Agreement of reported vascular access on the medical evidence report and on medicare claims at hemodialysis initiation.

BACKGROUND: The choice of vascular access type is an important aspect of care for incident hemodialysis patients. However, data from the Centers for Medicare & Medicaid Services (CMS) Medical Evidence Report (form CMS-2728) identifying the first access for incident patients have not previously been validated. Medicare began requiring that vascular access type be reported on claims in July 2010. We aimed to determine the agreement between the reported vascular access at initiation from form CMS-2728 and from Medicare claims. METHODS: This retrospective study used a cohort of 9777 patients who initiated dialysis in the latter half of 2010 and were eligible for Medicare at the start of renal replacement therapy to compare the vascular access type reported on form CMS-2728 with the type reported on Medicare outpatient dialysis claims for the same patients. For each patient, the reported access from each data source was compiled; the percent agreement represented the percent of patients for whom the access was the same. Multivariate logistic analysis was performed to identify characteristics associated with the agreement of reported access. RESULTS: The two data sources agreed for 94% of patients, with a Kappa statistic of 0.83, indicating an excellent level of agreement. Further, we found no evidence to suggest that agreement was associated with the patient characteristics of age, sex, race, or primary cause of renal failure. CONCLUSION: These results suggest that vascular access data as reported on form CMS-2728 are valid and reliable for use in research studies.

Hemoglobin level variability: anemia management among variability groups.

BACKGROUND/AIMS: Hemoglobin level variability in hemodialysis patients is common, and has been associated with comorbidity, intercurrent illness, and mortality risk. We aimed to describe the influence of anemia management interventions (erythropoiesis-stimulating agents [ESAs], intravenous iron, and transfusions) on hemoglobin variability. METHODS: We studied all Medicare primary payer hemodialysis patients who survived and had ESA claims in the first 6 months of 2004 (n = 159,720). Monthly hemoglobin values were categorized as low (<11 g/dl), intermediate (11-12.5 g/dl), and high (>12.5 g/dl). Variability groups were classified based on lowest and highest hemoglobin categories during a 6-month observation period. ESA, intravenous iron, and transfusion use were characterized by variability group. RESULTS: Patients with consistently low or low and intermediate hemoglobin received the highest ESA doses and the most frequent transfusions, while patients with consistently or intermittently intermediate or high hemoglobin received lower ESA doses and fewer transfusions. Intravenous iron doses were highest initially for patients with consistently high hemoglobin; these doses subsequently declined. Iron doses were lowest for patients with consistently intermediate hemoglobin. CONCLUSIONS: Anemia management protocols describing coordinated administration of ESAs and iron may help to increase the number of patients achieving target hemoglobin levels.

EPO adjustments in patients with elevated hemoglobin levels: provider practice patterns compared with recommended practice guidelines.

BACKGROUND: This study investigates provider practices regarding recombinant human erythropoietin (rHuEPO) dose when patient hemoglobin levels exceeded National Kidney Foundation-Dialysis Outcomes Quality Initiative target levels and reached 13 g/dL or greater (>or=130 g/L). METHODS: The study population (N = 167,796) was hemodialysis patients prevalent on January 1, 2003, who were on renal replacement therapy at least 90 days with Medicare as primary payer and rHuEPO claims in 2 or more consecutive months. Patient characteristics were obtained from the Centers for Medicare & Medicaid Services (CMS) Medical Evidence Report, and comorbid conditions were determined from Medicare claims. Providers and rHuEPO claims were linked by using CMS-assigned provider numbers and the CMS Annual End-Stage Renal Disease Facility Survey. Between-provider differences in patient characteristics were examined by using chi-square test, and provider effect on appropriate response, by using logistic regression. RESULTS: DaVita's percentage of monthly claims for patients with hemoglobin levels of 13 g/dL or greater (>or=130 g/L; 16.7%) and mean monthly rHuEPO dose (54,299 units) were highest. Dialysis Clinic Inc's percentage of such claims (2.0%) and mean monthly dose (38,687 units) were lowest. Dialysis Clinic Inc, Fresenius, and Renal Care Group had the highest percentage of recommended dose adjustments (mean, 70% of units); hospital-based units had the lowest (59%). By adjusted odds ratio, adjustments were 20% more likely for Dialysis Clinic Inc, Fresenius, and Renal Care Group compared with DaVita, National Nephrology Associates, hospital-based units, and independents (17% to 28% less likely). CONCLUSION: rHuEPO dose reduction practices are dependent on specific dialysis providers and whether units are hospital based or independent.

Reuse-associated mortality in incident hemodialysis patients in the United States, 2000 to 2001.

BACKGROUND: The impact of dialyzer reuse on the mortality of hemodialysis patients is debated. This study assesses reuse-associated mortality across US dialysis provider systems (for-profit, not-for-profit; hospital-based, and freestanding units) in incident patients. METHODS: Incident Medicare hemodialysis patients who initiated dialysis therapy from January 1, 2000, to December 31, 2001, were included and followed up to December 31, 2002. A 3-month entry period was used to determine comorbidity and disease severity. Applying various analytic approaches, mortality rates for patients treated with reused (or reprocessed) or single-use dialyzers were compared. Because of differences among dialysis units, facility clustering was addressed. RESULTS: Of 75,831 patients, 61,391 patients (81.0%) were classified as on reuse, and 14,440 patients (19.0%), as on single use, as of the start of follow-up. The overall mortality rate was 25.0/100 patient-years. No difference in mortality risk was found between patients treated with reuse compared with single use in an intent-to-treat approach (hazard ratio, 0.98; 95% confidence interval, 0.94 to 1.02; P = 0.266) after adjusting for chain affiliation, for-profit status, year of dialysis inception, age, sex, race, renal diagnosis, comorbidity, and hospitalization days. Findings were similar in an as-treated approach (hazard ratio, 0.97; 95% confidence interval, 0.93 to 1.01; P = 0.136). No survival advantage associated with single use was found for subgroups. CONCLUSION: No overall survival advantage or disadvantage is associated with dialyzer reuse compared with single use in incident hemodialysis patients in the United States; however, continued monitoring is advised.

The association of initial hemodialysis access type with mortality outcomes in elderly Medicare ESRD patients.

BACKGROUND: Dialysis access is critical for therapy delivery. Few studies have linked type of dialysis access to patient survival in the elderly population. METHODS: We included 1995 to 1997 incidence Medicare hemodialysis patients (N = 66,595) who were 67 years and older at dialysis therapy initiation. Medicare Physician/Supplier claims were used to determine initial access type: simple fistula, autologous vein graft, synthetic graft, and hemodialysis catheter. We used International Classification of Diseases, Ninth Revision, Clinical Modification, codes to determine vascular access placement for renal failure. A Cox regression analysis assessed risk for death within 1 year, with explanatory variables of incidence year, age, sex, race, diabetes, initial access type, body mass index, days from first access placement date to initial dialysis date, and serum albumin, creatinine, and blood urea nitrogen levels. RESULTS: One-year crude death rates were 24.9%, 27.2%, 28.1%, and 41.5% for patients with simple fistulae, autologous vein grafts, synthetic grafts, and hemodialysis catheters, respectively. Patients with simple fistulae (the reference) had the lowest (P < 0.0001) likelihood of death compared with those with synthetic grafts (hazard ratio [HR], 1.160; 95% confidence interval [CI], 1.084 to 1.241) or catheters (HR, 1.696; 95% CI, 1.593 to 1.806). No difference (P > 0.09) in mortality risk was detected between simple fistulae and autologous vein grafts or between autologous vein grafts and synthetic grafts. CONCLUSION: In the US Medicare dialysis population, type of initial hemodialysis access was associated with 1-year mortality. Mortality risks were (in ascending order) fistulae, grafts, and catheters.

Anemia treatment in the pre-ESRD period and associated mortality in elderly patients.

BACKGROUND: Anemia is a common complication of advancing chronic kidney disease, yet little is known about the consistency of anemia treatment before end-stage renal disease (ESRD) and mortality on dialysis therapy. METHODS: We studied 89,193 incident Medicare patients with ESRD in 1995 to 1997 aged 67 plus years with claims 2 years before their dialysis therapy initiation. Patients were classified as follows: no epoetin, 25% or less (least consistent), greater than 25% to 50%, greater than 50% to 75%, and greater than 75% (most consistent) epoetin treatment in the available months from the first pre-ESRD epoetin dose to the first ESRD service date. Cox regression modeled the risk for 1-year death in the post-ESRD period, adjusting for age, sex, race, diabetic status, albumin level, and incidence year. RESULTS: Sixty percent of patients had hematocrits less than 30% at ESRD initiation, yet only 15.6% (N = 13,877) had epoetin claims before ESRD. The most consistent epoetin treatment group had hematocrits increase from 27.5% to 30.8% (P < 0.0001) by month 4 of treatment. Patients with the most consistent epoetin treatment had a greater mean hematocrit (29.2% +/- 0.11%; P < 0.0001) and albumin level (3.31 +/- 0.01 g/dL [33.1 g/L]) at initiation than those with the least consistent treatment (28.1% +/- 0.10% and 3.21 +/- 0.01 g/dL [32.1 g/L], respectively). The relative risk for death in patients with the least consistent versus the most consistent (the reference) epoetin treatment was 1.460 (95% CI, 1.245 to 1.713; P < 0.0001) 1 year after the first ESRD service date. CONCLUSION: Elderly patients with consistent pre-ESRD epoetin treatment had lower risks for death in the first year of dialysis therapy after ESRD initiation.

Hemoglobin level variability: associations with mortality.

BACKGROUND/OBJECTIVES: Awareness of hemoglobin level variability in dialysis patients is increasing, as is interest in its potential implications. In this retrospective, national study of associations between the degree of hemoglobin level variability in the first 6 mo of 2004 and subsequent mortality rates in the following 6 mo, 159,720 hemodialysis patients receiving epoetin therapy were studied. DESIGN, SETTING, PARTICIPANTS, MEASUREMENTS: Monthly hemoglobin values were categorized as low (L; < 11 g/dl), intermediate (I; 11 to 12.5 g/dl), and high (H; >12.5 g/dl). Variability groups were classified on the basis of the lowest and highest hemoglobin categories seen during the 6-mo observation period: low-low (L-L), 1.4%; intermediate-intermediate (I-I), 6.0%; high-high (H-H), 2.3%; low-intermediate (L-I), 18.3%; intermediate-high (I-H), 31.7%, and low-high (L-H), 40.2%. RESULTS: On multivariate analysis, adjusted hazards ratios for subsequent mortality events were as follows: I-I, 1.0 (reference category); I-H, 1.02 (95% confidence interval [CI] 0.95 to 1.11); H-H, 1.06 (95% CI 0.93 to 1.21); L-H, 1.19 (95% CI 1.10 to 1.28); L-I, 1.44 (95% CI 1.33 to 1.56), and L-L, 2.18 (95% CI 1.93 to 2.45). Persistently and transiently low hemoglobin levels and highly variable hemoglobin levels were associated with increased risk of death; transiently and persistently high hemoglobin levels were not associated with increased risk of death. Bayesian modeling indicated that > or =3 mo with hemoglobin levels <11 g/dl may be associated with of increased risk of death. CONCLUSIONS: Number of months with hemoglobin values below the target range, rather than hemoglobin variability itself, may be the primary driver of increased risk of death. Further research is needed to distinguish cause from effect and to understand the underlying mechanisms.

Hemoglobin level variability: associations with comorbidity, intercurrent events, and hospitalizations.

National payment policies target a hemoglobin range of 11 to 12.5 g/dl for patients with ESRD. However, clinical complications and provider practices may contribute to wide fluctuations over time. This study evaluated the frequency with which patients maintain stable hemoglobin levels below, within, and above the Centers for Medicare & Medicaid Services target range and assessed patterns of hemoglobin level change that resulted in large fluctuations across the target range during a 6-mo period. All hemodialysis patients who survived the first 6 mo of 2003, had Medicare as primary payer, and had Medicare outpatient erythropoietin claims in each of the first 6 mo of 2003 (n = 152,846) were studied. Six patient groups were defined on the basis of patterns of hemoglobin level fluctuation: Consistently low (<11 g/dl), consistently target range (11 to 12.5 g/dl), consistently high (> or =12.5 g/dl), low-amplitude fluctuation with low hemoglobin levels, low-amplitude fluctuation with high hemoglobin levels, and high-amplitude fluctuation. Only 10.3% of patients maintained stable hemoglobin levels during the 6 mo and only 6.5% in the target range. The consistently low group had the highest percentage of hospitalizations and the highest number of comorbid conditions. High-amplitude fluctuation was the most common pattern (39.5%), with hemoglobin levels falling below and rising above the target range during the 6-mo period. Hemoglobin levels in almost 90% of patients are in some degree of flux at any point in time, and the fluctuation is highly associated with clinical complications and provider practices.

Projecting the number of patients with end-stage renal disease in the United States to the year 2015.

The size of the prevalent ESRD population in the United States increased dramatically during the 1990s, from 196,000 in 1991 to 382,000 in 2000. Incidence also increased considerably during the same period, from 53,000 to 93,000 per year. If previous trends in ESRD incidence and prevalence continue, then current levels of health care resources that are devoted to the care of these patients will eventually be unable to meet the demand. This study discusses a Markov model developed to predict ESRD incidence, prevalence, and mortality to the year 2015 and incorporating expected changes in age/race distributions, diabetes prevalence, ESRD incidence, and probability of death. The model predicted that by 2015 there will be 136,166 incident ESRD patients per year (lower/upper limits 110,989 to 164,550), 712,290 prevalent patients (595,046 to 842,761), and 107,760 ESRD deaths annually (96,068 to 118,220). Incidence and prevalence counts are expected to increase by 44 and 85%, respectively, from 2000 to 2015 and incidence and prevalence rates per million population by 32 and 70%, respectively. The financial and human resources that will be needed to care for these patients in 2015 will be considerably greater than in 2005.

Dialyser reuse-associated mortality and hospitalization risk in incident Medicare haemodialysis patients, 1998-1999.

BACKGROUND: The reuse of haemodialysers has been practiced in the United States for >20 years. We investigated mortality and hospitalization risk according to various reuse practices, testing the hypothesis that outcomes are improved in patients treated with dialysers cleaned with bleach and sterilized with formaldehyde. METHODS: We studied 1998 and 1999 incident Medicare haemodialysis patients, with follow-up through December 31, 2000 (49 273 patients). Clinical conditions and dialysis therapy were characterized from Medicare claims data. Included were patients who could be linked to a dialysis provider. Demographic characteristics were obtained from the Centers for Medicare and Medicaid Services (CMS) Medical Evidence Report. Mortality information was obtained from the CMS ESRD Death Notification; hospitalization information, from Medicare in-patient claims files. Data on reuse practices were obtained from the annual survey of haemodialysis units conducted by the Centers for Disease Control and Prevention. RESULTS: Cox regression analyses found no significant differences in mortality or first-hospitalization risk for patients in dialysis units not using bleach as a cleaning agent. Outcomes for patients treated in units using glutaraldehyde did not vary according to use of bleach. In the analysis of first-hospitalization risk, there was no difference according to various germicide/bleach combinations. Overall, there was no significant difference in relative risk of death or in hospitalization risk among the reuse groups (including the no-reuse group). CONCLUSIONS: For the 1998-1999 period, reuse practices were not associated with a survival advantage or disadvantage. Our findings may reflect the National Kidney Foundation's 1997 introduction of clinical practice guidelines, the intent of which was to bring about increased consistency of care within the dialysis community in the United States.