Dialysis Bundling and Small Dialysis Organizations: A Call for Close Monitoring

Abstract

Related Article, p. 947 Related Article, p. 947 More than 400,000 people undergo treatment with maintenance dialysis in the United States.1Collins A.J. Foley R.N. Herzog C. et al.US Renal Data System 2012 annual data report.Am J Kidney Dis. 2013; 61 (suppl 1): e1-e480Abstract Full Text Full Text PDF PubMed Scopus (391) Google Scholar Although patients with end-stage kidney disease, both those treated with dialysis and those with a functioning kidney transplant, constitute only 1.3% of the Medicare population, they account for 7.5% of total Medicare spending.1Collins A.J. Foley R.N. Herzog C. et al.US Renal Data System 2012 annual data report.Am J Kidney Dis. 2013; 61 (suppl 1): e1-e480Abstract Full Text Full Text PDF PubMed Scopus (391) Google Scholar In an attempt to control costs, the US Centers for Medicare & Medicaid Services instituted the prospective payment system (PPS) for dialysis, known as the “bundle,” on January 1, 2011. The policy's intention is to control dialysis costs by adding services that previously were billable separately, such as additional laboratory tests and medications, to the composite dialysis payment rate. Initially, only injectable medications, such as erythropoiesis-stimulating agents (ESAs), intravenous iron, and vitamin D, were included in the bundle; the plan is to add oral dialysis-related medications (phosphate binders, oral iron and vitamin D formulations, and calcimimetics) in 2014.2Centers for Medicare & Medicaid Services (CMS), HHSMedicare program; end-stage renal disease prospective payment system Final rule.Fed Regist. 2010; 75: 49029-49214PubMed Google Scholar The introduction of the PPS was closely followed by the Quality Incentive Program (QIP), which began on January 1, 2012. The QIP, which is based on clinical data collected from dialysis units, penalizes 0%-2% of dialysis facility income for failure to meet anemia and dialysis adequacy targets.3Centers for Medicare & Medicaid Services (CMS), HHSMedicare program; end-stage renal disease quality incentive program Final rule.Fed Regist. 2011; 76: 627-646PubMed Google Scholar This is the first Medicare program that ties provider payments to performance.4Watnick S. Weiner D.E. Shaffer R. Inrig J. Moe S. Mehrotra R. Dialysis Advisory Group of the American Society of NephrologyComparing mandated health care reforms: the Affordable Care Act, accountable care organizations, and the Medicare ESRD program.Clin J Am Soc Nephrol. 2012; 7: 1535-1543Crossref PubMed Scopus (28) Google Scholar There is a concern that small dialysis organizations (SDOs) will be particularly adversely affected by the PPS,5Bhat P. Bhat J.G. The 2011 ESRD prospective payment system: perspectives from a for-profit small- to medium-sized dialysis organization.Am J Kidney Dis. 2011; 57: 556-558Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar specifically because of their inability to obtain large-volume discounts for medications and to administer their own pharmacy and laboratory services, as well as the higher costs to SDOs of adapting and maintaining electronic medical records and electronic data transmission. STEPPS (Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations) is a prospective surveillance program designed to describe trends in treatment and provider and patient outcomes before and after implementing the PPS program in a representative sample of 51 SDO facilities. Early results from STEPPS, extending from October 2010 to June 2011, are published in this issue of AJKD.6Brunelli S.M. Monda K.L. Burkart J.M. et al.Early trends from the Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations (STEPPS).Am J Kidney Dis. 2013; 61: 947-956Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar As detailed in the article, compared with other SDOs, STEPPS SDOs were less likely to be rural and were slightly larger. Compared to the general US dialysis population, STEPPS patients were slightly older, had shorter dialysis vintage, were less likely to be African American, were more likely to be Hispanic, and had a lower prevalence of reimbursement case-mix adjusters. STEPPS reported that from October 2010 to June 2011, there was a non–statistically significant increase in the incidence of patients undergoing peritoneal dialysis in SDOs, which is similar to the increasing use of peritoneal dialysis in the general US population.7US Renal Data SystemArchives USRDS Web Site.http://www.usrds.org/presentations2012.aspxGoogle Scholar No significant changes were observed in patient to staff ratios, duration of hemodialysis sessions, urea reduction ratios, or numbers of facility discharges. There was a significant trend toward a decreased number of missed treatments after the PPS was introduced. STEPPS also reported the following trends in anemia management in participating SDOs: a decrease in per-administration and cumulative monthly doses of intravenous ESAs with a parallel decrease in mean hemoglobin values, a decreased percentage of participants with hemoglobin levels >12 g/dL, and an increased percentage of participants with hemoglobin levels <10 g/dL. These findings align with reports from the DOPPS (Dialysis Outcomes and Practice Patterns Study) Practice Monitor,8Robinson B. Fuller D. Zinsser D. et al.The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor: rationale and methods for an initiative to monitor the new US bundled dialysis payment system.Am J Kidney Dis. 2011; 57: 822-831Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar as well as a US Renal Data Systems (USRDS) presentation at the 2012 American Society of Nephrology (ASN) Meeting.9US Renal Data System USRDS: assessment of the new bundled dialysis payment system and overview of the ESRD Program. Presented at: American Society of Nephrology Kidney Week 2012 Special Session, October 30 to November 4, 2012, San Diego, CA.http://www.usrds.org/presentations2012.aspxGoogle Scholar STEPPS observed a greater decrease in mean ESA dose and greater proportion of patients with hemoglobin levels <10 g/dL than the DOPPS Practice Monitor,8Robinson B. Fuller D. Zinsser D. et al.The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor: rationale and methods for an initiative to monitor the new US bundled dialysis payment system.Am J Kidney Dis. 2011; 57: 822-831Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar, 10Robinson B.M. Fuller D.S. Bieber B.A. Turenne M.N. Pisoni R.L. The DOPPS Practice Monitor for US dialysis care: trends through April 2011.Am J Kidney Dis. 2012; 59: 309-312Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar whereas USRDS investigators found that ESA doses and mean hemoglobin levels were lower in patients of SDOs compared with patients in some large providers, but similar to those of hospital-based and independent facilities. Further monitoring is necessary to establish ongoing trends and the influence of the PPS changes on SDOs specifically. Both STEPPS and an early DOPPS report8Robinson B. Fuller D. Zinsser D. et al.The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor: rationale and methods for an initiative to monitor the new US bundled dialysis payment system.Am J Kidney Dis. 2011; 57: 822-831Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar suggest that there is a greater hemoglobin level decline and a greater proportion of patients with hemoglobin levels <12 g/dL in African American participants, although in a later report, DOPPS reported similar hemoglobin levels between African American and non–African American participants.11Pisoni R.L. Fuller D.S. Bieber B.A. Gillespie B.W. Robinson B.M. The DOPPS Practice Monitor for US dialysis care: trends through August 2011.Am J Kidney Dis. 2012; 60: 160-165Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar More worrisome is that STEPPS reported increases in the proportion of hemodialysis patients receiving transfusions and transfusion rates, and that these increases were predominantly for African American patients. In their ASN presentation, USRDS investigators also reported an increase in transfusions from around 2.5 per 100 patients per month to more than 3-3.5 per 100 patients per month, but found no obvious difference between African American and white patients.9US Renal Data System USRDS: assessment of the new bundled dialysis payment system and overview of the ESRD Program. Presented at: American Society of Nephrology Kidney Week 2012 Special Session, October 30 to November 4, 2012, San Diego, CA.http://www.usrds.org/presentations2012.aspxGoogle Scholar Beginning in 2012, the QIP penalized providers who had a high proportion of patients with hemoglobin levels <10 g/dL, but in 2013, this minimum hemoglobin level was eliminated from the clinical quality measures to reflect new US Food and Drug Administration ESA labeling.12US Food and Drug AdministrationFDA Drug Safety communication: modified dosing recommendations to improve the safe use of erythropoiesis-stimulating agents (ESAs) in chronic kidney disease.http://www.fda.gov/Drugs/DrugSafety/ucm259639.htmDate: June 2011Google Scholar In view of the increasing burden of blood transfusions that might lead to patient allosensitization and worse transplantation outcomes, it might be prudent to make transfusion rates reportable and include it as a QIP metric to penalize facilities that have excessive transfusion rates. Increased transfusion rates in African American patients are even more concerning in view of the observation that African Americans already have lower transplantation rates and worse transplantation outcomes.13Malek S.K. Keys B.J. Kumar S. Milford E. Tullius S.G. Racial and ethnic disparities in kidney transplantation.Transpl Int. 2011; 24: 419-424Crossref PubMed Scopus (67) Google Scholar Because late DOPPS and USRDS data do not report lower hemoglobin values and higher transfusion rates in African American patients compared with white patients, it is possible that these findings are unique to SDOs. Future research is needed to identify subgroups of patients and providers and their combinations that are affected negatively by the new payment policy. If other studies report lower hemoglobin levels and, more importantly, higher transfusion rates for African American patients, new consideration should be given to adding race to case-mix adjustment in order to allow higher ESA use to prevent transfusion in this patient population. Changes in bone and mineral disease management in the reporting SDOs include decreased use of injectable vitamin D analogues and increased use of oral medications, including cinacalet, phosphate binders, and oral activated vitamin D, which paralleled a concomitant decrease in serum calcium concentration and increase in parathyroid hormone (PTH) values (phosphorus concentration remained stable). The DOPPS Practice Monitor reported similar trends in April 2011,8Robinson B. Fuller D. Zinsser D. et al.The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor: rationale and methods for an initiative to monitor the new US bundled dialysis payment system.Am J Kidney Dis. 2011; 57: 822-831Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar but by August 2011, PTH values had leveled off.10Robinson B.M. Fuller D.S. Bieber B.A. Turenne M.N. Pisoni R.L. The DOPPS Practice Monitor for US dialysis care: trends through April 2011.Am J Kidney Dis. 2012; 59: 309-312Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar Managing bone and mineral metabolism in patients with end-stage renal disease will continue to change as oral medications become included in the bundle by 2014. How these changes will translate into clinical outcomes, such as parathyroidectomies, fractures, hospitalizations, and mortality, remains to be determined. Unfortunately, randomized controlled trials with clinical outcomes that can guide the management of mineral and bone metabolism are few and the goals of care are poorly defined. In conclusion, it appears that after implementation of the PPS, there has been a trend for decreased use of injectable medications, which resulted in lower hemoglobin values and higher PTH levels in patients of SDOs. The hemoglobin levels observed in the SDO setting were decreased to a greater extent than those observed in the end-stage renal disease population overall. Additionally, in SDOs, anemia management changes, including increasing rates of transfusions, are more profound in African American patients. Further monitoring is crucial to ensure that certain patient groups and providers are not disproportionally disadvantaged by the payment restructuring. Previously, Medicare has successfully changed dialysis payment for physicians in a way that incentivized physicians to see their dialysis patients more frequently, and this increased frequency of visits to dialysis providers was associated with a reduction in patient hospitalizations.14Slinin Y. Guo H. Li S. et al.Association of provider-patient visit frequency and patient outcomes on hemodialysis.J Am Soc Nephrol. 2012; 23: 1560-1567Crossref PubMed Scopus (26) Google Scholar Future studies that focus on patient outcomes, such as hospitalizations and deaths, related to the introduction of the bundle are of paramount importance. Changes to the payment system should continue to drive down the costs of dialysis, enhance the use of evidence-based therapies, decrease the use of ineffective treatments, and correct inequalities that may be introduced by the comprehensive payment system. Support: None. Financial Disclosure: The authors declare that they have no relevant financial interests. Circulating α-Klotho Levels in CKD and Relationship to ProgressionAmerican Journal of Kidney DiseasesVol. 61Issue 6Previewα-Klotho is reported to have protective effects against kidney injury, and its renal expression is decreased in many experimental models of kidney disease. However, circulating α-klotho levels in human chronic kidney disease (CKD) and the relationship to progression are unknown. Full-Text PDF