Sources of drug coverage among Medicare beneficiaries with ESRD.

Despite extensive use of prescription medications in ESRD, relatively little is known about the participation of Medicare ESRD beneficiaries in the Part D program. Here, we quantitated the sources of drug coverage among ESRD beneficiaries and explored the Part D plan preferences of ESRD beneficiaries with regard to deductibles, coverage gaps, and monthly premiums. We obtained data on beneficiary sources of creditable coverage, characteristics of Part D plans, demographics, and residence from the Centers for Medicare and Medicaid Chronic Condition Data Warehouse and identified beneficiaries with ESRD from the US Renal Data System. We found that a substantial proportion (17.0%) of ESRD beneficiaries lacked a known source of creditable drug coverage in 2007 and 64.3% were enrolled in Part D. Of those enrolled, 72% received the Medicare Part D low-income subsidy. ESRD beneficiaries who enrolled in standalone Part D plans without the assistance of the low-income subsidy tended to prefer more comprehensive coverage options. In conclusion, more outreach is needed to ensure that beneficiaries who lack coverage obtain the coverage they need and that ESRD beneficiaries join the best plans for managing their disease and accompanying comorbid conditions.

Utilization and costs of cardiovascular disease medications in dialysis patients in Medicare Part D.

BACKGROUND: Cardiovascular disease (CVD) is a major source of mortality and morbidity in dialysis patients. Population-level descriptions of CVD medication use are lacking in this population. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Adult dialysis patients in the United States, alive on December 31, 2006, with Medicare Parts A and B and enrollment in Medicare Part D continuously in 2007. PREDICTOR: CVDs and demographic characteristics. OUTCOME: ≥1 prescription fill during follow-up (2007). MEASUREMENTS: Average out-of-pocket costs per user per month and average total drug costs per member per month were calculated. RESULTS: Of 225,635 dialysis patients who met inclusion criteria during the entry period, 70% (n = 158,702) had continuous Part D coverage during follow-up. Of these, 76% received the low-income subsidy. ß-Blockers were the most commonly used CVD medication (64%), followed by renin-angiotensin system inhibitors (52%), calcium channel blockers (51%), lipid-lowering agents (44%), and α-agonists (23%). Use varied by demographics, geographic region, and low-income subsidy status. For CVD medications, mean out-of-pocket costs per user per month were $3.44 and $49.59 and mean total costs per member per month were $124.02 and $110.32 for patients with and without the low-income subsidy, respectively. LIMITATIONS: Information was available for only filled prescriptions under the Part D benefit; information for clinical contraindications was lacking, information for over-the-counter medications was unavailable, and medication adherence and persistence were not examined. CONCLUSIONS: Most Medicare dialysis patients in 2007 were enrolled in Part D, and most enrollees received the low-income subsidy. ß-Blockers were the most used CVD medication. Total costs of CVD medications were modestly higher for low-income subsidy patients, but out-of-pocket costs were much higher for patients not receiving the subsidy. Further study is warranted to delineate sources of variation in the use and costs of CVD medications across subgroups.

Diagnosis of cardiac disease in pediatric end-stage renal disease.

BACKGROUND: Cardiac disease is a significant cause of morbidity and mortality in children with end-stage renal disease (ESRD). This study aimed to report the frequency of cardiac disease diagnostic methods used in US pediatric maintenance hemodialysis patients. METHODS: A cross-sectional analysis of all US pediatric (ages 0.7-18 years, n = 656) maintenance hemodialysis patients was performed using data from the Centers for Medicare and Medicaid Services ESRD Clinical Performance Measures Project. Clinical and laboratory information was collected in 2001. Results were analysed by age, sex, race, Hispanic ethnicity, dialysis duration, body mass index (BMI), primary ESRD cause and laboratory data. RESULTS: Ninety-two percent of the patients had a cardiovascular risk factor (63% hypertension, 38% anemia, 11% BMI > 94th percentile, 63% serum phosphorus > 5.5 mg/dL and 55% calcium-phosphorus product ≥ 55 mg(2)/dL(2)). A diagnosis of cardiac disease was reported in 24% (n = 155) of all patients: left ventricular hypertrophy/enlargement 17%, congestive heart failure/pulmonary edema 8%, cardiomyopathy 2% and decreased left ventricular function 2%. Thirty-one percent of patients were not tested. Of those tested, the diagnostic methods used were chest X-rays in 60%, echocardiograms in 35% and electrocardiograms in 33%; left ventricular hypertrophy/enlargement was diagnosed using echocardiogram (72%), chest X-ray (20%) and electrocardiogram (15%). CONCLUSIONS: Although 92% of patients had cardiovascular risk factors, an echocardiography was performed in only one-third of the patients. Our study raises the question of why echocardiography, considered the gold standard for cardiac disease diagnosis, has been infrequently used in pediatric maintenance dialysis patients, a high-risk patient population.

Differences in mortality among Mexican-American, Puerto Rican, and Cuban-American dialysis patients in the United States.

BACKGROUND: The Hispanic ethnic group is heterogeneous, with distinct genetic, cultural, and socioeconomic characteristics, but most prior studies of patients with end-stage renal disease focus on the overall Hispanic ethnic group without further granularity. We examined survival differences among Mexican-American, Puerto Rican, and Cuban-American dialysis patients in the United States. STUDY DESIGN: Prospective observational study. SETTING & PARTICIPANTS: Data from individuals randomly selected for the End-Stage Renal Disease Clinical Performance Measures Project (2001 to 2005) were examined. Mexican-American (n = 2,742), Puerto Rican (n = 838), Cuban-American (n = 145), and Hispanic-other dialysis patients (n = 942) were compared with each other and with non-Hispanic (n = 33,076) dialysis patients in the United States. PREDICTORS: Patient characteristics of interest included ethnicity/race, comorbidities, and specific available laboratory values. OUTCOMES: The major outcome of interest was mortality. RESULTS: In the fully adjusted multivariable model, 2-year mortality risk was significantly lower for the Mexican-American and Hispanic-other groups compared with non-Hispanics (adjusted hazard ratio, 0.79; 95% confidence interval, 0.73 to 0.85; adjusted hazard ratio, 0.81; 95% confidence interval, 0.71 to 0.92, respectively). Differences in 2-year mortality rates within the Hispanic ethnic groups were statistically significant (P = 0.004) and ranged from 21% lower mortality in Mexican Americans to 3% higher mortality in Puerto Ricans compared with non-Hispanics. LIMITATIONS: Include those inherent to an observational study, potential ethnic group misclassification, and small sample sizes for some Hispanic subgroups. CONCLUSION: Mexican-American and Hispanic-other dialysis patients have a survival advantage compared with non-Hispanics. Furthermore, Mexican Americans, Cuban Americans, and Hispanic others had a survival advantage compared with their Puerto Rican counterparts. Future research should continue to examine subgroups within Hispanic ethnicity to understand underlying reasons for observed differences that may be masked by examining the Hispanic ethnic group as only a single entity.

Clinical outcomes in pediatric hemodialysis patients in the USA: lessons from CMS' ESRD CPM Project.

Although prospective randomized trials have provided important information and allowed the development of evidence-based guidelines in adult hemodialysis (HD) patients, with approximately 800 prevalent pediatric HD patients in the United States, such studies are difficult to perform in this population. Observational data obtained through the Center for Medicare & Medicaid Services' (CMS') End Stage Renal Disease (ESRD) Clinical Performance Measures (CPM) Project have allowed description of the clinical care provided to pediatric HD patients as well as identification of risk factors for failure to reach adult targets for clinical parameters such as hemoglobin, single-pool Kt/V (spKt/V) and serum albumin. In addition, studies linking data from the ESRD CPM Project and the United States Renal Data System have allowed evaluation of associations between achievement of those targets and the outcomes of hospitalization and death. The results of those studies, while unable to prove cause and effect, suggest that the adult ESRD CPM targets may assist in identifying pediatric HD patients at risk for poor outcomes.

Predictors of central venous catheter use at the initiation of hemodialysis.

Central venous catheter (CVC) use at hemodialysis (HD) initiation remains high, despite reports of CVC-associated morbidity and mortality, and efforts at early arteriovenous fistula placement. In order to determine predictors of CVC use at the start of HD, data from the end-stage renal disease (ESRD) Clinical Performance Measures (CPM) Project was linked to the Centers for Medicare & Medicaid Services Medical Evidence (2728) Form. Of the 4071 incident hemodialysis patients in study years 1999-2003, 71.6% used a CVC at dialysis initiation. After controlling for demographic and co-morbid variables, patients with a CVC were 24% more likely to be female (p = 0.006), and 38% more likely to have ischemic heart disease (p = 0.002), while those with obesity (BMI > or = 30) were 24% less likely to start dialysis with a CVC (p = 0.006). Pre-ESRD hypoalbuminemia (< 3.5 g/dl) was associated with a twofold higher risk of CVC use (p = < 0.001), while patients with pre-ESRD anemia (hgb < 11 g/dl) were 29% more likely to use a CVC at dialysis initiation (p = 0.006) compared to those with hemoglobin > or = 11 g/dl. Patients receiving predialysis erythropoietin had a 41% lower odds of CVC use at dialysis initiation (p = < 0.001). Finally, dialysis year was predictive of CVC use; in 2002, 76% of patients initiated dialysis with a CVC compared with 66% in 1998 (p < 0.001). Overall, female gender, ischemic heart disease, lack of obesity, factors suggesting poor pre-ESRD care, and successive year of dialysis initiation were predictive of CVC use at hemodialysis initiation.

Predictors of delayed transition from central venous catheter use to permanent vascular access among ESRD patients.

BACKGROUND: Early arteriovenous fistula (AVF) creation is necessary to curb the use of central venous catheters (CVCs) and reduce their complications. We sought to examine patient characteristics that may influence persistent CVC use 90 days after dialysis therapy initiation among patients using a CVC. METHODS: Data from the 1999 to 2003 Clinical Performance Measures Project was linked to the Centers for Medicare & Medicaid Services Medical Evidence (2728) form. RESULTS: Most patients (59.4%) starting dialysis with a CVC failed to transition to permanent access within 90 days, whereas 25.4% received a graft and only 15.2% received an AVF. Older patients (>75 years) were more than 2-fold more likely to remain CVC dependent at 90 days (P = 0.0.001) compared with those younger than 50 years. In addition, race and sex were highly predictive of CVC dependence at 90 days; black females, white females, and black males were 75% (P < 0.001), 61% (P < 0.001), and 35% (P = 0.023) more likely than white males to maintain CVC use, whereas patients with ischemic heart disease and peripheral vascular disease were 35% (P = 0.023) and 39% (P = 0.007) more likely to remain CVC dependent at 90 days, respectively. CONCLUSION: Prolonged CVC dependence is more likely to occur among patients of older age, females, blacks, and those with cardiovascular comorbidity, suggesting inadequate or late access referral or greater primary access failure. Our findings suggest possible missed opportunities for early conversion of patients to permanent vascular access that may vary by race and sex.

Relationship between clinical performance measures and outcomes among patients receiving long-term hemodialysis.

BACKGROUND: Patients receiving long-term hemodialysis have a yearly mortality rate of 15% to 20%. OBJECTIVE: To determine whether attaining clinical performance measures for hemodialysis care is associated with favorable 12-month mortality and hospitalization rates. DESIGN: Cohort study. SETTING: Outpatient hemodialysis centers in the United States. PATIENTS: 15 287 patients who were selected from a 5% random sample of patients receiving long-term hemodialysis. MEASUREMENTS: The authors used data from the Centers for Medicare & Medicaid Services End-Stage Renal Disease Clinical Performance Measures Project from 1999 and 2000. The clinical performance measure targets were hemoglobin value of 110 g/L or greater; serum albumin value of 40 g/L or greater or 37 g/L or greater (bromcresol green and bromcresol purple laboratory methods, respectively); use of a fistula for vascular access; and measured single-pool Kt/V urea value of 1.2 or greater. The outcome measures were death or hospitalization during 1-year follow-up. RESULTS: 8364 patients (54.7%) were hospitalized and 3062 (20.0%) died during the 12-month follow-up period. Six percent of patients did not meet any clinical measure targets, 24% met 1 target, 39% met 2 targets, 24% met 3 targets, and 7% met all 4 targets. The unadjusted 12-month hospitalization and mortality rates for these 5 groups were 60%, 60%, 56%, 49%, and 43% (P < 0.001) and 29%, 25%, 21%, 14%, and 7% (P < 0.001), respectively. The risk for death increased for each additional guideline indicator that was not met: Adjusted hazard ratios were 4.6 (95% CI, 3.3 to 6.4), 3.5 (CI, 2.6 to 4.7), 2.6 (CI, 1.9 to 3.5), and 1.9 (CI, 1.4 to 2.6) for 0, 1, 2, or 3 targets met, respectively, compared with meeting 4 targets (referent). Similarly, the risk for hospitalization increased for each additional guideline indicator that was not met: Adjusted hazard ratios were 1.6 (CI, 1.4 to 1.9), 1.5 (CI, 1.3 to 1.7), 1.3 (CI, 1.1 to 1.5), and 1.1 (CI, 0.98 to 1.3), respectively. LIMITATIONS: It was not possible to determine the roles of severity of illness, other patient factors, or suboptimal care in failure to meet performance measures. CONCLUSIONS: In patients receiving long-term hemodialysis, meeting multiple clinical measure targets is associated with a decrease in hospitalization and mortality rates.

Outcomes for adolescent Hispanic hemodialysis patients: findings from the ESRD Clinical Performance Measures Project.

BACKGROUND: There is limited information regarding outcomes of dialytic care for Hispanic adolescent hemodialysis patients. METHODS: Ethnicity information was collected for all adolescent in-center hemodialysis patients for the Centers for Medicare & Medicaid Services 2000 End-Stage Renal Disease (ESRD) Clinical Performance Measures Project. Associations between intermediate outcomes and Hispanic ethnicity were determined. Associations of ethnicity and other demographic/clinical variables with hospitalization and transplantation during the 12-month follow-up period were examined. RESULTS: Twenty-two percent of patients were identified as Hispanic; 40%, as non-Hispanic black; and 32%, as non-Hispanic white. Hispanic patients were younger and more likely to have congenital/urological causes of ESRD. More Hispanic patients had a mean single-pool Kt/V of 1.2 or greater compared with non-Hispanic blacks and non-Hispanic whites (87% versus 73% and 79%; P = 0.036). More Hispanic patients had a mean serum albumin level of 3.5/3.2 g/dL (bromcresol green/bromcresol purple method) or greater (> or = 35/32 g/L; 91% versus 82% and 76%; P = 0.017). More Hispanic patients compared with non-Hispanic blacks and non-Hispanic whites were dialyzed with a catheter for 90 days or longer (30% versus 21% and 23%; P = 0.027). In the final multivariate Cox proportional hazard models, Hispanic patients were at a slightly decreased risk for hospitalization compared with non-Hispanics (adjusted hazard ratio [adjHR], 0.63; P = 0.031) and were as likely to undergo a first transplantation as non-Hispanic whites (adjHR, 0.56; P = 0.099). CONCLUSION: Adolescent Hispanic hemodialysis patients experience equivalent or better intermediate outcomes of dialytic care than non-Hispanics. They experienced a decreased risk for subsequent hospitalization and are as likely to undergo transplantation within 12 months as non-Hispanic whites.

Impact of specialization of primary nephrologist on the care of pediatric hemodialysis patients.

BACKGROUND: Children with end-stage renal disease (ESRD) receiving hemodialysis may have their care overseen primarily by a pediatric nephrologist or internal medicine (IM) nephrologist. METHODS: To examine specific clinical outcomes by nephrologist specialization, a cross-sectional analysis of demographic and clinical data collected in the 2002 ESRD Clinical Performance Measures Project was performed. RESULTS: Of 653 pediatric patients meeting inclusion criteria, 27% were cared for by IM nephrologists, and 73%, by pediatric nephrologists. Pediatric nephrologists were significantly more likely than IM nephrologists to care for patients who were younger and of Hispanic ethnicity. Patients of pediatric compared with IM nephrologists also were more likely to have a congenital cause of ESRD, smaller body mass index, and longer time on dialysis therapy. No significant differences in achieving a mean Kt/V of 1.2 or greater or mean hemoglobin level of 11 g/dL or greater (> or =110 g/L) according to nephrologist specialization were observed. After adjustment for patient clinical characteristics, no significant difference in use of arteriovenous fistulae was observed. Patients cared for by pediatric nephrologists were less likely to achieve a mean serum albumin level of 4.0/3.7 g/dL (40/37 g/L; bromcresol green laboratory method/bromcresol purple laboratory method; adjusted odds ratio, 0.60; 95% confidence interval, 0.42 to 0.86). Patients cared for by pediatric nephrologists had significantly greater serum calcium levels, lower serum phosphate levels, and lower intact parathyroid hormone levels. CONCLUSION: Using adult-focused clinical care targets, care provided by pediatric and IM nephrologists to pediatric patients receiving hemodialysis in the United States is similar. However, differences exist, and the significance of these differences requires further study.

Diabetes is the strongest risk factor for lower-extremity amputation in new hemodialysis patients.

OBJECTIVE: End-stage renal disease (ESRD) patients, especially those with diabetes, have an increased risk of nontraumatic lower-extremity amputation (LEA). The present study aims to examine the association of demographic and clinical variables with the risk of hospitalization for LEA among incident hemodialysis patients. RESEARCH DESIGN AND METHODS: The study population consisted of incident hemodialysis patients from the study years 1996-1999 of the ESRD Core Indicator/Clinical Performance Measures (CPM) Project. Cox proportional hazard modeling was used to identify factors associated with LEA. RESULTS: Four percent (116 of 3,272) of noncensored incident patients had an LEA during the 12-month follow-up period. Factors associated with LEA included diabetes as the cause of ESRD or preexisting comorbidity (hazard ratio 6.4, 95% CI 3.4-12.0), cardiovascular comorbidity (1.8, 1.2-2.8), hemodialysis inadequacy (urea reduction ratio [URR] <58.5% (1.9, 1.1-3.3), and lower serum albumin level (1.6, 1.1-2.3). Among patients with diabetes, hemodialysis inadequacy and cardiovascular comorbidity were risk factors for LEA (2.6, 1.4-4.8, and 1.7, 1.1-2.6, respectively). CONCLUSIONS: These data suggest that diabetes is a potent risk factor for LEA in new hemodialysis patients. In ESRD patients with diabetes, a multipronged approach may reduce the rate of LEA. Potentially beneficial strategies include adherence to hemodialysis adequacy guidelines, aggressive treatment of cardiovascular comorbidities, and the utilization of LEA prevention strategies recommended for the general population of patients with diabetes.

Potential cost savings of erythropoietin administration in end-stage renal disease.

BACKGROUND: In a Department of Veterans Affairs randomized controlled trial, a lower dose of recombinant human erythropoietin (epoetin) was shown to attain target hematocrit levels when administered subcutaneously compared with intravenously. Since epoetin is expensive, optimizing the therapeutic effect of epoetin using a strategy that includes subcutaneous administration could lead to substantial cost savings. METHODS: We used an economic cost projection model to estimate potential savings to the Medicare End-Stage Renal Disease Program that could occur during a transition from intravenous to subcutaneous administration of epoetin among hemodialysis patients. Data included clinical results from the Department of Veterans Affairs randomized controlled trial, the 1998 Centers for Medicare and Medicaid Services' End-Stage Renal Disease Core Indicators Survey, and the 1997-1998 Medicare claims files. In sensitivity analyses, we varied the expected dose reductions (10% to 50%) and the proportion of patients (25% to 100%) who switched to subcutaneous administration. RESULTS: Medicare cost savings were estimated at $47 to $142 million annually as 25% to 75% of hemodialysis patients who received epoetin intravenously switched to subcutaneous administration while reducing the dose by 32%. A minimal reduction (10%) in epoetin dose would result in Medicare cost savings of an estimated $15 to $44 million annually. CONCLUSION: Administering epoetin subcutaneously would provide substantial cost savings to Medicare. For the transition to occur, consensus among stakeholders is needed, especially among patients whose treatment satisfaction and health-related quality of life would be most affected.

Response to inadequate dialysis in chronic peritoneal dialysis patients. Results from the 2000 Centers for Medicare and Medicaid (CMS) ESRD Peritoneal Dialysis Clinical Performance Measures (PD-CPM) Project.

BACKGROUND: It is not known if patient prescriptions are being changed if patients are receiving an inadequate dose of peritoneal dialysis. METHODS: Data from the 2000 Centers for Medicare and Medicaid were used to obtain data on dialysis adequacy and dialysis prescriptions. RESULTS: A total of 359 of 1,268 (28%) adult peritoneal dialysis patients had a total weekly Kt/V urea (twKt/V) less than 2.0 and 436 of 1,245 (35%) patients had a total weekly creatinine clearance (twCrCl) less than 60 L/wk/1.73 m2, defined as "inadequate dialysis." Among chronic ambulatory peritoneal dialysis (CAPD) patients, 81 of 188 (43%) patients had inadequate dialysis and a change in the peritoneal dialysis prescription within 6 months of the initial adequacy value. Among cycler patients, 106 of 197 (54%) patients had inadequate dialysis and a change in the prescription. Thirty-six of 46 (78%) CAPD patients and 48 of 56 (86%) cycler patients had an improvement in twKt/V after the prescription was revised. Thirty-two of 42 (76%) CAPD patients and 45 of 57 (79%) cycler patients had an improvement in twCrCl after the prescription was changed. For these patients, twKt/V increased from 1.6 +/- 0.3 to 2.1 +/- 0.5, with an increase in the peritoneal Kt/V urea from 1.5 +/- 0.3 to 1.9 +/- 0.4. Similarly, twCrCl increased from 46.3 +/- 7.5 to 59.1 +/- 10.6 L/wk/1.73 m2 with an increase in the peritoneal CrCl dose from 42.0 +/- 9.1 to 52.7 +/- 9.9 L/wk/1.73 m2. CONCLUSION: About half of peritoneal dialysis patients with inadequate dialysis did not have a prescription change and could benefit from modifications in their dialysis prescription.

Developing clinical performance measures based on the Dialysis Outcomes Quality Initiative Clinical Practice Guidelines: process, outcomes, and implications.

BACKGROUND: The National Kidney Foundation-Dialysis Outcomes Quality Initiative (NKF-DOQI) Clinical Practice Guidelines established a widely accepted set of recommendations for high-quality dialysis care. To enhance the End-Stage Renal Disease Core Indicators Project, an ongoing effort to assess and improve dialysis care in the United States, the Centers for Medicare and Medicaid Services (CMS) commissioned a project to develop clinical performance measures (CPMs) based on the NKF-DOQI guidelines. METHODS: The CMS contracted with Qualis Health, a private nonprofit organization serving as a Medicare Quality Improvement Organization, to facilitate a 9-month project to develop dialysis CPMs with the participation of a broad range of stakeholders from the renal community. Work groups were established to develop CPMs addressing 4 areas: hemodialysis adequacy, peritoneal dialysis adequacy, vascular access management, and anemia management. The NKF-DOQI guidelines were prioritized based on the strength of the evidence supporting the guidelines, the feasibility of developing performance measures, and the significance of the areas addressed to the quality of care delivered to dialysis patients. Expert panels developed data specifications, sampling approaches, data-collection tools, and analytic strategies. RESULTS: Sixteen CPMs were developed based on 22 of 114 NKF-DOQI guidelines. After establishing reliability through field-testing of data-collection instruments, the CPMs were applied to a sample of 8,838 randomly selected hemodialysis patients and 1,650 randomly selected adult peritoneal dialysis patients in summer 1999. CONCLUSION: The development of CPMs based on the NKF-DOQI Clinical Practice Guidelines for dialysis care was accomplished in a timely and effective manner by engaging a broad range of stakeholders and technical experts. The CPMs are important tools to assess and improve the quality of dialysis care in the United States. Few comparable efforts exist in other fields of medicine.

Comparison of urea reduction ratio and hematocrit data reported in different data systems: results from the Centers for Medicare & Medicaid Services and the Renal Network Inc.

BACKGROUND: Urea reduction ratio (URR) and hematocrit values reported on the Centers for Medicare & Medicaid Services (CMS) claims were compared with data from two different databases. METHODS: URRs and hematocrits from two different CMS databases (National Claims History and End-Stage Renal Disease Clinical Performance Measures [CPM] Project) and one Network database (The Renal Network Data System [TRNDS]) were compared for October through December 1998 and December 1998, respectively. A sample of records from the regional database was validated by independent chart review. RESULTS: Nationally, the percentage of agreement for patients with URRs of 65% or greater and less than 65% was 94% (kappa, 0.81; 95% confidence interval [CI], 0.80 to 0.83); regionally, the percentage of agreement was 95% (kappa, 0.85; 95% CI, 0.84 to 0.86). Nationally, linear regression of hematocrit values from both data sources yielded r(2) congruent with 0.61 each month and r(2) = 0.70 for average values during the 3-month study period. Nationally, the percentage of agreement for patients with hematocrits of 33% or greater and less than 33% was 84% (kappa approximately 0.66) each month. Regionally, linear regression of monthly hematocrit values from both data sources yielded r(2) = 0.66, and percentage of agreement for patients with hematocrits of 33% or greater and less than 33% was 87% (kappa, 0.71; 95% CI, 0.70 to 0.73). Validation of a sample of records in the TRNDS database resulted in 98% agreement for patients with URRs of 65% or greater and less than 65% and 96% agreement for patients with hematocrits of 33% or greater and less than 33%. CONCLUSION: Although there is general agreement between clinical variables submitted on the claims and in the CPM Project, some variation exists. Data from either source yield the same information when classifying patients as above or below threshold values.

Comparison of mortality and intermediate outcomes between medicare dialysis patients in HMO and fee for service.

End-stage renal disease (ESRD) is the only disease entitlement for Medicare; therefore, most patients with ESRD have Medicare coverage. Patients with ESRD are prohibited by law from enrolling in health maintenance organizations (HMOs), the only group prohibited within Medicare. However, they may remain in an HMO if they enrolled in such a plan before their kidneys failed. Thus, it is possible to compare patients with ESRD in HMOs with those in fee-for-service (FFS) plans. To determine whether mortality, transplantation rates, and intermediate outcomes differed between Medicare ESRD beneficiaries enrolled in HMO versus FFS providers, a retrospective cohort analysis was performed of patients with ESRD from three Health Care Financing Administration data sets containing administrative and outcome information for Medicare ESRD beneficiaries from 1990 to 1998. On December 31, 1998, a total of 278,510 prevalent patients with ESRD were in FFS plans, and 18,332 patients were in HMOs. HMO patients were older and more likely to be white and male and have diabetes mellitus and comorbid cardiovascular conditions than FFS patients. Unadjusted 2-year survival rates were 48.4% and 49.3% for FFS and HMO patients, respectively. In a multivariate model, HMO status had no significant effect on mortality, which was greater with older age, male sex, and white race. In 1998, unadjusted renal transplantation rates were 23.5% and 15.5% for FFS and HMO patients, respectively; age adjustment abrogated the apparent difference. For FFS and HMO patients, adequate hemodialysis was delivered to 72% and 82%, and 56% and 62% had hematocrits greater than the benchmark, respectively. There was no statistical difference in these outcomes in multivariate comparison. In conclusion, care by HMO for patients with an expensive chronic illness can achieve outcomes similar to those for FFS patients. Claims of poorer care and worse outcomes for patients with ESRD enrolled onto an HMO, an argument used to justify continued prohibition against widespread participation by patients with ESRD, are not supported.

Improving the care of ESRD patients: a success story.

Medicare's health care quality improvement program (HCQIP) is a national effort to improve beneficiaries' quality of care. The end stage renal disease (ESRD) HCQIP was implemented in 1994 in response to criticism about the poor quality of care received by ESRD patients. Quality improvement efforts initiated by the ESRD Networks and dialysis providers in response to the HCQIP have demonstrated substantial improvement in care for dialysis patients. This article describes the evolution of the ESRD HCQIP and its successful application in the ESRD program.

Current management of anemia in adult hemodialysis patients with end-stage renal disease.

The management of anemia in adult end-stage renal disease (ESRD) patients receiving hemodialysis in dialysis facilities is examined. Clinical information was collected for a random sample of adult (age > or = 18 years) patients who received hemodialysis for ESRD between October and December 1999 and included hemoglobin concentrations, epoetin alfa doses and routes of administration, iron prescribing patterns, transferrin saturation levels, and serum ferritin concentrations. Patients whose data did not include hemoglobin concentrations with the weekly epoetin dose were excluded from the analysis. Associations by patient characteristics and geographic region were examined for clinical intermediate outcomes and epoetin alfa and iron prescribing practice patterns. Data were submitted for 8154 patients, and hemoglobin values linked to weekly epoetin alfa doses were available for 7573 of those patients. The mean hemoglobin concentration for patients in the sample was 11.4 +/- 1.3 g/dL. Sixty-seven percent of patients had mean hemoglobin values > or = 11 g/dL. Females, blacks, patients 18-44 years old, and patients receiving hemodialysis for less than six months exhibited significantly lower mean hemoglobin values despite being prescribed, on average, significantly higher epoetin alfa doses than males, whites, older patients, and patients receiving hemodialysis for six months or more (p < 0.001). There was significant regional variation in the prescribing patterns for s.c. epoetin alfa and i.v. iron (p < 0.001). Multivariable logistic regression analysis found significant associations between mean hemoglobin values > 11 g/dL and certain patient characteristics, including white race, hemodialysis for six months or longer, lower prescribed weekly epoetin alfa doses, prescription of i.v. iron, mean transferrin saturation levels > or = 20%, mean Kt/V > or = 1.2, and higher mean serum albumin values. Prescribing patterns for i.v. iron did not vary by the status of patients' iron stores. Regional and patient-specific variations in parameters of anemia management provide pharmacists with the opportunity to contribute to a multidisciplinary team approach to improve the care of hemodialysis patients.

Risk factors for early mortality in U.S. peritoneal dialysis patients: impact of residual renal function.

BACKGROUND: Potential risk factors for 1-year mortality, including the peritoneal component of dialysis dose, residual renal function, demographic data, hematocrit, serum albumin, dialysate-to-plasma creatinine ratio, and blood pressure, were examined in a national cohort of peritoneal dialysis patients randomly selected for the Centers for Medicare and Medicaid Services End-Stage Renal Disease (ESRD) Core Indicators Project. METHODS: The study involved retrospective analysis of a cohort of 1,219 patients receiving chronic peritoneal dialysis who were alive on December 31, 1996. RESULTS: During the 1-year follow-up period, 275 patients were censored and 200 non censored patients died. Among the 763 patients who had at least one calculable adequacy measure, the mean [+/- standard deviation (SD)] weekly Kt/V urea was 2.16 +/- 0.61 and the mean weekly creatinine clearance was 66.1 +/- 24.4 L/1.73 m2. Excluding the 365 patients who were anuric, the mean (+/- SD) urinary weekly Kt/V urea was 0.64 +/- 0.52 (median: 0.51) and the mean (+/- SD) urinary weekly creatinine clearance was 31.0 +/- 23.3 L/1.73 m2 (median: 26.3 L/1.73 m2). By Cox proportional hazard modeling, lower quartiles of renal Kt/V urea were predictive of 1-year mortality; lower quartiles of renal creatinine clearance were of borderline significance for predicting 1-year mortality. The dialysate component of neither the weekly creatinine clearance nor the weekly Kt/V urea were predictive of 1-year mortality. Other predictors of 1-year mortality (p < 0.01) included lower serum albumin level, older age, and the presence of diabetes mellitus as the cause of ESRD, and, for the creatinine clearance model only, lower diastolic blood pressure. CONCLUSION: Residual renal function is an important predictor of 1-year mortality in chronic peritoneal dialysis patients.

Healthcare system interventions for inequality in quality: corrective action through evidence-based medicine.

Racial differences in the use of diagnostic and therapeutic services have an impact on outcomes in patients with chronic kidney disease. Important contributors to these racial disparities are inadequate insurance, poor access to health services' networks, and overt prejudice or subconscious bias. The use of an appropriate dose of hemodialysis is a fundamental health intervention for end-stage renal disease, which can act as a measure of the adequacy of healthcare provision. When the dose of hemodialysis was analyzed by race, the greatest deficiency in care was observed for African Americans, who had a 60% greater likelihood of receiving inadequate dialysis compared with whites. The Centers for Medicare and Medicaid Services (CMS) have developed and implemented evidence-based clinical practice guidelines, designed to improve the services provided by the renal community. This approach positively impacted on dialysis doses received by patients, such that between 1993 and 1997, the percentage of patients receiving a benchmark urea reduction ratio (URR) > or = 65% increased from 43% in 1993 to 72% in 1997. However, the most dramatic improvement was seen among African Americans who had a 92% increase in the proportion of patients achieving a URR > or = 65%. Rather than focusing on who is treated, processes should be adopted to focus on how patients are treated. Increasing the use of evidence-based practices offers strategies aimed at assuring equal treatment for all and encompasses physician accountability, without the need for specific race-based intervention programs.