Kidney Failure and the Federal Government -- Copyright -- Acknowledgments -- Contents -- PART I Overview -- Summary -- THE CONGRESSIONAL CHARGE TO THE INSTITUTE OF MEDICINE -- BASIC ASSUMPTIONS -- ESRD PATIENTS AND THEIR TREATMENT -- ACCESS -- ETHICS -- THE PROVIDER COMMUNITY -- REIMBURSEMENT AND QUALITY -- Reimbursement Effects on Quality -- Outpatient Dialysis Reimbursement Issues -- Covered Services -- Rate-Setting and Payment Policy -- QUALITY ASSESSMENT AND ASSURANCE -- DATA SYSTEMS -- RESEARCH -- NOTES -- REFERENCES -- 1 Introduction -- THE CONGRESSIONAL CHARGE -- BASIC ASSUMPTIONS -- CONTEXT OF THIS STUDY -- STUDY METHODS -- THE ESRD PATIENT POPULATION -- NATIONAL EXPENDITURES FOR ESRD -- ORGANIZATION OF THE REPORT -- NOTES -- REFERENCES -- PART II Patients and Providers -- 2 Perspectives of ESRD Patients -- EXPERIENCES WITH RENAL FAILURE -- Patient Relationships with Physicians and Staff -- Patient Education -- Patient-Related Services -- Effect of Erythropoietin -- ECONOMIC EFFECTS OF KIDNEY FAILURE -- CONCLUSIONS -- NOTE -- REFERENCE -- 3 Ethical Issues -- PATIENT ACCEPTANCE CRITERIA -- WITHDRAWAL FROM TREATMENT -- Guidelines -- Advance Directives -- TREATING THE PROBLEM PATIENT -- CONCLUSIONS AND RECOMMENDATIONS. -- NOTES -- REFERENCES -- 4 The Patient Population -- INCIDENCE AND PREVALENCE -- COMPOSITION OF THE ESRD POPULATION -- MORTALITY ISSUES -- Unadjusted Mortality -- Adjusted Mortality -- Subgroup Mortality -- STATE AND REGIONAL MORTALITY DATA -- CROSS-NATIONAL MORTALITY DATA -- PROJECTIONS TO THE YEAR 20006 -- NOTES -- REFERENCES -- 5 The ESRD Patient Population: Special Groups -- PEDIATRIC PATIENTS -- ELDERLY ESRD PATIENTS -- DIABETIC PATIENTS -- HYPERTENSIVE PATIENTS -- Hypertension in the United States -- Relationship Between Hypertension and Hypertensive ESRD -- Epidemiology of ESRD Attributed to Hypertension.

Intervention -- MINORITY PATIENTS -- CONCLUSION -- NOTES -- REFERENCES -- 6 Structure of the Provider Community -- OVERVIEW -- Outpatient Dialysis Facilities -- Kidney Transplant Centers -- Pediatric Facilities -- CHANGING STRUCTURE OF THE OUTPATIENT DIALYSIS COMMUNITY -- Hospital-Based Versus Independent Providers9 -- Hospital-Based Providers -- Patients -- Independent Providers -- Outpatient Dialysis Facilities -- Not-For-Profit Versus For-Profit Providers11 -- Not-For-Profit Providers -- For-Profit Providers -- Size of Outpatient Dialysis Facilities12 -- Facility Ownership -- CONCLUSIONS -- NOTES -- REFERENCES -- PART III Access -- 7 Access Problems of ESRD Patients -- ESRD PATIENTS NOT ELIGIBLE FOR MEDICARE -- Who Are the Reported Noneligibles? -- Magnitude of the Problem -- Geographic Variations -- Payment Sources -- State Medicaid Programs -- State Kidney Programs -- Other ESRD Programs -- Conclusions and Recommendations -- MEDICARE-ELIGIBLE ESRD PATIENTS -- Pediatric Patients -- Elderly Patients -- Barriers to Access -- Information -- Insurance -- Transportation -- Rehabilitation Services -- Preventive Services -- STATE REGULATIONS -- Specific Limits to Access and Geographic Variations -- Implications of Regulations for Access and Quality -- NOTES -- REFERENCES -- 8 Access to Kidney Transplantation -- OVERVIEW -- THE MEDICARE KIDNEY TRANSPLANT BENEFIT -- DISTRIBUTION OF KIDNEY TRANSPLANTS -- SUPPLY OF DONOR ORGANS -- CONCLUSIONS AND RECOMMENDATIONS -- NOTES -- REFERENCES -- PART IV Reimbursement and Quality -- 9 Medicare ESRD Payment Policy -- KIDNEY TRANSPLANT SERVICES -- Renal Transplant Center Reimbursement -- Physician and Medication Reimbursement -- OUTPATIENT DIALYSIS SERVICES -- Facility Reimbursement -- Historical Overview -- Current Policy -- Special Provisions for Home Dialysis.

Special Provisions for Recombinant Human Erythropoietin (EPO) -- Physician Reimbursement -- INPATIENT DIALYSIS SERVICES -- Hospital Reimbursement -- Physician Reimbursement -- NOTES -- REFERENCES -- 10 Reimbursement Effects on Quality -- EFFECTS OF REIMBURSEMENT ON MORTALITY -- Assessing the Effects of Reimbursement on Mortality -- EFFECTS OF REIMBURSEMENT ON HOSPITALIZATION -- EFFECTS OF REIMBURSEMENT ON UNIT STAFFING -- What Factors Are Causing These Changes? -- What Are the Consequences of These Staffing Changes? -- Nurses -- Technicians -- Social Workers -- Dietitians -- Implications of Changing Staff Patterns for Quality -- EFFECTS OF REIMBURSEMENT ON INNOVATION -- Hemodialysis -- Peritoneal Dialysis -- Dialysis Research Support -- SUMMARY -- CONCLUSIONS -- NOTES -- References -- 11 Outpatient Dialysis Reimbursement Issues -- COVERED SERVICES IN THE COMPOSITE RATE -- THE RATE-SETTING PROCESS -- Timeliness of Cost Data -- Sampling Versus the Universe -- Medicare Part A Cost Principles -- The Calculation of Cost per Treatment -- Oversight of the Rate-Setting Process -- FACILITY PAYMENT POLICY ISSUES -- Level of Payment -- Dual Composite Rate -- Rebasing and Updating -- Inflation (or Market Basket) -- Patient Complexity (Case Mix) -- Technological Advances and Productivity -- Methods for Rebasing and Updating -- Labor Portion of the Composite Rate -- PHYSICIAN PAYMENT POLICY ISSUES -- CONCLUSIONS AND RECOMMENDATIONS -- NOTES -- REFERENCES -- APPENDIX 1 -- APPENDIX 2 -- Dissenting View of C.R. Neu -- Note -- 12 Quality Assessment and Assurance -- PRINCIPLES OF QA -- THINKING ABOUT QUALITY -- Structure -- Process -- Outcomes -- Outcomes and Process and Structure -- Proximate Clinical Indicators -- Functional-and Health-Status Assessments -- Patient Satisfaction -- Quality of Life -- Adjustment for Patient Complexity.

RESPONSIBILITIES OF FEDERAL AGENCIES -- Public Health Service -- Centers for Disease Control -- Food and Drug Administration -- National Institutes of Health -- Agency for Health Care Policy and Research -- Health Care Financing Administration -- Conditions of Coverage -- State Survey Process -- HSQB and the ESRD Networks -- Bureau of Policy Development -- Office of Research and Demonstrations -- Coordination Within HCFA -- Quality Assessment and Assurance Data Needs -- CONTINUOUS QUALITY IMPROVEMENT -- The Dialysis Facility: Practical Considerations -- Examples of ESRD Quality Assurance -- CONCLUSIONS AND RECOMMENDATIONS -- NOTES -- REFERENCES -- APPENDIX 1 QUALITY OF CARE IN ESRD: AN EXAMPLE OF A PROXIMATE CLINICAL INDICATOR -- Treating Anemia in Dialysis Patients1 -- Potential Use as an Outcome Indicator -- Potential Use as Process Indicators -- NOTE -- References -- APPENDIX 2 EXAMPLES OF ESRD QUALITY ASSURANCE -- Dialysis Clinic, Inc., Cincinnati (DCI-C) -- Greenfield Health Systems -- National Medical Care, Inc. (NMC) -- Reference -- PART V Data And Research -- 13 Data Systems -- HEALTH CARE FINANCING ADMINISTRATION -- U.S. RENAL DATA SYSTEM -- UNITED NETWORK FOR ORGAN SHARING -- NATIONAL END-STAGE RENAL DISEASE REGISTRY -- ADEQUACY OF DATA SYSTEMS -- RECOMMENDATIONS -- NOTES -- REFERENCES -- 14 Research Needs -- REFERENCES -- APPENDIXES -- A Glossary -- B Acronyms and Initialisms -- C Commissioned Papers and Contractor Reports -- Intergovernmental Health Policy Project, George Washington University -- Medical Media Associates, Inc. -- Urban Institute -- D Survival Analysis Methods for the End-Stage Renal Disease (ESRD) Program of Medicare -- GENERAL ISSUES IN SURVIVAL ANALYSIS -- Overview -- Examples -- Identification of the Study Population -- The Importance of a Comparison Group -- Biased Comparisons.

Interpreting Standard Errors for Population Data -- Accounting for Random Variation -- Important Versus Significant -- Analysis of Provider Versus Patient -- Choice of Parameter for Mortality Summaries -- Type I and Type II Error Issues -- Projections and Extrapolations -- Accuracy of Counts -- ADJUSTING MORTALITY ANALYSES FOR PATIENT CHARACTERISTICS -- Patient Characteristics Related to Mortality -- Currently Available Data -- Unavailable or Difficult-to-Evaluate Data -- Multivariable Methods -- Stratification -- Modeling -- Simultaneous Effects of Variables -- Constraints on the Adjustment Process -- STATISTICAL METHODS OF ANALYSIS FOR ESRD MORTALITY DATA -- Descriptive Parameters for One Group -- Death Proportions -- Death Rates -- Survival Curves -- Expected Lifetimes -- Comparative Parameters -- Regression Models -- Specific Models and Methods -- Poisson Regression for Death Rates -- Cox Models for Relative Rates and Survival Functions -- Logistic Regression for the Probability of Death -- Conditional Logistic Regression and Sampling from the Risk Set -- Fully Parametric Models -- Prevalent Versus Incident Cohort Analyses -- Frailty -- Treatment Modality -- Publication of Standard Death Rates -- Institutional Characteristics -- Internal and External Standardization -- INTERNATIONAL COMPARISONS -- Limitations -- Etiology -- Age -- Withdrawal Rates -- Patient Follow-up -- Directions for Further Research -- REFERENCES -- E Institute of Medicine ESRD Study Committee Public Hearing, May 5, 1989, Chicago, Illinois -- List of Participants -- F Institute of Medicine ESRD Study Committee Public Hearing on ''Issues in Dialysis Reimbursement Reimbursement Rate-Setting -- List of Participants -- G Institute of Medicine ESRD Study Committee Workshop on ESRD Staffing, November 3, 1989, Washington, D.C. -- List of Participants.

H Institute of Medicine ESRD Study Committee Workshop on Kidney Transplantation, December 13, 1989, Washington, D.C.