Marc N. Turenne

Analysis of the Association of Dialyzer Reuse Practices and Patient Outcomes

This historic prospective study assessed the relationship between dialyzer reuse practices and hemodialysis patient mortality through 1 year of follow-up. Medicare patient demographic and survival data were combined with dialyzer reuse data from the Centers for Disease Control and Preventions annual survey of dialysis-related diseases. Data were analyzed for the US Medicare hemodialysis population of never transplanted patients prevalent on January 1, 1989, and January 1, 1990, who were treated in freestanding dialysis units that used primarily conventional (not high-flux) dialyzers. Time to mortality, or transplant, and other censoring on December 31st of each year was regressed with proportional hazards models on patient, dialysis unit, and reuse measures. Age-, race-, and diagnosis-standardized mortality ratios for dialysis units were also regressed with weighted least squares techniques against dialysis unit and reuse measures. The results showed that patients treated in dialysis units that disinfected dialyzers with a peracetic acid, hydrogen peroxide, acetic acid mixture, or glutaraldehyde experienced higher mortality than patients treated in units that used formalin or in units that did not reuse dialyzers. The relative risk of mortality, compared with patients treated in nonreuse dialysis units, was 1.17 (P = 0.010) for glutaraldehyde and 1.13 (P < 0.001) for the peracetic acid mixture. The relative risk for formalin compared with the reference group of nonreuse was 1.06 (P = 0.088). With adjustment for several patient and dialysis unit characteristics, dialyzer reuse with certain germicides was associated with a significantly elevated mortality risk. This elevated risk, the etiology of which is currently not known, may represent a large number of potentially avoidable deaths per year. Only a large, nationally based analysis of this type has sufficient sample size to detect mortality risks such as these.

Chronic Illness, Treatment Choice and Workforce Participation

Choices with respect to labor force participation and medical treatment are increasingly intertwined. Technological advances present patients with new choices and may facilitate continued employment for the growing number of chronically ill individuals. We examine joint work/treatment decisions of end stage renal disease patients, a group for whom these tradeoffs are particularly salient. Using a simultaneous equations probit model, we find that treatment choice is a significant predictor of employment status. However, the effect size is considerably smaller than in models that do not consider the joint nature of these choices.

Growth rates in pediatric dialysis patients and renal transplant recipients.

We compared growth rates by modality over a 6- to 14-month period in 1,302 US pediatric end-stage renal disese (ESRD) patients treated during 1990. Modality comparisons were adjusted for age, sex, race, ethnicity, and ESRD duration using linear regression models by age group (0.5 to 4 years, 5 to 9 years, 10 to 14 years, and 15 to 18 years). Growth rates were higher in young children receiving a transplant compared with those receiving dialysis (ages 0.5 to 4 years, delta = 3.1 cm/yr v continuous cycling peritoneal dialysis [CCPD], P < 0.01; ages 5 to 9 years, delta = 2.0 to 2.6 cm/yr v CCPD, chronic ambulatory peritoneal dialysis (CAPD), and hemodialysis, P < 0.01). In contrast, growth rates in older children were not statistically different when comparing transplantation with each dialysis modality. For most age groups of transplant recipients, we observed faster growth with alternate-day versus daily steroids that was not fully explained by differences in allograft function. Younger patients (<15 years) grew at comparable rates with each dialysis modality, while older CAPD patients grew faster compared with hemodialysis or CCPD patients (P < 0.02). There was no substantial pubertal growth spurt in transplant or dialysis patients. This national US study of pediatric growth rates with dialysis and transplantation shows differences in growth by modality that vary by age group.

Hemodialysis Therapy in the United States: What Is the Dose and Does It Matter?

There is an ongoing discussion in the renal community about how to monitor the treatment of hemodialysis patients in the United States. Comparison of the US patient experience to that of other countries with populations of similar health status is one way to assess treatment. Another technique involves examining the level of dialysis therapy US patients receive. This paper reviews recent studies which found that the United States has higher mortality than both Japan and Europe and provides additional information as to why those comparisons might be underestimating the mortality differences. We also examine the data on the level of dialysis US patients receive, both as a prescription and as delivered care. We conclude that US patients receive less hemodialysis therapy than their European and Japanese counterparts, and that in general US patients are not receiving the level of dialysis they were prescribed. These factors are correlated with an increased mortality among US hemodialysis patients.

The initial impact of Medicare's new prospective payment system for kidney dialysis

BACKGROUND Medicare implemented a new prospective payment system (PPS) on January 1, 2011. This PPS covers an expanded bundle of services, including services previously paid on a fee-for-service basis. The objectives of the new PPS include more efficient decisions about treatment service combinations and modality choice. METHODS Primary data for this study are Medicare claims files for all dialysis patients for whom Medicare is the primary payer. We compare use of key injectable medications under the bundled PPS to use when those drugs were separately billable and examine variability across providers. We also compare each patients dialysis modality before and after the PPS. RESULTS Use of relatively expensive drugs, including erythropoiesis-stimulating agents, declined substantially after institution of the new PPS, whereas use of iron products, often therapeutic substitutes for erythropoiesis-stimulating agents, increased. Less expensive vitamin D products were substituted for more expensive types. Drug spending overall decreased by ∼

The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor: Rationale and Methods for an Initiative to Monitor the New US Bundled Dialysis Payment System

25 per session, or about 5 times the mandated reduction in the base payment rate of ∼

Using Knowledge of Multiple Levels of Variation in Care to Target Performance Incentives to Providers

5. Use of peritoneal dialysis increased in 2011 after being nearly flat in the years prior to the PPS, with the increase concentrated in patients in their first or second year of dialysis. Home hemodialysis continued to increase as a percentage of total dialysis services, but at a rate similar to the pre-PPS trend. CONCLUSION The expanded bundle dialysis PPS provided incentives for the use of lower cost therapies. These incentives seem to have motivated dialysis providers to move toward lower cost methods of care in both their use of drugs and choice of modalities.

Has Dialysis Payment Reform Led to Initial Racial Disparities in Anemia and Mineral Metabolism Management

A new initiative of the US Dialysis Outcomes and Practice Patterns Study (DOPPS), the DOPPS Practice Monitor (DPM), provides up-to-date data and analyses to monitor trends in dialysis practice during implementation of the new Centers for Medicare & Medicaid Services (CMS) end-stage renal disease Prospective Payment System (PPS; 2011-2014). We review DPM rationale, design, sampling approach, analytic methods, and facility sample characteristics. Using stratified random sampling, the sample of ~145 US facilities provides results representative nationally and by facility type (dialysis organization size, rural/urban, free standing/hospital based), achieving coverage similar to the CMS sample frame at average values and tails of the distributions for key measures and patient characteristics. A publicly available web report (www.dopps.org/DPM) provides detailed trends, including demographic, comorbidity, and dialysis data; medications; vascular access; and quality of life. Findings are updated every 4 months with a lag of only 3-4 months. Baseline data are from mid-2010, before the new PPS. In sum, the DPM provides timely representative data to monitor effects of the expanded PPS on dialysis practice. Findings can serve as an early warning system for possible adverse effects on clinical care and as a basis for community outreach, editorial comment, and informed advocacy.

Blood Transfusion Practices in Dialysis Patients in a Dynamic Regulatory Environment

Background:In developing “pay-for-performance” and capitation systems that provide incentives for improving the quality and efficiency of care, policymakers need to determine which healthcare providers to evaluate and reward. Objectives:This study demonstrates methods for determining and understanding the relative contributions of facilities and physicians to the quality and cost of care. Specifically, this study distinguishes levels of variation in resource utilization (RU), based on research to support the development of an expanded Medicare dialysis prospective payment system. Research Design:Mixed models were used to estimate the variation in RU across institutional providers, physicians, patients, and months (within patients), after adjusting for case-mix. Subjects:The study includes 10,367 Medicare hemodialysis patients treated in a 4.2% stratified random sample of dialysis facilities in 2003. Measures:Monthly RU was measured by the average Medicare allowable charge per dialysis session for separately billable dialysis-related services (mainly injectable medications and laboratory tests) from Medicare claims. Results:There was financially significant variation in RU across institutional providers and to a lesser degree across physicians, after adjusting for differences in case-mix. The remaining variation in RU reflects unexplained differences across patients that persist over time and transitory fluctuations for individual patients. Conclusions:The greater variation in RU occurring across dialysis facilities than across physicians is consistent with targeting payments to facilities, but alignment of incentives between facilities and physicians remains an important goal. Similar analytic methods may be useful in designing payment policies that reward providers for improving the quality of care.

Using Race as a Case-Mix Adjustment Factor in a Renal Dialysis Payment System: Potential and Pitfalls

Implementation of the Medicare ESRD prospective payment system (PPS) and changes to dosing guidelines for erythropoiesis-stimulating agents (ESAs) in 2011 appear to have influenced use of injectable medications among dialysis patients. Given historically higher ESA and vitamin D use among black patients, we assessed the effect of these policy changes on racial disparities in the management of anemia and mineral metabolism. Analyses used cross-sectional monthly cohorts for a period-prevalent sample of 7384 maintenance hemodialysis patients at 132 facilities from the Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor. Linear splines with knots at each policy change were used in survey-weighted regressions to estimate time trends in hemoglobin (Hgb), erythropoietin (EPO) dose, intravenous (IV) iron dose, ferritin, transferrin saturation (TSAT) concentration, parathyroid hormone (PTH), IV vitamin D dose, cinacalcet use, and phosphate binder use. From August 2010 to December 2011, mean Hgb declined from 11.5 to 11.0 g/dl (P<0.001), mean EPO dose declined from 20,506 to 14,777 U/wk (P<0.001), and mean serum PTH increased from 340 to 435 pg/ml (P<0.001). No meaningful differences by race were observed regarding the rates of change of management practices or laboratory measures (all P>0.21). Mean EPO and vitamin D dose and serum PTH levels remained higher in blacks. Despite evidence that anemia and mineral metabolism management practices have changed significantly over time, there was no immediate indication of racial disparities resulting from implementation of the PPS or ESA label change. Further studies are needed to examine effects among patient and facility subgroups.