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.

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.

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.

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.

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.

The biological and economic value of oral organic iron in maintenance dialysis.

With the widespread use of recombinant erythropoietin (EPO) for patients with end-stage renal disease (ESRD), management of iron deficiency is an ongoing issue for the renal team. Effective iron replacement and maintenance play a vital role in efficient use of EPO. For hemodialysis patients, intravenous (i.v.) iron has proven convenient and, as an ancillary drug outside of the composite rate, generates profits for dialysis facilities. Improvements in the vehicle with which i.v. iron is administered have led to a reduction in severe or fatal reactions common with iron dextran products. Oral iron has had a spotty track record as an effective therapy for dialysis patients. Compliance has been hindered by patient discomfort when taking oral iron. Patients on peritoneal dialysis and those with chronic kidney disease remain good candidates for oral iron because of convenience, and oral formulas could prove more effective even in the hemodialysis patient population if they were better tolerated and better absorbed, and if using them would not place an economic burden on the patient and/or an economic hardship on the facility. In a capitated/bundled payment environment, oral iron may become a blessing rather than a curse for facilities that need to find more economic ways of providing services. Heme-iron, now undergoing clinical studies, may be a reliable replacement for i.v. iron in that scenario.