally in academia), or written by OTA staff on the basis of contractors’

papers.

OTA subjects each case study to an extensive

review process. Initial drafts of cases are reviewed

by OTA staff and by members of the advisory

panel to the associated project. For commissioned

cases, comments are provided to authors, along

with OTA’s suggestions for revisions. Subsequent

drafts are sent by OTA to numerous experts for

review and comment. Each case is seen by at least

30 reviewers, and sometimes by 80 or more outside reviewers. These individuals may be from

relevant Government agencies, professional societies, consumer and public interest groups, medical practice, and academic medicine. Academicians such as economists, sociologists, decision

analysts, biologists, and so forth, as appropriate,

also review the cases.

Although cases are not statements of official

OTA position, the review process is designed to

satisfy OTA’s concern with each case study’s

scientific quality and objectivity. During the various stages of the review and revision process,

therefore, OTA encourages, and to the extent possible requires, authors to present balanced information and recognize divergent points of view.

///
Health Technology Case Study Seriesa

Case Study Case study title; author(s); - Case Study -

‘Case study title; author(s);

Series No. OTA publication numberb

Series No. OTA publication numberb

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

Formal Analysis, Policy Formulation, and End-Stage Renal

Disease;

Richard A. Rettig (OTA-BP-H-9(1)) c

The Feasibility of Economic Evaluation of Diagnostic Procedures: The Case of CT Scanning;

Judith L. Wagner (OTA-BP-H-9(2))

Screening for Colon Cancer: A Technology Assessment;

David M. Eddy (OTA-BP-H-9(3))

Cost Effectiveness of Automated Multichannel Chemistry

Analyzers;

Milton C. Weinstein and Laurie A. Pearlman

(OTA-BP-H-9(4))

Periodontal Disease: Assessing the Effectiveness and Costs of

the Keyes Technique;

Richard M. Scheffler and Sheldon Rovin

(OTA-BP-H-9(5))

The Cost Effectiveness of Bone Marrow Transplant Therapy

and Its Policy Implications;

Stuart O. Schweitzer and C. C. Scalzi (OTA-BP-H-9(6))

Allocating Costs and Benefits in Disease Prevention Programs:

An Application to Cervical Cancer Screening;

Bryan R. Luce (Office of Technology Assessment)

(OTA-BP-H-9(7))

The Cost Effectiveness of Upper Gastrointestinal Endoscopy;

Jonathan A. Showstack and Steven A. Schroeder

(OTA-BP-H-9(8))

The Artificial Heart: Cost, Risks, and Benefits;

Deborah P. Lubeck and John P. Bunker

(OTA-BP-H-9(9))

The Costs and Effectiveness of Neonatal Intensive Care;

Peter Budetti, Peggy McManus, Nancy Barrand, and

Lu Ann Heinen (OTA-BP-H-9(10))

Benefit and Cost Analysis of Medical Interventions: The Case

of Cimetidine and Peptic Ulcer Disease;

Harvey V. Fineberg and Laurie A. Pearlman

(OTA-BP-H-9(11))

Assessing Selected Respiratory Therapy Modalities: Trends and

Relative Costs in the Washington, D.C. Area;

Richard M. Scheffler and Morgan Delaney

(OTA-BP-H-9(l2))

Cardiac Radionuclide Imaging and Cost Effectiveness;

William B. Stason and Eric Fortess (OTA-BP-H-9(13))

Cost Benefit/Cost Effectiveness of Medical Technologies: A

Case Study of Orthopedic Joint Implants;

Judith D. Bentkover and Philip G. Drew (OTA-BP-H-9(14))

Elective Hysterectomy: Costs, Risks, and Benefits;

Carol Korenbrot, Ann B. Flood, Michael Higgins,

Noralou Roos, and John P. Bunker (OTA-BP-H-9(15))

The Costs and Effectiveness of Nurse Practitioners;

Lauren LeRoy and Sharon Solkowitz (OTA-BP-H-9(16))

Surgery for Breast Cancer;

Karen Schachter Weingrod and Duncan Neuhauser

OTA-BP-H-9(l7))

.—— -——— —

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

The Efficacy and Cost Effectiveness of Psychotherapy;

Leonard Saxe (Office of Technology Assessment)

(OTA-BP-H-9(18))d

Assessment of Four Common X-Ray Procedures;

Judith L. Wagner (OTA-BP-H-9(19))e

Mandatory Passive Restraint Systems in Automobiles: Issues

and Evidence;

Kenneth E. Warner (OTA-BP-H-15(20))f

Selected Telecommunications Devices for Hearing-Impaired

Persons;

Virginia W. Stern and Martha Ross Redden

(OTA-BP-H-16(21))g

The Effectiveness and Costs of Alcoholism Treatment;

Leonard Saxe, Denise Dougherty, Katharine Esty,

and Michelle Fine (OTA-HCS-22)

The Safety, Efficacy, and Cost Effectiveness of Therapeutic

Apheresis;

John C. Langenbrunner (Office of Technology Assessment)

(OTA-HCS-23)

Variation in Length of Hospital Stay: Their Relationship to

Health Outcomes;

Mark R. Chassin (OTA-HCS-24)

Technology and Learning Disabilities;

Candis Cousins and Leonard Duhl (OTA-HCS-25)

Assistive Devices for Severe Speech Impairments;

Judith Randal (Office of Technology Assessment)

(OTA-HCS-26)

Nuclear Magnetic Resonance Imaging Technology: A Clinical,

Industrial, and Policy Analysis;

Earl P. Steinberg and Alan Cohen (OTA-HCS-27)

Intensive Care Units (ICUs): Clinical Outcomes, Costs, and

Decisionmaking;

Robert A. Berenson (OTA-HCS-28)

The Boston Elbow;

Sandra J. Tanenbaum (OTA-HCS-29)

The Market for Wheelchairs: Innovations and Federal Policy;

Donald S. Shepard and Sarita L. Karen (OTA-HCS-30)

The Contact Lens Industry: Structure, Competition, and Public

Policy;

Leonard G. Schifrin and William J. Rich (OTA-HCS-31)

The Hemodialysis Equipment and Disposable Industry;

Anthony A. Romeo (OTA-HCS-32)

Technologies for Managing Urinary Incontinence;

Joseph Ouslander, Robert Kane, Shira Vollmer, and Melvyn

Menezes (OTA-HCS-33)

The Cost Effectiveness of Digital Subtraction Angiography in

the Diagnosis of Cerebrovascular Disease;

Matthew Menken, Gordon H. DeFriese, Thomas R. Oliver,

and Irwin Litt (OTA-HCS-34)

The Effectiveness and Costs of Continuous Ambulatory

Peritoneal Dialysis (CAPD)

William B. Stason and Benjamin A. Barnes (OTA-HCS-35)

aAvai]able for ~a]e by the Superintendent of Documents, U.S. Government CIBac&-ound paper F3 t. The Imp]jcatjons of Cost-Effectiveness Analysis of

Printing Office, Washington, DC, 20402, and by the National Technical Medical Technology.

Information Service, 5285 Port Royal Rd., Springfield, VA, 22161. Call eBackground paper #5 t. The 

Implications of Cost-Effectiveness Analysis of

OTA’S Publishing Office (224-8996) for availability and ordering infor- Medical Technology.

mation. fBackground paper #1 to C)TA’S May 1982 report Technology and ~andibc)riginal publication numbers appear in parentheses. capped People.

c

The first 17 cases in the series were 17 separately issued cases in Background gBackground Paper #2 to Technology and Handicapped People.

Paper #2: Case Studies of Medical Technologies, prepared in conjunction

with OTA’S August 1980 report The Imp/icatiorrs of Cost-Effectiveness Analysis of Medical Technology.

iv
OTA Project Staff for Case Study #35

H. David Bantal and Roger C. Herdman,2 Assistant Director, OTA

Health and Life Sciences Division

Clyde J. Behney, Health Program Manager

Anne Kesselman Burns, Project Director

Pamela J. Simerly,3 Research Assistant

Edward Seibert,4 Research Assistant

Virginia Cwalina, Administrative Assistant

Beckie I. Erickson, s P. C./Word Processor Specialist

Brenda Miller, ’ P. C./Word Processor Specialist

Jennifer Nelson, ’ Secretary

Diann G. Hohenthaner,8 Secretary/Word Processor Specialist

Carol A. Guntow,9 Clerical Assistant

IUnt]l August 1983

‘Since December 1983.

‘Until September 1984.

‘September 1984

‘Since January 1984.

“Until January 1985.

‘Until January 1984.

“S]nce February 1985,

‘Since October 1984

v
Medical Technology and Costs of the Medicare Program Advisory Panel*

Stuart Altman, Panel Chair

Dean, Florence Heller School, Brandeis University

Frank Baker

Vice President

Washington State Hospital Association

Robert Blendon

Senior Vice President

The Robert Wood Johnson Foundation

Jerry Cromwell

President

Health Economics Research

Chestnut Hill, MA

Karen Davis

Chair, Department of Health Policy and

Management

School of Hygiene and Public Health

Johns Hopkins University

Robert Derzon

Vice President

Lewin & Associates

Washington, DC

Howard Frazier

Director

Center for the Analysis of Health Practices

Harvard School of Public Health

Clifton Gaus

President, Foundation for Health Services

Research

Washington, DC

Jack Hadley

Director

Center for Health Policy Studies

Georgetown University

Kate Ireland

Chairman, Board of Governors

Frontier Nursing Service

Wendover, KY

Judith Lave

Professor

Department of Health Economics

University of Pittsburgh

Mary Marshall

Delegate

Virginia House of Delegates

Walter McNerney

Professor of Health Policy

J. L. Kellogg Graduate School of Management

Northwestern University

Morton Miller

Immediate Past President

National Health Council

New York, NY

James Mongan

Executive Director

Truman Medical Center

Kansas City, MO

Seymour Perry

Deputy Director

Institute for Health Policy Analysis

Georgetown University Medical Center

Robert Sigmond

Director, Community Programs for

Affordable Health Care

Advisor on Hospital Affairs, Blue Cross/Blue

Shield Associations

Anne Somers

Professor

Department of Environmental and

Community and Family Medicine

UMDNJ–Rutgers Medical School

Paul Torrens

School of Public Health

University of California, Los Angeles

Keith Weikel

Group Vice President

AMI

McLean, VA

*The affiliations of the Panel members reflect their positions during the assessment (June 1982-July 1984).

vi
Contents

Page

CHAPTER 1: INTRODUCTION, SUMMARY OF FINDINGS, AND SUGGESTED FUTURE DIRECTIONS 3

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Scope of the Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Organization of the Case Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Summary of Findings.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Effectiveness of Alternative Dialysis Modalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Costs of Treatment for ESRD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Clinical Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Quality of Life.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Costs of Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Effects of Medicare’s 1983 Composite Reimbursement Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Suggested Future Directions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Better Medical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Better Cost Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Eligibility for the ESRD Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ., 10

CHAPTER 2: END-STAGE RENAL DISEASE: SCOPE AND TRENDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

End-Stage Renal Disease Defined.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Prevalence of End-Stage Renal Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Medicare’s End-Stage Renal Disease Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Clinical Characteristics and Outcomes of Persons Enrolled in the ESRD Program . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Trends in the Use of Chronic Dialysis Modalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

CHAPTER 3: PHYSIOLOGY AND TECHNIQUES OF MODALITIES FOR CHRONIC RENAL DIALYSIS. 19

Hemodialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Principles and Physiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Continuous Ambulatory Peritoneal Dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .,., . 20

Principles and Physiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Comparative Efficiency of Dialysis by Hemodialysis and Continuous Ambulatory Peritoneal Dialysis . . . . . . . . 21

CHAPTER 4: CLINICAL EFFECTIVENESS OF CONTINUOUS AMBULATORY

PERITONEAL DIALYSIS AND HEMODIALYSIS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Patient Survival . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Ability to Continue on a Dialysis Modality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Patient Morbidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Hospitalization Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ., . . . . . . . . 29

Complications of Dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ., . . . . 30

Quality of Life on Dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Burden of Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Effects of Case-Mix Differences on the Outcomes of Chronic Dialysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Characteristics of ESRD Populations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Implications of Differences in Patient Characteristics for Health Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Use of a “Standard Population” to Report Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

CHAPTER 5: COSTS OF TREATMENT FOR END-STAGE RENAL DISEASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Projected Cost of Dialysis From Cost Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Projected Cost of Dialysis From 1982 Medicare ESRD Reimbursement Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Projected Costs of Dialysis Under HCFA’s 1983 Composite Reimbursement Rates . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Financial Incentives Created by HCFA’s 1983 Composite Reimbursement Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Cost Implications of the Direct Purchase of Supplies for Home Dialysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

CHAPTER 6: ANALYSIS OF END-STAGE RENAL DISEASE EXPENDITURES . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Methods of the Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51

ESRD Program Data Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

patient Subgroups for Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Costs of Hospitalizations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Costs of Outpatient Dialysis and Physician Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

vii
Contents—continued

Page

Total Costs of Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Costs of Changing Dialysis Modality and Costs of Dying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Population Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Costs of Dialysis and Physician Services (Part B Costs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Rates and Costs of Hospitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Total Costs of Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

“Cost of Changing" Dialysis Modality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

“Cost of Dying” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Predictors of Hospitalization in Survivors Who Continue on a Single Dialysis Modality . . . . . . . . . . . . . . . . . . 58

Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

APPENDIX A: ACKNOWLEDGMENTS AND HEALTH PROGRAM ADVISORY COMMITTEE. . . . . . . . . . . . 65

APPENDIX B: GLOSSARY OF ACRONYMS AND TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

List of Tables

Table No. Page

l-1. Comparison of CAPD and HD as Currently Practiced . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

l-2. Advantages and Disadvantages of CAPD Relative to HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2-1. Estimated Prevalence and Incidence of End-Stage Renal Disease in the United States, 1982 . . . . . . . . . . . . . 14

3-1. Strategies for Solute Removal With Hemo- or Peritoneal Dialysis to Maintain Average BUN = 80mg/dl . . . . 22

4-1. Patient Survival and the Ability of Patients to Continue CAPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

4-2. Patient Survival on HA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

4-3. Comparisons of Patient Survival on CAPD and HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

4-4. Prior Treatment Modalities inpatients Entering the NIH CAPD Registry . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

4-5. Reasons for Leaving CAPD Other Than Transplantation or Return of Renal Function . . . . . . . . . . . . . . . . . 28

4-6. Hospitalization Rates by Dialysis Modality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

4-7. Hospitalization and Complication Rates in Patients on CAPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

4-8. Summary of Studies of the Employment Status of ESRD Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4-9. National Kidney Dialysis and Kidney Transplantation Study: Functional Impairment and Current

Employment Status by Type of Dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4-10. NIH CAPD Registry: Characteristics of CAPD Population Enrolled, 1981 and 1982... . . . . . . . . . . . . . . . . 35

4-11. Patients Beginning Chronic Dialysis in 1981 Under the ESRD Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4-12. National Kidney Dialysis and Kidney Transplantation Study: Population Characteristics of Random

Samples of Prevalent Patients Undergoing Chronic Dialysis in Eleven Selected Dialysis Facilities, in 1981..... 37

4-13, Patient Survival addability to Continue on a Dialysis Modality in “Standard Population” of ESRD Patients . 38

5-1. Cost of Dialysis per Patient-Year as Estimated From Health Care Financing Administration and General

Accounting Office Cost Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5-2. Cost of Dialysis per Patient-Year From 1982 Medicare Reimbursement Rates . . . . . . . . . . . . . . . . . . . . . . . . . 45

5-3. Estimated Projected Cost of Dialysis per Patient-Year Under HCFA’s 1983 Composite Reimbursement Rates . . 46

5-4. Comparison Between Estimates of the Projected Cost of Dialysis per Patient-Year Based on HCFA and

GAO Cost Audits and HCFA’s 1983 Composite Reimbursement Rates: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

5-5. Estimates of the Annual Cost of CAPD Supplies and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

6-l. Distribution of the ESRD Population by Clinical Subgroup and Dialysis Modality for 1981 and 1982

Files and for the Merged File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

6-2. Demographic Characteristics of ESRD Program Participants by Clinical Subgroup and Dialysis Modality

for the Merged File. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

6-3, Mean Costs of Dialysis and Physician Services by Clinical Subgroup and Dialysis Modality . . . . . . . . . . . 55

6-4. Comparisons of the Estimated Costs of Dialysis From Different Data Sources by Dialysis Modality . . . . . 55

6-5. Mean Frequency of Hospitalizations by Clinical Subgroup and Dialysis Modality . . . . . . . . . . . . . . . . . . . . . 56

6-6. Mean Number of Hospital Days and Estimated Hospital Costs per Patient-Year by Clinical Subgroup

and Dialysis Modality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

6-7. Distribution of Lengths of Hospital Stay by Clinical Subgroup and Dialysis Modality . . . . . . . . . . . . . . . . . 57

6-8. Total Costs of Care per Patient-Year by Clinical Subgroup and Dialysis Modality . . . . . . . . . . . . . . . . . . . . 57

6-9. Distribution of Total Cost of Care per Patient-Year by Clinical Subgroup and Dialysis Modality . . . . . . . 58

6-10. Mean Costs Per Patient-Year of a Single Change in the Modality of Dialysis Among Survivors . . . . . . . . 59

6-11. Mean Costs of Dying in Patients on a Single Dialysis Modality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

6-12. Predictors of Days of Hospitalization in Survivors on Continuous Dialysis by a Single Modality . . . . . . . 59

6-13. Estimated Total Costs per Patient-Year of Care by Modality of Dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

.,. Viii
Chapter 1

Introduction, Summary of

Findings, and Suggested

Future Directions
Chapter 1

Introduction, Summary of Findings, and

Suggested Future Directions

INTRODUCTION

Thirty years ago end-stage renal disease (ESRD)

was uniformly fatal. Today a variety of chronic

renal dialysis techniques and renal transplantation offer the opportunity for markedly improved

prognoses for afflicted individuals. Associated

with the use of these technologies, however, have

been formidable costs. Medicare’s ESRD program

was established in 1972 in recognition of the

devastating financial consequences of ESRD treatment for the patient and his or her family (37).

This program, which transferred the major financial burden from the individual to the taxpayer,

has grown rapidly. In 1983, its estimated enrollment reached 73,000, including 68,000 persons on

chronic dialysis and more than 5,000 who received

renal transplants. Growth rates in enrollment are

projected to be about 5 percent per year between

1980 and 1990.1

The historic standard chronic renal dialysis, the

most common treatment for ESRD, is hemodialysis (HD) performed in the hospital or in independent dialysis centers (center HD). Home

hemodialysis (home HD) has achieved only limited acceptance, in part because of the extensive

home support that is required and in part because

fiscal incentives have favored facility dialysis.

The advent of continuous ambulatory peritoneal dialysis (CAPD) in the late 1970s has dramatically changed treatment options available to

the patient with ESRD. Since it was approved for

reimbursement by Medicare in 1979, the use of

CAPD has increased rapidly, and, by 1983, an

estimated 8,000 patients, two-thirds of patients

on home dialysis, or 12 percent of the entire

chronic dialysis population were being treated by

this modality. Diffusion has resulted from a combination of strong professional endorsement, patient acceptance, and vigorous marketing efforts

by industrial producers of CAPD supplies and

equipment. Some projections suggest that up to

40 percent of the ESRD population maybe suitable candidates for CAPD.

Congress’ concern over the rising costs of the

ESRD program led the Health Care Financing Administration (HCFA) in 1982 to propose prospectively set reimbursement rates designed to control

these costs while providing incentives to increase

the use of CAPD and other home dialysis techniques. This case study was initiated in response

to controversy that surrounded the introduction

of these new reimbursements rates to obtain an

objective evaluation of the relative costs and medical effectiveness of the most commonly used techniques for renal chronic dialysis.

The request for this case study came from the

Senate Committee on Finance to the Director of

the Office of Technology Assessment in a letter

that expressed concern over the rapid expansion

in the use of CAPD despite the lack of conclusive evidence of its effectiveness in relation to

HD.

2 The attention of the Senate Finance Committee, in turn, was attracted by public debate

over regulations proposed by HCFA to establish

prospective reimbursement for dialysis services “to

encourage home dialysis and provide incentives

for economy and efficiency in furnishing these

services” (16). HCFA’s rationale (15) was:

Since home dialysis is a less expensive alternative to dialysis conducted in facilities, its

growth will help control the escalating cost of

the ESRD Program.

CAPD is the preferred treatment for many patients because it causes relatively little disruption

in the patient’s life.

‘These projections could be lower if preventive medical efforts,

such as widespread hypertension treatment, reduce the incidence

of ESRD or could be higher if more lenient patient selection criteria

are adopted in the face of expanded treatment options,

‘Letter from Senate Finance Committee to John H. Gibbons, Director, OTA, Apr. 26, 1982.

3
4

Because of the potential benefits to many patients, we would like to provide facilities and

physicians with incentives to serve patients who

are appropriate candidates for CAPD.

The new reimbursement rates that went into effect on August 1, 1983 do, in fact, appear to have

created significant financial incentives for home

SCOPE OF THE STUDY

This study:

● compares the medical effectiveness of HD

performed in dialysis centers and hospitals

with CAPD or HD performed at home;

● evaluates the costs of treatment by each of

these modalities; and

● identifies critical issues that require 

evaluation.

It does not, however, contain an actual

effectiveness analysis of CAPD relative to

further

costhome

dialysis. Significant questions have been raised,

however, over the equity of these rates and the

effects they may have on the quality of patient

care and on the overall expenditures of the Medicare ESRD program. The Federal Government,

medical community, and patients alike have important stakes in the answers to these questions.

and center HD. The data required to make the

results of such an analysis meaningful simply do

not exist. Furthermore, chronic renal dialysis is

not compared to renal transplantation. Most experts believe that evidence is overwhelming that

a transplant from a living related donor is the

preferred treatment when circumstances permit.

While the relative merits of cadaveric transplantation and chronic dialysis are more controversial,

no explicit comparison is made in order to avoid

the risk of diverting attention from the major polPhoto credit: Travenol Laboratories, Inc.

Chrissy Sass, age 11, receives CAPD.

icy issues that surround the chronic dialysis end

of the treatment spectrum for ESRD.

Photo credit: National Kidney Foundation

Young patient on chronic hemodialysis.

The major limitations of this study stem from

shortcomings of available information on the

effectiveness and costs of ESRD treatments. For

example, most clinical studies fail to control adequately for differences in patient characteristics
5

that may have important effects on the outcomes

of treatment. Hence, comparisons among dialysis modalities are tenuous. On the cost side, little

is known of the true resource costs of treatment,

and projections must be made from charge and

reimbursement data.

Moreover, moving targets are being assessed.

The technologies of CAPD and HD are evolving,

and today’s treatment results may be outdated

tomorrow. At the same time, the intricate interactions of technological factors, professional attitudes, and organizational relationships among

health care institutions and health care industries

are changing in a climate of altered financial incentives. This state of dynamic flux indicates the

critical need to monitor carefully changes in ESRD

treatment effectiveness and costs to better inform

future clinical and policy decisions.

ORGANIZATION OF THE CASE STUDY

In chapter 2, the dimensions of the ESRD problem are discussed, and in chapter 3 the major modalities of chronic dialysis treatment are described:

center HD, home HD, and CAPD. Then, in chapter 4, evidence on the effectiveness and safety of

each modality is examined, giving special emphasis to the important influences of the medical, sociodemographic, and psychological characteristics

of patients on treatment outcomes. In chapter 5,

the costs of treatment are estimated from cost audits performed by HCFA and the General Accounting Office (GAO); from average Medicare

ESRD reimbursements rates; and from actual expenditures of the Medicare ESRD program.

SUMMARY OF FINDINGS

Effectiveness of Alternative

Dialysis Modalities

Patient survival, morbidity from complications

of treatment and related medical problems, and

the quality of life experienced by patients on dialysis are all important measures of clinical effectiveness. The ability of a patient to continue on

a prescribed treatment also is important because

of the significant morbidity and costs associated

with the need to change dialysis modalities.

Table 1-1 compares the characteristics of dialysis by CAPD and HD, and table 1-2 presents

CAPD’s most frequently mentioned advantages

and disadvantages relative to HD. Arguments advanced in support of CAPD have focused on the

freedom it allows the patient in controlling his or

Finally, in chapter 6, Medicare ESRD data for

1981 and 1982 are examined in detail to determine

cost differences between patients who remain on

a single dialysis modality and survive compared

to those who change from one treatment modality to another (“the cost of changing”) and to those

w-ho die while on

dying”).

The remainder

major findings of

ture directions.

a single modality (“the cost of

of this chapter summarizes the

the case study and suggests fuher own treatment regimen and the continuous

nature of the dialysis it provides. In many ways,

CAPD’s continuous treatment more closely approximates normal renal function than intermittent HD sessions. Countering arguments in favor

of HD include its long-standing record of success,

the more efficient clearance of low molecular

weight toxins produced, and, in the case of center HD, the better medical supervision patients

receive as a result of regular visits to dialysis

centers.

These arguments, though germane, cannot be

accepted as prima facie evidence supporting the

superiority of one treatment modality or another

without systematic demonstration of related objective health benefits. Unfortunately, evidence

comparing the clinical effectiveness of the differ-
6

Table 1-1. –Comparison of Continuous Ambulatory Peritoneal Dialysis (CAPD)

and Hemodialysis (HD) as Currently Practiced

CAPD HD

Estimated ESRD program

beneficiaries in 1983 . . . . . . . . . . 8,000

Number of facilities

providing therapy . . . . . . . . . . . . . 600

Setting:

Facility . . . . . . . . . . . . . . . . . . . . . . 0

Home . . . . . . . . . . . . . . . . . . . . . . . 100 ”/0

Dialysis. . . . . . . . . . . . . . . . . . . . . . . . Continuous with three to five 2-liter

peritoneal exchanges per day. Each

exchange takes 30 minutes. Sterile

technique critical

Clearance of low molecular

weight blood solutes . . . . . . . . . . 70 liters per week

Clearance of higher molecular weight

solutes (actual values not known

because substances not identified chemically) . . . . . . . . . . . . . . More effective

Access for dialysis. . . . . . . . . . . . . . Catheter placement in abdomen

a minor surgical procedure

requires

Complications . . . . . . . . . . . . . . . . . . Peritonitis. Exit or tunnel infections.

Catheter obstruction. Hernias. Intestinal obstruction. Hydrothorax

60,000

1,190

920/o

80/0

Intermittent with an average of three sessions per week each lasting 3 to 6

hours. Patient’s circulation is connected to a dialysis machine

135 liters per week

Less effective

Creation of vascular arteriovenous fistula

between a superficial artery and vein

can be performed under local

anesthesia

Thrombosis of fistula. Sepsis related to

the fistula. Accidental hemorrhage

during dialysis. Vascular collapse following dialysis. Occasional failures of

dialysis equipment

SOURCE: Office of Technology Assessment,

ent dialysis modalities is incomplete at the present

time. All available information comes either from

small clinical series, dialysis registries, or the

Medicare ESRD data system. No controlled clinical trial has been performed to compare CAPD

and HD directly. In the absence of such a trial,

case-mix differences among populations studied,

differences in the expertise of providers, and

differences in definitions and data collection techniques obscure comparisons. Moreover, since experience with CAPD in substantial numbers of pa- ●

tients is limited to the past 2 or 3 years, long-term

effects cannot be evaluated. Conversely, most information on HD dates from the 1970s and does

not necessarily reflect current technology. ●

Despite the caveats, the following conclusions

appear justified:

●

●

One- and two-year survival rates on CAPD

and HD are comparable.

Annual hospitalization rates, as one measure of morbidity, are somewhat higher for ●

CAPD than HD. The higher rate for CAPD

appears primarily to reflect days of hospitalization required to train patients in the use

of the technique, to initiate dialysis, and to

treat episodes of peritonitis, Patients who are

successful in being able to continue on CAPD

experience about the same hospitalization

rates as do patients on HD. These findings

emphasize the “startup costs” of CAPD treatment and the importance of selecting patients

with the motivation and physical abilities required to perform repetitive sterile dialysate

exchanges over long periods of time.

Both survival and hospitalization rates are

better for patients on home HD than either

CAPD or center HD, but these differences

can be attributed to favorable case selection.

Peritonitis and infections around the peritoneal catheter are the most important complications of CAPD. The several technologies

that have been developed to facilitate sterile

dialysate exchanges have not yet been tested

sufficiently to determine whether their use

will actually reduce rates of peritonitis.

Thrombosis and infection of vascular access

sites, accidental hemorrhage, and vascular

collapse after dialysis sessions are the most

frequently mentioned complications of HD.
7

Table 1-2.—Advantages and Disadvantages of

CAPD Relative to HD

Advantages of CAPD:

●

●

●

●

●

●

●

●

CAPD is continuous and avoids the fluctuations of

fluid and body chemistries associated with

intermittent HD sessions. This is of particular

advantage in patients with cardiovascular disease

and hypertension.

CAPD allows patients flexibility in adapting dialysate

exchanges to their daily schedules.

CAPD avoids dependency on a dialysis machine.

CAPD avoids the problems of vascular access and

accidental hemorrhage that accompany HD.

CAPD provides more clearance of higher molecular

weight toxins.

CAPD permits improved blood sugar control in

diabetics through the intraperitoneal administration

of insulin.

CAPD may be accompanied by a greater sense of

well-being and improved appetite and permits a more

liberal dietary protein intake.

CAPD does not require the extensive family support

that home HD does.

Disadvantages of CAPD:

●

●

●

●

●

●

●

CAPD is-complicated by frequent episodes of

peritonitis in many patients.

CAPD provides less dialysis than HD in terms of the

elimination of low molecular weight toxins.

CAPD results in the loss of 8 or more grams of protein

per day in the dialysate that must be compensated for

by additional dietary intake.

CAPD may lead to obesity or increased serum

triglycerides and, hence, to the possibility

of accelerated atherogenesis.

CAPD may be complicated by infection around the

peritoneal catheter or by obstruction of the catheter.

CAPD requires faithful long-term compliance with

meticulous aseptic techniques.

CAPD patients may receive less rigorous medical

supervision than that provided by thrice-weekly

center HD sessions.

SOURCE” Off Ice of Technology Assessment.

The frequency of these complications, however, is not well documented in studies that

reflect current technology.

● Excluding deaths and patients who subsequently receive renal transplants, only 50 to

80 percent of patients who start on CAPD

are still on it at the end of 1 year. This relatively high failure rate is an important problem for CAPD and underscores the need to

establish carefully defined patient selection

criteria.

● Failure rates for HD could not be documented. To be meaningful, such results

would have to coincide with the period of

time that CAPD has been available as an

alternative form of treatment.

●

●

●

Documentation of quality of life differences

among patients on CAPD, home HD, and

center HD are sparse. Information from the

only study that directly addresses this issue

(the National Kidney Dialysis and Kidney

Transplantation Study) suggests that patients

on CAPD are less likely to be employed and

have greater functional impairment than patients on either home HD or center HD.

These differences are largely eliminated when

adjustments are made for case-mix variables,

however, and should not be construed to indicate a poorer quality of life attributable to

CAPD.

No systematic information could be found

that assesses the relative “burdens of treatment” of CAPD and HD. Critical determinants appear to be the relatively inflexible

treatment schedule and machine dependency

in the case of HD and the requirement for

long-term compliance with multiple daily dialysis exchanges in the case of CAPD. The

burden on the family may be considerable,

especially for home HD.

Patient characteristics that appear to be particularly important determinants of outcomes

on chronic renal dialysis are age, the cause

of ESRD, the presence of comorbid medical

conditions, and the time elapsed since the

diagnosis of ESRD.

Costs of Treatment for ESRD

Treatment for patients on chronic renal dialysis includes the dialysis treatments themselves,

physician services both for the supervision of dialysis and for the treatment of other medical problems, any required hospitalizations, and ancillary

services such as laboratory tests and medications.

In this case study, estimates of the costs of one

or more of these components of care are derived

from three separate sources: cost audits performed

by HCFA and the GAO, Medicare’s average reimbursement rates for dialysis, and information on

actual expenditures of the ESRD program. Each

of these sources has its limitations, and no one

source can be pointed to as providing the “best”

estimate. The distinction between the costs of dialysis projected from cost audit figures or aver-
— —

8

age reimbursement rates, and actual ESRD program expenditures are important ones. The former

assumes average treatment regimens and full compliance, while the latter refers only to services actually billed for and, hence, reflects variations in

treatment regimens among patients and patient

compliance failures.

Despite the vicissitudes of cost estimates, the

following conclusions seem warranted:

●

●

●

The cost of HD performed in hospital-based

dialysis centers is higher than that in independent centers. Whether this higher cost can

be justified by a “sicker case-mix” of patients

treated in hospitals, as hospitals claim, or is

due to higher overhead and failures to take

advantage of economies of scale cannot be

judged from existing information.

The results of HCFA’s and GAO’s cost audits do not justify the claim that home dialysis (CAPD or home HD) is less expensive

than HD in an independent center.

Analysis of 1981 and 1982 Medicare ESRD

expenditures provide estimates of the annual

cost of dialysis that are considerably lower

for each dialysis modality than those projected from the cost audits. The figure for

CAPD, in fact, is less than half that from the

cost audits and must be considered suspect.

Aberrances in billings for CAPD, factors related to CAPD’s status as a new technology,

CONCLUSIONS

Clinical Effectiveness

CAPD appears to bean acceptable alternative

to HD for, at least, selected persons with ESRD.

Survival rates on the two modalities appear similar, but somewhat higher overall morbidity occurs in patients on CAPD due to the frequent episodes of peritonitis that occur in some patients.

These conclusions must be considered tentative

in view of the relatively short-term experience

with CAPD and the case-mix differences among

populations from which results have been reported.

●

●

●

and failures of compliance all are possible explanations.

The cost of home dialysis (CAPD or home

HD) to the ESRD program may depend importantly on whether the patient purchases

supplies through a bulk purchaser such as a

dialysis center or directly from the supplier.

Alternative price lists for CAPD supplies and

equipment suggest that the cost of CAPD

could vary by as much as $6,000 per year.

The higher prices would seem likely to be applied to the individual purchaser unless Medicare were to negotiate a preferred customer

relationship.

Medicare’s ESRD expenditures for hospitalizations are similar in patients able to continue

on CAPD or center HD (about $3,000 per

patient-year) but are higher than those of patients who are stable on home HD ($2,400

per patient-year). Hospital costs double,

however, in patients who have to change

from one modality to another. These “costs

of changing” underscore the cost implications

of proper patient selection for a dialysis modality.

Reasonable estimates of the average annual

cost of treatment of a patient on chronic renal dialysis range from $20,000 to $30,000

(1982 dollars). Dialysis treatments themselves

account for at least 70 percent of this total.

Quality of Life

No conclusion is warranted that a patient’s

quality of life is better (or worse) on CAPD than

on HD. Each modality has its advantages and disadvantages. Individual preferences for one form

of therapy or the other undoubtedly vary widely

among patients and among families,

Costs of Treatment

Differences in the cost of treatment by CAPD,

by HD performed in independent dialysis centers,
9

and by home HD are sufficiently small that they

can be accounted for by the variations in methods used in the available cost estimates and by

case-mix differences. A conclusion that home dialysis (CAPD or home HD) is less expensive than

HD in an independent center appears unwarranted. Treatment by HD in hospital dialysis

centers, however, is more expensive than in other

settings.

Effects of Medicare’s 1983 Composite

Reimbursement Rates

These rates were designed to encourage home

dialysis by providing equal reimbursement for

home and center dialysis. They dramatically reduced reimbursement for HD in hospital dialysis

centers (from an averaged $159 to $131 per treatment) and in independent dialysis centers (from

$138 to $127 per treatment), and, simultaneously,

adjusted physician cavitation rates for dialysis supervision to provide incentives for home dialysis.

SUGGESTED FUTURE DIRECTIONS

Efforts to compare alternative dialysis modalities more conclusively and, ultimately, to contain the costs of the ESRD program without

compromising health benefits depend on the availability of better medical and cost information and

better definition of criteria for program eligibility.

Better Medical Information

The most critical need is for better information

by which to judge the relative effectiveness of dialysis modalities. Better information on survival,

medical morbidity, and quality of life parameters

all are needed.

Two approaches are possible. One would be

to create a dialysis registry that would enroll patients as they begin on any one of the three major chronic dialysis modalities. This registry could

be similar to the present National Institute of

Health (NIH) CAPD Registry, but would include

additional information on patients’ clinical characteristics, such as comorbidity and ESRD treatTheir impact on the balance between home dialysis (CAPD and home HD) and center HD can

only be speculated upon, however. The financial

disincentive provided for hospital-based HD is

strong, and suggests that hospitals may well find

it necessary to discontinue outpatient dialysis and

either transfer patients to independent dialysis

centers for HD or put them on CAPD or home

HD. Incentives for independent centers are less

clear. If the HCFA audit results accurately reflect

dialysis centers’ resource costs, centers may respond by attempting to increase the efficiency of

center HD, while at the same time reducing marginal costs by accepting transfers from hospital

units that close. Alternatively, they may increase

the use of home dialysis, especially if favorable

prices can be obtained from suppliers of CAPD

and home dialysis equipment and supplies. The

possibility that dialysis centers will see it to be

in their best interests to “assign” purchase of supplies, and hence bypass the new prospective payment rates, is a real one that will need to be carefully monitored.

ment history. Such data are essential to adjust for

case-mix and for achieving valid comparisons

among treatment modalities. The advantages of

this approach are that it would benefit from the

experience already gained in the NIH CAPD

Registry and would be relatively inexpensive.

A more scientifically rigorous approach would

be a randomized clinical trial (RCT) in which dialysis modalities were compared directly. Obstacles to such a trial involve its relatively high cost,

the risk that changes in technology might render

findings of the trial obsolete, and whether an RCT

is actually feasible. Since each major dialysis modality is well established and has its strong advocates, it is not certain whether randomization of

treatments would be acceptable or, if the study

was accepted, whether patient selection criteria

could be agreed upon that would permit enrollment of a sufficiently broad spectrum of the ESRD

population that the results would be widely generalizable. Despite these drawbacks, the feasibility

of a controlled clinical trial should be carefully

explored.

98-824 0 - 85 - 2 : QL 3
—. —.

10

Better Cost Information

Better cost information is needed both to evaluate HCFA’s 1983 reimbursement regulations and

to guide future policy decisions. Three issues seem

central.

The first is the need to better define the relationship between the resource costs of component

medical services (dialysis treatments, dialysis supplies and equipment, physician care, and days of

hospitalization) and reimbursement rates. Carefully conceived and executed cost audits are one

means to this end.

Second, better information is needed on actual

expenditures for the treatment of ESRD, including the dialysis treatments themselves, resulting

complications, and associated medical problems.

Costs of treatment to the ESRD program for each

patient depends both on the unit costs of component services and on their utilization. Refinement

of Medicare’s ESRD information system would

appear to be the most practical way to monitor

utilization and expenditures.

Third, a broader economic study should be undertaken to better understand the societal burden

of ESRD compared to the economic and health

benefits of treatment. This study would examine

social costs, such as lost wages and disability pensions, and opportunity costs, such as those of family support, in addition to medical care costs.

Eligibility for the ESRD Program

Finally, the fundamental question of who

should qualify for ESRD treatment needs attention. The cost implications of expanding enrollment in the ESRD program far exceed those of

the costs of treatment for any individual patient.

As the effectiveness, safety, and acceptability of

treatment technologies improve, there will be a

natural inclination among physicians and among

patients to apply them earlier and earlier in the

natural history of chronic renal failure and for

more and more marginal indications. This same

tendency has been observed in the case of other

medical technologies, such as coronary artery bypass surgery and total hip replacement. If cost

containment in the ESRD program is to be

achieved, the problem of defining medical criteria

for eligibility will have to be explicitly addressed.

A consensus conference that involves ethicists,

lawyers, and economists, as well as physicians,

would be a reasonable first step in this direction.
Chapter 2

End-Stage Renal Disease:

Scope and Trends
Chapter 2

End-Stage Renal Disease:

Scope and Trends

END-STAGE RENAL DISEASE DEFINED

The primary functions of the kidney are to remove waste products generated by the body’s

metabolism and to regulate the body’s balance of

fluid and electrolytes. Chronic renal failure refers

to the permanent deterioration of the kidney’s

ability to adequately perform these functions, and

uremia refers to the symptomatic phase of renal

failure. The toxic products that cause the symptoms of uremia have not been fully elucidated.

Candidates include small molecules such as urea

and creatinine that come from the breakdown of

proteins and so-called middle molecules (substances with molecular weights of around 5,000).

The exact nature of middle molecules remains obscure as does their importance.

Renal function is classically measured in terms

of the ability of the kidney to clear urea or creatinine from the blood. Clearance of a specific substance is defined as the volume of plasma containing

an amount of the substance equal to that removed

per unit of time into the urine or dialysate. For

example, if in 1 minute the urine excreted by the

kidneys contains 50 mg of urea (volume not considered), and if the concentration of urea in the

plasma were 50 mg per 100 ml, then the clearance

would be 100 ml/min. Normal clearance values

are 40 to 80 ml/min for urea and 80 to 125 ml/min

for creatinine. Values below 5 ml/min for creatinine are generally judged to be an absolute indication for dialysis treatment, though this criterion

is not universally accepted. The presence of symptoms of uremia, such as nausea or shortness of

breath, or deleterious physical findings, such as

mental stupor, pleural fluid, or bone disease, may

lead physicians to begin treatment at higher levels of residual renal function.

PREVALENCE OF END-STAGE RENAL DISEASE

The prevalence of end-stage renal disease

(ESRD) is usually equated to the number of patients receiving chronic renal dialysis rather than

to the number of people with any given level of

renal failure. In the United States, where access

to treatment has been made essentially universal

because of Medicare’s ESRD program, this assumption has some validity. Other countries,

however, have established restrictive criteria for

admission to chronic dialysis programs. In these

countries, including several in Western Europe,

dialysis rates substantially underestimate the true

prevalence of disease. Moreover, patients who

have undergone successful renal transplantation

are removed from the ESRD pool of patients by

this definition, even though they remain on immunosuppressive therapy and are susceptible to

substantial risks and infectious complications as

a result.

An estimated 70,000 persons in the United

States were receiving chronic dialysis at the end

of 1982, including 65,438 enrolled in the ESRD

program and an additional 4,000 to 5,000 persons

who are treated by the Veteran’s Administration

or by State programs. Patients diagnosed with

ESRD for the first time during 1982 numbered

slightly fewer than 23,000, and the net increase

in patients on chronic dialysis during 1982 was

6,212 after accounting for deaths, transplants, and

returns to chronic dialysis after rejection of transplanted kidneys (see table 2-1).

The size of the chronic dialysis population is

projected to increase by about 5 percent per year

13
14

Table 2-1.– Estimated Prevalence and Incidence of End-Stage Renal Disease in the United States, 1982

Prevalence:

Dialysis population on Jan. 1, 1982............58,948

Incidence:

Started on dialysis for first time ever:

Center dialysis. . . . . . . . . . . . . . . . . . . . . . ......20,098

Home dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,699

Restarted on dialysis:

Center dialysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . 493

Home dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Returned to dialysis after transplant:

Center dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,415

Home dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

24,906

Losses:

Deaths:

Center dialysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11,018

Home dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,484

Recovered kidney function:

Center dialysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . 744

Home dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Received transplant:

From center dialysis.. . . . . . . . . . . . . . . . . . . . . . 4,078

From home dialysis . . . . . . . . . . . . . . . . . . . . . . . 682

Discontinued dialysis (? reason):

Center dialysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . 559

Home dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

18,694

Prevalencem

Dialysis population on Dec. 31, 1982 . . . . . . . . . . . 65,160a

aDiffer~ from the 65,765 reported in the su~ey Surnrnary table for undefined reasons, perhaps related to Missing data for some categories

SOURCE: ESRD Medical Information System–Facillty Survey Tables (Jan. I-Dec. 31, 1982).

between 1980 and 1990 and, thereafter, decline the population, changes in the incidence of ESRD,

gradually to a growth rate of 1 percent per year changes in the mortality rates of individuals on

by 2020 (11). Many factors will affect these projec- chronic dialysis, and changes in the use rate and

tions, including changes in the age distribution of success of renal transplantation.

— — - —. MEDICARE’S END-STAGE RENAL

The ESRD program was authorized in the Social Security Amendments of 1972 (Public Law

92-603) and was implemented in 1973. The program recognized the availability of life-saving,

though imperfect, treatment for ESRD by hemodialysis and renal transplantation and the catastrophic financial consequences of these treatments for the afflicted individuals. For some

analysts, the ESRD program provided a limited

test of issues relevant to universal national health

insurance.

The program’s growth has been dramatic. In

1974, 16,000 persons were enrolled, and the cost

to U.S. taxpayers was about $250 million. By

1981, enrollees had grown to over 64,000 at a cost

of $1.6 billion. The annual growth rate was 42

percent between 1974 and 1975, 24 percent between 1977 and 1978, and 11 percent between

1980 and 1981 (11). This decreasing rate of growth

reflects primarily the success of the program in

enrolling the pool of patients with ESRD who previously had been untreated or were defraying the

cost of treatment in other ways.

DISEASE PROGRAM

About 93 percent of persons with ESRD are

eligible for benefits (9). Persons covered by the

armed services, or by certain State or private insurance programs are exceptions, while many veterans have dual entitlement to the Veteran’s

Administration health care system and Medicare’s

ESRD program,

The ESRD program covers not only the costs

of dialysis or renal transplantation but also provides the full spectrum of Medicare benefits

whether or not they directly relate to the care of

ESRD or its complications. In 1979, 55 percent

of ESRD program costs were estimated to be for

outpatient dialysis services, 29 percent for hospital care, 15 percent for physician services, and

1 percent for other miscellaneous items (12). Escalation in the total costs of the program reflects

primarily the increasing numbers of persons enrolled and the increasing costs of hospitalization

rather than increases in the costs of dialysis. Reimbursement rates for dialysis have, in fact, been

frozen since 1979.
15

CLINICAL CHARACTERISTICS AND OUTCOMES OF PERSONS

ENROLLED IN THE ESRD PROGRAM

New enrollees in 1980 were older, more likely

to be black, and more likely to have diabetic

nephropathy than enrollees in earlier years. The

proportion of the ESRD population having diabetic nephropathy, for example, increased from

7 percent in 1973 to 16 percent in 1977 and to 22

percent in 1980 (11). This trend toward increased

enrollment of diabetics in the United States stands

in contrast to other countries where diabetes, until

recently, has often been an indication for withholding therapy.

Survival of patients on chronic dialysis remained stable between 1977 and 1980, with

slightly over 80 percent of patients surviving 1

year and 54 to 57 percent surviving 3 years (11).

Survival varied considerably according to the age

of the patient, however, with l-year survival after the onset of renal failure during 1973-79 ranging from 88 percent in patients 24 years of age

or younger to 64 percent in those over 75 years

of age. Corresponding 5-year survival rates were

64 and 22 percent, respectively. These figures exclude renal transplant patients (11). Patients with

TRENDS IN THE USE OF CHRONIC

Dialysis can be provided either in centers located in hospitals or in independent facilities or

can be performed at home. Hemodialysis (HD)

and intermittent peritoneal dialysis (IPD) may be

performed either in centers or in the home, while

continuous ambulatory peritoneal dialysis (CAPD)

is solely a home technique. In 1980, 47 percent

of the chronic dialysis population received dialysis in hospital centers, 39 percent in independent centers, and 14 percent at home. Since that

time, the proportion of patients on home dialysis has increased steadily to 18 percent in 1982,

primarily as a result of the increased use of CAPD.

About 32 percent of home dialysis patients were

on CAPD at the end of 1980, 47 percent by the

end of 1981, and 56 percent at the end of 1982.

a primary diagnosis of glomerulonephritis fared

considerably better than those with a diagnosis

of diabetic nephropathy (5-year survival of 47 percent vs. 21 percent).

The survival rates between 1977 and 1980 were

stable despite trends toward enrolling persons who

were at higher risk of mortality by virtue of being

older and more likely to have diabetic nephropathy. Compensatory improvements in dialysis

technology or general medical management may

account for the stability of survival rates, but no

direct evidence on this point is available.

Persons enrolled in the ESRD program, excluding those receiving renal transplants, were hospitalized an average of 1.6 times during 1981 for

a total of 16,7 days (11). Hospitalization rates

were age dependent and ranged from an average

of 12.8 days in persons 25 years of age or younger to 20.3 days in persons 65 years or older.

ESRD program beneficiaries spent more than four

times as many days in the hospital than other

Medicare recipients (45).

DIALYSIS MODALITIES

More than two-thirds of all home dialysis patients

were estimated to be on CAPD by March 1983

(46).

Dialysis rates and the utilization of home dialysis techniques vary widely among the States (38).

In 1979, the number of patients dialyzed per million of population ranged from a low of 20 (Wyoming) to a high of 383 (Hawaii). Even among

States with populations of 3 million or more (a

population size chosen to minimize statistical fluctuations), the rate varied from 119 per million

(Kentucky) to 282 per million (New York). Use

of home dialysis at the same time varied from zero

(North Dakota, South Dakota, and Wyoming) to

over 40 percent (Indiana, Utah, and Washington).
16

Complex interactions of patient characteristics, Future increases in the use of home dialysis will

demographic factors, physician acceptance, and depend on these same factors and well may be

entrepreneurial motivations, no doubt, underlie influenced by the financial incentives created by

both variations in dialysis rates and variations in Medicare’s 1983 composite reimbursement rates

the popularity of home dialysis. that favor home dialysis.
Chapter 3

Physiology and Techniques

of Modalities for Chronic

Renal Dialysis
Chapter 3

Physiology and Techniques of Modalities

for Chronic Renal Dialysis

The purpose of this chapter is to acquaint the

nonmedical reader with the methods of dialysis

that have been developed to substitute for kidneys whose function has deteriorated below a

level that can support life. ’ Most attention is fo-

‘See Appendix B.—Glossary of Acronyms and Terms for definitions of selected medical terms.

HEMODIALYSIS

Principles and Physiology

HD depends on the concept of circulating a patient’s blood outside the body through a thinwalled synthetic tube or group of tubes (dialyzer),

which are bathed in aqueous solution (dialysate).

The semipermeable properties of the dialyzing

membrane permit the exchange of selected dissolved substances (solutes) between the dialysate

and the blood. Dialysis, crudely, may be likened

to the exchange that takes place through the screen

of a porch. The screen permits free passage of air

to and from, since air molecules are much smaller

than the screen’s mesh. Large insects are totally

unable to pass through the screen, but smaller insects or other airborne particles may be able to

penetrate with some difficulty or delay. With current HD technology, blood circulates through

thousands of hollow capillary fibers which are

bathed in a continuously flowing dialysate that

is discarded after a single passage past the fibers.

During HD, small molecules (e.g., urea and

creatinine) diffuse rapidly from the blood through

the membrane and into the dialysate. HD, therefore, is ideally suited to adjust the concentration

of these small molecules in the blood and in other

extracellular fluid compartments of the body that

are in free communication with the blood. Equilibrium occurs more slowly, however, with body

compartments that are more remote from the circulating blood, including intracellular fluid and

cerebrospinal fluid. Middle molecules diffuse

cused on hemodialysis (HD), the historical standard of medical treatment for renal failure, and

on continuous ambulatory peritoneal dialysis

(CAPD). Only brief mention is made of the less

widely used approaches (e.g., continuous cycling

peritoneal dialysis [CCPD] and intermittent peritoneal dialysis [IPD]).

through the dialyzing membrane more slowly,

and large molecules such as proteins (molecular

weight 50,000 and greater) are effectively blocked.

In clinical practice, the composition of the dialysate is adjusted carefully to minimize excessive

disturbances in the water and salt balance of the

body and, hence, to reduce the small but finite

risk of hypertensive crises, cardiac arrhythmias

or circulatory collapse. The volume of dialysate,

the surface area of the dialyzer, the rate of flow

of blood through the dialysis tubing, and the duration and frequency of dialysis sessions are

tailored to the needs of the individual patient.

Technique

The application of HD requires access to the

patient’s circulation. Originally, this was accomplished by inserting a cannula into a superficial

artery, which was then connected by external tubing to a cannula in an adjacent vein. These connections formed an arteriovenous connection, or

fistula. In recent years, the cannula and external

tubing have been replaced by a direct anatomosis between the artery and vein beneath the skin

which is accessed by large bore needles at the time

of dialysis. This latter technique has greatly

reduced the risk of infection. Most commonly, the

arteriovenous fistula is placed in the forearm, but

other sites are possible if occlusion of the fistula

or local infection requires its relocation.

19
— — —

20

HD requires two or three dialysis sessions per

week, each lasting 3 to 5 hours. During dialysis

the arteriovenous fistula is connected to the dialyzer, and dialysis solution is circulated past the

dialyzer at an average rate of about 500 ml/min.

The patient usually is given an anticoagulant,

heparin, to prevent the blood from clotting as it

circulates through the dialyzer.

HD may be administered in a hospital, in an

independent dialysis center, or at home. The first

two options are collectively referred center H D

or facility HD. Alternatively, the patient may purchase or lease the dialysis equipment and receive

dialysis treatments at home with the aid of family, friends, or salaried assistants. This is known

as home HD.

CONTINUOUS AMBULATORY PERITONEAL DIALYSIS

Principles and Physiology

Like HD, CAPD is based on the principles of

diffusion of fluids and solutes across a semipermeable membrane. In the case of CAPD, however,

the dialyzing membrane is the membrane lining

the abdominal cavity (peritoneum). Instead of the

patient’s blood being circulated outside the body,

the normal capillary circulation that supplies the

peritoneum is used. During each exchange, up to

2 liters of dialysate is introduced into the peritoneal cavity through a catheter that penetrates

the abdominal wall and is left for 4 to 8 hours

before being removed through the same catheter

by gravity drainage.

The composition of the dialysate is adjusted so

that the transfer of fluid and solutes favors normalization of the patient’s fluid and electrolyte

balance. The transfer of water across the peritoneum is controlled by the concentration of glucose in the dialysate. Higher concentrations of glucose favor the transfer of water into the peritoneal

cavity. Thus, if a patient is overhydrated, excess

water can be removed. This feature of CAPD can

be particularly advantageous in the patient with

hypertension or edema. In some diabetics, insulin may be introduced into the dialysate, thereby

obviating the need for daily insulin injections.

The small volume of dialysate used in CAPD

results in a rapid decrease in the concentration gradient during an exchange. Since a high gradient

favors the diffusion of low molecular weight solutes from the patient to the dialysate, transfer

will be rapid initially but will then decrease to the

point that relatively little net transfer takes place

towards the end of a period. CAPD, therefore,

is less efficient than HD in eliminating low molecular weight solutes. The “middle” molecules mentioned previously are removed more effectively,

however, because the effective pore size of the

peritoneum is larger than that of the HD dialyzing membrane.

In contrast to the intermittent nature of HD,

the multiple daily exchanges of CAPD result in

essentially continuous dialysis. There are several

consequences. Fluctuations in concentrations of

solutes are relatively small during CAPD, and

rapid changes of fluid volume are avoided. Furthermore, the equilibrium between body fluid

compartments (blood, extracellular fluid, intracellular fluid, and cerebrospinal fluid) is disturbed

less than with HD. The clinical significance of this

latter phenomenon is not completely known but

is at least a theoretical advantage of CAPD.

Although changes in the filtration characteristics of the peritoneal membrane might be expected

to occur during the long-term use of CAPD, observations over intervals of months to several

years have not consistently demonstrated measurable effects.

Technique

Analogous to the need for vascular access in

HD, CAPD requires that a catheter be placed in

the peritoneal cavity to permit exchanges of dialysate. The original technique to insert the catheter (a Tenckhoff® catheter with multiple terminal perforations or some modification) required

a hospital admission and a “mini’’-laparotomy.

A more recent technique permits the catheter to

be placed percutaneously through a stylus, thus

avoiding the need for a laparotomy and hospitalization.
21

The catheter is placed in a dependent position

in the peritoneal cavity in a manner that minimizes the likelihood of catheter obstruction and

the risk of erosion into other abdominal organs.

It is then led out obliquely through a subcutaneous track to decrease the risk of subsequent infection. There are several types of devices that

place flanges and spongy materials around the

catheter to reduce the likelihood of fluid leaks

from the peritoneal cavity and to impede the

migration of bacteria.

When CAPD is first begun in a patient, an automated cycling machine is often used to facilitate

exchanges. Thereafter, exchanges are performed

by gravity feed. The volume of fluid exchanged

depends on the size and tolerance of the patient

and ranges from 500 cc in children to 3,000 cc,

with an average for adults being between 1,500

and 2,000 cc. Four or five exchanges are performed daily, including one exchange in which

the dialysate remains in the abdomen overnight.

The exchange procedure takes 30 to 45 minutes

and requires a moderate amount of physical dexterity. Meticulous, sterile techniques must be followed while connecting the dialysate bag to the

peritoneal catheter (a process called “spiking”) to

prevent infection of the peritoneal cavity (peritonitis). The long-term compliance required with

these exacting procedures may be extremely difficult for some patients.

Recent technical advances in CAPD have centered on reducing the risk of peritonitis. Several

approaches have been proposed, including:

● Sterile Connection Device (SCD)® (Dupont

Co.): This device eliminates the need to

manually “spike” the dialysate bags to connect them to the peritoneal catheter tubing

by performing a sterile “heat-weld” between

●

●

the tubes of the dialysate bag and that of the

catheter.

Peridex CAPD Filter Set® (Millipore Co.): A

filter is placed in the line conveying dialysate to the peritoneum to remove bacteria or

fungi that may have contaminated the system during “spiking. ” Each filter is designed

for 2 weeks of use.

CAPD UV Germicidal System® (Travenol

Laboratories, Inc.): Ultraviolet light is used

to sterilize the connection between the dialysate bag and the catheter or its extension.

This system improves sterile technique but

does not eliminate the need for the manual

“spiking” procedure.

Although each of these approaches has promise, none has yet been shown to actually reduce

peritonitis rates in properly controlled studies.

Two other relatively infrequently used techniques for peritoneal dialysis deserve mention:

●

●

Intermittent Peritoneal Dialysis (IPD): This

technique is similar in principle to CAPD but

involves intermittent dialysis sessions of up

to 10 hours each 3 or 4 days a week during

which dialysate exchanges are cycled at rates

of about 2 liters per hour. Schedules are

highly individualized to the needs of the individual patient.

Continuous Cycling Peritoneal Dialysis

(CCPD): CCPD is very similar to CAPD but

employs a machine that permits continuous

dialysate exchanges to be performed automatically during sleep. Dialysate volumes of

10 liters or more are cycled, but not more

than 2 liters are in the abdominal cavity at

any one time. This technique obviates the inconvenience of multiple daily exchanges and

may reduce the risk of peritonitis.

COMPARATIVE EFFICIENCY OF DIALYSIS BY HEMODIALYSIS

AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS

Table 3-1 provides comparisons between the urea clearance (L/week). The results are from a

efficiency of dialysis by HD, CAPD, and IPD as single study (29) and are based on the dialysis remeasured by urea clearance (ml/min) and weekly quirements of a 70 kg individual with a urea gen-
22

Table 3-1.-Strategies for Solute Removal With Hemo- or Peritoneal Dialysis to Maintain Average

BUN = 80 mg/dla

Urea clearance Urea

during treatment Treatment clearance

Method of dialysis (ml/min) (hr/wk) (L/wk)

Hemodialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150 15 135

Intermittent peritoneal dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 64 85

Continuous cycling or continuous 35 40 85

ambulatory peritoneal dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 168 70

%UN (Blood Urea Nitrogen). The eource from which this table was taken does not make the distinction between a time averaged BUN and predialysis BUN for patients

receiving hemodialyeie. Lowrie indicates that a pradialysis BUN of 60 mgldl is equivalent to an average BUN of 50-60 mg/dl in patients being treated with hemodialysis.

SOURCE: A. S. Levy and J. T. Barrington, “Continuous Peritoneal Dialysis for Chronic Renal Failure,” Medklne 61:330-339, 1962.

eration rate of 5.7 mg/min and no residual renal

function. Other studies provide similar, though

not identical, findings.

HD is the more efficient method of dialysis.

Urea clearance per unit of time by HD is twice

that of two normal kidneys and more than 2 0

times that with CAPD. Because dialysis treatment

time with CAPD (168 hours per week) is much

longer than that with HD (9 to 15 hours per

week), the weekly urea clearance by CAPD is

slightly over half that provided by HD (70 vs. 135

L/wk).

Controversy is brisk over whether the amount

of dialysis provided by CAPD is clinically adequate, since it is less than that provided by HD

as measured by urea clearance (30). This controversy, in large part, is related to uncertainty

over the nature of the toxic substances responsible for the signs and symptoms of the uremic state.

Nephrologists who believe that urea clearance

serves as an appropriate marker for the removal

of other toxic substances point to the greater efficiency of HD, while other nephrologists who believe that “middle molecules” are important emphasize the greater ability of CAPD to remove

these substances and downplay implications of

differences in urea clearances. As of this writing,

this controversy is unresolved.
Chapter 4

Clinical Effectiveness of

Continuous Ambulatory Peritoneal

Dialysis and Hemodialysis
Chapter 4

Clinical Effectiveness of

Continuous Ambulatory Peritoneal

Dialysis and Hemodialysis

Comparison of the effectiveness of chronic dialysis modalities requires information from controlled trials that involve patients with similar

clinical characteristics. To date no such trials have

been performed. In their absence, this case study

takes information from reported clinical observations to draw qualitative conclusions on the

relative effectiveness of continuous ambulatory

peritoneal dialysis (CAPD), home hemodialysis

(HD), and center HD. Further, the influence of

case-mix differences on clinical outcomes is assessed from those few studies that have retrospectively examined the influence of patient

characteristics on medical outcomes.

Patient survival is undeniably the central measure of treatment effectiveness in end-stage renal

disease (ESRD). Chronic dialysis techniques (and

PATlENT SURVIVAL

Tables 4-1, 4-2, and 4-3 present survival data

for patients receiving CAPD or HD. Where possible, the differences between center HD and home

HD are distinguished. All results are unadjusted

for differences in the duration of ESRD, age, or

other risk factors. Furthermore, these results do

not account for the effects of varying actuarial

methods. Overall, l-year survival on CAPD

ranges from 74 percent in the Registry of the European Dialysis and Transplant Association

(EDTA) (28) to 86 percent in the most recent

results from the National Institutes of Health

(NIH) CAPD Registry (46) (table 4-l). Single institution studies give higher figures, perhaps due to

special local expertise or patient selection factors.

Two-year survival on CAPD in the EDTA regisrenal transplantation) have markedly enhanced

survival in patients with ESRD. Survival alone

is an inadequate yardstick, however, and factors

that relate to quality of life on dialysis also need

to be considered. To this end, the following factors are examined in addition to survival: the ability of the patient to tolerate and remain on a

dialysis modality (referred to as “procedure survival”), morbidity as measured by complication

rates and the need for hospitalization, and proxies for the “quality of life” such as physical activity levels and ability to return to work. The

“burden of treatment” as perceived by the patient

and his or her family is also important, especially for a chronic illness such as ESRD. Information on this point is extremely limited, however.

try is 60 percent, while 2 year data had not been

reported by the NIH CAPD Registry by 1983.

Survival estimates for HD are from ESRD program enrollees (27), the Michigan Kidney Registry (50), and the EDTA Registry (51) (table 4-2).

In the ESRD program, survival on chronic dialysis was reported as 81 percent at 1 year and 56

percent at 3 years, but this report did not break

results down by dialysis modality. It can be assumed that, in the period 1977-80 to which the

results apply, the overwhelmingly dominant modality was HD and that the ratio of center HD

to home HD was about 9 to 1. The Michigan Kidney Registry survival rates of 78 percent at 1 year

and 61 percent at 2 years are for center HD alone,

25

98-824 0 - 85 - 3 : (JL 3
- . . . .- . - . . . . - - . . - - . . . .

Table 4-1.— Patient Survival and the Ability of Patients to Continue CAPD

Patient survival Continued on CAPDb

Sourcea and population Calendar year(s) Number of patients Patient-years 0.5 yr 1 yr 2 yr 0.5 yr 1 yr 2 yr

Nolph, et al., 1983 (NIH CAPD Registry). . 1981 567 320 930/0 900/0 — 79%0

NIH CAPD Registry, 1982 . . . . . . . . . . . . . . 1981-82 4,858 — 93 86 – 76

88

Kramer, et al., 1982 (EDTA Registry) . . . . . 1979-81 2,905 — 80 74 60 53

62

Oliver, 1983 (Churchill Hospital, Oxford) . 1978-82 126 124 91 86 80 72

Rubin, 1983 . . . . . . . . . . . . . . . . . . . . . . . . . . 1979-81 56 80

Amair, 1982d . . . . . . . . . . . . . . . . . . . . . . . . .

— — —

1978-81 20 24

Baum, 1983e . . . . . . . . . . . . . . . . . . . . . . . . .

—

1979-82 20 — 95 95 95 78

600/0

62

82

41

53

57

50

87

78

—

56 (18 mo)

76 (18 mo)c

28

46C

38

35

76

53

aFull citations found in the References.

bRefem t. the ~rcent of the initi~ Cohofi who remain on CApD. Hence, the denominator includes deaths and patients undergoing transplantation, as well aS PatiefltS who change from one dialysis modalitY to another.

Cpercent of patients still on Chronic dialysis who remain in @pD, Excludes deaths and transplants.

dAll patients were diabetics.

epatients were children with a mean age of 11.9 years, The mean period of obsemation was 0.95 yt3WS.

SOURCE: Office of Technology Assessment

I
— . .

27

Table 4-2.—Patient Survival on HD

Sourcea and Calendar Dialysis Number Survival

population years modality of patients 1 yr 2 yr 3 yr Comment

Krakauer, et al., 1983. . 1977-80 Predominantly

HD 65,270 81 0/0 — 56°/0 ESRD program enrollees beginning dialysis in 1977-80. Results

overestimate survival in ESRD,

because they exclude deaths

during the 3-month period following diagnosis before the patient becomes eligible for

enrollment in the ESRD program. The vast majority (98+ 0

/0)

of patients would have been on

home or center HD in these

years in an approximate ratio of

10:90

Weller, et al., 1982 1974-78 Center HD only 1,560 70.80/o 53,20/o — Actuarial survival curves were

(Michigan Kidney All center HD 2,396 78.1 61.2 calculated separately for paRegistry) . . . . . . . . . . tients on center HD only and all

patients on center HD including

those subsequently transplanted or changed to another

dialysis modality

aFull citations found in the References.

SOURCE’ Office of Technology Assessment

Table 4.3.—Comparisons of Patient Survival on CAPD and HD

Sourcea and Calendar Dialysis Number Survival

population years modality of patients 1 yr Comments

Wing, et al., 1983

(EDTA Registry) . . . . 1979-81 HD – 840/o Results apply to a low-risk “standard population”

CAPD – 78 ages 20 to 60. Reference does not specify whether

HD was in the home or in a center

Bovbjerg, et al., 1983

(ESRD program) . . . . 1981 Home HD 109 91 ESRD program enrollees who began dialysis beCenter HD 2,929 86 tween 1/1/81 and 3/31/81. The reference does not

CAPD 174 87 state whether survival rates are annualized or

merely refer to survival in calendar year 1981 folIowing enrollment

aFull citations found in the References.

SOURCE’ Office of Technology Assessment.

and the EDTA Registry reported an 84 percent

1-year survival on HD in a low-risk “standard

population.”

First-year survival after the 3-month preenrollment period required by the ESRD program is

greater in patients on home HD (91 percent) than

for those on CAPD or center HD (87 and 86 percent, respectively) (8) (table 4-3). The better result

in the home HD group is consistent with other

reports and has been attributed to the selection

of younger and healthier patients for home HD.

On balance, these results suggest that early survival on CAPD is equivalent to that on HD. This

conclusion must be considered tentative, however,

because studies of HD generally apply to earlier

time periods, and because none of these studies

takes into account the characteristics of the populations being dialyzed.
..—

28

ABILITY TO CONTINUE ON A DIALYSIS MODALITY

The ability of a patient to remain on a dialysis

modality over a prolonged period of time is important both because failures usually reflect

treatment-related morbidity and because the cost

of treating complications or changing modalities

may be considerable.

For this study, systematic information on abandonment rates for HD was unobtainable. For example, no recent reports from sizable patient populations or registries could be found that described

the frequency of transfer from HD to peritoneal

dialysis or to cadaveric renal transplantation because of vascular access or other complications

of dialysis. That failure rates of HD may be appreciable, however, can be inferred from the NIH

CAPD Registry results that indicate that, among

patients beginning CAPD between January 1,

1981, and March 31, 1982, 48.3 percent had previously received HD (table 4-4). Presumably,

these patients either had vascular access problems,

or for some other reason, preferred to change to

CAPD.

Abandonment rates of patients on CAPD, on

the other hand, have been well documented (table 4-1), and in fact, constitute the main argument

against its proliferation. Patients still on CAPD

after 1 year range from 41 percent in the European experience (28) to 62 percent in the 1983 report from the NIH CAPD Registry (46). The corresponding 2-year rate is 28 percent in Europe,

and the 18-month rate is 56 percent in this country (28).

Calculation of abandonment rates depends importantly on whether elective transfers, deaths not

Table 4-4.—Prior Treatment Modalities in Patients

Entering the NIH CAPD Registry

Number of

Prior treatment patients Percent

Hemodialysis . . . . . . . . . . . . . . . . . . . . 1,225 48.30/o

None . . . . . . . . . . . . . . . . . . . . . . . . . . . 749 29.5

Intermittent peritoneal dialysis . . . . . 483 19.0

Transplant . . . . . . . . . . . . . . . . . . . . . . . 61 2.4

Continuous cycling peritoneal dialysis 20 0.8

Totals . . . . . . . . . . . . . . . . . . . . . . . . . 2,538 100.0%

SOURCE: U.S. Department of Health and Human Services, National Institutes

of Health, “CAPD Patient Registry Patient Population Demographics

and Selected Outcome Measures, ” Report No. 82-83, July 1, 1983.

directly related to procedure complications, transplanted patients, and patients who spontaneously

recover renal function are counted in the population at risk. Hence, results must be examined

closely. The above figures include in the denominator all patients starting on CAPD regardless of

the reason for departure. Therefore, they significantly overestimate departures for reasons of

procedure-related morbidity alone. When deaths

and transplanted patients are removed, 1-year

continuation rates for CAPD become 53 and 82

percent for the European and U.S. experiences,

respectively.

Excessive peritonitis or noncompliance was the

reason given for discontinuing CAPD in 27 percent of patients in the NIH CAPD Registry, and

peritonitis alone was the reason in 50 percent of

those in EDTA (see table 4-5). Inability to control “fluid/chemistry” or inadequate dialysis was

the reason given for 12 and 10 percent of patients

in these two registries, respectively.

Table 4-5.—Reasons for Leaving CAPD Other Than

Transplantation or Return of Renal Function

Number

Reason of patients Percent

NIH CAPD Registry:a

Medical (not lack of fluid or

chemical control) . . . . . . . . . . . . . . 257

Noncompliance or excessive

peritonitis. . . . . . . . . . . . . . . . . . . . . 176

Patient or family choice . . . . . . . . . . 101

CAPD not able to control

fluid/chemistry. . . . . . . . . . . . . . . . . 80

Other. . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Socioeconomic . . . . . . . . . . . . . . . . . . 8

39%0

27

16

12

5

1

Totals . . . . . . . . . . . . . . . . . . . . . . . . 652 100%

European Dialysis and Transplant Association (EDTA):b

Peritonitis. . . . . . . . . . . . . . . . . . . . . . . 153 50%

Other abdominal . . . . . . . . . . . . . . . . . 43 14

Inadequate dialysis. . . . . . . . . . . . . . . 31 10

Inability to cope . . . . . . . . . . . . . . . . . 28 9

Other. . . . . . . . . . . . . . . . . . . . . . . . . . . 28 9

Patient’s request. . . . . . . . . . . . . . . . . 22 7

Family’s request . . . . . . . . . . . . . . . . . 3 1

Totals . . . . . . . . . . . . . . . . . . . . . . . . 308 100%0

au,s, Department of Health and Human Services, National Institutes of Health,

“CAPD Patient Registry Patient Population Demographics and Selected Outcome Measures,” Report No. 82-83, July 1, 1983.

bp. Kramer, M. Broyer, F. P, Brunner, et al., “Combined Report on Regular DWsis and Transplantation in Europe, X11, 1981 ,“ presented at the XIXth Congress

of the European Dialysis and Transplantation Association, Madrid, Spain, September 1982.
29

Better information on failures of HD will be re- dressed through a combination of better patient

quired to permit valid comparisons with CAPD. selection, better patient training, and improved

Nonetheless, the high failure rates on CAPD give sterile techniques.

rise to justifiable concern that needs to be adPATIENT MORBIDITY

Hospitalization Rates

Comparison of hospitalization rates indicates

that patients receiving CAPD are hospitalized

about 20 days per patient-year (range 19.7 to 23.2

days); those on center HD about the same or

somewhat less (19.3 and 13.4 days in two studies);

and patients on home HD about 9 days per

patient-year (tables 4-6 and 4-7). About half of

hospital stays in patients on CAPD were for complications of treatment, especially peritonitis, and

the rest were for a variety of medical problems

(33,51). No population-based data comparable to

those in the NIH CAPD Registry are available for

HD in the United States.

Although they are useful benchmarks, these

crude hospitalization rates provide only a tentative basis for comparing morbidity among dialysis modalities. Most important, they do not

account for differences among the treated populations that may influence the need for hospitaliTable 4-6.—Hospitaiization Rates by Dialysis Modality

Number of Days of hospitalization per patient-year

Sourcea and population Calendar year patient-years Center HD Home HD CAPD Home IPD

Blagg and Wahl, 1983b

430

(Northwest Kidney Center) . . 1982 19.3 9.2 19.7 26.3

Evans, 1983 (National Kidney

Dialysis and Kidney

Transplantation Study). . . . . . 1981 859 13.4 8.2 20.6 —

aFull citations found in the References.

bupdated hoS~itali~ation rates areas follows: CApD—I&2 days/pt.yr; center HD—9,1 days/pt-yr; home HD—9.1 dayslpt-yr; and lpD—28.l dayslpt-yr. (C. Blagg, Personal

communication, 1983).

SOURCE: Office of Technology Assessment.

Table 4-7.—Hospitalization and Complication Rates in Patients on CAPD

Hospitalizations per Complications per patient-year

Calendar patient-year Exit or tunnel Catheter

Sourcea and population year(s) Number Admissions Days Peritonitis infections replacement

Nolph, 1983, (NIH CAPD

Registry) . . . . . . . . . . . . . . . . . . 1981 567 2.5 25.9 2.0 0.7 0.4

NIH CAPD Registry, 1982 . . . . . 1981-82 4,858 23.2 1.8 0.7 0.3

Kramer, 1982 . . . . . . . . . . . . . . . . 1981 895 ~ – 41.80/o — —

49.7

4-6 7.0

> 6 1.5

Wing, et al., 1983b (EDTA) . . . . . 1981 1,504 — 20 Males 1.4 — —

Females 1.6

Oliver, 1983 (Churchill Hospital,

Oxford). . . . . . . . . . . . . . . . . . . . 1981-82 126 — — 1.6 — —

Amair, et al., 1982C . . . . . . . . . . . 1978-81 20 – – 0.6 — —

aFull citations found in the References.

bFlgures are for a ,,standard population,, that includes only patients PO to C(I years of age, without diabetes, malignancy, or other severe systemic illnOSS, Or a primary

diagnosis of ESRD having systemic disease implications (e.g., collagen disease).

CAII patients were diabetics.

SOURCE: Office of Technology Assessment.
30

zation. The shorter periods of hospitalization experienced by patients on home HD, in particular,

have been attributed to favorable patient selection factors. Age is one such factor, and the existence of comorbid conditions is another.

Furthermore, interpretation of hospitalization

rates requires consideration of the length of time

patients have been on a dialysis modality. For example, annualized hospitalization rates are considerably higher during the first 3 months of

CAPD than in subsequent months. These higher

rates reflect the hospital days required to initiate

dialysis, the fact that patients starting out on dialysis are usually ill and require time to stabilize

prior to discharge, and the days for treatment of

complications that occur early in the course of dialysis. The same considerations apply to HD. A

comparison of annualized days of hospitalization

between two groups of patients which differ only

in the proportion of patients beginning on dialysis would indicate a deceptive differential.

Finally, interpretation of reported hospitalization rates is complicated by methodological problems, including differences in the criteria used for

including a patient in the study and differences

in the method for dating the onset of dialysis. For

example, a criterion that requires a patient to be

on a dialysis modality for 30 days to qualify for

entry into a study will result in a different casemix from one that counts all patients started on

a dialysis modality regardless of the duration of

treatment.

Complications of Dialysis

Many patients on chronic renal dialysis have

underlying medical problems such as hypertension, diabetes, and cardiovascular disease. Some

treatment complications, therefore, may be more

accurately regarded as part of a preexisting disease process than as a consequence of the treatment itself. Patients with ESRD due to diabetic

nephropathy, for example, are at a higher than

normal risk of developing cerebrovascular disease

and suffering strokes. A high incidence of such

a complication should be attributed at least in part

to the diabetic disease process rather than to the

specific technique of dialysis. Treatment complications, as other health outcomes, therefore, must

be examined in the context of the population

treated.

Complications of Hemodialysis

Complications of HD can be broadly classified

into those occurring during dialysis, complications

related to vascular access, and late complications

seen in chronically treated patients. Although all

are well known to occur, systematic data describing their frequencies could not be found for this

case study.

The intermittent nature of HD and its efficiency

as a method of dialysis can cause fluctuations in

vascular-volume and serum chemistries that may

lead to hypotension or cardiac arrhythmias or

make hypertension more difficult to control.

Associated shifts in central nervous system fluid

balance have been alleged to contribute to some

of the neurological symptoms that have been observed.

Extracorporeal circulation of the patient’s blood

through the dialyzer traumatizes and causes some

destruction of red blood cells. Although’ usually

not serious, this red cell destruction, coupled with

the loss of residual blood left in the dialyzer, blood

loss due to numerous laboratory tests, and occasional blood leakage through the dialysis membrane, may aggravate the anemic state in ESRD.

Blood transfusions occasionally are needed, and

they increase the risk of serum hepatitis.

Patients are usually given the drug heparin during center HD to prevent coagulation of blood as

it circulates extracorporeally. Careful medical supervision is required to restore normal coagulation as the blood returns to the body to minimize

the risk of internal hemorrhage. This appears to

be particularly important in diabetic patients who

may be prone to ocular hemorrhages when repeatedly given anticoagulant drugs. Patients on

home HD rarely receive heparin, because of the

meticulous monitoring that is required.

There have been several deaths reported to have

resulted from failures of the temperature regulating devices in the dialysis equipment. Clearly,

equipment failures represent another potential

complication of HD.
31

Vascular access is an absolute requirement of

HD. The subcutaneous arteriovenous fistulae that

are created for this purpose are subject to thrombosis and, rarely, to septic complications from

repeated needle punctures. Replacement or transfer of the fistula to another site maybe required,

and eventual depletion of convenient anatomical

sites may necessitate change to another dialysis

modality or renal transplantation. Access difficulties are only rarely encountered in young adults

but are more likely in older patients with arteriosclerotic vessels and in diabetics. Children are

also at higher risk of this complication because

of the smaller sizes of their blood vessels.

The development of cardiovascular morbidity

including myocardial infarctions, cerebrovascular accidents, and advanced peripheral vascular

disease in patients on HD may result from the

progression of preexisting disease, but at least circumstantial evidence suggests that the pace of

these disorders may be accelerated by HD. Similarly, some reports attribute the occurrence of dementia to the presence of excessive amounts of

aluminum in the dialysate. The possible importance of aluminum in antacid preparations taken

by patients with ESRD also needs to be further

evaluated.

Finally, the patient’s dependence on a machine

and reliance on the services of others when on

HD, together with his/her awareness of social,

parental, and conjugal inadequacies have been implicated as causes of severe depression and occasional suicides reported in patients on chronic HD.

Complications of CAPD

Peritonitis, or infection of the abdominal cavity, is far and away the most important complication of CAPD. The average patient in the NIH

CAPD Registry suffered 1.8 episodes of peritonitis per patient-year (table 4-7), even though onethird of patients had no episodes during their first

year of treatment (46). Peritonitis led to an average of slightly more than 10 days of hospitalization per patient-year and to occasional deaths. If

detected and treated early, in some cases, peritonitis may be treated at home and cause minimal

morbidity.

Peritonitis often results from a failure of the patient to adhere strictly to sterile procedures in effecting dialysate exchanges. Inadequate understanding of what is required, impaired manual

dexterity, poor vision, and poor or inconsistent

motivation all may be contributing factors.

A variety of approaches have been tried to improve CAPD techniques and to reduce the risk

of peritonitis (10,21,35,44). To date, there is no

evidence that the rates of the disease have been

materially affected.

Reported peritonitis rates must be interpreted

with caution because of widely varying definitions

of what constitutes an episode. The presence of

symptoms and signs such as fever and abdominal pain, cloudy dialysate effluent, a white cell

count greater than 100 per cubic millimeter in the

effluent, or a positive culture for bacteria, fungi,

or other infectious agents all have been used individually or collectively. Causative organisms include a wide variety of bacteria and fungi (3,25,

36,41,46).

A second complication of CAPD has been infection of the subcutaneous tunnel in which the

peritoneal catheter lies. Treatment with antibiotics

or replacement of the catheter may be required.

The NIH CAPD Registry indicates that these “exit

or tunnel infections” occur an average of 0.7 times

per patient-year (table 4-7).

Leakage of fluid around peritoneal catheter, obstruction to flow of dialysate in or out of the abdomen due to adherent organs or fibrous adhesions, inadequate circulation of the dialysate

throughout the peritoneal cavity, adhesions, deep

pelvic pain, intestinal obstruction, and perforation of neighboring abdominal viscera are additional reported complications of CAPD (23,40).

For one reason or another, catheter replacement

is required 0.3 to 0.4 times per patient-year (table 4-7).

In some patients, the peritoneum may undergo

chronic changes during CAPD that reduces its effectiveness as a dialyzing membrane (48). These

changes are incompletely understood at the present time, but many cases have been reported in

which dialysis efficiency decreased over a period
32

of months (19). Moreover, during acute peritonitis, changes in the vascularity and dialyzing

characteristics of the peritoneum may require alteration in the dialysis regimen or temporary discontinuation of CAPD. Usually this is required

only if the infection is severe or resistant to antibiotic treatment.

Several metabolic effects of CAPD require mention even though they do not necessarily constitute complications. CAPD results in the loss of

8 to 10 grams of protein per day into the dialysate, more than half of which is albumin (6,7,

18,26). Hence, protein depletion can become a

clinically important problem unless dietary intake

compensates for this loss. Daily diets of 1.2 to 1.5

grams of protein per kilogram of body weight

have been recommended (18) and generally can

be achieved. A second metabolic effect of CAPD

is weight gain due to absorption of glucose from

the dialysate. This high carbohydrate intake also

may induce elevation of serum triglycerides in

susceptible patients, and potentially, accelerate

atherogenesis. These metabolic effects require further study.

QUALITY OF LIFE ON DIALYSIS

Enthusiasm for the benefits of chronic renal dialysis in terms of improved survival must be tempered by the imperfect ability of treatment to free

the patient from the symptoms of uremia, to ensure full participation in desired physical and social activities, and to maintain normal economic

productivity. Even individuals who have undergone successful renal transplants do not lead normal lives, and patients on chronic dialysis are even

more restricted. An important consideration is

whether patients with ESRD may place less value

on future years of life than healthy persons do

and much greater value on the near-term balance

between life’s satisfactions and the frustrations of

chronic illness and its treatment. Stated in economic terms, the pragmatic discount rate the patient intuitively applies to a life dominated by

ESRD maybe so large that differences in survival

may be given little weight in decisions about therapeutic choices. Although difficult to quantify,

this tradeoff between future years of life and the

A variety of abdominal hernias have developed

in patients on CAPD due to increased pressure

created in the abdominal cavity by the dialysate.

Preexisting weakness of the abdominal wall and

poor muscle tone are predisposing causes, and

women and older men seem especially prone to

this complication. In one report involving 51 patients, 12 hernias were observed, but only 7 of

these developed after the start of CAPD (40a).

Other studies have reported up to an 11 percent

incidence of abdominal hernias, many of which

developed at the site of the peritoneal catheter insertion (17). Rarely, a hiatus hernia has been noted

to develop or increase in size during CAPD.

Pleural effusions may occur even in the absence

of any obvious opening in the diaphragm, presumably due to fluid transfer through transdiaphragmatic lymphatic and other pathways (31,

42,43).

Other rare complications include: the development of ascites, dialysate draining from the vagina, uterine prolapse, rectocystocoeles, hemorrhoids, and chronic low back pain.

present quality of life is a very real one that must

be faced in any realistic evaluation of treatments

for ESRD.

Available information does not definitively support one or another dialysis modality as being superior in terms of the ensuing quality of the patient’s life on dialysis. Individuals’ values vary

widely, and it is probable that selection factors

play a decisive role. Several studies do provide

some useful insights, however (13,14,20,24).

These studies all focus on relatively objective

measures of the quality of life, including the degree of functional impairment the patient experiences and his or her employment status. More

subjective phenomena such as satisfaction with

life, the sense of well-being, the relative value of

different activities, and the perceived burden of

treatment (physician visits, machine dependency,

ritualism) on the patient and the family have received less attention.
— .

33

Gutman (20) evaluated 2,481 patients on

chronic HD in selected facilities and found that

only 60 percent of nondiabetics and only 23 percent of diabetics were “normally active, ” while

21 and 51 percent, respectively, were severely debilitated or moribund. Of the nondiabetics, only

34 percent were employed full-or part-time, and

14 percent worked at home. Return to full- or

part-time employment depended importantly on

pretreatment employment status, and while 55

percent of patients with a previous skilled job

returned to work, only 27 percent of those with

an unskilled job and 16 percent of those who were

previously unemployed did so.

Johnson’s study (24) provides complementary

information by comparing quality of life measures of patients on chronic HD with those patients

who either were awaiting a first transplant, had

had a successful transplant, or had a failed transplant. Patients on chronic dialysis were more

likely to feel tired, engaged in fewer physical activities, were less sexually active, and felt more tied

down by their treatment than did patients with

successful transplants. They were also less likely

to be employed full-time or do full-time housework.

A summary of studies reporting employment

status in ESRD patients compiled by Evans (13)

is presented in table 4-8. Results vary widely.

Differences no doubt reflect variations in casemix, prior employment status, definitions of what

constitutes full- or part-time employment, dialysis modality, and quality of ESRD treatment.

The National Kidney Dialysis and Kidney

Transplantation Study is the first attempt to

directly compare quality of life measures among

different dialysis modalities and transplantation.

Information is currently available only for functional impairment and current employment status, although future publications will evaluate

differences on subjective and psychological measures as well. Table 4-9, which is adapted from a

report of this study, indicates that fewer patients

on center HD and CAPD were “able to carry on

normal activities and to work” (67 and 71 percent, respectively) than home HD patients (83 percent) or successful transplant (88 percent). Patients

on CAPD were less likely to be employed (16 percent) than those on center HD (24 percent), home

HD (40 percent), or those who had had a successful renal transplant (54 percent). These differences

are impressive until they are adjusted by multiple regression analysis for differences among populations in age, sex, education, and perceived

health status. After adjustment, the employment

rate of patients on CAPD was still lower than on

Table 4-8.—Summary of Studies of the Employment Status of ESRD Patients

Number Place of Employment status

Study reference Year of patients Dialysis Full-time Part-time Not employed

Baillod, et al.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1969 60 Mostly at

hom e 920/o

Cameron, et al. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1970 24 Facility 77%

25 Home 920/o

Pendras and Pollard . . . . . . . . . . . . . . . . . . . . . . . . . . 1970 110 Home 73% 240/o 3%

Strauch, et al. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1971 178 Facility 28.90/o 71.1% 

Freyberger. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1973 48 Facility 550/0 240/o 21“!0

Reichsman and Levy . . . . . . . . . . . . . . . . . . . . . . . . . . 1972 25 Facility 560/o 44%

Malmquist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1973 17 Facility 47 ”/0 53%

Foster, et al. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1973 21 Facility 47 ”/0 53%

Cadnapaphornchoi, et al. . . . . . . . . . . . . . . . . . . . . . . 1974 41 Home 31 .9 ”/0 31 .60/0 36.50/o

Kaplan DeNour and Czaczkes . . . . . . . . . . . . . . . . . . 1976 95 Facility 28.40/o 36.80/o 34.70/0

Disney and Row . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1974 300 Facility 51 .2 ”/0 31.4% 17.4”!0

123 Home 81 .30/0 10.40/0 8.30/o

Brunner, et al. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1976 9,000 Facility 36.80/o 30.80/o 32.40/o

2,500 Home 68.00/0 16.8 ”/0 15.20/.

Bryan, et al. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1978 3,462 Facility 5.7% 7.1 “/0 87.20/o

1,198 Home 20.8% 10.3 ”/0 68.9%

Tews, et al. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1980 227 Hospital 23.00/o 27.00/o 50.0 ”/0

65 Limited care 40.00/0 20.0% 40.0%

190 Home 56.00/o 19.0”/0 25.00/o

SOURCE: The full citations of the studies can be found in R. W, Evans, “Health Services Utilization and Disability Days: Indicators of the Quality of Patient Care Among

ESRD Patients,” Efatte//e /+urnan Affairs Research Centers Update No 18, Jan. 6, 1983,

98-824 0 - 85 - 4 : QL 3
34

Resbarch Centers Update No. 18, Jan. 8, 1983.

center HD but only marginally so. Inclusion of

previous employment status might have affected

comparisons even more.

The National Kidney Dialysis and Kidney

Transplantation Study is an important one. It is

cross-sectional, however, and relies primarily on

self-reported information. A prospective, longitudinal study will be required to confirm and extend its findings.

Burden of Treatment

Some argue that the quality of life maybe better on CAPD than on HD because of the freedom

it permits from chronic symbiosis with a machine

and its relatively flexible schedule of treatments.

On CAPD, dialysate exchanges can be performed

at the convenience of the patient, while HD sessions must be scheduled in advance with the dialysis center. CAPD, however, imposes the burden of performing four or five daily exchanges,

each of which requires meticulous attention to

sterile technique. Center HD, on the other hand,

frees the patient from responsibility for successful dialysis and places this responsibility on the

professional staff. Home HD lies between CAPD

and center HD by permitting more flexibility in

scheduling dialysis sessions. It encourages selfresponsibility, but at the cost of machine dependency and the need for considerable support by

family of home health aides. Clearly, tradeoffs

exist, and different value judgments on the part

of the patients will favor one method of treatment

or the other. The physician often plays an important role in clarifying these choices and helping

the patient through a perplexing and unfamiliar

decision process.

EFFECTS OF CASE= MIX DIFFERENCES ON

THE OUTCOMES OF CHRONIC DIALYSIS

Whether patient survival, hospitalization or such as age and the presence of diabetes, will afcomplication rates, the quality of life, or some feet several of these outcomes regardless of the

combination is used as the outcome measure of modality of treatment. Other patient characterinterest, patient characteristics may have a pro- istics, however, may be treatment specific in the

found influence on results. Some characteristics, sense that they adversely affect outcomes on one
35

type of treatment but not on another. Socioeconomic and psychological characteristics of the patient also may be critical determinants of success.

Differences in patient characteristics must be taken

into account if valid comparisons between treatment modalities are to be achieved.

All studies cited thus far in this case study were

uncontrolled. They were performed in populations that differed widely in age, sex, race, comorbidity, and prior treatment for ESRD. Also, the

calendar years of treatment varied, and undoubtable, so did the techniques and quality of treatment. Only the NIH CAPD and EDTA Registries

report annual results from broadly representative

populations of patients and providers. Other

studies are either series of patients from single institutions or from selected multiple institutions

and involve potential biases in patient selection

and in the selection of “better” institutions and

providers.

A randomized clinical trial would be the most

definitive approach to resolving controversy over

the relative merits of different treatment modalities for ESRD. In the absence of such a study, the

best that can be done is to examine available information critically in an attempt to make the

comparisons among studies more valid. ‘

Characteristics of ESRD Populations

Tables 4-10, 4-11, and 4-12 summarize the characteristics of patients in three distinct but overlapping ESRD populations: those enrolled in the

NIH CAPD Registry, those who enrolled in the

ESRD program early in 1981, and those sampled

in the National Kidney Dialysis and Kidney

Transplantation Study. All three studies include

patients on CAPD. The age, sex, and race distributions of patients on CAPD in the three reports

are very similar. Information on primary ESRD

diagnosis and comorbidity is variable, however.

The two studies that compare CAPD to home

HD and center HD reveal several important differences in the characteristics of populations treated

(tables 4-11 and 4-12):

● Patients on center HD are, on average,

slightly older than those on CAPD and definitely older than those on home HD.

Table 4-10.—NIH CAPD Registry: Characteristics

of CAPD Population Enrolled in the NIH CAPD

Registry in 1981 and 1982

Size of population . . . . . . . . . . . . . . . . . . . . . .........4,858

Demographics:

Age:

<20 yr. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5%

20-39 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

40-49 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

50-59 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

60-69 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

70+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

101% 

Race:

White . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 ”/0

Black . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

100 ”/0

Sex:

Male. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 ”/0

Female . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 ”/0

100 ”/0

Primary diagnosis:

Diagnosis available in . . . . . . . . . . . . . . . . . . . . . . . . 66 ”/0

When diagnosis available:

Glomerulonephritis . . . . . . . . . . . . . . . . . . . . . . . . . 23

Diabetic nephropathy . . . . . . . . . . . . . . . . . . . . . . . 19

Hypertensive renal disease . . . . . . . . . . . . . . . . . . 17

Polycystic kidney disease . . . . . . . . . . . . . . . . . . . 8

Chronic pyelonephritis . . . . . . . . . . . . . . . . . . . . . . 4

Systemic immunologic diseases . . . . . . . . . . . . . 3

Interstitial nephritis . . . . . . . . . . . . . . . . . . . . . . . . 3

Obstructive uropathy . . . . . . . . . . . . . . . . . . . . . . . 3

Rapidly progressive GN . . . . . . . . . . . . . . . . . . . . . 2

Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Unknown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

100 ”/0

SOURCE: U.S. Department of Health and Human Services, National Institutes

●

●

●

of Health, “CAPD Patient Registry Patient Population Demographic and

Selected Outcome Measures,” Report No. 82-S3, July 1, 19S3.

Patients on CAPD or home HD are much less

likely than center HD patients to be black.

The proportion of patients on home HD who

are male is much higher than that on the

other types of dialysis.

The proportion of patients with diabetes is

higher in the CAPD population than in the

center HD or home HD populations.

Implications of Differences in Patient

Characteristics for Health Outcomes

If the population differences noted above were

generally applicable to patients on dialysis, what

would be their impact on the outcomes of treatment? Several recent studies address this question

by examining the individual effects of age, sex,
36

Table 4.11 .—Patients Beginning Chronic Dialysis

in 1981 Under the ESRD Program

CAPD Home HD Center HD

Size of population . . . . . . 174 109

General demographics:

Mean age (yr) . . . . . . . . 51 47

Race (o/o):

Black . . . . . . . . . . . . . 17 13

White . . . . . . . . . . . . . 78 84

Other . . . . . . . . . . . . . 3 2

Sex (0/0):

Female . . . . . . . . . . . . 49 29

Male . . . . . . . . . . . . . . 51 71

Medical diagnosis

recorded (Al”) . . . . . . . . . 69 72

When diagnosis available (o/o):

Diabetes (10 or 2°) . . . . 36 14

Hypertension (10 or 2°) 72 70

Malignant disease,

past or present. . . . . 2 1

Number of associated diseases present:

1 25 35

2-4 : : : : : : : : : : : : : : : : 39 43

5+ . . . . . . . . . . . . . . . 30 18

First year outcomes:

Died (o/o) . . . . . . . . . . . . 13 9

Hospitalization:

Hospitalized (o/o). . . . 71 55

Hospital days . . . . . . 22 15

Hospital stays . . . . . 1.7 1.3

2,929

55

27

67

3

42

58

67

24

71

6

25

46

24

14

56

16

1.2

SOURCE: R. R. Bovbjerg, L. H. Kiamond, P. J. Held, and M. V. Pauly, “Continuous Ambulatory Peritoneal Dialysis: Preliminary Evidence in the Debate Over Efficacy and Cost,” Hea/fh Affaks 96-102, summer 1983,

Includes only patients whose “first dialysis was in the period from

Janua~-March 19S1 .“ The paper did not state whether the 3-month waiting period prior to eligibility for the ESRD program was taken into account. Nor did it state whether first year outcomes were annualized

or limited to calendar year, 1981.

race, primary diagnosis of ESRD, or comorbidity

on patient survival (5,11,22,27):

● Age: Patient survival unequivocally and importantly is influenced by age. The magnitude of the age effect is exemplified by the

survival statistics from the ESRD program

(27):

Survival

Age (years) l-year 3-year

11-20 . . . . . . . . . . . . . . . . 95% 88%

21-30 . . . . . . . . . . . . . . . . 91% 78%

31-40 . . . . . . . . . . . . . . . . 89% 71%

41-50 . . . . . . . . . . . . . . . . 88% 68%

over 50 . . . . . . . . . . . . . . 77% 48%

Older patients also have markedly higher

rates of hospitalization even in the absence

of renal disease (45).

● Cause of ESRD: Patients with ESRD due to

diagnoses of diabetic nephropathy or primary hypertensive disease experience poorer

survival than patients with glomerulonephritis.

Comorbidity: Survival is adversely influenced by the number of coexisting serious

diseases such as ischemic heart disease, prior

myocardial infarction, hypertension, congestive heart failure, or complications of diabetes.

Sex and Race: The effects of race and sex appear to be small and inconsistent. The finding that black individuals with primary

hypertension seem to survive better than

their white counterparts is interesting, but

may be explained by age or comorbidity differences.

The above results describe only the relationship

between a single patient characteristic and survival. Determination of the relative importance

of various characteristics in combination, however, is obviously critical if case-mix differences

are to be removed from outcome measures in order to permit valid retrospective comparisons between treatment modalities.

A limited number of published studies address

this issue in multivariate analyses. In one, Vollmer

found striking independent effects on survival of

age and the number of associated diseases at the

inception of treatment (49). In another, Hutchinson demonstrated significant effects of age, duration of diabetes, and presence of left-sided heart

failure on survival (22). These studies offer some

important insights and, hopefully, will stimulate

further similar efforts.

Finally, “time to treatment bias” or “timedependence” (50) may exert important effects on

comparisons among dialysis modalities or between dialysis and transplantation over and beyond those created by differences in patient characteristics. ESRD treatment begins at the time of

diagnosis and often involves several sequential

treatment modalities. A patient must survive a

period of dialysis, for example, before he or she

can receive a transplant or may have survived a

period of HD before being transferred to CAPD.

In either case, survival experience on the prior

treatment must be taken into account when evaluating outcomes on the second treatment. When

adjustments are made for time to treatment,

differences in survival between home HD and cen-
37

Table 4-12.—National Kidney Dialysis and Kidney Transplantation Study: Population

Characteristics of Random Samples of Prevalent Patients Undergoing Chronic Dialysis

in Eleven Selected Dialysis Facilities, in 1981

Dialysis type and location

CAPD/CCPDa Home HD Center HD

Sample size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

General demographics:

Mean age (yr) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Race(%)

Black . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

White . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sex (O/0)

Male. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Female . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Education . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Primary renal diagnosis (%)

Interstitial nephritis . . . . . . . . . . . . . . . . . . . . . . . .

Polycystic kidney disease . . . . . . . . . . . . . . . . . . .

Disease involving glomerular structures . . . . . . .

Hypertensive renal disease . . . . . . . . . . . . . . . . . .

Nephrosclerosis . . . . . . . . . . . . . . . . . . . . . . . . . . .

Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Morbidity (%)b

:

Angina or myocardial infarction . . . . . . . . . . . . . .

Other cardiovascular problem . . . . . . . . . . . . . . . .

Respiratory disease . . . . . . . . . . . . . . . . . . . . . . . .

Gastrointestinal problems ........,.. . . . . . . . .

Neurological problems, including stroke . . . . . .

Musculoskeletal disorders including

bone disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Average number of comorbid conditions . . . . . . . .

61(CAPD)

20(CCPD)

52

10

84

6

46

54

12

13

10

30

10

7

16

13

20

19

7

12

7

21

7

0.94

287

49

61

39

13

15

25

6

9

10

21

13

0.98

347

54

42

54

4

50

50

11

7

8

34

19

1

12

10

25

35

17

25

14

30

31

1.77

%APD is continuous ambulatory peritoneal dialysis; CCPD is continuous cycling peritoneal dialysis.

bTotals may be greater than 100 percent because patients may have more than onecomorbid condition.

SOURCE: R. W. Evans, ’’Health Services Utilization and Disability Days: indicators oftheQuaiKy of PatientCareAmong ESRD

Patients/’ Batte//e Human Affaks Research Centers Update No. 18, Jan.6, 1963.

ter HD and between center HD and cadaveric

transplantation are markedly narrowed, especially

if age is simultaneously controlled. Thus, the

time to initiation of a treatment following the

diagnosis of ESRD, as well as the demographic

and medical characteristics of patients, are critical considerations.

Use of a "Standard Population” to

Report Outcomes

The only systematic attempt to take case-mix

considerations into account was reported at a

symposium conducted by the American Society

for Artificial Internal Organs at its meeting in

April 1983. At this meeting, several dialysis program directors presented their results for a ’’standard population” of patients 20 to 60 years of age

at the onset of treatment. This standard population excluded patients who were “high risk, ” either by virtue of having primary ESRD diagnoses with systematic implications such as primary

hypertension, diabetic nephropathy and collagen

diseases, or by having severe comorbidity such

as cardiovascular disease or malignancy. The goal

of the presentations was to minimize population

differences and obtain comparable results for

CAPD and HD.

The results of available reports’ from these

presentations are summarized in table 4-13. Both

patient survival and the ability of patients to re-

‘As of May 1984, when this case study was received for final

editing.
Table 4-13.—Patient Survival and Ability to Continue on a Dialysis Modality in “Standard Population” of ESRD Patientsa

Modality of Calendar Number of Patient survival Continued on modalityc

dialysis Sourceb

year(s) patients 0.5 yr 1 yr 2 yr 5 yr 0.5 yr 1 yr 2 yr

CAPD Nolph, et al., 1983d

1981-82 2,137 97 ”/0 94% — 88 ”/0 830/o —

CAPD Wing, et al., 1983e

—

1976-81 1,504 — 78 63

HD

—

Wing, et al., 1983e

— — —

— 84 64

HD Blagg and Wahl, 1983

— — —

1976-82 367

—

— 96 88 73 — — —

Interval mortality— Interval procedures failure—

3-mo intervalsf

3-mo intervals

3 mo 6 mo 12 mo 24 mo 3 mo 6 mo 1 yr 2 yr

CAPD Wing, et al., 1983 1976-82 1,504 7.80/o 4.9 ”/0 5.30/0 10.0 ”/0 25.30/o 11.4% 11 .2 ”/0 13.4 ”/0

HD Wing, et al., 1983 1976-82 35,532 5.3 3.9 3.6 3.3 15.1 11.4 6.8 5.2

~he “standard population” is defined as one 20 to 60 years of age at the date of first treatment; which does not have diabetes, malignancy, or other severe systemic illness; excludes primary diagnoses

for ESRD such as collagen disease, primary hypertension, oxalosis, and/or myloidosis; and excludes high risk patients with cardiovascular disease.

bFull citations found in the References,

Calculations reflect both deaths and treatment failures resulting in transfers to other forms of chronic dialysis, Transplants are excluded and hence, are not considered to repreSent failUreS Of dialysis.

dDeaths are ascribed to CAPD if they occurred within 2 weeks of change to any other treatment modality.

eln su~ival calculations patients were censored on the day of change in treatment modality.

fThree.month intewal rates are estimated from bar graPhs and, therefore, are appro~imate populations at risk at each interval were not specified, but presumably excluded those removed at previous interValS.

SOURCE: Office of Technology Assessment.
39

main on CAPD after 1 year of treatment appears

to be better in the United States than in Europe.

One possible explanation for these differences is

that the European Registry did not permit the exclusion of patients at high risk of cardiovascular

events. Patient survival at 1 year on HD in a single U.S. center (5) appeared to be similar to that

for CAPD in the NIH CAPD Registry (33).

Examination of survival within discrete intervals of followup in the European registry provides

some interesting contrasts between CAPD and

HD (table 4-13). The mortality rate on HD was

highest in the first 3 months of treatment and then

quickly plateaued, while mortality on CAPD fluctuated at higher levels than HD over the entire

period of observation. Procedure failure was

higher in the first 3 to 6 months of treatment for

both modalities, but remained higher for CAPD

than for HD during subsequent time periods.

This effort to “compare” outcomes of dialysis

in a standard population, though commendable,

falls far short of what is needed to establish credible comparisons among dialysis modalities. For

example, important residual differences in age

were found between patients on CAPD and HD

in the EDTA Registry (51). Furthermore, there is

a possible deception in limiting comparisons to

a low risk population. Subtle differences between

dialysis techniques, if they exist, are more likely

to become manifest in patients at a higher risk of

mortality or morbidity. An analysis confined to

low risk patients may obscure these differences.
Chapter 5

Costs of Treatment

End-Stage Renal Disease
— —.-

Chapter 5

Costs of Treatment for

End- Stage Renal Disease

INTRODUCTION

The rapidly escalating expenditures of the EndStage Renal Disease (ESRD) program have been

well recorded. Less attention has been given,

however, to how these expenditures distribute

among the components of care involved—dialysis

treatments themselves, physician services, and

hospitalizations. Furthermore, the relationship between ESRD program expenditures and the resource costs of the services they cover has been

virtually unexplored. Better cost information is

urgently needed.

Preliminary insights can be gained, however,

from existing information. To this end, this chapter examines the results of the cost audits of dialysis treatment facilities that have been performed

and projects the costs of dialysis from these audits and from average Medicare ESRD reimbursement rates. These results refer only to the cost of

dialysis treatments themselves, with or without

physician supervision, and do not include hospitalizations or medical care unrelated to dialysis. In chapter 6, Medicare ESRD reimbursement

data for 1981 and 1982 are analyzed, and the total costs of treatment of ESRD, including hospitalizations, are compared for continuous ambulatory peritoneal dialysis (CAPD), center hemodialysis (HD), and home HD.

The diverse sources of information and diverse

measures of cost used create a confusing array of

results. To help clarify interpretation the following

●

●

●

●

●

definitions are used:

Cost: The dollar value of a product or service determined by audit or special investigation. The word cost is also used in a generic

sense.

Charge or Price: The dollar value placed on

a product or service by a supplier or

provider.

Reimbursement Rate: The dollar value of a

product or service as determined by a Federal program (or health insurer) based either

on costs or charges or on some proportion

of costs or charges.

Projected Cost: The dollar value of a service calculated as the product of unit cost or

average reimbursement rate and assumed

utilization.

Expenditure: The dollars actually paid for a

product or service based on costs, charges,

reimbursement rates, or some combination.

Expenditures usually take the perspective of

a particular program (e. g., the ESRD program), the individual payor, or some combination of payers.

PROJECTED COST OF DIALYSIS FROM COST AUDITS

In response to the ESRD Program Amendments

of 1978 (Public Law 98-292), the Health Care

Financing Administration (HCFA) performed an

audit in 1980 of a selected sample of 105 facilities

(66 hospitals and 39 independent dialysis centers).

From this audit, HCFA estimated a median cost

of $135 per HD treatment in a hospital center and

$108 per treatment in an independent dialysis

center (15). Home dialysis costs were not assessed.

The Omnibus Budget Reconciliation Act of 1981

(Public Law 97-35) promoted home dialysis and

led to a subsequent HCFA audit of 23 centers and

2 State programs that provided both center dialysis and supervised home dialysis. The centers

selected were from those having large patient

populations. Cost estimates obtained were $87 per

treatment for home HD and $114 per “treatment

equivalent” for home CAPD. (Because CAPD

43
. —

44

treatments are given daily, the the weekly costs

of dialysis were divided by three to provide a cost

equivalent to that for a single HD treatment, since

HD treatment schedules generally call for three

treatments per week. )

In 1981, the General Accounting Office (GAO)

performed an independent audit of home dialysis costs from data provided by carriers and financial intermediaries on 656 randomly selected

patients (47). This audit estimated costs of $103

per treatment for home HD and $110 for CAPD

(47). An interesting finding of the GAO audit was

that 70 percent of home dialysis patients were purchasing their supplies and equipment directly from

commercial suppliers rather than through supervising dialysis centers. The question arises as to

whether the higher estimate obtained for home

HD in the GAO audit may, at least in part, reflect

higher prices of supplies to individual purchasers.

Alternative explanations, of course, might be

differences in sampling techniques and the audit

methodology.

The HCFA audit has been widely criticized, because its sample of dialysis centers was not representative, and because it used less than optimal

auditing techniques. This is particularly true for

the examination of home dialysis costs, which

HCFA admits was done hastily under considerable time pressure. Despite their limitations,

HCFA figures were used as the basis for calculating Medicare’s recently implemented composite

reimbursement rates.

Table 5-1 presents projections of the yearly cost

of dialysis treatments based on HCFA and GAO

Table 5-1 .—Cost of Dialysis per Patient-Year as

Estimated From Health Care Financing Administration

and General Accounting Office Cost Audits

Dialysis modality Cost/day a Cost/yr

b

Health Care Financing Administration Audit:

Center HD:

Hospital center . . . . . . . . . . . . . . . . . $135 $21,060

Independent center. . . . . . . . . . . . . . 108 16,848

Home HD . . . . . . . . . . . . . . . . . . . . . . . . 87 13,572

CAPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114 17,784

General Accounting Office Audit:

Home HDC . . . . . . . . . . . . . . . . . . . . . . . $103 $16,068

CAPDC 

. . . . . . . . . . . . . . . . . . . . . . . . . . . 110 17.160

aRepresents median cosw from 1980 data for center HD (67 hospital and 38 independent centers) and 1981 data for home dialysis (23 centers).

bAss ume s full compliance with regimens of 3 dialysis treatments or “treatment

equivalents” (CAPD) per week,

c Repre s ents mean costs of home dialysis in 1981 ~

SOURCE: Office of Technology Assessment,

audits. These figures refer only to the cost of the

dialysis treatments and do not include physician

fees. They assume full compliance with prescribed

dialysis treatments. The yearly cost of HD in a

hospital center is slightly over $4,000 more expensive than HD in an independent dialysis center. CAPD appears to cost about the same as HD

in an independent center, and home HD is less

expensive than either CAPD or center HD (how

much depends on whether one prefers the HCFA

or GAO audit results). If the cost of a home health

aide to assist with home HD were added, any cost

savings from home HD would be greatly reduced

or eliminated.

PROJECTED COST OF DIALYSIS FROM 1982 MEDICARE

ESRD REIMBURSEMENT RATES

Reimbursement rates paid by the ESRD program provide a second method by which to assess the projected costs of dialysis. Differences between estimates based on ESRD reimbursement

rates and cost audit results would reflect profit

margins (revenues minus costs), if the cost audit

results accurately reflect resource costs and if complete collection of deductibles and the 20 percent

coinsurance required by Medicare were achieved.

Medicare’s ESRD reimbursement rates in 1982

averaged $159 per treatment in a hospital center

and $138 in an independent center. No comparable figures exist for home dialysis. Multiple formulae have been used to determine reimbursements for home dialysis, which alternatively, have

been based on reasonable costs to the hospital or

independent center, negotiated Target Rate Reimbursement Agreements with centers, or reason-
45

able charges for supplies and equipment billed by

the patient or the commercial supplier.

Physician supervision of dialysis is not included

in these reimbursement rates and has averaged

$220 per month for center dialysis and $154 for

home dialysis under the cavitation-based “alternative reimbursement method” option. Average

estimates for physician services billed under the

“fee for service” option were not obtained for this

study.

Table 5-2 shows projected yearly costs of

$24,804 for HD in a hospital center and $21,528

in an independent center. These figures, which are

18 percent and 28 percent higher than costs projected from the HCFA cost audit for hospital and

independent centers, respectively, provide crude

estimates of the magnitude of “profits” enjoyed

by dialysis centers.

Physician supervision of dialysis adds $2,640

to the average yearly cost of center HD and $1,848

per year for supervision of home dialysis.

Table 5-2.—Cost of Dialysis Per Patient-Year From

1982 Medicare Reimbursement Rates

Projected yearly costa

Dialysis modality . . . . . . . . . Dialysis Physician Total

HD—Hospital center . . . . . . $24,804b

$2,640’ $27,444

HD—independent center. . . 21,528d

2,640 24,168

aASSurneS 156 dlalysls treatments Per Year (s Per Week)

baased on a reimbursement rate of $159 per treatment for HD In a hospital dial.

ysis center,

cBased on the average monthly physician reimbursement rate of $220 Per Pa.

tient for supervision of dialysis in a center

dBased on the ESRD “screen” or maximum allowed reimbursement rate Of $138

per treatment for HD performed in an independent center Most centers obtained

the maximum rate

SOURCE” Office of Technology Assessment

PROJECTED COSTS OF DIALYSIS UNDER HCFA’s

1983 COMPOSITE REIMBURSEMENT RATES

The composite reimbursement rates that were

implemented on August 1, 1983 were designed to

encourage home dialysis and, at the same time,

to help contain the costs of the ESRD program.

Under this rate structure, a single rate is applied

to all dialysis performed under the supervision of

a center, and a single monthly rate is paid for physician supervision regardless of whether the treatment is furnished in the center or at home. The

regulation does not in any way alter the ability

of the patient to purchase equipment and supplies

directly from the supplier. Reasonable charges

continue to be the basis for these purchases.

HCFA’s assumptions are that dialysis centers

will be provided an incentive to offer home dialysis alternatives to their patients because of the

lower resource cost of home dialysis. In addition,

HCFA assumes that physicians will encourage

home dialysis because they will be reimbursed the

same amount for the lesser effort required to supervise home patients than is required by dialysis treatments performed three times a week in a

center.

Average reimbursement rates were set at $127

per treatment for dialysis supervised by an independent center and $131 per treatment supervised

by a hospital center. The rates were based on a

formula that took into consideration the distribution of dialysis among home and center dialysis settings and relied heavily on the HCFA cost

audit results. Adjustments are to be made to these

average rates to adjust for geographic wage differences. Furthermore, dialysis training sessions are

to be reimbursed at an additional $20 per session.

Exceptions to the above rates will be granted under special circumstances. Physicians are reimbursed at an average rate of $184 per patient per

month, again adjusted for geographic wage differences.

Table 5-3 shows the projected average yearly

costs of dialysis under the 1983 HCFA prospective reimbursement formula. Compared to cost

estimates based on 1982 ESRD reimbursement

rates (table 5-2), the yearly cost of center HD will

be reduced by 18 percent in hospital centers and

by 8 percent in independent centers.
46

Table 5-3.—Estimated Projected Cost of Dialysis Per

Patient-Year Under HCFA’s 1983 Composite

Reimbursement Rates

Projected yearly costa

Dialysis modality

and location Dialysis b Physician c

Total

Center HD:

Hospital . . . . . . . . . . . . . $20,436 $2,208 $22,644

Independent . . . . . . . . . . 19,812 2,208 22,020

Home HD or CAPD:

Supervised by

hospital . . . . . . . . . . . . $20,436 $2,208 $22,644

Supervised by

independent center. . 19,812 2,208 22,020

aASSUrneS fult compliance with 156 treatments per year (3 Per week X 52 weeks)

or, In the case of CAPD, “treatment equivalents. ”

bBased on average per treatment reimbursement rates Of $131 and $127 in hospital and independent centers, respectively, regardless of dialysis modality or

location

cBased on an average monthly cap!tation rate of $184 for Supervision of dialysis.

SOURCE” Office of Technology Assessment.

Average physician cavitation fees under the

1983 composite rate formula will increase from

$1,848 per year to $2,208 per year (19 percent)

for supervision of home dialysis and decrease

from $2,640 per year to $2,208 (16 percent) for

center dialysis.

The most obvious effect of the new rates is to

reduce the level of reimbursement for center dialysis from $159 to $131 in hospitals and from

$138 to $127 in independent centers.

FINANCIAL INCENTIVES CREATED BY HCFA’s 1983 COMPOSITE

REIMBURSEMENT RATES

If the HCFA cost audit results represent valid

estimates of the average resource costs of dialysis treatments, financial incentives favoring one

dialysis modality or another should operate in relation to differences between reimbursement rates

and the unit costs determined by the audits. The

validity of the cost audit results can be questioned,

but, pending better cost information, no better

assumption is obvious.

I The estimated yearly costs of dialysis from the

I cost audits and from the 1983 composite reimbursement rates are compared in table 5-4.

Three observations are germane:

1. a strong disincentive has been created for

performing HD in hospital dialysis centers;

2. approximately similar incentives exist in independent centers for center HD and CAPD;

and

3. a very strong incentive has been created for

home HD that would be mitigated if unit

costs rise as a result of the need to furnish

more home health aides when home HD is

offered to a broader spectrum of patients

with more comorbidity or less than adequate

home support.

If these incentives alone were to drive utilization, center HD, home HD, and CAPD all would

Table 5-4.—Comparison Between Estimates of the

Projected Cost of Dialysis Per Patient-Year Based

on HCFA and GAO Cost Audits and HCFA’s

1983 Composite Reimbursement Rates

Projected yearly cost

1983

Dialysis type cost Composite Percent

and location audits a

rates bdifference

Center HD:

Hospital . . . . . . . . . . . . . $21,060 $20,436 – 3 %

Independent center. . . . 16,848 19,812 18

Home HD:

Supervised by hospital

center . . . . . . . . . . . . . 13,572 20,436 51

Supervised by

independent center. . 13,572 19,812 46

Direct purchasec . . . . . . 16,068 7 ?

CAPD:

Supervised by hospital

center . . . . . . . . . . . . . 17,784 20,436 15

Supervised by

independent center. . 17,784 19,812 11

Direct purchase . . . . . . . 17,160 ? ?

a

From table 5-1

b

From table 5-3.

cFrom the results of the GAO audit in which 70 percent of the patient sam Ple

were purchasing supplies directly from the supplier.

SOURCE: Office of Technology Assessment.

be expected to increase under the 1983 rates

largely at the expense of HD in hospital dialysis

centers.

Many factors other than financial incentives

created by the 1983 rates, of course, may affect
47

patterns of utilization. The change in cavitation influenced by convictions about patient suitabilrates for physician supervision of dialysis, for ex- ity and medical effectiveness, in addition to finanample, clearly favors home dialysis over center cial considerations. Finally, patient acceptance

dialysis. Because the physician plays a major role almost certainly will become an increasingly imin the selection of dialysis modality, this finan- portant determinant as public information on

cial incentive may be at least as powerful as that medical effectiveness and quality of life consideroperating on dialysis centers, Physician accept- ations become more widely distributed.

ance of home dialysis techniques will be strongly

COST IMPLICATIONS OF THE DIRECT PURCHASE

OF SUPPLIES FOR HOME DIALYSIS

HCFA’s 1983 rates apply only to the reimbursement of dialysis centers and do not affect the ability of the patient to purchase equipment and supplies for home dialysis directly from suppliers. The

GAO cost audit indicated that 70 percent of home

dialysis patients were direct purchasers under previous regulations. Questions that need to be raised

include:

1. Are prices for supplies purchased directly by

the patient higher than those for supplies

purchased by a hospital or independent dialysis center?

2. If so, will the new reimbursement rates affect the number of direct purchasers and in

what direction?

Higher prices for direct purchasers and any increase in their numbers, obviously, will be inflationary for the ESRD program.

In the absence of regulations to the contrary,

suppliers probably do charge individuals higher

prices than they do bulk purchasers such as dialysis centers or hospitals. CAPD provides an example of the possible consequences. Patients on

CAPD require nearly 3,000 liters of sterile dialysate solution per year packaged in plastic bags plus

a variety of ancillary supplies, including sterilization or “prep” kits, connecting tubes, and other

apparatus. Two estimates of the yearly cost of

supplies, provided by Travenol Laboratories, Inc.,

the supplier with the dominant market share,

range from $13,000 per year (1) to over $19,000

per year (Travenol Price List, November 1, 1982).

The details of these estimates appear in table 5-

5. This wide range suggests that prices to direct

purchasers may, in fact, be considerably higher.

Table 5.5.—Estimates

CAPD Supplies

of the Annual Cost of

and Equipment

Travenol Laboratories Testimony to

Congress (1982)a

. . . . . . . . . . . . . . . . . . . . . ... , . ...13,147

Travenol Price List–Nov. 1, 1982b . ..............19.688

aBased on four exchanges per day or 1,460 per year at $732 Per bag, $1 00 for

a prep kit for each exchange, and $1,000 for other ancillaries

bBased on 1,460 exchanges per year with Dianeal 137 Soi UtlOn, 1 5 or 2 liter%

at $64,20 for case of 6 and Prep Kit Model 3 at $6300 for case OT 30 w!t h each

exchange, and $1,000 for other ancillaries,

SOURCE Off Ice of Technology Assessment

Furthermore, it suggests that, if Medicare is to retain the direct purchase option, it should establish limits on allowable charges that are directly

linked to production costs, and at the same time,

ensure a preferred customer relationship for persons enrolled in the ESRD program.

It is difficult to predict how many home dialysis patients will select the direct purchase option

under the new rates. On the one hand, dialysis

centers may find the new reimbursement rates and

financial arrangements with suppliers sufficiently

attractive that they will actively encourage patients to obtain their supplies through the center.

In this case, the proportion, and even the total

number, of direct purchasers might fall. If, however, centers see the financial incentives created

by the new rates to be insufficient to offset the

operational problems of distributing supplies, they

might take actions to “assign” supply functions

to the supplier or encourage direct purchase. This

latter scenario would create the risk for ESRD program cost escalation.

In summary, it appears highly likely that

HCFA’s intent to encourage diffusion of home dialysis techniques will be fulfilled. Far less certain,
however, are the effects this diffusion will have changes in the organization and patterns of utilion stemming the rising tide of ESRD costs. As a zation of dialysis services as they occur; and to

prudent purchaser of services, HCFA should con- devise mechanisms for determining the effects of

sider taking the necessary steps to reassess the eq- these reimbursement decisions on the quality of

uity of the new rates in relation to the resource ESRD treatment as well as its costs.

costs of the services they cover; to monitor
Chapter 6

Analysis of End-Stage Renal

Disease Expenditures
Chapter 6

Analysis of End-Stage Renal

Disease Expenditures

INTRODUCTION

The End-Stage Renal Disease (ESRD) program

reimburses its beneficiaries for dialysis treatments,

for physician services, and for hospital care. Analysis of data collected in conjunction with monitoring expenditures of the program, therefore,

provides an alternative method by which to estimate the costs of treatment by different dialysis

modalities.

Two major distinctions must be kept in mind

when the results of this analysis are compared to

those projected from cost audits or average ESRD

program reimbursement rates presented in chapter 5. First, projected costs assume full compliance with average prescribed dialysis regimens,

while dialysis costs estimated from Medicare Part

B expenditures reflect actual billings and, therefore, any deviations from average regimens or

failures in compliance. Part B expenditures include

physician services and ancillaries in addition to

those of dialysis treatments per se.

Second, the ESRD program, by recording the

frequency of hospitalizations, allows estimation

of hospital costs. The total costs of medical care,

therefore, can be calculated as the basis for comparing dialysis modalities and thereby offset any

METHODS OF THE ANALYSIS

ESRD Program Data Files

The ESRD program records the following information on each beneficiary:

●

●

●

Patient characteristics such as age, sex, race,

and primary ESRD diagnosis.

Time in the program (a 3-month waiting

period is required after the diagnosis of ESRD

before enrollment occurs).

Aggregated Medicare payments under Part

B for dialysis treatments, supplies and equiplower dialysis costs by any higher costs of hospitalization identified. In the case of continuous ambulatory peritoneal dialysis (CAPD), for example, some claim that any savings in the cost of

dialysis are negated by added hospitalizations due

to frequent bouts of peritonitis.

This analysis examines expenditures by the

Medicare ESRD program on behalf of its beneficiaries during 1981 and 1982. The primary objective is to compare the cost of uninterrupted treatment by center hemodialysis (HD), home HD, and

CAPD. In addition, any increases in costs incurred by patients who are unable to tolerate one

modality of treatment and are changed to another

modality, and the costs associated with dying are

examined . These incremental “costs of changing”

or “costs of dying” are particularly important to

the extent that “procedure survival” or patient survival differ among dialysis modalities.

Although many questions have been raised

about the reliability of Medicare ESRD reimbursement data, there is no reason to believe a priori

that comparisons among dialysis modalities

should be biased even though actual dollar figures

may be suspect.

ment, and physician services. These figures

exclude a 20 percent coinsurance and deductibles.

. Admission and discharge dates for hospitalizations related to the treatment or complications of ESRD. This criterion is very

broadly interpreted because of the widespread systemic manifestations of renal disease. Days of hospitalization are converted

to dollars by using the national average

Medicare per diem rate for the year in

question.

51
—

52

The data files obtained for this analysis included

all persons enrolled in the ESRD program, with

the exception of patients who had undergone renal transplantation at any time and patients who

first enrolled in the ESRD program during 1981

or 1982. Transplanted patients were excluded because of the special problems that maybe encountered in the dialysis of patients with failed transplants. Newly enrolled patients were excluded

because of concern that the startup costs of dialysis might obscure differences in costs of maintenance treatment.

Patient Subgroups for Analysis

The 1981 and 1982 files were merged

subgroups of patients were identified:

and 10

Continuous Dialysis on a Single Modality From

January 1, 1981 to December 31, 1982 a n d

Survived:

1. Center HD (hospital or independent center)

2. Home HD

3. CAPD

Single Change of Dialysis Modality Between

January 1, 1981 and December 31, 1982 and

Survived:

4. CAPD to center HD

5. Center HD to CAPD

6. CAPD to home HD

7. Home HD to CAPD

Continuous Dialysis on a Single Modality From

January 1, 1981 Until Death Between July 1, 1982

and December 31, 1982:

8. Center HD

9. Home HD

10. CAPD

In all survivor subgroups (subgroups 1 to 7),

the analysis was limited to data that applied to

the 18-month period from April 1, 1981 to October 31, 1982. The first 3 months of 1981 and

the last 3 months of 1982 were excluded to eliminate any expenditures for hospitalizations that

might have been associated with the startup of

therapy or with complications that might have led

to a change in therapy or death after December

31, 1982. Another exclusion was deaths before

July 1, 1982; this was done to ensure a sufficiently

long period of observation prior to death that stable estimates of expenditures prior the terminal

costs of dying would be obtained.

Variables examined in each subgroup were:

●

●

●

●

●

●

●

age on July 1, 1981;

sex;

race;

time in ESRD Program prior to January 1,

1981;

aggregate Medicare Part B reimbursements;

number of hospitalizations; and

duration of each hospitalization.

Dates of change of dialysis modality depend on

information provided in claims submitted by dialysis centers or physicians. Change dates tended

to clump around the end of quarters (March 31,

June 30, September 30, December 31). The listed

date was accepted if it were other than the end

of a quarter, but the date of the midpoint of the

preceding quarter was arbitrarily assigned for

changes reported in claims dated within 3 days

of the end of the quarter on the assumption that

actual dates of change were randomly distributed.

Dates of hospital admission and discharge were

provided only for the first five hospitalizations

in any calendar year for any given patient. In

those few patients with more than five hospitalizations, the average length of stay of the first five

hospitalizations was used as an estimate of the

duration of hospitalization on subsequent admissions,

Costs of Hospitalizations

Hospital days per patient-year

to dollars as follows:

are converted

0.68 x 1.047 x 1.07

The average national hospital per diem rate for

Medicare patients was $348 in 1981 and $412 in

1982. The factor 0.68 is the proportion of the hospital per diem rate that Medicare reimburses. The

factor 1.047 adjusts for hospital administrative

and overhead costs not otherwise included in the

per diem rate, and the factor 1.07 adjusts for the

average coinsurance and deductibles patients pay

towards the cost of their Part A Medicare treat-
53

ment. Adjusted average per diem rates are $265.11

for 1981 and $313.86 for 1982.

This formulation assumes that days of hospitalization for patients with ESRD are of average

intensity and, hence, average cost. To the extent

that ESRD patients may require more days in intensive care units, more ancillary services, or more

nursing services than the average patient, this assumption will underestimate the true cost of

hospitalizations. Similarly, to the extent that renal

dialysis during hospitalizations is billed separately

under Medicare Part B, costs of hospitalization

will be further underestimated. No reliable information is currently available on either issue.

Costs of Outpatient Dialysis and

Physician Services

Medicare Part B reimbursements are assumed

to represent 80 percent of all bills for dialysis and

physician services rendered in both outpatient and

inpatient sites. To estimate total costs, adjustment

is made for the 20 percent coinsurance that must

be borne by the patient or another payor, but the

annual deductible of $75 is ignored. Part B costs

RESULTS

Population Characteristics

The distribution of the ESRD population among

defined subgroups for the 1981 and 1982 files

separately and for the merged file are shown on

table 6-1. Patients remaining continuously on one

dialysis modality predominate in each file, and

include 90.9 percent of patients in the merged file.

The number of deaths in the merged file are about

half those in the 1981 or 1982 files, because only

deaths between July 1, 1982 and December 31,

1982 were included. Fewer than 1 percent of patients experienced multiple changes in dialysis

modality. Of note is that among patients who

changed dialysis modality, many more change

from center HD to CAPD than in the reverse

direction. This finding no doubt reflects both the

larger population of center HD patients at risk for

change and the increasing acceptance of CAPD

as a viable alternative. Sample sizes in the merged

file are of tolerable size for analysis except for the

change group of CAPD to home HD.

are assumed to accrue at a uniform rate throughout the year. The cost of outpatient care and physician services per patient-year, therefore are calculated as:

Medicare Part B 365

reimbursements in X length of period X 1.25

period of observation of observation

Total Costs of Care

Total costs are presented as the sum of the costs

of hospitalizations and Part B costs per patientyear of treatment.

Costs of Changing Dialysis Modality

and Costs of Dying

The “cost of changing” and the “cost of dying”

are estimated as the difference between the actual

total cost and the total cost predicted from the

relevant dialysis subgroup(s) that survived on a

single dialysis modality (subgroups 1 to 3). For

change subgroups, predicted expenditures are

weighted by the number of days a patient was on

each dialysis modality.

Table 6-2 shows the demographic characteristics of patient subgroups for the merged file. Patients who are continuously on CAPD are, on

average, slightly younger than those on center HD

(49.7 years vs. 53.9 years), while the age of patients on home HD is intermediate (51.0 years).

Patients who die are, on average, 6 to 8 years

older than their surviving counterparts. A markedly higher proportion of ESRD program participants on continuous center HD are black (37

percent) than those on either home HD (20 percent) or CAPD (16 percent). Modest male predominance is seen among patients on home HD

(57 percent) and CAPD (55 percent).

Costs of Dialysis and Physician

Services (Part B Costs)

The estimated cost per patient-year of continuous dialysis is $16,915 for center HD, $12,024

for home HD and $7,631 for CAPD (table 6-3).

For center HD, this amount is about 60 percent
54

Table 6-1 .—Distribution of the ESRD Population by Clinical Subgroup and Dialysis Modality for

1981 and 1982 Files and for the Merged File

Table 6-2.—Demographic Characteristics of ESRD Program Participants by

Clinical Subgroup and Dialysis Modality for the Merged File
—

55

Table 6-3.—Mean Costs of Dialysis and Physician

Services by Clinical Subgroup and Dialysis Modality

Mean costs per patient-year

Clinical and ESRD Estimated

dialysis subgroupsa

reimbursements total costb

Continuous dialysis on a single

modality and survived:

Center HD. . . . . . . . . . . . . . . $13,532

Home HD . . . . . . . . . . . . . . . 9,619

CAPD . . . . . . . . . . . . . . . . . . . 6,105

Single change of dialysis modality

and survived:

CAPD to center HD. . . . . . . 10,833

Center HD to CAPD . . . . . . 10,549

CAPD to home HD . . . . . . . 5,331

Home HD to CAPD . . . . . . . 7,626

Continuous dialysis on a single

modality but died:

Center HD. . . . . . . . . . . . . . . 14,086

Home HD . . . . . . . . . . . . . . . 11,675

CAPD . . . . . . . . . . . . . . . . . . . 6,058

$16,915

12,024

7,631

13,604

13,186

6,664

9,533

17,608

14,594

7,573

acenter H D ~aY be at either a hospital or independent dialysis center. Home

HD and CAPD are supervised by a hospital, independent center or, rarely, by

Indlwdual physicians

bESRD reimbursements multiplied by 1.25 to adjust for the 20 percent coinsur.

ance charged to the patient under Part B of the Medicare ESRD program.

of yearly costs projected from average ESRD program reimbursement rates for dialysis plus the

average cost of physician supervision. For home

HD and CAPD, they are about 80 percent and

40 percent, respectively, of those projected from

the HCFA cost audit results plus the estimated

average cost of physician supervision (table 6-4).

Several explanations are possible to account for

these differences. One is that ESRD enrollees who

are stable on a single dialysis modality require less

frequent dialysis and less physician supervision

than the “average” ESRD patient. Although this

may be true, it could account for only a small fraction of the discrepancies, because costs in the

subgroups of patients who changed modalities

(weighted by the time on each modality) and in

the subgroups of patients who died are only

slightly higher than in the continuous dialysis subgroups.

A second explanation maybe that a significant

proportion of patients have dialysis prescribed less

frequently than the assumed three times a week

for HD and four times per day for CAPD. Some

estimates suggest that this may occur in 20 to 25

percent of patients, and especially in those with

some residual renal function.

Third, failures in compliance maybe important.

Compliance with treatment regimens for chronic

diseases has been well demonstrated to be extremely difficult; that with treatment for ESRD,

undoubtable, is no exception.

Fourth, incomplete rendering of bills to the

ESRD program may occur either because of dual

entitlement to coverage or, in the case of a new

technology such as CAPD, because of cost incentives offered by industrial suppliers. Nearly 4,000

patients have dual entitlement to coverage by the

Veterans Administration and by the ESRD program. ESRD reimbursements for these individuals, naturally, would be low. Data files do not

permit identification and exclusion of these patients.

Finally, some bills submitted by providers may

not be recorded in the Part B data system. Even

though physicians have been instructed to submit all bills for ESRD patients to this system, they

may not always do so.

Whatever their explanations, discrepancies between projected dialysis costs and actual costs deTable 6-4.—Comparisons of the Estimated Costs of Dialysis From Different Data Sources by Dialysis Modality

Cost audits (1980-81) Medicare ESRD

Average Medicare reimbursements under

Dialysis type HCFAa GAOa

reimbursement rates (1982) Part B (1981 -82)b

Center HDC:

Hospital center . . . . . . . . . . . $21,060 — $24,804 $16,915

Independent center . . . . . . . 16,848 — 21,528 16,915

Home HD . . . . . . . . . . . . . . . . . . 13,572 16,068 — 12,024

CAPD . . . . . . . . . . . . . . . . . . . . . 17,784 17,160 — 7,631

aEXcludeS physjclan Services not billed through the facility.

bEStimateS are for patients who continue on a single form of dialysis for at least 2 years and include physician services

cMedlcare part B data did not permit differentiation of center H D by whether It was performed in a hospital or independent dlalysls center.

SOURCE Off Ice of Technology Assessment
56

I

I

1

I

(

I

I

I

1

I

I

I

I

I

I

termined from the ESRD data system require fur- the 18 months of observation than center HD pather evaluation, especially in the case of CAPD. tients (76 vs. 69 percent), and patients on home

HD were least likely to have been hospitalized (58

Rates and Costs of Hospitalization percent).

Patients on any one dialysis modality who sur- Hospital days per patient-year among survivors

vived averaged slightly over one hospitalization on a single dialysis modality were higher for center

per patient-year (table 6-5), Patients who changed HD (11.9 days) than either CAPD (10.6 days) or

dialysis modality or died had nearly double these home HD (8.9 days) (table 6-6). These hospitalirates of hospitalization. Somewhat more CAPD zation rates are lower than those reported in chappatients had at least one hospitalization during ter 4, because they are for patients who are on

Table 6-5.—Mean Frequency of Hospitalizations by Clinical Subgroup and Dialysis Modality

All patients

Mean number of

hospitalizations

Clinical and dialysis subgroups Number per patient-year

Continuous dialysis on a single modality and survived:

Center HD . . . . . . . . . . . . . . . . . . . . 20,192 1.3

Home HD. . . . . . . . . . . . . . . . . . . . . 418 1.0

CAPD . . . . . . . . . . . . . . . . . . . . . . . . 357 1.3

Single change of dialysis modality and survived:

CAPD to center HD . . . . . . . . . . . . 108 2.4

Center HD to CAPD . . . . . . . . . . . . 388 2.3

CAPD to home HD. . . . . . . . . . . . . 9 1.3

Home HD to CAPD . . . . . . . . . . . . 49 1.6

Continuous dialysis on a single modality but died:

Center HD . . . . . . . . . . . . . . . . . . . . 1,499 2.5

Home HD. . . . . . . . . . . . . . . . . . . . . 21 2.1

CAPD . . . . . . . . . . . . . . . . . . . . . . . . 29 2.4

Patients with one or more hospitalization

Mean number of

Percent of all hospitalizations

patients per patient-year

690/o 1.9

58 1.7

76 1.7

96 2.5

93 2.5

78 1.7

84 2.0

94 2.7

81 2.6

90 2.7

%enter HD may be at either a hospital or independent dialysis center. Home HD and CAPD are supervised by a hospital, independent center or, rarely, by individual

physicians.

SOURCE: Office of Technology Assessment.

Table 6-6.—Mean Number of Hospital Days and Estimated Hospital Costs per

Patient-Year by Clinical Subgroup and Dialysis Modality

Patients with one or

All patients more hospitalization

Hospital days per Annual hospital Hospital days per

Clinical and dialysis subgroups patient-year costs patient-year

Continuous dialysis on a single modality and survived:

Center HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.9 $3,342 17.1

Home HD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.9 2,443 15.3

CAPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10.6 2,953 14.0

Singe change of dialysis modality and survived:

CAPD to center HD . . . . . . . . . . . . . . . . . . . . 23.1 6,655 23.9

Center HD to CAPD . . . . . . . . . . . . . . . . . . . . 17.6 5,151 18.9

CAPD to home HD . . . . . . . . . . . . . . . . . . . . . 9.9 2,806 12.8

Home HD to CAPD . . . . . . . . . . . . . . . . . . . . 11.4 3,340 13.7

Continuous dialysis on a single modality but died:

Center HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31.1 9,205 33.2

Home HD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.4 6,403 26.5

CAPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26.0 7,763 29.0

acenter l+D may be at either a hospital or independent dialysis center. Home HD and CApD are supewised by a hospital, independent center or, rarely, by individual

physicians.

SOURCE: Office of Technology Assessment.
—

57

continuous dialysis and exclude hospitalizations

related to startup of dialysis or change in modality. Patients changing from CAPD to center HD

had more hospital days than those changing from

center HD to CAPD or from home HD to CAPD

(23.1, 17.6, and 11.4 days, respectively). Patients

who remained on a single dialysis modality, but

died, were hospitalized between two and three

times as many days as their surviving counterparts. Distributions of lengths of hospital stays

are shown in table 6-7. The highest proportions

of patients with long periods of hospitalization

occur in the group changing from CAPD to center HD and in nonsurvivors.

In nonsurvivors, hospitalization rates in the last

3 months of life were three times those experienced

earlier in the last year in life, but during the

preceding months were more than twice those in

stable survivors. This pattern of increasing hospital utilization reflects the crescendo of complications and medical interventions that often precede death.

Annual hospital costs directly reflect lengths of

stay because of the assumption that the average

Medicare per diem rate applies to each hospital

day (table 6-8). Hence, any differences between

patient groups in the intensity of care required,

Table 6-7.—Distribution of Lengths of Hospital Stay by Clinical Subgroup and Dialysis Modality

Days per patient-yearb

Clinical and dialysis subgroups Number O 1-3 4-6 7-9 10-19 20-29 ‘30-39 40-49 50-59 >60

Continuous dialysis on a single modality and survived:

Center HD . . . . . . . . . . . . . . . . . . . . 20,192 31% 14% 12% 7% 17% 80/0 5% 3% 2% 30/0

Home HD. . . . . . . . . . . . . . . . . . . . . 418 42 11 13 5 14 7 3 3 1 2

CAPD . . . . . . . . . . . . . . . . . . . . . . . . 357 24 16 18 9 17 8 4 1 3 1

Single change of dialysis modality and survived:

CAPD to center HD . . . . . . . . . . . . 108 4 9 9 7 23 19 14 7 5 4

Center HD to CAPD . . . . . . . . . . . . 388 7 11 14 12 23 14 7 6 3 3

CAPD to home HD. . . . . . . . . . . . . 9 22 11 11 11 33 11 0 0 0 0

Home HD to CAPD . . . . . . . . . . . . 49 16 12 12 14 25 14 4 0 2 0

Continuous dialysis on a single modality but died:

Center HD . . . . . . . . . . . . . . . . . . . . 1,499 6 6 6 6 19 15 12 9 6 15

Home HD. . . . . . . . . . . . . . . . . . . . . 21 19 0 5 10 19 24 14 5 0 5

CAPD . . . . . . . . . . . . . . . . . . . . . . . . 29 10 4 4 7 28 4 17 17 7 4

acenter H D may be at either a hospital or Independent dlalysls center Home H D and CAPD are supervised by a hospital, independent center or rarelY by I ndlvldual

physicians

bRows may not add to 100 percent because of rounding

SOURCE Off Ice of Technology Assessment

Table 6-8.—Total Costs of Care Per Patient-Year by Clinical Subgroup and Dialysis Modality

Costs of dialysis and costs of

Clinical and dialysis subgroups physician servicesb

hospitalization Total costs

Continuous dialysis on a single modality and survived:

Center HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $16,915 $3,342 $20,257

Home HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12,024 2,443 14,485

CAPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7,631 2,953 10,584

Single change of dialysis modality and survived:

CAPD to center HD . . . . . . . . . . . . . . . . . . . . . . . . . 13,604 6,655 20,259

Center HD to CAPD . . . . . . . . . . . . . . . . . . . . . . . . . 13,186 5,151 18,337

CAPD to home HD . . . . . . . . . . . . . . . . . . . . . . . . . . 6,664 2,806 9,470

Home HD to CAPD . . . . . . . . . . . . . . . . . . . . . . . . . . 9,533 3,340 12,873

Continuous dialysis on a single modality but died:

Center HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17,608 9,205 26,813

Home HD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14,594 6,403 20,997

CAPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7,573 7,763 15,336

‘Center HD may be at either a hospital or Independent dialysis center. Home HD and CAPD are supervised by a hospital, independent center or, rarely, by individual

physicians

bESRD reimbursements multiplied by 125 to ad)ust for the 20 percent coinsurance charged to the patient under Part B of the Medicare ESRD pro9ram

calculated Using adjusted average national Med!care Per diem rate

SOURCE Off Ice of Technology Assessment
58

operating room use, and diagnostic test requirements are not captured. Costs per year for hospital care range from $2,443 in patients continuously on home HD to $9,205 in patients on center

HD who die; and costs are slightly lower in patients continuously on CAPD than those who remain on center HD ($2,953 vs. $3,342 per year).

Total Costs of Care

The total cost of care per patient-year in “continuous survivors” was $20,257 for center HD,

$14,485 for home HD, and $10,584 for CAPD (table 6-8). Interpretation of the low figure for CAPD

I again must be tempered by concern over the relia1 bility of the unexpectedly low Part B reimburse- 1 ments recorded for this modality. Patients who 1

I changed from CAPD to center HD experienced

higher costs than for the reverse direction of

change ($20,259 vs. $18,337) due primarily to

differences in the cost of hospitalizations.

I

Total costs distribute widely. Higher proportions of patients with costs above $25,000 per patient year are notable for continuous survivors on

center HD, changes from CAPD to center HD or

the reverse, and for patients who die (table 6-9).

“Cost of Changing” Dialysis Modality

Estimated costs of changing dialysis modality

are shown in table 6-10. Predicted costs are those

that would have applied if the patient accrued

costs at the rates of patients on continuous dialysis by each of the dialysis modalities involved.

Change dates were used to time-weight predicted

costs. Total change costs range from $1,621 in patients who change from home HD to CAPD, and

to $4,922 for those who change from CAPD to

center HD. By far the largest contribution to the

costs of change involving CAPD and center HD

arise from additional days of hospitalization. No

doubt these days reflect both requirements to treat

complications of the previous treatment and those

to begin the new treatment. Results in the group

who changed from CAPD to home HD are suspect because of the small numbers of patients involved.

“Cost of Dying”

The incremental cost of dying, shown in table

6-11, ranges from $4,752 in patients on CAPD to

$6,556 in patients on center HD. These costs relate only to death in patients on a single modality of dialysis for 18 months prior to death and

exclude those whose terminal events led to either

a change in chronic dialysis modality or to transplantation.

Predictors of Hospitalization in

Survivors Who Continue on a

Single Dialysis Modality

Case-mix differences, as well as dialysis modality, may influence the need for hospitalization,

To examine the independent effects of sociodemoTable 6.9.—Distribution of Total Costs of Care per Patient-Year by Clinical Subgroup and Dialysis Modality

Clinical and $5,000- $10,000- $15,000- $20,000- $25,000- $30,000- $40,000-

dialysis subgroups Number <$5,000 9,999 14,999 19,999 24,999 29,999 39,999 49,999 >$50,000

Continuous dialysis on a single modality and survived:

Center HD . ................20,192 7% 16% 17% 13% 11 % 14 % 17% 4% 1%

Home HD . . . . . . . . . . . . . . . . . . 418 12 28 18 17 13 5 5 1 1

CAPD . . . . . . . . . . . . . . . . . . . . . 357 19 36 24 13 6 1 1 0 0

Single change of dialysis modality and survived:

CAPD to center HD . . . . . . . . . 108 5 11 21 18 12 12 18 3 0

Center HD to CAPD . . . . . . . . . 388 4 15 24 20 14 12 8 3 0

CAPD to home HD . . . . . . . . . . 9 0 56 33 11 0 0 0 0 0

Home HD to CAPD. . . . . . . . . . 49 16 21 27 16 14 6 0 0 0

Continuous dialysis on a single modality but died:

Center HD . . . . . . . . . . . . . . . . . 1,499 8 13 14 12 13 23 11 5

Home HD . . . . . . . . . . . . . . . . . . 21 19 9 19 24 10 0 14 0

CAPD . . . . . . . . . . . . . . . . . . . . . 29 7 27 10 28 14 7 7 0 0

%enter HD may be at either a hospital or independent dialysis center. Home HD and CAPD are supervised by a hospital, independent center or, rarely, by individual

physicians

SOURCE: Office of Technology Assessment,
55

Table 6-10.—Mean Costs Per Patient-Year of a Single Change in the Modality of Dialysis Among Survivors

Dialysis change Number Actual Predicted Difference

Costs of dialysis and physician services:

CAPD to center HD . . . . . . . . . . . . . . . . . . . . . . . 108 $13,604 $12,599 $1,005

Center HD to CAPD . . . . . . . . . . . . . . . . . . . . . . 388 13,186 12,463 723

CAPD to home HD . . . . . . . . . . . . . . . . . . . . . . . 9 6,664 8,733 –2,069

Home HD to CAPD . . . . . . . . . . . . . . . . . . . . . . . 49 9,533 8,741 792

Hospitalization costs:

CAPD to center HD . . . . . . . . . . . . . . . . . . . . . . . 108 $6,655 $2,738 $3,917

Center HD to CAPD . . . . . . . . . . . . . . . . . . . . . . 388 5,151 2,681 2,470

CAPD to home HD . . . . . . . . . . . . . . . . . . . . . . . 9 2,806 2,333 473

Home HD to CAPD . . . . . . . . . . . . . . . . . . . . . . . 49 3,340 2,511 829

Total costs:

CAPD to center HD . . . . . . . . . . . . . . . . . . . . . . . 108 $20,259 $15,337 $4,922

Center HD to CAPD . . . . . . . . . . . . . . . . . . . . . . 388 18,337 15,144 3,193

CAPD to home HD . . . . . . . . . . . . . . . . . . . . . . . 9 9,470 11,066 – 1,596

Home HD to CAPD . . . . . . . . . . . . . . . . . . . . . . . 49 12,873 11,252 1,621

SOURCE Office of Technology Assessment.

Table 6-11 .—Mean Costs of Dying in Patients on a

Single Dialysis Modality

Total costs per patient-year

Dialysis modality Died Survived Difference

Center HD . . . . . . . . . $26,813 $20,257 $6,556

Home HD . . . . . . . . . . 20,997 14,485 6,512

CAPD . . . . . . . . . . . . . 15,336 10,584 4,752

SOURCE: Office of Technology Assessment

graphic characteristics, lengths of time on chronic

dialysis, and dialysis modality on days of hospitalization, a multiple regression analysis was performed using the number of hospital days during 18 months of observation as the dependent

variable (table 6-12). Longer length of time on dialysis and female gender were significantly associated (p < 0.05) with more days in the hospital.

Older age was less strongly associated (p < 0.06),

and race was not associated with longer periods

of hospitalization. After adjustment for these patient characteristics, home HD patients still experienced fewer hospital days, but no difference

in hospital days was seen between patients on

CAPD and center HD.

These findings reemphasize the importance of

case-mix differences in explaining differences in

costs and morbidity among patients on chronic

dialysis.

Table 6-12.—Predictors of Days of Hospitalization in Survivors on Continuous Dialysis by a Single Modalitya

Factor Coefficient Standard error F value Level of significance

Ageb

. . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.02103 0.01104 3.63 p <0.06

Sexc 

. . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.73479 0.32495 5.11 p <0.03

Raced 

. . . . . . . . . . . . . . . . . . . . . . . . . . . 0.07393 0.33034 0.05 p <0.83 n.s.

Length of time on dialysise 

. . . . . . . . 0.00038 0.00013 7.73 p <0.01

Dialysis groupf 

. . . . . . . . . . . . . . . . . . . 3.23 p <0.04

Home HD . . . . . . . . . . . . . . . . . . . . . –2.83343 1.16193 5.95 p <0.02

CAPD . . . . . . . . . . . . . . . . . . . . . . . . . –0.97231 1.25590 0.59 p <0.44 n.s.

Center HD. . . . . . . . . . . . . . . . . . . . . . . — — — —

apat1ent8 who continuedon a single rJla@ls rnodallty from 111181 to 12131182 and survived, persons with no hospitalizations are entered aS zero days sarnPlf3 siZeS

are: Center HD 20,192; home HD 418; CAPD 357.

bAs of 711181.

cFemale = 1; male = O.

dNOn.White = 1; white = O.

eLengthOf tin-te in ESRD program Prior to 111181.

fcornpared to center HD as referent.

SOURCE: Office of Technology Assessment.
60

DISCUSSION

This analysis of Medicare ESRD reimbursement

data provides the only available estimates of actual expenditures for chronic renal dialysis which

distinguishes between the costs of dialysis itself

and those for associated hospitalizations. The focus on three distinct clinical populations—patients

who are able to continue for a prolonged period

of time on one dialysis modality and survive,

those who require a single change in modality,

and those who remain on a single modality but

die—facilitates cost comparisons by creating relatively homogeneous subgroups. Costs of continuous dialysis, costs associated with changing dialysis modality, and the added costs incurred by

ESRD patients who die, therefore, can be estimated.

The costs of dialysis alone estimated from

ESRD reimbursement data differ substantially

from those projected from cost audits or average

ESRD program reimbursement rates (table 6-4).

Despite the vagaries of these comparisons the following conclusions seem warranted:

●

●

●

Hemodialysis in hospital centers is the most

expensive form of dialysis treatment.

Home HD appears less expensive than center HD, although much or all of the difference probably would be nullified if health

aides to assist with home dialysis treatments

were required or if opportunity costs were

assigned to the time family members must

spend learning and assisting the patient with

home HD.

The cost of CAPD is uncertain. Estimates

from Medicare ESRD program data are

markedly lower than those projected from

cost audits or from the prices of supplies and

equipment. One can only speculate on possible explanations for this discrepancy. Underreporting of dialysis costs in the Medicare

data system seems most likely.

Perhaps the most important finding of this

study is that patients who are able to remain on

CAPD experience no more days of hospitalization than those who continue on center HD (although more than patients on home HD). The

higher hospitalization rates for CAPD reported

in the literature, therefore, probably reflect days

of hospitalization related to startup of dialysis or

early failures.

This result, coupled with the demonstration of

the high costs associated with changing dialysis

modalities, underscores the importance of carefully selecting those patients most likely to succeed on a given treatment modality. Public policy decisions on financial incentives for one or

another type of dialysis treatment need to take

into account the likelihood of changes in treatment modality and the cost of change.

Finally, this study demonstrates the effects of

patient characteristics, such as sex, age, and total length of time on dialysis, on the need for hospitalization. Case-mix differences have important

effects on hospitalization rates, and hence, on the

costs of ESRD treatment and on survival that are

independent of the dialysis modality. To facilitate valid comparisons, future cost studies need

to include consideration of differences in population characteristics.

The total costs of care for ESRD patients estimated in this analysis are similar to those by Eggers (12) using 1979 Medicare ESRD data (table

6-13). The slightly lower costs in the 1981-82 data,

despite inflation, are probably due to the fact that

the figures were obtained in clinically stable

patients and exclude the additional costs of dying or changing from one dialysis modality to

another.

The limitations of this analysis of Medicare

ESRD reimbursement data need to be acknowledged. These limitations relate both to the fact

that the patient samples used in the analysis were

Table 6-13.—Estimated Total Costs Per

Patient-Year of Care by Modality of Dialysis

Medicare (ESRD) data

Dialysis modality 1 979a

1981-82

Center HD. . . . . . . . . . . . . . . $23,562 $20,257

Home HD . . . . . . . . . . . . . . . 18,629 14,485

CAPD . . . . . . . . . . . . . . . . . . . – 10,584

ap,w, Eggers, unpublished paper on the ESRD program, Office Of Research and

Demonstration, Health Care Financing Administration, U.S. Department of

Health and Human Services, 1983.

SOURCE: Office of Technology Assessment
61

selected subsets of the ESRD population and to

deficiencies of the Medicare ESRD medical information system.

Patients were included in the analysis only if

they had remained on one or another dialysis modality for at least 1 year; hence, early procedure

failures and patients newly enrolled in the ESRD

program were excluded. Similarly excluded were

patients who had previously undergone renal

transplantations and those with multiple changes

in dialysis modality. The rationale was to focus

attention on the costs of treatment in groups that

were relatively homogeneous in terms of the clinical course of dialysis. The tradeoff is that the results can be generalized only to about two-thirds

of ESRD program beneficiaries on chronic dialysis.

Deficiencies of the Medicare ESRD data system

include, first, that dates of change in dialysis modality are often inaccurate, and, hence, compromise calculations of the “cost of changing. ”

Second, significant delays are often experienced

in receiving or recording bills that are submitted.

The effects of this problem were minimized, so

far as hospital costs were concerned, by terminating the period of observation 3 months prior to

the end of 1982. Third, Part B reimbursements

are reported only in aggregate for the calendar

year and do not permit dissection either by their

rate of accrual during the year or according to

source (dialysis center, physician, commercial

supplier). The aberrant result for Part B CAPD

costs is particularly troublesome. Fourth, the extent to which the hospital per diem rates used to

estimate hospitalization costs also capture dialysis treatments in hospitals could not be ascertained.

Finally, information on patient characteristics

is limited. The primary ESRD diagnosis was available for only slightly more than 60 percent of patients, and no information was available on

comorbidity. This last deficiency compromised

the extent to which case-mix differences could be

explored. Relatively straightforward changes in

the Medicare ESRD data collection methods could

rectify many of these deficiencies and greatly facilitate future assessments of the ESRD program

and chronic renal dialysis in general.
Appendixes
Appendix A.—Acknowledgments and

Health Program Advisory Committee

The development of this case study was greatly aided by the advice of a number of people. The authors and

OTA staff would like to express their appreciation to the Medical Technology and Costs of the Medicare Program Advisory Panel, to the Health Program Advisory Committee, and especially to the following individuals:

Albert L. Babb

University of Washington

Seattle, WA

Christopher Blagg

Northwest Kidney Center

Seattle, WA

John D. Bower

The University of Mississippi

Jackson, MS

John P. Capelli

Our Lady of Lourdes Medical Center

Camden, NJ

Barbara Carmen

Boston, MA

Chiam Chary tan

Booth Memorial Medical Center

Flushing, NY

Morris Cullen

Kaiser-Permanente Medical Program

Oakland, CA

William V. Demboski

E.I. du Pont de Nemours & Co., Inc.

Wilmington, DE

Robert Doherty

Medical Services and Governmental Affairs

Washington, DC

Frank Doyle

Office of Reimbursement Policy

Health Care Financing Administration

Baltimore, MD

Paul Eggers

Office of Research

Health Care Financing Administration

Baltimore, MD

Roger W. Evans

Battelle Human Affairs Research Centers

Seattle, WA

Richard N. Fine

UCLA School of Medicine

Los Angeles, CA

Norwick B. H. Goodspeed

Travenol Laboratories, Inc.

Deerfield, IL

Philip J. Held

The Urban Institute

Washington, DC

Gladys H. Hirschman

National Institute of Arthritis, Diabetes, and

Digestive and Kidney Diseases

National Institutes of Health

Bethesda, MD

Nathan W. Levine

Henry Ford Hospital

Detroit, MI

Edmund Lowrie

National Medical Care, Inc.

Waltham, MA

John E. Marshall

National Center for Health Services Research

Rockville, MD

Fitzhugh Mullan

Office of Medical Applications of Research

National Institutes of Health

Bethesda, MD

Karl D. Nolph

University of Missouri

Health Sciences Center

Columbia, MO

D. Oliver

Churchill Hospital

Oxford University

Oxford, England

Robert E, Read

E.I. du Pont de Nemours & Co., Inc.

Wilmington, DE

Lester B. Salans

National Institute of Arthritis, Diabetes, and

Digestive and Kidney Diseases

National Institutes of Health

Bethesda, MD

65
. .

I

I

I

66

Bernadette S. Schumaker John M. Weller

Bureau of Eligibility, Reimbursement, and University Hospital

Coverage Ann Arbor, MI

Health Care Financing Administration

Baltimore, MD

Steven M. Teutsch

Centers for Disease

Atlanta, GA

Anthony J. Wing

St. Thomas Hospital

London, England

Control

HEALTH PROGRAM ADVISORY COMMITTEE

Sidney S. Lee, Committee Chair

President, Milbank Memorial Fund

New York, NY

Stuart H. Altman*

Dean

Florence Heller School

Brandeis University Washington, DC

Patricia King

Professor

Georgetown Law Center

Waltham, MA Joyce C. Lashof

H. David Banta Dean

Consultant School of Public

World Health Organization University of

The Netherlands Berkeley, CA

Carroll L. Estes**

Chair

Department of Social and Behavioral Sciences

School of Nursing

University of California, San Francisco

San Francisco, CA

Rashi Fein

Professor

Department of Social Medicine and Health Policy

Harvard Medical School

Boston, MA

Harvey V. Fineberg

Dean

School of Public Health

Harvard University

Boston, MA

Melvin A. Glasser***

Director

Health Security Action Council

Committee for National Health Insurance

Washington, DC

Health

California, Berkeley

Alexander Leaf

Professor of Medicine

Harvard Medical School

Massachusetts General Hospital

Boston, MA

Margaret Mahoney*

President

The Commonwealth Fund

New York, NY

Frederick Mosteller

Professor and Chair

Department of Health Policy and Management

School of Public Health

Harvard University

Boston, MA

Norton Nelson

Professor

Department of Environmental Medicine

New York University Medical School

New York, NY

‘Until April 1983.

● *Until March 1s184.

● **Until &tober 1983. ● Until August 1983.
67

Robert Oseasohn University of California, San Francisco

Associate Dean San Francisco, CA

University of Texas, San Antonio

San Antonio, TX

Nora Piore

Senior Advisor

The Commonwealth Fund

New York, NY

Mitchell Rabkin**

President

Beth Israel Hospital

Boston, MA

Dorothy P. Rice

Regents Lecturer

Department of Social and Behavioral Sciences

School of Nursing

● ● Until April 1983.

Richard K. Riegelman

Associate Professor

George Washington

School of Medicine

Washington, DC

University

Walter L. Robb

Vice President and General Manager

Medical Systems Operations

General Electric Co.

Milwaukee, WI

Frederick C. Robbins

President

Institute of Medicine

Washington, DC

Rosemary Stevens

Professor

Department of History and Sociology of Science

University of Pennsylvania

Philadelphia, PA
Appendix B.— Glossary of Acronyms and Terms

Glossary of Acronyms

CAPD—continuous ambulatory peritoneal dialysis

CCPD—continuous cycling peritoneal dialysis

EDTA —European Dialysis and Transplant Association

ESRD —end-stage renal disease

GAO —General Accounting Office

HCFA —Health Care Financing Administration

HD —hemodialysis

IPD —intermittent peritoneal dialysis

NIH –National Institutes of Health

RCT —randomized clinical trial

SCD —sterile connection device

Glossary of Terms

Anticoagulant: Any substance that suppresses, delays,

or nullifies the coagulation or clotting of blood.

Arteriosclerotic: Pertaining to or affected with

arteriosclerosis. A group of diseases characterized

by thickening and loss of elasticity of arterial walls.

Arteriovenous: Pertaining to or affecting an artery and

a vein.

Ascites: The excessive accumulation of fluid in the

abdominal cavity.

Atherogenesis: The formulation of masses of

degenerated fatty or lipid material in the arterial

wall associated with atherosclerosis.

Cannula: A tube for insertion into a duct or cavity.

This is used to attain a continuous flow of liquid

into and out of an organ.

Cardiac arrhythmias: Variations from the normal rate

or rhythm of heart beats.

Dementia: A general designation for mental deterioration; also referred to as aphrenia, aphronesia, and

athymia.

Diabetic nephropathy: A disease of or an abnormal

state of the kidneys caused by diabetes.

Effectiveness: Same as efficacy except that it refers to

,,

. . . average or actual conditions of use. ”

Efficacy: The probability of benefit to individuals in

a defined population from a medical technology

applied for a given medical problem under ideal

conditions or use.

Electrolyte balance: The state in which the body has

the correct amount of positively and negatively

charged ions in its system.

End-stage renal disease: Chronic renal failure that

occurs when an individual irreversibly loses a

sufficient amount of kidney function so that life

cannot be sustained without treatment intervention.

Hemodialysis, continuous ambulatory peritoneal

dialysis, and kidney transplant surgery are forms

of therapy.

Fistula: An abnormal passage between two organs or

from an internal organ to the surface of the body.

Glomerulonephritis: Inflammation of the kidneys characterized by the inflammation of the capillary loops

in the glomeruli of the kidneys. It occurs in acute,

subacute, and chronic forms.

Hemorrhage: The escape of blood from the blood

vessels, either into surrounding tissues or into the

environment.

Heparin: A substance occurring in various tissues or

produced artificially that renders the blood unable

to coagulate.

Hydrothorax: An abnormal accumulation of watery

fluid within the pleural cavity.

Hypertension: A common and significant

cardiovascular disorder characterized by

persistently high arterial blood pressure, ranging

from 140 to 200 mm Hg systolic and 90 to 110 mm

Hg diastolic pressure.

Hypotension: Abnormally low blood pressure that is

seen in shock but not necessarily indicative of it.

Immunosuppressive: Pertaining to or inducing the artificial prevention or diminution of the immune response.

Incidence: The frequency of new occurrences of disease within a defined time interval. Incidence rate

is the number of new cases of specified disease

divided by the number of people in a population

over a specified period of time, usually 1 year.

Laparotomy: Surgical incision through the abdominal

section.

Medicare: A nationwide, federally administered health

insurance program authorized in 1965 to cover the

cost of hospitalization, medical care, and some related services for eligible persons over age 65,

persons receiving Social Security Disability Insurance payments for 2 years, and persons with endstage renal disease. Medicare consists of two separate, but coordinated programs—Hospital Insurance (Part A) Program and the Supplementary

Medical Insurance (Part B) Program. Health insurance protection is available to insured persons without regard to income.

Modality: A possible or preferred manner or procedure used in order to carry out a particular function.

Peritoneum: The smooth transparent serous

membrane that lines the cavity of the abdomen.

Peritonitis: Inflammation of the peritoneum.

Pleural effusion: The accumulation of fluid within the

pleural spaces that occurs either as a result of dis68
69

ease involving the pleurae (the serous membranes

investing the lungs and lining the thoracic cavity)

or as a result of diseases of other organs that affect

the dynamics of pleural fluid production.

Prevalence: In epidemiology, the number of cases of

disease, infected persons, or persons with disabilities

or some other condition, present at a particular time

and in relation to the size of the population. It is

a measure of morbidity at a point in time.

Prima facie: True, valid, or self-evident.

Serum triglycerides: Neutral fats synthesized from

carbohydrates for storage in animal fat cells.

Symbiosis: In parasitology, the living together or close

association of two dissimilar organisms.

Thrombosis: The formulation, development, or presence of a solid mass in a blood vessel or in the heart.

It is composed of fibrin, platelets, and, in most

instances, erythrocytes,

Uremia: The retention of excessive byproducts of

protein metabolism in the blood, and the toxic

condition produced thereby.

Uterine prolapse: Protrusion of the uterus through the

vaginal orifice.

Validity: A measure of the extent to which an observed

situation reflects the “true” situation,

Internal validity: A measure of the extent to which

study results reflect the true relationship of a

“risk factor” (e.g., treatment or technology) to

the outcome of interest in study subjects.

External validity: A measure of the extent to which

study results can be generalized to the population that is represented by individuals in the

study, assuming that the characters of that population are accurately specified.

Vascular access site: Pertaining to entry into the blood

vessel system.
—

References
References

1.

2.

3.

4.

5.

6.

7.

8

9.

10.

11,

Abbey, G. M., testimony of the Vice President of

Travenol Laboratories, Inc., before the 97th Congress of the United States, Second Session Hearing of the House of Representatives Subcommittee on Oversight of the Committee on Ways and

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