Pay-for-Performance Incentives for Home Dialysis Use and Kidney Transplant.

Importance: The Centers for Medicare & Medicaid Services' mandatory End-Stage Renal Disease Treatment Choices (ETC) model, launched on January 1, 2021, randomly assigned approximately 30% of US dialysis facilities and managing clinicians to financial incentives to increase the use of home dialysis and kidney transplant. Objective: To assess the ETC's association with use of home dialysis and kidney transplant during the model's first 2 years and examine changes in these outcomes by race, ethnicity, and socioeconomic status. Design, Setting, and Participants: This retrospective cross-sectional study used claims and enrollment data for traditional Medicare beneficiaries with kidney failure from 2017 to 2022 linked to same-period transplant data from the United Network for Organ Sharing. The study data span 4 years (2017-2020) before the implementation of the ETC model on January 1, 2021, and 2 years (2021-2022) following the model's implementation. Exposure: Receiving dialysis treatment in a region randomly assigned to the ETC model. Main Outcomes and Measures: Primary outcomes were use of home dialysis and kidney transplant. A difference-in-differences (DiD) approach was used to estimate changes in outcomes among patients treated in regions randomly selected for ETC participation compared with concurrent changes among patients treated in control regions. Results: The study population included 724 406 persons with kidney failure (mean [IQR] age, 62.2 [53-72] years; 42.5% female). The proportion of patients receiving home dialysis increased from 12.1% to 14.3% in ETC regions and from 12.9% to 15.1% in control regions, yielding an adjusted DiD estimate of -0.2 percentage points (pp; 95% CI, -0.7 to 0.3 pp). Similar analysis for transplant yielded an adjusted DiD estimate of 0.02 pp (95% CI, -0.01 to 0.04 pp). When further stratified by sociodemographic measures, including age, sex, race and ethnicity, dual Medicare and Medicaid enrollment, and poverty quartile, there was not a statistically significant difference in home dialysis use across joint strata of characteristics and ETC participation. Conclusions and Relevance: In this cross-sectional study, the first 2 years of the ETC model were not associated with increased use of home dialysis or kidney transplant, nor changes in racial, ethnic, and socioeconomic disparities in these outcomes.

Social Risk and Dialysis Facility Performance in the First Year of the ESRD Treatment Choices Model.

Importance: The End-Stage Renal Disease Treatment Choices (ETC) model randomly selected 30% of US dialysis facilities to receive financial incentives based on their use of home dialysis, kidney transplant waitlisting, or transplant receipt. Facilities that disproportionately serve populations with high social risk have a lower use of home dialysis and kidney transplant raising concerns that these sites may fare poorly in the payment model. Objective: To examine first-year ETC model performance scores and financial penalties across dialysis facilities, stratified by their incident patients' social risk. Design, Setting, and Participants: A cross-sectional study of 2191 US dialysis facilities that participated in the ETC model from January 1 through December 31, 2021. Exposure: Composition of incident patient population, characterized by the proportion of patients who were non-Hispanic Black, Hispanic, living in a highly disadvantaged neighborhood, uninsured, or covered by Medicaid at dialysis initiation. A facility-level composite social risk score assessed whether each facility was in the highest quintile of having 0, 1, or at least 2 of these characteristics. Main Outcomes and Measures: Use of home dialysis, waitlisting, or transplant; model performance score; and financial penalization. Results: Using data from 125 984 incident patients (median age, 65 years [IQR, 54-74]; 41.8% female; 28.6% Black; 11.7% Hispanic), 1071 dialysis facilities (48.9%) had no social risk features, and 491 (22.4%) had 2 or more. In the first year of the ETC model, compared with those with no social risk features, dialysis facilities with 2 or more had lower mean performance scores (3.4 vs 3.6, P = .002) and lower use of home dialysis (14.1% vs 16.0%, P < .001). These facilities had higher receipt of financial penalties (18.5% vs 11.5%, P < .001), more frequently had the highest payment cut of 5% (2.4% vs 0.7%; P = .003), and were less likely to achieve the highest bonus of 4% (0% vs 2.7%; P < .001). Compared with all other facilities, those in the highest quintile of treating uninsured patients or those covered by Medicaid experienced more financial penalties (17.4% vs 12.9%, P = .01) as did those in the highest quintile in the proportion of patients who were Black (18.5% vs 12.6%, P = .001). Conclusions: In the first year of the Centers for Medicare & Medicaid Services' ETC model, dialysis facilities serving higher proportions of patients with social risk features had lower performance scores and experienced markedly higher receipt of financial penalties.

Medicare Advantage Enrollment Among Beneficiaries With End-Stage Renal Disease in the First Year of the 21st Century Cures Act.

Importance: Before 2021, most Medicare beneficiaries with end-stage renal disease (ESRD) were unable to enroll in private Medicare Advantage (MA) plans. The 21st Century Cures Act permitted these beneficiaries to enroll in MA plans effective January 2021. Objective: To examine changes in MA enrollment among Medicare beneficiaries with ESRD after enactment of the 21st Century Cures Act overall and by race or ethnicity and dual-eligible status. Design, Setting, and Participants: This cross-sectional time-trend study used data from Medicare beneficiaries with ESRD (both kidney transplant recipients and those undergoing dialysis) between January 2019 and December 2021. Data were analyzed between June and October 2022. Exposures: 21st Century Cures Act. Main Outcomes and Measures: Primary outcomes were the proportion of Medicare beneficiaries with prevalent ESRD who switched from traditional Medicare to MA between 2020 and 2021 and those with incident ESRD who newly enrolled in MA in 2021. Individuals who stayed in traditional Medicare were enrolled in 2020 and 2021 and those who switched to MA were enrolled in traditional Medicare in 2020 and MA in 2021. Results: Among 575 797 beneficiaries with ESRD in 2020 or 2021 (mean [SD] age, 64.7 [14.2] years, 42.2% female, 34.0% Black, and 7.7% Hispanic or Latino), the proportion of beneficiaries enrolled in MA increased from 24.8% (December 2020) to 37.4% (December 2021), a relative change of 50.8%. The largest relative increases in MA enrollment were among Black (72.8% relative increase), Hispanic (44.8%), and dual-eligible beneficiaries with ESRD (73.6%). Among 359 617 beneficiaries with TM and prevalent ESRD in 2020, 17.6% switched to MA in 2021. Compared with individuals who stayed in traditional Medicare, those who switched to MA had modestly more chronic conditions (6.3 vs 6.1; difference, 0.12 conditions [95% CI, 0.10-0.16]) and similar nondrug spending in 2020 (difference, $509 [95% CI, -$58 to $1075]) but were more likely to be Black (difference, 19.5 percentage points [95% CI, 19.1-19.9]) and have dual Medicare-Medicaid eligibility (difference, 20.8 percentage points [95% CI, 20.4-21.2]). Among beneficiaries who were newly eligible for Medicare ESRD benefits in 2021, 35.2% enrolled in MA. Conclusions and Relevance: Results suggest that increases in MA enrollment among Medicare beneficiaries with ESRD were substantial the first year after the 21st Century Cures Act, particularly among Black, Hispanic, and dual-eligible individuals. Policy makers and MA plans may need to assess network adequacy, disenrollment, and equity of care for beneficiaries who enrolled in MA.

Medicaid Expansion and Medicare-Financed Hospitalizations Among Adult Patients With Incident Kidney Failure.

Importance: Although Medicare provides health insurance coverage for most patients with kidney failure in the US, Medicare beneficiaries who initiate dialysis without supplemental coverage are exposed to substantial out-of-pocket costs. The availability of expanded Medicaid coverage under the Patient Protection and Affordable Care Act (ACA) for adults with kidney failure may improve access to care and reduce Medicare-financed hospitalizations after dialysis initiation. Objective: To examine the implications of the ACA's Medicaid expansion for Medicare-financed hospitalizations, health insurance coverage, and predialysis nephrology care among Medicare-covered adults aged 19 to 64 years with incident kidney failure in the first year after initiating dialysis. Design, Setting, and Participants: This cross-sectional study used a difference-in-differences approach to assess Medicare-financed hospitalizations among adults aged 19 to 64 years who initiated dialysis between January 1, 2010, and December 31, 2018, while covered by Medicare Part A (up to 5 years postexpansion). Data on patients were obtained from the Renal Management Information System's End Stage Renal Disease Medical Evidence Report, which includes data for all patients initiating outpatient maintenance dialysis regardless of health insurance coverage, treatment modality, or citizenship status, and these data were linked with claims data from the Medicare Provider Analysis and Review. Data were analyzed from January to August 2022. Exposure: Living in a Medicaid expansion state. Main Outcomes and Measures: Primary outcomes were number of Medicare-financed hospitalizations and hospital days in the first 3 months, 6 months, and 12 months after dialysis initiation. Secondary outcomes included dual Medicare and Medicaid coverage at 91 days after dialysis initiation and the presence of an arteriovenous fistula or graft at dialysis initiation for patients undergoing hemodialysis. Results: The study population included 188 671 adults, with 97 071 living in Medicaid expansion states (mean [SD] age, 53.4 [9.4] years; 58 329 men [60.1%]) and 91 600 living in nonexpansion states (mean [SD] age, 53.0 [9.6] years; 52 677 men [57.5%]). In the first 3 months after dialysis initiation, Medicaid expansion was associated with a significant decrease in Medicare-financed hospitalizations (-4.24 [95% CI, -6.70 to -1.78] admissions per 100 patient-years; P = .001) and hospital days (-0.73 [95% CI, -1.08 to -0.39] days per patient-year; P < .001), relative reductions of 8% for both outcomes. Medicaid expansion was associated with a 2.58-percentage point (95% CI, 0.88-4.28 percentage points; P = .004) increase in dual Medicare and Medicaid coverage at 91 days after dialysis initiation and a 1.65-percentage point (95% CI, 0.31-3.00 percentage points; P = .02) increase in arteriovenous fistula or graft at initiation. Conclusions and Relevance: In this cross-sectional study with a difference-in-differences analysis, the ACA's Medicaid expansion was associated with decreases in Medicare-financed hospitalizations and hospital days and increases in dual Medicare and Medicaid coverage. These findings suggest favorable spillover outcomes of Medicaid expansion to Medicare-financed care, which is the primary payer for patients with kidney failure.

Comparison of mortality between Medicare Advantage and traditional Medicare beneficiaries with kidney failure.

OBJECTIVES: To compare risk-adjusted 1-year mortality between Medicare Advantage (MA) and traditional Medicare (TM) enrollees with kidney failure who initiated dialysis. STUDY DESIGN: Longitudinal analysis of mortality and enrollment data for Medicare beneficiaries. METHODS: The study compared mortality between MA and TM enrollees with kidney failure who initiated dialysis in 2016, accounting for their enrollment switches between MA and TM during 12 months prior to dialysis initiation. Analyses were adjusted for risk scores and fixed effects for the month of dialysis initiation and county of residence. RESULTS: The difference in risk-adjusted 1-year mortality between MA stayers (Medicare beneficiaries who were continuously enrolled in MA prior to dialysis initiation) and TM stayers (those who were continuously enrolled in TM prior to initiating dialysis) was -0.1 percentage points (95% CI, -1.0 to 0.8); however, the difference increased to -1.0 percentage points (95% CI, -3.2 to 1.2) when comparing TM-to-MA switchers (those who switched from TM to MA before initiation) with TM stayers, a comparison more prone to favorable selection bias given our finding that TM-to-MA switchers were healthier than MA stayers. CONCLUSIONS: Among Medicare beneficiaries with kidney failure who initiated dialysis, risk-adjusted 1-year mortality rate is not different between MA and TM stayers. If there is remaining favorable selection in MA due to unobserved health status, our finding provides a lower-bound estimate of the MA impact on mortality among beneficiaries with kidney failure.

Despite National Declines In Kidney Failure Incidence, Disparities Widened Between Low- And High-Poverty US Counties.

National estimates suggest that kidney failure incidence is declining in the US. However, whether this trend is evident in areas with socioeconomic disadvantage is unknown. We examined trends in kidney failure incidence by county-level poverty between 2000 and 2017 and divided the study period into period 1 (2000-05), period 2 (2006-11), and period 3 (2012-17). The magnitude of disparity in kidney failure incidence between high- and low-poverty counties increased from 42.8 more incident cases per million in high-poverty counties in period 1 to 100.1 more in period 3. Despite a national decline, kidney failure incidence increased in high-poverty counties, and disparities between high- and low-poverty counties widened from 2000 to 2017. Achieving the Department of Health and Human Services objective of reducing incident kidney failure cases by 25 percent by 2030 will require focused attention on preventing kidney failure in counties with higher poverty.

Evaluation of Racial, Ethnic, and Socioeconomic Disparities in Initiation of Kidney Failure Treatment During the First 4 Months of the COVID-19 Pandemic.

Importance: Persons with kidney failure require treatment (ie, dialysis or transplantation) for survival. The burden of the COVID-19 pandemic and pandemic-related disruptions in care have disproportionately affected racial and ethnic minority and socially disadvantaged populations, raising the importance of understanding disparities in treatment initiation for kidney failure during the pandemic. Objective: To examine changes in the number and demographic characteristics of patients initiating treatment for incident kidney failure following the COVID-19 pandemic by race and ethnicity, county-level COVID-19 mortality rate, and neighborhood-level social disadvantage. Design, Setting, and Participants: This cross-sectional time-trend study used data from US patients who developed kidney failure between January 1, 2018, and June 30, 2020. Data were analyzed between January and July 2021. Exposures: COVID-19 pandemic. Main Outcomes and Measures: Number of patients initiating treatment for incident kidney failure and mean estimated glomerular filtration rate (eGFR) at treatment initiation. Results: The study population included 127 149 patients with incident kidney failure between January 1, 2018, and June 30, 2020 (mean [SD] age, 62.8 [15.3] years; 53 021 [41.7%] female, 32 932 [25.9%] non-Hispanic Black, and 19 835 [15.6%] Hispanic/Latino patients). Compared with the pre-COVID-19 period, in the first 4 months of the pandemic (ie, March 1 through June 30, 2020), there were significant decreases in the proportion of patients with incident kidney failure receiving preemptive transplantation (1805 [2.1%] pre-COVID-19 vs 551 [1.4%] during COVID-19; P < .001) and initiating hemodialysis treatment with an arteriovenous fistula (2430 [15.8%] pre-COVID-19 vs 914 [13.4%] during COVID-19; P < .001). The mean (SD) eGFR at initiation declined from 9.6 (5.0) mL/min/1.73 m2 to 9.5 (4.9) mL/min/1.73 m2 during the pandemic (P < .001). In stratified analyses by race/ethnicity, these declines were exclusively observed among non-Hispanic Black patients (mean [SD] eGFR: 8.4 [4.6] mL/min/1.73 m2 pre-COVID-19 vs 8.1 [4.5] mL/min/1.73 m2 during COVID-19; P < .001). There were significant declines in eGFR at initiation for patients residing in counties in the highest quintile of COVID-19 mortality rates (9.5 [5.0] mL/min/1.73 m2 pre-COVID-19 vs 9.2 [5.0] mL/min/1.73 m2 during COVID-19; P < .001), but not for patients residing in other counties. The number of patients initiating treatment for incident kidney failure was approximately 30% lower than projected in April 2020. Conclusions and Relevance: In this cross-sectional study of US adults, the COVID-19 pandemic was associated with a substantially lower number of patients initiating treatment for incident kidney failure and treatment initiation at lower levels of kidney function during the first 4 months, particularly for Black patients and people living in counties with high COVID-19 mortality rates.

Medicaid Expansion and Incidence of Kidney Failure among Nonelderly Adults.

BACKGROUND: Low-income individuals without health insurance have limited access to health care. Medicaid expansions may reduce kidney failure incidence by improving access to chronic disease care. METHODS: Using a difference-in-differences analysis, we examined the association between Medicaid expansion status under the Affordable Care Act (ACA) and the kidney failure incidence rate among all nonelderly adults, aged 19-64 years, in the United States, from 2012 through 2018. We compared changes in kidney failure incidence in states that implemented Medicaid expansions with concurrent changes in nonexpansion states during pre-expansion, early postexpansion (years 2 and 3 postexpansion), and later postexpansion (years 4 and 5 postexpansion). RESULTS: The unadjusted kidney failure incidence rate increased in the early years of the study period in both expansion and nonexpansion states before stabilizing. After adjustment for population sociodemographic characteristics, Medicaid expansion status was associated with 2.20 fewer incident cases of kidney failure per million adults per quarter in the early postexpansion period (95% CI, -3.89 to -0.51) compared with nonexpansion status, a 3.07% relative reduction (95% CI, -5.43% to -0.72%). In the later postexpansion period, Medicaid expansion status was not associated with a statistically significant change in kidney failure incidence (-0.56 cases per million per quarter; 95% CI, -2.71 to 1.58) compared with nonexpansion status and the pre-expansion time period. CONCLUSIONS: The ACA Medicaid expansion was associated with an initial reduction in kidney failure incidence among the entire, nonelderly, adult population in the United States; but the changes did not persist in the later postexpansion period. Further study is needed to determine the long-term association between Medicaid expansion and changes in kidney failure incidence.

The current and future landscape of dialysis.

The development of dialysis by early pioneers such as Willem Kolff and Belding Scribner set in motion several dramatic changes in the epidemiology, economics and ethical frameworks for the treatment of kidney failure. However, despite a rapid expansion in the provision of dialysis - particularly haemodialysis and most notably in high-income countries (HICs) - the rate of true patient-centred innovation has slowed. Current trends are particularly concerning from a global perspective: current costs are not sustainable, even for HICs, and globally, most people who develop kidney failure forego treatment, resulting in millions of deaths every year. Thus, there is an urgent need to develop new approaches and dialysis modalities that are cost-effective, accessible and offer improved patient outcomes. Nephrology researchers are increasingly engaging with patients to determine their priorities for meaningful outcomes that should be used to measure progress. The overarching message from this engagement is that while patients value longevity, reducing symptom burden and achieving maximal functional and social rehabilitation are prioritized more highly. In response, patients, payors, regulators and health-care systems are increasingly demanding improved value, which can only come about through true patient-centred innovation that supports high-quality, high-value care. Substantial efforts are now underway to support requisite transformative changes. These efforts need to be catalysed, promoted and fostered through international collaboration and harmonization.

Association of Medicaid Expansion With 1-Year Mortality Among Patients With End-Stage Renal Disease.

Importance: The Affordable Care Act Medicaid expansion may be associated with reduced mortality, but evidence to date is limited. Patients with end-stage renal disease (ESRD) are a high-risk group that may be particularly affected by Medicaid expansion. Objective: To examine the association of Medicaid expansion with 1-year mortality among nonelderly patients with ESRD initiating dialysis. Design, Setting, and Participants: Difference-in-differences analysis of nonelderly patients initiating dialysis in Medicaid expansion and nonexpansion states from January 2011 to March 2017. Exposure: Living in a Medicaid expansion state. Main Outcomes and Measures: The primary outcome was 1-year mortality. Secondary outcomes were insurance, predialysis nephrology care, and type of vascular access for hemodialysis. Results: A total of 142 724 patients in expansion states (mean age, 50.2 years; 40.2% women) and 93 522 patients in nonexpansion states (mean age, 49.7; 42.4% women) were included. In Medicaid expansion states, 1-year mortality following dialysis initiation declined from 6.9% in the preexpansion period to 6.1% after expansion (change, -0.8 percentage points; 95% CI, -1.1 to -0.5). In nonexpansion states, mortality rates were 7.0% before expansion and 6.8% after expansion (change, -0.2 percentage points; 95% CI, -0.5 to 0.2), yielding an adjusted absolute reduction in mortality in expansion states of -0.6 percentage points (95% CI, -1.0 to -0.2). Mortality reductions were largest for black patients (-1.4 percentage points; 95% CI, -2.2, -0.7; P=.04 for interaction) and patients aged 19 to 44 years (-1.1 percentage points; 95% CI, -2.1 to -0.3; P=.01 for interaction). Expansion was associated with a 10.5-percentage-point (95% CI, 7.7-13.2) increase in Medicaid coverage at dialysis initiation, a -4.2-percentage-point (95% CI, -6.0 to -2.3) decrease in being uninsured, and a 2.3-percentage-point (95% CI, 0.6-4.1) increase in the presence of an arteriovenous fistula or graft. Changes in predialysis nephrology care were not significant. Conclusions and Relevance: Among patients with ESRD initiating dialysis, living in a state that expanded Medicaid under the Affordable Care Act was associated with lower 1-year mortality. If this association is causal, further research is needed to understand what factors may have contributed to this finding.

Peritoneal dialysis education: Challenges and innovation.

Peritoneal dialysis is the most common modality for home dialysis and to ensure patients have access to dialysis at home, training programs have to ensure that the fellows attain clinical competency in the care of such patients. The limited data available however are sobering; about 10 years ago, 44% of nephrologists reported that they did not feel competent in the care of patients undergoing peritoneal dialysis. There are recognizable challenges in ensuring clinical competency of trainees that may need creative solutions. It is important for training program directors to evaluate the state of training at their institution, identify their unique barriers, and work to overcome them in the interest of ensuring that fellows are trained in all aspects of nephrology.

Components of A Successful Peritoneal Dialysis Program.

Although varying widely among different countries and geographic regions, the development of peritoneal dialysis invariably requires a well-established program. Key ingredients for the successful delivery of this therapy include adequate chronic kidney disease education, governmental or nongovernmental reimbursement, qualified physicians and nurses trained in the principles and practice of peritoneal dialysis, clinical management that incorporates an excellent and well-trained peritoneal dialysis team, a feasible and well-designed program for catheter insertion, a sound patient training and follow-up scheme, and continuous quality improvement. Some programs are enhanced by an active clinical research portfolio and other appropriate supportive systems. All of these factors are interlinked and inseparable from one another in ensuring a high-quality peritoneal dialysis program.

Changes in the worldwide epidemiology of peritoneal dialysis.

As the global burden of chronic kidney disease continues to increase, so does the need for a cost-effective renal replacement therapy. In many countries, patient outcomes with peritoneal dialysis are comparable to or better than those with haemodialysis, and peritoneal dialysis is also more cost-effective. These benefits have not, however, always led to increased utilization of peritoneal dialysis. Use of this therapy is increasing in some countries, including China, the USA and Thailand, but has proportionally decreased in parts of Europe and in Japan. The variable trends in peritoneal dialysis use reflect the multiple challenges in prescribing this therapy to patients. Key strategies for facilitating peritoneal dialysis utilization include implementation of policies and incentives that favour this modality, enabling the appropriate production and supply of peritoneal dialysis fluid at a low cost, and appropriate training for nephrologists to enable increased utilization of the therapy and to ensure that rates of technique failure continue to decline. Further growth in peritoneal dialysis use is required to enable this modality to become an integral part of renal replacement therapy programmes worldwide.

The Evolving Ethics of Dialysis in the United States: A Principlist Bioethics Approach.

Throughout the history of dialysis, four bioethical principles - beneficence, nonmaleficence, autonomy and justice - have been weighted differently based upon changing forces of technologic innovation, resource limitation, and societal values. In the 1960s, a committee of lay people in Seattle attempted to fairly distribute a limited number of maintenance hemodialysis stations guided by considerations of justice. As technology advanced and dialysis was funded under an amendment to the Social Security Act in 1972, focus shifted to providing dialysis for all in need while balancing the burdens of treatment and quality of life, supported by the concepts of beneficence and nonmaleficence. At the end of the last century, the importance of patient preferences and personal values became paramount in medical decisions, reflecting a focus on the principle of autonomy. More recently, greater recognition that health care financial resources are limited makes fair allocation more pressing, again highlighting the importance of distributive justice. The varying application and prioritization of these four principles to both policy and clinical decisions in the United States over the last 50 years makes the history of hemodialysis an instructive platform for understanding principlist bioethics. As medical technology evolves in a landscape of changing personal and societal values, a comprehensive understanding of an ethical framework for evaluating appropriate use of medical interventions enables the clinician to systematically negotiate and optimize difficult ethical situations.

ISPD Cardiovascular and Metabolic Guidelines in Adult Peritoneal Dialysis Patients Part I - Assessment and Management of Various Cardiovascular Risk Factors.

Cardiovascular disease contributes significantly to the adverse clinical outcomes of peritoneal dialysis (PD) patients. Numerous cardiovascular risk factors play important roles in the development of various cardiovascular complications. Of these, loss of residual renal function is regarded as one of the key cardiovascular risk factors and is associated with an increased mortality and cardiovascular death. It is also recognized that PD solutions may incur significant adverse metabolic effects in PD patients. The International Society for Peritoneal Dialysis (ISPD) commissioned a global workgroup in 2012 to formulate a series of recommendations regarding lifestyle modification, assessment and management of various cardiovascular risk factors, as well as management of the various cardiovascular complications including coronary artery disease, heart failure, arrhythmia (specifically atrial fibrillation), cerebrovascular disease, peripheral arterial disease and sudden cardiac death, to be published in 2 guideline documents. This publication forms the first part of the guideline documents and includes recommendations on assessment and management of various cardiovascular risk factors. The documents are intended to serve as a global clinical practice guideline for clinicians who look after PD patients. The ISPD workgroup also identifies areas where evidence is lacking and further research is needed.

Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.

The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembled a work group composed of clinicians and scientists representing academia, the FDA, and the pharmaceutical and dialysis industries with expertise related to pharmacokinetics, AKI, and/or CRRT. The work group critically evaluated key considerations in the assessment of pharmacokinetics and drug dosing in CRRT, practical constraints related to conducting pharmacokinetic studies in critically ill patients, and the generalizability of observations made in the context of specific CRRT prescriptions and specific patient populations in order to identify efficient study designs capable of addressing the knowledge deficit without impeding drug development. Considerations for the standardized assessment of pharmacokinetics and development of corresponding drug dosing recommendations in critically ill patients with AKI receiving CRRT are proposed.

Effect of Medicare dialysis payment reform on use of erythropoiesis stimulating agents.

OBJECTIVE: In 2011, the Centers for Medicare and Medicaid Services (CMS) replaced fee-for-service reimbursement for erythropoiesis stimulating agents (ESAs) with a fixed-sum bundled payment for all dialysis-related care and pay-for-performance incentives to discourage maintaining patients' hematocrits above 36 percent. We examined the impact of the new payment policy on the use of ESAs. DATA SOURCES: CMS's Renal Information Management System. STUDY DESIGN: Regression discontinuity design assessing the use of ESAs by hematocrit level before and after the implementation of the payment policy change. DATA EXTRACTION: Secondary data from 424,163 patients receiving hemodialysis treatment between January 2009 and June 2011. PRINCIPAL FINDINGS: The introduction of bundled payments with pay-for-performance initiatives was associated with an immediate and substantial decline in the use of ESAs among patients with hematocrit >36 percent and little change in the use of ESAs among patients with hematocrit ≤36 percent. In the first two quarters of 2011, the use of ESAs during dialysis fell by about 7-9 percentage points among patients with hematocrit levels >36 percent. No statistically significant differences in ESA use were observed at the thresholds of 30 or 33 percent. CONCLUSIONS: CMS's payment reform for dialysis care reduced the use of ESAs in patients who may not benefit from these agents.

The changing landscape of home dialysis in the United States.

PURPOSE OF REVIEW: To discuss the changing landscape of home dialysis in the United States over the past decade, including recent research on clinical outcomes in patient undergoing peritoneal dialysis and home hemodialysis, and to describe the impact of recent payment reforms for patients with end-stage renal disease. RECENT FINDINGS: Accumulating evidence supports the conclusion that clinical outcomes for patients treated with peritoneal dialysis or home hemodialysis are as good as or better than for patients treated with conventional in-center hemodialysis. The recent implementation of the Medicare-expanded prospective payment system for the care of end-stage renal disease patients has resulted in substantial growth in the utilization of peritoneal dialysis in the United States. Utilization of home hemodialysis has also grown, but the contribution of the expanded prospective payment system to this growth is less certain. SUMMARY: Home dialysis, including peritoneal dialysis and home hemodialysis, represents an important alternative to in-center hemodialysis that is effective and patient-centered. Over the coming decade, the growth in the number of end-stage renal disease patient treated with home dialysis modalities should prompt further comparative and cost-effectiveness research, increased attention to racial and ethnic disparities, and investments in home dialysis education for both patients and providers. VIDEO ABSTRACT: http://links.lww.com/CONH/A13.