Increased Access, Persistent Disparities: Trends in Disparities in Peritoneal Dialysis (PD) Use, 2009-2019.

Peritoneal dialysis (PD) use has increased in the United States since 2009, but how this has affected disparities in PD use is unclear. We used data from the United States Renal Data System to identify a cohort of incident dialysis patients from 2009 to 2019. We used logistic regression models to examine how odds of PD use changed by demographic characteristics. The incident PD population increased by 203% from 2009 to 2019, and the odds of PD use increased in every subgroup. PD use increased more among older people because the odds for those aged 75 years or older increased 15% more per 5-year period compared with individuals aged 18-44 years (odds ratio [OR] 1.68, 95% confidence interval [CI], 1.64 to 1.73 versus OR 1.46, 95% CI, 1.42 to 1.50). The odds of PD use increased 5% more per 5-year period among Hispanic people compared with White people (OR 1.58, 95% CI, 1.53 to 1.63 versus OR 1.51, 95% CI, 1.48 to 1.53). There was no difference in odds of PD initiation among people who were Black, Asian, or of another race. The odds of PD use increased 5% more for people living in urban areas compared with people living in nonurban areas (5-year OR 1.54, 95% CI, 1.52 to 1.56 versus 5-year OR 1.46, 95% CI, 1.42 to 1.50). The odds of PD use increased 7% more for people living in socioeconomically advantaged areas compared with people living in more deprived areas (5-year OR 1.60, 95% CI, 1.56 to 1.63 for neighborhoods with lowest Social Deprivation Index versus 5-year OR 1.50, 95% CI, 1.48 to 1.53 in the most deprived areas). Expansion of PD use led to a reduction in disparities for older people and for Hispanic people. Although PD use increased across all strata of socioeconomic deprivation, the gap in PD use between people living in the least deprived areas and those living in the most deprived areas widened.

Association of the End-Stage Renal Disease Treatment Choices Payment Model With Home Dialysis Use at Kidney Failure Onset From 2016 to 2022.

Importance: The Centers for Medicare & Medicaid Services designed a mandatory payment model to incentivize home dialysis use: the End-Stage Renal Disease Treatment Choices (ETC). Outpatient dialysis facilities and health care professionals providing nephrology services were randomly assigned to ETC participation at the hospital referral region level. Objective: To assess the association between ETC and home dialysis use in the incident dialysis population in its first 18 months of implementation. Design, Setting, and Participants: A cohort study with controlled, interrupted time series analysis of the US End-Stage Renal Disease Quality Reporting System database was conducted, using generalized estimating equations. All adults initiating home-based dialysis in the US between January 1, 2016, and June 30, 2022, without a prior kidney transplant were included in the analysis. Exposures: Prior to vs after ETC onset in January 1, 2021, and random assignment to ETC participation of facilities and health care professionals involved in patient care. Main Outcomes and Measures: Percentage of patients started on incident home dialysis and yearly change in percentage initiating home dialysis. Results: A total of 817 177 adults initiated home dialysis during the study period, of whom 750 314 were included in the study cohort. The cohort included 41.4% women; 26.2% of the patients were Black, 17.4% were Hispanic, and 49.1% were White. Approximately half (49.6%) of the patients were aged at least 65 years. A total of 31.2% received care from health care professionals assigned to ETC participation, and 33.6% had Medicare fee-for-service coverage. Overall, home dialysis use increased from 10.0% in January 2016 to 17.4% in June 2022. Home dialysis use increased more in ETC markets than in non-ETC markets after January 2021 (by 1.07%; 95% CI, 0.16%-1.97%). The rate of increase in home dialysis use in the entire cohort nearly doubled after January 2021 to 1.66% per year (95% CI, 1.14%-2.19%) compared with before 2021, when the rate was 0.86% per year (95% CI, 0.75%-0.97%), but the difference in rate of increase in home dialysis use was not significant between ETC and non-ETC markets. Conclusions and Relevance: This study noted that, although the overall rate of dialysis use at home was greater after ETC implementation, the increase occurred more among patients in ETC markets than among those in non-ETC markets. These findings suggest that federal policy and financial incentives affected care for the entire incident dialysis population in the US.

Associations of COVID-19 Outcomes with Dialysis Modalities and Settings.

How maintenance dialysis modality, dialysis setting, and residence in a nursing facility have jointly associated with coronavirus disease 2019 (COVID-19)-related outcomes in the United States is relevant to future viral outbreaks. Using Medicare claims, we determined the incidence of COVID-19-related infection, hospitalization, and death between March 15, 2020 and June 5, 2021. The exposure was one of five combinations of dialysis modality and care setting: in-facility hemodialysis without a recent history of skilled nursing facility care, in-facility hemodialysis with a recent history of skilled nursing facility care, hemodialysis in a skilled nursing facility, home hemodialysis, and (home) peritoneal dialysis. Patient-weeks were pooled to estimate the adjusted associations of event incidence with each dialysis modality/setting during four intervals in 2020-2021. Relative to in-facility hemodialysis without a recent history of skilled nursing facility care, home dialysis was associated with 36%-60% lower odds of all events during weeks 12-23 of 2020; 24%-37% lower odds of all events during weeks 24-37 of 2020; 20%-33% lower odds of infection and hospitalization during the winter of 2020-2021; and similar odds of all events thereafter. In contrast, exposure to skilled nursing facilities was associated with 570%-1140% higher odds of all events during spring of 2020, although excess risk attenuated as the pandemic transpired, especially among patients who received hemodialysis in skilled nursing facilities. In conclusion, home dialysis was associated with lower risks of COVID-19 diagnosis, hospitalization, and death until vaccines were available, whereas care in skilled nursing facilities was associated with higher risks.

Cinacalcet and gastrointestinal bleeding risk in patients receiving hemodialysis.

PURPOSE: Secondary hyperparathyroidism (SHPT) is common among dialysis patients, and calcimimetics are a mainstay of treatment. This study assessed whether cinacalcet use is associated with gastrointestinal bleeding in a large hemodialysis cohort. METHODS: A linked database of clinical records and medical claims for patients receiving hemodialysis in a large dialysis organization, 2007-2010, was used. A nested case-control study was performed among patients aged ≥18 years who had received hemodialysis for ≥90 days, had Medicare Parts A, B, and D coverage for ≥1 year, and had clinical evidence of SHPT (parathyroid hormone >300 pg/mL). Cases were those who experienced death or hospitalization caused by gastrointestinal bleeding. Each case was matched to up to four controls. Exposure was measured by any cinacalcet use, current use, past use, cumulative exposure days, and cumulative dosage. Conditional logistic models were used to assess the association. RESULTS: Of 48 437 patients included, 2570 experienced gastrointestinal bleeding events (2498 non-fatal, 72 fatal), and 2465 (2397 non-fatal, 68 fatal) were matched to 9500 controls; 17.2% of cases and 15.8% of controls had cinacalcet exposure and 11.1% of both cases and controls had current use. The adjusted odds ratios (95% CI) of gastrointestinal bleeding for any use, current use, and past use of cinacalcet were 1.04 (0.91-1.19), 0.97 (0.83-1.13), and 1.22 (0.99-1.50), respectively, with no use as the reference. CONCLUSION: The results do not suggest an elevated risk of gastrointestinal bleeding resulting in hospitalization or death for hemodialysis patients exposed to cinacalcet.

Initial Effects of COVID-19 on Patients with ESKD.

BACKGROUND: Reports from around the world have indicated a fatality rate of patients with coronavirus disease 2019 (COVID-19) in the range of 20%-30% among patients with ESKD. Population-level effects of COVID-19 on patients with ESKD in the United States are uncertain. METHODS: We identified patients with ESKD from Centers for Medicare and Medicaid Services data during epidemiologic weeks 3-27 of 2017-2020 and corresponding weeks of 2017-2019, stratifying them by kidney replacement therapy. Outcomes comprised hospitalization for COVID-19, all-cause death, and hospitalization for reasons other than COVID-19. We estimated adjusted relative rates (ARRs) of death and non-COVID-19 hospitalization during epidemiologic weeks 13-27 of 2020 (March 22 to July 4) versus corresponding weeks in 2017-2019. RESULTS: Among patients on dialysis, the rate of COVID-19 hospitalization peaked between March 22 and April 25 2020. Non-Hispanic Black race and Hispanic ethnicity associated with higher rates of COVID-19 hospitalization, whereas peritoneal dialysis was associated with lower rates. During weeks 13-27, ARRs of death in 2020 versus 2017-2019 were 1.17 (95% confidence interval [95% CI], 1.16 to 1.19) and 1.30 (95% CI, 1.24 to 1.36) among patients undergoing dialysis or with a functioning transplant, respectively. Excess mortality was higher among non-Hispanic Black, Hispanic, and Asian patients. Among patients on dialysis, the rate of non-COVID-19 hospitalization during weeks 13-27 in 2020 was 17% lower versus hospitalization rates for corresponding weeks in 2017-2019. CONCLUSIONS: During the first half of 2020, the clinical outcomes of patients with ESKD were greatly affected by COVID-19, and racial and ethnic disparities were apparent. These findings should be considered in prioritizing administration of COVID-19 vaccination.

Factors Associated with Elective Withdrawal of Maintenance Hemodialysis: A Case-Control Analysis.

BACKGROUND: Associations of demographic factors with elective dialysis withdrawal and setting of death, patterns of illness trajectories preceding death, and how illness trajectories, particularly worsening putative disability, are associated with elective withdrawal are poorly understood. METHODS: Using United States Renal Data System data, we performed a case-control analysis of hemodialysis patients who died in 2010-2015. A disability proxy score characterized disability; logistic regression identified characteristics associated with death from withdrawal and with death setting; and group-based trajectory models characterized the trajectory of disability in the months preceding death. RESULTS: We identified 14,571 (9.2%) patients who withdrew and 144,305 (90.8%) who died of a non-withdrawal cause. Women were more likely than men to withdraw (OR 1.19, 95% CI 1.15-1.24). The most rural patients were more likely to withdraw than the most urban (OR 1.37, 95% CI 1.25-1.50). Medicaid coverage (a marker for impoverishment) was associated with less withdrawal (OR 0.90, 95% CI 0.86-0.94). Disability proxy score was strongly related to withdrawal: the OR for patients in the highest score category was 31.16 (95% CI 28.40-34.20) versus those with a score of 0. Women and whites (vs. blacks) were overrepresented in the worst, versus better, proxy disability score trajectory. In-hospital death and death in the intensive care unit were more common in women and minorities than in men and whites, but less common in the most rural patients. CONCLUSIONS: Important differences separate patients who electively withdraw from those who die of non-withdrawal causes. Worsening disability, in particular, may be a marker for withdrawal.

Increases in institutionalization, healthcare resource utilization, and mortality risk associated with Parkinson disease psychosis: Retrospective cohort study.

INTRODUCTION: Patients with Parkinson disease (PD) often develop psychosis (P). The association of PDP with death and long-term custodial care (CC) has not been well studied. METHODS: Medicare Parts A, B, and D data, 2007-2015, were used to define cohorts of PD and PDP patients. PD was defined by ≥ 2 ICD-9-CM codes (332.0x) at least 30, but no more than 365, days apart, and PDP by ≥ 2 codes for psychotic symptoms. Outcomes were CC use, defined as nursing home stays of >100 consecutive days, and death. To compare the association of PDP with outcomes, PDP patients were matched to PD patients without psychosis. RESULTS: Within 1 year of PDP diagnosis, 12.1% of PDP patients used CC, versus 3.5% of non-PDP patients 1 year after the matching date; corresponding percentages at 5 years were 25.8% and 10.0%. Cumulative incidence curves for CC and for death differed significantly (P < 0.0001). PDP was associated with RRs of 3.38 (95% CI, 2.93-3.90) for CC and 1.34 (1.23-1.45) for death. Other factors associated with CC were age (3.57, 2.08-6.14, age ≥90 versus ≤70 years) and female sex (1.37, 1.18-1.58). Female sex was associated with a lower RR for death (0.76, 0.70-0.82). Health care utilization and costs were substantially higher for PDP than for non-PDP patients. CONCLUSION: In PD patients, psychosis was associated with a more than 3-fold increased risk of CC and a nearly one-third increased risk of death. Women entered CC more often than men, likely because they lived longer in the setting of PD.

Adherence to Kidney Disease: Improving Global Outcomes Mineral and Bone Guidelines for Monitoring Biochemical Parameters.

BACKGROUND: Mineral and bone disorder (MBD) is common in patients with chronic kidney disease (CKD), and is associated with risk of fractures, cardiovascular disease, and death. Kidney Disease: Improving Global Outcomes (KDIGO) guidelines recommend monitoring CKD-MBD biochemical markers, including parathyroid hormone (PTH), phosphorus, 25-hydroxyvitamin D (25D), calcium, and alkaline phosphatase (ALP), in patients with moderate-to-severe CKD. METHODS: To determine guideline adherence, we used administrative claims records from the 20% sample of Medicare beneficiaries with Parts A, B, and D coverage, 2007 to 2015, and identified cohorts of patients with nondialysis stage 3, 4, or 5 CKD. Testing for biochemical markers during follow-up was defined based on laboratory procedure codes. Baseline factors associated with laboratory testing were determined using logistic regression. All analyses were performed separately by CKD stage. RESULTS: A total of 640,946 stage 3, 136,278 stage 4, and 22,076 stage 5 CKD patients, 50.2-52.9% women, mean age 74.4-78.0 years, were followed for a mean of 2.5, 1.3, and 0.7 years respectively. The frequency of testing was low for PTH (35.2-48.2%), phosphorus (46.6-62.0%), and 25D (29.3-46.7%). Testing was somewhat higher for calcium (88.1-95.4%) and ALP (63.5-88.1%); most tests were features of larger panels (e.g., basic metabolic panel). Older age, most comorbid conditions, and lack of prior nephrology care were associated with lower likelihood of testing. CONCLUSIONS: In fee-for-service Medicare beneficiaries, laboratory testing for CKD-MBD biochemical markers appears to be suboptimal in relation to KDIGO guidelines. Competing priories, such as management of comorbid disease and preparation for renal replacement therapy, may distract from CKD-MBD monitoring.

Prevalence, treatment patterns, and healthcare resource utilization in Medicare and commercially insured non-dialysis-dependent chronic kidney disease patients with and without anemia in the United States.

BACKGROUND: Anemia is common in non-dialysis-dependent chronic kidney disease (NDD-CKD) patients, but detailed information on prevalence and treatment is lacking. METHODS: We evaluated anemia prevalence and treatment using two datasets: the Medicare 20% random sample (ages 66-85 years), and the Truven Health MarketScan database (ages 18-63 years). We selected stage 3-5 NDD-CKD patients with and without anemia from both databases during 2011-2013. We evaluated anemia prevalence and treatment (erythropoietin stimulating agents [ESAs], intravenous [IV] iron, red blood cell [RBC] transfusions) following anemia diagnosis during a 1-year baseline period, and healthcare utilization during a 1-year follow-up period. We used Poisson regression models to compare healthcare utilization in patients with and without anemia, adjusting for demographics, baseline comorbid conditions, inflammatory conditions, and CKD stage. RESULTS: We identified 218,079 older and 56,188 younger stage 3-5 NDD-CKD patients. Anemia prevalence increased with age in both datasets; was higher in women, black patients (Medicare only), and patients with comorbid conditions; and rose sharply with increasing CKD stage. Of 15,716 younger anemic patients, 11.7%, 10.8%, and 9.4% were treated with RBC transfusion, ESAs, and IV iron, respectively. Corresponding proportions of 109,251 older anemic patients were 22.2%, 12.7%, and 6.7%. Regardless of age, anemic patients were more likely than non-anemic patients to use healthcare resources, including hospitalizations and emergency department, hematologist, nephrologist, and outpatient visits. Anemic NDD-CKD patients were more likely to be treated with RBC transfusion than with ESAs or IV iron. CONCLUSION: More research is necessary to determine best approaches to anemia management in CKD.

Readmissions Following a Hospitalization for Cardiovascular Events in Dialysis Patients: A Retrospective Cohort Study.

BACKGROUND: Hospitalization for cardiovascular disease (CVD) is common among patients receiving maintenance dialysis, but patterns of readmissions following cardiovascular events are underexplored. METHODS AND RESULTS: In this retrospective analysis of prevalent, Medicare-eligible patients receiving dialysis in 2012-2013, all live-discharge hospitalizations attributed to CVD were ascertained. Rates of all-cause, CVD-related, and non-CVD-related readmissions and death in the ensuing 10 and 30 days were calculated. Multinomial logistic modeling was used to assess the relationship between potential explanatory factors and outcomes of interest. Among 142 210 analyzed hospitalizations, mean age at time of index CVD hospitalization was 64.9±14.1 years; 50.4% of index hospitalizations were for women, and 41.4% were for white patients. Fully 15.6% and 34.2% of CVD hospitalizations resulted in readmission within 10 and 30 days, respectively; less than half of readmissions were CVD related (42.5%, 10 days; 43.1%, 30 days). Death within 30 days, regardless of readmission, occurred after 4.5% of index hospitalizations; 51.2% were attributed to CVD. Compared with ages 65 to 69 years, younger age tended to be associated with increased readmission risk (adjusted relative risk for ages 18-44 years: 1.55; 95% confidence interval, 1.48-1.63). Readmission risk did not differ between white and black patients, but risk of death without readmission was markedly lower for black patients (relative risk: 0.60; 95% confidence interval, 0.55-0.67). CONCLUSIONS: Roughly 1 in 3 CVD hospitalizations resulted in 30-day readmission; nearly 1 in 20 was followed by death within 30 days. Risk of death without readmission was higher for white than black patients, despite no difference in risk of readmission.

Factors Associated With Withdrawal From Maintenance Dialysis: A Case-Control Analysis.

BACKGROUND: Little is known about differences in the clinical course between patients receiving maintenance dialysis who do and do not withdraw from dialysis therapy. STUDY DESIGN: Case-control analysis. SETTING & PARTICIPANTS: US patients with Medicare coverage who received maintenance hemodialysis for 1 year or longer in 2008 through 2011. PREDICTORS: Comorbid conditions, hospitalizations, skilled nursing facility stays, and a morbidity score based on durable medical equipment claims. OUTCOME: Withdrawal from dialysis therapy. MEASUREMENTS: Rates of medical events, hospitalizations, skilled nursing facility stays, and a morbidity score. RESULTS: The analysis included 18,367 (7.7%) patients who withdrew and 220,443 (92.3%) who did not. Patients who withdrew were older (mean age, 75.3±11.5 [SD] vs 66.2±14.1 years) and more likely to be women and of white race, and had higher comorbid condition burdens. The odds of withdrawal among women were 7% (95% CI, 4%-11%) higher than among men. Compared to age 65 to 74 years, age 85 years or older was associated with higher adjusted odds of withdrawal (adjusted OR, 1.61; 95% CI, 1.54-1.68), and age 18 to 44 years with lower adjusted odds (adjusted OR, 0.36; 95% CI, 0.32-0.40). Blacks, Asians, and Hispanics were less likely to withdraw than whites (adjusted ORs of 0.36 [95% CI, 0.35-0.38], 0.47 [95% CI, 0.42-0.53], and 0.46 [95% CI, 0.44-0.49], respectively). A higher durable medical equipment claims-based morbidity score was associated with withdrawal, even after adjustment for traditional comorbid conditions and hospitalization; compared to a score of 0 (lowest presumed morbidity), adjusted ORs of withdrawal were 3.48 (95% CI, 3.29-3.67) for a score of 3 to 4 and 12.10 (95% CI, 11.37-12.87) for a score ≥7. Rates of medical events and institutionalization tended to increase in the months preceding withdrawal, as did morbidity score. LIMITATIONS: Results may not be generalizable beyond US Medicare patients; people who withdrew less than 1 year after dialysis therapy initiation were not studied. CONCLUSIONS: Women, older patients, and those of white race were more likely to withdraw from dialysis therapy. The period before withdrawal was characterized by higher rates of medical events and higher levels of morbidity.

Data completeness as an unmeasured confounder in dialysis facility performance comparison with 1-year follow-up
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;Aims: Standardized mortality and hospitalization ratios (SMRs, SHRs) are used to measure dialysis facility performance in the US, with adjustment for demographics and comorbid conditions derived from the end-stage renal disease (ESRD) Medical Evidence (ME) Report. Sensitivities are low for ME-based comorbidity, and levels of under-reporting may differ among facilities. We aimed to assess the effect of data inaccuracy on performance comparison. METHODS: Using the United States Renal Data System ESRD database, we included patients who initiated hemodialysis July 1 - December 31 in each of the years 2006 - 2010, had Medicare as primary payer, were aged ≥ 66 years, and had no prior transplant. Patients were followed from dialysis initiation to the earliest of death, transplant, modality change, or 1 year. SMRs and SHRs were calculated for for-profit/non-profit and rural/urban facilities for ME-based and claims-based comorbidity, separately. Cox models were used for expected number of deaths and piecewise Poison models for expected number of hospitalizations. Comorbidity agreement was measured by κ-statistic. Testing of differences between ME-based and claims-based SMRs/SHRs was performed by bootstrap. RESULTS: In all, 73,950 incident hemodialysis patients were included. κ-values for comorbidity agreement were low, < 0.5, except for diabetes (0.77). Percentages of claims-based comorbidity were similar for for-profit and non-profit facilities; ME-based comorbidity was lower for for-profit facilities. Differences between ME-based and claims-based SMRs/SHRs were statistically significant. Compared with ME-based SMRs/SHRs, claims-based ratios decreased 0.9/0.6% for for-profit and 1/0.7% for urban facilities and increased 3.4/2.8% for non-profit and 5.9/4.1% for rural facilities. CONCLUSIONS: Comorbidity data source may affect performance evaluation. The impact is larger for smaller groups.
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The incidence, prevalence, and outcomes of glomerulonephritis derived from a large retrospective analysis.

The incidence and period prevalence of glomerulonephritis (GN) with resultant rates of death and end-stage renal disease (ESRD) in the United States are unknown. Therefore, we assessed the presumptive burden of GN in a 20% Medicare sample, 5,442,495 individuals, and an Optum Clinformatics Employer Group Health Plan sample of 13,712,946 individuals. GN was established using International Classification of Diseases, Ninth Revision, Clinical Modification claims-based algorithms. Outcomes were all-cause mortality and ESRD rates. Cox proportional hazards modeling was used to determine factors associated with outcomes in incident patients. For secondary (systemic immunologic disease) and primary GN, respectively, incidence rates per 100,000 patient-years were 134 (95% CI: 132-136) and 57 (56-58) in the Medicare cohort, and 10 (9-10) and 20 (19-21) in the health plan cohort. Period prevalence per 100,000 individuals was 917 (909-952) and 306 (302-311) in Medicare and 52 (51-54) and 70 (68-71) in the health plan. Death rates in incident Medicare patients were 3.9-fold higher for secondary and 2.7-fold higher for primary GN compared with no GN. ESRD rates were typically 1 to 2 orders of magnitude higher compared with no GN. In the Medicare cohort, women with incident secondary GN were less likely than men to progress to ESRD (hazard ratio: 0.70; 95% CI: 0.62-0.80) and death (0.82; 0.79-0.86). Black patients were more likely than white patients to progress to ESRD (secondary GN, 1.56; 1.31-1.85; primary GN, 1.57; 1.35-1.83), but not to death. Thus, in the United States, GN based on health claims data is associated with increased likelihood of progression to ESRD and death.

Effects of Epoetin Alfa Titration Practices, Implemented After Changes to Product Labeling, on Hemoglobin Levels, Transfusion Use, and Hospitalization Rates.

BACKGROUND: Little is known about epoetin alfa (EPO) dosing at dialysis centers after implementation of the US Medicare prospective payment system and revision of the EPO label in 2011. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Approximately 412,000 adult hemodialysis patients with Medicare Parts A and B as primary payer in 2009 to 2012 to describe EPO dosing and hemoglobin patterns; of these, about 70,000 patients clustered in about 1,300 dialysis facilities to evaluate facility-level EPO titration practices and patient-level outcomes in 2012. PREDICTOR: Facility EPO titration practices when hemoglobin levels were <10 and >11g/dL (grouped treatment variable) determined from monthly EPO dosing and hemoglobin level patterns. OUTCOMES: Patient mean hemoglobin levels, red blood cell transfusion rates, and all-cause and cause-specific hospitalization rates using a facility-based analysis. MEASUREMENTS: Monthly EPO dose and hemoglobin level, red blood cell transfusion rates, and all-cause and cause-specific hospitalization rates. RESULTS: Monthly EPO doses declined across all hemoglobin levels, with the greatest decline in patients with hemoglobin levels < 10g/dL (July-October 2011). In 2012, nine distinct facility titration practices were identified. Across groups, mean hemoglobin levels differed slightly (10.5-10.8g/dL) but within-patient hemoglobin standard deviations were similar (∼0.68g/dL). Patients at facilities implementing greater dose reductions and smaller dose escalations had lower hemoglobin levels and higher transfusion rates. In contrast, patients at facilities that implemented greater dose escalations (and large or small dose reductions) had higher hemoglobin levels and lower transfusion rates. There were no clinically meaningful differences in all-cause or cause-specific hospitalization events across groups. LIMITATIONS: Possibly incomplete claims data; excluded small facilities and those without consistent titration patterns; hemoglobin levels reported monthly; inferred facility practice from observed dosing. CONCLUSIONS: Following prospective payment system implementation and labeling revisions, EPO doses declined significantly. Under the new label, facility EPO titration practices were associated with mean hemoglobin levels (but not standard deviations) and transfusion use, but not hospitalization rates.

Epoetin Alfa and Outcomes in Dialysis amid Regulatory and Payment Reform.

Erythropoiesis-stimulating agents (ESAs) are commonly used to treat anemia in patients with CKD, including those receiving dialysis, although clinical trials have identified risks associated with ESA use. We evaluated the effects of changes in dialysis payment policies and product labeling instituted in 2011 on mortality and major cardiovascular events across the United States dialysis population in an open cohort study of patients on dialysis from January 1, 2005, through December 31, 2012, with Medicare as primary payer. We compared observed rates of death and major cardiovascular events in 2011 and 2012 with expected rates calculated on the basis of rates in 2005-2010, accounting for differences in patient characteristics and influenza virulence. An abrupt decline in erythropoietin dosing and hemoglobin concentration began in late 2010. Observed rates of all-cause mortality, cardiovascular mortality, and myocardial infarction in 2011 and 2012 were consistent with expected rates. During 2012, observed rates of stroke, venous thromboembolic disease (VTE), and heart failure were lower than expected (absolute deviation from trend per 100 patient-years [95% confidence interval]: -0.24 [-0.08 to -0.37] for stroke, -2.43 [-1.35 to -3.70] for VTE, and -0.77 [-0.28 to -1.27] for heart failure), although non-ESA-related changes in practice and Medicare payment penalties for rehospitalization may have confounded the results. This initial evidence suggests that action taken to mitigate risks associated with ESA use and changes in payment policy did not result in a relative increase in death or major cardiovascular events and may reflect improvements in stroke, VTE, and heart failure.

Administrative Data and the Philosopher's Stone: Turning Heart Failure Claims Data into Quantitative Assessment of Left Ventricular Ejection Fraction.

BACKGROUND: Administrative data are widely used in observational assessment of patient-centered clinical outcomes. In studies of cardiovascular outcomes, claims data are limited by lack of quantitative information, such as left ventricular ejection fraction. We aimed to determine whether left ventricular ejection fraction can be assessed from heart failure claims. METHODS: This observational, retrospective study used administrative and echocardiographic databases to identify heart failure patients (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 428.XX) who received echocardiograms. The study cohort included patients with at least one inpatient or outpatient claim for systolic (428.2X) or diastolic (428.3X) heart failure from January 1, 2007, through July 10, 2013, who received an echocardiogram within 30 days of the claim. Receiver operating characteristic (ROC) curves were used to determine the optimal left ventricular ejection fraction cut-off threshold between ICD-9-CM heart failure codes 428.2 (systolic) and 428.3 (diastolic). Bootstrapping was used to determine a 95% confidence interval for the best cut-off. RESULTS: A total of 2714 echocardiograms with ascertainable left ventricular ejection fraction were performed within 30 days of a heart failure diagnosis. ICD-9-CM codes 428.2 and 428.3 accounted for 28.9% and 18.2%, respectively, of all heart failure codes. The resulting ROC curve had a best threshold cut-off for ejection fractions of 43.5% (confidence interval 39.5%-44.5%). The area under the curve was 0.812, with positive predictive value 0.72 and negative predictive value 0.81. CONCLUSIONS: Subject to study limitations, we conclude that assessing left ventricular ejection fraction using heart failure claims is possible.

Patient characteristics, disease burden, and medication use in stage 4 - 5 chronic kidney disease patients.

AIMS: We aimed to assess demographic characteristics, comorbidity and hospitalization burdens, laboratory abnormalities, and patterns of chronic kidney disease (CKD)-related medication use in a large cohort of patients with CKD stage 4 - 5. METHODS: In a retrospective cohort analysis, the Medicare 5% sample and Truven MarketScan employer group health plan databases were used to examine patients aged ≥ 65 and < 65 years, respectively. CKD was determined by ≥ 1 inpatient or ≥ 2 outpatient claims with relevant ICD-9-CM diagnosis codes during the 1-year baseline period. The follow-up period was 1 year from day 91 after the index date RESULTS: In the Medicare data, 12,930 (1.1%) CKD stage 4 - 5 patients were identified. Mean age was 79.2 ± 7.4 years; 56.1% were women and 83.1% white; 46.8% had atherosclerotic heart disease, and 36.9% congestive heart failure; 37.9% were hospitalized within 1 year. In the MarketScan data, 6,010 (0.04%) patients were identified. Mean age was 55.2 ± 8.8 years; 48.0% were women; 21.4% were hospitalized within 1 year. Heart failure was the leading cause of hospitalization for both groups. Parathyroid hormone levels were > 300 pg/mL for 39.1% of MarketScan patients, but only 20.9% received activated vitamin D. ESAs were administered to 28.2% of MarketScan patients with iron saturation < 30% and to 7.7% with hemoglobin > 11.5% and saturation ≥ 30%. CONCLUSIONS: Comorbidity burdens and hospitalization rates were high for patients with advanced, non-dialysis requiring CKD. While hyperparathyroidism and anemia were common, appropriate medication use was not optimal, suggesting opportunities for improved care.

Controlling confounding of treatment effects in administrative data in the presence of time-varying baseline confounders.

PURPOSE: Confounding, a concern in nonexperimental research using administrative claims, is nearly ubiquitous in claims-based pharmacoepidemiology studies. A fixed-length look-back window for assessing comorbidity from claims is common, but it may be advantageous to use all historical claims. We assessed how the strength of association between a baseline-identified condition and subsequent mortality varied by when the condition was measured and investigated methods to control for confounding. METHODS: For Medicare beneficiaries undergoing maintenance hemodialysis on 1 January 2008 (n = 222 343), we searched all Medicare claims, 1 January 2001 to 31 December 2007, for four conditions representing chronic and acute diseases, and classified claims by number of months preceding the index date. We used proportional hazard models to estimate the association between time of condition and subsequent mortality. We simulated a confounded comorbidity-exposure relationship and investigated an alternative method of adjustment when the association between the condition and mortality varied by proximity to follow-up start. RESULTS: The magnitude of the mortality hazard ratio estimates for each condition investigated decreased toward unity as time increased between index date and most recent manifestation of the condition. Simulation showed more biased estimates of exposure-outcome associations if proximity to follow-up start was not considered. CONCLUSIONS: Using all-available claims information during a baseline period, we found that for all conditions investigated, the association between a comorbid condition and subsequent mortality varied considerably depending on when the condition was measured. Improved confounding control may be achieved by considering the timing of claims relative to follow-up start.

Comorbidity ascertainment from the ESRD Medical Evidence Report and Medicare claims around dialysis initiation: a comparison using US Renal Data System data.

BACKGROUND: The end-stage renal disease Medical Evidence Report serves as a source of comorbid condition data for risk adjustment of quality metrics. We sought to compare comorbid condition data in the Medical Evidence Report around dialysis therapy initiation with diagnosis codes in Medicare claims. STUDY DESIGN: Observational cohort study using US Renal Data System data. SETTING & PARTICIPANTS: Medicare-enrolled elderly (≥66 years) patients who initiated maintenance dialysis therapy July 1 to December 31, 2007, 2008, or 2009. INDEX TESTS: 12 comorbid conditions ascertained from claims during the 6 months before dialysis therapy initiation, the Medical Evidence Report, and claims during the 3 months after dialysis therapy initiation. REFERENCE TEST: None. RESULTS: Comorbid condition prevalence according to claims before dialysis therapy initiation generally exceeded prevalence according to the Medical Evidence Report. The κ statistics for comorbid condition designations other than diabetes ranged from 0.06 to 0.43. Discordance of designations was associated with age, race, sex, and end-stage renal disease Network. During 23,930 patient-years of follow-up from 4 to 12 months after dialysis therapy initiation (8,930 deaths), designations from claims during the 3 months after initiation better discriminated risk of death than designations from the Medical Evidence Report (C statistics of 0.674 vs 0.616). Between the Medical Evidence Report and claims, standardized mortality ratios changed by >10% for more than half the dialysis facilities. LIMITATIONS: Neither the Medical Evidence Report nor diagnosis codes in claims constitute a gold standard of comorbid condition data; results may not apply to nonelderly patients or patients without Medicare coverage. CONCLUSIONS: Discordance of comorbid condition designations from the Medical Evidence Report and claims around dialysis therapy initiation was substantial and significantly associated with patient characteristics, including location. These patterns may engender bias in risk-adjusted quality metrics. In lieu of the Medical Evidence Report, claims during the 3 months after dialysis therapy initiation may constitute a useful source of comorbid condition data.

Red blood cell transfusion, hyperkalemia, and heart failure in advanced chronic kidney disease.

PURPOSE: In recent years, the use of red blood cell (RBC) transfusion for the treatment of chronic kidney disease (CKD)-related anemia has increased. We used the OptumInsight medical claims database to study the association between receiving a transfusion and hyperkalemia and heart failure events. METHODS: Persons 18-64 years of age with diagnosed stage 4 or 5 CKD (not requiring dialysis) between 2006 and 2010 were followed until their first hospitalization or emergency room visit with a diagnosis of hyperkalemia or heart failure, termination of insurance coverage, or death. We used a case-only design and conditional logistic regression to estimate rate ratios (RR) and 95% confidence intervals (CIs) describing associations between RBC transfusion and the risks of hyperkalemia or heart failure. We used single (1:1) and variable (1:m) self-control matching intervals, with adjustment for time-varying confounders. RESULTS: Seven thousand eight hundred twenty-nine individuals met our inclusion criteria; two-thirds were age 50 years or older; 43% were women and 51% had diabetes. Rates of hyperkalemia and heart failure were 7.9/100 person-years (95%CI: 7.3, 8.5) and 16.3/100 person-years (95%CI: 15.5, 17.2), respectively. RBC transfusion was associated with an increased risk of both hyperkalemia (single interval matched RR = 12.0, 95%CI: 1.3, 109; multiple interval matched RR = 6.1, 95%CI: 2.5, 15.1) and heart failure (single interval matched RR = 1.7, 95%CI: 0.3, 9.2; multiple interval matched RR = 3.8, 95%CI: 1.4, 10.3). CONCLUSION: In patients with advanced CKD, RBC transfusion appears to be associated with an elevated risk of hyperkalemia and heart failure; further investigation into these risks is warranted.