Atlas of CKD

Introduction to Volume One : CKD

Chapters

This year's ADR presents data on the breadth of kidney disease and its impact on both individuals and society as a whole. To explore this idea, we turn this year to one of the most human characteristics of all – the ability to express ourselves through music. In the wide diversity of musical expression

We see similarities to the far–ranging impact of kidney disease across different racial and ethnic populations; in the lyrics of American music of the twentieth century – ranging from the Big Band era to folk music of the 1960s – we see expressions of emotion that can illustrate how kidney disease touches patients and their loved ones. The emotional implications of life with kidney disease, particularly for those on dialysis, are substantial, and relate not only to the physical elements of the disease but to its enormous financial stresses and its impact on personal relationships. Understanding these broad implications, we hope that the emotional connections expressed through American music help frame our reporting on kidney disease in the United States. We approach Volume One from the perspective that the implications of CKD were under–appreciated prior to February, 2002, when a new CKD classification staging system was proposed. The five–stage system was developed using population–level data from the National Health and Nutrition Examination Survey (NHANES), a surveillance system coordinated by the National Center for Health Statistics at the Centers for Disease Control and Prevention. The conceptual model of this system was based on similar approaches for populations at risk for diabetes and hypertension, two well-known diseases that damage the kidney as well as other organ systems. The model characterizes progressive stages of CKD, from early evidence of kidney damage – such as albumin in the urine – to overt reductions in the filtering capacity of the kidney, defined by the estimated glomerular filtration rate (eGFR).

There are many issues related to defining the levels of eGFR and urine albumin which indicate "true disease" in the kidney during the early stages of CKD, as compared to a normal reduction in kidney filtering capacity (particularly in the elderly). Improving on the MDRD method, a new estimating formula – the CKD–EPI equation – was published in the Annals of Internal Medicine in May, 2009; we compare these two equations, providing a perspective for readers on the strengths and weaknesses of each.

While the USRDS and others will continue to investigate these issues in both the clinical and public health arenas, already there are important data available on the impact of CKD, data based both on biochemical information and on the definition of the disease within the Medicare and health plan datasets. The impact of the CKD staging system as a predictor of morbidity and mortality is now well known on a population level, but its translation into the care of individual patients must continue to evolve to help clinicians provide the best care to their patients affected by kidney disease. In the Précis we highlight some of the most important data from the chapters, and address the burden of CKD — an area of major public policy and public health concern. In Chapter One we then define the CKD population, using NHANES data to examine how chronic conditions such as diabetes and congestive heart failure interact with CKD in a random sample of the U.S. population. We compare CKD populations identified through the MDRD and CKD–EPI equations, and address the burden of CKD across age, gender, and racial groups, as well as among patients with other chronic diseases. We also examine awareness, treatment, and control of hypertension, diabetes, and lipid disorders, and conclude with mortality prediction models, using both the MDRD and CKD–EPI equations.

Using data from the Medicare claims system and the employer group health plan datasets, we consolidate data on identification and care of CKD patients into Chapter Two. We begin by summarizing basic descriptive and comorbidity information from the major datasets used by the USRDS – the 5 percent Medicare sample, and the MarketScan and Ingenix i3 databases. We then illustrate the actual CKD burden in the NHANES population, and show that data gleaned only from the 585 diagnosis codes under–reports this burden. Data on laboratory testing of at–risk patients show that rates of evaluation for kidney disease – through urine microalbumin and serum creatinine testing – are low. We conclude the chapter by looking at the likelihood of receiving nephrologist care after a CKD diagnosis, and at prescription drug therapy among patients with CKD.

In Chapter Three we address morbidity and mortality among patients with CKD. We begin with comparisons of hospitalization rates in CKD and non–CKD patients, looking both at all–cause hospitalizations and at those for cardiovascular disease and infection, and giving particular attention to hospitalizations for infection. We conclude with data on mortality rates by CKD stage and across risk groups. Cardiovascular disease in the CKD population is the focus of Chapter Four, in which we evaluate, by CKD stage, major cardiovascular diagnoses and interventions, medication use, survival, and hospitalization. Data on prescription drug therapy are obtained from the Medicare Part D database, and address recommended therapies for major cardiovascular diagnoses and for patients receiving certain revascularization procedures.

This year we have added a chapter on Medicare Part D prescription drug use to both the CKD and ESRD volumes, defining the populations using the benefit and looking at various types of coverage, including the low income subsidy (LIS). We begin by looking at enrollment patterns in the general Medicare and CKD populations, then present data on monthly premiums, deductibles, gap coverage, and copayments. Data on the costs of Part D enrollment show total expenditures and per person per year (PPPY) costs; we also look at costs of specific medications in the general Medicare population and among those with early– or late–stage CKD. And, because CKD patients use substantial amounts of prescription drugs, we also look at their likelihood of reaching the coverage gap compared to that of their counterparts in the general Medicare population.

We conclude the CKD volume with Chapter Six, addressing the costs associated with CKD. We look at PPPY costs in the CKD population as a whole and in those with diabetes or cardiovascular disease, examine components of costs for CKD patients, and detail Medicare Part D costs by CKD stage, race, and LIS status.

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Atlas of CKD

Precis

Introduction to Chronic Kidney Disease in the United States

In this edition of the ADR we have consolidated chapters to bring greater focus to issues affecting those with kidney disease, and have highlighted data on racial disparities. New areas this year include prescription drug use and the extensive burdens of hospitalization. The universal impact of chronic diseases was codified in 2005 in a report from the World Health Organization. The presentation focused on premature loss of life and on the economic impact of deaths during individuals' most productive years. While there has been little attention paid to kidney disease on a public health level, the reality is that many countries struggle with the costs of providing end–stage renal disease (ESRD) care through dialysis and kidney transplantation, costs which place ministries of finance at odds with ministries of health. The enormous demand for organs – particularly kidneys – has also led to transplant tourism, in which patients travel elsewhere to buy living donor kidneys for transplantation. While this practice has been denounced by the Istanbul Declaration on organ trafficking and transplant tourism, the large number of patients across the globe who have advancing kidney disease continues to fuel demand.

The growing number of ESRD patients thus needs to be addressed in terms not only of its public health disease burden, but of costs to the healthcare system, and of the high demand for replacement organs. And the overall prevention of kidney disease needs to be viewed in context of competing demands for resources, particularly in the difficult economic times faced around the world in 2011.

As shown in the Venn diagrams on the next page, the prevalence of CKD and congestive heart failure in the general population has changed little since the beginning of the decade, while the burden of diabetes has increased. Because diabetes is a major cause of kidney disease, it should be a primary target for early detection and intervention to reduce the development of CKD and slow the progression to ESRD.

With diabetes and hypertension major risk factors for CKD, awareness, treatment, and control of these conditions are crucial. NHANES data show that blood pressure control in the general population improved between 2001–2004 and 2005–2009. The overall prevalence of hypertension is 28–29 percent, but reaches 80–85 percent in those with an eGFR less than 60 ml/min/1.73 m2, while elevated LDL cholesterol is present in 36 and 81 percent of these populations, respectively.

While CKD has been characterized from population–level estimates in the NHANES data, much of the disease is silent and unrecognized, complicating any full assessment of its impact. We present data on CKD recognized through diagnosis codes reported on claims – an approach which clearly underestimates CKD in the Medicare population, but has been shown to have high specificity, indicating individuals likely to have the disease. As identified from these codes, CKD has grown from 3.3 percent in 1998 to 8.5 percent in 2009. It is probable that this represents increased recognition of the disorder, since the disease burden identified through NHANES data has grown little over the same period. Costs for CKD patients are now 23 percent of Medicare expenditures in the fee–for–service sector; when added to costs for ESRD patients, it appears that 31 percent of all Medicare expenditures are incurred by patients with a diagnosis of kidney disease.

Despite this high disease burden, the rate of progression to ESRD has been relatively stable over the last several years, suggesting that CKD patients are dying at a higher rate before they reach ESRD or that they are progressing to ESRD at a slower rate. The continuing decline in rates of death from cardiovascular disease (the major cause of mortality in the CKD population), along with improved treatment and control of hypertension and increased use of ACEIs/ARBs/renin inhibitors, suggest that progression of CKD to ESRD may indeed have slowed.

Data on testing of patients at high risk of kidney disease show that, while creatinine testing is fairly routine among patients with diabetes, at 87 percent, only 33 percent receive urine microalbumin testing; this number falls to just 5 percent in patients with hypertension. These data suggest a lack of screening for kidney disease in high–risk patients, despite the fact that these measurements are recommended by the American Diabetes Association and the American Heart Association. In addition, referral to a nephrologist after CKD diagnosis is only 31 percent at 12 months; patients are twice as likely to see a cardiologist.

New figures show that, when compared to the general population, Medicare Part D prescription drug coverage with the low income subsidy is 50 percent higher among CKD patients, and twice as high for patients with ESRD. CKD patients also have a 40 percent probability of reaching the coverage gap, or "donut hole," compared to 22 percent of patients in the general Medicare population.

Figure 1.1 Distribution of NHANES participants with diabetes, congestive heart failure, & markers of CKD, with GFR estimated by MDRD & CKD–EPI equations (see page 122 for analytical methods. NHANES participants age 20 & older.)

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Atlas of CKD

Precis

CKD in the General Population | identification & care of CKD patients

Figure 1.3 Cumulative distribution curves of NHANES 2001–2008 participants, by method used to estimate GFR (page 40) (see page 122 for analytical methods. NHANES 2001–2008 participants age 20 & older.)

In cumulative frequency distributions of eGFR in U.S. adults, the creatinine–based CKD–EPI methodology for eGFR calculations yields higher estimates of GFR than those achieved with the creatinine–based MDRD method.

Table 1b Awareness, treatment, & control of hypertension, hypercholesterolemia, HDL, total cholesterol, & diabetes, by ACR, eGFR, & method used to estimate GFR (percent of NHANES participants; page 42) (see page 123 for analytical methods. NHANES 1999–2008 participants age 20 & older; those with Stage 5 CKD excluded. For analysis definitions, see page 42.)

With both methods , 81 percent of 1999–2004 participants with eGFRs less than 60 had hypercholesterolemia (based on elevated LDL), but only 18–21 percent were successfully treated. The proportion of participants with hypercholesterolemia in the later period was lower, at 66–69 percent, but little improvement was observed in rates of treatment.

In 2005–2008, approximately 15 percent of participants with CKD had a high total cholesterol level, while 40–50 percent had glycohemoglobin levels above the recommended 7 percent.

Nearly 24 percent of prevalent Medicare patients age 65 and older had coded diabetes in 2009, compared to 10 percent of MarketScan patients age 50–64. One in ten Medicare patients had diagnosed congestive heart failure, and 7 percent had diagnosed CVA, compared to 1 percent of their MarketScan counterparts.

Figure 2.1 Distribution of point prevalent general Medicare (age 65+) & MarketScan (age 50–64) patients with coded diabetes, CKD, CHF, & CVA, 2009 (page 47) (see page 123 for analytical methods. Point prevalent general (fee–for–service) Medicare patients age 65 & older; point prevalent MarketScan patients age 50–64. Diabetes, CKD, CHF, & CVA determined from claims.)

The prevalence of recognized CKD in the Medicare population increased three–fold between 2000 and 2009, from 2.7 to 8.5 percent. While the proportions of patients with CKD in the MarketScan and Ingenix i3 populations are smaller, the net increases from 2000 and 2001 to 2009 parallel the growth in the Medicare population.

Table 2b Prevalence (%) of recognized CKD, by dataset, year, & age (page 48) (see page 123 for analytical methods. Prevalent pts surviving cohort year, age 65 & older (Medicare, 2009) & 20–64 (MarketScan & Ingenix i3, 2008).)

Figure 2.6 Probability of microalbumin & creatinine testing in Medicare patients at risk for CKD, (page 50) (see page 123 for analytical methods. Medicare patients from the 5 percent sample, age 20 & older, with both Part A & Part B coverage in the prior year; patients diagnosed with CKD or ESRD during prior year are excluded. Tests tracked during each year.)

In 2009, the probability of creatinine testing in Medicare patients at risk for CKD was 0.77; the probability of receiving a microalbumin test (which must be ordered separately), in contrast, was 0.10.

The probability of microalbumin testing in those with diabetes was 0.33, compared to 0.05 in patients with hypertension. Having both diagnoses greatly increases the odds of developing CKD. The probability of creatinine testing in patients with both conditions was 0.93, while that of a urine microalbumin test was 0.35. Because microalbumin testing must be ordered separately, it may represent a true intent to assess kidney disease.

Figure 2.10 Cumulative probability of a physician visit at month 12 following CKD diagnosis, by physician specialty & dataset (page 54) (see page 123 for analytical methods. Patients alive & eligible all of 2008. CKD diagnosis represents date of first CKD claim during 2008;)

In the year after being diagnosed with CKD, the probability of seeing a primary care physician is much higher than the probability of seeing a cardiologist or nephrologist, at 0.77 in the MarketScan population, and 0.93 in patients with Medicare coverage. And in both populations, the probability of a cardiology visit is much higher than that of a nephrologist visit, at 0.63 versus and 0.31, respectively, in Medicare patients and 0.36 versus 0.27 in the MarketScan population.
physician claims searched during 12 months following that date.

Figure 2.14 Medicare Part D & MarketScan CKD patients with at least one claim for an ACEI/ARB/renin inhibitor in the 12 months following the disease-defining entry period, by CKD diagnosis code, 2008 (pg 56) (see page 123 for analytical methods. Point prevalent Medicare CKD patients age 65 & older & MarketScan CKD patients age 50–64.)

Figure 2.16 Medicare Part D & Marketscan CKD pts with at least one claim for a DHP calcium channel blocker in the 12 months following the disease-defining entry period, by CKD diagnosis code, 2008 (page 56) (see page 123 for analytical methods. Point prevalent Medicare CKD patients age 65 & older & MarketScan CKD patients age 50–64.)

Figure 2.18 Medicare Part D & Marketscan CKD patients with at least one claim for a diuretic in the 12 months following the disease–defining entry period, by CKD diagnosis code, 2008 (page 57) (see page 123 for analytical methods. Point prevalent Medicare CKD patients age 65 & older & MarketScan CKD patients age 50–64.)

These figures present data on medication use among CKD patients in the Medicare 5 percent and MarketScan databases in 2009. Among Medicare Part D patients with a diagnosis of diabetes or hypertension, 69 and 64 percent, respectively, had evidence of ACEI/ARB/renin inhibitor use, compared to 77 and 73 percent in the MarketScan population; use was generally higher in patients with earlier stages of CKD.

In patients with hypertension or cardiovascular disease, use of a dihydropyridine calcium channel blocker was slightly higher in the Medicare population, and more common in those with later-stage CKD.

Potassium–sparing diuretics or combination diuretic products (e.g. potassium–sparing plus thiazide diuretics) are rarely used in CKD patients. Thiazide and loop diuretics, in contrast, receive much wider use, with 30 and 33 percent, respectively, of Medicare and MarketScan patients receiving a thiazide diuretic, and 46 and 25 percent a loop diuretic. Across all stages of CKD, loop diuretic use is more common in Medicare patients than in the MarketScan population.

Figure 3.1 Unadjusted & adjusted all–cause hospitalization rates in the Medicare & MarketScan populations, by CKD status (page 61) (see page 124 for analytical methods. Medicare: Jan. 1 point prev. pts, age 66+ on Dec. 31 of prior year. MarketScan: Jan. 1 point prev. pts, age 50–64 on Dec. 31 of prior year. Adj: gender/prior hosp./comorbidity; ref: Medicare pts age 66+, 2005.)

Figure 3.5 Adjusted rates of hospitalization for cardiovascular disease, by dataset & CKD diagnosis code, 2009 (page 63) (see page 124 for analytical methods. Medicare: Jan 1, 2009 point prev. pts, age 66 & older on Dec. 31, 2008. MarketScan & Ingenix i3: Jan 1, 2009 point prev. pts, age 50–64 on Dec 31, 2008. Adj: gender/prior hosp./comorbidity; ref: Medicare pts age 66 & older, 2009.)

Figure 3.6 Adjusted rates of hospitalization for infection, by dataset & CKD diagnosis code, 2009 (page 63) (see page 124 for analytical methods. Medicare: Jan 1, 2009 point prev. pts, age 66 & older on Dec. 31, 2008. MarketScan & Ingenix i3: Jan 1, 2009 point prev. pts, age 50–64 on Dec 31, 2008. Adj: gender/prior hosp./comorbidity; ref: Medicare pts age 66 & older, 2009.)

Figure 3.9 Unadjusted & adjusted all–cause mortality rates in Medicare CKD & non–CKD patients, 2009 (page 66) (see page 124 for analytical methods. Jan, 1 point prev. Medicare pts age 66 & older. Adj: age/gender/race/prior hosp./comorbidities. Ref: 2005 pts.)

Unadjusted hospitalization rates in the CKD population – reflecting total disease burden – are 3–5 times those of non–CKD patients. When adjusted, rates for CKD patients are 1.4 times higher, illustrating CKD's net impact if the populations had similar comorbidity and disease severity. CKD patients, however, carry a heavy burden of CVD, which adjustments cannot fully address since CVD interacts so strongly with CKD itself.

Among Medicare patients, the rate of 166 cardiovascular admissions per 1,000 patient years in those with Stage 4–5 CKD is 45 percent higher than the rate of 115 reported for those with CKD of Stages 1–2. Compared to those of patients in the early stages of CKD, rates of admission for infection are 38–55 percent greater among patients with CKD of Stages 4–5.

The unadjusted mortality rate in Medicare CKD patients age 66 and older was 147 in 2009. When adjusted for patient characteristics and complexity, however, the rate is lowered considerably, reaching 77 in 2009.

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Atlas of CKD

Precis

Cardiovascular Disease | Prescription Drug Coverage

Figure 4.1 Cardiovascular disease in patients with or without chronic kidney disease, 2009 (page 71) (see page 125 for analytical methods. December 31 point prevalent Medicare enrollees age 66 & older, with fee–for–service coverage for all of 2009.)

Elderly patients with CKD carry a larger burden of comorbid cardiovascular illness than do those those without CKD, and have a significant additional burden of CHF, AMI, and stroke. Forty–four percent of elderly CKD patients, for example, have CHF, compared to just 20 percent of their counterparts without CKD.

Figure 4.7 Prescription drug therapy in patients with CHF, by CKD status , 2008 (page 75) (see page 125 for analytical methods. January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

Figure 4.11 Percent of patients treated for CHF, by type of medication & CKD status, 2008 (page 75) (see page 125 for analytical methods. January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

Despite prior reports of the underutilization of evidence–based therapies in patients with CKD, it appears that this finding is no longer accurate, as beta blocker use is now more common in these patients than in their non–CKD counterparts. Use of ACEIs/ARBs is nearly identical in both populations, despite possible concerns over deterioration of renal function or hyperkalemia in CKD patients. Combination therapy with ACEIs/ARBs and beta blockers is also nearly identical in both CKD and non–CKD patients, at 38–39 percent. Perhaps reflecting the potential toxicity of digoxin therapy in CKD patients, a slightly lower percentage of CKD patients with CHF receive this medication.

Figure 5.1 Sources of prescription drug coverage in Medicare enrollees, 2008 (page 79)

Fifty–six to 60 percent of general Medicare patients and patients with CKD, diabetes, or cardiovascular disease were enrolled in Part D in 2008, as were 67 percent of patients with ESRD. The proportion with other creditable coverage is similar among CKD and Medicare patients, at about 12 percent, but a higher proportion of CKD patients have retiree drug subsidy coverage, at 21 compared to 15 percent. Figure 5.1; see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.

Figure 5.5 Medicare Part D enrollees, by low income subsidy (LIS) status, 2008 (page 81) (see page 126 for analytical methods. January 1, 2008 point prevalent Medicare enrollees.)

Fifty–one percent of CKD patients with part d coverage had LIS benefits in 2008, compared to 73 and 64 percent of dialysis and transplant patients. CKD patients are thus more likely to reach the coverage gap and have higher premiums, deductibles, and drug copayments.

Figure 5.13 Per person per year costs for Medicare Part D enrollees, by low income subsidy (LIS) status, 2008 (page 84) (see page 126 for analytical methods. Medicare pts surviving 2007 with Medicare as primary payor & enrolled in Part D, & period prevalent dialysis pts, 2008, with Medicare as primary payor.)

Figure 5.16 Cumulative percent of Part D non–LIS enrollees who reach the coverage gap, by CKD stage, 2008 (page 86) (see page 126 for analytical methods. Jan 1 point prev. Medicare enrollees.)

Table 5g Top 15 drugs used in Medicare Part D enrollees with Stage 3–5 CKD, by frequency & net cost, 2008 (page 88) (see page 126 for analytical methods. Part D claims for all patients in the Medicare 5 percent sample.)

PPPY total costs for Part D–covered medications in 2008 were 3.3–3.8 times greater for LIS patients than for those without LIS. » Figure 5.13; see page 126 for analytical methods. Medicare pts surviving 2007 with Medicare as primary payor & enrolled in Part D, & period prevalent dialysis pts, 2008, with Medicare as primary payor.

In 2008, 42 percent of all CKD patients (not on dialysis) reached the coverage gap, compared to 23 percent of general Medicare patients ; this varied little by CKD stage.

Figure 6.1 Point prevalent distribution & annual costs of Medicare (fee–for–service) patients, age 65 & older, with diagnosed diabetes, CHF, & CKD, 2009 (page 93) (see page 126 for analytical methods. Populations estimated from the 5 percent Medicare sample using a point prevalent model (see appendix for details). Population further restricted to patients age 65 & older, without ESRD. Diabetes, CHF, & CKD determined from claims; costs are for calendar year 2009.)

Congestive heart failure (CHF) affects 9.6 percent of patients in the fee–for–service population, and accounts for 15.9 percent of costs. Nearly 23 percent of patients have diabetes; 32.4 percent of expenditures go toward their care. And while patients with CKD represent only 7.6 percent of the population, their care accounts for 22.3 percent of total expenditures.

Figure 6.5 Overall expenditures for CKD in the Medicare population (page 95) (see page 126 for analytical methods. Point prevalent Medicare CKD patients age 65 & older. *Medicare Part D data not available for 2009.)

Figure 6.7 Overall expenditures for CKD & congestive heart failure in the Medicare population (page 95) (see page 126 for analytical methods. Point prevalent Medicare CKD patients age 65 & older. *Medicare Part D data not available for 2009.)

In 1993, costs for Medicare patients with CKD accounted for 3.8 percent of overall Medicare expenditures. In 2009, excluding Medicare Part D drug benefits, CKD costs reached $34 billion, and accounted for nearly 16 percent of total Medicare dollars.

Costs for CKD patients with congestive heart failure (CHF) accounted for 34.6 percent of total Medicare CHF dollars in 2009 – accounting for $16 billion of the $47 billion spent by Medicare on patients with this disease.

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Atlas of CKD

Chapter One

Chronic Kidney Disease in the General Population

In this chapter we use data from the National Health and Nutrition Examination Survey (NHANES), a valuable source of information for assessing disease burden and high–risk subsets among representative U.S. adults.

On the next page we begin by showing the overall burden and interactions of diabetes, congestive heart failure, and CKD – three interrelated chronic diseases of clear public health relevance – and compare prevalence estimates in 2001–2004 and 2005–2008. While the prevalence of diabetes has clearly increased, and the prevalence of congestive heart failure has remained stable, the prevalence of CKD appears to have declined slightly, from 15.8 percent to 15.1 percent when calculated with the MDRD formula, and from 14.7 percent to 14.5 percent when calculated with the CKD–EPI formula; prevalence estimates of CKD in 1988–1994 were 12.8 and 12 percent, respectively.

Estimates of CKD burden are partly dependent on the equation used to define the estimated glomerular filtration rate (eGFR): when the newer CKD–EPI equation is used, the prevalence of eGFR less than 60 ml/min/1.73 m2 is lowered by a factor of 0.88 (6.9 percent versus 7.8 percent) compared with the estimate from the older MDRD Study equation. Regardless of the method used to estimate GFR, low eGFR and high urinary albumin/creatinine ratio (ACR) are most likely to be found in the presence of age greater than 60, diabetes, hypertension, and cardiovascular disease.

Exploring the implications of CKD, diabetes, and cardiovascular disease in the general population, this chapter sets the stage for Chapter Two, in which we discuss the implications of CKD in datasets that are less well defined in terms of biochemical data, but that provide extensive information on morbidity, interventions, and costs not contained in the NHANES data or other samples.

Table 1.a Prevalence & odds ratios of CKD in NHANES 2001–2008 participants, by ACR & method used to estimate GFR, age, gender, race/ethnicity, & risk factor (percent of participants) (see page 122 for analytical methods. NHANES 2001–2008 participants age 20 & older. For Figure 1.2, odds ratios use populations without the risk factor as reference.)

With a single creatinine–based eGFR and the MDRD and CKD–EPI equations, 26 percent of NHANES participants age 60 or older have an eGFR of less than 60 ml/min/1.73 m2 (CKD Stages 3–5); 19.7 percent have a urinary albumin/creatinine ratio greater or equal to 30 mg/g. For all adults, multivariate associations of CKD for eGFR and ACR methodologies include older age, female gender, and self–reported diabetes, hypertension, and cardiovascular disease.

Figure 1.2 Odds ratios of CKD in NHANES 2001–2008 participants, by risk factor & method used to estimate eGFR (see page 122 for analytical methods. NHANES 2001–2008 participants age 20 & older. For Figure 1.2, odds ratios use populations without the risk factor as reference.)
Figure 1.3 Cumulative eGFR distribution curves of NHANES 2001–2008 participants, by method used to estimate GFR (see page 122 for analytical methods. NHANES 2001–2008 participants age 20 & older.)

In cumulative frequency distributions of eGFR in U.S. adults, the creatinine–based CKD-EPI methodology for eGFR calculations yields higher estimates of GFR than those achieved with the creatinine–based MDRD method.

Figure 1.4 Prevalence of comorbidity in NHANES 2001–2008 participants, by risk factor, eGFR, & method used to estimate GFR (see page 122 for analytical methods. NHANES 2001–2008 participants age 20 & older.)
Figure 1.5 Prevalence of comorbidity in NHANES 2001–2008 participants, by risk factor, expanded eGFR categories, & method used to estimate GFR (see page 122 for analytical methods. NHANES 2001–2008 participants age 20 & older.)
Figure 1.6 Distribution of NHANES 2001–2008 participants, by age, eGFR, & method used to estimate GFR (see page 122 for analytical methods. NHANES 2001–2008 participants age 20 & older.)
Figure 1.7 Prevalence of comorbidity in NHANES 2001–2008 participants, by risk factor & albumin/creatinine ratio (see page 122 for analytical methods. NHANES 2001–2008 participants age 20 & older.)

With both creatinine–based MDRD and CKD–EPI estimates, prevalence estimates of diabetes, hypertension, cardiovascular disease (CVD, not including CHF), and CHF are noticeably higher in participants with eGFRs below 60 ml/min/1.73 m2. Approximately 64–68 percent of NHANES participants with an eGFR less than 60, for example, have hypertension, compared to 26 percent of those with an eGFR of 60 or greater, and their prevalence of CVD is nearly five-fold greater.

The prevalence of disease rises with CKD severity. In participants with eGFRs less than 30, 30–<45, and 45–<60, for example, 40, 27, and 18 percent have diabetes, compared to 7 percent of those with an eGFR of 60 or above. And in participants with an eGFR less than 30, 84–85 percent have hypertension and 35–36 percent have CHF, compared to 5.0 and 1.5 percent, respectively, of participants with an eGFR of 60 or greater.

Slightly more than 75 percent of NHANES participants with an MDRD–estimated eGFR less than 60 ml/min/1.73 m2 are age 60 years or older, compared with 85 percent when eGFR is calculated with the CKD–EPI equation.

The prevalence of comorbid illness among NHANES participants rises with albumin/creatinine ratio (ACR). Four percent of participants with an ACR less than 10 mg/g have diabetes, compared to 26 percent of those whose ACR is 30 or greater. Hypertension and CVD are present in 24 and 4.5 percent of participants with an ACR below 10, compared to 51 and 13.5 percent of those with an ACR of 30 or greater.

Table 1.b Awareness, treatment, & control of hypertension, hypercholesterolemia, HDL, total cholesterol, & diabetes, by ACR, eGFR, & method used to estimate GFR (percent of NHANES participants) (see page 123 for analytical methods. NHANES 1999–2008 participants age 20 & older; those with Stage 5 CKD excluded.)

Here we use NHANES data from two time periods to evaluate awareness, treatment, and control of disease conditions, using estimates of glomerular filtration rate (eGFR) from the MDRD and CKD–EPI methods (both creatinine–based).

In 1999–2004, using the MDRD method, 81 percent of participants with an eGFR less than 60 ml/min/1.73 m2 had hypertension; only 15 percent, however, were aware of their condition and on a successful treatment regime. In 2005–2008 participants, 80 percent were hypertensive and 21 percent were being treated successfully. With the CKD–EPI method, 85 percent of the 1999–2004 cohort were hypertensive and 15 percent were being treated sucessfully, compared to 85 and 23 percent in 2005–2008. Among 1999–2004 participants with eGFRs of 60 or greater (both MDRD and CKD–EPI formulas), 28 percent had hypertension and approximately 7 percent were being successfully treated compared to 30 and 11 percent in 2005–2008.

With both the MDRD and CKD–EPI formulas, 81 percent of 1999–2004 participants with eGFRs less than 60 had hypercholesterolemia (based on elevated LDL), but only 18–21 percent were successfully treated. The proportion of participants with hypercholesterolemia in the later period was lower, at 66–69 percent, but little improvement was observed in rates of successful treatment.

In 2005–2008, approximately 15 percent of participants with CKD had a high total cholesterol level, while 40–50 percent had glycohemoglobin levels above the recommended 7 percent.

Figure 1.8 Predicting death: sensitivity & specificity of different eGFR thresholds: MDRD equation, NHANES 1988–1994 participants (see page 123 for analytical methods. NHANES III (1988–1994) participants age 20 & older.)
Figure 1.9 Predicting death: sensitivity & specificity of different eGFR thresholds: CKD–EPI equation, NHANES 1988–1994 participants (see page 123 for analytical methods. NHANES III (1988–1994) participants age 20 & older.)
Figure 1.10 Predicting death: sensitivity & specificity of different ACR thresholds, NHANES 1988–1994 participants (see page 123 for analytical methods. NHANES III (1988–1994) participants age 20 & older.)
Figure 1.11 Mortality rates in NHANES 1999–2004 participants, by eGFR: MDRD equation (see page 123 for analytical methods. NHANES 1999–2004 participants age 20 & older.)
Figure 1.12 Mortality rates in NHANES 1999–2004 participants, by eGFR: CKD-EPI equation (see page 123 for analytical methods. NHANES 1999–2004 participants age 20 & older.)

For screening purposes, it can be useful to know the efficacy of different threshold levels for predicting death or survival in patients with CKD. For death within a finite time interval, a threshold where individuals classified as "normal" show low mortality rates (a high proportion of true negatives, with high specificity for predicting death) and those classified as "abnormal" show high mortality rates (a high proportion of true positives, with high sensitivity for predicting death) might be attractive for defining subgroups in which intensive follow-up and treatment may be appropriate, and for classification purposes as well. Figures 1.8–10 show sensitivity and specificity values for different threshold renal values among NHANES III participants (1988–1994) followed through 2006. Conventionally used thresholds – like <60 ml/min/1.73 m2 for eGFR and –30 mg/g for ACR – exhibit low sensitivity and high specificity values for predicting death. Here we show annual mortality rates in 1994–2004 NHANES participants. For eGFR below 90 ml/min/1.73 m2, mortality rates are higher with the CKD–EPI formula; for eGFRs above 90, rates are lower.

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Atlas of CKD

Chapter Two

Identification and Care of Patients with Chronic Kidney Disease

Introduction

The identification of CKD is a significant challenge, as most datasets lack the biochemical data that provide the greatest precision in identifying the disease. And while random samples such as the NHANES dataset contain biochemical information, they rarely include event rates or economic data, making it difficult to evaluate access to care for this high–risk population, or to examine the interactions of CKD with diabetes and cardiovascular disease.

The USRDS uses several datasets to assess the recognized CKD population, including the general Medicare 5 percent sample, with an average of 1.2 million individuals each year. Few datasets, however, are large enough to allow assessment of younger CKD populations, and few contain the laboratory data needed to determine the actual burden of the disease. To address these issues we use data from employer group health plans (EGHPs), including the Thomson Reuters MarketScan dataset, with information from 40 Fortune 100 companies, 80 percent of which are self–insured. This dataset contains information on approximately 17 million lives per year, with claims for services but no laboratory data. We also employ data from United Health Group's Ingenix i3 LabRx dataset, with information on 5.7 million lives per year from employers that are only 20 percent self–insured. This dataset contains provider charges but no paid claims; it does, however, contain biochemical data provided by contract laboratories in the United Healthcare system. Other ordered labs can be tracked, but results are not available.

The mean age of the Medicare population age 65 and older is 75.3 overall and 77.8 for those with CKD – a contrast to the EGHP population, at 44.3 and 52.4, respectively, for MarketScan patients, and 42.7 and 51.2 for those in the Ingenix i3 dataset. As expected, disease prevalence is lower for the younger EGHP patients. Interesting, however, is the similar disease burden in the MarketScan and Ingenix i3 populations, which are associated with two very different sets of employers with different health plan payment systems.

New, stage–specific ICD–9–CM codes (585.x) were introduced in the fall of 2005, providing an opportunity to track populations with reported diagnosis codes over time. CKD is also defined through codes for diabetes (250.4x) and hypertension (403.9x), and through codes specific to kidney disease, such as glomerular disease (583.x). Definition of the total recognized CKD population must therefore take into consideration a variety of codes beyond the 585.x series.

The recognized prevalent CKD population has been growing rapidly since 2003, a year after the new CKD stage classification system was published. Stage–specific codes are now being used more frequently, and use of the 585.9 code — for unknown/unspecified stage — has been falling.

The testing of patients at high risk for kidney disease has long been a focus of the USRDS, and has been added as well to the Healthy People 2020 goals developed by the Department of Health and Human Services (see the HP2020 chapter in Volume Two). But while urine testing for microalbuminuria has been recommended by the American Diabetes Association for some time, there has been slow progress in its use. In 2009, for example, just one in three patients with diagnosed diabetes received this test, in contrast to the 87 percent receiving creatinine testing. Because microalbumin testing must be ordered separately, it may represent a true intent to assess kidney disease. Recent papers addressing the risk stratification of kidney disease use both the urine microalbumin level and urine albumin/creatinine ratio, emphasizing that both tests are needed to fully assess kidney disease and its associated risks of death and progression to ESRD (Lancet 2010).

Data on physician care show that patients are far more likely to visit a cardiologist than a nephrologist after a CKD diagnosis. This may relate to concerns of primary care physicians that they'll lose contact with patients, as specialists assume aspects of care; it may also be difficult for patients to navigate what is for them a new system of care. Consultations within the hospital setting may present fewer barriers, an idea which should receive future assessment.

Approximately 70 percent of Medicare CKD patients with diagnosed diabetes, and 80 percent of those in the younger MarketScan population, receive ACEIs/ARBs. Beta blocker use reaches 70 percent for patients with congestive heart failure, but only 60 percent in those with hypertension; the very high rates of cardiovascular events and of sudden death among CKD patients may provide a background for studies assessing the value of beta blockers across the board for the CKD population. Use of lipid lowering agents reaches 60–70 percent in patients with CKD and diabetes or cardiovascular disease. Recent data from the SHARP trial (November, 2010), showing improvement in event rates with treatment, may increase use of these agents.

The many challenges of caring for CKD patients include fluid overload, congestive heart failure, and hypertension. Use of loop diuretics increases with CKD stage, while use of therapy with an erythropoiesis stimulating agent (ESA) is greatest in patients with Stage 4–5 CKD, consistent with advancing anemia. Use of oral vitamin D, most common among patients in the private health plans, is in part related to prescription drug coverage. The vitamin may be considered a nutritional supplement in most patients, but it is part of the required therapy to control secondary hyperparathyroidism in patients with CKD.

The identification and care of CKD patients is very complex. Disparities do exist and should be addressed, as these patients have very high event rates and high rates of progression to ESRD, making them a very costly and multifaceted population.

Figure 2.1 Distribution of point prevalent general Medicare (age 65 & older) & MarketScan (age 50–64) patients with coded diabetes, CKD, CHF, & CVA, 2009 (see page 123 for analytical methods. Point prevalent general (fee–for–service) Medicare patients age 65 & older; point prevalent MarketScan patients age 50–64. Diabetes, CKD, CHF, & CVA determined from claims.)

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Atlas of CKD

Chapter Two

Identification and Care of Patients with Chronic Kidney Disease

Prevalence of Recognized CKD

Table 2.a Descriptive parameters of CKD datasets, by age, gender, race, ethnicity, & coded comorbidity (see page 123 for analytical methods. Prevalent patients surviving 2008, without ESRD, age 65 & older (Medicare) & 20–64 (MarketScan & Ingenix i3).)

This table presents descriptive data on patients in the three datasets used throughout Volume One of the ADR: the 1.2 million Medicare patients age 65 and older in the 5 percent sample, the 17.7 million patients age 20–64 in the MarketScan database, and the 5.8 million, also age 20–64, in the Ingenix i3 database. Information on race and ethnicity is not available in the MarketScan and Ingenix i3 data.

Data on comorbidity in part reflect the older age of the Medicare population. Nearly 92 percent of Medicare CKD patients, for example, have hypertension, compared to 60 and 67 percent, respectively, of those in the MarketScan and Ingenix i3 databases. Thirty–three percent of Medicare CKD patients have congestive heart failure, compared to 9.1 and 7.8 percent in the MarketScan and Ingenix i3 populations. And the rate of cancer in Medicare CKD patients is 18.4 percent, compared to 14.2 and 12.6 percent, respectively, in MarketScan and Ingenix i3 participants.

Table 2.b Prevalence (%) of recognized CKD, by dataset, year, & age (see page 123 for analytical methods. NHANES 1999-–2008 participants age 20 & older; those with Stage 5 CKD excluded)

Figure 2.2 Prevalence of recognized CKD,by census region & dataset (see page 123 for analytical methods. Prevalent patients surviving cohort year, age 65 & older (Medicare, 2009) & 20–64 (MarketScan & Ingenix i3, 2008).)

The prevalence of recognized CKD in the Medicare population increased three-fold between 2000 and 2009, from 2.7 to 8.5 percent. While the proportions of patients with CKD in the MarketScan and Ingenix i3 populations are smaller, the net increases from 2000 and 2001 to 2009 parallel the growth noted in the Medicare population, at 0.3 to 0.8 and 0.4 (2001) to 0.8 percent, respectively.

By census region, prevalence of CKD in the Medicare population ranges from 7.9 percent in the west to 8.7 in the south; rates in the MarketScan and Ingenix i3 populations are highest in the south, at 0.88 and 0.92, respectively.

Figure 2.3 Trends in CKD prevalence: Medicare patients age 65 & older, by race (see page 123 for analytical methods. Prevalent patients surviving cohort year, without ESRD, age 65 & older (Medicare) & 20–64 (MarketScan & Ingenix i3).)
Figure 2.4 Trends in CKD prevalence: MarketScan patients age 20–64 (see page 123 for analytical methods. Prevalent patients surviving cohort year, without ESRD, age 65 & older (Medicare) & 20–64 (MarketScan & Ingenix i3).)
Figure 2.5 Trends in CKD prevalence: Ingenix i3 patients age 20–64 (see page 123 for analytical methods. Prevalent patients surviving cohort year, without ESRD, age 65 & older (Medicare) & 20–64 (MarketScan & Ingenix i3).)

Among Medicare patients, claims data identify 12.8 percent of African Americans, and 8.1 percent of whites, as having prevalent CKD in 2009, compared to 10.5 and 6.3 percent identified using only the combined 585 codes. The difference is even more pronounced in the EGHP population, with claims data identifying prevalent CKD rates nearly twice as high as those found using solely the stage–specific codes.

The most commonly reported stage-specific code in the prevalent CKD population is 585.3 (Stage 3), at 2.9 and 4.4 percent for white and African American Medicare patients, respectively, and 0.18 and 0.19 percent among MarketScan and Ingenix i3 patients.

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Atlas of CKD

Chapter Two

Identification and Care of Patients with Chronic Kidney Disease

Probability & Odds of a CKD Diagnosis Code

Table 2.d Percent of patients with CKD, by demographic characteristics, comorbidity, & dataset, 2009 (see page 123 for analytical methods. Medicare patients age 65 & older & MarketScan patients age 50–64, alive & eligible for all of 2009. CKD claims as well as other diseases identified in 2009. NHANES 2001–2008 participants, age 20 & older. eGFR estimated by MDRD method; CKD includes Stages 1–5.)
Table 2.e Percent of patients with CKD of Stage 3 or higher, by demographic characteristics, comorbidity, & dataset, 2009 (see page 123 for analytical methods. Medicare patients age 65 & older & MarketScan patients age 50–64, alive & eligible for all of 2009. CKD claims as well as other diseases identified in 2009. NHANES 2001–2008 participants, age 20 & older. eGFR estimated by MDRD method; CKD includes Stages 1–5.)
Table 2.f Adjusted odds ratio of a CKD diagnosis code, by demographic characteristics, comorbidity, & dataset, 2009 (see page 123 for analytical methods. Medicare patients age 65 & older & MarketScan patients age 50–64, alive & eligible for all of 2009. CKD claims as well as other diseases identified in 2009. NHANES 2001–2008 participants, age 20 & older. eGFR estimated by MDRD method; CKD includes Stages 1–5.)

Nearly 16 percent of NHANES participants have CKD. The likelihood of CKD increases with age, and is highest in participants age 85 and older, at 80 percent. CKD is recognized in women more often than in men, at 17.6 and 13.3 percent, respectively. By race, 16 percent of whites and African Americans have CKD. Sixty–three percent of NHANES participants age 85 and older have CKD of Stage 3 or higher.

Among Medicare patients age 65 and older, a CKD diagnosis code is more likely in older patients, women, and African Americans, and in patients with hypertension or cardiovascular disease (CVD). The odds of a code in patients age 75–84 and 85 and older are 42 and 84 percent higher, respectively, than in patients age 64–74. The odds are lower in women compared to men, and 40 percent higher in African Americans compared to whites. And in patients with diabetes, hypertension, or cardiovascular disease, the odds are 2–4 times higher than those in patients without these conditions.

In MarketScan patients age 55–59 and 60–64, the odds of a CKD diagnosis code are 17 and 40 percent higher compared to patients age 50–64, are lower in women compared to men, and are three times higher in patients with diabetes, hypertension, or cardiovascular disease than in patients without these conditions.

Figure 2.7 Odds ratio of a CKD diagnosis code in Medicare patients age 65 & older, by age, gender, & race, 2009 (see page 123 for analytical methods. Medicare patients age 65 & older & MarketScan patients age 50–64, alive & eligible for all of 2009. CKD claims as well as other diseases identified in 2009.)
Figure 2.8 Odds ratio of a CKD diagnosis code in MarketScan patients age 50–64, by age & gender, 2009 (see page 123 for analytical methods. Medicare patients age 65 & older & MarketScan patients age 50–64, alive & eligible for all of 2009. CKD claims as well as other diseases identified in 2009.)
Figure 2.9 Odds ratio of a CKD diagnosis code in Medicare & MarketScan patients, by comorbidity, 2009 (see page 123 for analytical methods. Medicare patients age 65 & older & MarketScan patients age 50–64, alive & eligible for all of 2009. CKD claims as well as other diseases identified in 2009.)

The odds of a CKD diagnosis code in Medicare patients age 65 and older, and in MarketScan patients age 50–64, are higher in older patients, males, and African Americans. And in both populations, patients with hypertension, cardiovascular disease, or diabetes are 2–3 times more likely to have a CKD diagnosis code compared to patients without these diseases.

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Atlas of CKD

Chapter Two

Identification and Care of Patients with Chronic Kidney Disease

Probability & Odds of Seeing a Physician after CKD Diagnosis

Figure 2.10 Cumulative probability of a physician visit at month 12 following CKD diagnosis in 2008, by physician specialty & dataset (see page 123 for analytical methods. Patients alive & eligible all of 2008. CKD diagnosis represents date of first CKD claim during 2008; physician claims searched during 12 months following that date.)

In the year after being diagnosed with CKD, the cumulative probability of seeing a primary care physician is much higher than the probability of seeing a cardiologist or nephrologist, at 0.77 in the MarketScan population, and 0.93 in patients with Medicare coverage. And in both populations, the cumulative probability of a cardiology visit is much higher than that of a nephrologist visit, at 0.63 versus and 0.31, respectively, in Medicare patients and 0.36 versus 0.27 in the MarketScan population.

Table 2.g Cumulative probability of a physician visit at month 12 after CKD diagnosis in 2008, by demographic characteristics, physician specialty, & dataset (see page 123 for analytical methods. Patients alive & eligible all of 2008. CKD diagnosis represents date of first CKD claim during 2008; physician claims searched during 12 months following that date.)

The type of physician seen by month 12 following a CKD diagnosis changes dramatically with the severity of CKD. In Medicare patients with any CKD, for example, the probability of seeing a nephrologist is 0.25–0.35 across demographic groups; in those with a diagnosis code of 585.3 or higher, the probability is 0.48–0.64. In the MarketScan population, the probability of seeing a nephrologist is 0.27 overall, increasing to 0.51 in patients with a diagnosis code of 585.3 or higher.

Table 2.h Cumulative probability of a physician visit at month 12 after a CKD diagnosis code of 585.3 or higher in 2008, by demographic characteristics, physician specialty, & dataset (see page 123 for analytical methods. Patients alive & eligible all of 2008. CKD diagnosis represents date of first CKD claim during 2008; physician claims searched during 12 months following that date.)

Table 2.i Hazard ratio of seeing a nephrologist 12 months after CKD diagnosis in 2008, by demographics, comorbidity, CKD stage, & dataset (see page 123 for analytical methods. Patients alive & eligible all of 2008. CKD diagnosis represents date of first CKD claim during 2008; physician claims searched during 12 months following that date.)

Among Medicare patients age 65 and older, African Americans are 15 percent more likely than their white counterparts to have seen a nephrologist 12 months after CKD diagnosis. For CKD patients with diabetes or cardiovascular disease, the likelihood of seeing a nephrologist is 22 and 14 percent higher, respectively, than in CKD patients without these conditions, and is more than twice as high in patients with hypertension. In patients with a CKD diagnosis code of Stage 3 or higher the likelihood of seeing a nephrologist is nearly four times that found in patients with CKD of an unknown stage or CKD of Stages 1–2.

Figure 2.11 Hazard ratio of Medicare patients seeing a nephrologist 12 months after CKD diagnosis in 2008, by age, gender, & race (see page 123 for analytical methods. Patients alive & eligible all of 2008. CKD diagnosis represents date of first CKD claim during 2008; physician claims searched during 12 months following that date.)
Figure 2.12 Hazard ratio of MarketScan patients seeing a nephrologist 12 months after CKD diagnosis in 2008, by age & gender (see page 123 for analytical methods. Patients alive & eligible all of 2008. CKD diagnosis represents date of first CKD claim during 2008; physician claims searched during 12 months following that date.)
Figure 2.13 Hazard ratio of patients seeing a nephrologist 12 months after CKD diagnosis in 2008, by comorbidity, CKD stage, & dataset (see page 123 for analytical methods. Patients alive & eligible all of 2008. CKD diagnosis represents date of first CKD claim during 2008; physician claims searched during 12 months following that date.)

Factors associated with a higher likelihood of seeing a nephrologist 12 months after a CKD diagnosis include Medicare patients of African American race, and those with diabetes, hypertension, cardiovascular disease, or a CKD diagnosis code of 585.3 or higher.

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Atlas of CKD

Chapter Two

Identification and Care of Patients with Chronic Kidney Disease

Prescription Drug Therapy

Figure 2.14 Medicare Part D & MarketScan CKD patients with at least one claim for an ACEI/ARB/renin inhibitor in the 12 months following the disease–defining entry period, by CKD diagnosis code, 2008
Figure 2.15 Medicare Part D & MarketScan CKD patients with at least one claim for a beta blocker in the 12 months following the disease-defining entry period, by CKD diagnosis code, 2008
Figure 2.16 Medicare Part D & MarketScan CKD patients with at least one claim for a DHP calcium channel blocker in the 12 months following the disease–defining entry period, by CKD diagnosis code, 2008
Figure 2.17 Medicare Part D & MarketScan CKD patients with at least one claim for a lipid lowering agent in the 12 months following the disease–defining entry period, by CKD diagnosis code, 2008

In Medicare Part D patients with CHF or hypertension, beta blocker use was 70 and 60 percent, respectively, and 74 and 50 percent in the MarketScan population; use of this medication tends to be more common in patients with later stages of CKD.

Use of lipid lowering agents is more apparent in patients with diabetes than in those with cardiovascular disease. In the Medicare population, for example, 69 percent with diabetes received some form of this medication, compared to 62 percent with cardiovascular disease; in MarketScan patients, use was 75 and 67 percent, respectively. Figures 2.14–17; see page 123 for analytical methods. Point prevalent Medicare CKD patients age 65 & older & MarketScan CKD patients age 50–64.

Figure 2.18 Medicare Part D & MarketScan CKD patients with at least one claim for a diuretic in the 12 months following the disease–defining entry period, by CKD diagnosis code, 2008
Figure 2.19 Medicare Part D & MarketScan CKD patients with at least one claim for an ESA in the 12 months following the disease–defining entry period, by CKD diagnosis code, 2008
Figure 2.20 Medicare Part D & MarketScan CKD patients with at least one claim for oral vitamin D in the 12 months following the disease–defining entry period, by CKD diagnosis code, 2008
Figure 2.21 Medicare Part D & MarketScan CKD patients with at least one claim for a phosphate binder in the 12 months following the disease–defining entry period, by CKD diagnosis code, 2008

Potassium-sparing diuretics or combination diuretic products (e.g. potassium-sparing plus thiazide diuretics) are rarely used in CKD patients. Thiazide and loop diuretics, in contrast, receive much wider use, with 30 and 33 percent, respectively, of Medicare and MarketScan patients receiving a thiazide diuretic, and 46 and 25 percent a loop diuretic. Across all stages of CKD, loop diuretic use is more common in Medicare patients than in the MarketScan population.

Overall, less than 7 percent of Medicare and MarketScan CKD patients used an erythropoiesis stimulating agent (ESA) – either EPO or DPO – in 2008. Nearly 21 percent of MarketScan patients with CKD of Stages 4–5, however, received an ESA.

Use of oral vitamin D is limited in CKD patients. In those with CKD of Stages 4–5, calcitriol was used by approximately 16–17 percent of Medicare Part D and MarketScan enrollees in 2008, while paricalcitol and inactive vitamin D received greater use in the MarketScan population.

In Medicare Part D and MarketScan patients with CKD of Stages 4–5, calcium acetate and sevelamer are the most widely used phospate binders. » Figures 2.18–21; see page 123 for analytical methods. Point prevalent Medicare CKD patients age 65 & older & MarketScan CKD patients age 50–64.

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Atlas of CKD

Chapter Three

Morbidity and Mortality in patients with chronic Kidney Disease

Introduction

Assessing morbidity in patients with chronic kidney disease requires longitudinal data from a defined population, with relatively complete information on all–cause and cause–specific hospitalization. Such data are rarely available on a random sample of the U.S. population, since it is very difficult to track patients across multiple insurers. Health plan datasets from Medicare and from employer group health plans (EGHPs), however, can capture information well, particularly over a one–year period, and they provide a unique opportunity to assess morbidity.

In this chapter we use data from three insurers which represent large populations. Medicare data, for instance, cover 95 percent of individuals age 65 and older. We also employ the Thomson Rueters MarketScan dataset and the United Healthcare Ingenix i3 LabRx dataset, both from large EGHPs. MarketScan data cover health plan expenditure claims for employers that are approximately 80 percent self–insured, compared to just 20 percent in the Ingenix i3 data. For each dataset we use diagnosis codes to define CKD during a one–year entry period, noting hospitalizations and services in the one–year follow–up period.

Because increasing recognition of CKD can create biases in the data, with a potentially lower disease burden in patients diagnosed earlier in the course of their disease, we have added adjusted rates based on comorbidity and disease severity. On the next page, for example, we examine hospitalization rates in Medicare and MarketScan patients with and without CKD. Unadjusted rates in the CKD population – reflecting its total disease burden – are 3–5 times those of non–CKD patients. Once adjustments have been added for gender, prior hospitalizations, and comorbidity, rates for CKD patients are 1.4 times higher. This illustrates the net impact of CKD if the populations were to have similar comorbidity and severity of disease. CKD patients, however, carry a heavy burden of cardiovascular disease (CVD), which adjustments cannot fully address since CVD interacts so strongly with CKD itself.

Not surprisingly, rates of cardiovascular hospitalization are greater for patients with CKD – particularly those in more advanced stages of the disease — than for patients without. Hospitalization rates overall vary with comorbidity, and interact with degrees of CKD. Illustrating the graded impact of advancing kidney disease, adjusted all–cause rates are 38 percent higher in Medicare CKD patients than in patients without the disease, 27 percent higher in Stage 1–2 patients than in non–CKD patients, 7 percent greater for Stage 3 than for Stages 1–2, and 37 percent higher for Stages 4–5 versus Stages 1–2.

Secondary to multiple defects in the ability to kill bacteria, infectious complications are more frequent in patients with kidney disease, particularly those with Stage 4 CKD and those on dialysis. Adjusted rates of hospitalization for lung infections, for example, are 13–81 percent higher among Medicare patients with various stages of CKD than in those without recognized kidney disease, while hospitalizations secondary to circulatory infections such as bacteremia and sepsis are 1.5–2.0 times greater. After adjusting for comorbidity and prior history of hospitalizations – a measure of disease severity – rates of hospitalization due to infection are substantially higher, across organ systems, among those with CKD.

Data on mortality in CKD and non-CKD patients illustrate the impact of adjustments for comorbidity and disease severity on absolute death rates. Adjusting for age, gender, race, comorbidity, and prior hospitalizations, mortality among CKD patients in 2009 is 56 percent greater than among non–CKD patients. As with hospitalization, CKD is thus a risk multiplier for mortality. The decline in rates since 1995 may partially reflect increased recognition of CKD, as illustrated by the increasing percentage of patients carrying the diagnosis; it may also indicate classification bias rather than a true reduction. Adjustments over time, however, appear to mitigate some of these issues, as the drop in mortality rates since 1995 is greater than that seen among patients without CKD.

Patterns in mortality by CKD stage parallel those seen with hospitalization; the adjusted rate in patients with CKD of Stages 4–5, for example, is 76 percent greater than that in non–CKD patients. The impact of diabetes and congestive heart failure as risk multipliers is also important, particularly given that cardiovascular risk factors are relatively under–treated in the U.S.

Figure 3.1 Unadjusted & adjusted all–cause hospitalization rates in the Medicare & MarketScan populations, by CKD status (see page 124 for analytical methods. Medicare: point prevalent patients on January 1 of the year, age 66 & older on December 31 of the prior year. MarketScan: point prevalent patients on January 1 of the year, age 50–64 on December 31 of the prior year. Adj: gender/prior hospitalization/13 comorbidities; ref: Medicare patients age 66 & older, 2005.)

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Atlas of CKD

Chapter Three

Morbidity and Mortality in patients with chronic Kidney Disease

Hospitalization Rates in CKD & non–CKD Patients

Figure 3.2 Adjusted hospitalization rates in Medicare patients, by comorbidity & CKD diagnosis code, 2009 (see page 124 for analytical methods. Point prevalent Medicare patients on January 1, 2009, age 66 & older on December 31, 2008. Adj: age/gender/race/prior hospitalization/comorbidity; rates by one factor are adjusted for the others. Ref: Medicare patients age 66 & older, 2009.)

In both CKD and non-CKD populations age 66 and older, adjusted rates of hospitalization increase with greater comorbidity. In 2009, for example, admissions for Stage 4–5 CKD patients with both diabetes and cardiovascular disease reached 778 per 1,000 patient years – more than twice the rate among patients with neither diagnosis.

By race, hospitalization rates are generally higher among African Americans compared to whites, reaching 18 percent for those with Stage 4–5 CKD, and 6.1 percent for those with CKD of Stages 1–2.

Figure 3.3 Adjusted hospitalization rates in Medicare patients, by race & CKD diagnosis code, 2009 (see page 124 for analytical methods. Point prevalent Medicare patients on January 1, 2009, age 66 & older on December 31, 2008. Adj: age/gender/race/prior hospitalization/comorbidity; rates by one factor are adjusted for the others. Ref: Medicare patients age 66 & older, 2009.)
Table 3.a Adjusted hospitalization rates (per 1,000 patient years at risk) in Medicare patients, by CKD diagnosis code, 2009

Among Medicare patients age 66 and older, adjusted admission rates are greater for patients with CKD compared to those without, and for patients with Stage 4–5 CKD compared to those in an earlier stage. With the exception of patients with Stage 3 CKD, the highest rates by race occur among African Americans. By gender, admissions for patients with some stage of CKD are consistently higher among women. » Table 3.a; see page 124 for analytical methods. Medicare: point prevalent patients on January 1, 2009, age 66 & older on December 31, 2008. Adj: age/gender/race/prior hospitalization/comorbidity; rates by one factor are adjusted for the others. Ref: Medicare patients age 66 & older, 2009.

Figure 3.4 Adjusted all–cause hospitalization rates, by dataset & CKD diagnosis code, 2009 (see page 124 for analytical methods. Medicare: point prevalent patients on January 1, 2009, age 66 & older on December 31, 2008. MarketScan & Ingenix i3: point prevalent patients on January 1, 2009, age 50–64 on December 31, 2008. Adj: gender/prior hospitalization/comorbidity; ref: Medicare patients age 66 & older, 2009.)
Figure 3.5 Adjusted rates of hospitalization for cardiovascular disease, by dataset & CKD diagnosis code, 2009 (see page 124 for analytical methods. Medicare: point prevalent patients on January 1, 2009, age 66 & older on December 31, 2008. MarketScan & Ingenix i3: point prevalent patients on January 1, 2009, age 50–64 on December 31, 2008. Adj: gender/prior hospitalization/comorbidity; ref: Medicare patients age 66 & older, 2009.)
Figure 3.6 Adjusted rates of hospitalization for infection, by dataset & CKD diagnosis code, 2009 (see page 124 for analytical methods. Medicare: point prevalent patients on January 1, 2009, age 66 & older on December 31, 2008. MarketScan & Ingenix i3: point prevalent patients on January 1, 2009, age 50–64 on December 31, 2008. Adj: gender/prior hospitalization/comorbidity; ref: Medicare patients age 66 & older, 2009.)
Figure 3.7 Adjusted rates of hospitalization for other causes, by dataset & CKD diagnosis code, 2009 (see page 124 for analytical methods. Medicare: point prevalent patients on January 1, 2009, age 66 & older on December 31, 2008. MarketScan & Ingenix i3: point prevalent patients on January 1, 2009, age 50–64 on December 31, 2008. Adj: gender/prior hospitalization/comorbidity; ref: Medicare patients age 66 & older, 2009.)

Adjusted all–cause hospitalization rates, and rates of hospitalization for cardiovascular disease, infection, and other causes, are each higher among Medicare patients age 66 and older than in the younger MarketScan and Ingenix i3 populations. Rates are also greatest for patients with CKD compared to those without, and are generally higher in the later stages of the disease.

All–cause hospitalization rates, for example, are 37 percent higher among Medicare patients with Stage 4–5 CKD than among their counterparts with Stages 1–2, reaching 559 admissions per 1,000 patient years; in the MarketScan and Ingenix i3 populations, rates are 53 and 42 percent higher in those with later–stage CKD.

Among Medicare patients, the rate of 166 cardiovascular admissions per 1,000 patient years in those with Stage 4–5 CKD is 45 percent higher than the rate of 115 reported for those with CKD of Stages 1–2. And rates of 147 and 106 reported for MarketScan and Ingenix i3 patients with later–stage CKD are 111 and 37 percent greater, respectively, than those for patients in the earliest stages of the disease.

Compared to those of patients in the early stages of CKD, rates of admission for infection among patients with CKD of Stages 4–5 are 54–55 percent greater among Medicare and Ingenix i3 patients, and 38 percent higher in the MarketScan population.

Figure 3.8 Adjusted rates of hospitalization due to infection, by CKD stage & major organ system, 2009 (see page 124 for analytical methods. January 1, 2009 point prevalent Medicare patients, age 66 & older on December 31, 2008. Adj: age/gender/race/prior hospitalization/13 comorbidities. Ref: 2009 Medicare patients age 66 & older.)

In 2009, the overall adjusted rate of hospitalization due to infection among CKD patients age 66 and older reached 82 admissions per 1,000 patient years, compared to 56 among non–CKD patients. The rate rises by CKD stage, from 69 among those with CKD of Stages 1–2 to 107 in Stage 4–5 patients.

By major organ system, rates of hospitalization due to infection are consistently greater among CKD patients than among those without the disease, and generally reach their highest levels in patients with Stage 4–5 CKD. The rate of hospitalizations related to lung infections, for example, reaches 33 admissions per 1,000 patient years in Stage 4–5 patients, while the rate of hospitalizations related to infections of the circulatory system reaches 26.

Table 3.b Unadjusted & adjusted rates of hospitalization due to infection (admissions per 1,000 patient years), by organ system, 2009 (see page 124 for analytical methods. January 1, 2009 point prevalent Medicare patients, age 66 & older on December 31, 2008. Adj: age/gender/race/prior hospitalization/13 comorbidities. Ref: 2009 Medicare patients age 66 & older.)

Among non–CKD patients age 66 and older, adjusted rates of hospitalization for infection are higher than unadjusted rates. Among their counterparts with CKD, in contrast, adjustments for age, gender, race, prior hospitalization, and comorbidity consistently lower the hospitalization rate.

Rates generally increase with age. Adjusted rates for all hospitalizations due to infection are the same in men and women, while rates related to circulatory and respiratory infections are greater among men, and those related to genitourinary infections are higher among women. By race, the adjusted rate for infections of the circulatory system among African Americans reaches 28 admissions per 1,000 patient years, compared to 20 among whites and patients of other races.

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Atlas of CKD

Chapter Four

Cardiovascular Disease in Patients with Chronic Kidney Disease

Introduction

This chapter focuses on the association of cardiovascular disease and CKD. As shown on the next page, elderly patients with CKD carry a larger burden of comorbid cardiovascular illness than do those those without CKD, and have a significant additional burden of CHF, AMI, and stroke. Forty–four percent of elderly CKD patients, for example, have CHF, compared to just 20 percent of their counterparts without CKD.

On the following page we present data on the relation of CKD stage to CHF, AMI, PAD, cerebrovascular disease, atrial fibrillation, and the use of defibrillators and coronary revascularization. One general finding is that the characteristics of patients with unknown or unspecified CKD stage typically mirror those of patients with advanced CKD. Not surprisingly, the burden of comorbid cardiovascular disease increases with age. Among Stage 4–5 CKD patients age 85 and older, for example, 49 percent also have CHF.

We next illustrate geographic variations and temporal trends in rates of CHF and CVA/TIA among CKD patients, and look as well at the use of diagnostic testing in these patients.

The last section of the chapter explores drug therapy in patients with cardiovascular disease, and begins with a table providing drug–specific data on the treatment of cardiovascular illness as related to CKD stage. We then present maps showing the percentage of CHF patients who receive an ACEI/ARB or beta blocker. Rates range from a low of 73 percent both for non–CKD patients in the District of Columbia and for CKD patients in Wyoming, to a high of 89 and 96 percent for non–CKD and CKD patients, respectively, in Rhode Island.

Data on drug therapy for CHF show that in whites and African Americans the use of beta blockers is, surprisingly, higher in CKD patients than in their non–CKD counterparts, at 63–65 compared to 54–59 percent. Beta blocker use is also high in patients with AMI, particularly non–whites. Despite earlier concerns relating to the effectiveness of statin therapy in CKD patients, there is no apparent difference in use between CKD and non–CKD patients with AMI.

Among patients with atrial fibrillation, beta blockers are more commonly used in those with CKD, at 64–65 percent compared to 55–59 in the non–CKD population. Warfarin therapy is used to a lesser extent in African Americans than in patients of other races, regardless of CKD status. One interesting finding is the more frequent use of amiodarone in CKD patients with atrial fibrillation, at 11–19 percent across racial groups compared to 7–10 percent in those without CKD.

In patients with CVA/TIA, warfarin is used more frequently in those with CKD than in those without, at 14–17 compared to 9–13 percent. Clopidogrel, in contrast, is used in 57 percent of white patients without CKD and 51 percent of whites with the disease.

Venn diagrams at the end of the chapter illustrate medication use in CKD and non–CKD patients with CHF. Despite prior reports of the underutilization of evidence–based therapies in patients with CKD, it appears that this finding is no longer accurate, as beta blocker use is now more common in these patients than in their non–CKD counterparts. Use of ACEIs/ARBs is nearly identical in both populations, despite possible concerns over deterioration of renal function or hyperkalemia in CKD patients. Combination therapy with ACEIs/ARBs and beta blockers is also nearly identical in both CKD and non–CKD patients, at 38–39 percent. Perhaps reflecting the potential toxicity of digoxin therapy in CKD patients, a slightly lower percentage of CKD patients with CHF receive this medication. Digoxin is no longer considered first–line therapy for CHF, but it should be remembered that some agents have multiple treatment indications; it is possible that some CHF patients are receiving digoxin therapy for other reasons, such as atrial fibrillation.

Figure 4.1 Cardiovascular disease in patients with or without chronic kidney disease, 2009 (see page 125 for analytical methods. December 31 point prevalent Medicare enrollees age 66 & older, with fee–for–service coverage for all of 2009.)

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Atlas of CKD

Chapter Four

Cardiovascular Disease in Patients with Chronic Kidney Disease

Rates of Cardiovascular Disease

Table 4.a Cardiovascular disease & intervention (percent), by CKD status & diagnosis code, 2009 (see page 124 for analytical methods. December 31 point prevalent Medicare enrollees age 66 & older, with fee–for–service coverage for all of the calendar year.)

This table provides a snapshot of cardiovascular disease prevalence related to demography and CKD stage. CHF, common in elderly patients and those with advanced CKD, was identified in 7.4 percent of non–CKD patients age 66 and older in 2009. In patients with the most advanced CKD, in contrast, this number reached 42 percent. Only 0.5 percent of Stage 4–5 patients, however, received an implantable defibrillator. Although the frequencies are considerably lower, CKD stage and age are also associated with a higher occurrence of AMI, which is more frequent in men.

Peripheral arterial disease is a common cardiovascular condition in patients with CKD, identified in 28 percent of those with Stage 4–5 CKD – three times the rate in non–CKD patients. And cerebrovascular ischemia occurs more than twice as frequently in later–stage CKD patients, at 20 versus 8 percent. Advanced age is also associated with an increased occurrence of CVA/TIA.

Consistent with prior publications, data here show that CKD stage, as well as advanced age and male gender, are associated with the prevalence of atrial fibrillation. Thirty percent of patients age 85 or older and with CKD of Stages 4–5 had atrial fibrillation in 2009.

patients with chf

Figure 4.2 Geographic variations in rates (per 1,000 population) of congestive heart failure (CHF) in patients with CKD, by HSA (see page 125 for analytical methods. January 1 point prevalent Medicare enrollees with a first CHF diagnosis (4.3) or first hospitalized CVA/TIA (4.5) in 1999 or 2009, age 66 & older, with fee–for–service coverage for 12 months before CHF diagnosis or admission for stroke.)
Figure 4.3 Patients with CHF who receive diagnostic testing, by CKD status (see page 125 for analytical methods. January 1 point prevalent Medicare enrollees with a first CHF diagnosis (4.3) or first hospitalized CVA/TIA (4.5) in 1999 or 2009, age 66 & older, with fee–for–service coverage for 12 months before CHF diagnosis or admission for stroke.)

patients with a cva/tia

Figure 4.4 Geographic variations in rates (per 1,000 population) of CVA/TIA in CKD patients, by HSA (see page 125 for analytical methods. January 1 point prevalent Medicare enrollees with a first CHF diagnosis (4.3) or first hospitalized CVA/TIA (4.5) in 1999 or 2009, age 66 & older, with fee–for–service coverage for 12 months before CHF diagnosis or admission for stroke.)

Figure 4.5 Patients hospitalized for CVA/TIA who receive diagnostic testing, by CKD status (see page 125 for analytical methods. January 1 point prevalent Medicare enrollees with a first CHF diagnosis (4.3) or first hospitalized CVA/TIA (4.5) in 1999 or 2009, age 66 & older, with fee–for–service coverage for 12 months before CHF diagnosis or admission for stroke.)

There has been a striking reduction in the rate of CHF in CKD patients, from 416 per 1,000 population in 1999 to 325 in 2009; these findings may suggest selection bias. The change in geographic pattern, however, is unexplained, with the earlier clustering of CHF in the northeast shifting to a higher concentration in the southern states. Geographic patterns for CVA/TIA, in contrast, have remained stable, and the rate has declined more modestly, from 210 to 194.

There has been minimal change in the use of coronary angiography or stress testing to detect ischemic heart disease. Use of echocardiography, in contrast, has increased from 40–41 percent of both CKD and non–CKD patients in 1999 to 49–50 ten years later.

Among patients hospitalized for cerebrovascular events, the greatest change in diagnostic testing has occurred in the use of non–invasive angiography, which tripled between 1999 and 2009 – reaching 24 percent in CKD patients, and 32 percent in those without CKD. Trans–thoracic echocardiography, used in 45–46 percent of patients in 1999, was employed in 54 and 60 percent of CKD and non–CKD patients, respectively, in 2009. Trans–esophageal echocardiography, in contrast, continues to be used in only 3–5 percent of patients. Given to 82–85 percent of patients in 2009, CT scan or MRI are the most commonly used diagnostic tests.

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Chapter Four

Cardiovascular Disease in Patients with Chronic Kidney Disease

Drug Therapy in Patients with Cardiovascular Disease

Table 4.b Cardiovascular disease & pharmacological intervention (percent), by CKD status & diagnosis code, 2008 (see page 125 for analytical methods. January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

Despite prior reports on the underutilization of evidence–based therapies in the CKD population, there appears to have been a sea change in the treatment of cardiovascular disease in these patients. Although there are likely to be concerns over deteriorating renal function and hyperkalemia, more than half of patients with CHF and milder stages of CKD – and 48 percent of those with Stage 4–5 CKD – receive ACEIs/ARBs. Close to two–thirds of CKD patients with CHF, and an impressive 84 percent of Stage 4–5 CKD patients with AMI, receive a beta blocker.

Although the efficacy of statin therapy in CKD patients has been controversial (these agents were widely prescribed in 2008, particularly for patients in the setting of "secondary prevention"), 66 percent of Stage 4–5 patients with AMI, and 49 percent of those with CVA/TIA, received a statin in 2009; this number reached 71 percent in patients undergoing coronary revascularization.

Warfarin therapy is used in 56 percent of non–CKD patients with atrial fibrillation, compared to 45 percent of patients with Stage 4–5 CKD. Use of amiodarone, in contrast, is more frequent in Stage 4–5 patients, at 14 versus 8 percent.

Figure 4.6 Geographic variations in the percent of patients with CHF who receive medication for their condition, by CKD status & state, 2008 (see page 125 for analytical methods.January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

Figure 4.7 Prescription drug therapy in patients with CHF, by CKD status & race, 2008 (see page 125 for analytical methods.January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

Figure 4.8 Prescription drug therapy in patients with AMI, by CKD status & race, 2008 (see page 125 for analytical methods.January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

Figure 4.9 Prescription drug therapy in patients with atrial fibrillation, by CKD status & race, 2008 (see page 125 for analytical methods.January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

Figure 4.10 Prescription drug therapy in patients with CVA/TIA, by CKD status & race, 2008 (see page 125 for analytical methods.January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

Figure 4.11 Percent of patients treated for CHF, by type of medication & CKD status, 2008 (see page 125 for analytical methods.January 1 point prevalent Medicare enrollees age 66 & older, with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008, & with survival & Part D coverage for one month after event.)

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Atlas of CKD

Chapter Five

Presciption Drug Coverage in CKD Patients Medicare Part

Introduction

As of September 2008, 26 million Medicare–enrolled elderly and disabled people, as well as individuals with ESRD, were enrolled in a Medicare Part D prescription drug plan (PDP). Before 2006, these patients obtained drug coverage through various insurance plans, state Medicaid programs, or pharmaceutical–assistance programs, received samples from physicians, or paid out–of–pocket. After 2006, however, the majority obtained Part D coverage. Fifty–six to 60 percent of general Medicare patients and patients with CKD, diabetes, or cardiovascular disease were enrolled in Part D in 2008, as were 67 percent of patients with ESRD.

The retiree drug subsidy, designed to encourage employers to supply prescription coverage to Medicare–covered retirees that is at least as valuable as the Medicare Part D standard plan, provides employers with a tax–free rebate for 28 percent of retirees' drug costs. Other patients are enrolled in employer group health plans or government/military plans ("creditable coverage"), which provide coverage that is equivalent to or better than Part D.

The proportion of patients with other creditable coverage is similar among CKD and Medicare patients, at about 12 percent, but a higher proportion of CKD patients have retiree drug subsidy coverage, at 21 compared to 15 percent. Nine percent of CKD patients have no known source of drug coverage – a level lower than in the Medicare population, and similar to that of patients with diabetes or cardiovascular disease.

Prior to the start of the Medicare Part D program in 2006, patients dually–enrolled in Medicare and Medicaid received prescription benefits under state Medicaid programs. The Part D program, however, offers a substantial low–income subsidy (LIS) benefit to enrollees with limited assets and income, including those who are dually–enrolled. The LIS provides full or partial waivers for many out–of–pocket cost–sharing requirements, including premiums, deductibles, and copayments, and provides full or partial coverage during the coverage gap ("donut hole"). Nearly three in four dialysis patients enrolled in Part D have LIS, compared to 51 and 38 percent of their counterparts with CKD and in the general Medicare population. In general, CKD patients thus pay proportionally lower out-of-pocket costs than Medicare patients for their Part D prescriptions.

Part D does not cover every medication prescribed to Medicare enrollees. Several drug categories – including over–the–counter medications, barbiturates, benzodiazepines, anorexia and weight loss or gain medications, prescription vitamins (except for prenatal vitamins), and cough and cold medications — are excluded from the Part D program by law. This means that some drugs commonly used in CKD patients (oral iron, ergocalciferol, cholecalciferol) are not currently covered through Medicare Part D. Oral calcitriol, doxercalciferol, and paricalcitol, however, are not considered prescription vitamins, and are thus covered.

The Medicare Part D program works in concert with Medicare Part B, which covers medications administered in physician offices (e.g. erythropoiesis stimulating agents in CKD patients). Access to certain medications is dependent on whether the drug is included on the PDP formulary. A PDP could, for example, decide to include calcitriol and doxercalciferol on its formulary, but not paricalcitol.

Part D benefits can be managed through a stand–alone PDP or through a Medicare Advantage (MA) plan, which provides medical as well as prescription benefits. CKD patients can chose to enroll in an MA plan; ESRD patients, in contrast, are precluded from entering an MA plan if they are not already enrolled in one when they reach ESRD. Most data presented in this chapter encompass both types of plans.

Medicare-enrolled CKD patients obtain outpatient medication benefits through Part B, Part D, retiree drug subsidy plans, or other creditable coverage, including employer group health plans, Veterans Administration benefits, Medicaid wrap–around programs, and state kidney programs. Some also pay out–of–pocket for plan expenses and copayments, over–the–counter medications, and low–cost generic agents at retailers.

Figure 5.1 Sources of prescription drug coverage (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

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Chapter Five

Presciption Drug Coverage in CKD Patients Medicare Part

Medicare Part D Enrollment Patterns in Patients with CKD

Figure 5.2 Sources of prescription drug coverage in Medicare enrollees, by age, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)
Figure 5.3 Sources of prescription drug coverage in Medicare enrollees, by race, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)
Figure 5.4 Sources of prescription drug coverage in Medicare enrollees, by CKD stage, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

Among both general Medicare beneficiaries and those with CKD, the percentage enrolled in Part D declines with age. In the CKD population, however, 91 and 75 percent of those age 20–44 and 45–64, respectively, are enrolled, compared to 81 and 65 percent of their general Medicare counterparts.

Nearly 73 percent of general Medicare patients age 20–44 receive the low income subsidy (LIS). It is important to note that most patients in these younger two age groups are disabled. In the two older age groups, similar proportions of general Medicare and CKD patients age 65 and older are enrolled in Part D, at 55–58 percent. The proportion of patients with LIS declines with age in both populations, but CKD patients in each age category are more likely to receive this subsidy.

Patterns of coverage by race are similar in the general Medicare and CKD populations, with both Part D enrollment overall and Part D coverage with LIS highest in Asian and African American patients, and lowest in whites. LIS coverage is higher across races for CKD patients than among their general Medicare counterparts.

There is less variation in Part D enrollment by CKD stage, with 54 and 60 percent of CKD Stage 3 and Stage 4–5 patients enrolled in Part D, respectively, compared to 59 percent of general Medicare patients. In the CKD population, LIS is least common among those with Stage 3 CKD, at 24 percent.

Figure 5.5 Medicare Part D enrollees, by low income subsidy (LIS) status & population, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

Fifty–one percent of Medicare patients with part D coverage had LIS benefits in 2008, compared to 73 percent of dialysis patients and 64 percent of those with a kidney transplant. CKD patients are thus more likely to experience the coverage gap and to have higher premiums, deductibles, and drug copayments, on average, than dialysis and transplant patients.

Table 5.a Medicare Part D enrollees with low income subsidy (LIS), by CKD stage & demographic characteristics, 2008 (percent) (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

The proportion of patients with LIS varies more by age and race than by CKD stage. In each category, patients with known CKD are more likely to have LIS than their general Medicare counterparts. Among CKD patients, women are far more likely to have LIS than men; in the general Medicare population, in contrast, proportions are similar by gender. In both the general Medicare and CKD populations, Asians are the most likely by race to have LIS, and whites the least.

Figure 5.6 Geographic variations in the percent of Medicare Part D enrollees with low income subsidy (LIS), 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.

There is substantial state–to–state variability in the percentage of Medicare Part D enrollees with LIS, and the patterns seen in CKD and ESRD patients differ from those of the general Medicare population. In each state there is a monotonic increase in the percentage of patients receiving LIS as populations change from general Medicare to CKD and then to ESRD patients. In Delaware, Minnesota, and Utah, the difference between general Medicare and CKD patients is less than 4 percentage points; in California, in contrast, it is more than 25.

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Chapter Five

Presciption Drug Coverage in CKD Patients Medicare Part

Overall Costs of Part D Enrollment

Figure 5.11 Net Part D payment for Medicare enrollees (see page 126 for analytical methods. Medicare Part D enrollees.)

In 2008, total net Part D payment for patients with identified kidney disease (CKD patients not on dialysis, and ESRD patients) was $5 billion – 10 percent of total Part D prescription drug costs. These costs do not include costs of drugs billed to Part B, including intradialytic medications (ESAs, IV vitamin D, iron) and immunosuppressants.

Figure 5.12 Per person per year Medicare & out–of–pocket Part D costs for enrollees, 2008 (see page 126 for analytical methods. Medicare patients surviving 2007 with Medicare as primary payor & enrolled in Part D. Medicare PPPY: sum of Medicare payment & low income subsidy. Out–of–pocket: sum of patient payment & other qualifying amounts.

At $4,255, the per person per year (PPPY) total cost of medications covered by Medicare Part D is 1.74 times higher in CKD patients than in the general Medicare population. Proportional to total Part D costs, however, out–of–pocket costs are lower in CKD patients, representing 17 percent of their PPPY costs compared to 19 percent for the general Medicare population. There is little variation in total Medicare Part D or out–of–pocket costs across CKD stages.

Figure 5.13 Per person per year Part D costs for enrollees, by low income subsidy (LIS) status, 2008

PPPY total costs for Part D–covered medications in 2008 were 3.3–3.8 times greater for LIS patients than for those without LIS. Costs in LIS and non–LIS patients vary from $3,694 and $978 PPPY, respectively, in the general Medicare population to $5,451 and $1,672 among patients with CKD, and to $6,674 and $2,043 among those on dialysis. Figure 5.13; see page 126 for analytical methods. Medicare patients surviving 2007 with Medicare as primary payor & enrolled in Part D, & period prevalent dialysis patients, 2008, with Medicare as primary payor. Medicare PPPY: sum of Medicare payment & low income subsidy.

Table 5.b Total per person per year (PPPY) Medicare part D costs (dollars) for enrollees, by CKD stage & low income subsidy (LIS) status, 2008 (see page 126 for analytical methods. Medicare patients surviving 2007 with Medicare as primary payor & enrolled in Part D. Medicare PPPY: sum of Medicare payment & low income subsidy.)

Total per person per year (PPPY) Medicare Part D costs vary widely between those with and without LIS. Overall, there is less variation by CKD stage and gender (except for patients with Stage 1–2 CKD and LIS, in whom costs are lower for women) and more by age and race. Because they are Medicare–enrolled due to disability, patients younger than 65 have higher Part D costs than older patients of the same CKD stage. By race, and regardless of LIS status, PPPY costs in the Medicare population are highest for African Americans, and in the CKD population are highest for whites.

Figure 5.14 Geographic variations in Parts A & B & Part D PPPY costs (dollars) in general Medicare & CKD patients, by HSA, 2008 (see page 126 for analytical methods. Medicare patients surviving 2007 with Medicare as primary payor & enrolled in Part D. Medicare PPPY: sum of Medicare payment & low income subsidy.

General Medicare and CKD Part A and Part B per person per year costs show similar geographic patterns and are highest in areas of Texas, Mississippi, California, and Florida. CKD Part A and B costs are twice those found in general Medicare patients, averaging $24,925 and $10,334, respectively, in the upper quintile. Similar geographic cost patterns exist as well for Part D patients. CKD Part D costs in the upper quintile average $4,416, compared to $2,640 for general Medicare Part D; costs for both populations tend to be highest in Alaska, parts of California and Appalachia, and areas in New England.

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Chapter Five

Presciption Drug Coverage in CKD Patients Medicare Part

Coverage Phase Analyses for Part D Enrollees

Figure 5.15 Part D–non–LIS enrollees who reach each coverage phase, by CKD stage, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)
Figure 5.16 Cumulative percent of Part D non–LIS enrollees who reach the coverage gap, by CKD stage, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)
Figure 5.17 Cumulative percent of Part D non–LIS enrollees who reach catastrophic coverage after reaching the coverage gap, by CKD stage, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)

Part D enrollees without the low income subsidy (LIS) may encounter three coverage phases, depending on total and out–of–pocket costs per year. In 2008, patients with total Part D drug costs up to $2,510 fell into the initial coverage phase, while those with costs over that amount entered the coverage gap ("donut hole"), in which they were responsible for 100 percent of drug costs. Patients whose out–of–pocket total reached $4,050 then entered the catastrophic coverage phase, in which they paid only a fraction of overall drug costs.

In 2008, 42 percent of all CKD patients (those not on dialysis) reached the coverage gap, compared to 23 percent in the general Medicare population; this varied little by CKD stage. Eight percent reached catastrophic coverage, compared to 3 percent of general Medicare patients.

Patients with Stage 3 CKD reach the coverage gap slightly sooner, on average, than those with CKD of other stages, while general Medicare patients take the longest. And 18–21 percent of CKD patients who reach the coverage gap subsequently attain catastrophic coverage, compared to 12.5 percent of general Medicare patients. Patients with Stage 4–5 CKD reach catastrophic coverage slightly faster than do patients in the earlier stages of CKD, and patients with CKD of any stage reach this coverage considerably faster than general Medicare patients.

Table 5.c Twelve–month probability of reaching the coverage gap in Part D non–LIS enrollees, by CKD stage, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)

Across CKD stages, 40–46 percent of non–LIS Part D enrollees reach the coverage gap within 12 months; this varies little by age or gender. In the general Medicare population, white patients are more likely to reach the gap. This is true in the overall CKD population as well, but for Stage 3–5 CKD patients the probability is highest among Asians, and lowest in African Americans. By comorbidity, patients with diabetes reach the gap at a higher rate than do those with other diagnoses. Not surprisingly, the likelihood of reaching the gap rises with the number of prescription fills per month in the previous year.

Table 5.d Rate of Part D–covered prescription fills per person per month in Part D non–LIS enrollees, by CKD stage, 2008 (see page 126 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)

Number, fill rate, and prescription cost influence whether patients stay in the initial coverage phase or progress to the coverage gap and then to catastrophic coverage. Among CKD patients who reach the initial coverage phase or coverage gap, the fill rate rises monotonically from Stages 1–2 to Stages 4–5. In patients reaching catastrophic coverage, however, the rate decreases monotonically with CKD stage.

Among patients who reach the coverage gap, the fill rate consistently declines from that of the initial coverage period. This could be due either to a reduction in medication adherence or to a decision to obtain medications outside the Part D plan, and it is a pattern not seen in patients who reach catastrophic coverage. In these patients, the fill rate rises as patients move from initial coverage to the gap, and then again as they reach catastrophic coverage. Patients with a higher number of Part D medications could be incentivized to fill prescriptions in order to reach this phase more quickly, as their out–of–pocket expenses then decrease dramatically.

Table 5.e Top 15 drugs used in general Medicare Part D enrollees, by frequency & net cost, 2008 (see page 126 for analytical methods. Part D claims for all patients in the Medicare 5 percent sample (claims & costs scaled up by a factor of 20 to estimate totals). Costs are the sum of Medicare payment & low income subsidy. All patients in the Medicare 5 percent sample (5.e). CKD Stage 1–2 (5.f) & CKD Stage 3–5 (5.g) Medicare patients, with Medicare as primary payor for calendar year 2007; all Part D claims for calendar year 2008 are included.)

In terms of frequency of use, the top 15 drugs covered by Medicare Part D are similar in the general Medicare and CKD populations. Furosemide, for example, is the most frequently used drug in the CKD population, and fifth on the list for general Medicare patients. Two drugs — hydrochlorothiazide and metformin — appear in the top 15 for general Medicare patients, but not for CKD patients, in whom furosemide (a loop diuretic) has a more potent diuretic effect, and metformin is contraindicated secondary to the increased risk of lactic acidosis. Carvedilol, allopurinol, and atenolol, in contrast, make the list only for CKD patients. Interestingly, potassium chloride is one of the most frequently used medications in the CKD population, which may indicate a more aggressive use of diuretics in these patients.

When ranked by net cost, the list of medications used in the general Medicare population contains more psychiatric drugs than do the lists for CKD patients. Epoetin alfa, in contrast, appears only in the CKD lists. Regardless of CKD stage, the highest net costs in the CKD population are for insulin, reflecting both the high prevalence of diabetes in these patients and the fact that many new insulin therapies are still under patent and not available as generics.

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Atlas of CKD

Chapter Five

Presciption Drug Coverage in CKD Patients Medicare Part

Medicare Part D Prescription Drug Use & Costs

Figure 5.18 Top 15 drugs in general Medicare Part D enrollees, by frequency, 2008 (see page 126 for analytical methods. Part D claims for all patients in the Medicare 5 percent sample (5.18–19). Medicare CKD patients with Medicare as primary payor for calendar year 2007; includes Part D claims for calendar year 2008 (5.20–21). Cumulative percentage is the percentage of all Part D, & costs are the sum of Medicare payment & low income subsidy. Claims & costs scaled up by a factor of 20 to estimate totals.)
A Levothyroxine
B Metoprolol
C Simvastatin
D Lisinopril
E Furosemide
F Amlodipine
G Atorvastatin
H Atenolol
I Hydrochlorothiazide
J Metformin
K Potassium chloride
L Omeprazole M Warfarin
N Clopidogrel bisulfate
O Insulin

Figure 5.19 Top 15 drugs in general Medicare Part D enrollees, by cost, 2008 (see page 126 for analytical methods. Part D claims for all patients in the Medicare 5 percent sample (5.18–19). Medicare CKD patients with Medicare as primary payor for calendar year 2007; includes Part D claims for calendar year 2008 (5.20–21). Cumulative percentage is the percentage of all Part D, & costs are the sum of Medicare payment & low income subsidy. Claims & costs scaled up by a factor of 20 to estimate totals.)
A Atorvastatin
B Clopidogrel bisulfate
C Insulin
D Quetiapine
E Olanzapine
F Esomeprazole
G Donepezil
H Fluticasone/salmeterol
I Risperidone
J Pioglitazone
K Aripiprazole
L Lansoprazole
M Oxycodone
N Pantoprazole
O Divalproex

Figure 5.20 Top 15 drugs in Medicare Part D enrollees with CKD, by frequency, 2008 (see page 126 for analytical methods. Part D claims for all patients in the Medicare 5 percent sample (5.18–19). Medicare CKD patients with Medicare as primary payor for calendar year 2007; includes Part D claims for calendar year 2008 (5.20–21). Cumulative percentage is the percentage of all Part D, & costs are the sum of Medicare payment & low income subsidy. Claims & costs scaled up by a factor of 20 to estimate totals.)
A Furosemide
B Metoprolol
C Levothyroxine
D Amlodipine
E Lisinopril
F Insulin
G Simvastatin
H Potassium chloride
I Clopidogrel bisulfate
J Warfarin
K Atorvastatin
L Omeprazole
M Carvedilol
N Allopurinol
O Atenolol

Figure 5.21 Top 15 drugs in Medicare Part D enrollees with CKD, by cost, 2008 (see page 126 for analytical methods. Part D claims for all patients in the Medicare 5 percent sample (5.18–19). Medicare CKD patients with Medicare as primary payor for calendar year 2007; includes Part D claims for calendar year 2008 (5.20–21). Cumulative percentage is the percentage of all Part D, & costs are the sum of Medicare payment & low income subsidy. Claims & costs scaled up by a factor of 20 to estimate totals.)
A Insulin
B Clopidogrel bisulfate
C Atorvastatin
D Esomeprazole
E Donepezil
F Epoetin Alfa
G Pioglitazone
H Quetiapine
I Fluticasone/salmeterol
J Pantoprazole
K Olanzapine
L Lansoprazole
M Tamsulosin
N Omeprazole
O Oxycodone

As measured by total days supply, insulin therapies represented 2.8 percent of Part D drug use among CKD patients in 2008, but 6.2 percent of their Part D costs the same relative proportion seen in general Medicare patients, where insulin therapies represented 1.3 percent of Part D drug use and 2.9 percent of costs. This suggests that CKD patients are being prescribed branded insulin therapies at about the same rate as their general Medicare counterparts. The same is true of clopidogrel, accounting for 2.1 percent of Part D use in the CKD population, and 1.5 percent among general Medicare patients.

Epoetin alfa, used for anemia treatment in CKD patients, accounted for 2.1 percent of their total Part D costs in 2008. This may represent CKD patients who are self–administering epoetin alfa at home, rather than having it administered in a doctor's office, where billing would be covered under Medicare Part B rather than Part D.

Furosemide, metoprolol, and levothyroxine were the top three drugs, as measured by total days supply, in the identified CKD population in 2008; they accounted for nearly 12 percent of total Part D drug use in this population. The top 15 drugs represented 37 and 34 percent of Part D use and costs in these patients, similar to the 35 and 30 percent seen in general Medicare patients.

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Atlas of CKD

Chapter Six

Costs of Chronic Kidney Disease

Introduction

Determining the economic impact of CKD on the healthcare system is challenging on several levels. The case definition is dependent on reported data. A biochemical definition would be the most quantitative, but health plan datasets rarely contain this information on a large scale. A definition of the CKD cohort using diagnosis codes, however, may represent only the more advanced — and thus most expensive — cases. In addition, CKD is a highly interactive disease, associated with cardiovascular disease, diabetes, stroke, and infectious complications.

Given these limitations, we have developed a method using diagnosis codes to create a point prevalent CKD cohort. In the 2009 ADR, "new" CKD patients were included in order to produce a period prevalent cohort parallel to that created for the ESRD population. These patients, however, accounted for a disproportionate percentage of overall costs, which could not be directly attributed to their CKD status. The reasons for this are numerous, but may include a high rate of acute kidney injury. This year we include only patients classified as having CKD on January 1 of a given year, resulting in a true point prevalent cohort. When compared to the 2009 ADR, costs reported here for CKD patients are thus significantly lower, while those for non–CKD patients are higher. It is unclear which method most accurately depicts true CKD costs. Each has its strengths and weaknesses, and the differences reflect the uncertainty involved in using claims to classify CKD.

We begin by presenting data from Medicare on the chronic diseases associated with the greatest population–level expenditures. Congestive heart failure (CHF), for example, affects 9.6 percent of patients in the fee–for–service population, and accounts for 15.9 percent of costs. Nearly 23 percent of patients have diabetes; 32.4 percent of expenditures go toward their care. And while patients with CKD represent only 7.6 percent of the population, their care accounts for 22.3 percent of total expenditures.

While patients in each of these populations may carry other major diagnoses such as arthritis, cataracts, hip fractures, and chronic lung disease, on a population level these three groups consume very large portions of the Medicare budget. On this basis alone, targeting the CKD population would have a large impact if improvements in care led to reduced hospitalizations, a major source of cost to the healthcare system. Overall, CKD patients incur per person per year (PPPY) costs of just over $20,000, compared to $6,800 for patients without ESRD, CKD, diabetes, or CHF (see Reference Table K.5 in this volume). CKD patients who also carry a diagnosis of heart failure incur up to $35,000 PPPY. These costs approach 40–45 percent of the $80,000 PPPY incurred by a hemodialysis patient (Figure 11.7, Volume Two). In addition, costs for inpatient/outpatient and physician/supplier services exceed $20,000 per person per year, and Part D expenditures add an additional $3,500 per year. CKD patients thus incur nearly half the costs of the hemodialysis population – a group which, with the exception of some populations with rare diseases, is the most expensive in the Medicare system.

We conclude this chapter with data on the Medicare Part D benefit, a program which began in 2006. In 2008, Part D costs accounted for 14 percent of total Medicare expenditures in the CKD population. CKD patients with both diabetes and congestive heart failure had the highest per person per year Part D expenditures that year, at $4,645, in contrast to $1,985 for all Medicare patients. Costs vary considerably in relation to the low income subsidy (LIS); net Part D costs for CKD patients with the LIS are more than three times higher than for their non–LIS counterparts, while out–of–pocket Part D costs range from $122–$154 in LIS patients to $1,218–$1,383 in patients without LIS. Given the large costs of Part D covered medications in CKD patients, and a relative lack of information on the effect of particular medications in this population, there is substantial opportunity for comparative–effectiveness and cost–effectiveness research using Part D data.

Figure 6.1 Point prevalent distribution & annual costs of Medicare (fee–for–service) patients, age 65 & older, with diagnosed diabetes, CHF, & CKD, 2009 (see page 126 for analytical methods. Populations estimated from the 5 percent Medicare sample using a point prevalent model (see appendix for details). Population further restricted to patients age 65 & older, without ESRD. Diabetes, CHF, & CKD determined from claims; costs are for calendar year 2009.)

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Atlas of CKD

Chapter Six

Costs of Chronic Kidney Disease

Overall Costs of Chronic Kidney Disease

Figure 6.2 Overall PPPY costs in CKD patients, by CKD diagnosis code, dataset, & year (see page 126 for analytical methods. Point prevalent Medicare patients age 65 & older (5 percent Medicare sample, 6.2–4) & MarketScan patients age 50–64 (6.2).)
Figure 6.3 PPPY costs in Medicare CKD pts with DM, by CKD diagnosis code, race, & year (see page 126 for analytical methods. Point prevalent Medicare patients age 65 & older (5 percent Medicare sample, 6.2–4) & MarketScan patients age 50–64 (6.2).)
Figure 6.4 PPPY costs in Medicare CKD pts with CHF, by CKD diagnosis code, race, & year (see page 126 for analytical methods. Point prevalent Medicare patients age 65 & older (5 percent Medicare sample, 6.2–4) & MarketScan patients age 50–64 (6.2).)

In 2009, overall per person per year (PPPY) costs for patients with CKD reached $20,432 for Medicare patients age 65 and older, and $16,682 for patients age 50–64 in the MarketScan database. Compared to costs for patients with CKD of Stages 1–2, costs for those with Stage 4–5 CKD were 39 percent greater in the Medicare population and 66 percent higher among MarketScan patients.

Among Medicare patients with both CKD and diabetes, PPPY costs for African Americans reached $25,166 in 2009, 11.4 percent higher than the $22,593 incurred by whites. Costs for those with Stage 4–5 CKD were 43 and 34 percent greater, respectively, for African Americans and whites than costs for their counterparts with CKD of Stages 1–2.

In 2009, costs for African American Medicare patients with both CKD and congestive heart failure were 14.8 percent higher than costs for whites with both diagnoses, at $35,074 and $30,566, respectively. And for patients with Stage 4–5 CKD, costs were 13.7 and 19 percent higher among whites and African Americans, respectively, than costs in those with CKD of Stages 1–2.

Figure 6.5 Overall expenditures for CKD in the Medicare population (see page 126 for analytical methods. Point prevalent Medicare CKD patients age 65 & older. *Medicare Part D data not available for 2009.)
Figure 6.6 Overall expenditures for CKD & diabetes in the Medicare population (see page 126 for analytical methods. Point prevalent Medicare CKD patients age 65 & older. *Medicare Part D data not available for 2009.)
Figure 6.7 Overall expenditures for CKD & congestive heart failure in the Medicare population ((see page 126 for analytical methods. Point prevalent Medicare CKD patients age 65 & older. *Medicare Part D data not available for 2009.)

In 1993, costs for Medicare patients with CKD accounted for 3.8 percent of overall Medicare expenditures. In 2009, excluding Medicare Part D drug benefits, costs reached $34 billion, and accounted for nearly 16 percent of total Medicare dollars.

CKD patients with diabetes accounted for 26.1 percent of total Medicare diabetes costs in 2009, totaling $18 billion — an eleven–fold increase since 1993. This rise demonstrates the enormous economic burden that diabetes presently imposes on the healthcare system, and gives a sense of the future as well; the American Diabetes Association projects that, by 2050, 29 million Americans will be diagnosed with the disease.

Costs for CKD patients with CHF accounted for 34.6 percent of total Medicare CHF dollars in 2009 – $16 billion of the $47 billion spent by Medicare on patients with this disease.

Figure 6.8 Per person per year expenditures for CKD in the Medicare population, by at–risk group (see page 126 for analytical methods. Point prevalent Medicare CKD patients age 65 & older. *Medicare Part D data not available for 2009.)

In 2009, per person per year costs (excluding part D) for CKD totaled $20,432 overall, and were highest in CKD patients with both diabetes and CHF, at $34,121; costs for CKD patients with no diabetes or CHF, in contrast, totaled $14,449 – nearly 58 percent lower.

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Atlas of CKD

Chapter Six

Costs of Chronic Kidney Disease

Components of Costs for Chronic Kidney Disease

Table 6.a Per person per year (PPPY) inpatient/outpatient & physician/supplier net costs (dollars) for CKD, by CKD diagnosis code, 2009 (see page 127 for analytical methods. Medicare CKD patients age 65 & older, 2009.)

Among Medicare patients with chronic kidney disease, per person per year (PPPY) net inpatient/outpatient costs are generally higher for those in a later stage of the disease. In 2009, for example, total costs for patients with Stage 4–5 CKD were 45 percent higher than costs for those in Stages 1–2, at $19,052 and $13,120, respectively. Costs associated with medical and surgical DRGS accounted for 35–38 percent of total inpatient/outpatient costs, while home health agency and skilled nursing accounted for 24–26 percent.

Physician/supplier costs in 2009 totaled $6,159 PPPY for patients with Stage 4–5 CKD, 22.6 percent higher than the $5,023 for patients with Stage 1–2. Prescription drugs accounted for 9–13 percent of total physician/supplier costs.

Figure 6.9 Overall per person per year (PPPY) Part D expenditures, by year & at–risk group (see page 127 for analytical methods. Populations & costs estimated from 5 percent Medicare sample; include point prevalent patients with Medicare as primary payor, enrolled in Part D, & not enrolled in Medicare Advantage. CKD, diabetes, & CHF defined from claims. Medicare net pay estimated from Part D as sum of plan payment & low income subsidy.)
Figure 6.10 Per person per year (PPPY) Part D expenditures, by year & at–risk group: whites (see page 127 for analytical methods. Populations & costs estimated from 5 percent Medicare sample; include point prevalent patients with Medicare as primary payor, enrolled in Part D, & not enrolled in Medicare Advantage. CKD, diabetes, & CHF defined from claims. Medicare net pay estimated from Part D as sum of plan payment & low income subsidy.)
Figure 6.11 Per person per year (PPPY) Part D expenditures, by year & at–risk: African Americans (see page 127 for analytical methods. Populations & costs estimated from 5 percent Medicare sample; include point prevalent patients with Medicare as primary payor, enrolled in Part D, & not enrolled in Medicare Advantage. CKD, diabetes, & CHF defined from claims. Medicare net pay estimated from Part D as sum of plan payment & low income subsidy.)

Between 2007 and 2008, Medicare Part D expenditures per person per year (PPPY) rose 4.4 percent overall and 1.6 percent for patients with CKD, to $1,985 and $3,547, respectively. Costs rise with patient complexity, reaching $3,963 for those with CKD and diabetes, and $4,645 for those with an additional diagnosis of congestive heart failure (CHF). Costs for patients with no CKD, diabetes, or CHF showed the greatest one–year increase, at 6.3 percent, but these patients were the least costly, with PPPY costs of $1,944.

At $4,162 PPPY, Part D drug costs in African American CKD patients were 23.8 percent greater in 2008 than costs among their white counterparts – differences that can be attributed to different levels of LIS coverage. Costs for African Americans with CKD, diabetes, and CHF reached $4,853, 7 percent greater than the costs incurred by white patients with the same diagnoses. This is important in context of the upcoming implementation of the ESRD prospective payment system, which will include certain oral drugs.

Not all drugs are covered through the Medicare Part D benefit. Notable exclusions particularly relevant to CKD include all over–the–counter medications (e.g. calcium carbonate) and vitamins and minerals (e.g. cholecalciferol, ergocalciferol). Oral vitamin D hormones (calcitriol, paricalcitol, doxercalciferol) are covered under the Part D benefit, but not all plans cover all available products.

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Atlas of CKD

Chapter Six

Costs of Chronic Kidney Disease

Medicare Part D Costs

Table 6.b Top 25 drugs used in general Medicare Part D enrollees with CKD, by frequency & net cost, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Counts & costs obtained from 5 percent Medicare sample, & scaled up by a factor of 20 to estimate total Medicare CKD costs.)

Figure 6.12 Total Part D costs, by CKD stage, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Counts & costs obtained from 5 percent Medicare sample, & scaled up by a factor of 20 to estimate total Medicare CKD costs.)
Figure 6.13 Part D costs as a proportion of total Medicare CKD expenditures, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Counts & costs obtained from 5 percent Medicare sample, & scaled up by a factor of 20 to estimate total Medicare CKD costs.)

In terms of frequency of use, the top 25 drugs covered by Medicare Part D in 2008 represent key cardiovascular drug classes, diabetes agents, gastrointestinal agents, and pain products used in patients with CKD.

Net cost rankings are based on a combination of frequency of use (based on total days supply) and cost. Metoprolol makes the top 25 list primarily due to frequency of use; total days supply reached nearly 83 million, with a total cost of $34 million (about $0.41 per day). Olanzapine (an atypical antipsychotic), in contrast, with a total days supply of 4.2 million, cost $54 million – about $13 per day. And in contrast to both of those oral agents, the net cost of epoetin alfa, a parenteral product, was about $31 per day; data on total days supply for parenteral medications, however, may not be as accurate as data for oral medications.

Total costs for Medicare Part D medications in CKD patients reached $3.5 billion in 2008, representing 14.4 percent of total Medicare CKD expenses. The proportion varies by CKD stage, with Part D drugs accounting for 17 percent of costs in Stage 1–2 CKD patients, and 13 percent for those with CKD of Stages 4–5.

Figure 6.14 Total Part D CKD net costs, by low income subsidy (LIS) status & CKD stage, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)
Figure 6.15 PPPY Part D CKD net costs, by low income subsidy (LIS) status & CKD stage, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)
Figure 6.16 PPPY out–of–pocket Part D CKD costs, by LIS status & CKD stage, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)
Figure 6.17 PPPY Part D net CKD $ for antihyper–tensives, by LIS status & CKD stage, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)
Figure 6.18 PPPY Part D net CKD $ for antihyper–tensives, by LIS status & race, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)
Figure 6.19 PPPY Part D net CKD costs for diabetes agents, by LIS status & CKD stage, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)
Figure 6.20 PPPY net CKD costs for diabetes agents, by LIS status & race, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)
Figure 6.21 PPPY Part D net CKD $ for lipid lowering agents, by LIS status & CKD stage, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)
Figure 6.22 PPPY Part D net CKD $ for lipid lowering agents, by LIS status & race, 2008 (see page 127 for analytical methods. Includes Part D claims for all CKD patients, defined from claims on a point prevalent basis, for calendar years 2008. Costs are estimated net pay: sum of plan covered payments & low income subsidy amounts. Costs obtained from 5 percent Medicare sample, & for Figure 6.14 are scaled up by a factor of 20 to estimate total Medicare Part D net costs for CKD.)

In 2008, overall net Part D CKD costs – a total of $3.5 billion – were dominated by costs for patients with the low income subsidy (LIS). Per patient per year (PPPY) costs were similar across CKD stage, and varied from $5,287 in LIS patients with CKD of an unknown/unspecified stage to $5,734 in those with Stage 3 CKD; costs for these patients were three times higher than those of patients without LIS. Out–of–pocket Part D PPPY costs ranged from $122–$154 in LIS patients to $1,218–$1,383 in patients without LIS.

Figures 6.17–22 illustrate PPPY costs for various drug classes by LIS status and CKD stage or race. Costs for patients with Stage 3 CKD are higher than for patients with CKD of other stages, and Asian patients with LIS have higher Part D costs than do their counterparts of other races. There is less cost variability in patients without LIS.

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Atlas of ESRD

Introduction to Volume Two: ESRD

Chapters

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.

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 relationships to the society in which they find themselves. So too does kidney disease have a unique and profound impact on different 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 historical 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 determine 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 Evidence (ME) form (CMS form 2728), used to register all ESRD patients. We also look at dialysis modality use, the transplant 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, prevalence, patient characteristics, and modalities of therapy. As in prior years, we illustrate trends in incidence and prevalence by age, gender, race, and ethnicity, and present data on modality use and insurance coverage. We examine nephrology referral prior to ESRD, and look at levels of estimated kidney 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 stimulating agents (ESAs), and, from the most recent version of the Medical Evidence form, on serum albumin, hemoglobin, cholesterol, triglycerides, and hemoglobin A1c levels at initiation.

Chapter Two, on clinical indicators of care, assesses dialysis 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 prescription 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 differences 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 population, 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 infection. 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 catheters 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 population (Jencks et al.).

We next look at further at hospitalizations due to infection, 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 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 cardiovascular 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 mortality during the first year of hemodialysis, illustrating a sharp increase in all–cause rates in month two of treatment, following 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 Medicare Part D prescription drug benefit in the ESRD population. 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 coverage 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 transplants 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 cardiovascular 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 population continue to be low, with fewer than one in three children receiving this treatment, despite their high rates of pneumonia 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 progressively higher rates over the first 15 months after the initiation 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 Cardiovascular – 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 Survival in ESRD. A prospective, multi–center study of prevalent hemodialysis patients, the study will be conducted in collaboration 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 organizations (SDOs). Large dialysis organizations (LDOs) now treat 63 percent of dialysis patients in the United States; SDOs 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 intervention 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 expenditures 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 international 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 Medical 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.

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Introduction

Peritoneal dialysis now accounts for 6–7 percent of the incident and prevalent dialysis populations, a level far lower than the 12–18 percent in the 1980s and 1990s; there are signs, however, that use of this therapy is growing. The number of kidney transplants reached 17,736 in 2009, while the prevalent transplant population increased 4.2 percent, to 172,553, despite continued growth in the number of patients on the transplant wait list. The median time on the kidney–only and kidney–pancreas wait lists was 1.7 years.

In the rest of this Précis we highlight data from Volume Two. We show, for instance, that rates of new ESRD cases remain quite stable, at 355 per million population in 2009. While ESRD due to diabetes has also been stable over the last decade, at a rate of 154, ESRD caused by hypertension has grown 10 percent. The prevalence of ESRD continues to grow at a rate of 2 percent per year, reaching 1,738 in 2009.

Patients who see a nephrologist for more than 12 months before starting dialysis are the most likely to use a fistula or internal graft at the first outpatient dialysis treatment. Since nephrologists are central to discussions with patients and families about ESRD treatment options, greater pre–ESRD referral would help ensure increased use of fistulas, which are associated with the lowest rates of adverse events.

The treatment of anemia has changed during the last four years, after changes in product labeling from the FDA and in payment structures from CMS. Hemoglobin levels at the initiation of dialysis have fallen below 10 g/dl, a level not seen since December, 2000, while the percentage of patients using an erythropoiesis stimulating agent (ESA) prior to initiation has also fallen – to 22 percent, a level not seen since April, 1996. Hemoglobin levels at six months following the start of ESRD therapy are now lower than in 2001, yet the ESA dose is substantially higher. Hemoglobin levels in the prevalent dialysis population have decreased as well.

Hospitalizations continue to be an area of concern, with admissions for infection in hemodialysis patients 43 percent higher than in 1993. New data on rehospitalizations show that rates are twice as high for ESRD patients as in the general Medicare population. Mortality rates continue to improve, though more slowly for the first year of treatment than for the years following. Rates for ESRD patients, however, are 2.0–2.5 times greater than for general Medicare patients with cancer, diabetes, congestive heart failure, or CVA/TIA.

This year we present new data on the Medicare Part D prescription drug benefit, which started in 2006. ESRD and non–ESRD CKD patients have higher Part D coverage with the low income subsidy than do general Medicare patients and, not surprisingly, out–of–pocket expenditures are greatest for ESRD patients, at nearly $6,000 per year compared to $1,985 in the general Medicare population and $3,550 for those with a diagnosis of CKD.

The kidney transplant wait list continues to grow, reaching 80,848 in 2009; 17,736 transplants were performed that year. Living donor donation rates appear to be rebounding, while donations from deceased donors have been stable. Risk factor monitoring among transplant patients has improved, yet rates of influenza vaccinations are still relatively low.

Highlighted data on pediatric ESRD patients show that the number with cystic kidney disease has increased, while there are fewer patients with glomerular disease. Rates of hospitalization for pneumonia are greatest overall in patients younger than 10, and, in the hemodialysis population, mortality is greatest in the first months of therapy.

Dialysis providers continue to consolidate, with Fresenius Medical Care announcing the purchase of additional units in July, 2011; the company thus maintains its position as the largest provider of dialysis care in the United States. Dialysis Clinic, Inc. continues to have the lowest standardized hospitalization and mortality ratios among the large providers, while, among the smaller providers, hospital–based units have the highest standardized mortality ratios.

We conclude the Précis with data on the costs of ESRD patient care, which rose very little in 2009. Costs per person per year remain highest for hemodialysis patients, at $82,285, compared to $61,588 and $29,983 for peritoneal dialysis and transplant patients.

Figure p1 Distribution of general (fee–for–service) Medicare patients & costs for CKD, CHF, diabetes, & ESRD, 1999 & 2009 (see page 378 for analytical methods. Period prevalent general (fee–for–service) Medicare patients. Diabetes, CKD, & congestive heart failure determined from claims, 1998–1999 & 2008–2009; costs are for calendar years 1999 & 2009.)

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Trends in Patient Counts & Spending

Table pa 1 Summary statistics on reported ESRD therapy in the United States, by age, race, ethnicity, gender, & primary diagnosis, 2009
Table pa 2 Wait–list for kidney & kidney/pancreas transplants
Table pa 3 Medicare & non–Medicare spending*

A Incident counts: include all known ESRD patients, regardless of any incomplete data on patient characteristics and of U.S. residency status.
B Includes only residents of the 50 states and Washington D.C. Rates are adjusted for age, race, and/or gender using the estimated July 1, 2005 U.S. resident population as the standard population. All rates are per million population. Rates by age are adjusted for race and gender. Rates by gender are adjusted for race and age. Rates by race are adjusted for age and gender. Rates by disease group and total adjusted rates are adjusted for age, gender, and race. Adjusted rates do not include patients with other or unknown race.
C Patients are classified as receiving dialysis or having a functioning transplant. Those whose treatment modality on December 31 is unknown are assumed to be receiving dialysis. Includes all Medicare and non–Medicare ESRD patients, and patients in the U.S. Territories and foreign countries.
D Deaths are not counted for patients whose age is unknown.
E Age is computed at the start of therapy for incidence, on December 31 for point prevalence, at the time of transplant for transplants, and on the date of death for death.
F Includes patients whose modality is unknown.
G Unadjusted total rates include all ESRD patients in the 50 states and Washington D.C.
H Total transplants as known to the USRDS; 57 transplants with unknown donor type excluded from counts.
I Adjustments using the Bureau of Labor Statistics inflationary adjustment and the CMS inflation adjustment for the medical component.
* Values for cells with ten or fewer patients are suppressed. "." Zero patients in this cell.

In 2009, 116,395 new dialysis and transplant patients initiated ESRD therapy, for an adjusted rate per million population of 355. More than 571,000 patients were receiving treatment on December 31, 2009, for an adjusted rate of 1,738 per million population. Nearly 399,000 of these patients were being treated with dialysis, while 172,553 had a functioning graft; 90,118 ESRD patients died during the year. A total of 17,736 transplants were performed during 2009, including 6,388 from living donors. More than 34,000 patients were added to the transplant wait list, 85,539 were on the kidney–alone and kidney/pancreas wait lists at the end of 2009, and the median time on the list (for pediatric and adult patients combined) was 1.7 years.

With Medicare spending for ESRD at $29 billion, and non–Medicare spending at $13.5 billion, total ESRD costs in 2009 reached $42.5 billion. Medicare costs per person per year were more than $70,000 overall, ranging from $29,983 for transplant patients to $82,285 for those receiving hemodialysis therapy. » Table p.a; see page 378 for analytical methods. Dialysis & transplant patients, 2009.

Figure p2 Counts of new & returning dialysis patients (see page 378 for analytical methods. CMS Annual Facility Survey.)

The number of new dialysis patients rose 3.5 percent in 2009 — up from a 1.2 percent growth in 2008 — to 112,782. Just over 5,600 patients with graft failure returned to dialysis from transplant, a one–year increase of 2.7 percent. The number of patients restarting dialysis increased 6.6 percent, to 3,492. Overall, the CMS Annual Facility Survey showed 121,880 patients starting or restarting dialysis in 2009, up 3.6 percent from 2008.

Figure p3 Patient counts, by modality (Incident & December 31 point prevalent ESRD patients.)

The size of the prevalent dialysis population increased 4 percent in 2009, reaching 398,861, and is now 40 percent larger than in 2000. The size of the transplant population rose 4.2 percent, to reach 172,553 patients, while the number of incident patients rose 3.3 percent, to 116,395. These data suggest longer lifespans for prevalent patients, ultimately influencing the steady growth of this population and the annual expenditures these patients incur.

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Incidence, Prevalence, Modality, pre–ESRD Care

Figure 1.3 Adjusted incident rates of ESRD & annual percent change (page 186)

After a 0.9 percent decline in 2008, the adjusted incident rate of end–stage renal disease rose 1.1 percent in 2009, to 355 per million population. Prior to the slight decline in 2007 and 2008, the rate of new ESRD cases had increased or remained stable each year since 1996. » Figure 1.3; see page 379 for analytical methods. Incident ESRD patients. Adj: age/gender/race; ref: 2005 ESRD patients.

Figure 1.9 Adjusted prevalent rates of ESRD & annual percent change (page 188) (see page 379 for analytical methods. December 31 point prevalent ESRD patients. Adj: age/gender/race; ref: 2005 ESRD patients.)

The adjusted rate of prevalent cases of ESRD rose 2.1 percent in 2009 — up slightly from the 1.9 percent growth in 2008 – to 1,738 per million population. This rate is nearly 23 percent higher than that seen in 2000. The annual rate of increase has remained between 1.9 and 2.4 percent since 2003.

Figure 1.6 Incident counts & adjusted rates of ESRD, by race (page 186)
Figure 1.12 Prevalent counts & adjusted rates of ESRD, by race (page 188) (see page 379 for analytical methods. Incident ESRD patients. Adj: age/gender; ref: 2005 ESRD patients.)

By race, rates for African Americans and Native Americans in 2009 were 976 and 523 per million population, respectively – 3.5 and 1.9 times greater than the rate of 277 found among whites. Since 2000, the rate of new ESRD cases has grown 7.2 percent among whites and 6.4 percent among Asians, while remaining stable in the African American population.

By race, rates of prevalent ESRD remain greatest in the African American and Native American populations, at 5,284 and 2,735 per million population in 2009, compared to 1,279 and 2,101 among whites and Asians. The rate among Hispanics reached 2,538 in 2009, 1.5 times greater than that in the non–Hispanic population.

Figure 1.15 Incident patient distribution, by first modality & payor (page 190) (see page 379 for analytical methods. Incident ESRD patients.)

Forty-five percent of new hemodialysis patients are covered solely by Medicare, 13.5 percent have dual Medicare/Medicaid coverage, and 15.3 percent are covered by a Medicare HMO provider. Medicare covers 41 and 22 percent of new peritoneal dialysis and transplant patients, while 9.8 and 4.2 percent are dually–enrolled, and 9.8 and 3.5 percent have HMO coverage.

Figure 1.16 Prevalent patient distribution, by modality & payor (page 191) (see page 379 for analytical methods. December 31 point prevalent ESRD patients.)

Figure 1.19 Access use at first outpatient hemodialysis, by pre–ESRD nephrology care, 2009 (page 192) (see page 379 for analytical methods. Incident hemodialysis patients, 2009.)

Among hemodialysis patients who have seen a nephrologist for more than a year prior to starting ESRD therapy, less than half initiate treatment using a catheter; these patients have the greatest likelihood at initiation of having an arteriovenous fistula (AV) or maturing fistula, at 30 and 19.2 percent, respectively. Patients with no pre–ESRD nephrology care most frequently start treatment with a catheter, at 82 percent.

Figure 1.20 Mean hemoglobin at initiation, by pre–ESRD ESA treatment (page 193) (see page 379 for analytical methods. Incident ESRD patients.)

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Patient Care | Hospitalization

Figure 2.2 Patient distribution, by mean monthly hemoglobin (g/dl; page 198) (see page 381 for analytical methods. Period prevalent dialysis patients.)

During 2009, 40 percent of prevalent dialysis patients had a mean monthly hemoglobin within the previous KDOQI target of 11–12 g/dl. The mean EPO dose per week averaged 18,206 units, down from a peak of nearly 20,000 during 2004–2007, when a greater proportion of patients had hemoglobins nearing 12 g/dl.

Figure 2.4 Mean monthly hemoglobin after initiation, by year (page 198) (see page 381 for analytical methods. Incident dialysis patients.)

When compared to 2005 incident patients, those starting dialysis in 2009 did so with slightly lower hemoglobins one month post–initiation, at 10.6 and 10.3 g/dl, respectively. At six months, the mean monthly hemoglobin in 2009 patients was within the KDOQI target of 11–12 g/dl, at 11.5.

Figure 2.15 Cumulative number of Part D medications in ESRD patients, by race/ethnicity & low income subsidy (LIS) status, 2008 (page 202) (see page 381 for analytical methods. Point prevalent Medicare enrollees alive on January 1, with Part D enrollment, October 1–December 31, 2007 & 2008.)

Table 2c Access events & complications in prevalent dialysis patients (ESRD CPM data; rate per patient year; page 201) (see page 381 for analytical methods. Catheter, fistula, graft: prevalent hemodialysis patients age 20 & older, ESRD CPM & claims data. Peritoneal dialysis device: prevalent peritoneal dialysis patients age 20 & older.)

Among prevalent hemodialysis patients in 2007 (the most recent year of available CPM data), the most common access–related event was replacement with a catheter, at 0.86 events per year for patients already using a catheter, and 0.12 and 0.24, respectively, for those with an arteriovenous (AV) fistula or graft. Sepsis is more common than infection, regardless of access type. In 2007, for example, the rate of sepsis among catheter patients was 1.6 times higher than rates of infection; among AV fistula patients, the rate was three times higher.

Figure 3.1 Change in adjusted all–cause & cause–specific hospitalization rates, by modality (page 207) (see page 382 for analytical methods. Period prevalent ESRD patients. Adj: age/gender/race/primary diagnosis; ref: ESRD patients, 2005.)
Figure 3.4 Cause–specific rehospitalization rates 30 days post live hospital discharge, by age (page 210) (see page 382 for analytical methods. Period prevalent hemodialysis patients age 20 & older, 2009; unadjusted. Includes live hospital discharges from January 1 to December 31, 2009.
Figure 3.7 Adj. 1st–year hosp adm rates & days (from day 90) in matched HD & PD dialysis pts (see page 383 for analytical methods. Incident hemodialysis & peritoneal dialysis patients age 20 & older. Adj: age/gender/race/primary diagnosis; ref: 2005 incident hemodialysis & peritoneal dialysis patients. Rates show first–year admissions from day 90 to one year after initiation.)

The rate of admissions for infection in the ESRD population is now 43 percent greater than in 1993, while the rate for vascular access procedures has fallen 48 percent. Hospitals have made significant progress in using less costly settings to address vascular access interventions, but equivalent progress in lowering the rate of infectious complications is lacking. In the peritoneal dialysis population there has been little change in the overall rate of hospitalization for infection. Admissions for peritonitis, in contrast, have fallen.

The percent of patients who are rehospitalized and alive following an all–cause index hospitalization was 33 percent overall in 2009, and highest in patients age 20–44, at 41.5 percent. For cardiovascular, infectious, or vascular access hospitalizations, the percentages rehospitalized and discharged alive were again highest in the younger cohort, at 45, 35, and 33 percent, respectively.

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Prescription Drug Coverage

Figure 6.1 Sources of prescription drug coverage in Medicare enrollees, 2008 (page 235) (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

Fifty–eight to 59 percent of elderly CKD and general Medicare patients were enrolled in Part D in 2008, compared to 72, 61, and 53 percent of hemodialysis, peritoneal dialysis, and kidney transplant patients.

Figure 6.15 Per person per year Medicare & out–of–pocket costs for Part D enrollees, 2008 (page 240) (see page 387 for analytical methods. All patients enrolled in Part D.)

At $5,536 and $6,183, the per person per year (PPPY) total cost of medications covered by Medicare Part D is 2.3–2.5 times higher, respectively, in dialysis and transplant patients than in the general Medicare population. Proportional to total Part D costs, however, out–of–pocket costs are lower in ESRD patients, representing 8–10 percent of PPPY costs, compared to 19 percent in the general Medicare population.

Figure 6.20 Part D non–LIS enrollees who reach each coverage phase, 2008 (page 242) (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)

In 2008, 42–48 percent of CKD, hemodialysis, peritoneal dialysis, and transplant patients reached the coverage gap, and 8–13 percent reached catastrophic coverage, compared to 23 and 3 percent, respectively, in the general Medicare population.

Table 6.c Top 25 drugs used by Part D–enrolled dialysis patients, by frequency & net cost, 2008 (page 244) (see page 388 for analytical methods. Part D claims for all dialysis patients, 2008.)

In 2008, cardiovascular and gastrointestinal medications, phosphate binders, insulin, and cinacalcet were the predominant drugs used in the dialysis population. Metoprolol, a beta blocker, continued to be the most frequently used drug, reflecting the extensive use of beta blockers for CHF and atrial fibrillation, and after myocardial infarction, PCI, and CABG. Sevelamer HCl was the predominant phosphate binder, and, at $255 million, topped the list in terms of net Part D costs, with cinacalcet coming in at $213 million. Costs for calcium acetate, insulin therapies, and lanthanum carbonate costs were each close to $50 million.

Sevelamer carbonate represented 5.3 percent of sevelamer use in 2008. Together, costs for sevelamer hydrochloride and carbonate reached $270 million – about 21 percent of the $1.26 billion in Part D costs in the dialysis population.

Table 6.d Top 25 drugs used by Part D–enrolled transplant patients, by frequency & net cost, 2008 (page 245) (see page 388 for analytical methods. Part D claims for all transplant patients, 2008.)

Among transplant patients, prednisone (a generic immunosuppressant) was the most frequently used medication in 2008, followed by metoprolol and insulin. Trimethoprim–sulfamethoxazole, used for prophylaxis against pneumocystis carinii pneumonia, was sixth on the list. Except for tacrolimus, no trade name immunosuppressant made the top 25 list in terms of frequency, not surprising given that most are covered under Medicare Part B. Valganciclovir, which is used for prophylaxis against cytomegalovirus and does not have an available generic, topped the list by cost, though not by frequency. The immunosuppressants tacrolimus, mycophenolate mofetil, sirolimus, cyclosporine, and mycophenolate sodium do appear on the list by cost, implying that their costs are relatively higher than the frequency of their use.

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Transplantation

Figure 7.1 Trends in transplantation: unadjusted rates, wait list, & total transplants, patients age 20 & older (page 249)

In 2009, the most recent year of available data, 17,736 kidney transplants were performed in the United States – 323 more than in the previous year, ending a two–year decline in the annual number of transplants performed. There were 420 more living donor transplants performed in 2009 compared with 2008, an increase of 7 percent, compared with a 1 percent decline in deceased donor transplants. The number of living–unrelated transplants rose 11 percent, compared with a 3 percent increase in living–related transplants. Unadjusted incident & transplant rates: limited to ESRD patients age 20 & older, thus yielding a computed incident rate higher than the overall rate presented elsewhere in the ADR. Wait list counts: patients age 20 & older listed for a kidney or kidney–pancreas transplant on December 31 of each year. Wait time: patients age 20 & older entering wait list in the given year. Transplant counts: patients age 20 & older as known to the USRDS.

Figure 7.4 Outcomes for wait–listed adult patients within three years of listing, by blood type (page 250) (see page 388 for analytical methods. Pts age 18 & older listed for a first–time kidney or kidney–pancreas transplant.)

The percentage of adult patients receiving a deceased donor transplant within three years of listing has fallen considerably since 1991, and varies by blood type. It continues to be highest for those of blood type AB – at 50 percent for patients listed in 2006 — and lowest for those of type O or B. The percentage receiving a living donor transplant has been rising, and varies little by blood type.

Figure 7.12 Deceased donor transplants, by age, gender, race, & primary diagnosis (page 252) (see page 388 for analytical methods. Pts age 18 & older. Includes kidney–alone & kidney–pancreas transplants.)

Since 2000, the number of deceased donor transplants among patients age 65 and older has more than doubled, to 1,911, and there has been an increase of 47 percent among patients age 50–64. Among those age 18–34, in contrast, transplants have fallen 24 percent, to 1,166. Among African Americans and Asians, the number of transplants has grown 45 and 92 percent, respectively.

Figure 7.14 Living donor transplants, by age, gender, race, & primary diagnosis (page 252) (see page 388 for analytical methods. Patients age 18 & older. Includes kidney–alone & kidney–pancreas transplants.)

Among patients younger than 50, the number of living donor transplants has fallen 3–7 percent since 2000. For those age 50–64, in contrast, the number is now 41 percent higher, and for patients age 65 and older it has more than doubled. While living donor transplants among whites and African Americans have increased just 9–10 percent in this period, they have tripled among Asians.

Figure 7.22 Primary diagnoses of cardiac & infectious hospitalizations in the first & second years post–transplant (page 254) (see page 389 for analytical methods. First–time, kidney–only tx recipients, age 18 & older, with Medicare primary payor coverage, transplanted in 2005–2009.)

In the first and second years after transplant, 22–23 percent of cardiovascular hospitalizations are due to CHF. Hospitalizations for coronary atherosclerosis and CVA/TIA rise from 6.2 and 5.0 percent in year one to 12 and 10 percent in year two. UTI, septicemia, and pneumonia are the most common diagnoses among transplant patients admitted for infection.

Figure 7.32 Follow–up care & screening in the first 12 months post–transplant, by age (page 255) (see page 389 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only transplant.)

In 2008, 24 percent of recipients age 18–49 received an influenza vaccination in the 12 months post–transplant, compared to 32 percent of those 60–64, and 45 percent of those age 65 and older. Lipid screening rates range from 84 percent in the youngest adults to 93 percent in those age 60–64. Since 2003, nearly all recipients have received a CBC test in the year after transplant.

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Pediatric ESRD | ESRD Providers

Figure 8.1 Incident & prevalent counts & adjusted rates in the pediatric ESRD population, by primary diagnosis (page 259) (see page 390 for analytical methods. ESRD patients age 0–19. Adj: age/gender/race; ref: 2005 ESRD patients.)

The overall incidence of ESRD in the pediatric population rose slowly between 1984 and 1990, a period when expertise in pediatric dialysis and transplantation was growing. Consistent with findings in the adult population, incidence due to glomerular disease has been declining gradually since 1990, and the number of patients has remained remarkably consistent. Both the incidence of ESRD due to cystic kidney disease and the number of children with this diagnosis, however, have been rising, a finding that merits investigation to determine whether the disease is truly increasing or if earlier recognition and treatment have led to more children coming to ESRD.

Figure 8.3 Hospital admissions for pneumonia, by modality, age, & race, 2006–2009 (page 262) (see page 390 for analytical methods. Period prevalent ESRD patients age 0–19, 2006–2009; unadjusted.)

Overall rates of admission for pneumonia are greatest in patients age 0–4, at 91 per 1,000 patient years at risk. By modality, pneumonia admissions for transplant patients age 0–4 reach 96, compared to 29 for those of the same age on hemodialysis, and 84 for those treated with peritoneal dialysis.

Figure 8.10 Adjusted all–cause mortality in the first months of ESRD, by age & modality, 2001–2008 (page 265) (see page 390 for analytical methods. Incident pts age 0–19, 2001–2008 (8.10–12) & 2000–2004 (8.13). Adj: age/gender/race/primary diagnosis. Ref: incident ESRD pts age 0–19, 2004–2005.)

In the first month of therapy, mortality in patients age 0–4 reaches 153 deaths per 1,000 patient years at risk, compared to 24 for ages 5–9, and 5.3 for ages 10–14. Overall, all–cause mortality in pediatric patients reaches 48 in the first month after initiation, peaks at 57 in the next two months, then falls to 28 in months 9–<12.

Figure 10.1 Distribution of patients, by unit affiliation, 2009 (page 273) (see page 391 for analytical methods. CMS Annual Facility Survey, 2009.)

At the end of 2009, 122,216 prevalent patients were being treated by Fresenius in 1,742 units, 110,299 were receiving care in one of DaVita's 1,556 units, and 13,023 patients were being treated by Dialysis Clinic Inc. (DCI), with 213 units. These three major providers manage the majority of the 5,760 dialysis units across the United States. Small dialysis organizations (SDOs), comprising 20–199 units, treated 44,793 patients in 605 units, while independent and hospital–based providers treated 58,090 and 38,596 patients in 848 and 796 units, respectively.

Figure 10.4 Dialysis unit distribution, by affiliation & time managed (time under chain management), 2009 (page 274) (see page 391 for analytical methods. CMS Annual Facility Survey, 1988–2009.)

The percentage of units remaining under consistent ownership for five or more years was nearly 60 in 2009. Major unit purchases by DaVita and Fresenius in 2005 and 2006 reduced the proportions of their units with five or more years of ownership to 51 and 60 percent, down from approximately 70 percent in 2004 (2010 Annual Data Report). The most consistent ownership remains that of Dialysis Clinic, Inc., with nearly 90 percent of units in 2009 owned for five years or longer.

Figure 10.5 Distribution of prevalent EPO–treated dialysis patients, by hemoglobin level & unit affiliation, 2009 (page 275) (see page 391 for analytical methods. Period prevalent dialysis patients, 2009.)

In 2009, the proportion of EPO–treated prevalent dialysis patients with a hemoglobin of 10–<12 g/dl varied little by provider, ranging from 72 to 79 percent, and reaching 78 percent overall. Twenty–five percent of DCI patients had a hemoglobin greater than 12 g/dl, compared to 18–19 percent of those receiving treatment in Fresenius or independent units.

Figure 10.18 All–cause standardized hospitalization & mortality ratios, by unit affiliation, 2009 (page 278) (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)

Figure 10.19 All–cause standardized hospitalization & mortality ratios in large dialysis organizations, 2009 (page 278) (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)

For 2009, standardized hospitalization ratios (SHRs) are almost equal in small and large dialysis organizations (SDOs and LDOs), as are standardized mortality ratios (SMRs). Independent facilities have the highest SHR, and hospital–based facilities the highest SMR. By unit affiliation among the LDOs, DCI continues to have the lowest ratios for both hospitalization and mortality.

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Costs of ESRD

Figure 11.6 Total Medicare ESRD expenditures, by modality (page 284) (see page 392 for analytical methods. Period prevalent ESRD patients; patients with Medicare as secondary payor are excluded.)

Figure 11.7 Total Medicare ESRD expenditures per person per year, by modality (page 284) (see page 392 for analytical methods. Period prevalent ESRD patients; patients with Medicare as secondary payor are excluded.)

After rising 11 percent between 2007 and 2008, total Medicare expenditures for hemodialysis and transplant rose only 0.2 and 0.4 percent in 2009, to $20.8 and $2.4 billion, while costs for peritoneal dialysis fell 3.3 percent, to $1.1 billion. Per person per year costs fell less than 1 percent across modalities, to $82,285 for hemodialysis, $61,588 for peritoneal dialysis, and $29,983 for transplant.

Figure 11.9 Total Medicare spending for injectables (page 284) (see page 392 for analytical methods. Period prevalent dialysis patients.)

Figure 11.19 Total PPPY outpatient expenditures, by dialysis modality & race, 2009 (page 287) (see page 392 for analytical methods. Period prevalent dialysis patients, 2009.)

In 2009, per person per year (PPPY) outpatient dialysis expenditures were 5.5 percent higher in African Americans than in whites, at $32,030 and 30,365, respectively. When comparing costs by modality in unmatched dialysis populations, those for hemodialysis were 26 percent higher than those for peritoneal dialysis. This difference was sustained among hemodialysis patients matched to peritoneal patients, at 25 percent for whites and 29 percent for African Americans.

Figure 11.21 PPPY expenditures for ESAs, by dialysis modality & race, 2009 (page 287)

Figure 11.22 PPPY expenditures for IV vitamin D, by dialysis modality & race, 2009 (page 287)

Figure 11.23 PPPY expenditures for IV iron, by dialysis modality & race, 2009 (page 287)

Per person per year (PPPY)costs for erythropoiesis stimulating agents (ESAs) are higher for hemodialysis patients than for those on peritoneal dialysis, and greater in African Americans than in whites. In unmatched populations, costs for hemodialysis compared to peritoneal dialysis are 75 and 44 percent greater in whites and African Americans, respectively; costs for the matched hemodialysis patients are 74 and 50 percent higher.

PPPY expenditures for IV vitamin D are 74 percent greater for African Americans than for whites.

IV iron costs in matched hemodialysis patients are 5.0–5.6 times higher than those for peritoneal dialysis patients. Costs for IV antibiotics in 2009 were highest in patients on peritoneal dialysis, at $14.48 and $18.16 among whites and African Americans, respectively. » Figures 11.20–23; see page 392 for analytical methods. Period prevalent dialysis patients, 2009.

Table 11.a Top 25 Part D prescription drugs used in the ESRD population, by frequency & net cost, 2008 (page 288) (see page 392 for analytical methods. Period prevalent ESRD patients enrolled in Part D, 2008.)

This table displays the top 25 Part D prescriptions used in ESRD patients by frequency, as measured in total days supply, and by net cost, a reflection of both frequency of use and cost. In 2008, cardiovascular and gastrointestinal medications, phosphate binders, insulin products, levothyroxine, cinacalcet, prednisone, and pain medications were the predominant drugs used in the ESRD population. Metoprolol, a beta blocker, continues to be the most frequently used drug, reflecting the extensive use of beta blockers for congestive heart failure and atrial fibrillation, and after myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft. Sevelamer HCl is the predominant phosphate binder, and, at $260 million, topped the list in terms of net Part D costs, with cinacalcet coming in at $228 million. Costs for calcium acetate, and lanthanum carbonate each near $50 million.

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Atlas of ESRD

Health People 2020

Introduction

The Healthy People program, now in its third decade, was established to improve the health of all Americans through the development and evaluation of national health objectives. HP2020, launched on December 2, 2010, is the next step in the continuum of care, with its foundation based on the success of the four previous HP initiatives. One of the major goals of the HP2020 program is to "reduce new cases of chronic kidney disease (CKD) and its complications, disability, death, and economic costs." The development and progression of CKD, which results in reduced quality of life, is a major health concern. The HP2020 CKD objectives are designed to further reduce the long–term burden of kidney disease, improve the quality of life among those with the condition, and eliminate disparities – racial or otherwise – within the healthcare system. To accomplish these goals, the HP2020 program developed 14 objectives related to CKD, along with targets designed to evaluate the program's success. We provide data for ten of these objectives, plus information on microalbumin testing in non–CKD patients diagnosed with diabetes. Because we use the Medicare 5 percent data to evaluate objectives related to CKD patients not on dialysis, results are limited to those age 65 and older.

In 2009, 11.5 percent of hospital patients with acute kidney injury had a follow–up renal evaluation six months post-discharge, a slight increase from the 10.5 percent seen in 2008, but below the objective's modest goal of 12.4 percent.

Patients with diabetes are at increased risk of CKD. HP2020 has set a goal that 37 percent of persons with diagnosed diabetes obtain an annual urinary microalbumin measurement. The percentage of elderly patients with diabetes receiving this measurement rose from 12.3 in 2000 to 37.3 in 2009, just over the suggested HP2020 target, but less than would be expected from clinical guidelines.

Serum creatinine and microalbumin are important laboratory markers for monitoring the presence and progression of CKD, and lipid tests are important for assessing cardiovascular risk in this population. In 2009, 28.2 percent of patients received these recommended medical evaluations, an increase from 26.7 percent in 2008, and just below the minimal recommended HP2020 target of 28.4 percent.

Patients with either Type 1 or Type 2 diabetes and CKD require more comprehensive laboratory monitoring. The hemoglobin A1c test is used to assess blood glucose control over prolonged periods of time in patients with diabetes, while diabetic retinopathy can be detected through regular eye examinations. One in four elderly diabetic patients receives A1c and eye testing along with serum creatinine, lipid, and microalbumin tests, almost meeting the HP2020 target of 25.4 percent, but a level certainly in need of further improvement.

Use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) is a recommended medical treatment to slow the progression of CKD in patients with diabetes and CKD. In 2008, 73.2 percent of fee-for-service beneficiaries age 65 and older and enrolled in Medicare Part D received these medications, well above the now outdated HP2020 target of 60 percent.

A major HP2020 health objective is targeted at reducing new cases of ESRD, a disease which greatly affects an individual's quality of life, and is an enormous burden on the healthcare system, accounting for approximately 6 percent ($29 billion) of total Medicare costs. In 2009, the rate of new ESRD cases stood at 355 per million population, 11. 5 percent above the new HP2020 target of 318.5, but showing relatively little improvement over the past ten years.

Patients with diabetes are at increased risk of ESRD. The rate of kidney failure due to diabetes fell from 2006 to 2008, but remained similar in 2009, at 154 per million population – 10.6 percent above the HP2020 target of 139.2.

In past ADRs the USRDS raised concerns that late referral to a nephrologist prior to ESRD, or the lack of such referral, may contribute to higher morbidity and mortality in the first year of treatment. HP2020 has set a target referral rate of 29.8 percent — a conservative goal that should be updated. Rates have increased since 2005, from 25.6 percent to 28.4 percent in 2009.

We have reported on the high use of catheters at the first outpatient hemodialysis session, and on the associated risks. Among patients who have seen a nephrologist for more than a year, fewer than half use a catheter; they also have the greatest likelihood at initiation of having an arteriovenous (AV) fistula or maturing internal access. In an effort to improve vascular access for hemodialysis patients, HP2020 has developed objectives designed to increase the use of AV fistulas. In 2007, 49.6 percent of prevalent hemodialysis patients had an AV fistula as their primary vascular access, just under the 50.6 percent HP2020 target. The proportion of prevalent patients using a catheter as the only mode of vascular access stood at 27.7 percent in 2007, slightly above the target of 26.1 percent. And in 2009, 32 percent of incident hemodialysis patients used an AV fistula or had a maturing fistula for their primary mode of vascular access, still below the HP2020 target of 34.5 percent.

ESRD patients who receive a kidney transplant have lower mortality and hospitalization rates than those on dialysis. First–year all–cause mortality rates in hemodialysis patients, for example, are four times higher than rates among transplant patients. HP2020 has set a goal of 18.8 percent of dialysis patients younger than 70 being wait–listed and/or receiving a deceased donor kidney transplant within one year of ESRD initiation. In 2008, 19.7 percent of patients met this criterion. Additional goals call for 19.7 percent of patients with treated chronic kidney failure to receive a transplant with three years of registration on the waiting list (the number was 16.7 for 2006 patients), and for increasing the number who receive a transplant at the start of ESRD; of 2009 incident patients younger than 70, only 3.2 percent received a preemptive transplant.

Expanded HP2020 objectives call for reductions in total death rates for persons on dialysis, reduced death rates in the first three months of renal replacement therapy, and a reduced cardiovascular death rate in dialysis and transplant patients. The most impressive gain toward achieving an HP2020 objective is the continued decline in cardiovascular mortality rates in prevalent dialysis patients, from 121.5 per 1,000 patient years at risk in 1999 to 82.6 in 2009, just slightly above the HP2020 goal of 81.3. There have also been positive developments in reducing the death rate in dialysis patients in the first three months after initiation of therapy, from 382.6 in 2001 to 353.7 in 2009; this remains far, however, from the target of 319.9.

Additional information on the HP2020 program objectives can be found at www.healthypeople.gov.

Many HP2010 targets were set 2–3 years before release of the goals, & may need to be updated.

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Atlas of ESRD

Health People 2020

Recommended care among patients with AKI, diabetes, & CKD

HP2020 CKD–3

Increase the proportion of hospital patients who incurred acute kidney injury who have follow–up renal evaluation in six months post discharge

TARGET: 12.4%

In 2000, just 2.1 percent of patients age 65 and older who were hospitalized for acute kidney injury had a follow–up renal evaluation during the following six months. By 2009 this had increased to 11.5 percent, close to the Healthy People 2020 goal of 12.4 percent.

The lowest rate of follow–up evaluation occurs in the oldest patients, with just 6.2 percent of those age 85 and older receiving such care, compared to 16 percent of those age 65–74. By race and ethnicity, rates range from 9.5 percent among American Indians/Alaskan Natives to 17.5 percent in the Asian population.

Table 3 Medicare patients age 65 & older (5 percent Medicare sample) with a hospitalized AKI event in given year. (see page 378 for analytical methods.)

HP2020 D–12

Increase the proportion of persons with diagnosed diabetes who obtain an annual urinary microalbumin measurement

TARGET: 37.0%

In the diabetic population age 65 and older, the percentage of patients receiving an annual urinary microalbumin measurement has increased from 12.3 in 2000 to 37.3 in 2009, just over the HP2020 target of 37 percent.

Rates fall with age, from 42 percent among those age 65–74 to 24 percent among those 85 and older. By race and ethnicity, rates range from 24 percent among American Indians/Alaskan Natives to nearly 40 percent in the Asian population. Testing may, however, be under–reported in Native Americans, as the Indian Health Service does not report claims through the Medicare system.

Rates vary little by gender, at 38 percent for men and 37 percent for women in 2009. » Table HP2020 D–12; see page 378 for analytical methods.

Table D12 Medicare patients with diabetes, age 65 & older.

HP2020 CKD–4

Increase the proportion of persons with diabetes and chronic kidney disease who receive recommended medical evaluations

In the Medicare CKD population age 65 and older, 28.2 percent received serum creatinine, lipid, and microalbumin testing in 2009 — a considerable increase from the level of 6 percent in 2000, and nearly reaching the Healthy People 2020 goal of 28.4 percent. Testing rates by race range from 19 percent among American Indians/Alaskan Natives to 38 percent among Asians. Rates vary little by gender, and by age are lowest among the oldest patients, at 14 percent.

In the diabetic CKD population age 65 and older, 25.2 percent of patients in 2009 received serum creatinine, microalbumin, glycosylated hemoglobin (A1c), and lipid testing, as well as an eye examination; this also nearly reaches the HP2020 goal, set at 28.4 percent. The reported percentage of patients receiving comprehensive diabetic testing is lowest among American Indians/Alaskan Natives, at just 11 percent (care provided by the Indian Health Service, however, is not reported to Medicare), and highest among Asians, at 27 percent. Rates again vary little by gender, and decrease by age.

HP2020 CKD–4.1 TARGET: 28.4%

Increase the proportion of persons with chronic kidney disease who receive medical evaluation with serum creatinine, lipids, and microalbumin

Table 4 1 Medicare patients age 65 & older with CKD (4.1–2) & diabetes (4.2). (see page 378 for analytical methods.)

HP2020 CKD–4.2 TARGET: 25.4%

Increase the proportion of persons with type 1 or type 2 diabetes and chronic kidney disease who receive medical evaluation with serum creatinine, microalbumin, HbA1c, lipids, and eye examinations

Table 4 2 Medicare patients age 65 & older with CKD (4.1–2) & diabetes (4.2). (see page 378 for analytical methods.)

HP2020 CKD–5

Increase the proportion of persons with diabetes and chronic kidney disease who receive recommended medical treatment with angiotensin–converting enzyme inhibitors or angiotensin II receptor blockers

TARGET: 60.0%

In 2008, 73 percent of patients age 65 and older with diabetes and CKD received recommended medical treatment with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs), considerably higher than the Healthy People 2020 target of 60 percent.

Whites are more likely to receive this treatment than blacks/African Americans, at 75 and 65 percent, while 77, 72, and 71 percent, respectively, of American Indians/Alaska Natives, Asians, and Hispanics/Latinos received these medications. Use varies little by gender, at 79–80 percent. And by age, 74, 72, and 77 percent, respectively, of patients age 65–74, 75–84, and 85 and older received ACEIs/ARBs in 2008.

Table 5 Fee–for–service beneficiaries enrolled in Medicare Part D, age 65 & older. (see page 378 for analytical methods.)

HP2020 CKD–8

Reduce the rate of new cases of end-stage renal disease (ESRD)

TARGET: 318.5 new cases per million population

At 355 per million population, the rate of new cases of ESRD is now 4.1 percent greater than in 2000, and considerably higher than the HP2020 goal of 318.5.

There is substantial variation by race in the rate of new ESRD cases. Among whites and Asians, for example, the rates are 288 and 344, respectively. But the rate among blacks/African Americans is 1,015, and for Native Hawaiians/Pacific Islanders it reaches 2,188. By ethnicity, the rate ranges from 355 among those who are not Hispanic or Latino to 516 among those who are. And the rate of 452 cases per million population among men is 60 percent greater than the rate of 282 among women.

Table 8 Incident ESRD patients. Adj: overall, age/gender/race; rates by age adjusted for gender/race; rates by gender adjusted for age/race; rates by race/ethnicity adjusted for age/gender. Ref: 2005 patients. (see page 378 for analytical methods.)

HP2020 CKD–9

Reduce kidney failure due to diabetes

The rate of kidney failure due to diabetes has varied little in the last decade, with a range of 153–160 cases per million population; the rate of 154 seen in 2009 was the same as that occurring in 2000. The HP2020 goal of 139.2 is met only by whites, by women, and by patients younger than 44.

The highest rate of diabetic ESRD occurs among Native Hawaiians/Pacific Islanders, at 1,363; the rate among blacks/African Americans reaches 435. In 2009, the adjusted rate of kidney failure due to diabetes among diabetic patients was 2,423 per million population, 8.5 percent lower than in 2007 but still above the HP2020 target of 2,374.

HP2020 CKD–9.1 TARGET: 139.2 per million population

Reduce kidney failure due to diabetes

Table 9 1 Incident ESRD patients. Adj: age/gender/race; ref: 2005. NHIS 2006–2010 used to estimate diabetes prevalence; SUDDAN used for national estimates (9.2). *Values for cells with ten or fewer patients are suppressed. (see page 378 for analytical methods.)

HP2020 CKD–9.2 TARGET: 2,374.1 per million population

Reduce kidney failure due to diabetes among persons with diabetes

Table 9 2 Incident ESRD patients. Adj: age/gender/race; ref: 2005. NHIS 2006–2010 used to estimate diabetes prevalence; SUDDAN used for national estimates (9.2). *Values for cells with ten or fewer patients are suppressed. (see page 378 for analytical methods.)

HP2020 CKD–10

Increase the proportion of chronic kidney disease patients receiving care from a nephrologist at least 12 months before the start of renal replacement therapy

TARGET: 29.8%

In 2009, 28.4 percent of patients beginning ESRD therapy on hemodialysis had seen a nephrologist for at least 12 months prior to initiation; this is close to the 29.8 percent goal set by Healthy People 2020, and up slightly from the level of 25.6 percent seen in 2005.

By race, rates of pre-ESRD nephrologist care range from 23.8 percent among Native Hawaiians/Pacific Islanders to nearly 30 percent among whites; rates by ethnicity are lowest among Hispanics/Latinos, at 21.8 percent. There is little difference in pre-ESRD care by gender; by age, however, rates range from 23.3 percent among those age 20–44 to 37.6 percent in the pediatric population. » Table HP2020 CKD-10; see page 378 for analytical methods. Incident hemodialysis patients with a valid Medical Evidence form; nephrologist care determined from Medical Evidence form.

Table 10 Incident hemodialysis patients with a valid Medical Evidence form; nephrologist care determined from Medical Evidence form.

HP2020 CKD–11

Improve vascular access for hemodialysis patients

Identified through the ESRD CPM dataset, use of an arteriovenous (AV) fistula as the primary mode of vascular access in prevalent hemodialysis patients has increased from 27 percent in 1998 to 50 percent in 2007 (the most recent year of available CPM data). By race, use is highest among Asian patients, at 57 percent, and lowest among African Americans, at 42. The most dramatic variations occur by gender, with fistula use at just 40 percent among women, compared to 57 percent among men. Patients age 65 and older have the lowest use by age of fistulas as their primary access, at 47 percent, compared to 55 percent among those age 18–44.

Among prevalent hemodialysis patients, use of a catheter as the only mode of vascular access has remained relatively stable since the late 1990s. At 28 percent overall in 2007, use ranges by race from 19 percent among Asian patients to 29 percent among whites. Use remains highest among women, at 32 percent compared to 24 percent for men, and is similar among age groups, with a range of 27–30 percent.

Overall, just 32 percent of patients starting hemodialysis therapy in 2009 – 29 percent of women, and 35 percent of men – had a maturing AV fistula or were using one as their primary vascular access. This varies by race from 31 percent among blacks/African Americans to 41 percent among American Indians/Alaskan Natives.

Programs such as HP2020 and the Fistula First Initiative continue to work to increase the use of fistulas and promote early placement prior to initiation of ESRD therapy.

HP2020 CKD–11.1 TARGET: 50.6%

Increase the proportion of adult hemodialysis patients who use an arteriovenous fistula as the primary mode of vascular access

Table 11 1 Prevalent year represents year of data collection. DNC: data not collected (11.1–2). (see page 378 for analytical methods. Prevalent hemodialysis patients; ESRD CPM data. Vascular access determined from "current access" within CPM data.)

HP2020 CKD–11.2 TARGET: 26.1%

Decrease the proportion of adult hemodialysis patients who use catheters as the only mode of vascular access

Table 11 2 Prevalent year represents year of data collection. DNC: data not collected (11.1–2). (see page 378 for analytical methods. Prevalent hemodialysis patients; ESRD CPM data. Vascular access determined from "current access" within CPM data.)

HP2020 CKD–11.3 TARGET: 34.5%

Increase the proportion of adult hemodialysis patients who use arteriovenous fistulas or have a maturing fistula as the primary mode of vascular access at the start of renal replacement therapy (see page 378 for analytical methods. Prevalent hemodialysis patients; ESRD CPM data. Vascular access determined from "current access" within CPM data.)

Table 11 3 Incident hemodialysis patients age 18 & older

HP2020 CKD–12

Increase the proportion of dialysis patients wait-listed and/or receiving a deceased donor kidney transplant within one year of end–stage renal disease start (among patients under 70 years of age)

TARGET: 18.8% of dialysis patients

In 2008, the proportion of dialysis patients wait-listed and/or receiving a deceased donor kidney transplant within one year of end–stage renal disease start was 16.9 percent – slightly below the HP2020 target of 18.8 percent.

The target is currently met only among Asians, individuals of two or more races, and those age 0–19 and 20–44. Those furthest from the target include American Indian/Alaskan Natives and individuals age 65 to less than 70.

Table 12 Incident ESRD patients younger than 70 (see page 379 for analytical methods.)

HP2020 CKD–13

Increase the proportion of patients with treated chronic kidney failure who receive a transplant (among patients under 70 years of age)

The goal of Objective 13.1 is to have 19.7 percent of incident ESRD patients younger than 70 transplanted within three years of initiation; as of 2006, just 16.7 percent of patients meet this goal. Rates are lowest among blacks/African Americans, American Indians/Alaskan Natives, and Native Hawaiians/other Pacific Islanders, at 9.1–10.9 percent.

After remaining at 68–70 percent through the 1990s and mid–2000s, the percentage of pediatric ESRD patients transplanted fell to 64 in 2006. The proportion of patients receiving a preemptive transplant was 3.2 percent in 2006.

HP2020 CKD–13.1 TARGET: 19.7%

Increase the proportion of patients receiving a kidney transplant within three years of end–stage renal disease

Table 13 1 Incident ESRD patients younger than 70 (see page 379 for analytical methods.)

HP2020 CKD–13.2

Increase the proportion of patients who receive a preemptive transplant at the start of ESRD

Table 13 2 Incident ESRD patients younger than 70 (see page 379 for analytical methods.)

HP2020 CKD–14

Reduce deaths in persons with end–stage renal disease

Since 1998, the overall death rate among prevalent patients on dialysis has fallen 14 percent, from 232 deaths per 1,000 patient years to just under 200 in 2009 – approaching the HP2020 target of 190.8. By race, the rate ranges from 146 among Asians to 235 among whites; by ethnicity, it is 149 among Hispanics and Latinos and 209 among those not in either group. The mortality rate has fallen for all groups since 1998; for Hispanics and Latinos, and for those age 0–44, the rate has declined more than 20 percent.

The rate of mortality in the first three months of ESRD has fallen from its peak of 388 in 2003, but, at 354 in 2009, remains a distance from the HP2020 target of 319.9 deaths per 1,000 patient years at risk. The highest rate by race occurs among whites, at 412 compared to 158 among American Indians/Alaskan Natives, and 207–212 among Asians and Native Hawaiians/Pacific Islanders.

At 82.6 deaths per 1,000 patient years in 2009, the rate of cardiovascular mortality among dialysis patients is close to the HP2020 goal of 81.3. The rate has fallen 31 percent overall since 1998, and 35 percent for whites and for patients age 65 and older. By race, the rate is highest, once again, among whites, at 95 compared to 67–70 among blacks/African Americans, American Indians/Alaskan Natives, and Asians.

For patients with a functioning transplant, the overall rate of mortality in 2009 rose slightly from the previous year, to 32.6 deaths per 1,000 patient years – a bit above the HP2020 goal of 29.4. By race, mortality ranges from 17.9 among Asians to 59.4 among American Indians/Alaskan Natives.

The rate of cardiovascular mortality among transplant patients has fallen 37 percent since 1998, but, at 5.4 deaths per 1,000 patient years, still remains above the HP2020 target of 4.5. The rate is just 1.7 among Asian patients, but 9.4 among American Indians/Alaskan Natives.

HP2020 CKD–14.1 TARGET: 190.8 deaths per 1,000 patient years

Reduce the total death rate for persons on dialysis

Table 14 1 Period prevalent dialysis patients; unadjusted (see page 379 for analytical methods.)

HP2020 CKD–14.2 TARGET: 319.9 deaths per 1,000 patient years at risk

Reduce the death rate in dialysis patients within the first three months of initiation of renal replacement therapy

Table 14 2 Incident dialysis patients; unadjusted (see page 379 for analytical methods.)

HP2020 CKD–14.3 TARGET: 81.3 deaths per 1,000 patient years at risk

Reduce the cardiovascular death rate for persons on dialysis

Table 14 3 Period prevalent dialysis patients; unadjusted (see page 379 for analytical methods.)

HP2020 CKD–14.4 TARGET: 29.4 deaths per 1,000 patient years at risk

Reduce the total death rate for persons with a functioning kidney transplant

Table 14 4 Period prevalent transplant patients; unadjusted (see page 379 for analytical methods.)

HP2020 CKD–14.5 TARGET: 4.5 cardiovascular deaths per 1,000 patient years at risk

Reduce the cardiovascular death rate in persons with a functioning transplant

Table 14 5 Period prevalent transplant patients; unadjusted (see page 379 for analytical methods.)

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© 2011 - All rights reserved

Atlas of ESRD

Chapter One

Incidence, Prevalence, Patient Characteristics, and Treatment Modalities

Introduction

The number of incident dialysis cases rose 3.3 percent in 2009, to 113,636; with 2,759 patients receiving a pre–emptive transplant as their first ESRD modality, 116,395 total patients began ESRD therapy in 2009. More than 106,000 dialysis patients started ESRD treatment on hemodialysis, and 7,094 started on peritoneal dialysis – 6.1 percent of patients with a known dialysis modality. The rate of new ESRD cases per million population has been relatively stable since 2000, and rose just 1.1 percent in 2009, to 355. Growth in the incident population continues to be driven by a linear increase in the number of patients age 45–64; growth in the population age 65 and older, in contrast, has slowed considerably.

The December 31, 2009 prevalent population included 370,274 patients on hemodialysis and 27,522 on peritoneal dialysis, as well as 172,553 with a functioning kidney transplant; the total treated ESRD population thus rose above 570,000. The rate of prevalent ESRD cases reached 1,738 per million population, an increase of 2.1 percent from 2008, and consistent with a similar rise per year since 2002.

In previous ADRs we have introduced comparisons that include matched hemodialysis and peritoneal dialysis populations. This year we more completely define these comparison populations, using 17 characteristics from the Medical Evidence form submitted for all new ESRD patients. As seen in the figure on the next page, the incident hemodialysis population is considerably different from the peritoneal dialysis population before the match; after the match, however, these differences are markedly reduced. These matched populations are used later in the ADR to compare hospitalization rates and the costs of patient care.

By primary diagnosis, the adjusted rate of new ESRD cases due to diabetes increased 0.5 percent in 2009, to 154.1 per million population. The rate of ESRD caused by glomerulonephritis was unchanged, and also consistent with levels seen in the early 1990s. It is not clear if these findings are related to improved blood pressure control and greater use of ACEIs/ARBs/renin inhibitors – data consistent with recent trends seen in NHANES data – or if hypertension and diabetes are now so common that there is some misclassification of primary diagnosis.

Racial and ethnic discrepancies persist, with 2009 incident rates in the African American and Native American populations 3.5 and 1.9 times greater, respectively, than the rate among whites, and the rate in the Hispanic population 1.5 times higher than that of non–Hispanics.

Insurance coverage of ESRD patients continues to shift. In the incident hemodialysis population, for example, coverage by the Medicare Advantage program has reached its highest level, at 15.3 percent in 2009. Dual Medicare/Medicaid coverage has fallen to 13.5 percent, and Medicare fee–for–service coverage is now at 45 percent, its lowest level. Medicare as primary payor now covers just 74 percent of incident hemodialysis patients – down from nearly 95 percent in 1978.

In the prevalent population, Medicare is the primary payor for 83 percent of hemodialysis patients, down nearly 2 percentage points since 1998. With private insurance covering a greater proportion of peritoneal dialysis and transplant patients, Medicare is the primary payor for just 78 and 53 percent of these patients, respectively.

Data on patient care at the start of ESRD therapy show that the percentage of patients receiving any erythropoiesis stimulating agent (ESA) prior to initiation continues to decline, most likely due to recent concern over potential adverse events when hemoglobin levels are targeted to a level above 12 g/dl. The mean hemoglobin at initiation of ESRD treatment is now 9.8 g/dl, with one patient in five treated with an ESA; in 2006, these numbers were 10.1 g/dl and 29 percent, respectively.

Whether calculated by the MDRD formula or the newer CKD–EPI formula, the increase in the estimated glomerular filtration rate (eGFR) at the initiation of ESRD therapy continued in 2009. Using the MDRD formula, for example, 54 percent of new patients had an eGFR greater than 10 ml/min/1.73 m2; with the CKD–EPI formula, this number falls to 45 percent.

Biochemical data, collected on the Medical Evidence form since 2005, show that 57 percent of new patients in 2009 had an albumin less than the lower limit of normal, and 52 percent had a hemoglobin lower than 10 g/dl. Total cholesterol was greater than 200 mg/dl in 16.3 percent of patients, while 70 percent had an LDL level lower than 100 mg/dl, and 58 percent had an HDL level less than 40 mg/dl. Among patients with diabetes, 28 percent had a hemoglobin A1c level greater than 7 percent.

Recent changes and new incentives in the bundled prospective payment system for dialysis patients, starting in January, 2011, may alter several characteristics of the incident and prevalent populations. The USRDS will continue to monitor these populations closely and assess the impact of this payment system on the ESRD population.

Figure 1.1 Incident & prevalent patient counts (USRDS), by modality (see page 379 for analytical methods. Incident & December 31 point prevalent ESRD patients (1.1); incident ESRD patients (1.2).)

Figure 1.2 Absolute standardized differences before & after hemodialysis patients are matched to peritoneal dialysis patients (see page 379 for analytical methods. Incident & December 31 point prevalent ESRD patients (1.1); incident ESRD patients (1.2).)

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914 South 8th Street Suite S-206
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(612) 347-7776 or 1-888-998-7737
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© 2011 - All rights reserved

Atlas of ESRD

Chapter One

Incidence, Prevalence, Patient Characteristics, and Treatment Modalities

Incident Counts & Rates

Figure 1.3 Adjusted incident rates of ESRD & annual percent change (see page 379 for analytical methods. Incident ESRD patients. Adj: age/gender/race; ref: 2005 ESRD patients.)

Figure 1.4 Geographic variations in adj. inc. rates of ESRD per million pop., 2009, by HSA (see page 379 for analytical methods. Incident ESRD patients. Adj: age/gender/race; ref: 2005 ESRD patients.)

In 2009, the adjusted incident rate of ESRD was 355 per million population, and geographically averaged 452 in the upper quintile. The highest adjusted rates occur in the Ohio Valley, portions of Texas and California, and the southwestern states. (Rates are not adjusted for ethnicity.)

Table 1.a Patient demographics & adjusted rates, by ESRD network: incident dialysis patients, 2009 (see page 379 for analytical methods. Incident dialysis patients.*Values for cells with ten or fewer patients are suppressed. Adj: age/gender/race; ref: 2005 patients.)

With an overall rate for incident dialysis patients of 348 per million population in 2009, rates by network range from 236 in Network 16 to 421 in Network 8. The distribution of patients by race continues to vary widely across the country. African Americans, for example, constitute just 6.4 percent of the new dialysis population in Network 16, but 49–55 percent of patients in Networks 6 and 8.

Figure 1.5 Incident counts & adjusted rates of ESRD, by age (see page 379 for analytical methods. Incident ESRD patients. Adj: gender/race (1.5), age/gender (1.6–7), age/gender/race (1.8); ref: 2005 ESRD patients.)
Figure 1.6 Incident counts & adjusted rates of ESRD, by race (see page 379 for analytical methods. Incident ESRD patients. Adj: gender/race (1.5), age/gender (1.6–7), age/gender/race (1.8); ref: 2005 ESRD patients.)
Figure 1.7 Incident counts & adjusted rates of ESRD, by Hispanic ethnicity (see page 379 for analytical methods. Incident ESRD patients. Adj: gender/race (1.5), age/gender (1.6–7), age/gender/race (1.8); ref: 2005 ESRD patients.)
Figure 1.8 Incident counts & adjusted rates of ESRD, by primary diagnosis (see page 379 for analytical methods. Incident ESRD patients. Adj: gender/race (1.5), age/gender (1.6–7), age/gender/race (1.8); ref: 2005 ESRD patients.)

Since 2000, the adjusted incident rate of ESRD has grown 12 percent for patients age 75 and older, to 1,762 per million population in 2009, while rates for those age 0–19 and 20–44 have increased 9.6 and 9.8 percent, respectively, to 15.5 and 131. Rates for patients age 45–64 and 65–74, in contrast, though rising slightly during the decade, are now the same as in 2000, at 610 and 1,407.

As in the previous two years, 13 percent of new ESRD patients in 2009 were Hispanic. The incident rate in this population continues to fall – 1.5 percent in 2009, to 501 per million population – yet remains 1.5 times greater than that seen among non–Hispanics.

With the exception of an uptick in 2006, the rate of new ESRD cases caused by diabetes has remained quite stable since 2000, and was 154 per million population in 2009. The rate of ESRD due to hypertension, in contrast, has grown 8.7 percent since 2000, to 101, while that of ESRD due to glomerulonephritis has fallen 23 percent, to 23.8.

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914 South 8th Street Suite S-206
Minneapolis, MN 55404
(612) 347-7776 or 1-888-998-7737
usrds@usrds.org
© 2011 - All rights reserved

Atlas of ESRD

Chapter One

Incidence, Prevalence, Patient Characteristics, and Treatment Modalities

Incident Counts & Rates

Figure 1.9 Adjusted prevalent rates of ESRD & annual percent change (see page 379 for analytical methods. December 31 point prevalent ESRD patients. Adj: age/gender/race; ref: 2005 ESRD patients.)

The adjusted rate of prevalent cases of end–stage renal disease rose 2.1 percent in 2009 – up slightly from the 1.9 percent growth in 2008 – to 1,738 per million population. This rate is nearly 23 percent higher than that seen in 2000. The annual rate of increase has remained between 1.9 and 2.4 percent since 2003.

Figure 1.10 Geographic variations in adj. prev. rates of ESRD per million pop., 2009, by HSA (see page 379 for analytical methods. December 31 point prevalent patients. Adj: age/gender/race; ref: 2005 ESRD patients.)

In 2009, the rate of prevalent ESRD was 1,738 per million population. Geographic patterns generally follow those found in the incident population, with rates in the upper quintile averaging 2,278. (Rates are not adjusted for ethnicity.)

Table 1.b Patient demographics & adjusted rates, by ESRD network: December 31 point prevalent dialysis patients, 2009 (see page 379 for analytical methods. December 31 point prevalent dialysis patients. *Values for cells with ten or fewer patients are suppressed. Adj: age/gender/race; ref: 2005 patients.)

In 2009, the overall rate for December 31 point prevalent dialysis patients was 1,210 per million population. The percentage of prevalent patients with ESRD caused by diabetes ranges from 39 in Networks 1, 5, and 10 to 53 in Networks 14 and 15.

Table 1.c Patient demographics & adjusted rates, by ESRD network: December 31 point prevalent transplant patients, 2009 (see page 379 for analytical methods. December 31 point prevalent transplant patients. Adj: age/gender/race; ref: 2005 patients.)

For December 31, 2009 point prevalent transplant patients, the adjusted rate per million population is lowest in Network 6, at 414, and greatest in Network 11, at 786. As in the incident population, racial discrepancies persist. In Network 6, for example, African Americans account for 67 percent of prevalent dialysis patients, but only 39 percent of the prevalent transplant population.

Figure 1.11 Prevalent counts & adjusted rates of ESRD, by age (see page 379 for analytical methods. December 31 point prevalent ESRD patients. Adj: gender/race (1.11); age/gender (1.12–13); age/gender/race (1.14); ref: 2005 ESRD patients.)
Figure 1.12 Prevalent counts & adjusted rates of ESRD, by race (see page 379 for analytical methods. December 31 point prevalent ESRD patients. Adj: gender/race (1.11); age/gender (1.12–13); age/gender/race (1.14); ref: 2005 ESRD patients.)
Figure 1.13 Prevalent counts & adjusted rates of ESRD, by Hispanic ethnicity (see page 379 for analytical methods. December 31 point prevalent ESRD patients. Adj: gender/race (1.11); age/gender (1.12–13); age/gender/race (1.14); ref: 2005 ESRD patients.)
Figure 1.14 Prevalent counts & adjusted rates of ESRD, by primary diagnosis (see page 379 for analytical methods. December 31 point prevalent ESRD patients. Adj: gender/race (1.11); age/gender (1.12–13); age/gender/race (1.14); ref: 2005 ESRD patients.)

Reaching 6,066 per million population in 2009, the adjusted rate of prevalent ESRD for patients age 65–74 has increased 28 percent since 2000, while the rate among those age 75 and older has grown 37 percent, to 5,545. Among those age 20–44 and 45–64, in contrast, growth has been 13 and 20 percent, respectively.

Rates of ESRD due to diabetes and hypertension rose 2.2 and 2.7 percent, respectively, in 2009, to 647 and 429 per million population. ESRD caused by cystic kidney disease rose 2.4 percent, to 83, and ESRD due to glomerulonephritis remained stable, at 263.

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Chapter One

Incidence, Prevalence, Patient Characteristics, and Treatment Modalities

Incident & Prevalent modality

Table 1.d Incident counts & adjusted rates of ESRD at initiation & day 90, by modality, age, gender, race, ethnicity, & primary diagnosis, 2009 (see page 379 for analytical methods. Incident ESRD patients, 2009; unknowns dropped. Ref: 2005 patients.)

In 2009, 104,252 new patients began ESRD therapy on hemodialysis, 6,966 were placed on peritoneal dialysis, and 2,500 received a preemptive transplant (these data exclude patients with missing demographic information). The rate per million population reached 325 for hemodialysis, 21.9 for peritoneal dialysis, and 7.9 for transplant.

Dramatic differences by race persist, with the rate for African American patients initiating on hemodialysis at 928 per million population – 3.7 times greater than the rate of 251 among whites. The rate for patients who receive a preemptive transplant, in contrast, is 32 among Asians, compared to 6–7 among whites and African Americans and 22 among Native Americans.

Past studies have suggested high mortality and significant movement between modalities in the first 90 days after ESRD initiation. The total number of patients with a known modality fell 12 percent between initiation and day 90. The hemodialysis population at day 90 was 14 percent smaller than at initiation; the peritoneal dialysis and transplant populations, in contrast, gained 1.4 and 21 percent, respectively.

Between initiation and day 90, the rate per million population for hemodialysis fell from 325 to 280, while the rate for transplant rose from 7.9 to 9.5, and that for peritoneal dialysis remained relatively steady, rising from 21.9 to 22.2.

Figure 1.15 Incident patient distribution, by first modality & payor (see page 379 for analytical methods. Incident ESRD patients.)

Forty–five percent of new hemodialysis patients are covered solely by Medicare, 13.5 percent have dual Medicare/Medicaid coverage, and 15.3 percent are covered by a Medicare HMO provider. Medicare covers 41 and 22 percent of new peritoneal dialysis and transplant patients, while 9.8 and 4.2 percent are dually–enrolled, and 9.8 and 3.5 percent have HMO coverage. Coverage by non–Medicare insurers has increased for hemodialysis patients from 5.4 percent in 1978 to nearly 17 percent in 2009.

Table 1.e Prevalent counts & adjusted rates of ESRD, by modality, age, gender, race, ethnicity, & primary diagnosis, 2009 (see page 379 for analytical methods. December 31 point prevalent ESRD patients, 2009; unknowns dropped. Ref: 2005 patients.)

On December 31, 2009, more than 362,000 ESRD patients were receiving hemodialysis therapy, 27,015 were being treated with peritoneal dialysis, and 167,589 had a functioning graft. Rates of ESRD in the prevalent population continue to be highest among African Americans, at 4,166 per million population for hemodialysis, 192 for peritoneal dialysis, and 918 for transplant. Rates for peritoneal dialysis and transplant are similar in the Native American and Asian populations; at 1,992, however, the rate of Native Americans receiving hemodialysis is 54 percent greater than that found in the Asian population and more than double that found in whites.

Figure 1.16 Prevalent patient distribution, by modality & payor (see page 379 for analytical methods. December 31 point prevalent ESRD patients.)

Nine in ten prevalent hemodialysis patients had some type of Medicare coverage in 2009, with 40 percent covered solely by Medicare, and 32 percent under Medicare/Medicaid. In the transplant population, in contrast, just 32 percent are covered solely by Medicare. Transplant patients younger than 65 and not disabled lose their entitlement after three years with a functioning graft. Coverage by non–Medicare insurers continues to increase in the dialysis population, in 2009 reaching 10.8 and 10.2 percent for hemodialysis and peritoneal dialysis patients, respectively.

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Atlas of ESRD

Chapter One

Incidence, Prevalence, Patient Characteristics, and Treatment Modalities

Patient Care Prior to Initiation | Anemia | Laboratory Values

Table 1.f Pre–ESRD nephrologist care (column percent), 2009 (see page 379 for analytical methods. Incident ESRD patients, 2009.)

More than 43 percent of patients starting ESRD therapy in 2009 had not seen a nephrologist prior to initiation. Of these patients, 89 percent initiated with a catheter and only 3 percent with a fistula; 12.4 percent had a maturing internal access. Patients with more than one year of pre–ESRD nephrologist care, in contrast, were far more likely to initiate with a fistula, at 25.4 percent.

Figure 1.17 Pre–ESRD nephrologist care, by primary diagnosis, 2009 (see page 379 for analytical methods. Incident ESRD patients, 2009.)

Among patients beginning ESRD therapy in 2009, 45 percent of those with a primary diagnosis of hypertension had received no pre–ESRD nephrologist care, compared to 16 percent of those with cystic kidney disease. One in two patients with cystic kidney disease had received more than 12 months of nephrologist care, compared to 23 and 26 percent of those with hypertension or diabetes.

Figure 1.18 First access in patients with >12 mos. of nephrologist care, by primary diag., 2009 (see page 379 for analytical methods. Incident hemodialysis patients, 2009.)

Among patients receiving more than 12 months of nephrologist care prior to starting ESRD therapy in 2009, half of those with a primary diagnosis of cystic kidney disease had a fistula as their first access, compared to 29–34 percent of those with ESRD due to diabetes, hypertension, or glomerulonephritis.

Figure 1.19 Access use at first outpatient hemodialysis, by pre–ESRD nephrology care, 2009 (see page 379 for analytical methods. Incident hemodialysis patients, 2009.)

Figure 1.20 Mean hemoglobin at initiation, by pre–ESRD ESA treatment (see page 379 for analytical methods. Incident ESRD patients (1.20–23); incident ESRD patients, 2009 (1.g).)

Figure 1.21 Variations in the % of patients initiating dialysis with hemoglobin <10 g/dl, 2009 (see page 379 for analytical methods. Incident ESRD patients (1.20–23); incident ESRD patients, 2009 (1.g).)

Table 1.g Percent of patients initiating dialysis with laboratory values outside the test's normal limit, by age, gender, race, ethnicity, & primary diagnosis, 2009
eGFR: ml/min/1.73 m2; serum albumin < lab lower limit.
*A1c data include only patients with diabetes as their primary diagnosis or as a comorbidity.

Figure 1.22 Patient distribution at initiation, by eGFR (ml/min/1.73 m2): MDRD formula (see page 379 for analytical methods. Incident ESRD patients (1.20–23); incident ESRD patients, 2009 (1.g).)

Figure 1.23 Patient distribution at initiation, by eGFR (ml/min/1.73 m2): CKD–EPI formula (see page 379 for analytical methods. Incident ESRD patients (1.20–23); incident ESRD patients, 2009 (1.g).)

In the incident ESRD population, the mean hemoglobin at initiation has continued to fall from its peak in 2006, reaching 9.85 g/dl overall, 9.94 for patients receiving pre–ESRD treatment with an erythropoiesis stimulating agent (ESA), and 9.81 for patients without ESA treatment; 22 percent of new patients at the end of 2009 had received a pre–ESRD ESA.The percentage initiating dialysis with a hemoglobin less than 10 g/dl is highest in parts of Texas and states along the Gulf Coast and Atlantic Seaboard, averaging 56 percent in the upper quintile.

The likelihood of starting dialysis with laboratory values outside the normal limit is, with few exceptions, similar across demographic and disease categories. Overall, 57 percent of patients start treatment with a serum albumin below the test's lower limit, and 52 percent have a hemoglobin less than 10 g/dl. Sixteen percent initiate with a total cholesterol greater than 200 mg/dl, 70 percent have low density lipid (LDL) measurements less than 100 mg/dl, and 58 percent have high density lipid (HDL) levels below the Adult Treament Panel (ATP) III target of 40 mg/dl. Triglyceride levels above 150 mg/dl occur in 38 percent of incident patients, and 28 percent have a glycosylated hemoglobin (A1c) level above the recommended maximum of 7 percent.

Comparisons of estimated glomerular filtration rates (eGFRs) at the initiation of ESRD therapy indicate that patients are starting treatment sooner than in the past. In 2009, using the MDRD and CKD–EPI formulas to estimate GFR, 34 and 29 percent, respectively, initiated treatment with eGFRs of 10–<15 ml/min/1.73 m2, compared to 23 and 17.7 percent in 2000. And 19.8 and 15.5 percent started with eGFRs of 15 or greater, in contrast to 9.8 and 7.4 percent in 2000.

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Chapter Two

Clinical Indicatiors and Preventive Care

Introduction

Over the past decade, improvements in ESRD care have been addressed by several organizations. Most notable is CMS's assessment of provider performance under the ESRD Clinical Performance Measures (CPM) project, which looks at the implementation of guidelines from the National Kidney Foundation's Dialysis Outcomes Quality Initiative (KDOQI). KDOQI targets for dialysis therapy, vascular access, and clinical indicators are shown on the next page, along with targets based on practice guidelines and safety issues. The CPM project is currently undergoing transition to a full web–based data entry system, including monthly laboratory data from providers. There have been challenges in implementing the system, but by the spring of 2012 most providers should be entering data. Until that time, some elements traditionally reported under the CPM program will not be up to date.

Vascular access has received increased attention since the release of data on high catheter use at initiation and on increasing rates of hospitalization due to infection in the first months of therapy. The CMS Fistula First program has worked to increase the use of arteriovenous (AV) fistulas, with their lower complication rates and associated costs. But just 35 percent of 2009 incident hemodialysis patients had an AV access either in use or maturing at the first outpatient dialysis treatment.

Views of anemia treatment continue to evolve, as safety concerns about targeting higher hemoglobin levels emerge from clinical trials. Just 8.1 percent of patients in a given month now have a hemoglobin level of 13 g/dl or above, considerably lower than the 23 percent seen in December, 2006. Anemia correction in patients treated with erythropoiesis stimulating agents (ESAs) has also changed. At six months after initiation, mean hemoglobin levels in these patients are now 11.5 g/dl, lower than the 11.7 noted in 2001, but the ESA doses used to achieve these levels are higher than in 2001. It is not clear why such high doses are being used to achieve a lower hemoglobin level, but these differences imply that the current use of ESAs is now considerably less effective than in the past.

The new bundled prospective payment system for dialysis patients, implemented in January, 2011, will substantially change incentives for ESA use. Recent changes in the FDA label for ESAs may also impact achieved hemoglobin levels. Data on iron dosing practices show an increased use of IV iron products, and large doses given in the first six months of dialysis treatment, practices which may also change under the new dialysis payment system.

Comprehensive patient care has long been a focus of the ADR. Among diabetic patients, there continues to be slow but steady progress in the use of glycemic control monitoring, lipid monitoring, and eye examinations, although only 17 percent of prevalent patients received all three types of care in 2006–2008. Influenza vaccination rates have again begun to improve, reaching 64.3 percent among prevalent patients in 2009 – still, however, below the target of 90 percent. And there has been progress in the pneumococcal pneumonia vaccination rate, which reached 25.8 percent in 2008–2009.

We next examine vascular access placement and complications. As long recognized, catheters have the highest rates of infectious complications among patients on dialysis, and fistulas the lowest — particularly important when considering, as shown in Chapter Three, that such complications are a major source of morbidity. This year we show that hospitalizations due to vascular access infections are again declining; there has, however, been a steady rise in those for bacteremia/sepsis. These changes need to be monitored, as the use of cuffed catheters may still expose patients to the risk of infection.

We conclude with new data on use of the Medicare Part D drug benefit. In 2008, ESRD patients used an average of 12–13 medications within a year, though this varies by low income subsidy status. In any single month, patients refill an average of five prescriptions, with antihypertensive medications accounting for 20 percent. The number of reported refills may, however, be affected by the dispensed amount, as some plans allow a 90–day supply on a single refill.

Beta blockers are used by 60 percent of dialysis and transplant patients, a rate 6.5 times greater than that reported in the Dialysis Morbidity and Mortality Study (DMMS, a USRDS Special Study) in the 1990s. Use of lipid lowering agents has reached 40 percent in the dialysis population, and 50 percent among transplant patients; again higher than that reported in the DMMS. Four of five dialysis patients use a phosphate binder. And among patients with diabetes, insulin therapy is used by 50 percent of those on dialysis, and 70 percent of those with a transplant; sulfonylureas are used by close to 20 percent of both dialysis and transplant patients.

Chapter Six presents additional information on the Part D prescription drug benefit, addressing the low income subsidy and the coverage gap, illustrating enrollment among ESRD, CKD, and general Medicare patients, and reporting on the most frequently used medications. These analyses will be expanded in the 2012 ADR, as more Part D data become available to the USRDS.

Figure 2.1 Quality indicators: percentage of patients meeting clinical & preventive care guidelines (see page 380 for analytical methods.)

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Chapter Two

Clinical Indicatiors and Preventive Care

Anemia Treatment | Preventive Care

Figure 2.2 Patient distribution, by mean monthly hemoglobin (g/dl) (see page 381 for analytical methods. Period prevalent dialysis patients.)
Figure 2.3 Mean monthly hemoglobin & mean EPO dose per week (see page 381 for analytical methods. Period prevalent dialysis patients.)

Figure 2.4 Mean monthly hemoglobin after initiation, by year (see page 381 for analytical methods. Incident dialysis patients; EPO doses in 2.5 adjusted for inpatient days.)
Figure 2.5 Mean EPO dose per week after initiation, by year (see page 381 for analytical methods. Incident dialysis patients; EPO doses in 2.5 adjusted for inpatient days.)

Figure 2.6 Months with IV iron in the first six months of dialysis (EPO–treated patients) (see page 381 for analytical methods. Incident dialysis patients.)
Figure 2.7 Total IV iron dose in the first six months of dialysis (EPO–treated patients) (see page 381 for analytical methods. Incident dialysis patients.)

The proportion of incident dialysis patients receiving IV iron in each of the first six months of dialysis continued to increase in 2009, reaching 43 percent. A greater proportion of these patients received higher doses of IV iron than in previous years. In 2000 and 2005, for example, 22 and 30 percent, respectively, received a total iron dose of more than 2,700 units in the first six months of dialysis; this rose to 36 percent in 2009.

Figure 2.8 A1c testing in ESRD patients with diabetes, by number of tests (see page 381 for analytical methods. Point prevalent Medicare ESRD patients with diabetes, age 18–75.)
Figure 2.9 Lipid testing in ESRD patients with diabetes, by number of tests (see page 381 for analytical methods. Point prevalent Medicare ESRD patients with diabetes, age 18–75.)
Figure 2.10 Diabetic eye examinations in patients with diabetes, by number of tests (see page 381 for analytical methods. Point prevalent Medicare ESRD patients with diabetes, age 18–75.)

The American Diabetes Association recommends that patients with diabetes receive 2–4 glycosylated hemoglobin (A1c) tests per year, depending on changes in therapy and the attainment of treatment goals. In 2008–2009, 73 percent of diabetic ESRD patients received two or more A1c tests in a year, up from just 34 percent in 1996–1997.

Patients with diabetes are generally predisposed to lipid abnormalities, putting them at risk for cardiovascular disease. Ideally, fasting lipid profiles should be measured at least once per year in normal adults, and more often in those with high–risk lipid values. In 1996–1997, just 21 percent of ESRD patients with diabetes had at least two annual lipid tests; this improved to 58 percent in 2008–2009.

While many patients with diabetes suffer from problems with vision due to cataracts, glaucoma, or retinopathy, frequent eye examinations continue to be uncommon among ESRD patients with diabetes. In 2008–2009, only one in five received two or more tests in a year.

Figure 2.11 Comprehensive diabetic monitoring in ESRD patients with diabetes (see page 381 for analytical methods. Point prevalent Medicare ESRD patients with diabetes, age 18–75.)

Comprehensive diabetic monitoring includes at least four A1c tests, two lipid profile tests, and one eye examination yearly. While the rate of comprehensive monitoring has been increasing over time, in 2008–2009 only 17 percent of prevalent ESRD patients with diabetes received this testing.

Table 2.a Vaccination rates (percent), by age, race/ethnicity, & modality (see page 381 for analytical methods. Point prevalent ESRD patients.)

Rates of reported influenza vaccinations continue to improve overall, reaching 64.3 percent in 2009, though they remain noticeably lower in children than in adults. By modality, rates are highest in hemodialysis patients, at 69.3 percent, compared to 46.5 percent among transplant patients. Rates should be interpreted with caution, as patients may be vaccinated through non–Medicare programs.

Overall, just over one in four ESRD patients received a vaccination for pneumococcal pneumonia in 2008–2009. Rates are more than twice as high for dialysis patients as for those with a transplant.

Dialysis patients should begin a series of three hepatitis B vaccinations soon after initiating therapy. The likelihood of receiving just one vaccination, however, remains low, with an overall rate of just 22.1 percent in 2009.

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Atlas of ESRD

Chapter Two

Clinical Indicatiors and Preventive Care

Vascular Access

Figure 2.12 Vascular access at first outpatient dialysis (see page 381 for analytical methods. Incident hemodialysis patients.)

At their first outpatient hemodialysis session, nearly 65 percent of patients have a catheter alone, up from 62 percent in 2005; 82 percent are using either a catheter alone or a catheter with a maturing arteriovenous fistula or graft. Fourteen percent of patients now begin therapy with a fistula, up only slightly from 11.8 percent in 2005.

Figure 2.13 Vascular access use at initiation, by race, 2009 (see page 381 for analytical methods. Incident hemodialysis patients, 2009.)

At the start of ESRD therapy, 66 percent of white hemodialysis patients are using a catheter alone, compared to 63 percent of African Americans and 60 percent of patients of other races. Arteriovenous fistula use varies from 13 percent among African Americans to 16.3 percent among those of other races.

Figure 2.14 Geographic variations in the percent of hemodialysis patients using an internal access at initiation, by race & HSA, 2009 (see page 381 for analytical methods. Incident hemodialysis patients, 2009.)

In 2009, the percentage of hemodialysis patients starting ESRD with an arteriovenous fistula or graft showed wide variations across the county among both whites and African Americans. In the lower quintile, an average of 13.5 and 12.1 percent, respectively, initiated treatment with an internal access; means in the upper quintile were 23.5 and 23.3 percent.

By location, whites and African Americans residing in the Pacific Northwest, Alaska, and portions of Minnesota and New England were the most likely to initiate dialysis with an internal access.

Table 2.b Access use in prevalent dialysis patients, by age, gender, race, & ethnicity (ESRD CPM data; percent) (see page 381 for analytical methods. Prevalent hemodialysis patients age 20 & older; ESRD CPM data.)

As reported in the USRDS 2010 Annual Data Report, the use of catheters remained at 18–19 percent between 2003 and 2007 (the most recent year of available CPM data). Overall, arteriovenous fistula use during this period increased from 38.6 to 55.0 percent, while use of arteriovenous grafts fell from 42.9 to 27.2 percent.

Table 2.c Access events & complications in prevalent dialysis patients (ESRD CPM data; rate per patient year) (see page 381 for analytical methods. Catheter, fistula, graft: prevalent hemodialysis patients age 20 & older, ESRD CPM & claims data. Peritoneal dialysis device: prevalent peritoneal dialysis patients age 20 & older.)

Among prevalent hemodialysis patients in 2007 (the most recent year of available CPM data), the most common access–related event was replacement with a catheter, at 0.86 events per year for patients already using a catheter, and 0.12 and 0.24, respectively, for those with an arteriovenous (AV) fistula or graft. Sepsis is more common than infection, regardless of access type. In 2007, for example, the rate of sepsis among catheter patients was 1.6 times higher than the rate of infection; among AV fistula patients, the rate was three times higher.

In peritoneal dialysis patients, the rate of access replacement with another peritoneal access has decreased by a factor of two since 1998, while rates of replacement with an internal hemodialysis access or hemodialysis catheter have each fallen, but to a lesser degree. Rates of peritonitis have declined slightly since 1998, while rates of access infection have increased from 0.46 to 0.56; since 2003, the rate of sepsis has fallen from 0.52 to 0.44.

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Atlas of ESRD

Chapter Two

Clinical Indicatiors and Preventive Care

Medicare Part D Use

Figure 2.15 Cumulative number of medications in Part D–enrolled ESRD patients, by race/ethnicity & low income subsidy (LIS) status, 2008 (see page 381 for analytical methods. Point prevalent Medicare enrollees alive on January 1, with Part D enrollment, October 1–December 31, 2007 & 2008.)
Figure 2.16 Estimated daily number of medications in Part D–enrolled ESRD patients, by modality, race/ethnicity, & low income subsidy (LIS) status, 2008 (see page 381 for analytical methods. Point prevalent Medicare enrollees alive on January 1, with Part D enrollment, October 1–December 31, 2007 & 2008.)

Most patients with ESRD have enrolled in and use their Medicare Prescription Drug Plan (Part D) for many medications. (In Chapter Six we present more detail on Part D enrollees.)

Dialysis and transplant patients received an average of 13.6 and 12.4 distinct medications, respectively, through their Part D plan in 2008. White dialysis patients received the greatest number, at 14.1, and LIS patients received more than did their non–LIS counterparts. On any given day, dialysis patients had an average of 4.7 available Part D medications, while transplant patients had 5.3. Antihypertensives comprised more than one–fourth of the daily medication load.

Figure 2.17 Part D–enrolled ESRD patients on antihypertensives, by modality & race/ethnicity, 2008 (see page 381 for analytical methods. Point prevalent Medicare enrollees alive on January 1, with Part D enrollment, October 1–December 31, 2007 & 2008.)

Compared to transplant patients, a higher proportion of dialysis patients receive ACEIs/ARBs/renin inhibitors, beta blockers, hydralazine, and minoxidil. Among dialysis patients, use of beta blockers, DHP calcium channel blockers, and ACEIs/ARBs/renin inhibitors is highest among Asians. In the transplant population, beta blockers, DHP calcium channel blockers, central alpha agonists, diuretics, hydralazine, and minoxidil are used most frequently among African Americans.

Figure 2.18 Part D–enrolled ESRD patients using lipid lowering agents, by modality & race/ethnicity, 2008 (see page 381 for analytical methods. Point prevalent Medicare enrollees alive on January 1, with Part D enrollment, October 1–December 31, 2007 & 2008.)
Figure 2.19 Part D–enrolled ESRD patients using oral vitamin D analogs, by modality & race/ethnicity, 2008 (see page 381 for analytical methods. Point prevalent Medicare enrollees alive on January 1, with Part D enrollment, October 1–December 31, 2007 & 2008.)
Figure 2.20 Part D–enrolled dial. pts using phosphate binders, by modality & race/eth., 2008 (see page 381 for analytical methods. Point prevalent Medicare enrollees alive on January 1, with Part D enrollment, October 1–December 31, 2007 & 2008.)
Figure 2.21 Part D–enrolled ESRD patients with diabetes using diabetes agents, by modality & race/ethnicity, 2008 (see page 381 for analytical methods. Point prevalent Medicare enrollees alive on January 1, with Part D enrollment, October 1–December 31, 2007 & 2008.)

Fifty–two percent of transplant patients, and 41 percent of those on dialysis, receive statins. Ezetimibe use is relatively low compared to that of statins, and most frequently given to transplant patients; its use may rise, however, based on results from the prospective Study of Heart and Renal Protection (SHARP) trial, which showed a lower rate of atherosclerotic events in Stage 3–5 CKD and dialysis patients receiving a simvastatin/ezetimibe combination compared to a placebo.

Transplant patients are more than twice as likely to receive an oral active vitamin D agent than dialysis patients. More than 76 percent of dialysis patients receive a phosphate binder, with 49, 37, and 11 percent, respectively, on sevelamer, calcium acetate, and lanthanum. Combined use of phosphate binders is not common, and use of sevelamer is highest by race among Asians.

In terms of diabetic medications, insulin use is more common in transplant patients with diabetes than in those on dialysis; the opposite is true for sulfonylureas. Thiazolidinedione use is similar by modalities.

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Atlas of ESRD

Chapter Three

Hospitalization

Introduction

The Annual Data Report has increasingly focused on cause–specific hospitalization as an important surveillance issue. This year we introduce data on infectious complications across organ systems, trying to determine areas of greatest risk to patients. There is a pressing need to address these complications in the hemodialysis population, with the rate of admissions for infection now 43 percent greater than in 1993. The rate for vascular access procedures has, in contrast, fallen 48 percent. Hospitals have made significant progress in using less costly settings to address vascular access interventions, but equivalent progress in lowering the rate of infectious complications is lacking. The use of dialysis catheters continues to have the largest associated risk, a finding well known in the dialysis community.

In the peritoneal dialysis population there has been little change in the overall rate of hospitalization for infection. Admissions for peritonitis, in contrast, have fallen, and in 2009 the rate was close to that for vascular access infections in the hemodialysis population. This latter rate has shown an encouraging decline since 2005, but caution is needed in interpreting this trend, given the increasing rates of hospitalization for bacteremia/sepsis in both the hemodialysis and peritoneal dialysis populations. It is not clear if this increase is related to use of dialysis catheters, even among peritoneal dialysis patients, as a hemodialysis catheter is used as a temporary access until peritoneal dialysis is resumed. Since temporary use of hemodialysis in peritoneal dialysis patients does not change their modality status unless hemodialysis is used for longer than 60 days, detailed assessments of this temporary use of hemodialysis catheters are needed to help define the source of the increased hospitalization rates.

These data look at hospitalization as a single, isolated event. Next we examine data on rehospitalization, overall and by major organ systems, within 30 days of a hospital discharge. Particularly striking is the 36 percent all–cause rehospitalization rate among hemodialysis patients, and the fact that the highest rates occur among patients age 20–44. Among patients with an index hospitalization for cardiovascular disease, almost half of the rehospitalizations are related to that primary indication. Interestingly, rates of rehospitalization have changed little over the past decade. It is not clear exactly what type of care is delivered at the index hospitalization to treat the noted condition, and what additional therapy might be given after the initial discharge. Given that fluid overload, congestive heart failure, and vascular access complications are major complications for hemodialysis patients, these findings provide important information on areas for improvement.

We next highlight organ–specific rates of hospitalization for infection. Among hemodialysis patients, rates of hospitalization for both skin and lung infections have been rising since 1993. In the peritoneal dialysis and transplant populations, in contrast, hospitalizations for lung infections have been falling since the early part of the decade, and, interestingly, are similar for both cohorts – each comprised of healthier patients, but with very different modalities for kidney replacement treatment. Musculoskeletal infections, including osteomyelitis and joint infections, peaked among hemodialysis patients in 2005, and are almost twice as common in these patients than in those on peritoneal dialysis or with a transplant. The recent drop in abdominal infections in the peritoneal dialysis population is consistent with the improved connection of the peritoneal dialysis catheter to the solution bags. Overall, infections are a major public health concern for the ESRD population, and increased efforts by all members of the care team are needed to address these complications.

We conclude this chapter by comparing hospitalization rates in the peritoneal dialysis and hemodialysis populations, addressing as well the substantial selection bias between the two treatments. (The method for matching these populations, which uses an array of comorbidity and severity of disease measures, is defined in the analytical methods for Chapter One.) In the traditional comparison, overall hospitalization rates in the first and second years are considerably higher for hemodialysis patients than for those treated with peritoneal dialysis. When hemodialysis patients are matched to those on peritoneal dialysis, however, these differences are attenuated, and the higher rates of hospitalizations due to infection in the first year are reversed by the second year. Overall, however, it still that appears peritoneal dialysis patients have fewer hospitalizations than their matched hemodialysis counterparts.

Figure 3.1 Change in adjusted all-cause & cause–specific hospitalization rates, by modality (see page 382 for analytical methods. Period prevalent ESRD patients. Adj: age/gender/race/primary diagnosis; ref: ESRD patients, 2005.)

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Atlas of ESRD

Chapter Three

Hospitalization

Hospitalization in Matched Dialysis Populations

Figure 3.7 Adj. 1st–year hosp adm rates & days (from day 90) in matched HD & PD dialysis pts
Figure 3.8 Unadjusted rates of hospitalization in 2006–2007 matched incident hemodialysis & peritoneal dialysis patients: all patients (see page 383 for analytical methods. Incident hemodialysis & peritoneal dialysis patients age 20 & older, 2006–2007; unadjusted. First–year rates show admissions from day 90 to one year after initiation; second–year rates include patients alive & uncensored at the end of the first year.)
Figure 3.9 Unadjusted rates of hospitalization in 2006–2007 matched incident hemodialysis & peritoneal dialysis patients: whites (see page 383 for analytical methods. Incident hemodialysis & peritoneal dialysis patients age 20 & older, 2006–2007; unadjusted. First–year rates show admissions from day 90 to one year after initiation; second–year rates include patients alive & uncensored at the end of the first year.)

In hemodialysis matched to peritoneal dialysis populations, first–year hospitalization rates (from day 90) in 2008 were 26 percent higher for hemodialysis patients than for peritoneal patients, at 1.9 and 1.5, respectively, per patient year. Hospital days per patient year followed suit, and were 30 percent higher in the matched hemodialysis population, at 12.4 compared to 9.5 days in peritoneal dialysis patients. » Figure 3.7; see page 383 for analytical methods. Incident hemodialysis & peritoneal dialysis patients age 20 & older. Adj: age/gender/race/primary diagnosis; ref: 2005 incident hemodialysis & peritoneal dialysis patients. Rates show first–year admissions from day 90 to one year after initiation.

When hemodialysis patients are matched to peritoneal dialysis patients, unadjusted hospital admission rates in the first year after initiation are 25 percent higher in the hemodialysis population, at 1,921 and 1,542 per 1,000 patient years. Rates for cardiovascular disease, infection, and dialysis–related infection are 36, 8, and, 18 percent higher. In the second year following initiation, however, rates of admission for infection and dialysis access infection are 20 and 39 percent lower in hemodialysis patients compared to peritoneal dialysis patients. Similar patterns are evident in white patients.

Figure 3.10 Unadjusted rates of hospitalization in 2006–2007 matched incident hemodialysis & peritoneal dialysis patients: African Americans (see page 383 for analytical methods. Incident hemodialysis & peritoneal dialysis patients age 20 & older, 2006–2007; unadjusted.)

In African American hemodialysis matched to peritoneal dialysis populations, unadjusted hospital admission rates in the first year after initiation are 22 percent higher in hemodialysis patients, at 2,064 and 1,699, respectively, per 1,000 patient years. Rates of admission for a dialysis access infection are 14 percent higher, but those for overall infection, in contrast, are 8 percent lower. In the second year following initiation, overall hospitalization rates are 8 percent higher in the matched hemodialysis population overall, and 33 percent higher for cardiovascular disease; admission rates for infection and for infection related to a dialysis access, however, are 23 and 37 percent lower.

Table 3.d Unadjusted all–cause & cause–specific first–year (from day 90) hospitalization rates in matched incident hemodialysis & peritoneal dialysis patients (see page 383 for analytical methods. Incident hemodialysis & peritoneal dialysis patients age 20 & older; unadjusted. Rates show first–year admissions from day 90 to one year after initiation.)

In matched dialysis populations, unadjusted all–cause hospitalization rates per 1,000 patient years in 2007–2008, are, on average 33 percent higher in hemodialysis patients compared to peritoneal dialysis patients across categories of age, gender, race, ethnicity, and primary diagnosis. Similar patterns are evident for cause–specific admissions as well, where admission rates for cardiovascular events, infection, and access–related infection are 50, 17, and 14 percent higher in matched hemodialysis patients compared to rates in those on peritoneal dialysis.

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Atlas of ESRD

Chapter Four

Cardiovascular Disease in Patients with End–Stage Renal Disease

Drug Therapy in Patients with Cardiovascular Disease

Table 4.b Cardiovascular disease & pharmacological interventions (row percent), by diagnosis & modality, 2008 (see page 385 for analytical methods. January 1 point prevalent ESRD patients with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008.)

Figure 4.5 Prescription drug therapy in prevalent ESRD patients with CHF, by modality & race, 2008 (see page 385 for analytical methods. January 1 point prevalent ESRD patients with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008.)
Figure 4.6 Prescription drug therapy in prevalent ESRD patients with AMI, by modality & race, 2008 (see page 385 for analytical methods. January 1 point prevalent ESRD patients with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008.)
Figure 4.7 Prescription drug therapy in prevalent ESRD patients with CVA/TIA, by modality & race, 2008 (see page 385 for analytical methods. January 1 point prevalent ESRD patients with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008.)
Figure 4.8 Prescription drug therapy in prevalent ESRD patients with atrial fibrillation, by modality & race, 2008 (see page 385 for analytical methods. January 1 point prevalent ESRD patients with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008.)
Figure 4.9 Patients treated for CHF, by type of medication & modality, 2008 (see page 385 for analytical methods. January 1 point prevalent ESRD patients with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008.)
Figure 4.10 Patients treated for atrial fibrillation, by type of medication & modality, 2008 (see page 385 for analytical methods. January 1 point prevalent ESRD patients with a first cardiovascular diagnosis or procedure between January 1 & November 30, 2008.)

Despite two negative statin trials in dialysis patients (4D and AURORA) there has been no apparent dampening in enthusiasm for the use of these agents. In 2008, statins were used in 57 percent of hemodialysis patients with AMI, and 64 and 70 percent of those undergoing PCI and CABG. Recent publication of results from the SHARP trial (Baigent et al.) might be expected to further increase statin use across the spectrum of CKD.

Only 2–4 percent of patients with PAD receive cilostazol, an approved therapy; 17–24 percent receive clopidogrel, and 39–54 percent statin therapy. As noted in a recent KDIGO Controversies Conference Summary, PAD should be a special cardiovascular target for further improvement in all stages of kidney disease.

It is noteworthy that beta blockers have been shown to be of benefit only in those with systolic heart failure. Their putative benefits in patients with "diastolic heart failure" are still unproven, and it is likely that some classified as having CHF actually have preserved left ventricular systolic function, and what would be classified as "diastolic heart failure." Nearly 65 percent of dialysis patients with CHF receive a beta blocker, and use is nearly identical in whites and African Americans.

Among 2008 patients with CHF, 37 percent of those on dialysis, and 35 percent of those with a transplant, received an ACEI/ARB and beta blocker concurrently; 65 and 76 percent were on a regimen that included a beta blocker; and 48 and 43 percent received an ACEI/ARB (Figure 4.9). Forty–two percent of dialysis patients treated for AFIB, and 57 percent of AFIB patients with a transplant, received warfarin, while just 19 and 13 percent received amiodarone. Perhaps reflecting the complex pharmacokinetic interactions related to warfarin and amiodarone therapy, only 7–8 percent of patients received concurrent warfarin and amiodarone. Given the relatively frequent use of amiodarone in ESRD patients with atrial fibrillation, further data regarding the efficacy and safety of this agent in this special population would be helpful to clinicians.

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Atlas of ESRD

Chapter Six

Prescription Drug Coverage in ESRD Patients (Medicare Part D)

Introduction

As of September, 2008, 26 million Medicare–enrolled elderly and disabled people, as well as individuals with ESRD, were enrolled in a Medicare Part D prescription–drug plan (PDP). Before 2006, these patients obtained prescription drug coverage through various insurance plans, state Medicaid programs, or pharmaceutical–assistance programs, received samples from physicians, or paid out–of-pocket. After 2006, however, the majority obtained Part D coverage. As shown on the next page, 58–59 percent of elderly CKD and general Medicare patients were enrolled in Part D in 2008, compared to 72, 61, and 53 percent of hemodialysis, peritoneal dialysis, and kidney transplant patients.

The retiree drug subsidy, designed to encourage employers to supply prescription coverage to Medicare-covered retirees that is at least as valuable as the Medicare Part D standard plan, provides employers with a tax–free rebate for 28 percent of retirees' drug costs. Other patients are enrolled in employer group health plans or government/military plans ("creditable coverage") which provide coverage that is equivalent to or better than Part D.

The proportion of patients with no known source of drug coverage is highest in the peritoneal dialysis and transplant populations. Given that many of these patients are employed, it is likely that some have sources of prescription drug coverage not tracked by Medicare.

Prior to the start of the Medicare Part D program in 2006, patients dually–enrolled in Medicare and Medicaid received prescription benefits under state Medicaid programs. The Part D program, however, offers a substantial low–income subsidy (LIS) benefit to enrollees with limited assets and income, including those who are dually-enrolled. The LIS provides full or partial waivers for many out–of–pocket cost–sharing requirements, including premiums, deductibles, and copayments, and provides full or partial coverage during the coverage gap ("donut hole"). Compared to patients in the general Medicare population, a higher proportion of dialysis, transplant, and elderly CKD patients receive LIS benefits, and thus, in general, pay proportionally lower out–of–pocket costs for their Part D prescriptions.

The Medicare Part D program works in concert with Medicare Part B, which covers medications administered in physician offices (e.g. erythropoiesis stimulating agents (ESAs) in CKD patients), those administered during hemodialysis (e.g. ESAs, intravenous vitamin D and iron products, IV antibiotics, and resuscitative medications), and most immunosuppressant medications required in the three–year period following a Medicare–covered kidney transplant. Medicare–covered transplant patients lose eligibility for Part B benefits after three years, but, if they become Medicare–eligible due to age or disability, they again become eligible for Part B for immunosuppressant coverage. Patients whose kidney transplant is not covered by Medicare, but who become Medicare–eligible due to age or disability, can enroll in and receive their immunosuppressant medications through Part D. Prescription drugs not covered for beneficiaries under Part B may be covered by Part D, but coverage depends on whether the drug is included on the plan formulary.

Part D benefits can be managed through a stand–alone PDP or through a Medicare Advantage (MA) plan, which provides medical as well as prescription benefits. The majority of dialysis and transplant patients are covered through PDPs (as patients may not enroll in Medicare Advantage after ESRD onset), but data in this chapter encompass both types of plans.

Figure 6.1 Sources of prescription drug coverage in Medicare enrollees, 2008 (Figure 6.1; see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

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Atlas of ESRD

Chapter Six

Prescription Drug Coverage in ESRD Patients (Medicare Part D)

Medicare Part D Enrollment Patterns

Figure 6.2 Sources of prescription drug coverage in Medicare ESRD enrollees, by age & modality, 2008 (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

Sources of prescription drug coverage in Medicare ESRD patients vary widely by age and modality. In each age category, for example, transplant patients are markedly less likely than those on dialysis to have the low income subsidy (LIS). Younger patients on either modality have the highest Part D enrollment, and the monotonic decrease in the percentage of patients with LIS as age increases is striking – three in four dialysis patients age 20–44 with Part D receive LIS assistance, in contrast to just 35 percent of patients age 75 and older.

Figure 6.3 Sources of prescription drug coverage in Medicare ESRD enrollees, by race/ethnicity & modality, 2008 (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

The proportion of dialysis patients enrolled in Part D varies by race and ethnicity, from 67 percent among whites to 78 and 81 percent among African Americans and Hispanics, respectively. Eighty–three percent of African Americans and Hispanics with Part D coverage have LIS, compared to 64 percent of whites, and African Americans treated with dialysis are the least likely to have no known prescription drug coverage. These general trends hold true for kidney transplant patients as well, although their Part D enrollment is less than that of dialysis patients.

Figure 6.4 General Medicare & incident ESRD patients enrolled in Medicare Part D (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1. Incident (day 90; 6.4) & prevalent ESRD patients (6.5).)
Figure 6.5 General Medicare & prevalent ESRD patients enrolled in Medicare Part D (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1. Incident (day 90; 6.4) & prevalent ESRD patients (6.5).)

The steady increase in Part D enrollment among both incident and prevalent hemodialysis and peritoneal dialysis patients parallels that seen in general Medicare patients; the lower enrollment of peritoneal dialysis patients is most likely explained by their higher employment rate. Enrollment among the small number of patients transplanted within 90 days of ESRD initiation (about 2,300 per year) remains about 30 percent.

Figure 6.6 Patients enrolled in Medicare Part D, by dual eligibility & low income subsidy (LIS) status, 2008 (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

Patients dually–enrolled in Medicaid and Medicare qualify for LIS, and, if they do not choose a plan, are automatically enrolled in a Medicare Part D plan. Sixty–five percent of hemodialysis patients with Part D coverage are dually–eligible LIS beneficiaries, compared to 32 percent of the general Medicare population. An additional but smaller proportion of patients (6–12 percent) receive LIS after an application documenting low income and resources. Overall, 74 percent of hemodialysis patients with Part D coverage receive LIS benefits, compared to 64 percent of peritoneal dialysis and transplant patients, 51 percent of those with CKD, and 38 percent of general Medicare patients.

Figure 6.7 Medicare Part D enrollees with low income subsidy (LIS) (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)
Figure 6.8 Medicare Part D enrollees with low income subsidy (LIS), by age (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)
Figure 6.9 Medicare Part D enrollees with low income subsidy (LIS), by race (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, 2008.)

The proportion of Part D–enrolled patients with LIS declined slightly from 2006 to 2008, probably due to increasing elective enrollment among patients without dual eligiblity. The majority of younger patients (those younger than 65, primarily persons with ESRD or disabilities) enrolled in Part D have LIS. Among those age 65 and older, LIS enrollment is highest in the hemodialysis and CKD populations. By race, white Part D beneficiaries are less likely to have LIS than African Americans or those of other races. In 2008, the spread between general Medicare and hemodialysis patients with LIS was largest in white beneficiaries, at 33 percentage points.

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Atlas of ESRD

Chapter Six

Prescription Drug Coverage in ESRD Patients (Medicare Part D)

Overall Costs of Part D Enrollment

Figure 6.14 Total estimated net Part D payment for enrollees (see page 387 for analytical methods. All patients enrolled in Part D.)

Total net Part D payment for patients with identified kidney disease (hemodialysis, peritoneal dialysis, and transplant patients, and CKD patients not on dialysis) was $5 billion in 2008 – 10 percent of total Part D prescription drug costs. These costs do not include costs of drugs billed to Part B, including intradialytic medications (ESAs, IV vitamin D, iron) and immunosuppressants.

Figure 6.15 Per person per year Medicare & out–of–pocket Part D costs for enrollees, 2008 (see page 387 for analytical methods. All patients enrolled in Part D.)

At $5,536 and $6,183, the per person per year (PPPY) total cost of medications covered by Medicare Part D is 2.3–2.5 times higher, respectively, in dialysis and transplant patients than in the general Medicare population. Proportional to total Part D costs, however, out–of–pocket costs are lower in ESRD patients, representing 8 percent of PPPY costs for hemodialysis patients and 10 percent for both peritoneal dialysis and transplant patients, compared to 19 percent in the general Medicare population.

Figure 6.16 Per person per year Medicare & out–of–pocket Part D costs for enrollees, by low income subsidy (LIS) status, 2008 (see page 387 for analytical methods. All patients enrolled in Part D.)

Across populations, total Part D medication costs are approximately twice as high in patients with LIS benefits than in those without. In the LIS population, however, out–of–pocket costs represent only 2–3 percent of these total expenditures, compared to 40–41 percent in each of the non–LIS populations. Regardless of LIS status, total PPPY Part D costs are 1.8–2.4 times greater for patients with ESRD than for those in the general Medicare population.

Figure 6.17 Per person per year Part D costs for enrolled dialysis patients, by low income subsidy (LIS) status & race, 2008 (see page 387 for analytical methods. Period prevalent dialysis patients enrolled in Part D.)

Among dialysis patients with LIS benefits, Part D costs per person per year are $6,496–$6,945 for whites, African Americans, and Asians, compared to $5,481 for patients of other races. There is no wide variation in costs for non–LIS populations.

Figure 6.18 Total Medicare Part B & Part D medication costs, by modality, 2008 (see page 387 for analytical methods. Period prevalent ESRD patients.

Medicare Part D covers most medications taken by ESRD patients at home, while Medicare Part B covers those administered during dialysis (erythropoiesis stimulating agents, IV vitamin D, and so on) as well as immunosuppressive medications for patients with Medicare–covered transplants. In 2008, Medicare Part D costs for ESRD patients reached $1.54 billion, while Medicare Part B costs were $1.87 billion.

Figure 6.19 Total per person per year Part B & Part D medication costs, by low income subsidy (LIS) status, modality, & year (see page 387 for analytical methods. Period prevalent ESRD patients.)

In 2008, hemodialysis patients with LIS benefits had combined Part B and Part D medication costs of $14,536 per person per year. Regardless of LIS status, combined costs were greatest in hemodialysis patients.

Part B costs declined slightly between 2006 and 2008, most likely a result of lower ESA doses. Part D costs in dialysis patients, however, increased during this period, possibly reflecting shifting tier placement by prescription drug plans for some branded drugs. And in transplant patients, Part B and Part D costs were unstable, particularly from 2006 to 2007, which may reflect patient, pharmacy, and/or payor confusion over which program was paying for immunosuppressive medications as Medicare Part D was implemented in 2006.

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Atlas of ESRD

Chapter Six

Prescription Drug Coverage in ESRD Patients (Medicare Part D)

Coverage Phase Analyses for Part D Enrollees

Figure 6.20 Part D non–LIS enrollees who reach each coverage phase, 2008 (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)
Figure 6.21 Cumulative percent of Part D non–LIS enrollees who reach the coverage gap, 2008 (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)
Figure 6.22 Cumulative percent of Part D non–LIS enrollees who reach catastrophic coverage after reaching the coverage gap, 2008 (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)

Part D enrollees who do not have the low income subsidy (LIS) may encounter three coverage phases, depending on total and out–of–pocket (OOP) costs per year. In 2008, patients with total Part D drug costs up to $2,510 fell into the initial coverage phase, while those with costs over that amount entered the coverage gap ("donut hole"), in which they were responsible for 100 percent of drug costs. Patients whose total OOP costs reached $4,050 then entered the catastrophic coverage phase, in which they paid only a fraction of overall drug costs.

On average, peritoneal dialysis patients reach the coverage gap sooner than CKD or other ESRD patients, while general Medicare patients take the longest. Twenty–four to 26 percent of ESRD patients who reach the coverage gap will subsequently attain catastophic coverage, compared to 19 percent in the CKD population, and 12.5 percent of general Medicare patients. ESRD and CKD patients thus reach catastrophic coverage much faster than do general Medicare patients.

Table 6.a Twelve–month probability of reaching the coverage gap in Part D non-LIS enrollees, by modality, 2008 (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)

The twelve-month probability of non-LIS Part D enrollees reaching the coverage gap is 45–48 percent across ESRD modalities, but varies by demographic characteristic. Patients age 20–44, men, and African Americans are the least likely to reach the gap; by comorbidity, patients with diabetes reach it at a higher rate than do those with other diagnoses. Not surprisingly, the likelihood of reaching the gap rises with the number of prescription fills per month in the previous year.

Table 6.b Part D–covered prescription fills per person per month in Part D non–LIS enrollees, by modality, 2008 (see page 387 for analytical methods. Point prevalent Medicare enrollees alive on January 1, excluding those in employer–sponsored & national PACE Part D plans.)

Number, fill rate, and prescription cost influence whether patients stay in the initial coverage phase or progress to the coverage gap and then to catastrophic coverage. Among those who reach one of the latter two phases, transplant patients have the highest fill rate. Among those who reach the gap but do not get to catastrophic coverage, the fill rate declines once the gap is reached. This could be due either to a reduction in medication adherence or to a decision to obtain medications outside the Part D plan, and it is a pattern not seen in patients who reach catastrophic coverage. In these patients, the fill rate rises as each phase is reached. Patients with a higher number of Part D medications could be incentivized to fill prescriptions in order to reach this phase phase more quickly, as their out–of–pocket expenses then decrease dramatically.

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Atlas of ESRD

Chapter Six

Prescription Drug Coverage in ESRD Patients (Medicare Part D)

Medicare Part D Prescription Drug Use & Costs

Table 6.c Top 25 drugs used by Part D–enrolled dialysis patients, by frequency & net cost, 2008 (see page 388 for analytical methods. Part D claims for all dialysis patients, 2008.)

Figure 6.23 Top 15 drugs used by Part D–enrolled hemodialysis patients, by frequency, 2008 (see page 388 for analytical methods. Part D claims for all hemodialysis patients, 2008.)

A Metoprolol
B Sevelamer HCl
C Insulin
D Amlodipine
E Calcium acetate
F Cinacalcet
G Lisinopril
H Clonidine
I Simvastatin
J Levothyroxine
K Clopidogrel
L Furosemide
M Carvedilol
N Omeprazole
O Atorvastatin

Figure 6.24 Top 15 drugs used by Part D–enrolled hemodialysis patients, by cost, 2008

A Sevelamer HCl
B Cinacalcet
C Calcium acetate
D Insulin
E Lanthanum carbonate
F Clopidogrel
G Atorvastatin
H Esomeprazole
I Amino acids 8%
J Pantoprazole
K Sevelamer carbonate
L Lansoprazole
M Nifedipine
N Pioglitazone
O Clonidine

In 2008 hemodialysis patients, the top 15 medications (in terms of total days supply) accounted for nearly 42 percent of all Part D medications.

Sevelamer hydrochloride represented only 4.3 percent of total Part D drugs used in these patients, but accounted for 20.3 percent of their net Part D drug costs. Calcium acetate, in contrast, accounted for 3.1 percent of the medications and 4 percent of costs, demonstrating the stark contrast in costs to Medicare between use of a generic phosphate binding agent (calcium acetate) versus branded phosphate binding products (sevelamer hydrochloride or carbonate). Similarly, cinacalcet — available only in branded form — represented 2.9 percent of total Part D drugs used in 2008, but 16.9 percent of their costs.

Table 6.d Top 25 drugs used by Part D–enrolled transplant patients, by frequency & net cost, 2008 (see page 388 for analytical methods. Part D claims for all hemodialysis patients, 2008.)

Figure 6.25 Top 15 drugs used by Part D–enrolled transplant patients, by frequency, 2008 (see page 388 for analytical methods. Part D claims for all transplant patients, 2008.)

A Prednisone
B Metoprolol
C Insulin
D Amlodipine
E Furosemide
F Trimethoprim sulfamethoxazole/
G Atorvastatin
H Simvastatin
I Omeprazole
J Lisinopril
K Clonidine
L Nifedipine
M Levothyroxine
N Atenolol
O Pantoprazole

Figure 6.26 Top 15 drugs used by Part D–enrolled transplant patients, by cost, 2008 (see page 388 for analytical methods. Part D claims for all transplant patients, 2008.)

A Valganciclovir hydrochloride
B Tacrolimus
C Mycophenolate mofetil
D Insulin
E Cinacalcet
F Atorvastatin
G Epoetin Alfa
H Esomeprazole
I Sirolimus
J Lansoprazole
K Cyclosporine
L Pantoprazole
M Clopidogrel
N Darbepoetin alfa
O Nifedipine

Together, valganciclovir and tacrolimus represented 20 percent of all Part D drug costs for 2008 kidney transplant patients. Insulin therapies accounted for 4.7 percent of Part D medication use, but 7.1 percent of Part D costs; several new therapies continued under patent in 2008. Epoetin alfa and darbepoetin alfa, trade name products not among the most frequently used medications, were among those with the greatest cost, together accounting for 3.7 percent of Part D net costs among transplant patients.

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Atlas of ESRD

Chapter Seven

Transplantation

Introduction

Paired donation drove much of this increase. Reported living –to –living paired donation, when two incompatible donor–recipient pairs exchange to form two compatible pairs, increased 23 percent, with 277 transplants taking place in 2009. The continued expansion of regional kidney –paired exchange programs, along with the Kidney Paired Donation Pilot Program currently being tested by the Organ Procurement and Transplantation Network (OPTN), will likely increase the number of kidney –paired exchanges. Living–deceased paired donation, when a non–compatible donor donates to the deceased donor waiting list in exchange for priority listing of their intended recipient, rose 28 percent in 2009, with 127 transplants, while non–directed living donation rose 48 percent, to 119 transplants.

The number of patients on the wait list continues to increase, growing 6 percent in 2009 to reach 71,975 on December 31. New listings have grown 2 percent, with 28,494 candidates added to the list, paralleling a 2 percent increase in the ESRD incidence rate during the same period. Among new listings, 72 percent were active at listing; only 64 percent of listed patients, however, were designated as active on December 31, 2009. Twenty–one percent of 2008 incident ESRD patients were added to the wait list or received a deceased donor transplant within one year of initiation, a number remaining fairly stable over the past two decades. The percentage of adult candidates who receive a deceased donor transplant within three years of listing varies by candidate blood type, from 22 percent for those with Type O to 50 percent of those with Type AB.

Rates of deceased donation remained flat in 2009, at 21.6 donors per million population in 2009, and at 2.4 donations per 1,000 deaths in 2008 –2009 combined. Transplant rates per 100 dialysis patient years continue to decline, in 2009 reaching 2.5 and 1.4 for deceased and living donor transplants, respectively.

One–year survival with a functioning transplant continues to reach all–time highs, at 92 percent for recipients of first –time, deceased donor transplants, and 96 percent for recipients of first –time, living donor transplants in 2008. Five –year survival has increased to 70 and 83 percent. In 2009, delayed graft function was reported in 22 and 3 percent of deceased and living donor transplants, respectively. The rate varies, from 20 percent for standard criteria donors to 31 and 37 percent for expanded criteria donors and donations after cardiac death.

Attention continues to focus on reducing the incidence of acute rejection and other post –transplant complications, and on improving long –term outcomes. The incidence of reported acute rejection episodes during the first year post–transplant, reported in 10 percent of both deceased and living donor recipients in 2007, has declined more than 50 percent over the past decade. New –onset diabetes following transplant, however, remains common, with over 40 percent of adult, non–diabetic recipients having evidence of diabetes by the end of the third year after transplant. Twenty–eight percent of non–diabetic transplant recipients have claims for insulin during the first six months post–transplant, while 10 percent have claims for sulfonylureas. And in the three years post–transplant, lymphoproliferative disorders are reported in 0.5 and 1.9 percent of adult and pediatric recipients, respectively.

Congestive heart failure remains the leading cause of cardiovascular hospitalization during the first two years post –transplant, and urinary tract infections the leading cause of hospitalization due to infection. Among recipients who die with a functioning transplant, cardiovascular disease continues to be the leading cause of death, accounting for 30 percent of deaths, followed by infectious causes and malignancies at 21 and 9 percent.

During the first six months post–transplant, beta blockers are prescribed for 77 and 71 percent of deceased and living donor recipients. ACE inhibitors are prescribed for approximately 25 percent of all recipients, calcium channel blockers for 60 percent, and loop diuretics for 44 percent of deceased donor recipients and 26 percent of living donor recipients. Approximately 38 percent of transplant recipients with Medicare Part D coverage have claims for statins during the first six months post –transplant, and 90 percent of recipients age 35 or older at transplant have a lipid screening performed during the first year. Targeting post–transplant cardiovascular complications will continue to yield improvements in recipient outcomes.

Figure 7.1 Trends in transplantation: unadjusted rates, wait list, & total transplants, patients age 20 & older (see page 388 for analytical methods. Unadjusted incident & transplant rates: limited to ESRD patients age 20 & older, thus yielding a computed incident rate higher than the overall rate presented elsewhere in the ADR. Wait list counts: patients age 20 & older listed for a kidney or kidney –pancreas transplant on December 31 of each year. Wait time: patients age 20 & older entering wait list in the given year. Transplant counts: patients age 20 & older as known to the USRDS.)

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Atlas of ESRD

Chapter Seven

Transplantation

Wait List | Donation

Figure 7.2 Pts wait–listed or receiving a dec'd donor tx within one year of initiation, by age (see page 388 for analytical methods. Incident ESRD pts younger than 70 (7.2). Patients age 18 & older listed for a kidney or kidney–pancreas transplant on December 31 of each year (7.3).)
Figure 7.3 Wait list counts & multiple listings (see page 388 for analytical methods. Incident ESRD pts younger than 70 (7.2). Patients age 18 & older listed for a kidney or kidney–pancreas transplant on December 31 of each year (7.3).)

Sixty–two percent of pediatric patients starting ESRD therapy in 2008 were wait–listed or received a deceased donor transplant within one year, compared to 27 percent of those age 35–49. At the end of 2009, there were 53,075 active patients on the wait list for a kidney or kidney–pancreas transplant, and 28,636 inactive patients.

Figure 7.4 Outcomes for wait–listed adult patients within three years of listing, by blood type (see page 388 for analytical methods. Pts age 18 & older listed for a first–time kidney or kidney–pancreas transplant.)

The percentage of adult patients receiving a deceased donor transplant within three years of listing has fallen considerably since 1991, and varies by blood type. It continues to be highest for those of blood type AB – at 50 percent for patients listed in 2006 – and lowest for those of type O or B. The percentage receiving a living donor transplant has been rising, and varies little by blood type.

Figure 7.5 Outcomes for first–time wait–listed patients three years after listing in 2006, by age, race, & PRA (see page 388 for analytical methods. Pts age 18 & older listed for a first–time, kidney–only tx in 2006; transplanted patients may have subsequent outcomes in the three–year follow–up period.)

Of patients listed in 2006, 21 percent of whites and Asians received a living donor transplant within three years, compared to just 8.7 percent of African Americans. Forty–two and 47 percent of Asians and African Americans were still waiting after three years, rates considerably higher than the 31 percent among whites.

Figure 7.6 Unadj. median wait times (years) for adults tx'ed in 2009, by state of tx center (see page 388 for analytical methods. Pts age 18+ receiving a first–time, deceased–donor, kidney–only tx in 2009 (7.6). Pts age 18+, listed for a kidney or kidney–pancreas tx as of Jan. 1, 2009; see appendix for adjustments (7.7).)
Figure 7.7 Adj. mortality rates (per 100 person yrs of waiting) for wait–listed pts, by state, 2009 (see page 388 for analytical methods. Pts age 18+ receiving a first–time, deceased–donor, kidney–only tx in 2009 (7.6). Pts age 18+, listed for a kidney or kidney–pancreas tx as of Jan. 1, 2009; see appendix for adjustments (7.7).)

Median wait times for patients transplanted in 2009 exceeded four years in Alabama, Delaware, and New Jersey; the median was 2.3. Adjusted mortality among wait–listed patients in 2009 reached 6.7 deaths per 100 person years of waiting, and exceeded 10 in Idaho and West Virginia.

Figure 7.8 Likelihood of dying while awaiting transplant (see page 388 for analytical methods. Patients age 18 & older, listed for a first–time kidney or kidney–pancreas transplant (7.8); patients age 18 & older with Medicare primary coverage & listed for a kidney transplant in the given year (7.9).)
Figure 7.9 Three–year cumulative incidence of transfusion in wait–listed patients, by PRA (see page 388 for analytical methods. Patients age 18 & older, listed for a first–time kidney or kidney–pancreas transplant (7.8); patients age 18 & older with Medicare primary coverage & listed for a kidney transplant in the given year (7.9).)

For first-time transplant candidates, the probabilities of dying within one or five years have fallen to 0.03 and 0.26, respectively. Transfusions are most common among patients who are highly sensitized at the time of transplant (PRA of 80 percent or higher).

Figure 7.10 Donation rates, by age, gender, & race (see page 388 for analytical methods. Donors younger than 70 whose organs are eventually transplanted.)

Rates of kidney donation from deceased donors remain highest among those age 50–64 and among males, reaching 27.7 and 26.1 per million population, respectively, in 2009. Since 2005, rates by race have been highest in the African American population, reaching 26.4 in 2009, compared to just 8.6–9.6 among Native Americans and Asians.

Rates of donations from living donors are greatest among patients age 35–49, reaching 47 per million population in 2003–2005, and 43 in 2009. By race, rates in 2009 ranged from 10.8 and 14.3 among Native Americans and Asians to 22–23 among whites and African Americans.

Figure 7.11 Deceased donor donations (per 1,000 deaths), by state, 2008–2009 (see page 388 for analytical methods. Deaths from July 1, 2008 to July 1, 2009.)

In 2008–2009, the rate of donations from deceased donors was 2.4 per 1,000 deaths overall. Rates by state were greater than 4 per 1,000 deaths in Alaska, Delaware, Iowa, Indiana, and Utah.

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Chapter Seven

Transplantation

Transplant | Outcomes

Figure 7.12 Deceased donor transplants, by age, gender, race, & primary diagnosis (see page 388 for analytical methods. Pts age 18 & older. Includes kidney–alone & kidney–pancreas transplants.)

Figure 7.13 Adjusted transplant rates, by age, gender, race, & primary diagnosis: deceased donors (see page 388 for analytical methods. Patients age 18 & older. Adj: age/gender/race/primary diagnosis (rates by one factor adjusted for remaining three); ref: prevalent dialysis patients, 2009.)

The adjusted deceased donor transplant rate has grown 51 percent since 2000 for patients age 65 and older, while falling 39 percent for those age 18–34. By race, the rate is down 30 percent among whites, while 16589.pngrising 8.5 and 12 percent for African Americans and Asians.

Figure 7.14 Living donor transplants, by age, gender, race, & primary diagnosis (see page 388 for analytical methods. Patients age 18 & older. Includes kidney–alone & kidney–pancreas transplants.)

Figure 7.15 Adjusted transplant rates, by age, gender, race, & primary diagnosis: living donors (see page 388 for analytical methods. Patients age 18 & older. Adj: age/gender/race/primary diagnosis (rates by one factor adjusted for remaining three); ref: prevalent dialysis patients, 2009.)

Rates of living donor transplants peaked at the beginning of the decade, and have since fallen for many patient groups. As with deceased donor transplants, rates by race are now greatest in the Asian population, reaching 3 per 100 dialysis patient years in 2009 – 76 percent higher than in 2000.

Figure 7.16 Adjusted transplant rates (per 100 dialysis patient years) by state of patient residence & donor type, 2009 (see page 388 for analytical methods. Patients age 18 & older. Adj: age/gender/race/primary diagnosis; ref: prevalent dialysis patients, 2009.)

In 2009, the rate of deceased donor transplants reached 5.8 per 100 dialysis patient years in Vermont, and 4.0–4.2 in South Dakota, Maryland, and New Hampshire. Rates of living donor transplants were greatest in Wyoming, Montana, and Minnesota, at 3.2–3.8.

Figure 7.17 Outcomes: deceased donor transplants (see page 388 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only transplant. Adj (survival): age/gender/race/primary diagnosis.)
Figure 7.18 Outcomes: living donor transplants (see page 388 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only transplant. Adj (survival): age/gender/race/primary diagnosis.)

More than 96 percent of patients who receive a deceased donor kidney transplant, and nearly 99 percent of those receiving a kidney from a living donor, survive the first year with a functioning graft. For those transplanted in 2004, five–year survival reached 85 and 93 percent, respectively, and ten–year survival for those transplanted in 2000 reached 62 and 78 percent.

From 1991 to 2008, one–year all–cause graft survival increased from 81.5 percent to 91.9 percent among recipients of a deceased donor transplant, and from 92.4 to 96.4 percent in those with a transplant from a living donor. Between 1991 and 2000, ten–year all–cause graft survival rose from 31.9 to 41.4 for deceased donor transplant recipients. Among patients with a living donor transplant, survival fell slightly during the early 1990s, then increased again to reach 59.4 in 2000.

Figure 7.19 Acute rejection within the first year post–transplant (see page 388 for analytical methods. Pts age 18 & older (7.19); patients age 18 & older with a functioning graft at discharge (7.20).)
Figure 7.20 Transplants with delayed graft function (DGF), by donor type (see page 388 for analytical methods. Pts age 18 & older (7.19); patients age 18 & older with a functioning graft at discharge (7.20).)

The percentage of transplant patients experiencing an acute rejection has declined steadily over the past decade, and 74–76 percent of reported acute rejections are biopsy–proven. In 2009, delayed graft function was reported in 3.4 percent of transplants from living donors, compared to 20, 31, and 37 percent of SCDs, ECDs, and donations after cardiac death.

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Chapter Seven

Transplantation

Outcomes | Follow–up Care

Figure 7.21 Hospitalization rates in the first & second years post-transplant, 2006 (see page 389 for analytical methods. First–time, kidney–only tx recipients, age 18 & older, transplanted in 2007; ref: transplant patients, 2006.)

In the second year post-transplant, hospitalization rates for adult recipients are 54 percent lower than in the first year, at 67 admissions per 100 patient years. Admissions due to transplant complications fall 71 percent, to 11.7, while admissions due to cardiovascular causes and to infection fall 40 and 46 percent, to 8.7 and 17.5.

Figure 7.22 Primary diagnoses of cardiac & infectious hospitalizations in the first & second years post–transplant (see page 389 for analytical methods. First–time, kidney–only transplant recipients, age 18 & older, with Medicare primary payor coverage, transplanted in 2005–2009.)

In the first year after transplant, 22 percent of cardiovascular hospitalizations are due to congestive heart failure; this number rises only slightly in the second year, to 23 percent. Hospitalizations for coronary atherosclerosis and CVA/TIA also increase, from 6.2 and 5.0 percent, respectively, in year one to 11.8 and 9.8 percent in year two. Urinary tract infection, septicemia, and pneumonia are the most common diagnoses among transplant patients admitted for infection, at 16 percent in the second year after transplant.

Figure 7.23 Cumulative incidence of post–transplant lymphoproliferative disorder (PTLD) (see page 389 for analytical methods. Patients receiving a first–time, kidney–only transplant, 2002–2006 combined.)

Figure 7.24 Cumulative incidence of post–transplant diabetes (see page 389 for analytical methods. Patients receiving a first–time, kidney–only transplant, 2002–2006 combined.)

At 36 months after transplant, the cumulative incidence of post–transplant lymphoproliferative disorder (PTLD) is four times greater among pediatric patients than among adults, at 1.91 percent compared to 0.48. Adults, in contrast, have a higher incidence of post–transplant diabetes, reaching 41 percent at 36 months, compared to 12 percent among pediatric patients.

Figure 7.25 Adjusted rate of outcomes after transplant (see page 389 for analytical methods. Pts age 18+ at tx; adj: age/gender/race; ref: 2009 prev. dial. pts (7.25). First–time, kidney–only tx recipients, age 18+, 2005–2009, who died with functioning graft (7.26).)

Figure 7.26 Causes of death with function, 2005–2009 (see page 389 for analytical methods. Pts age 18+ at tx; adj: age/gender/race; ref: 2009 prev. dial. pts (7.25). First–time, kidney–only tx recipients, age 18+, 2005–2009, who died with functioning graft (7.26).)

The overall graft failure rate among adult transplant recipients fell to 6.4 per 100 patient years in 2009, while the rate of failure requiring dialysis or retransplantation fell to 3.1. Cardiovascular disease and infection are the main cause of death for 30 and 21 percent of adult patients who die with a functioning graft.

Figure 7.27 Immunosuppression use (see page 389 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only tx. CsA: cyclosporine A; CsM: cyclosporine microemulsion.)

Eighty–eight percent of patients transplanted in 2009 used tacrolimus as their initial calcineurin inhibitor, and mycophenolate has almost completely replaced azathioprine as the anti–metabolite used in new transplant recipients. Use of mTOR inhibitors, both initially and post–transplant, has continued to fall, while steroid use seems to be stabilizing.

Figure 7.28 Induction antibody use (see page 389 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only transplant.)

Figure 7.29 Cardiovascular medication use in the first 6 months post–tx, 2007–2008 (Part D data) (see page 389 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only transplant.)

In 2009, 26 percent of transplant patients recived IL2–RA, and 56 percent were on a T–cell depleting antibody; just 18 percent received no treatment. Use of cardiovascular medications in the first six months after transplant is highest among recipients of deceased donor transplants, reaching 77 percent for beta blockers and 64 percent for DHP calcium channel blockers.

Figure 7.30 Medications for lipid control in the first 6 months post–tx, 2007–2008 (Part D data) (see page 389 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only transplant.)
Figure 7.31 Medications for diabetes control in the first 6 mos. post–tx, 07–08 (Part D data) (see page 389 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only transplant.)

In the first six months after transplant, 38–39 percent of patients receive statins, while just 2.9–3.6 percent receive fibrates. Use of medications for diabetes control is far higher among patients who were diabetic at the time of transplant; insulin use, for example, reaches 83 percent in these patients, compared to 28 percent among those whose diabetes occurs post–transplant.

Figure 7.32 Follow–up care & screening in the first 12 months post–transplant, by age (see page 389 for analytical methods. Patients age 18 & older receiving a first–time, kidney–only transplant.)

In 2008, 24 percent of recipients age 18–49 received an influenza vaccination in the 12 months post-transplant, compared to 32 percent of those 60–64, and 45 percent of those age 65 and older. Lipid screening rates range from 84 percent in the youngest adults to 93 percent in those age 60–64. Since 2003, nearly all recipients have received a CBC test in the year after transplant.

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Chapter Eight

Pediatric End–Stage Renal Disease

Introduction

Pediatric end–stage renal disease patients pose unique challenges to providers and the healthcare system, which must address not only the disease itself, but the many extra–renal manifestations that affect patients' lives and families. To determine what progress may have been made in slowing the development of ESRD, we this year revisit trends in the incidence and prevalence of ESRD among children. The overall incidence of ESRD in the pediatric population rose slowly between 1984 and 1990, a period when expertise in pediatric dialysis and transplantation was growing. Consistent with findings in the adult population, and as shown on the next page, incidence due to glomerular disease has been declining gradually since 1990, and the number of patients has remained remarkably consistent. Both the incidence of ESRD due to cystic kidney disease and the number of children with this diagnosis, however, have been rising, a finding that merits investigation to determine whether the disease is truly increasing or if earlier recognition and treatment have led to more children coming to ESRD.

This year we have included a table showing the full range of diseases that cause ESRD in children, and covering the years 2000–2004 and 2005–2009. The total number of children beginning ESRD therapy grew nearly 4 percent between the two periods. Cystic/hereditary/congenital diseases accounted for 35 percent of new cases in 2005–2009, while 23 percent were caused by glomerular disease; focal glomerular sclerosis accounted for half of these reported cases. The third leading cause was secondary glomerular diseases, at 11 percent (54 percent of these patients had a primary diagnosis of lupus nephritis). In many disease groups males account for close to 60 percent of cases – not a surprising number, as congenital diseases such as posterior urethral valves occur only in males. For other diseases such as lupus nephritis, in contrast, males account for just one in five cases.

In 2005–2009, close to 40 percent of children received a kidney transplant in the first year of ESRD, up from 37 percent in 2000–2004. And in both periods, 4.2 percent of children died in the first year of ESRD treatment.

High rates of hospitalization for bacteremia/sepsis in the hemodialysis population, particularly for children age four and younger, is a major concern. Due to the challenges of internal access placement in children, hemodialysis is performed through a dialysis catheter, creating the same risk of complications from infection faced by adult patients. Infection control procedures developed for adults may, with some modification, be applicable for children, and should be investigated.

Influenza and pneumococcal pneumonia can, of course, lead to increased hospitalization rates and higher risks of mortality. Rates of vaccination against these diseases have improved in the pediatric population, but still remain far below both recommended levels and the levels seen in the adult population. There also continue to be discrepancies in vaccination rates by modality, with hemodialysis patients more likely to be vaccinated than children on peritoneal dialysis.

We next present data on hospitalizations after the initiation of ESRD therapy. The pattern of hospitalization is different in children compared to adults, with rates in children increasing steadily over the first 15 months. Among patients younger than 10, rates of hospitalization for infection rise 31 percent between month three and months 12–15; similar increases are noted for older children. By modality, these rates increase a striking 40 percent for hemodialysis patients, and 54 percent for those treated with peritoneal dialysis.

In contrast to patterns in hospitalization, those of mortality rates are similar to what is seen in the adult population, with rates peaking in the second month after initiation of treatment, then slowly declining through the rest of the first year. In the early months of therapy, the youngest children are at the highest risk of both hospitalization and death.

The most striking findings related to pediatric ESRD patients continued to center on the extreme vulnerability of patients younger than ten. And issues of infection control, which could lower the rate of complications, need to be addressed. In past ADRs we have also noted issues of uncontrolled hypertension and heart failure, and of sudden death, which remain issues of concern as well. None of these are new challenges, but the community will need to assess them and develop new approaches to improving outcomes in this vulnerable population.
Figure 8.1 ESRD patients age 0–19. Adj: age/gender/race; ref: 2005 ESRD patients.

Table 8.a Distribution of reported incident ESRD pediatric patients, by primary diagnosis, 2000–2004 (period A) & 2005–2009 (period B) (see page 390 for analytical methods. Incident ESRD patients age 0–19. *Values for cells with ten or fewer patients are suppressed. "." Zero values in this cell.)

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Atlas of ESRD

Chapter Eight

Pediatric End–Stage Renal Disease

Hospitalization & Mortality

Figure 8.7 Adjusted all–cause hospitalization rates in the first months of ESRD, by age & modality, 2001–2008 (see page 390 for analytical methods. Incident ESRD patients age 0–19, 2001–2008. Adj.: rates by age, gender/race/primary diagnosis; rates by modality, age/gender/race/primary diagnosis. Ref: incident ESRD patients age 0–19, 2004–2005.)
Figure 8.8 Adjusted cardiovascular hospitalization rates in the first months of ESRD, by age & modality, 2001–2008 (see page 390 for analytical methods. Incident ESRD patients age 0–19, 2001–2008. Adj.: rates by age, gender/race/primary diagnosis; rates by modality, age/gender/race/primary diagnosis. Ref: incident ESRD patients age 0–19, 2004–2005.)
Figure 8.9 Adjusted rates of hospitalization for infection in the first months of ESRD, by age & modality, 2001–2008 (see page 390 for analytical methods. Incident ESRD patients age 0–19, 2001–2008. Adj.: rates by age, gender/race/primary diagnosis; rates by modality, age/gender/race/primary diagnosis. Ref: incident ESRD patients age 0–19, 2004–2005.)

In the 3–15 months following initiation of ESRD therapy, adjusted all–cause admission rates for patients age 0–9 are 1.6–1.7 times greater than those of their counterparts age 10–19, increasing from 2,025 admissions per 1,000 patient years at risk in months 3–<6 to 2,525 in months 12–<15. By modality, admissions are lowest in transplant patients, and decline slightly over time, in contrast to the increase seen for both dialysis modalities. (Follow–up starts at month three after ESRD initiation in order to obtain complete admissions data, as in–center hemodialysis patients younger than 65 cannot bill Medicare for hospitalizations in the first 90 days.)

Rates of cardiovascular admissions are greatest by age in patients age 0–9 and 15–19, and reach 324–334 per 1,000 patient years at months 12–<15. Transplant patients have the lowest rates by modality, at just 22 in months 3–<6, compared to 340 and 278 for hemodialysis and peritoneal dialysis patients, respectively.

For each age group, admissions for infection rise between months 3–<6 and 6–<9, then level out; the highest rates occur among the youngest patients. By modality, rates are lowest for transplant patients, and similar over time in both the hemodialysis and peritoneal dialysis populations.

Figure 8.10 Adjusted all–cause mortality rates in the first months of ESRD (from day one), by age & modality, 2001–2008 (see page 390 for analytical methods. Incident patients age 0–19, 2001–2008 (8.10–12) & 2000–2004 (8.13). Adj: age/gender/race/primary diagnosis. Ref: incident ESRD patients age 0–19, 2004–2005.)
Figure 8.11 Adjusted cardiovascular mortality rates in the first months of ESRD (from day one), by age & modality, 2001–2008 (see page 390 for analytical methods. Incident patients age 0–19, 2001–2008 (8.10–12) & 2000–2004 (8.13). Adj: age/gender/race/primary diagnosis. Ref: incident ESRD patients age 0–19, 2004–2005.)
Figure 8.12 Adjusted rates of mortality due to infection in the first months of ESRD (from day one), by age & modality, 2001–2008 (see page 390 for analytical methods. Incident patients age 0–19, 2001–2008 (8.10–12) & 2000–2004 (8.13). Adj: age/gender/race/primary diagnosis. Ref: incident ESRD patients age 0–19, 2004–2005.)
Figure 8.13 Adjusted five–year survival (from day one), by age & modality, 2000–2004

Adjusted all–cause mortality rates for children age 0–4 are noticeably higher than those found in their older counterparts. In the first month of therapy, for example, mortality in younger children reaches 153 deaths per 1,000 patient years at risk, compared to 24 in those age 5–9, and 5.3 in those age 10–14.

Overall, the all–cause mortality rate in pediatric patients reaches 48 in the first month after initiation, peaks at 57 in the next two months, then falls to 28 in months 9–<12. Rates are highest in patients treated with hemodialysis, and lowest in those with a transplant.

Rates of mortality due to cardiovascular disease show similar patterns. For the youngest patients, the rate falls from 65 deaths per 1,000 patient years in the first month to 19 at the end of the year; rates for patients age five and older remain lower than 20 throughout the year. The overall rate of cardiovascular mortality is 19 in the first month, and declines to 7.9.

For most age groups, the rate of mortality due to infection peaks in months 1–<3, reaching 38 for the youngest patients. The overall rate is 11.3 during this period, and falls to 5.4 in months 9–<12.

For patients beginning ESRD therapy in 2000–2004, the overall probability of surviving five years was 0.88. By age, this ranges from a low of 0.78 among patients age 0–4 to 0.92 for ages 10–14. By modality, the highest probability is found in patients with a transplant, at 0.95, compared to 0.74 for those treated with hemodialysis.

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Chapter Nine

Nutrition, Rehabilitation/Quality of Life, and Cardiovascular Special Studies

Background and Purpose

ACTIVE/ADIPOSE is a prospective, multi–center study of prevalent hemodialysis patients coordinated by the United States Renal Data System (USRDS) Nutrition, Rehabilitation/Quality of Life, and Cardiovascular Special Studies Centers in collaboration with the NIH/NIDDK Division of Kidney, Urologic, and Hematologic Diseases and the USRDS Coordinating Center. Data sources include performance–based, body composition, and patient-reported measures as well as medical chart review and serum samples for nutritional and cardiac biomarkers. The study is designed to meet research objectives of each of the Special Studies Centers, and will also support investigation of associations between nutrition and cardiovascular parameters, cardiovascular and rehabilitation parameters, and nutrition and rehabilitation parameters.

Rehabilitation/Quality of Life Objectives

Chronic kidney disease appears to be a wasting disease, but little is known about potential modifiers of loss of lean body mass or other body compartments and the role of inflammatory markers and lipid abnormalities. Limitations in physical functioning (with decreased health-related quality of life) and increased risk of hospitalization and mortality are well documented issues in dialysis patients. The concept of frailty represents reduced physiologic capacity in neurologic control, mechanical performance, and energy metabolism, which heighten an individual's vulnerability to adverse outcomes. Rapidly accumulating evidence in the geriatric literature about factors contributing to frailty may provide important insights regarding dialysis patients' vulnerability to wasting, impaired functional status, morbidity, and mortality.

The ACTIVE/ADIPOSE study will assess prospectively, for the first time, the prevalence of frailty characteristics in a large cohort of hemodialysis patients, will investigate change in these characteristics over two annual follow–up evaluations, and will examine the association of frailty with changes in functional status, falls, hospitalization, and mortality. With regard to clinical care, the research has important implications for monitoring and intervening on risks for frailty and for decreased functional status and quality of life in patients on hemodialysis.

The exercise tolerance of most ESRD patients is low. It is unclear whether inactivity, one frailty indicator, is the best predictor of patients' functional decline, or whether other characteristics may better identify patients who are likely to lose physical function. Interventions geared towards increasing participation in moderate intensity physical activity could be a practicable way to address the problem of sedentary behavior in this population. Because the effects of interventions to increase moderate physical activity among patients on dialysis have not been well studied, and such programs are not widely available to dialysis patients. there is a great need for randomized trials in this area. More information is needed, however, to develop feasible interventions targeted to patients who are likely to participate and to benefit. It is vital to determine the rate of participation in physical activity among ESRD patients, the characteristics associated with higher physical activity, predictors of decline in physical performance or self–reported functioning, and predictors of the development of disability. The construct of frailty has been extensively studied in the general elderly population and found to be highly predictive of poor outcomes, but these studies have not been applied in the ESRD population.

nutrition objectives

Unintentional weight loss is another indicator associated with frailty. Longitudinal studies are needed to better understand the natural history of wasting with ESRD and its implications for long–term survival. Few studies have evaluated the pace and potential modifiers of loss of lean body mass, total body water (TBW), or other body compartments. Longer dialysis vintage has been shown to be associated with lower body weight, TBW, and body cell mass, and with decline in phase angle. Cross–sectional analyses probably underestimate these changes because of a bias towards better nutrition among survivors. This study will furnish information about the composition of weight loss over time, and simultaneously measure potential determinants of wasting such as inflammatory markers.

Higher body mass index (BMI) is associated with improved survival among patients with ESRD. This finding is contrary to the increased mortality seen among obese individuals in the general population, and is particularly puzzling because obesity is generally associated with insulin resistance, lipid alterations, and other factors that increase the risk of cardiovascular death, the major cause of death among patients with ESRD. There are many potential explanations for the apparently protective effect of high body fat among patients with ESRD, including 1) misclassification related to estimates of obesity based solely on height and weight, 2) starvation "protection" as a result of increased energy reserves in the form of higher body fat, 3) a "survivor bias" in the years leading up to ESRD, and 4) a diminished or paradoxical effect of obesity and its metabolic correlates in the setting of uremia. A major goal is to systematically evaluate the contributions of these factors to the observed survival advantage of higher BMI.

Data from ACTIVE/ADIPOSE will be useful for investigating whether baseline adiposity is associated with survival and other outcomes. Longitudinal body composition data can be used to determine whether baseline adiposity is associated with mitigation of wasting in dialysis patients, and will facilitate evaluation of the relations among adiposity, adipokines, fetuin A, Matrix gla protein and other factors associated with insulin resistance, vascular calcification, and cardiovascular outcomes in hemodialysis patients.

Cardiovascular Objectives

Compared to normal subjects, dialysis patients appear to be chronically in higher inflammatory states, as suggested by high serum levels of CRP and pro–inflammatory cytokines. While inflammation is a source of oxidative stress, and high serum CRP levels have been associated with higher mortality in dialysis patients (including those without documented ischemic heart disease), it is unclear which inflammatory mechanisms are involved and how they are related to specific types of clinical cardiovascular disease (e.g. coronary artery disease vs. cardiomyopathy). In the general population, an array of biomarkers reflecting critical components of the inflammatory pathway resulting in atherosclerotic plaque instability and myocardial necrosis has been related to clinical outcome. For example, the release of troponin from the myocardium has been used to provide risk stratification for patients with known chronic coronary artery disease and those presenting with acute coronary syndrome. It is important to identify biomarkers that predict both coronary artery disease and plaque rupture, and to examine the relationship of these biomarkers to long–term all–cause and cardiac mortality. Non–fatal cardiovascular events such as AMI and CHF hospitalization, and their association with biomarkers, can also be examined. The association between biomarkers and echocardiographic findings in ACTIVE/ADIPOSE will be examined at baseline and follow–up, and the study will facilitate relational studies of biomarkers, demographic variables including race and gender, comorbid medical conditions, medication use, and long–term morbidity and mortality.

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Chapte Ten

Providers

Introduction

Following consolidation of Gambro dialysis units into DaVita, and of Renal Care Group units into Fresenius, the landscape of dialysis providers appears to have stabilized. At the end of 2009, 122,216 prevalent patients were being treated by Fresenius in 1,742 units, 110,299 were receiving care in one of DaVita's 1,556 units, and 13,023 patients were being treated by Dialysis Clinic Inc. (DCI), with 213 units. These three major providers manage the majority of the 5,760 dialysis units across the United States. Small dialysis organizations (SDOs), comprising 20–199 units, treated 44,793 patients in 605 units, while independent and hospital-based providers treated 58,090 and 38,596 patients in 848 and 796 units, respectively.

Recent clinical trials have reported adverse outcomes with hemoglobin levels above 11 g/dl. In 2011, the Food and Drug Administration (FDA) removed the target hemoglobin range of 10–12 g/dl from package inserts of erythropoiesis stimulating agents (ESAs), instructing that ESA treatment for dialysis patients be initiated when the hemoglobin falls below 10 g/dl, and that providers reduce or interrupt the ESA dose if the level approaches or exceeds 11 g/dl. In 2009, nearly one–fifth of dialysis patients treated with erythropoietin (EPO) – across providers – had a hemoglobin level exceeding 12 g/dl. The FDA's "black box" warning is designed to encourage physicians to individualize ESA treatment in their patients, and should ultimately change ESA dosing patterns among dialysis providers, reducing the likelihood of ESRD patients reaching high hemoglobin levels.

The new prospective bundled dialysis payment system, also introduced in 2011, alters provider incentives for treatment. The effect of this system on patient treatment and outcomes, and of the FDA's changes in the labeling for ESAs, will be examined in future ADRs.

To maintain optimal hemoglobin levels, it is important that patients have adequate iron stores. In 2009, 66 percent of prevalent dialysis were treated with Venofer and 20 percent with Ferrlecit; INFeD is used sparingly, in only 0.2 percent of patients. As noted in earlier chapters, the number of patients receiving a total iron dose of 2,700 mg or more over the first six month of dialysis has increased from 22 percent in 2000 to 40 percent in 2009. Adequate safety studies on the use of these large doses of IV iron have yet to be performed, limiting our ability to assess this major change in clinical practice.

This year we again examine preventive care services delivered by providers, focusing on diabetic care and vaccinations. Glycemic control (A1c) testing in diabetic patients differs by unit affiliation, with 63–65 percent of patients in Fresenius, DaVita, SDO, and independent units receiving four or more A1c tests during 2008–2009, compared to 42–47 percent of patients in hospital–based and DCI units. Just 56 percent of diabetic patients on dialysis receive two or more lipid tests, and fewer than one in three are tested four or more times; those treated in an independent or hospital–based unit are more likely to receive four or more tests than their counterparts in chain-owned or SDO units. These practice patterns may change based on results from the SHARP study, demonstrating reduced atherosclerotic events when patients are treated with a combination lipid lowering therapy (Lancet, June 2011). Eye examinations are another important preventive care tool, used to detect diabetic retinopathy. Fewer than one in four prevalent dialysis patients with diabetes received an eye exam in 2008–2009. Rates of vaccination, both for influenza and for pneumococcal pneumonia, have improved over the years; patients dialyzing in units owned by DaVita are the most likely to receive these vaccinations.

Medicare payments vary considerably across provider groups. Per person per year (PPPY) expenditures for dialysis rose just 1.5 percent in 2009, to $17,851 overall, but ranged from a low of $17,016 in hospital-based units to a high of $18,717 in units owned by SDOs. PPPY costs for ESAs totaled $6,175 overall, and were again lowest in hospital–based facilities.

We conclude with an analysis of mortality and hospitalization ratios. Standardized hospitalization ratios (SHRs) and standardized mortality ratios (SMRs) in 2009 are similar across providers; SHRs, however, are slightly higher in independent facilities, while hospital-based facilities tend to have slightly higher SMRs. Among the large dialysis organizations, DCI continues to have the lowest statistically significant SHRs and SMRs. SDOs in the East North Central, Middle Atlantic, and New England census divisions have statistically significant higher SHRs. In hospital–based units, statistically significant higher SHRs and SMRs exist in the East South Central, South Atlantic, and West South Central divisions. The USRDS will continue to assess provider outcomes over time to determine areas for improvement.

Figure 10.1 Distribution of patients, by unit affiliation, 2009 (see page 391 for analytical methods. CMS Annual Facility Survey, 2009.)
(Figure: pt distribution by affilation)

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Atlas of ESRD

Chapte Ten

Providers

Provider Growth | Anemia Treatment

Figure 10.2 Percent change in the number of dialysis units & patients, 2004 to 2009, by ESRD network (see page 391 for analytical methods. CMS Annual Facility Survey, 1988–2009.)
Figure 10.3 Dialysis unit & patient counts, by unit affiliation, 2009 (see page 391 for analytical methods. CMS Annual Facility Survey, 1988–2009.)
Figure 10.4 Dialysis unit distribution, by affiliation & time managed (time under chain management), 2009 (see page 391 for analytical methods. CMS Annual Facility Survey, 1988–2009.)

Between 2004 and 2009, the number of dialysis units grew 41 percent in Network 9, and 44 percent in Network 14. In Network 2, in contrast, the number of units rose only 2 percent. Growth in the number of patients ranged from 12 percent in Network 2 to 27–30 percent in Networks 14, 15, 16, and 18.

In 2009, Fresenius and DaVita were the largest dialysis providers, with approximately 60 percent of all dialysis units and patients; units owned by DCI totaled 213, with just 3.4 percent of the total dialysis population. Small dialysis organizations (SDOs) – defined as those with 20–199 dialysis units – accounted for 11–12 percent of units and patients, and independently owned facilities accounted for 15 percent. Hospital–based facilities represented 14 percent of all dialysis units, and accounted for 10 percent of the dialysis population.

Figure 10.5 Distribution of prevalent EPO–treated dialysis patients, by hemoglobin level & unit affiliation, 2009 (see page 391 for analytical methods. Period prevalent dialysis patients, 2009.)

Figure 10.6 IV iron use in dialysis patients, by type of iron & unit affiliation, 2009 (see page 391 for analytical methods. Point prevalent dialysis patients, 2009 (10.6); incident dialysis patients treated with EPO, 2009 (10.7–8).)
Figure 10.7 Months with IV iron in the first six months of dialysis, by unit affiliation, 2009 (see page 391 for analytical methods. Point prevalent dialysis patients, 2009 (10.6); incident dialysis patients treated with EPO, 2009 (10.7–8).)
Figure 10.8 Mean total IV iron dose in the first six months of dialysis, by unit affiliation, 2009 (see page 391 for analytical methods. Point prevalent dialysis patients, 2009 (10.6); incident dialysis patients treated with EPO, 2009 (10.7–8).)
Figure 10.9 Dialysis patients with one or more transfusion events, by unit affiliation, 2009 (see page 391 for analytical methods. Point prevalent dialysis patients, 2009.)

In 2009, 20 percent of prevalent dialysis patients were treated with Ferrlecit, and 66 percent with Venofer; INFeD is now used sparingly, in only 0.2 percent of patients.

Choice of IV iron type varies considerably by provider. In units owned by DaVita and DCI, for example, 86–87 percent of patients receive Venofer, compared to 48–50 percent of patients treated in independently owned or hospital–based units. In these latter units, Ferrlecit is used by 37 and 28 percent of patients.

In the first six months of dialysis, the number of months in which patients receive IV iron is 4.6 overall, and slightly higher in for–profit units. The mean total IV iron dose is 2,348 mg overall, and highest in units owned by Fresenius, at 2,491.

In 2009, 15.1 percent of prevalent dialysis patients had one or more transfusion events. By unit affiliation, the percentage ranges from 12.7 in units owned by DCI to 17 in independently owned and hospital–based units.

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Atlas of ESRD

Chapte Ten

Providers

Standardized Hospitalization & Mortality Ratios

Figure 10.18 All–cause standardized hospitalization & mortality ratios, by unit affiliation, 2009 (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)
Figure 10.19 All–cause standardized hospitalization & mortality ratios in large dialysis organizations, 2009 (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)
Figure 10.20 All–cause standardized hospitalization & mortality ratios in small dialysis organizations, by U.S. Census Division, 2009 (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)
Figure 10.21 All–cause hospitalization & mortality ratios in hospital–based dialysis units, by U.S. Census Division, 2009 (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)

For 2009, standardized hospitalization ratios (SHRs) are almost equal in small and large dialysis organizations (SDOs and LDOs), as are standardized mortality ratios (SMRs). Independent facilities have the highest SHR, and hospital-based facilities the highest SMR. By unit affiliation among the LDOs, DCI continues to have the lowest ratios for both hospitalization and mortality.

Within the SDOs, three U.S. Census Divisions – East North Central, Middle Atlantic, and New England — have statistically significant higher SHRs; the Mountain and Pacific divisions have statistically significant lower ones. A mortality ratio less than one and statistically significant occurs only in the Pacific division. Among hospital–based units, the Mountain, Pacific, and West North Central divisions have lower SHRs, while the East South Central, South Atlantic, and West South Central divisions each have higher SHRs and SMRs.

Figure 10.22 All–cause standardized hospitalization & mortality ratios, by unit affiliation, 2009: whites (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)
Figure 10.23 All–cause standardized hospitalization & mortality ratios, by unit affiliation, 2009: African Americans (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)
Figure 10.24 All–cause standardized hospitalization & mortality ratios in hospital–based dialysis units, by U.S. Census Division, 2009: whites (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)
Figure 10.25 All–cause standardized hospitalization & mortality ratios in hospital–based dialysis units, by U.S. Census Division, 2009: African Americans (see page 391 for analytical methods. January 1 point prevalent hemodialysis patients, 2009, with Medicare as primary payor (SHRs); January 1 point prevalent hemodialysis patients, 2009 (SMRS). SHRS & SMRS are calculated based on national hospitalization & death rates. Adj: age/ gender/race/dialysis vintage.)

In units owned by Fresenius and DaVita, white patients have statistically significant higher SHRs, while African American patients have statistically significant lower SHRs in Fresenius units, and lower SMRs in DaVita units. In hospital–based units, SHRs are lower than one and statistically significant for whites, but higher than one for African Americans.

Among hospital–based dialysis units in the Middle Atlantic and South Atlantic divisions, white patients have a statistically significant higher SHR, as do African Americans in the East North Central, East South Central, Middle Atlantic, New England, South Atlantic, and West South Central divisions. In the Mountain and Pacific divisions, the SHR is lower than one for both whites and African Americans. SMRs greater than one and statistically significant are reported for both white and African American patients in the East South Central, South Atlantic, and West South Central divisions.

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Atlas of ESRD

Chapte Eleven

Costs of ESRD

Introduction

Total Medicare spending in 2009 rose 8.2 percent, to $491 billion, which included the cost of the new Part D prescription drug benefit. Costs for ESRD rose 3.1 percent, to $29 billion; this total does not, however, include Part D, since availability of the ESRD Part D data is one year behind that for the general Medicare population. When Part D costs are excluded, total Part A, B, and C Medicare expenditures were $434.5 billion in 2009, with the ESRD program accounting for 6.7 percent of this spending – a number consistent over many years. These expenditures cover the more than 571,000 patients in the Medicare ESRD population; costs for the non–Medicare population were an additional estimated $13.5 billion (data from Table p.a in the Précis).

Medicare HMO costs in 2009 rose to $3.13 billion, 15 percent higher than in 2008. This annual increase has been consistent since 2003, when the new Medicare hierarchical payment model, with disease burden risk adjusters, was implemented for Medicare Advantage (HMOs). Inpatient expenditures per person per year (PPPY) rose nearly 8 percent, down from their 18 percent growth in the previous year, while PPPY costs by modality remained nearly stable; for hemodialysis patients, these costs rose only 0.2 percent. Interestingly, there were large increases across modalities in 2008, from 9.5 percent for peritoneal dialysis patients to 11 percent for both hemodialysis and transplant patients. These year–to–year variations will need more complete assessment – including consideration of cause–specific hospitalizations – to define their exact source.

Per person per year costs for inpatient/outpatient services rose 3–4 percent across modalities in 2009. Physician/supplier costs, in contrast, while also increasing 4 percent in the hemodialysis population, rose 16.5 percent for patients receiving a transplant during the year, and nearly 23 percent for those with a functioning transplant. These changes in costs for transplant patients need further investigation to determine their association with inpatient and outpatient care and with particular CPT–coded services.

Recent attention to therapies using erythropoiesis stimulating agents (ESAs) has raised awareness of their costs to the healthcare system. After increasing each year since 1992 (including growth of 11–19 percent in 2002–2004) to reach nearly $2 billion, Medicare ESA costs were stable in 2004–2007, and in 2008 declined to a pre–2004 level of $1.8 billion. In 2009, however, they rose 5 percent, to $1.87 billion. Costs for IV vitamin D rose 12 percent in 2008, and then just 3.7 percent in 2009. And IV iron costs rose nearly 7 percent in 2009, to $286 million, a new high.

The Average Sale Price payment system for injectables was introduced in 2004, as investigations showed that many providers had very profitable discount agreements, accounting for significant margins paid under the Medicare system. The composite rate payment was thus rebased, and the margins generated for injectables were addressed by allowing providers to receive only 6 percent above the sale price, monitored under quarterly reporting to CMS. There have been other changes in ESA payment policies as well, including limited billing when hemoglobin levels are greater than 13 g/dl for three months. These alterations, along with changes in package insert warnings regarding ESA safety, have led to reductions in both ESA dosing and hemoglobin levels, as noted in earlier chapters.

This year we again examine racial differences in expenditure patterns, and look at costs by modality in matched hemodialysis and peritoneal dialysis populations. These analyses explore how racial differences in service utilization in the outpatient dialysis setting may be an important consideration in the new bundled payment system, and how variations in expenditure structures for hemodialysis and peritoneal dialysis may impact the way in which providers adapt to this new system.

The last spread of the chapter provides information on use of the Part D Medicare prescription drug benefit in the ESRD population, addressing the most frequent claims for medications, rank order by frequency and cost, and differences in use between the dialysis and transplant populations. Part D analyses were expanded this year, and we will provide greater detail in the 2012 ADR.

Figure 11.1 ESRD spending, by payor (see page 392 for analytical methods. Period prevalent dialysis patients. Data for 2006–2008 include Part D expenditures.)

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Atlas of ESRD

Chapte Eleven

Costs of ESRD

Overall Costs of ESRD & Injectables

Figure 11.2 Costs of the Medicare & ESRD programs (see page 392 for analytical methods.)

Total Medicare costs rose 8.2 percent in 2009, to $491 billion; costs for ESRD increased 3.1 percent, to $29 billion, accounting for 5.9 percent of the Medicare budget. ESRD data for 2009, however, do not include Part D costs — which amounted to $1.6 billion in 2008 – making ESRD's portion of Medicare costs appear lower than in prior years.

Figure 11.3 Estimated numbers of point prevalent ESRD patients (see page 392 for analytical methods. December 31 point prevalent ESRD patients (11.3). Total Medicare costs from claims data; include all Medicare as primary payor claims as well as amounts paid by Medicare as secondary payor (11.4–5). Period prevalent ESRD patients; patients with Medicare as secondary payor are excluded (11.6–7).)
Figure 11.4 Annual percent change in Medicare ESRD spending (see page 392 for analytical methods. December 31 point prevalent ESRD patients (11.3). Total Medicare costs from claims data; include all Medicare as primary payor claims as well as amounts paid by Medicare as secondary payor (11.4–5). Period prevalent ESRD patients; patients with Medicare as secondary payor are excluded (11.6–7).)
Figure 11.5 Total Medicare dollars spent on ESRD, by type of service (see page 392 for analytical methods. December 31 point prevalent ESRD patients (11.3). Total Medicare costs from claims data; include all Medicare as primary payor claims as well as amounts paid by Medicare as secondary payor (11.4–5). Period prevalent ESRD patients; patients with Medicare as secondary payor are excluded (11.6–7).)
Figure 11.6 Total Medicare ESRD expenditures, by modality (see page 392 for analytical methods. December 31 point prevalent ESRD patients (11.3). Total Medicare costs from claims data; include all Medicare as primary payor claims as well as amounts paid by Medicare as secondary payor (11.4–5). Period prevalent ESRD patients; patients with Medicare as secondary payor are excluded (11.6–7).)
Figure 11.7 Total Medicare ESRD expenditures per person per year, by modality (see page 392 for analytical methods. December 31 point prevalent ESRD patients (11.3). Total Medicare costs from claims data; include all Medicare as primary payor claims as well as amounts paid by Medicare as secondary payor (11.4–5). Period prevalent ESRD patients; patients with Medicare as secondary payor are excluded (11.6–7).)

The estimated number of point prevalent Medicare ESRD patients (Figure 11.3) rose 3.2 percent between 2008 and 2009, to more than 470,000, while the non–Medicare ESRD population rose 8.3 percent, to 101,351.

Because 2009 ESRD cost data do not include Part D expenditures, total Medicare ESRD expeditures for the year do not accurately reflect actual changes. We will include 2009 ESRD Part D costs in the 2012 ADR.

In 2009, 38 percent of Medicare's ESRD dollars were spent on inpatient services, 35 percent on outpatient care, and 21 percent on physician/supplier costs. After rising 11 percent between 2007 and 2008, total Medicare expenditures for hemodialysis and transplant rose only 0.2 and 0.4 percent in 2009, to $20.8 and $2.4 billion, while costs for peritoneal dialysis fell 3.3 percent, to $1.1 billion. Per person per year costs fell less than 1 percent across modalities, to $82,285 for hemodialysis, $61,588 for peritoneal dialysis, and $29,983 for transplant.

Figure 11.8 Per person per year inpatient/outpatient & physician/supplier net costs for Medicare & MarketScan (EGHP) patients with ESRD (see page 392 for analytical methods. Medicare: period prevalent ESRD patients; MarketScan: period prevalent ESRD patients age 64 & younger.)

Inpatient/outpatient costs per person per year (PPPY) for MarketScan patients with a transplant during 2009 fell nearly 6 percent from the previous year, to nearly $145,000, 48 percent more than the $98,000 incurred by their Medicare counterparts, for whom costs increased 4.1 percent. Costs for MarketScan patients with a functioning graft in 2009 were 5.2 percent higher than in 2008, at $33,452 – 2.9 times higher than the $11,384 reported for Medicare patients.

In 2009, physician/supplier PPPY costs for patients with a transplant during the year fell 3.8 percent for MarketScan patients, to $19,229; costs for their Medicare counterparts rose 16.5 percent, to $18,709.

Figure 11.9 Total Medicare spending for injectables (see page 392 for analytical methods. Period prevalent dialysis patients.)

Figure 11.10 Per person per year costs for injectables, 2009

Of the $2.78 billion spent in 2009 on injectables for dialysis patients, ESAs accounted for 68 percent, or $1.89 billion. The proportions of total costs for IV vitamin D, IV iron, and other injectables were 18.3, 10.3 and 3.6 percent, or $509 million, $286 million, and $99 million, respectively. Medicare costs per person per year for IV vitamin D and IV iron were highest for Zemplar and Ferrlecit, at $1,926 and $868, respectively.

Figure 11.11 Unadjusted per person per year costs (dollars) for injectables, by HSA, 2009 (see page 392 for analytical methods. Period prevalent dialysis patients.)

Per person per year costs for erythropoiesis stimulating agents (ESAs) and IV iron, and costs for IV vitamin D, both show a distinct geographic pattern, with costs highest along the Gulf Coast and the Eastern Seaboard, and lowest in the western half of the country. Costs average $7,248 and $1,812, respectively, in the upper quintile. » Figure 11.11; see page 392 for analytical methods. Period prevalent dialysis patients, 2009; unadjusted.

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Atlas of ESRD

Chapte Eleven

Costs of ESRD

Racial Differences | Matched & Unmatched dialysis populations

Figure 11.12 Total per person per year outpatient expenditures, by race (see page 392 for analytical methods. Period prevalent dialysis patients.)

Total per person per year outpatient expenditures in the prevalent dialysis population do not vary widely by race. In 2009, for example, costs were $30,365 for white patients, $32,030 for African Americans, and $29,633 for patients of other races.

Figure 11.13 Per person per year expenditures for laboratory tests, by race (see page 392 for analytical methods. Period prevalent dialysis patients.)
Figure 11.14 Per person per year expenditures for ESAs, by race (see page 392 for analytical methods. Period prevalent dialysis patients.)
Figure 11.15 Per person per year expenditures for IV vitamin D, by race (see page 392 for analytical methods. Period prevalent dialysis patients.)
Figure 11.16 Per person per year expenditures for IV iron, by race (see page 392 for analytical methods. Period prevalent dialysis patients.)
Figure 11.17 Per person per year expenditures for IV antibiotics, by race (see page 392 for analytical methods. Period prevalent dialysis patients.)
Figure 11.18 Per person per year expenditures for other injectables, by race (see page 392 for analytical methods. Period prevalent dialysis patients.)

In the prevalent dialysis population, per person per year (PPPY) costs for laboratory tests in 2009 are slightly higher for whites than African Americans, at $1,839 and $1,796, respectively. Costs for erythropoiesis stimulating agents (ESAs) are 14.5 percent higher for African Americans than for whites, at $6,746 and $5,892. Costs for IV iron are similar among whites and African Americans, at $789 and $814; IV vitamin D costs, in contrast, are 74 percent higher in African Americans than in whites, at $1,846 and $1,059. Overall PPPY costs for IV antibiotics fell 2.4 percent in 2009, to $13.28. Costs for all other injectables are $210 PPPY overall and $243 and $174, respectively, in whites and African Americans.

Figure 11.19 Total per person per year outpatient expenditures, by dialysis modality & race, 2009 (see page 392 for analytical methods. Period prevalent dialysis patients, 2009.)

In 2009, per person per year (PPPY) outpatient dialysis expenditures were 5.5 percent higher in African Americans than in whites, at $32,030 and $30,365, respectively. When comparing costs by modality in unmatched dialysis populations, those for hemodialysis were 26 percent higher than those for peritoneal dialysis. This difference was sustained when hemodialysis patients were matched to peritoneal patients, at 25 percent for whites and 29 percent for African Americans.

Figure 11.20 PPPY expenditures for laboratory tests, by dialysis modality & race, 2009 (see page 392 for analytical methods. Period prevalent dialysis patients, 2009.)
Figure 11.21 PPPY expenditures for ESAs, by dialysis modality & race, 2009 (see page 392 for analytical methods. Period prevalent dialysis patients, 2009.)
Figure 11.22 PPPY expenditures for IV vitamin D, by dialysis modality & race, 2009 (see page 392 for analytical methods. Period prevalent dialysis patients, 2009.)
Figure 11.23 PPPY expenditures for IV iron, by dialysis modality & race, 2009 (see page 392 for analytical methods. Period prevalent dialysis patients, 2009.)
Figure 11.24 PPPY expenditures for IV antibiotics, by dialysis modality & race, 2009 (see page 392 for analytical methods. Period prevalent dialysis patients, 2009.)
Figure 11.25 PPPY expenditures for other injectables, by dialysis modality & race, 2009 (see page 392 for analytical methods. Period prevalent dialysis patients, 2009.)

In 2009, per person per year costs for laboratory tests were greater in both matched (hemodialysis to peritoneal dialysis) and unmatched hemodialysis populations than for patients on peritoneal dialysis. The difference, however, varies by race. In unmatched populations, costs for hemodialysis patients compared to peritoneal patients are 7.3 percent greater for whites, and 6.0 percent greater for African Americans. In matched dialysis populations, costs are 5.1 and 7.4 percent greater, respectively.

Costs for erythropoiesis stimulating agents (ESAs) are higher for hemodialysis patients than for peritoneal dialysis patients, and greater in African Americans than in whites. In unmatched dialysis populations, costs for hemodialysis compared to peritoneal dialysis are 75 and 44 percent greater in whites and African Americans, respectively; costs for the matched hemodialysis patients are 74 and 50 percent higher.

PPPY expenditures for IV vitamin D are 74 percent greater for African Americans than for whites.

Intravenous iron costs in matched hemodialysis patients are 5.0–5.6 times higher than those for peritoneal dialysis patients, and costs for IV antibiotics are highest in patients on peritoneal dialysis, at $14.48 and $18.16 among whites and African Americans, respectively.

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Atlas of ESRD

Chapte Eleven

Costs of ESRD

Medicare Part D Costs

Table 11a Top 25 drugs used in Part D–enrolled ESRD patients, by frequency & net cost, 2008 (see page 392 for analytical methods. Period prevalent ESRD patients enrolled in Part D, 2008.)

This table displays the top 25 Part D prescription drugs used in Part D–enrolled ESRD patients by frequency, as measured in total days supply, and by net cost, a reflection of both frequency of use and cost. In 2008, cardiovascular and gastrointestinal medications, phosphate binders, insulin products, levothyroxine, cinacalcet, prednisone, and pain medications were the predominant drugs used in the ESRD population. Metoprolol, a beta blocker, continues to be the most frequently used drug, reflecting the extensive use of beta blockers for congestive heart failure and atrial fibrillation, and after myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft. Sevelamer HCl is the predominant phosphate binder, and, at $260 million, topped the list in terms of net Part D costs, with cinacalcet coming in at $228 million. Costs for calcium acetate, and lanthanum carbonate each near $50 million.

Sevelamer carbonate represented 5.3 percent of sevelamer use in 2008. Together, costs for sevelamer hydrochloride and carbonate reached $274 million – 18 percent of the $1.54 billion in Part D costs in the ESRD population. Medications typically used in kidney transplant patients also appear on the lists. Prednisone, a generic immunosuppressant, makes the list by frequency, but not cost. The immunosuppressants tacrolimus, mycophenolate mofetil, and valganciclovir (used for prophylaxis against cytomegalovirus) appear on the list by cost, but not by frequency, implying that their costs are relatively higher than the frequency of their use. There were no generic forms of tacrolimus or valganciclovir in 2008, while a generic version of mycophenolate entered the market in the middle of the year.

Figure 11.28 Total Part D net costs, by low income subsidy (LIS) status, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)
Figure 11.29 Per person per year (PPPY) Part D net costs, by LIS status, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)
Figure 11.30 PPPY out–of–pocket Part D costs, by LIS status, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)
Figure 11.31 PPPY Part D net costs for anti–hypertensives, by LIS status, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)
Figure 11.32 PPPY Part D net $ for antihypertensives in dialysis pts, by LIS status & race, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)
Figure 11.33 PPPY Part D net costs for diabetes agents, by LIS status, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)
Figure 11.34 PPPY Part D net costs for diabetes agents in dialysis pts, by LIS status & race, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)
Figure 11.35 PPPY Part D net $ for cinacalcet in dialysis patients, by LIS status & race, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)
Figure 11.36 PPPY Part D net $ for phosphate binders in dialysis pts, by LIS status & race, 2008 (see page 392 for analytical methods. Part D–enrolled general Medicare pts from the 5 percent sample, & period prevalent dialysis – transplant pts with Part D, 2008.)

In 2008, net Part D costs for ESRD patients represented 3 percent of overall Part D expenditures, and were dominated by costs for patients with the low income subsidy (LIS). Per patient per year (PPPY) costs are similar for dialysis and transplant patients, at $6,600 and $2,050 for LIS and non–LIS patients, respectively. Costs for LIS patients are more than three times those of non–LIS patients, and costs for patients with ESRD are twice those incurred in the general Medicare population.

On average, ESRD patients with LIS pay much less out–of–pocket in proportion to their net Part D costs than do general Medicare patients, reflecting the high proportion of ESRD patients with LIS. Non–LIS ESRD patients, in contrast, pay a similar proportion of out–of–pocket costs – about 41 percent – as do general Medicare patients, but much more in absolute amount.

Compared to general Medicare patients, dialysis patients with LIS have higher Part D costs for antihypertensives and diabetes agents; the opposite is true in non–LIS patients. Asian LIS patients have the highest costs by race for antihypertensives and phosphate binders, while costs for diabetes agents and cinacalcet are highest for whites and African Americans, respectively. There is less cost variability in non–LIS patients, though net Part D costs for antihypertensives are almost twice as high for non–LIS patients in the general Medicare population than for their ESRD counterparts.

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Atlas of ESRD

Chapte Twelve

International Comparisons

Prevalence of End–Stage Renal Disease | dialysis

Figure 12.6 Prevalence of ESRD, 2009 (see page 394 for analytical methods.)

Table 12.b Prevalence of ESRD, by year(per million population) (see page 394 for analytical methods.)

Taiwan and Japan continue to report the highest rates of prevalent ESRD, at 2,447 and 2,205 per million population, respectively, in 2009. The next highest rate is reported by the United States, at 1,811, followed by Jalisco (Mexico), and French–speaking and Dutch–speaking Belgium, at 1,314, 1,193, and 1,141, respectively. The lowest rates are reported by Bangladesh and the Philippines, at 140 and 110.

Data presented only for countries from which relevant information was available; "." signifies data not reported. All rates unadjusted. ^UK: England, Wales, & Northern Ireland (Scotland data reported separately). Data for Belgium & England/Wales/Northern Ireland do not include patients younger than 20 & 18, respectively. *Argentina (2005–2007, 2009), Bangladesh, Brazil, Czech Republic (2005–2008), Japan, Luxembourg, & Taiwan are dialysis only. †Latest data for Luxembourg, the Philippines, & Poland are for 2008. Data for France include 13 regions in 2005, 15 regions in 2006, 18 regions in 2007, & 20 regions in 2008 & 2009.

Figure 12.7 Percent distribution of prevalent dialysis patients, by modality, 2009 (see page 394 for analytical methods.)

Table 12.c Percent distribution of prevalent dialysis patients, by modality & year (see page 394 for analytical methods.)

In Hong Kong, four of five prevalent dialysis patients were treated with CAPD/CCPD in 2009. More than half of prevalent dialysis patients in Jalisco (Mexico) and Morelos (Mexico) use this therapy, as do 35 percent of those treated in New Zealand. In–center hemodialysis remains the most common mode of therapy worldwide; in New Zealand and Australia, however, 16.3 and 9.3 percent of patients, respectively, use home hemodialysis.

Data presented only for countries from which relevant information was available; "." signifies data not reported. All rates unadjusted. ^UK: England, Wales, & Northern Ireland (Scotland data reported separately). Data for Belgium & England/Wales/Northern Ireland do not include patients younger than 20 & 18, respectively. *Argentina (2005–2007, 2009), Bangladesh, Brazil, Czech Republic (2005–2008), Japan, Luxembourg & Taiwan are dialysis only. †Latest data for Luxembourg, the Philippines, & Poland are for 2008. Data for France include 13 regions in 2005, 15 regions in 2006, 18 regions in 2007, & 20 regions in 2008 & 2009.

Figure 12.8 Prevalent rates of functioning grafts, 2009 (see page 394 for analytical methods.)

Table 12.d Prevalent rates of functioning grafts, by year (per million population) (see page 394 for analytical methods.)

Reported prevalent rates of functioning grafts are greatest in Norway, the United States, and France, at 591, 562, and 509 per million population in 2009. Countries and regions reporting rates above 400 per million include Scotland, Canada, Jalisco (Mexico), Hong Kong, Finland, Belgium (both French– and Dutch–speaking), Austria, Spain, and Sweden. The Philippines, Morelos (Mexico), Romania, and Russia report rates below 40 per million population.

Data presented only for countries from which relevant information was available; "." signifies data not reported. All rates unadjusted. ^UK: England, Wales, & Northern Ireland (Scotland data reported separately). Data for Belgium & England/Wales/Northern Ireland do not include patients younger than 20 & 18, respectively. †Latest data for the Philippines, & Poland are for 2008. Data for France include 13 regions in 2005, 15 regions in 2006, 18 regions in 2007, & 20 regions in 2008 & 2009.

Figure 12.9 Transplant rates, 2009 (see page 394 for analytical methods.)

Table 12.e Transplant rates, by year (per million population) (see page 394 for analytical methods.)

Canada, Norway, Jalisco (Mexico), the United States, and the Netherlands reported transplant rates of 63.1, 60.5, 58.1, 57.7, and 50.0, respectively, per million population in 2009. Rates are less than 10 per million, in contrast, in Malaysia, the Philippines (2008), Bosnia and Herzegovina, Romania, Russia, Thailand, and Bangladesh.

Data presented only for countries from which relevant information was available; "." signifies data not reported. All rates unadjusted. ^UK: England, Wales, & Northern Ireland (Scotland data reported separately). Data for Belgium & England/Wales/Northern Ireland do not include patients younger than 20 & 18, respectively. †Latest data for the Philippines, Poland, Luxembourg, and the UK are for 2008. Data for France include 13 regions in 2005, 15 regions in 2006, 18 regions in 2007, & 20 regions in 2008 & 2009.

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	Counts	Adjusted Rates
0-4	293	12.5
5-9	154	6.7
10-14	294	13.7
15-19	659	29.0
20-29	2,900	62.4
30-39	6,218	146.0
40-49	12,690	282.6
50-59	22,917	580.9
60-64	14,274	953.2
65-69	14,007	1,275.0
70-79	25,207	1,670.9
80-84	9,963	1,930.7
85+	6,791	1,552.2

0-19	1,400	15.5
20-44	14,300	131.3
45-64	44,699	610.2
65-74	26,998	1,407.0
75+	28,970	1,761.9

Male	65,996	451.5
Female	50,393	281.9

White	76,377	277.2
African American	32,314	976.0
Native American	1,442	522.5
Asian	5,647	402.7

Hispanic	16,240	500.6
Non-Hispanic	100,155	344.9

Diabetes	50,970	154.1
Hypertension	32,688	101.1
Glomerulonephritis	7,612	23.8
Cystic kidney	2,662	8.4
Other urologic	1,590	4.9
Other cause	14,810	46.3
Unknown cause	4,245	13.3
Missing disease	1,818	3.7

All	116,395	355.4

	Counts	Adjusted Rates
0-4	707	30.6
5-9	1,068	46.8
10-14	1,902	90.0
15-19	4,061	177.5
20-29	18,968	409.0
30-39	44,227	1,039.4
40-49	86,752	1,942.5
50-59	133,001	3,341.4
60-64	73,886	4,887.4
65-69	63,955	5,828.8
70-79	94,059	6,296.5
80-84	29,413	5,873.4
85+	19,413	4,472.9

0-19	7,738	86.2
20-44	100,031	924.1
45-64	256,803	3,432.9
65-74	116,607	6,066.0
75+	90,233	5,545.4

Male	323,276	2,140.3
Female	248,127	1,407.5

White	347,268	1,248.7
African American	180,685	5,283.7
Native American	7,682	2,735.5
Asian	30,365	2,101.1

Hispanic	87,866	2,538.5
Non-Hispanic	483,548	1,685.3

Diabetes	215,245	646.8
Hypertension	140,498	429.3
Glomerulonephritis	84,883	262.7
Cystic kidney	27,254	83.4
Other urologic	13,108	40.8
Other cause	62,315	195.4
Unknown cause	21,563	66.0
Missing disease	6,548	13.5

All	571,414	1,737.8

Biochemical values: Albumin Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Albumin g/dl
0-4	3.20
5-9	3.44
10-14	3.43
15-19	3.34
20-29	3.15
30-39	3.13
40-49	3.11
50-59	3.11
60-64	3.14
65-69	3.15
70-79	3.16
80-84	3.15
85+	3.13

0-19	3.35
20-44	3.13
45-64	3.12
65-74	3.16
75+	3.15

Male	3.16
Female	3.11

White	3.16
African American	3.08
Native American	2.87
Asian	3.23

Hispanic	3.07
Non-Hispanic	3.15

Diabetes	3.06
Hypertension	3.24
Glomerulonephritis	3.23
Cystic kidney	3.80
Other urologic	3.23
Other cause	3.01
Unknown cause	3.17

All	3.14
Total N	259193

Biochemical values: Creatinine Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Creatinine mg/dl
0-4	4.19
5-9	5.82
10-14	7.62
15-19	9.30
20-29	9.17
30-39	8.34
40-49	7.51
50-59	6.71
60-64	6.15
65-69	5.91
70-79	5.48
80-84	5.13
85+	4.99

0-19	7.61
20-44	8.28
45-64	6.64
65-74	5.76
75+	5.19

Male	6.76
Female	5.67

White	5.83
African American	7.28
Native American	6.40
Asian	6.63

Hispanic	6.63
Non-Hispanic	6.23

Diabetes	5.81
Hypertension	6.50
Glomerulonephritis	7.57
Cystic kidney	6.72
Other urologic	7.59
Other cause	6.36
Unknown cause	6.89

All	6.28
Total N	334411

Biochemical values: Hematocrit Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Hematocrit %
0-4	30.72
5-9	29.67
10-14	29.55
15-19	28.84
20-29	28.62
30-39	29.29
40-49	29.63
50-59	29.76
60-64	29.88
65-69	30.00
70-79	30.29
80-84	30.54
85+	30.58

0-19	29.44
20-44	29.24
45-64	29.79
65-74	30.11
75+	30.47

Male	30.16
Female	29.70

White	30.35
African American	29.06
Native American	29.67
Asian	30.05

Hispanic	29.59
Non-Hispanic	30.02

Diabetes	29.85
Hypertension	30.07
Glomerulonephritis	30.22
Cystic kidney	32.08
Other urologic	29.68
Other cause	29.72
Unknown cause	29.69

All	29.96
Total N	308308

Biochemical values: Hgb Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Hgb g/dl
0-4	10.24
5-9	9.89
10-14	9.85
15-19	9.61
20-29	9.54
30-39	9.76
40-49	9.88
50-59	9.92
60-64	9.96
65-69	10.00
70-79	10.10
80-84	10.18
85+	10.19

0-19	9.81
20-44	9.75
45-64	9.93
65-74	10.04
75+	10.16

Male	10.05
Female	9.90

White	10.12
African American	9.69
Native American	9.89
Asian	10.02

Hispanic	9.86
Non-Hispanic	10.01

Diabetes	9.95
Hypertension	10.02
Glomerulonephritis	10.07
Cystic kidney	10.69
Other urologic	9.89
Other cause	9.91
Unknown cause	9.90

All	9.99
Total N	308308

Biochemical values: Hgb A1c Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Hgb A1c percent
0-4	5.60
5-9	7.18
10-14	7.72
15-19	6.16
20-29	7.03
30-39	7.58
40-49	7.36
50-59	7.36
60-64	7.25
65-69	7.23
70-79	7.07
80-84	6.86
85+	6.51

0-19	6.49
20-44	7.46
45-64	7.31
65-74	7.20
75+	6.83

Male	7.18
Female	7.21

White	7.09
African American	7.45
Native American	7.32
Asian	7.07

Hispanic	7.14
Non-Hispanic	7.21

Diabetes	7.48
Hypertension	6.78
Glomerulonephritis	6.40
Cystic kidney	6.13
Other urologic	6.67
Other cause	6.68
Unknown cause	6.55

All	7.19
Total N	56876

Biochemical values: Mean hgt. Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Mean hgt. cm
0-4	103.95
5-9	118.71
10-14	147.29
15-19	164.23
20-29	167.81
30-39	169.48
40-49	168.54
50-59	168.91
60-64	167.81
65-69	167.51
70-79	166.85
80-84	165.71
85+	164.87

0-19	146.46
20-44	169.21
45-64	168.66
65-74	167.30
75+	165.91

Male	173.15
Female	160.15

White	167.41
African American	168.58
Native American	166.68
Asian	160.84

Hispanic	162.73
Non-Hispanic	168.24

Diabetes	167.28
Hypertension	167.49
Glomerulonephritis	168.74
Cystic kidney	170.12
Other urologic	168.27
Other cause	166.99
Unknown cause	167.02

All	167.47
Total N	334258

Biochemical values: Mean wt. Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Mean wt. kg
0-4	27.65
5-9	30.12
10-14	45.89
15-19	66.49
20-29	77.83
30-39	85.66
40-49	87.12
50-59	86.90
60-64	85.70
65-69	83.29
70-79	78.32
80-84	72.82
85+	68.56

0-19	50.78
20-44	84.75
45-64	86.51
65-74	81.70
75+	73.43

Male	85.09
Female	76.76

White	81.24
African American	84.02
Native American	83.65
Asian	64.78

Hispanic	75.51
Non-Hispanic	82.42

Diabetes	85.89
Hypertension	77.70
Glomerulonephritis	81.39
Cystic kidney	81.02
Other urologic	74.30
Other cause	76.62
Unknown cause	76.82

All	81.45
Total N	334176

Biochemical values: Tot. Chol. Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Tot. Chol. mg/dl
0-4	186.80
5-9	212.37
10-14	197.12
15-19	180.29
20-29	177.90
30-39	175.86
40-49	171.37
50-59	162.48
60-64	155.74
65-69	150.27
70-79	145.63
80-84	141.10
85+	139.64

0-19	188.86
20-44	175.36
45-64	161.60
65-74	148.73
75+	142.04

Male	148.86
Female	166.27

White	152.19
African American	164.87
Native American	149.81
Asian	162.68

Hispanic	159.63
Non-Hispanic	155.47

Diabetes	154.98
Hypertension	153.36
Glomerulonephritis	175.05
Cystic kidney	160.58
Other urologic	148.79
Other cause	155.95
Unknown cause	152.01

All	156.20
Total N	88350

Biochemical values: LDL Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	LDL mg/dl
0-4	98.14
5-9	121.84
10-14	108.57
15-19	110.45
20-29	105.18
30-39	102.91
40-49	101.01
50-59	94.19
60-64	90.03
65-69	85.60
70-79	82.13
80-84	79.22
85+	81.05

0-19	109.69
20-44	103.13
45-64	93.86
65-74	84.25
75+	80.57

Male	86.34
Female	94.63

White	86.16
African American	97.74
Native American	82.61
Asian	93.47

Hispanic	93.00
Non-Hispanic	89.16

Diabetes	88.75
Hypertension	89.17
Glomerulonephritis	100.77
Cystic kidney	90.13
Other urologic	84.47
Other cause	89.81
Unknown cause	88.01

All	89.83
Total N	83355

Biochemical values: HDL Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	HDL mg/dl
0-4	40.94
5-9	44.66
10-14	41.66
15-19	40.15
20-29	40.06
30-39	39.92
40-49	39.65
50-59	39.27
60-64	39.11
65-69	38.78
70-79	38.93
80-84	39.92
85+	40.84

0-19	41.02
20-44	39.97
45-64	39.24
65-74	38.74
75+	39.80

Male	36.81
Female	42.90

White	37.89
African American	42.57
Native American	40.12
Asian	41.00

Hispanic	38.85
Non-Hispanic	39.47

Diabetes	39.36
Hypertension	39.92
Glomerulonephritis	40.57
Cystic kidney	39.46
Other urologic	37.68
Other cause	37.69
Unknown cause	38.88

All	39.37
Total N	85215

Biochemical values: Triglycer. Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	Triglycer. mg/dl
0-4	236.76
5-9	248.31
10-14	200.67
15-19	175.36
20-29	179.03
30-39	177.26
40-49	175.07
50-59	164.62
60-64	158.03
65-69	151.49
70-79	142.26
80-84	129.66
85+	122.56

0-19	199.87
20-44	177.50
45-64	164.07
65-74	149.03
75+	131.59

Male	150.98
Female	160.96

White	160.88
African American	139.70
Native American	157.81
Asian	165.55

Hispanic	165.28
Non-Hispanic	153.05

Diabetes	155.69
Hypertension	142.47
Glomerulonephritis	176.85
Cystic kidney	162.45
Other urologic	146.97
Other cause	167.50
Unknown cause	149.84

All	155.19
Total N	86701

Biochemical values: BMI Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	BMI kg/m²
0-4	20.97
5-9	18.55
10-14	20.84
15-19	24.46
20-29	27.54
30-39	29.68
40-49	30.21
50-59	30.38
60-64	30.36
65-69	29.64
70-79	28.10
80-84	26.49
85+	25.23

0-19	22.52
20-44	29.46
45-64	30.34
65-74	29.16
75+	26.65

Male	28.26
Female	29.81

White	28.88
African American	29.50
Native American	30.07
Asian	24.96

Hispanic	28.37
Non-Hispanic	29.03

Diabetes	30.60
Hypertension	27.61
Glomerulonephritis	28.40
Cystic kidney	27.87
Other urologic	26.17
Other cause	27.33
Unknown cause	27.40

All	28.94
Total N	330105

Biochemical values: GFR Incident patients with completed Medical Evidence forms; 2007-2009
Biochemical Marker	GFR ml/min/1.73m²
0-4	12.58
5-9	12.98
10-14	13.51
15-19	11.50
20-29	9.25
30-39	9.60
40-49	10.02
50-59	10.60
60-64	10.98
65-69	11.20
70-79	11.76
80-84	12.17
85+	12.41

0-19	12.28
20-44	9.64
45-64	10.64
65-74	11.39
75+	12.12

Male	11.47
Female	10.58

White	11.31
African American	10.79
Native American	10.30
Asian	9.93

Hispanic	10.28
Non-Hispanic	11.21

Diabetes	11.55
Hypertension	10.92
Glomerulonephritis	9.64
Cystic kidney	9.85
Other urologic	9.58
Other cause	11.06
Unknown cause	10.63

All	11.08
Total N	328413

Total patient deaths: ESRD patients period prevalent patients, by age, gender, race, ethnicity, primary diagnosis, & patient vintage
Year	2009
0-4	41
5-9	16
10-14	20
15-19	38
20-29	583
30-39	1,905
40-49	5,675
50-59	13,485
60-64	10,175
65-69	11,551
70-79	25,078
80-84	11,497
85+	10,054

0-19	115
20-44	4,634
45-64	27,189
65-74	23,938
75+	34,242

Male	50,212
Female	39,906

White	60,708
African American	24,799
Native American	1,076
Asian	3,092

Hispanic	10,394
Non-Hispanic	79,724

Diabetes	41,055
Hypertension	25,490
Glomerulonephritis	5,924
Cystic kidney	1,522
Other urologic	1,538
Other cause	10,270
Unknown cause	3,429

All	90,118

Ten-year survival probabilities: incident ESRD patients from day 91 to ten years + 90 days, by age, gender, race, ethnicity, & primary diagnosis
Adjusted	1999
0-19	74.5
20-44	52.5
45-64	25.3
65-74	6.5
75+	1.7

Male	19.8
Female	18.9

White	19.3
African American	18.1
Other race	25.7

Diabetes	13.2
Hypertension	20.8
Glomerulonephritis	30.9
Other cause	24.6

All	19.4

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Atlas of CKD

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Atlas of CKD

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Atlas of CKD

Introduction to Chronic Kidney Disease in the United States

Atlas of CKD

CKD in the General Population | identification & care of CKD patients

Atlas of CKD

Cardiovascular Disease | Prescription Drug Coverage

Atlas of CKD

Chronic Kidney Disease in the General Population

Atlas of CKD

Identification and Care of Patients with Chronic Kidney Disease

Introduction

Atlas of CKD

Identification and Care of Patients with Chronic Kidney Disease

Prevalence of Recognized CKD

Atlas of CKD

Identification and Care of Patients with Chronic Kidney Disease

Laboratory Testing of Patients at Risk for CKD

Atlas of CKD

Identification and Care of Patients with Chronic Kidney Disease

Probability & Odds of a CKD Diagnosis Code

Atlas of CKD

Identification and Care of Patients with Chronic Kidney Disease

Probability & Odds of Seeing a Physician after CKD Diagnosis

Atlas of CKD

Identification and Care of Patients with Chronic Kidney Disease

Prescription Drug Therapy

Atlas of CKD

Morbidity and Mortality in patients with chronic Kidney Disease

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Atlas of CKD

Morbidity and Mortality in patients with chronic Kidney Disease

Hospitalization Rates in CKD & non–CKD Patients

Atlas of CKD

Morbidity and Mortality in patients with chronic Kidney Disease

Mortality Rates

Atlas of CKD

Cardiovascular Disease in Patients with Chronic Kidney Disease

Introduction

Atlas of CKD

Cardiovascular Disease in Patients with Chronic Kidney Disease

Rates of Cardiovascular Disease

Atlas of CKD

Cardiovascular Disease in Patients with Chronic Kidney Disease

Drug Therapy in Patients with Cardiovascular Disease

Atlas of CKD

Presciption Drug Coverage in CKD Patients Medicare Part

Introduction

Atlas of CKD

Presciption Drug Coverage in CKD Patients Medicare Part

Medicare Part D Enrollment Patterns in Patients with CKD

Atlas of CKD

Presciption Drug Coverage in CKD Patients Medicare Part

Medicare Part D coverage plans

Atlas of CKD

Presciption Drug Coverage in CKD Patients Medicare Part