Strategies to Reduce Rehospitalization in Patients with CKD and Kidney Failure.

Readmissions in patients with nondialysis-dependent CKD and kidney failure are common and are associated with significant morbidity, mortality, and economic consequences. In 2013, the Centers for Medicare and Medicaid Services implemented the Hospital Readmissions Reduction Program in an attempt to reduce high hospitalization-associated costs. Up to 50% of all readmissions are deemed avoidable and present an opportunity for intervention. We describe factors that are specific to the patient, the index hospitalization, and underlying conditions that help identify the "high-risk" patient. Early follow-up care, developing volume management strategies, optimizing nutrition, obtaining palliative care consultations for seriously ill patients during hospitalization and conducting goals-of-care discussions with them, instituting systematic advance care planning during outpatient visits to avoid unwanted hospitalizations and intensive treatment at the end of life, and developing protocols for patients with incident or prevalent cardiovascular conditions may help prevent avoidable readmissions in patients with kidney disease.

A quick scoping review of efficacy, safety, economic, and health-related quality-of-life outcomes of short- and long-acting erythropoiesis-stimulating agents in the treatment of chemotherapy-induced anemia and chronic kidney disease anemia.

Erythropoiesis-stimulating agents (ESAs) are man-made forms of erythropoietin used in the treatment of anemia. This quick-scoping review of systematic literature reviews (SLRs) was conducted to define the clinical, economic, and health-related quality of life (HRQoL) outcomes for short-acting and long-acting ESAs in patients with chronic kidney disease-induced anemia (CKD-IA) and patients with chemotherapy-induced anemia (CIA). Embase, Medline, and the Cochrane Database of Systematic Reviews were searched from their establishment until October 2017. SLRs related to the use of short-acting and long-acting ESAs in the treatment of CIA and CKD-IA were included. Forty-eight studies met the inclusion criteria. The evidence suggests little difference in efficacy, HRQoL, and safety outcomes among ESA types. Cost-effectiveness and market price are likely to become determining factors driving the choice of agent. Comparative studies and costing models accounting for the utilization of biosimilars are needed to establish which ESAs are more cost-effective.

Rebasing the Medicare payment for dialysis: rationale, challenges, and opportunities.

After Medicare's implementation of the bundled payment for dialysis in 2011, there has been a predictable decrease in the use of intravenous drugs included in the bundle. The change in use of erythropoiesis-stimulating agents, which decreased by 37% between 2007, when its allowance in the bundle was calculated, and 2012, was because of both changes in the Food and Drug Administration labeling for erythropoiesis-stimulating agents in 2011 and cost-containment efforts at the facility level. Legislation in 2012 required Medicare to decrease (rebase) the bundled payment for dialysis in 2014 to reflect this decrease in intravenous drug use, which amounted to a cut of 12% or $30 per treatment. Medicare subsequently decided to phase in this decrease in payment over several years to offset the increase in dialysis payment that would otherwise have occurred with inflation. A 3% reduction from the rebasing would offset an approximately 3% increase in the market basket that determines a facility's costs for 2014 and 2015. Legislation in March of 2014 provides that the rebasing will result in a 1.25% decrease in the market basket adjustment in 2016 and 2017 and a 1% decrease in the market basket adjustment in 2018 for an aggregate rebasing of 9.5% spread over 5 years. Adjusting to this payment decrease in inflation-adjusted dollars will be challenging for many dialysis providers in an industry that operates at an average 3%-4% margin. Closure of facilities, decreases in services, and increased consolidation of the industry are possible scenarios. Newer models of reimbursement, such as ESRD seamless care organizations, offer dialysis providers the opportunity to align incentives between themselves, nephrologists, hospitals, and other health care providers, potentially improving outcomes and saving money, which will be shared between Medicare and the participating providers.

Recovery of renal function among ESRD patients in the US medicare program.

BACKGROUND: Patients started on long term hemodialysis have typically had low rates of reported renal recovery with recent estimates ranging from 0.9-2.4% while higher rates of recovery have been reported in cohorts with higher percentages of patients with acute renal failure requiring dialysis. STUDY DESIGN: Our analysis followed approximately 194,000 patients who were initiated on hemodialysis during a 2-year period (2008 & 2009) with CMS-2728 forms submitted to CMS by dialysis facilities, cross-referenced with patient record updates through the end of 2010, and tracked through December 2010 in the CMS SIMS registry. RESULTS: We report a sustained renal recovery (i.e no return to ESRD during the available follow up period) rate among Medicare ESRD patients of > 5% - much higher than previously reported. Recovery occurred primarily in the first 2 months post incident dialysis, and was more likely in cases with renal failure secondary to etiologies associated with acute kidney injury. Patients experiencing sustained recovery were markedly less likely than true long-term ESRD patients to have permanent vascular accesses in place at incident hemodialysis, while non-White patients, and patients with any prior nephrology care appeared to have significantly lower rates of renal recovery. We also found widespread geographic variation in the rates of renal recovery across the United States. CONCLUSIONS: Renal recovery rates in the US Medicare ESRD program are higher than previously reported and appear to have significant geographic variation. Patients with diagnoses associated with acute kidney injury who are initiated on long-term hemodialysis have significantly higher rates of renal recovery than the general ESRD population and lower rates of permanent access placement.

What is expected of a medical director in the Centers for Medicare and Medicaid Services Conditions of Coverage?

The Medicare Conditions for Coverage for dialysis facilities, effective since 2008, make the medical director responsible for all levels of quality patient care in the facility. This includes issues such as water quality, infection control, staff education, policy/procedure development and implementation, dialyzer reuse, involuntary discharges, and patient safety. Most importantly, the medical director is the leader of the team responsible for quality assessment and performance improvement, which is central to the process of continuous quality improvement in the dialysis facility and the basis for much of Medicare's evaluation of facility performance. Through the measures assessment tool, the Conditions for Coverage specify the required domains for quality improvement activities in the dialysis facility, including dialysis adequacy, nutrition, bone disease, anemia management, vascular access, medical errors, patient satisfaction, and infection control. Under the leadership of the medical director, the quality assessment and performance improvement team identifies opportunities for improvement, tests and implements interventions, collects data, interprets results, and links system change with improved outcomes. These activities are rigorously documented and provide evidence to Medicare that the facility is acting responsibly to provide the best possible services for which it is being paid. The medical director is fairly compensated for his/her services by the facility, but must always act in the patients' best interest when evaluating policy changes directed at cost containment. The success of a medical director in shepherding positive change in a dialysis facility can be immensely satisfying as it impacts on patients other than his/her own.

Anemia management under a bundled payment policy for dialysis: a preview for the United States from Japan.

The goal of a bundled payment policy for dialysis is to decrease overall expenditures and shift financial risk from the payer to the provider. The primary target for cost reduction is invariably erythropoiesis-stimulating agents (ESAs), because of their large costs and potential for dose sparing. Japan succeeded in reducing ESA doses and maintaining stable hemoglobin levels through modest increases in intravenous iron administration. Dialysis providers in the United States have this and other strategies available.

Burden of illness for patients with non-dialysis chronic kidney disease and anemia in the United States: review of the literature.

OBJECTIVE: To assess the health-related quality of life (HRQL) and economic burden of chronic kidney disease (CKD) related anemia in non-dialysis patients in the United States (US) via literature review. METHODS: MEDLINE, EMBASE, PROQOLID, and Cochrane Library/Renal Group Resources were searched. Studies were appraised for patient populations, disease-specific versus generic HRQL assessments, and type and magnitude of health-related costs. RESULTS: The treatment costs for CKD patients with anemia compared to those without anemia were significantly higher and were blunted but persistent after controlling for comorbidities and confounders. Intervention with erythropoiesis stimulating agents (ESA) decreased anemia and avoided hospital admissions. Costs were higher when anemia was poorly controlled or untreated. HRQL burden was mainly due to physical limitations and difficulty in ability to perform activities of daily living. Significant positive correlations between increases in hemoglobin levels and HRQL measures were reported. CONCLUSIONS: Although evidence is limited, the economic and HRQL burden of non-dialysis CKD-related anemia is substantial. Under-treatment of anemia may contribute to higher resource consumption and higher costs; however, patient co-morbidities, use of erythropoietin-stimulating agents, and overall management introduce potential confounds. The contribution of anemia to humanistic disease burden is due to a constellation of factors, including physical activity and functional status.

Healthcare expenditure and resource utilization in patients with anaemia and chronic kidney disease: a retrospective claims database analysis.

BACKGROUND/AIMS: We conducted a retrospective claims database analysis to examine the association of anaemia and anaemia management with healthcare expenditure and utilization in patients with chronic kidney disease (CKD) before the onset of dialysis. METHODS: Claims data on patients (aged > or =15 years) with CKD were collected from the Medstat Marketscan Commercial and Medicare Databases between 2000 and 2005. Using these data, patients were evaluated for anaemia of CKD, anaemia treatment status and healthcare costs and use. RESULTS: Of the 37,105 CKD patients, 9,807 (26%) had incident anaemia; 59% of these received at least one type of anaemia treatment, with 48% receiving an erythropoiesis-stimulating agent. The total adjusted per patient per month healthcare expenditure for all CKD patients was USD 2,749. Patients with anaemia had significantly greater overall expenditure, which was 38% higher than those without anaemia. Total expenditure was 17% higher for untreated versus treated anaemic patients, largely due to higher inpatient expenditure in the untreated cohort. CONCLUSION: This analysis suggests that the presence of anaemia is associated with greater medical expenditure in patients with CKD. However, we found that anaemia management may help to lower inpatient costs associated with anaemia in the CKD population.

Past, present, and future of chronic kidney disease anemia management in the United States.

The management of anemia in the United States during the past 2 decades and since the introduction of erythropoietin (EPO) has continuously evolved, shaped by the interplay of reimbursement, evidence, clinical performance measurement, and, most recently, risk management. A fee-for-service reimbursement system has driven average EPO doses higher than anywhere else in the world, despite opportunities to decrease such dosing through more effective iron management and subcutaneous administration. Calls by Congress for Medicare to constrain ESA costs and FDA relabeling of erythropoietic-stimulating agents (ESAs), in the wake of The Correction of Hemoglobin and Outcomes in Renal Insufficiency and The Cardiovascular risk Reduction by Early Anemia Treatment with Epoetin Beta trials, have in 2007 led to the first decrease in mean hemoglobin levels in US hemodialysis patients since EPO was introduced in 1989. The implementation of a case-mixed adjusted bundled payment system for ESRD services in 2011 will turn ESAs from a profit center to a cost center for dialysis providers. This is likely to have profound implications regarding anemia management directed at curtailing ESA dosing, including subcutaneous administration, more aggressive iron therapy, and decreased target hemoglobin levels. Medicare has developed a third generation of clinical performance measures (CPMs) for ESRD providers (facilities and physicians) to ensure that quality is maintained in the new fiscal environment. Unlike the previous generations, these new CPMs emphasize an upper limit of hemoglobin as well as a lower one. Payment for performance based on these CPMs will likely be a key driver of future practice patterns for anemia management.

Use of erythropoiesis-stimulating agents in patients with anemia of chronic kidney disease: overcoming the pharmacological and pharmacoeconomic limitations of existing therapies.

Stage 3 chronic kidney disease (CKD), which is characterized by a glomerular filtration rate of 30 to 60 mL/min/1.73 m2 (reference range, 90-200 mL/min/1.73m2 for a 20-year-old, with a decrease of 4 mL/min per decade), affects approximately 8 million people in the United States. Anemia is common in patients with stage 3 CKD and, if not corrected, contributes to a poor quality of life. Erythropoiesis-stimulating agents (ESAs), introduced almost 2 decades ago, have replaced transfusions as first-line therapy for anemia. This review summarizes the current understanding of the role of ESAs in the primary care of patients with anemia of CKD and discusses pharmacological and pharmacoeconomic issues raised by recent data. Relevant studies in the English language were identified by searching the MEDLINE database (1987-2006). Two ESAs are currently available in the United States, epoetin alfa and darbepoetin alfa. More frequent dosing with epoetin alfa is recommended by the labeled administration guidelines because it has a shorter half-life than darbepoetin alfa. Clinical experience also supports extended dosing intervals for both these ESAs. Use of ESAs in the management of anemia of CKD is associated with improved quality of life, increased survival, and decreased progression of renal failure. Some evidence suggests that ESAs have a cardioprotective effect. However, correction of anemia to hemoglobin levels greater than 12 g/dL (to convert to g/L, multiply by 10) appears to increase the risk of adverse cardiac outcomes and progression of kidney disease in some patients. The prescription of ESAs in the primary care setting requires an understanding of the accepted use of these agents, the associated pharmacoeconomic challenges, and the potential risks. This review considers the need to balance effective ESA dosing intervals against the potential risks of treatment.

The morbidity and cost implications of hemodialysis clinical performance measures.

Clinical performance measures, including dialysis dose, hemoglobin, albumin, and vascular access, are the focus of monitoring and quality improvement activities. However, little is known about the implications of clinical performance measures for hospital utilization and health care costs. We obtained clinical performance measures and hospitalization records for a national random sample of 10,650 hemodialysis patients and analyzed the relationship between changes in clinical performance measures and hospital utilization after adjustment for patient demographic and medical characteristics. Higher hemoglobin, higher albumin, and fistula or graft use were independently associated with fewer hospitalizations, fewer hospital days, and decreased Medicare inpatient reimbursement. For example, a 0.5 g/dL higher hemoglobin, a 0.25 g/dL higher albumin, fistula use, and graft use were associated with hospitalization rate ratios of 0.90 (95% confidence interval 0.85, 0.96), 0.64 (0.53, 0.77), 0.60 (0.52, 0.69), and 0.79 (0.71, 0.89), respectively. Moreover, there was a 2-3-fold variation in hospital utilization across end-stage renal disease networks that was still evident after adjustment for patient characteristics and clinical performance measures. Clinical performance measures, especially albumin and vascular access, are strongly associated with hospital utilization and health care costs. These results highlight the importance of targeting nutrition and vascular access in quality improvement efforts. The marked variation in hospital utilization across networks deserves further examination.