Introduction
This is the twenty-first annual report on the end-stage renal disease (ESRD) program in the United States, and the tenth in our atlas series, which provides an in-depth, graphic presentation of data spanning the last quarter century. Based on data developed for our previous editions of the Annual Data Report (ADR), chronic kidney disease (CKD) has been given a designated scope of work under the most recent USRDS contract. In 2008 we developed an entire volume focused on CKD, providing surveillance data from several sources, including the National Health and Nutrition Examination Survey (NHANES, a random sample survey of the health of the U.S. population), as well as administrative claims data from Medicare and employer group health plans. This year we expand the new volume, addressing, for example, CKD as defined by serum creatinine versus cystatin C measurements, the comorbidity burden in the CKD population, and awareness, treatment, and control of cardiovascular risk factors. Volume Two continues to focus on issues related to ESRD, and on the historical surveillance data that were the basis of the first USRDS reports.
At its inception, the ESRD program was expected to plateau at 40,000 prevalent patients — a number passed more than 20 years ago. ESRD was at first considered a rare disease, as defined by the Orphan Drug Act of 1983 and its subsequent amendments, but that definition also became outdated when the prevalent population exceeded 200,000 — the threshold defined by the act — in 1990. At the end of 2007 the ESRD program was treating 527,283 dialysis and transplant patients — a 4.0 percent increase from 2006.
The numbers of new ESRD cases documented in 2006 and 2007 are remarkably similar, at 111,008 and 111,000, respectively. The population returning to dialysis after a failed kidney transplant dropped 3.2 percent in 2007, to 5,398. Growth in the incident population should be viewed with caution, as it may take several years to determine if these findings will be sustained or are just a one-time observation. 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 the expenditures for that care, and present data on populations with diabetes, cardiovascular disease, CKD, and ESRD. The size of the recognized CKD population has grown since 1997, possibly reflecting the implementation, in May of 2005, of new diagnosis codes that include CKD stage. We look at the pre-ESRD care documented on the new Medical Evidence form, 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 appear to have consistently declined since 2004. Figures on ESRD expenditures show per person and total costs in the program, and compare costs for Medicare and employer group health plan patients during the transition from CKD to ESRD. Total Medicare expenditures for separately billed intravenous medications have been stable since 2004, reflecting changes in payment policies implemented by CMS.
We have reported data related to Healthy People 2010 objectives for a number of years, tracking progress in basic public health goals for the kidney disease population. Several targets are close to being met, including fistula use among relatively new dialysis patients and evaluations of those with diabetes. Cardiovascular death rates are down, and are approaching the target set almost a decade ago. We also present new data for Objective 4.3, on pre-ESRD care, and update our analyses for Objective 4.8, addressing the medical evaluation and treatment given to patients with both CKD and diabetes.
The USRDS recently added a chapter on emerging issues to the ADR in order to address timely issues related to the public health of the ESRD population. This year we continue to focus on the high mortality and morbidity in the first year on hemodialysis. Chapter One addresses cause-specific death and hospitalization rates, and illustrates their considerable impact in the first three months of hemodialysis. Growth in the rates of both infectious hospitalizations and vascular access infections is an area of major concern. We also revisit the issue of trends in the incidence of ESRD due to diabetes, highlighting its linear growth in African American and Native American populations under age 40 — a sharp contrast to the dramatic decline in rates among whites, and a source of public health concern, particularly as rates of obesity and diabetes in these minority populations have been growing over the past decade. Hypertension, diabetes, and the control of cardiovascular risk factors in these populations may be important areas on which to focus.
Incident and prevalent counts are reported in Chapter Two, along with updated projections of ESRD counts to 2020. The projected number of new ESRD patients is slowing compared to past projections, while the prevalent population is on target — most likely a result of lower death rates in those with ESRD. In this chapter we also look again at rates of ESRD in major metropolitan areas, which have been a concern for many years. Interestingly, the highest incidence of ESRD is reported in Denver, Colorado for both whites and African Americans. Rates of prevalent ESRD are also highest in Denver for these two populations, and in St. Louis, Missouri, for Hispanics. These findings may help direct public health programs in high-burden areas of the country.
In Chapter Three we present information from added data fields on the newly revised Medical Evidence form (2728), introduced in the spring of 2005. Information on vascular access, for example, shows the high rate of catheter use, with 82 percent of incident patients using a catheter at the first outpatient dialysis treatment. This high rate may contribute to greater mortality in the first year on dialysis, an area discussed in Chapters One and Six. Data on anemia treatment prior to initiation of ESRD therapy show that fewer patients are now being treated with erythropoiesis stimulating agents (ESAs), but this may reflect a change in the related question on the Medical Evidence form, which now specifically asks about ESA use prior to the first ESRD service date (rather than prior to a single dialysis treatment). Safety concerns raised by recent clinical trials may also have led providers to withhold therapy until patients have lower hemoglobin levels. The chapter concludes with information on laboratory values at the initiation of therapy, including total cholesterol, triglycerides, and glycosylated hemoglobin levels.
Chapter Four illustrates trends in modality use. Peritoneal dialysis is now used by just 6 percent of incident dialysis patients, down from 15 percent in the mid-1990s. The prevalent population on peritoneal dialysis remains steady, at a range of 12–13 percent between 2003 and 2007. New guidelines on peritoneal dialysis treatment, along with the emergence of daily home hemodialysis as a new modality, may change perceptions about the use of home therapies. The chapter also shows that insurance coverage in the ESRD populations appears to be changing, with a larger percentage of patients covered by Medicare Advantage. This may reflect new adjustments to the payment rates, with the inclusion of more chronic disease adjusters. The percentage of patients with dual Medicare/Medicaid coverage is growing in the prevalent hemodialysis population, possibly reflecting the continued high economic impact of ESRD on patient finances. The impact of Medicare Part D prescription drug coverage will be assessed in future ADRs when data become available.
Chapter Five, 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 show, for instance, that while influenza vaccination rates have increased, they have been under 60 percent for the last five years, despite a target of 90 percent. We also look at the marked differences in vascular access complication rates associated with the use of fistulas, catheters, and grafts.
Mortality data in Chapter Six show continued gains across most time periods in both the incident and prevalent populations. Even first-year mortality rates declined in the 2004–2007 cohorts, a new finding compared to the last decade. Infectious hospitalization rates among the prevalent hemodialysis population, which had been on the rise over the last decade, finally appear to be declining, an important change given the concern over high rates in the first months of dialysis. New data in this chapter address strokes in the prevalent and incident dialysis populations, and the impact of strokes on walking disability and subsequent mortality.
As we illustrate in Chapter Seven, the number of kidney transplants from living donors has continued to fall from its peak in 2004, while the number of transplants from deceased donors in 2007 remained stable. Waiting times continue to grow, due to the continued shortage of donated kidneys. Patterns of immunosuppressive drug use show marked changes since the mid-1990s, with MMF and tacrolimus now the most common combination. And death with a functioning graft is an area of concern, with cardiovascular disease accounting for 30 percent of these deaths once unknown cause of death is removed. We also present data on causes of hospitalization related to cardiovascular disease and infection.
In Chapter Eight, on the pediatric ESRD population, we lead with data on patient growth, based on reported height and weight measurements submitted by dialysis units for composite rate payment adjustments (begun in 2005). The growth of children receiving hemodialysis is considerably behind that of the normal pediatric population. We next present data on access to pre-ESRD care, including visits to a nephrologist, dietary counseling, and information on transplant options, as reported on the Medicare Evidence form. Data on vascular access use at the initiation of dialysis show that the use of catheters is high, and is associated with high rates of infectious events. We also present data on trends in hospitalizations and mortality during the first year of therapy.
In this year’s Chapter Nine, each Special Studies Center (SSC) addresses aspects of care related to its target areas. The Cardiovascular Special Studies Center presents data on event rates, survival, physician care, and costs related to cardiovascular disease and in its associated interventions. The Rehabilitation/Quality of Life SSC presents preliminary data on the Comprehensive Dialysis Study (CDS) of incident dialysis patients, addressing employment and disability. And the Nutrition SSC examines the intersection of physical activity, nutritional status, and inflammation, also using data from the CDS.
Over the past twenty years the landscape of dialysis providers has altered dramatically, with the consolidation of smaller providers into large dialysis chains. In 2005 and 2006 it changed even further, with the acquisition of Renal Care Group by Fresenius Medical Care, and the purchase of Gambro Healthcare by DaVita. These transitions create new challenges for the USRDS in assessing care. In Chapter Ten this year we again provide data on the duration of unit ownership among both the consolidated and remaining providers. We also address iron dosing practices and transfusion use, assess provider-specific billing for tests beyond those reimbursed in the composite rate (including calcium/phosphorus and complete blood counts), and provide data on per person per month costs for intervention and preventive care. Mortality and hospitalization comparisons have been presented in the ADR for many years; this year we continue to provide data on regional comparisons of large and small dialysis organizations as well as those that are hospital-based.
Chapter Eleven, on expenditures related to ESRD, begins with data on the overall costs of the Medicare ESRD program. We again present information on costs during the transition from CKD to ESRD in the Medicare and employer group health populations, and illustrate expenditures for clinical services, injectables, preventive care, and vascular access.
In Chapter Twelve we summarize data from the international community, illustrating differences in incidence, prevalence, diabetic ESRD, dialysis, and transplantation. We are again grateful to the registries which provide this information, allowing us to see the U.S. ESRD community through a wider lens.
Overall, surveillance data show improvements in survival in both the incident and prevalent ESRD populations. The provision of care has improved, with an increase in cardiovascular services and diabetic preventive care, though in areas such as vaccination rates there is still much progress to be made.
Mortality and morbidity among hemodialysis patients in the first year of ESRD therapy — particularly the increasing rate of hospitalizations due to infections — continue to be major concerns. Placement rates for dialysis catheters are down, but this may reflect the use of cuffed catheters, which remain in place longer and thus continue to expose patients to the risk of infection. The percentage of patients with hemoglobin levels above 13 g/dl has fallen since 2006, but levels in the incident population frequently exceed 12. And the continued, disappointing lack of progress in pediatric patient survival needs to be addressed. The USRDS will continue to investigate and report on patterns of care and associated morbidity and mortality, identifying areas for improvement in the care of patients with ESRD.
Most of the 2009 ADR contains data through December 31, 2007; data on patient characteristics, obtained from the Medical Evidence form, are complete through June, 2008.