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united states renal data system 2011 USRDS ANNUAL DATA REPORT volume two atlas of end-stage renal disease in the united states NATIONAL INSTITUTES OF HEALTH NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES DIVISION OF KIDNEY, UROLOGIC, & HEMATOLOGIC DISEASES
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Page 1: united states renal data system DATA REPORT 2011 … states renal data system DATA REPORT2011 USRDS ANNUAL volume two atlas of end-stage renal disease in the united states ... Carole

united states renal data system

2011 USRDS ANNUALDATA REPORTvolume twoatlas of end-stage renal disease in the united states

NATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASESDIVISION OF KIDNEY, UROLOGIC, & HEMATOLOGIC DISEASES

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CONTENTS

précis » an introduction to ckd in the u.s. 27

1 ckd in the general population 37

2 identification and care of patients with ckd 45

3 morbidity and mortality in patients with ckd 59

4 cardiovascular disease in patients with ckd 69

5 prescription drug coverage 77

6 costs of ckd 91reference tables: ckd 101

analytical methods: ckd 119

chapter details 132list of esrd figures and tables

appearing each year 134esrd program highlights 136overview of esrd in the u.s. 138overview of infection and

hospitalization 140

introduction 142précis » an introduction

to esrd in the u.s. 147healthy people 2020 1671 incidence, prevalence,

patient characteristics, and modalities 183

2 clinical indicators and preventive care 195

3 hospitalization 2054 cardiovascular disease 2175 mortality 2256 prescription drug

coverage 233

7 transplantation 2478 pediatric esrd 2579 special studies 26710 esrd providers 27111 costs of esrd 28112 international comparisons 291reference tables: esrd 303

analytical methods: esrd 371usrds products and services 400glossary 406cms forms 411colophon 418

data requests 400data release agreement 409

page130

volume twoESRD

volume oneCKD

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page131

My life has been a tapestry of rich and royal hue

An everlasting vision of the ever-changing view

A wondrous, woven magic in bits of blue and gold

A tapestry to feel and see, impossible to hold

Carole King, “Tapestry”

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chapterdetails

précis an introduction to esrd in the u.s. » 147

healthy people 2020 » 167recommended care among patients with aki, diabetes, and ckd; acei/arb treatment; esrd incidence; kidney failure due to diabetes; nephrologist care; vascular access; transplantation; mortality

1 incidence, prevalence, patient characteristics, and treatment modalities » 183incident counts and rates; prevalent counts and rates; incident and prevalent modality; patient care prior to initiation; anemia; laboratory values

2 clinical indicators and preventive care » 195anemia treatment; preventive care; vascular access; medicare part d use

3 hospitalization » 205overall hospitalization; rehospitalization; infectious hospitalization by major organ system; hospitalization in matched dialysis populations

4 cardiovascular disease » 217mortality; drug therapy

5 mortality » 225mortality; survival; mortality in the general and esrd populations

6 prescription drug coverage » 233medicare part d enrollment patterns; medicare part d coverage plans; overall costs of part d enrollment; coverage phase analyses for part d enrollees; medicare part d prescription drug use and costs

7 transplantation » 247wait list; donation; transplant; outcomes; follow-up care

8 pediatric esrd » 257esrd diagnosis in the pediatric population; infections; vaccinations; hospitalization; mortality

9 nutrition, rehabilitation/quality of life, and cardiovascular special studies » 267active/adipose: a cohort study to investigate the value of exercise in esrd/analyses designed to investigate the paradox of obesity and survival in esrd

10 esrd providers » 271provider growth; anemia treatment; preventive care; costs for intervention; standardized hospitalization and mortality ratios

11 costs of esrd » 281overall costs of esrd and injectables; racial differences; matched and unmatched dialysis populations; medicare part d costs

12 international comparisons » 291worldwide view of the incidence of esrd; incidence of esrd; prevalence of esrd; dialysis; transplantation

reference tables: esrd » 303

volume one ckdprécis » an introduction to ckd in the u.s. » 27

1 ckd in the general population » 37 strategies for

identifying ckd; comorbidity; awareness, treatment,

and control of disease conditions; mortality

2 identification and care of patients with ckd » 45 prevalence of

recognized ckd; laboratory testing of patients at risk for ckd;

probability and odds of a ckd diagnosis code; probability and odds of

seeing a physician post-ckd diagnosis; prescription drug therapy

3 morbidity and mortality in patients with ckd » 59 hospitalization rates

in ckd and non-ckd patients; infectious hospitalizations; mortality rates

4 cardiovascular disease in patients with ckd » 69

rates of cardiovascular disease; drug therapy

in patients with cardiovascular disease

5 prescription drug coverage » 77 medicare part d enrollment

patterns in patients with ckd; medicare part d coverage plans;

overall costs of part d enrollment; coverage phase analyses for

part d enrollees; medicare part d prescription drug use and costs

6 costs of ckd » 91 overall costs of ckd; components

of costs for ckd; medicare part d costs

reference tables: ckd » 101

page132

volume twoESRD

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page133

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ESRD DATAAPPEARING EACH YEAR IN THE ADR

précis p.1 Distribution of general Medicare pts & costs for CKD, CHF, diabetes, & ESRDp.a Summary statistics on reported ESRD therapy in the U.S.p.2 Counts of new & returning dialysis patientsp.3 Patient counts, by modality

chapter one 1.1 Incident & prevalent patient counts, by modality1.3, 1.9 Adj. rates of ESRD & annual percent change1.4, 1.10 Geographic variations in adj. rates of ESRD1.5–8 Incident counts & adj. rates of ESRD, by

age, race, ethnicity, & primary diagnosis1.11–14 Prevalent counts & adj. rates of ESRD, by

age, race, ethnicity, & primary diagnosis1.15–16 Patient distribution, by modality & payor1.19 Access use at first outpatient HD,

by pre-ESRD nephrology care1.20 Mean hemoglobin at initiation,

by pre-ESRD ESA treatment1.21 Patients initiating dialysis with hemoglobin <10 g/dl1.23 Patient distribution at initiation, by eGFR1.a–c Patient demographics & adj.

rates, by ESRD network1.d–e Counts & adj. rates of ESRD, by modality, age,

gender, race, ethnicity, & primary diagnosis1.f Pre-ESRD nephrologist care1.g Patients initiating dialysis with laboratory

values outside the normal limit

chapter two 2.2 Patient distribution, by mean monthly hemoglobin2.3 Mean monthly hemoglobin

& mean EPO dose per week2.4 Mean monthly hemoglobin after initiation2.5 Mean EPO dose per week after initiation2.6–7 IV iron in the first six months of dialysis2.8–11 Preventive care in ESRD patients with diabetes2.17 Part D-enrolled ESRD patients on antihypertensives2.a Vaccination rates2.b–c Access use, events, & complications

in prevalent dialysis patients

chapter three 3.1 Change in adj. all-cause & cause-specific

hospitalization rates, by modality 3.2–3 Adj. admission rates & days, by principal diagnosis & modality3.4 Cause-specific rehospitalization rates

30 days post live hospital discharge3.a All-cause & cause-specific hospitalization rates in HD patients3.b Adj. rates of rehospitalization & rates of death or rehospitalization,

by principal diagnosis of index hospitalization3.d Unadj. all-cause & cause-specific first-year hospitalization

rates in matched incident HD & PD patients

chapter four4.2, 4.a Unadj. cardiovascular mortality rates in prevalent dialysis patients4.b Cardiovascular disease & pharmacological interventions,

by diagnosis & modality

chapter five5.1 Adj. mortality (from day 90), by modality & year of treatment 5.3 Adj. mortality (from day one) in the first year of HD5.4 Adj. mortality in prevalent HD patients, by vintage5.6 Adj. mortality in the ESRD & general populations, by age5.a Adj. five-year survival probabilities, from

day one, in the incident ESRD population5.b Mortality rates in the ESRD & general Medicare populations

chapter six 6.1–2 Sources of prescription drug coverage in Medicare enrollees6.6 Patients enrolled in Medicare Part D, by dual eligibility & LIS status6.12 Medicare Part D non-LIS enrollees with gap

coverage or no deductible, by modality6.14 Total estimated net payment for Medicare Part D enrollees6.15 PPPY Medicare & out-of-pocket costs for Part D enrollees6.20 Part D non-LIS enrollees who reach each coverage phase6.a Twelve-month probability of reaching the

coverage gap in Part D non-LIS enrollees6.c–d Top 25 drugs used by Part D-enrolled patients,

by frequency & cost

chapter seven 7.1 Trends in transplantation 7.2 Patients wait-listed or receiving a deceased donor

transplant within one year of initiation7.8 Likelihood of dying while awaiting transplant7.9 Cumulative incidence of transfusion in wait-listed patients, by PRA7.10 Donation rates7.12, 7.14 Deceased & living donor transplants 7.17–18 Transplant outcomes

page134

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page135

7.19 Acute rejection within the first year post-transplant7.22 Primary diagnoses of cardiac & infectious hospitalizations post-transplant 7.23–24 Cumulative incidence of PTLD & diabetes7.25 Adj. rate of outcomes after transplant7.26 Causes of death with function7.27–28 Immunosuppression & induction antibody use7.29–31 Medication use in the first six months post-transplant7.32 Follow-up care & screening in the first 12 months

post-transplant, by age

chapter eight8.1 Incident & prevalent counts & adj. rates in the pediatric

ESRD population, by primary diagnosis8.a Distribution of incident ESRD pediatric patients, by primary diagnosis8.2–4 Rates of hospitalization in pediatric patients8.5–6 Vaccination rates in pediatric patients8.10 Adj. all-cause mortality rates in pediatric

patients in the first months of ESRD8.13 Adj. five-year survival in pediatric patients

chapter ten10.1 Distribution of patients, by unit affiliation10.3 Dialysis unit & patient counts, by unit affiliation10.4 Dialysis unit distribution, by affiliation & time managed10.5 Distribution of prevalent EPO-treated dialysis patients,

by hemoglobin level & unit affiliation10.6 IV iron use in dialysis patients, by type of iron & unit affiliation10.8 Mean total IV iron dose in the first six months of dialysis, by unit affiliation10.9 Dialysis patients with one or more transfusion events, by unit affiliation10.10–12 Preventive care in diabetic dialysis patients,

by unit affiliation & number of tests10.13–15 Vaccinations in dialysis patients, by unit affiliation10.16–17 PPPY costs for treatment & services in

dialysis patients, overall & by unit affiliation10.18–21 All-cause standardized hospitalization & mortality ratios

chapter eleven11.1 ESRD spending, by payor11.2 Costs of the Medicare & ESRD programs11.3 Estimated numbers of point prevalent ESRD patients11.4 Annual percent change in Medicare ESRD spending11.5 Total Medicare dollars spent on ESRD, by type of service11.6–7 Total Medicare ESRD expenditures overall & PPPY, by modality 11.9 Total Medicare spending for injectables 11.19 Total PPPY outpatient expenditures, by dialysis modality & race11.21–23 PPPY expenditures for ESAs, IV vitamin D, & IV iron11.26 Total Part D ESRD costs in the general Medicare & ESRD populations11.a Top 25 Part D prescription drugs used in the ESRD population

chapter twelve12.1 Comparison of unadjusted ESRD incidence & prevalence worldwide12.2 Geographic variations in the incidence of ESRD12.3, 12.a Incidence of ESRD12.4–5 Percentage of incident patients with ESRD due to diabetes12.6, 12.b Prevalence of ESRD12.7, 12.c Percent distribution of prevalent dialysis patients, by modality12.8, 12.d Prevalent rates of functioning grafts12.9, 12.e Transplant rates

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patients 116,395 number of new esrd

patients, 2009 TABLE P.A

355 adjusted rate of incident esrd, 2009 PER MILLION POPULATION; FIGURE 1.6WHITE 277 • AFRICAN AMERICAN 976 • NATIVE AMERICAN 523 • ASIAN 403

16 adjusted rate of incident esrd in pediatric patients, 2009 PER MILLION POPULATION; FIGURE 8.1

571,414 number of prevalent esrd patients, 2009 TABLE P.A

1,738 adjusted rate of prevalent esrd, 2009 PER MILLION POPULATION; FIGURE 1.12WHITE 1,279 • AFRICAN AMERICAN 5,284 • NATIVE AMERICAN 2,735 • ASIAN 2,101

86 adjusted rate of prevalent esrd in pediatric patients, 2009 PER MILLION POPULATION; FIGURE 8.1

72% prevalent hemodialysis patients enrolled

in medicare part d, 2008 FIGURE 6.5

53% prevalent transplant patients enrolled

in medicare part d, 2008 FIGURE 6.5

patient care 52%

patients with hemoglobin <10 g/dl at initiation, 2009 TABLE 1.G

73% diabetic patients receiving two or

more a1c tests, 2008–2009 FIGURE 2.8

58% diabetic patients receiving two or

more lipid tests, 2008–2009 FIGURE 2.9

20% diabetic patients receiving two or

more eye examinations, 2008–2009 FIGURE 2.10

14% patients using a fistula at first

outpatient dialysis, 2009 FIGURE 2.12

55% prevalent patients using

a fistula, 2007 TABLE 2.B

outcomes 1.9 adjusted all-cause admission rate, 2008–2009

ADMISSIONS PER PATIENT YEAR; TABLE 3.AWHITE 1.91 • AFRICAN AMERICAN 1.96 • OTHER RACE 1.53

532 adjusted cardiovascular admission rate for hemodialysis patients, 2009 ADMISSIONS PER 1,000 PATIENT YEARS; FIGURE 3.3

458 adjusted rate of admission for infection among hemodialysis patients, 2009 ADMISSIONS PER 1,000 PATIENT YEARS; FIGURE 3.3

220 adjusted all-cause first-year mortality among 2009 incident patients DEATHS PER 1,000 PATIENT YEARS AT RISK; FIGURE 5.1HEMODIALYSIS 233 • PERITONEAL DIALYSIS 134 • TRANSPLANT 57

204 adjusted all-cause fifth-year mortality among 2004 incident patients DEATHS PER 1,000 PATIENT YEARS AT RISK; FIGURE 5.1HEMODIALYSIS 246 • PERITONEAL DIALYSIS 253 • TRANSPLANT 62

0.32 adjusted five-year survival probability among white esrd patients incident in 2004 TABLE 5.A

0.38 adjusted five-year survival probability among african american esrd patients incident in 2004 TABLE 5.A

page136

programHIGHLIGHTS

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patient care 52%

patients with hemoglobin <10 g/dl at initiation, 2009 TABLE 1.G

73% diabetic patients receiving two or

more a1c tests, 2008–2009 FIGURE 2.8

58% diabetic patients receiving two or

more lipid tests, 2008–2009 FIGURE 2.9

20% diabetic patients receiving two or

more eye examinations, 2008–2009 FIGURE 2.10

14% patients using a fistula at first

outpatient dialysis, 2009 FIGURE 2.12

55% prevalent patients using

a fistula, 2007 TABLE 2.B

expenditures $29 billion total medicare esrd

expenditures, 2009 TABLE P.A

$82,285 total medicare expenditures per person per year for hemodialysis patients, 2009 TABLE P.A

$61,588 total medicare expenditures per person per year for peritoneal dialysis patients, 2009 TABLE P.A

$29,983 total medicare expenditures per person per year for transplant patients, 2009 TABLE P.A

$1.5 billion total estimated net part d payment for esrd patients, 2008 FIGURE 6.14HEMODIALYSIS $1.18 BILLION • PERITONEAL DIALYSIS $78 MILLION • TRANSPLANT $285 MILLION

$6,175 per person per year costs for erythropoiesis stimulating agents, 2009 FIGURE 10.17FRESENIUS $6,625 • DAVITA $6,470 • DCI $6,330 • SDO $5,782 • INDEPENDENT $5,635 • HOSPITAL-BASED $5,296

transplantation 17,736 total kidney transplants, 2009 TABLE P.A

DECEASED DONOR 11,291 • LIVING DONOR 6,388

22 rate of deceased donor kidney donation, 2009 PER MILLION POPULATION; FIGURE 7.10WHITE 21 • AFRICAN AMERICAN 26 • NATIVE AMERICAN 8.6 • ASIAN 9.6

23 rate of living donor kidney donation, 2009 PER MILLION POPULATION; FIGURE 7.10WHITE 23 • AFRICAN AMERICAN 22 • NATIVE AMERICAN 11 • ASIAN 14

2.5 adjusted rate of deceased donor kidney transplants, 2009 PER 100 DIALYSIS PATIENT YEARS; FIGURE 7.13WHITE 2.7 • AFRICAN AMERICAN 2.0 • ASIAN 3.6 • OTHER RACE 2.5

1.4 adjusted rate of living donor kidney donation, 2009 PER 100 DIALYSIS PATIENT YEARS; FIGURE 7.15WHITE 1.9 • AFRICAN AMERICAN 0.5 • ASIAN 3.0 • OTHER RACE 1.1

page137

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80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09

80 84 88 92 96 00 04 080

20,000

40,000

60,000

80,000

100,000

120,000

80 84 88 92 96 00 04 080

100,000

200,000

300,000

400,000

500,000

600,000

New patients

Omnibus Budget Reconciliation Act (OMBA) includes Medicare Secondary Payor provision

Composite rate payment system for dialysis becomes eff ective; cyclosporine introduced

1972 Congress authorizes medical coverage of ESRD1978 Congress authorizes creation of ESRD networks

EPO receives FDA approval; USRDS

publishes fi rst ADR

USRDS created

Center for Medicare & Medicaid Services (CMS) launches Fistula First initiative

New bundled prospective payment system for dialysis patients; implemented January 2011

U.S. Dept. of Health & Human Services develops Healthy People 2000 initiative

NIH begins National Kidney Disease Education Program (NKDEP)

United Network for Organ Sharing (UNOS) created

0,000 patients receive treatment for ESRD

Graphs: Figure 1.1Rates of new & existing patients: Figures 1. & 1.12Maps: Figures 1. & 1.10

1,00 patients receive treatment for ESRD

CMS adopts 2 new Clinical Performance Measures to

monitor the quality of care received by ESRD patients

UNOS begins to operate the Organ Procurement & Transplantation Network (OPTN)

National Kidney Foundation (NKF)

launches the Dialysis Outcomes Quality Initiative (KDOQI)

NKF publishes KDOQI guidelines; Health Care Financing Administration (HCFA) begins Hematocrit Measurement Audit program

enD-stAGe renAl dIseAse (ESRD)IN THE UNITED STATES

Total patientsMore than 116,000 people began treatment for end-stage renal disease (ESRD) in 2009.

U.S. patients newly diagnosed with ESRD

U.S. patients being treated for ESRD

per one million people in 2009

new patients

399

365

336

308

total patients

1,917

1,772

1,633

1,485

Nearly ten times more patients are now being treated for ESRD than in 1980.

19801 in 11,600

19801 in 3,450

20091 in 2,800

20091 in 575

85 88 91 94 97 00 03 06 09 0

100

200

300

Among dialysis patients, the adjusted number of deaths per 1,000 patient years at risk has fallen 24% since 1985.

2711985

2072009

0 50 100 150 200 250 300

Dialysis

Transplant

Generalpopulation

Age 65 & older: adjusted deaths per 1,000 patient years at risk

48

75

313

ESRD: 402,000 patients $23.3 billion 1%

Hemodialysis $82,285

Peritoneal dialysis 61,588

Transplant 29,983

New patients All patientsNew patients All patients

Large dialysis organizations—those owning 20 or more units

Small dialysis organizations

Units based in hospitals

Independently owned units

3,330 units

438 units

806 units

927 units

1,000 patients

Large dialysis organizationsSmall dialysis organizations—

those owning 20−199 units

Units based in hospitals

Independently owned units

3,511units605 units

796 units

848 units

1,000 patients

Mortality

2%Transplant

92%Hemodialysis

65%HemodialysisWhile most hemodialysis occurs in a dialysis unit, use of home hemodialysis is rising. In Australia and New Zealand, 9–16% of dialysis patients receive therapy at home.

5%Peritoneal dialysis

Diabetes & hypertension; race: Table p.aPie charts: Figure 1.1, Table 12.cTransplant wait list: Figures .1 & .

Mortality: Figures . & .2Unit ownership: Figure 10.1Costs: Figure p.1; Figure 11.

6%Peritonealdialysis

30%Transplant

Renal replacement therapyMost new patients begin therapy on hemodialysis.

And in the entire ESRD population, in 10 patients have a kidney transplant.

People are surviving longer on dialysis than in the past.

But mortality for dialysis patients is still far higher than in the general population.

Dialysis unit ownership

Costs of caring for patients with ESRD

total medicare spending

$289 billion

44% of new esrd cases have a primary diagnosis of diabetes28% have a primary diagnosis of hypertension

6 in 10 dialysis patients are treated in units owned by fresenius or davita

23,000 number of patients waiting for a kidney transplant in 1995

81,000 number waiting in 2009

2.3 yearsmedian time on transplant wait list

$42.5 billiontotal costs per year for esrd patient care

The rate of new esrd cases is 3.5 times higheramong african americans than among whites

1.3% of Medicare patients have esrd

They account for 8.1% of Medicare spending

Medicare spending per patient year, by type of renal replacement therapy

2011 USRDS ANNUAL DATA REPORT

volumeoneesrd

page138

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80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09

80 84 88 92 96 00 04 080

20,000

40,000

60,000

80,000

100,000

120,000

80 84 88 92 96 00 04 080

100,000

200,000

300,000

400,000

500,000

600,000

New patients

Omnibus Budget Reconciliation Act (OMBA) includes Medicare Secondary Payor provision

Composite rate payment system for dialysis becomes eff ective; cyclosporine introduced

1972 Congress authorizes medical coverage of ESRD1978 Congress authorizes creation of ESRD networks

EPO receives FDA approval; USRDS

publishes fi rst ADR

USRDS created

Center for Medicare & Medicaid Services (CMS) launches Fistula First initiative

New bundled prospective payment system for dialysis patients; implemented January 2011

U.S. Dept. of Health & Human Services develops Healthy People 2000 initiative

NIH begins National Kidney Disease Education Program (NKDEP)

United Network for Organ Sharing (UNOS) created

0,000 patients receive treatment for ESRD

Graphs: Figure 1.1Rates of new & existing patients: Figures 1. & 1.12Maps: Figures 1. & 1.10

1,00 patients receive treatment for ESRD

CMS adopts 2 new Clinical Performance Measures to

monitor the quality of care received by ESRD patients

UNOS begins to operate the Organ Procurement & Transplantation Network (OPTN)

National Kidney Foundation (NKF)

launches the Dialysis Outcomes Quality Initiative (KDOQI)

NKF publishes KDOQI guidelines; Health Care Financing Administration (HCFA) begins Hematocrit Measurement Audit program

enD-stAGe renAl dIseAse (ESRD)IN THE UNITED STATES

Total patientsMore than 116,000 people began treatment for end-stage renal disease (ESRD) in 2009.

U.S. patients newly diagnosed with ESRD

U.S. patients being treated for ESRD

per one million people in 2009

new patients

399

365

336

308

total patients

1,917

1,772

1,633

1,485

Nearly ten times more patients are now being treated for ESRD than in 1980.

19801 in 11,600

19801 in 3,450

20091 in 2,800

20091 in 575

85 88 91 94 97 00 03 06 09 0

100

200

300

Among dialysis patients, the adjusted number of deaths per 1,000 patient years at risk has fallen 24% since 1985.

2711985

2072009

0 50 100 150 200 250 300

Dialysis

Transplant

Generalpopulation

Age 65 & older: adjusted deaths per 1,000 patient years at risk

48

75

313

ESRD: 402,000 patients $23.3 billion 1%

Hemodialysis $82,285

Peritoneal dialysis 61,588

Transplant 29,983

New patients All patientsNew patients All patients

Large dialysis organizations—those owning 20 or more units

Small dialysis organizations

Units based in hospitals

Independently owned units

3,330 units

438 units

806 units

927 units

1,000 patients

Large dialysis organizationsSmall dialysis organizations—

those owning 20−199 units

Units based in hospitals

Independently owned units

3,511units605 units

796 units

848 units

1,000 patients

Mortality

2%Transplant

92%Hemodialysis

65%HemodialysisWhile most hemodialysis occurs in a dialysis unit, use of home hemodialysis is rising. In Australia and New Zealand, 9–16% of dialysis patients receive therapy at home.

5%Peritoneal dialysis

Diabetes & hypertension; race: Table p.aPie charts: Figure 1.1, Table 12.cTransplant wait list: Figures .1 & .

Mortality: Figures . & .2Unit ownership: Figure 10.1Costs: Figure p.1; Figure 11.

6%Peritonealdialysis

30%Transplant

Renal replacement therapyMost new patients begin therapy on hemodialysis.

And in the entire ESRD population, in 10 patients have a kidney transplant.

People are surviving longer on dialysis than in the past.

But mortality for dialysis patients is still far higher than in the general population.

Dialysis unit ownership

Costs of caring for patients with ESRD

total medicare spending

$289 billion

44% of new esrd cases have a primary diagnosis of diabetes28% have a primary diagnosis of hypertension

6 in 10 dialysis patients are treated in units owned by fresenius or davita

23,000 number of patients waiting for a kidney transplant in 1995

81,000 number waiting in 2009

2.3 yearsmedian time on transplant wait list

$42.5 billiontotal costs per year for esrd patient care

The rate of new esrd cases is 3.5 times higheramong african americans than among whites

1.3% of Medicare patients have esrd

They account for 8.1% of Medicare spending

Medicare spending per patient year, by type of renal replacement therapy

page139

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InfectIon and hosPItalIzatIonIN THE ESRD POPULATION

Patients with no nephrologist care prior to ESRD

82%

43%

Patients with at least one year of nephrologist care prior to ESRD

White African American

Many hospitalizations in hemodialysis patients are caused by vascular access complications

catheters are frequently used as an initial dialysisaccess. Their use, however, is associated with high rates

of infection and mortality

Among patients with a catheter, rates of vascular access infection are

4 times higherthan for those with a graft, and

8 times higherthan for those with a fi stula.*

Guidelines from the

KIDNEY DISEASE OUTCOMES QUALITY INITIATIVE (KDOQI), HEALTHY PEOPLE 2020, and the FISTULA FIRST initiative

recommend that catheter use be reduced, and that more patientsuse an arteriovenous fistula

Among all patients receiving hemodialysis therapy,

55% are using an arteriovenous fi stula

27% are using an arteriovenous graft, and

18%are using a catheter*

Catheter only Internal access (functional or maturing)

Vascular access among hemodialysis patients starting ESRD therapyPatients who see a nephrologist before ESRD are much less likely to have only a catheter at their fi rst hemodialysis session.

Vascular access at initiation: Figure 1.19Vascular access among all hemodialysis patients: Table 2.bInfection rates: Table 2.cMaps: Figure 2.1

*200 data; most recent available

Percent of hemodialysis patients using an internal access (fi stula or graft) at the start of ESRD therapy

percent of patients

20.5

18.8

17.0

15.3

0

50

100

150

In 2009, hemodialysis patients were hospitalized for vascular access infection at an adjusted rate of 109 admissions per 1,000 patient years.

591993

1092009

1362005

93 09050197

0 30 60 90 120

White

African American

Other race

Hispanic

Hospitalizations per 1,000 patient years

105

131

87

108

19938.7

18.1

14.9

Hospital days per year Hospitalization ratesPatients with ESRD are now spending fewer days each year in the hospital.

And all-cause hospitalization rates have fallen since 1993.

Transplant

Peritoneal dialysis

Hemodialysis

20095.7 days per year

11.8

11.9

-16%Transplant

-14%Peritoneal dialysis

-1.8%Hemodialysis

PERCENT CHANGE BETWEEN 1993 & 2009

But infection remains a major cause of hospitalizationand death among patients with ESRD

Since 1993, the rate of hospitalization due to

infection has increased 31% overall

-2.8%Transplant

3.1%Peritoneal dialysis

43%Hemodialysis

PERCENT CHANGE BETWEEN 1993 & 2009

Change in rates of hospitalization due to infection

Admissions for infection, per 1,000 patient years

236 transplant

573 peritoneal dialysis

458hemodialysis

Patients hospitalized for any infection

Patients hospitalized for a vascular access infection

Rehospitalization among hemodialysis patients

Hospital days: Figure .2Change in hospitalization rates: Figure .1Admissions: infection, vascular access: Figure .Vascular access hospitalizations by race: Table .cRehospitalization: Figure .

Adjusted rates of hospitalization for vascular access infection in hemodialysis patients, by race

The rate of hospitalization for vascular access infection in hemodialysis patients remains nearly twice as high as in 1993.

Patients rehospitalized within 30 days; alive

Patients rehospitalized within 30 days; died

Patients not rehospitalized within 30 days; died

1%

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InfectIon and hosPItalIzatIonIN THE ESRD POPULATION

Patients with no nephrologist care prior to ESRD

82%

43%

Patients with at least one year of nephrologist care prior to ESRD

White African American

Many hospitalizations in hemodialysis patients are caused by vascular access complications

catheters are frequently used as an initial dialysisaccess. Their use, however, is associated with high rates

of infection and mortality

Among patients with a catheter, rates of vascular access infection are

4 times higherthan for those with a graft, and

8 times higherthan for those with a fi stula.*

Guidelines from the

KIDNEY DISEASE OUTCOMES QUALITY INITIATIVE (KDOQI), HEALTHY PEOPLE 2020, and the FISTULA FIRST initiative

recommend that catheter use be reduced, and that more patientsuse an arteriovenous fistula

Among all patients receiving hemodialysis therapy,

55% are using an arteriovenous fi stula

27% are using an arteriovenous graft, and

18%are using a catheter*

Catheter only Internal access (functional or maturing)

Vascular access among hemodialysis patients starting ESRD therapyPatients who see a nephrologist before ESRD are much less likely to have only a catheter at their fi rst hemodialysis session.

Vascular access at initiation: Figure 1.19Vascular access among all hemodialysis patients: Table 2.bInfection rates: Table 2.cMaps: Figure 2.1

*200 data; most recent available

Percent of hemodialysis patients using an internal access (fi stula or graft) at the start of ESRD therapy

percent of patients

20.5

18.8

17.0

15.3

0

50

100

150

In 2009, hemodialysis patients were hospitalized for vascular access infection at an adjusted rate of 109 admissions per 1,000 patient years.

591993

1092009

1362005

93 09050197

0 30 60 90 120

White

African American

Other race

Hispanic

Hospitalizations per 1,000 patient years

105

131

87

108

19938.7

18.1

14.9

Hospital days per year Hospitalization ratesPatients with ESRD are now spending fewer days each year in the hospital.

And all-cause hospitalization rates have fallen since 1993.

Transplant

Peritoneal dialysis

Hemodialysis

20095.7 days per year

11.8

11.9

-16%Transplant

-14%Peritoneal dialysis

-1.8%Hemodialysis

PERCENT CHANGE BETWEEN 1993 & 2009

But infection remains a major cause of hospitalizationand death among patients with ESRD

Since 1993, the rate of hospitalization due to

infection has increased 31% overall

-2.8%Transplant

3.1%Peritoneal dialysis

43%Hemodialysis

PERCENT CHANGE BETWEEN 1993 & 2009

Change in rates of hospitalization due to infection

Admissions for infection, per 1,000 patient years

236 transplant

573 peritoneal dialysis

458hemodialysis

Patients hospitalized for any infection

Patients hospitalized for a vascular access infection

Rehospitalization among hemodialysis patients

Hospital days: Figure .2Change in hospitalization rates: Figure .1Admissions: infection, vascular access: Figure .Vascular access hospitalizations by race: Table .cRehospitalization: Figure .

Adjusted rates of hospitalization for vascular access infection in hemodialysis patients, by race

The rate of hospitalization for vascular access infection in hemodialysis patients remains nearly twice as high as in 1993.

Patients rehospitalized within 30 days; alive

Patients rehospitalized within 30 days; died

Patients not rehospitalized within 30 days; died

1%

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As noted in the introduction to Volume One, this year we use lyrics from American music to illustrate the human impact of kidney disease, with quotations that express some of the many emotions of the human spirit. Across the many perspectives and cultures represented in the United States, music draws on the unique viewpoints of songwriters and their relation-ships to the society in which they find themselves. So too does kidney disease have a unique and profound impact on dif-ferent populations, creating daily challenges in adapting to a life-changing disease.

The longing tones of the violin evoke the ways in which our hearts reach out to those living with the challenges of kidney disease. At the same time, seeing the versatility of the people affected by this disease is similar to watching an orchestra of diverse instruments harmonize in a unique arrangement, one that touches us on multiple levels. We hope that the use of music as a framework for this ADR helps us connect further to the varied audiences who read this document and use its information to guide healthcare for a vulnerable population of patients.

Volume Two continues to focus on ESRD, and on the his-torical surveillance data that were the basis of the first USRDS

reports. We summarize the ESRD program in the United States, and examine public health issues such as morbidity and mortality in the first year of therapy — an area in which there has been little progress over the last ten years. This year, however, we show that first-year survival has begun to improve, in parallel to the improved survival after the first year of treatment, something we have observed for a number of years.

At the end of 2009, the ESRD program was treating 571,414 dialysis and transplant patients — a 4.0 percent increase from 2008. There were 116,395 new cases of ESRD reported, 3.5 percent more than in 2008, and the largest increase since 2000. Growth in the incident population should, however, be viewed with caution, as it may take several years to deter-mine if the increase will be sustained. Late reporting of data is always an issue, as complete and stable incident counts sometimes take several years to be finalized.

In this year’s Précis we again provide an overview of ESRD patients in the U.S., their care, and their expenditures. We examine pre-ESRD care as reported on the ESRD Medical Evi-dence (ME) form (CMS form 2728), used to register all ESRD patients. We also look at dialysis modality use, the transplant

This is the twenty-third annual report on the end-stage renal disease (ESRD) program in the United States, and the twelfth in our atlas series, which provides an in-depth, graphic presentation of data spanning the last quarter century.

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wait list, and indicators of quality of care, and illustrate recent changes in hospitalization rates, mortality rates, and five-year survival in the dialysis population. Prevalent death rates have been falling for a number of years, and death rates in the first year of dialysis have declined since 2004. Figures on ESRD expenditures show per person and total costs in the program. Total Medicare expenditures for separately billed intravenous medications have been stable since 2004, reflecting changes in payment policies implemented by CMS.

Next we provide a full layout of the new Healthy People 2020 goals related to kidney disease. Many of the goals are new to the Healthy People chapter, and, in consultation with the HP2020 group at DHHS and the CDC, we will further develop related data in upcoming reports.

Chapter One consolidates information on incidence, prev-alence, patient characteristics, and modalities of therapy. As in prior years, we illustrate trends in incidence and preva-lence by age, gender, race, and ethnicity, and present data on modality use and insurance coverage. We examine nephrol-ogy referral prior to ESRD, and look at levels of estimated kid-ney function at initiation, using both the MDRD and CKD-EPI formulas. And we present data on the degree of anemia at initiation, on pre-ESRD treatment with erythropoiesis stimu-lating agents (ESAs), and, from the most recent version of the Medical Evidence form, on serum albumin, hemoglobin, cho-lesterol, triglycerides, and hemoglobin A1c levels at initiation.

Chapter Two, on clinical indicators of care, assesses dialy-sis adequacy, vascular access, anemia treatment, anemia correction in the first months of ESRD, IV iron therapy, and preventive care in the diabetic and general ESRD populations. We look, for instance, at the marked differences in vascular access complication rates associated with the use of fistulas, catheters, and grafts. New this year is information on pre-scription medication use under the new Medicare Part D benefit, first implemented in January, 2006. We assess data from 2008, the program’s second full year, looking at differ-ences in medication use among patients with and without

the low income subsidy, in the daily number of medications, and in use of antihypertensive medications, lipid lowering agents, oral vitamin D analogs, phosphate binders, and anti-diabetes agents.

Data on hospitalization and mortality are presented in Chapter Three. In the prevalent hemodialysis popula-tion, rates of hospitalization due to infection declined in 2006–2007, rose in 2008, and fell slightly in 2009; they remain, however, 43 percent higher than in 1993. Catheter placement rates have fallen (as shown in the HP2020 chapter), but there is concern that increased use of permanent cuffed catheters may expose patients to a long-term risk of infec-tion. Rates of hospitalization for vascular access infection have also declined, but those due to bacteremia/sepsis have increased, possibly due to a changing classification of these complications. A concurrent decrease in access infections in the peritoneal dialysis population suggests that these trends may be affected by factors outside of the dialysis populations themselves, but may also reflect the use of hemodialysis cath-eters in peritoneal dialysis patients whose peritoneal dialysis catheter has failed and who are waiting for placement of a new one in order to resume therapy.

New this year is a section on rehospitalization after a prior discharge. Twenty-two percent of hemodialysis patients are rehospitalized within 14 days of discharge, and 36 percent are readmitted within 30 days — a number substantially higher than the 20 percent reported for the general Medicare popu-lation (Jencks et al.).

We next look at further at hospitalizations due to infec-tion, adding data by organ system to give a more complete picture of this area of morbidity. We then conclude the chapter by looking at hospitalizations in matched dialysis populations. Comparisons of hemodialysis and peritoneal dialysis patients are challenging, since there is substantial selection bias in those treated with peritoneal dialysis. This year we compare hemodialysis patients, peritoneal dialysis patients, and hemodialysis patients matched to those on

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peritoneal dialysis, looking at hospital admissions in the first and second years after the initiation of ESRD therapy.

In Chapter Four we examine cardiovascular disease in patients with ESRD, beginning with data on cardiovas-cular mortality, then looking at prescription drug therapy used by patients with various cardiovascular diagnoses and by those undergoing cardiovascular procedures such as revascularization.

We begin Chapter Five, on mortality, by highlighting trends in the first and subsequent years on ESRD therapy, with data now showing similar reductions in mortality rates among patients of all vintages. Figures then detail mortal-ity during the first year of hemodialysis, illustrating a sharp increase in all-cause rates in month two of treatment, fol-lowing by a steady decline during the rest of the year. Five-year survival has been improving slowly, but survival in the first six months of treatment has changed little since 1996. The issue of early survival clearly merits increased attention, and the role of infectious complications — particularly those related to dialysis catheters — needs to be addressed. Perhaps the changing incentives in the new bundled payment system, directed at lowering costs and complications, may translate to reductions in the use of dialysis catheters and to a focus on preventive care.

New this year is a chapter focused on use of the Medi-care Part D prescription drug benefit in the ESRD popula-tion. In Chapter Six we show, for example, that CKD, dialysis, and transplant patients are quite different from those in the general Medicare population in their use of the low income subsidy (LIS). Heavy use of LIS among ESRD patients is also reflected in the proportion of patients who reach the cover-age gap. The chapter includes data on Medicare costs for the Part D benefit, on out-of-pocket expenditures for enrollees, and on the most frequently used and most expensive drugs.

As we illustrate in Chapter Seven, the number of trans-plants from deceased donors has slightly declined from its peak of 10,906 in 2006 to 10,679 in 2009, while the number

from living donors has rebounded to 5,981, a level just below the 6,028 reported for 2006. Waiting times continue to grow, due to the continued shortage of donated kidneys. And death with a functioning graft continues to be a concern, with car-diovascular disease accounting for 30 percent of deaths with a known cause. The rate of influenza vaccinations among transplant patients is still far lower than that in the dialysis population, with very little progress since 1991.

In Chapter Eight, on the pediatric ESRD population, we lead with data on incidence and prevalence since 1980, and present data on the full breadth of diseases that have accounted for new ESRD cases in pediatric patients over the last decade. Rates of influenza vaccinations in this popula-tion continue to be low, with fewer than one in three children receiving this treatment, despite their high rates of pneumo-nia and other respiratory infections. In contrast to adults, for whom hospitalization rates are high in the first months of dialysis and decline within the first year, children have pro-gressively higher rates over the first 15 months after the ini-tiation of ESRD therapy. Death rates in children are highest in the first six months of treatment, particularly for those younger than five. And as noted last year, five-year survival among children with ESRD has not changed in more than a decade.

In Chapter Nine, the Special Studies Centers of the USRDS — Nutrition, Rehabilitation/Quality of Life, and Car-diovascular — outline details of ACTIVE/ADIPOSE: A Cohort Study to Investigate the Value of Exercise in ESRD/Analyses Designed to Investigate the Paradox of Obesity and Sur-vival in ESRD. A prospective, multi-center study of prevalent hemodialysis patients, the study will be conducted in collabo-ration with the NIH/NIDDK Division of Kidney, Urologic, and Hematologic Diseases and the USRDS Coordinating Center.

The landscape of dialysis providers continued to evolve in 2009, with growth in some of the smaller dialysis orga-nizations (SDOs). Large dialysis organizations (LDOs) now treat 63 percent of dialysis patients in the United States; SDOs

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account for 11.6 percent, hospital-based units 10 percent, and independently owned units 15 percent. In Chapter Ten we provide data on the duration of unit ownership among both the consolidated and remaining providers. We also address iron dosing practices and transfusion use, and costs for inter-vention and preventive care. Comparisons of standardized hospitalization and mortality ratios show that hospital-based units have substantially narrowed the gap in outcomes over the past five years, with ratios now only 7 percent higher than the national average, compared to 20 percent in the past.

Chapter Eleven, on expenditures related to ESRD, begins with data on total spending by type of insurer. After a large increase in 2008, the change in expenditures between 2008 and 2009 was the lowest since 1998. The chapter includes data on expenditure patterns for injectable medications and laboratory testing, and we use the matched hemodialysis and peritoneal dialysis populations to better compare expendi-tures across modalities; such comparisons may influence modality use under the new CMS bundled payment system. We conclude with new data on costs associated with the Part D prescription drug benefit.

In Chapter Twelve we summarize data from the inter-national community. We are again grateful to the registries providing this information, allowing us to see the U.S. ESRD community through a wider lens.

Most of the 2011 ADR contains data through December 31, 2009; data on patient characteristics, obtained from the Med-ical Evidence form, are complete through June, 2010. Only Medicare Part D data through 2008 were available for this ADR; more recent data should be available for the 2012 edition.

Current estimated incident and prevalent counts can be found on the USRDS website.

render and the researcher’s guide Our real-time online query system allows users to build data tables and maps. The Renal Data Extraction and Referencing System (RenDER) can be accessed on our website.

To assist users of USRDS data, the Coordinating Center (CC) annually updates the Researcher’s Guide, which pro-vides information on all analytical methods used by the CC, along with a detailed index of files and variables in the USRDS researcher datasets. It is available on our website in PDF format.

usrds databaseThe USRDS dataset is a living record of patient care in the United States, continually updated with new data. Delays in data reporting are unavoidable, and we add late information as soon as it becomes available. This includes data from the Medical Evidence form, claims for hospital and physician services, and updates of the Medicare Enrollment Database received after the ADR has gone to press.

administrative oversightProject Officers (POs) Lawrence Agodoa, MD, and Paul Egg-ers, PhD, provide direct oversight of the CC and Special Stud-ies Centers (SSCs), and members of CMS, the ESRD networks, and the renal community provide crucial input and feedback through their committee participation.

The Steering Committee, the governing body of the USRDS, is responsible for the operations of the CC and SSCs. It works under the direction of the POs, and includes representatives from CMS, the National Institutes of Health, the CC, and the SSCs. Its responsibilities include coordination among the cen-ters, study design, project tracking, data management and validation, assurance of data availability for researchers and government officials, and oversight of ADR production.

The USRDS External Advisory Committee plays a major role in advising POs on special studies, data studies, and analyses. It is also responsible for reviewing manuscripts and ADRs.

The Special Studies Review and Implementation Commit-tee, the operations committee for SSC proposals and CC proj-ect support, is a collaboration of CMS, the ESRD networks, and

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Throughout the ADR, with the exception of NHANES data, CKD cohorts exclude ESRD patients.

8.2 9.2 9.9 10.8 7.6 12.2

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the providers. The Data Request Review Committee reviews data requests requiring more than two hours of staff time to fulfill, and makes recommendations to the POs based on the datasets requested and the ways in which the CC can improve data availability.

reading the mapsMany maps in the ADR are by Health Service Area (HSA), a group of counties described by authors of the CDC Atlas of United States Mortality as “an area that is relatively self-con-tained with respect to hospital care.”

Maps here present data divided into quintiles, with each range in a legend containing approximately one-fifth of the data points. In the sample map, for example, one-fifth of all data points have a value of 10.8 or above. Ranges include the number at the lower end of the range, and exclude that at the upper end (i.e, the second range in the sample map is 8.2–<9.2). To facilitate comparisons of maps with data for dif-ferent periods, we commonly apply a single legend to each map in a series. Because such a legend applies to multiple maps, the data in each individual map are not evenly distrib-uted in quintiles, and a map for a single year may not contain all listed colors or ranges.

Numbers in the first and last boxes indicate the mean val-ues of data points in the highest and lowest quintiles; these can be used to calculate the percent variation between quin-tiles. For maps with shared legends we have provided these values by repeating the legends and inserting the unique quintile values. Mean numbers within the quintiles can be calculated as a simple half-way point.

On the Excel page for each map (found on the website and CD-ROM) we include several numbers to help you interpret the maps and their relation to other data in the ADR. The map-specific mean is calculated using only the population whose data are included in the map itself. This mean will usually not match data presented in tables elsewhere in the ADR, and should be quoted with caution. The overall mean

includes all patients for whom data are available, whether or not their residency is known. We also include the number of patients excluded in the map-specific mean, and the total number of patients used for the overall calculation.

acknowledgementsThe ADR could not be produced without the extraordinary work of members of the ESRD community — including the staff of CMS and the ESRD networks — and the dedicated efforts of the USRDS staff and investigators. The efforts of the providers themselves are crucial in the collection of data used by the USRDS, and their dedication to this task is greatly appreciated.

We welcome feedback on all elements of USRDS work. All comments are reviewed by the Director, Deputy Director, and staff of the USRDS in order to improve future materials and to ensure a strong working relationship between the USRDS and the clinicians, researchers, patients, and others involved in the care of ESRD patients across the United States and throughout the world.