End-stage Renal Disease Prospective Payment Research Articles

COVID-19−Associated Decline in the Size of the End-Stage Kidney Disease Population in the United States

According to the United States Renal Data System (USRDS), the number of people with end-stage kidney disease (ESKD) in the United States has increased every year between 1980 and 2018.1Collins A.J. Foley R.N. Herzog C. et al.US Renal Data System 2010 annual data report.Am J Kidney Dis. 2011; 57 (A8, e1−e526)Abstract Full Text Full Text PDF Scopus (304) Google Scholar,2Johansen K.L. Chertow G.M. Foley R.N. et al.US Renal Data System 2020 annual data report: epidemiology of kidney disease in the United States.Am J Kidney Dis. 2021; 77: A7-A8Abstract Full Text Full Text PDF PubMed Scopus (162) Google Scholar Between 1980 and 2000, the increasing prevalence reflected mostly the rapidly increasing incidence of ESKD. Since 2000, the increasing prevalence has shifted toward improved survival among patients on maintenance dialysis, as well as those with a functioning kidney transplant. Recent forecasting of the size of the ESKD population had suggested continued growth during the 2020s.3McCullough K.P. Morgenstern H. Saran R. et al.Projecting ESRD incidence and prevalence in the United States through 2030.J Am Soc Nephrol. 2019; 30: 127-135Crossref PubMed Scopus (160) Google Scholar However, no forecast could have anticipated the novel coronavirus disease 2019 (COVID-19) pandemic. During the early part of the pandemic, all-cause mortality was 17% and 30% higher than expected among dialysis and transplant patients, respectively, whereas the number of patients who initiated kidney replacement therapy (KRT) declined sharply.2Johansen K.L. Chertow G.M. Foley R.N. et al.US Renal Data System 2020 annual data report: epidemiology of kidney disease in the United States.Am J Kidney Dis. 2021; 77: A7-A8Abstract Full Text Full Text PDF PubMed Scopus (162) Google Scholar,4Weinhandl E.D. Wetmore J.B. Peng Y. et al.Initial effects of COVID-19 on patients with ESKD.J Am Soc Nephrol. 2021; 32: 1444-1453Crossref PubMed Scopus (27) Google Scholar Considering that the rate of COVID-19 hospitalization was approximately 40 times higher among dialysis patients than in the general population,4Weinhandl E.D. Wetmore J.B. Peng Y. et al.Initial effects of COVID-19 on patients with ESKD.J Am Soc Nephrol. 2021; 32: 1444-1453Crossref PubMed Scopus (27) Google Scholar it is likely that substantial mortality also occurred during the past winter. In this report, we quantified the impact of COVID-19 on the size of the ESKD population at 1 year after the declaration of a national emergency. We analyzed data extracted from the End Stage Renal Disease Quality Reporting System (EQRS) in May 2021. For each epidemiologic week (Sunday to Saturday) from week 1 of 2015 to week 13 of 2021, we identified all patients with ESKD at the beginning of the week. We identified the KRT status (dialysis, transplant), age, and race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, Asian, other) of each patient. We tabulated numbers of patients in subgroups defined by each of these factors. In each subgroup, we fit a linear regression of weekly counts from week 1 of 2015 to week 13 of 2021; the model included only calendar time, which was parameterized as a second-order (i.e., quadratic) polynomial. Fitted models were used to derive forecasted weekly counts through week 13 of 2021; forecasted weekly counts of ESKD patients were derived by summing forecasted counts of dialysis and transplant patients. Between week 1 of 2015 and week 13 of 2020, the numbers of dialysis and transplant patients steadily increased, with little deviation from quadratic trends (Figure 1). As of week 13 of 2020, there were 808,354 ESKD patients, comprising 572,157 patients undergoing dialysis and 236,197 patients with a transplant. As of week 13 of 2021, there were 803,661 ESKD patients, representing a year-over-year decline of 0.6% and a “deficit” of 3.5%, relative to the forecast of 833,236 ESKD patients. Among patients undergoing dialysis, the year-over-year decline in census was 1.6%, representing a deficit of 3.8%, relative to forecast. In all dialysis patient subgroups except Asian patients, the census declined (Table 1). The largest deficits, relative to forecast, were observed among patients aged ≥75 years and non-Hispanic White patients. Among patients with a transplant, the census increased 1.8% between week 13 of 2020 and week 13 of 2021, but the census in week 13 of 2021 was nevertheless 2.9% lower than was forecasted. All transplant patient subgroups experienced year-over-year growth, with relatively larger growth in elderly (age ≥65 years), non-Hispanic Black, and Asian patients (Table 1). Still, all subgroups experienced lower growth than was forecasted.Table 1Forecasted and observed numbers of patients undergoing maintenance dialysis and patients with a functioning transplant in the United States during epidemiologic week 13 in each of 2020 and 2021, overall, by age, and by race/ethnicityPatients (N)Growth (%)2021 wk13 vs.2020 wk13ExcessaDuring epidemiologic week 13 of 2021. (%)Observed vs. forecasted2020 wk13Observed2021 wk13Observed2021 wk13ForecastedMaintenance dialysis Overall572,157563,237585,705–1.6%–3.8% By age (yr)18−44150,470104,339106,265–1.1%–1.8%45−64191,524188,450192,386–1.6%–2.0%65−74207,743205,032216,253–1.3%–5.2%75−9967,42065,41670,801–3.0%–7.6% By race/ethnicityNH White222,394213,573231,500–4.0%–7.7%NH Black184,633181,329184,038–1.8%–1.5%Hispanic112,476111,700115,459–0.7%–3.3%Asian28,42028,91730,034+1.7%–3.7%Functioning transplant Overall236,197240,424247,531+1.8%–2.9% By age (yr)18−4470,45170,79272,575+0.5%–2.5%45−6492,12693,14095,848+1.1%–2.8%65−7467,62270,22372,499+3.8%–3.1%75−995,9986,2696,609+4.5%–5.1% By race/ethnicityNH White115,724117,185120,191+1.3%–2.5%NH Black48,18349,34850,972+2.4%–3.2%Hispanic36,02936,70038,576+1.9%–4.9%Asian11,74212,30812,740+4.8%–3.4%NH, non-Hispanic; wk13, week 13.a During epidemiologic week 13 of 2021. Open table in a new tab NH, non-Hispanic; wk13, week 13. The President of the United States declared a national emergency on March 13, 2020. During the ensuing year, 3 large waves of COVID-19 swept the United States, resulting in nearly 600,000 deaths due to COVID-19.5Centers for Disease Control and PreventionCOVIDView.https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.htmlDate: 2020Date accessed: August 24, 2021Google Scholar Remarkably, for the first time in history (dating to 1980), the size of the ESKD population in the United States declined, led by a 1.6% decrease in the number of patients on dialysis. Relative to what was forecasted as a function of long-run trends, the numbers of dialysis and transplant patients in week 13 of 2021 were roughly 4% and 3% lower, respectively. These deficits can be attributed to a combination of changes in ESKD incidence, kidney transplant incidence, and mortality risk. The ESKD incidence was likely lower, kidney transplant incidence was somewhat higher (despite a decrease in living donor kidney transplantation),6Organ Procurement and Transplantation NetworkNational Data.https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/Date: 2021Date accessed: August 24, 2021Google Scholar and mortality risk was almost certainly higher, regardless of the type of KRT. Variability in year-over-year changes in patient counts among strata defined by age and race/ethnicity offer a mixed picture. Relative to forecasted counts, larger deficits among elderly patients probably reflect that age is a risk factor for COVID-19 hospitalization and death. A contributing factor may be lower incidence, due to COVID-19 mortality in people with advanced chronic kidney disease (CKD) and decisions to defer dialysis initiation in those who remained alive. With respect to race/ethnicity, the story may be more nuanced. Both Black and Hispanic people have suffered greatly during the pandemic. Acute kidney injury associated with COVID-19 may have accelerated loss of kidney function in patients with CKD,7Nugent J. Aklilu A. Yamamoto Y. et al.Assessment of acute kidney injury and longitudinal kidney function after hospital discharge among patients with and without COVID-19.JAMA Netw Open. 2021; 4: e211095Crossref PubMed Scopus (63) Google Scholar thereby placing upward pressure on ESKD incidence and partly countering the downward pressure of COVID-19 mortality on the number of dialysis patients. The precise calculus of how incidence and mortality influenced the size of ESKD population within subgroups remains to be elucidated. Our report is preliminary, with counts subject to minor revisions as late submissions of the End Stage Renal Disease Medical Evidence Report and Death Notification are collected. We suggest that there are 3 implications of these data. First, recent forecasts of the number of ESKD patients during the 2020s are now invalid. This has direct consequences for outpatient dialysis capacity and corresponding labor needs in the next several years, especially considering the drive toward greater adoption of home dialysis modalities. Second, due to the year-over-year decrease in the number of dialysis patients and an apparent surge in Medicare Advantage enrollment during the past open enrollment period,8Q1 2021 DaVita Inc. Earnings Conference Call. Denver, CO.https://pressreleases.davita.com/2021-04-29-DaVita-Inc-1st-Quarter-2021-ResultsDate: 2021Date accessed: August 24, 2021Google Scholar original Medicare (i.e., Parts A and B) is suddenly much less exposed to the total cost of care for dialysis patients. This shift has profound consequences not only for federal entitlement expenditures on ESKD, but also for quality measurement systems that have been built on Parts A and B claims. Third, as the base payment for an outpatient hemodialysis session covered by Part B has increased from $229.63 in 2011 to $239.33 in 2020,9Centers for Medicare & Medicaid ServicesMedicare program; end-stage renal disease prospective payment system, payment for renal dialysis services furnished to individuals with acute kidney injury, and end-stage renal disease quality incentive program. Department of Health and Human Services, Centers for Medicare & Medicaid Services, Baltimore, MD2020: 71398-71487Google Scholar dialysis providers have relied on steadily increasing treatment volume to address treatment cost inflation. For small and rural dialysis providers, which are more likely to operate with negative margins,10Medicare Payment Advisory CommissionMarch 2021 Report to the Congress: Medicare Payment Policy, Washington, DC.http://www.medpac.gov/docs/default-source/default-documentlibrary/mar21_medpac_report_to_the_congress_secv2.pdfDate: 2021Date accessed: August 24, 2021Google Scholar any decrease in the number of dialysis patients is a potential existential threat to operations, possibly forcing further consolidation among providers. As the pandemic abates, it is plausible that the ESKD population in the United States will grow again. After all, the US population is aging, thereby placing upward pressure on ESKD incidence. Nevertheless, with essentially static adjusted incidence of ESKD and likely expansion of sodium-glucose cotransporter-2 inhibitor use, it is also possible that the number of dialysis patients in the country is nearing an apex, thus providing an opportunity for the ESKD population to shift away from its long-standing mixture of 70% of patients undergoing dialysis and 30% of patients with a functioning transplant.2Johansen K.L. Chertow G.M. Foley R.N. et al.US Renal Data System 2020 annual data report: epidemiology of kidney disease in the United States.Am J Kidney Dis. 2021; 77: A7-A8Abstract Full Text Full Text PDF PubMed Scopus (162) Google Scholar However, the future is admittedly uncertain. Whether the number of people with advanced CKD and high risk of progression to ESKD has declined during the past year is unknown. Even the impact of COVID-19 on outcomes during the upcoming winter is unknown. Continued surveillance will be necessary to guide the nephrology community and policymakers alike. EDW reports a consulting relationship with Fresenius Medical Care North America, providing input in epidemiologic research about home dialysis; reports being employed by NxStage Medical and Fresenius Medical Care North America (after the acquisition of NxStage Medical) between March 2016 and April 2020; and reports being a scientific advisor or member via the Advisory Board of Home Dialyzors United, and the Board of Directors of the Medical Education Institute; and reports having other interests/relationships on the Scientific Methods Panel for the National Quality Forum. DTG reports having a consulting relationship with Amgen, providing general input in epidemiologic and biostatistical research; reports consultancy agreements with Amgen; and reports receiving research funding from Acadia, Amgen, AstraZeneca, DaVita, Genentech, Gilead, HRSA, Merck, National Institutes of Health, and Opko Renal. JBW reports participation in advisory boards of Aurinia Pharmaceuticals, OPKO Health, and Reata Pharmaceuticals; reports receiving honoraria for academic continuing medical education from Healio and NephSAP; reports consultancy agreements via ad hoc consulting for Bristol Myers Squibb (BMS)-Pfizer Alliance; reports receiving research funding from Amgen, AstraZeneca, BMS/Pfizer, Genentech, Merck, and OPKO Health; reports receiving honoraria from BMS-Pfizer Alliance (for advisory board activities, as noted below); and reports being a scientific advisor or member with BMS-Pfizer Alliance, and occasionally participating on ad hoc advisory boards. KLJ reports participation in the steering committee of Anemia Studies in Chronic Kidney Disease (ASCEND), a clinical trial program evaluating the efficacy and safety of daprodustat and supported by GlaxoSmithKline. The data reported here have been supplied by the United States Renal Data System (USRDS), which is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through contract 75N94019C00006. This study was completed by the USRDS Coordinating Center. The originally submitted manuscript was approved by the NIDDK contracting officer representative, Dr. Kevin Abbott. The NIDDK had no role in study design, data collection, analysis, or interpretation, or writing of the report. The USRDS Coordinating Center is located at the Chronic Disease Research Group, a division of the Hennepin Healthcare Research Institute in Minneapolis, Minnesota. The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the US Government.

Dialysis Center Productivity Accelerated after 2011 Payment Reform without Compromising Quality of Care

In January 2011, the Centers for Medicare & Medicaid Services (CMS) introduced the End-Stage Renal Disease Prospective Payment System (ESRD PPS) with the goal of creating strong economic incentives for Medicare dialysis providers to improve efficiency in the delivery of dialysis treatments, but without compromising quality of care. To date, no formal evaluations have been published of the impacts of the new payment reforms on dialysis center efficiency in the quantity and quality of care delivered in the pre vs. post PPS era. Our objective was to examine whether the goal of improved efficiency in the delivery of dialysis was achieved without compromise to quality of care in the four years following implementation of the End Stage Renal Disease Prospective Payment System (ESRD PPS) in 2011.

Changes in hemodialysis catheter management after introduction of the end-stage renal disease prospective payment system

BackgroundWe investigated whether implementation of the end-stage renal disease prospective payment system (ESRD PPS) was associated with changes in thrombolytic therapy use and other aspects of catheter management in hemodialysis (HD) patients.MethodsUsing quarterly, period prevalent cohorts of patients undergoing maintenance HD with a catheter in the US Renal Data System (2008–2015), we studied rates of claims for within- and outside-HD-unit thrombolytic use, and thrombus/fibrin sheath removal, and rates of delayed HD treatment after ESRD PPS implementation, January 1, 2011. Associations between PPS implementation and change in trend of rates of each outcome were assessed using covariate-adjusted Poisson regression, using a piecewise linear function for quarter-time (with breakpoint at PPS implementation).ResultsAmong an average of 69,428 quarterly catheter users, rates of claims for within-HD-unit thrombolytic use declined from 236.6 (Q1–2008) to 81.4 (Q4–2012) per 100 person-years (P < 0.0001, PPS association with change in trend); rates of claims for thrombus/fibrin sheath removal procedures increased from 3.9 (Q1–2008) to 8.8 (Q3–2015) per 100 person-years (P = 0.0001, PPS association with change in trend). Rates of delayed HD treatment increased from 1.6 (Q2–2008) to 2.3 (Q3–2015) per patient-quarter, although PPS implementation was associated with a decrease in this rising trend (1.6% increase per quarter pre-PPS, 1.2% post-PPS; P < 0.0001, change in trend).ConclusionsAfter PPS implementation, thrombolytic use decreased and thrombus/fibrin sheath removal increased. The increasing trend in delayed HD treatment appeared to slow after PPS implementation, but delayed sessions continued to increase year over year for unclear reasons.

Hemodialysis Facility Variation in Hospitalization and Transfusions Using Medicare Claims: The DOPPS Practice Monitor for US Dialysis Care

Since August 2010, the DOPPS (Dialysis Outcomes and Practice Patterns Study) Practice Monitor (DPM) has provided thrice-annual updates covering many aspects of US hemodialysis care based on manual chart reviews and electronic medical record extracts from more than 200 US hemodialysis facilities. Using data presented at the DPM website (www.dopps.org/DPM), the DPM can provide “early-warning” insights regarding contemporary (within 4-6 months) trends in US hemodialysis care, with additional analysis and interpretation shortly thereafter.1Fuller D.S. Pisoni R.L. Bieber B.A. Gillespie B.W. Robinson B.M. The DOPPS Practice Monitor for US dialysis care: trends through December 2011.Am J Kidney Dis. 2013; 61: 342-346Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar, 2Turenne M.N. Cope E.L. Porenta S. et al.Has dialysis payment reform led to initial racial disparities in anemia and mineral metabolism management?.J Am Soc Nephrol. 2015; 26: 754-764Crossref PubMed Scopus (17) Google Scholar A special focus and expertise of the DOPPS Program has been analysis of facility-level practice patterns, an approach that we now extend to Medicare claims data. In January 2011, the Centers for Medicare & Medicaid Services (CMS) implemented a major update to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)3Centers for Medicare & Medicaid ServicesMedicare Program; End-Stage Renal Disease Prospective Payment System; Final Rule and Proposed Rule.Fed Regist. 2010; 75: 49030-49214Google Scholar in which a transition in reimbursement for dialysis-related injectable medications from payment per dose to a fixed cost per patient was one of the most significant changes. Along with concerns expressed by many renal community stakeholders that patient care could be adversely affected under the new payment system,4American Society of Nephrology. ASN Comments on ESRD PPS and QIP Final Rule Nov. 2010. http://www.asn-online.org/policy/webdocs/nov2010guidanceonfinalrule.pdf. Accessed July 15, 2015.Google Scholar, 5Wish J.B. Anemia management under a bundled payment policy for dialysis: a preview for the United States from Japan.Kidney Int. 2011; 79: 265-267Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar the Government Accountability Office recommended that the CMS monitor dialysis quality metrics and access to dialysis care for beneficiaries following these payment reforms.6U.S. Government Accountability OfficeEnd-Stage Renal Disease: CMS Should Monitor Access to and Quality of Dialysis Care Promptly After Implementation of New Bundled Payment System. U.S. Government Accountability Office, Washington, DC2010Google Scholar In 2012, the CMS Claims-Based Monitoring Project,7Centers for Medicare & Medicaid Services (CMS). ESRD Payment Spotlight: ESRD Prospective Payment System (ESRD PPS) Overview of Claims-Based Monitoring Program. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Spotlight.html. Accessed July 15, 2015.Google Scholar using data from administrative Medicare claims for reimbursement, began issuing several reports each year regarding several ESRD care indicators. These reports include patient-level estimates of hospitalizations and of the percent of ESRD beneficiaries receiving red blood cell (RBC) transfusions. In addition to the patient-level trends reported by the Claims-Based Monitoring Project, the DPM now includes distributions of facility percent of Medicare beneficiaries with at least 1 claim for inpatient hospitalization or RBC transfusion within 1- and 6-month periods. Here, we describe DPM calculation methods and present initial results for trend analyses of Medicare claims from 2010 through 2013. Under a data use agreement (DUA) with CMS, the DOPPS has received de-identified Medicare 100% inpatient (Part A) and 100% outpatient (Part B) Limited Data Sets annually since 2010. Patients receiving in-center hemodialysis are identified by a “72x” type of bill (where x is any value)8Research Data Assistance Center. Claim Facility Type Code. Outpatient LDS Data Documentation. http://www.resdac.org/cms-data/variables/Claim-Facility-Type-Code. Accessed July 15, 2015.Google Scholar, 9Research Data Assistance Center. Claim Service Classification Type Code. Outpatient LDS Data Documentation. http://www.resdac.org/cms-data/variables/Claim-Service-classification-Type-Code. Accessed July 15, 2015.Google Scholar, 10Research Data Assistance Center. Claim Frequency Code. Outpatient LDS Data Documentation. http://www.resdac.org/cms-data/variables/Claim-Frequency-Code. Accessed July 15, 2015.Google Scholar and a “0821” revenue center code for each treatment occurrence.11Research Data Assistance Center. Revenue Center Code. Outpatient LDS Data Documentation. http://www.resdac.org/cms-data/variables/revenue-center-code. Accessed July 15, 2015.Google Scholar Claim records may report up to 45 revenue center codes per segment. The “claim-through” date12Research Data Assistance Center. Claim Through Date. Outpatient LDS Data Documentation. http://www.resdac.org/cms-data/variables/Claim-Through-Date. Accessed July 15, 2015.Google Scholar is used to identify the month for reporting purposes. Inpatient hospitalization is defined as any record present in the inpatient claims file. To identify claims with an RBC transfusion, we search for a list of Healthcare Common Procedure Coding System and International Classification of Diseases, Ninth Revision (procedure) codes identified from Claims-Based Monitoring Project documentation7Centers for Medicare & Medicaid Services (CMS). ESRD Payment Spotlight: ESRD Prospective Payment System (ESRD PPS) Overview of Claims-Based Monitoring Program. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/Spotlight.html. Accessed July 15, 2015.Google Scholar; these codes are shown in Box 1.Box 1Codes Used to Identify RBC Transfusions in Medicare ClaimsHCPCS•P9010, P9011, P9016, P9021, P9022, P9038, P9039, P9040, P9051, P9054, P9056, P9057, P9058, 36430ICD-9•99.03, 99.04Abbreviations: HCPCS, Healthcare Common Procedure Coding System; ICD-9, International Classification of Diseases, Ninth Revision; RBC, red blood cell. HCPCS•P9010, P9011, P9016, P9021, P9022, P9038, P9039, P9040, P9051, P9054, P9056, P9057, P9058, 36430 ICD-9•99.03, 99.04 Abbreviations: HCPCS, Healthcare Common Procedure Coding System; ICD-9, International Classification of Diseases, Ninth Revision; RBC, red blood cell. Each month, patients are assigned to a dialysis provider facility if that facility submitted claims for at least 8 in-center hemodialysis treatments provided to the patient in that month (revenue center code 0821). To reduce the influence of discrete value effects on the variance, we limit the analyses to facilities with at least 20 assigned patients in a given month. For each outcome, the DPM provides graphs and data tables denoting the percent of beneficiaries with the given claim type each month regardless of facility assignment (patient level) and mean and percentile values for the distribution of the percent of assigned facility patients with the given event in either a 1- or 6-month period. The percent of Medicare beneficiaries with an inpatient hospitalization claim has steadily declined from 14.6% in January 2010 to 12.5% in December 2013 (Fig 1). Adjusted for monthly seasonality patterns, the year-over-year relative decline was 1.7% between 2010 and 2011, 4.1% between 2011 and 2012, and 4.2% between 2012 and 2013. In July 2013, the percent of Medicare beneficiaries with at least 1 inpatient hospitalization claim within 6 months varied nearly 2-fold across facilities, from 27.4% (10th percentile) to 50.0% (90th percentile) of facility patients; the median (50th percentile) percent was 38.6% of facility patients (Fig 2).Figure 2Distribution of facility percent of Medicare beneficiaries with at least 1 inpatient hospitalization claim within 6 months, January 2010 to July 2013. Values for each month reflect distribution among facilities with 20+ patients. The diamond marker indicates the mean value, the circle marker, the median value.Adapted with permission from Arbor Research Collaborative for Health. Data source: Medicare Claims, 2010 to 2013 (DUA#23721).View Large Image Figure ViewerDownload Hi-res image Download (PPT) The percent of Medicare beneficiaries with an RBC transfusion claim per month increased overall, from 2.7% in January 2010 to 3.1% in December 2013 (Fig 3). Beginning with the 2011 claims data set, the number of Healthcare Common Procedure Coding System code fields available on each claim record increased from 6 to 25. Estimates reported in the DPM are based on all data available on the claim record and use all 25 fields when available. The inclusion of these additional claim fields increased the estimated percent with an RBC transfusion claim by 0.2% to 0.3% consistently since January 2011 (eg, 3.2% using all 25 fields vs 3.0% using the first 6 fields in January 2011). Adjusted for monthly seasonality patterns, the year-over-year relative increase was 21.4% between 2010 and 2011 and 7.2% between 2011 and 2012, with a 4.9% year-over-year relative decline between 2012 and 2013. In July 2013, the percent of Medicare beneficiaries with at least 1 RBC transfusion claim within 6 months varied 5-fold across facilities, from 3.6% (10th percentile) to 18.4% (90th percentile) of facility patients; the median (50th percentile) percent was 10.0% of facility patients (Fig 4).Figure 4Distribution of facility percent of Medicare beneficiaries with at least 1 red blood cell transfusion claim within 6 months, January 2010 to July 2013. Values for each month reflect distribution among facilities with 20+ patients. The diamond marker indicates the mean value, the circle marker, the median value. The maximum number of procedures per inpatient claim in the claims data set increased from 6 to 25 starting in January 2011.Adapted with permission from Arbor Research Collaborative for Health. Data source: Medicare Claims, 2010 to 2013 (DUA#23721).View Large Image Figure ViewerDownload Hi-res image Download (PPT) Using contemporary CMS claims data, the DPM identified a continual decline in hospitalization from 2010 to 2013 among Medicare beneficiaries treated with hemodialysis. In contrast, the percent of beneficiaries with an RBC transfusion claim during a month increased starting in 2011, perhaps due to the combined effects of the initial rollout of the revised PPS in January 20113Centers for Medicare & Medicaid ServicesMedicare Program; End-Stage Renal Disease Prospective Payment System; Final Rule and Proposed Rule.Fed Regist. 2010; 75: 49030-49214Google Scholar and the greater decline in hemoglobin levels following modifications to erythropoiesis-stimulating agent drug labeling and the ESRD Quality Incentive Program in June/July 2011.13US Food and Drug Administration, US Department of Health and Human Services. FDA Drug Safety Communication: modified dosing recommendations to improve the safe use of erythropoiesis-stimulating agents (ESAs) in chronic kidney disease. Safety Announcement June 24, 2011. http://www.fda.gov/drugs/drugsafety/ucm259639.htm. Accessed July 15, 2015.Google Scholar, 14Centers for Medicare & Medicaid Services (CMS), HHSMedicare Program; End-Stage Renal Disease Prospective Payment System and Quality Incentive Program; Ambulance Fee Schedule; Durable Medical Equipment; and Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies; Proposed Rule.Fed Regist. 2011; 76: 40498-40550Google Scholar However, the subsequent decline in the percent of beneficiaries with an RBC transfusion claim in a month, most notable in 2013, suggests a return toward 2010 levels. For both hospitalization and RBC transfusion claims, we observed wide variation among facilities, which could be driven by both patient case-mix and facility practice pattern factors. It is important to note that these results are not adjusted for patient case-mix and thus should not be used for formal benchmarking or in comparison to adjusted metrics such as the standardized hospitalization ratio or standardized transfusion ratio. The distribution of facility percent of patients with at least 1 inpatient hospitalization claim within 6 months is normally distributed, suggesting that there are no particular excesses of either strongly or poorly performing facilities. The observed net decline at all reported percentiles suggests that efforts to reduce hospitalizations are occurring on a very broad scale across US hemodialysis facilities. By contrast, the distribution of facility percent of patients with at least 1 RBC transfusion claim within 6 months appears to have a slight positive skew, suggesting the variation may be influenced by an excess of facilities with a higher percentage with an RBC transfusion claim. This may arise by clustering of high-risk patients in certain facilities or by similar skews in the facility percentage of patients treated to lower hemoglobin levels across facilities and/or the threshold of physician providers within a facility or within a hospital to which a facility refers patients for transfusion procedures. In summary, the DPM provides a uniquely rich source of data capable of identifying early warning insights regarding contemporary trends in US hemodialysis care. To that end, the DPM now incorporates Medicare claims data, providing facility-level distributions for the percent of Medicare ESRD beneficiaries hospitalized or with a claim for RBC transfusion during 1- and 6-month periods. As with the other DPM measures, stratified reporting of these estimates by patient-level (eg, transplantation eligible) or facility-level (eg, facility setting or location) subgroups is anticipated. Future work also may attempt to explain observed facility variation by incorporating patient case-mix adjustment for the covariates available in Medicare claims records (eg, age group, sex, race, and geography) and through facility-level linkage to more detailed contemporary DOPPS data. Support: The DOPPS Program is supported by Amgen, Kyowa Hakko Kirin, AbbVie Inc, Sanofi Renal, Baxter Healthcare, and Vifor Fresenius Medical Care Renal Pharma, Ltd. Additional support for specific projects and countries is also provided by Amgen, BHC Medical, Janssen, Takeda, and Kidney Foundation of Canada (for logistics support) in Canada; Hexal, Deutsche Gesellschaft fur Nephrologie (DGfN), Shire, and WiNe Institute in Germany; and the Japanese Society for Peritoneal Dialysis for Peritoneal Dialysis Outcomes and Practice Patterns Study in Japan. All support is provided without restrictions on publications. Financial Disclosure: Dr Pisoni has received speaker fees from Amgen, Kyowa Hakko Kirin, and Vifor and served on an advisory panel for Merck. Dr Robinson has received speaker fees for Kyowa Hakko Kirin. The other authors declare that they have no relevant financial interests.

Managing oral phosphate binder medication expenditures within the Medicare bundled end-stage renal disease prospective payment system: economic implications for large U.S. dialysis organizations.

From January 2016, payment for oral-only renal medications (including phosphate binders and cinacalcet) was expected to be included in the new Medicare bundled end-stage renal disease (ESRD) prospective payment system (PPS). The implementation of the ESRD PPS has generated concern within the nephrology community because of the potential for inadequate funding and the impact on patient quality of care. To estimate the potential economic impact of the new Medicare bundled ESRD PPS reimbursement from the perspective of a large dialysis organization in the United States. We developed an interactive budget impact model to evaluate the potential economic implications of Medicare payment changes to large dialysis organizations treating patients with ESRD who are receiving phosphate binders. In this analysis, we focused on the budget impact of the intended 2016 integration of oral renal drugs, specifically oral phosphate binders, into the PPS. We also utilized the model to explore the budgetary impact of a variety of potential shifts in phosphate binder market shares under the bundled PPS from 2013 to 2016. The base model predicts that phosphate binder costs will increase to $34.48 per dialysis session in 2016, with estimated U.S. total costs for phosphate binders of over $682 million. Based on these estimates, a projected Medicare PPS $33.44 reimbursement rate for coverage of all oral-only renal medications (i.e., phosphate binders and cinacalcet) would be insufficient to cover these costs. A potential renal drugs and services budget shortfall for large dialysis organizations of almost $346 million was projected. Our findings suggest that large dialysis organizations will be challenged to manage phosphate binder expenditures within the planned Medicare bundled rate structure. As a result, large dialysis organizations may have to make treatment choices in light of potential inadequate funding, which could have important implications for the quality of care for patients with ESRD.

Trends in US Vascular Access Use, Patient Preferences, and Related Practices: An Update From the US DOPPS Practice Monitor With International Comparisons

Since the bundled end-stage renal disease prospective payment system began in 2011 in the United States, some hemodialysis practices have changed substantially, raising the question of whether vascular access practice also has changed. We describe monthly US vascular access use from August 2010 to August 2013 with international comparisons, and other aspects of US vascular access practice. Prospective observational cohort study of vascular access. Maintenance hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor (DPM) in the United States (N=3,442; US patients) and 19 other nations (N=8,478). Country, patient demographics, time period. Vascular access use, pre-end-stage renal disease access timing of first nephrologist care and arteriovenous access placement, patient self-reported vascular access preferences (United States only), treatment practices as stated by medical directors. In the United States from August 2010 to August 2013, arteriovenous fistula (AVF) use increased from 63% to 68%, while catheter use declined from 19% to 15%. Although AVF use did not differ greatly across age groups, arteriovenous graft use was 2-fold higher among black (26%) versus nonblack US patients (13%) in 2013. Across 20 countries in 2013, AVF use ranged from 49% to 92%, whereas catheter use ranged from 1% to 45%. Patient-reported vascular access preferences differed by sex and race, with 16% to 20% of patients feeling uninformed regarding benefits/risks of different vascular access types. Among new (incident) US hemodialysis patients, AVF use remains low, with ∼70% initiating hemodialysis therapy with a catheter (60% starting with catheter when having≥4 months of predialysis nephrology care). In the United States, longer typical times to first AVF cannulation were reported. Noncompletion of surveys may affect the generalizability of findings to the wider hemodialysis population. AVF use has increased, with catheter use decreasing among prevalent US hemodialysis patients since the introduction of the prospective payment system. However, AVF use at dialysis therapy initiation remains low, suggesting that reforms affecting predialysis care may be necessary to incentivize improvements in fistula rates at dialysis therapy initiation as achieved for prevalent hemodialysis patients.

Hemoglobin Stability and Patient Compliance With Darbepoetin Alfa in Peritoneal Dialysis Patients After the Implementation of the Prospective Payment System

PurposeSince the Centers for Medicare & Medicaid Services implemented the End-Stage Renal Disease Prospective Payment System, dialysis providers have increasingly focused on balancing resource utilization and quality outcomes for the treatment of anemia in patients undergoing peritoneal dialysis. Limited data exist regarding anemia management outcomes for these patients in US-based dialysis centers after the implementation of the new payment system. MethodsThis was a retrospective, observational, cohort study of stable PD patients with end-stage renal disease who received darbepoetin alfa for anemia management over a 15-month period (April 1, 2011–June 29, 2012). The medication was administered by staff in the home-training unit instead of being self-administered at home. The primary end point was mean quarterly hemoglobin (Hb) levels. Variability in Hb levels was assessed over the 5 quarters by using repeated measures ANOVA to test for differences in the observed mean SDs. FindingsIn the 139 adult patients on stable peritoneal dialysis and meeting the eligibility criteria, mean (SD) Hb level by quarter was 10.8 (1.2) g/dL in quarters 2 and 3 of 2011, 10.5 (1.1) g/dL in quarter 4 of 2011, and 10.4 (1.1) g/dL in quarters 1 and 2 of 2012. Hb levels were stable (mean SDs, 0.58–0.72) over the 5 quarters of the study. Patient compliance with attendance for all scheduled home training unit visits was 84%. ImplicationsPD patients who underwent darbepoetin alfa administration and twice-monthly laboratory testing in the home-training unit had stable Hb levels. Despite more frequent center visits compared with a home-administered approach, patient compliance was high.

Development and Evaluation of the CAHPS (Consumer Assessment of Healthcare Providers and Systems) Survey for In-Center Hemodialysis Patients

The US Centers for Medicare & Medicaid Services assess patient experiences of care as part of the end-stage renal disease prospective payment system and Quality Incentive Program. This article describes the development and evaluation of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) In-Center Hemodialysis Survey. We conducted formative research to generate survey questions and performed statistical analyses to evaluate the survey's measurement properties. Formative research included focus groups, cognitive interviews, and field testing the survey with dialysis patients. We assessed internal consistency reliability (Cronbach alpha) and center-level reliability for 3 multi-item scales. We evaluated construct validity using correlations of the scales with global ratings of the kidney doctor, staff, and dialysis center. Response rate was 46% (1,454 completed surveys). Analyses support 3 multi-item scales: Nephrologists' Communication and Caring (7 items, alpha=0.89), Quality of Dialysis Center Care and Operations (22 items, alpha=0.93), and Providing Information to Patients (11 items, alpha=0.75). The communication scale was correlated the most strongly with the global rating of the "kidney doctor" (r=0.78). The Dialysis Center Care and Operations scale was correlated most strongly with global ratings of staff (r=0.75) and the center (r=0.69). Providing Information to Patients was correlated most strongly with the global rating of the staff (r=0.41). A relatively small number of patients completed the survey in Spanish. This study provides support for the reliability and validity of the CAHPS In-Center Hemodialysis Survey for assessing patient experiences of care at dialysis facilities. The survey can be used to compare care provided at different facilities.

The DOPPS Practice Monitor for US Dialysis Care: Potential Impact of Recent Guidelines and Regulatory Changes on Management of Mineral and Bone Disorder Among US Hemodialysis Patients

Dysregulation in mineral and bone metabolism may contribute to the development of vascular calcification, cardiovascular disease, and adverse clinical outcomes in patients with end-stage renal disease.1Goodman W.G. Goldin J. Kuizon B.D. et al.Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis.N Engl J Med. 2000; 342: 1478-1483Crossref PubMed Scopus (2436) Google Scholar Clinical management of mineral and bone disorder (MBD) typically is based on repeated measurement of laboratory markers, specifically parathyroid hormone (PTH), calcium, and phosphorus, and therapeutic interventions aimed at keeping these MBD markers within specific target ranges. The 2009 KDIGO (Kidney Disease: Improving Global Outcomes) guideline2Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work GroupKDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD).Kidney Int Suppl. 2009; 113: S1-S130PubMed Google Scholar and the 2010 KDOQI (Kidney Disease Outcomes Quality Initiative) US commentary3Uhlig K. Berns J.S. Kestenbaum B. et al.KDOQI US commentary on the 2009 KDIGO clinical practice guideline for the diagnosis, evaluation, and treatment of CKD-mineral and bone disorder (CKD-MBD).Am J Kidney Dis. 2010; 55: 773-799Abstract Full Text Full Text PDF PubMed Scopus (218) Google Scholar suggest different target levels for these markers than previously recommended in the 2003 KDOQI guideline.4National Kidney FoundationK/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease.Am J Kidney Dis. 2003; 42: S1-S202Crossref PubMed Scopus (667) Google Scholar The most notable change was a less stringent range for PTH levels, with the previously recommended range of 150-300 pg/mL relaxed to 2-9 times the upper limit of the assay normal range (about 130-600 pg/mL). These different recommended target ranges may have led to changes in clinical practices in the field of MBD. Additionally, the end-stage renal disease prospective payment system5Centers for Medicare & Medicaid ServicesMedicare program; end-stage renal disease prospective payment system. Final rule.Fed Regist. 2010; 75: 49029-49214PubMed Google Scholar implemented in January 2011 also may have led to changes in utilization of MBD-related intravenous (IV) drugs. For example, the prospective payment system may have affected prescription of vitamin D analogues, especially in patient subgroups that require higher average doses6US Government Accountability OfficeEnd-Stage Renal Disease: CMS Should Monitor Access to and Quality of Dialysis Care Promptly After Implementation of New Bundled Payment System. US Government Accountability Office, Washington, DC2010Google Scholar (eg, black patients, Medicaid recipients, and patients aged <55 years). We report on trends using data between August 2010 and April 2013 from the national sample of the US Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor (DPM; www.dopps.org/dpm). Each monthly cross-section between August 2010 and April 2013 included approximately 3,489 patients. Trend outcomes reported here include serum levels of PTH, total calcium, and phosphorus; MBD-related treatments, including IV and oral vitamin D analogues, cinacalcet, and phosphate binders; and MBD targets reported from surveys of DOPPS medical directors between 2009 and 2012. Trends in upper target levels of MBD markers were analyzed with the Mantel-Haenszel χ2 test. Survey-weighted linear and logistic regressions were used to model longitudinal trends in serum levels of PTH (log-transformed), total calcium, and phosphorus, as well as the proportion of patients with PTH levels ≥ 600 pg/mL. Contrast adjustments included time (using a linear spline with 1 knot at April 2011 to improve model fit), race (black vs nonblack), Medicaid status (yes vs no), and age group (<55 vs ≥55 years). Upper limits of targets for PTH (P < 0.001) and calcium levels (P = 0.02) increased from 2009 through 2012, while phosphorus targets remained largely unchanged (Fig 1). The percentage of facilities reporting an upper PTH target ≥ 600 pg/mL sharply increased from 3% in 2009 and 7% in 2010 to 40% in 2012. Likewise, the percentage of facilities reporting an upper limit for calcium target of 10.5 mg/dL increased from 26% in 2009 and 21% in 2010 to 37% in 2012. The majority of facilities (76%-83%) reported an upper phosphorus target of 5.5 mg/dL in each survey year, with no clear trend observed (P = 0.4). The median proportion of patients per facility-month with a reported PTH measurement within 3 months declined modestly by 2% per year from 100% in 2010 to 94% in 2013. Similarly, the adjusted odds of an individual patient having a PTH measurement reported within a 3-month period declined significantly from August 2010 to April 2013 (odds ratio, 0.98/month; 95% confidence interval, 0.97-0.99). Mean (median) PTH levels increased from 339 pg/mL (245 pg/mL) in August 2010 to 433 pg/mL (321 pg/mL) in April 2011, increases of 28% and 31%, respectively (P < 0.001), but were relatively stable since then (P = 0.1; Fig 2). Between August 2010 and April 2013, the percentage of patients with PTH levels ≥ 600 pg/mL nearly doubled, from 11% to 19%, and the percentage of patients with PTH levels ≥ 300 pg/mL increased from 36% to 56%. Although relative increases in mean PTH levels were not different for black patients (P = 0.3 vs nonblack), patients aged <55 years (P = 0.1 vs ≥55 years), and patients with Medicaid (P = 0.3 vs non-Medicaid), mean absolute PTH levels were higher in each of these subgroups (all P < 0.001). Mean PTH levels in 2012 were on average 10.4% higher for patients in facilities reporting an upper PTH target of 600 pg/mL versus 300 pg/mL (P = 0.09). Overall, no clear changes were observed for IV vitamin D prescription (73.5%; trend P = 0.9) or cinacalcet prescription (22.7%; trend P = 0.2). Although many facilities switched IV vitamin D preparation from paricalcitol to doxercalciferol during this period (P = 0.003), the increase in PTH levels did not differ by doxercalciferol versus paricalcitol prescription for treated patients (preparation-time interaction P = 0.9). The reported measurement frequency of serum calcium (P = 0.8; mean, 94%/mo) and serum phosphorus levels (P = 0.2; mean, 95%/mo) did not change over time. Although statistically significant, the observed increase in serum calcium levels (from 8.97 to 9.03 mg/dL; P = 0.003) and decrease in serum phosphorus levels (from 5.23 to 5.18 mg/dL; P < 0.001) likely were too small to be clinically meaningful (Fig 2). No temporal trend in dialysate calcium concentration was observed (P = 0.7). Phosphate-binder use increased slightly, from 78% to 80% (P = 0.003). During this time of clinical guideline and reimbursement policy changes, PTH levels have increased overall among US dialysis patients. Overall, this trend is consistent with findings from other DOPPS countries, with the exception of Japan.7Tentori F. Bieber B.A. Morgenstern H. et al.Parathyroid hormone (PTH) levels rose over time in hemodialysis (HD) patients: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS) [European Renal Association-European Dialysis and Transplant Association Congress (ERA-EDTA) abstract].Nephrol Dial Transplant. 2012; 27: ii52-ii54Google Scholar Because no trends in therapeutic regimens were observed that may explain the increase in PTH levels, it is likely that changes in MBD targets suggested in the 2009 KDIGO chronic kidney disease–MBD guideline2Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work GroupKDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD).Kidney Int Suppl. 2009; 113: S1-S130PubMed Google Scholar played a significant role. PTH levels were higher at dialysis units that reported higher PTH target levels. Whereas the increase in the upper limit of PTH target occurred sharply between 2010 and 2011, the shift toward higher targets for serum calcium level occurred more gradually. Given the recent increase in the percentage of patients with very high PTH levels, clinicians should continue to monitor MBD marker levels. Additional studies are needed to provide a higher level of evidence supporting a specific PTH target. Support: The DOPPS program is supported by Amgen, Kyowa Hakko Kirin, AbbVie Inc, Sanofi Renal, Baxter Healthcare, Vifor Fresenius Medical Care Renal Pharma Ltd, and Fresenius Medical Care. Additional support for specific projects and countries also is provided in Canada by Amgen, BHC Medical, Janssen, Takeda, and Kidney Foundation of Canada (for logistics support); in Germany by Hexal, DGfN, Shire, and WiNe Institute; and for PDOPPS in Japan by the Japanese Society for Peritoneal Dialysis. All support is provided without restrictions on publications. Dr Tentori is supported in part by award number K01DK087762 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIDDK or the National Institutes of Health. Financial Disclosure: Dr Robinson has received a speaker's fee from Kyowa Hakko Kirin. Dr Pisoni has received speaker's fees from Amgen, Kyowa Hakko Kirin, and Vifor and has served on an advisory panel for Merck. Dr Tentori has received honoraria from Amgen, Dialysis Clinic, and Renal Research Institute. The other authors declare that they have no other relevant financial interests.

The DOPPS Practice Monitor for US Dialysis Care: Update on Trends in Anemia Management 2 Years Into the Bundle

From Arbor Research Collaborative for Health, Ann Arbor, MI. Originally published online October 21, 2013. Concepts presented in this article are based on data available at the DPM website and may have appeared in resources and media releases distributed by DPM. Address correspondence to Douglas S. Fuller, MS, Arbor Research Collaborative for Health, 340 E Huron St, Ste 300, Ann Arbor, MI 48104. E-mail: doug.fuller@arborresearch.org 2013 by the National Kidney Foundation, Inc. 0272-6386/$36.00 http://dx.doi.org/10.1053/j.ajkd.2013.09.006 The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor (DPM) was developed to detect and report on trends in dialysis care before, during, and after implementation of the end-stage renal disease prospective payment system (PPS), which was initiated by the US Centers for Medicare & Medicaid Services (CMS) in January 2011. The DPM is based on a national sample of US hemodialysis facilities, with sampling weighting techniques used to calculate nationally representative statistics. The DPM is updated every 4 months at www.dopps.org/DPM, with data available after a lag period of just 2-4 months. The rationale and methods of the DPM have been described previously and statistics based on the DPM sample have been shown to closely correspond to other published national data. As a continuation of previous publications in AJKD, here we highlight trends in anemia from August 2010 through December 2012. As discussed in previous DPM updates, several changes provided direct impetus for US dialysis centers to change anemia management during this period: the addition of previously separate billable services including erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron to the composite bundled dialysis payment rate, a revised ESA label approved by the US Food and Drug Administration (FDA) that removed a specific target for hemoglobin (Hb) level (June 2011), and soon after, the discontinuation by the CMS Quality Incentive Program of the payment penalty for Hb levels , 10 g/dL. DPM data reported here reflect an average of 3,504 (range, 2,131-4,191) hemodialysis patients in 96 (range, 74-110) facilities per month over a 29-month period. Data are aggregated across facilities and dialysis organizations; thus, aggregated trends may not reflect trends in individual facilities or dialysis organizations.

The DOPPS Practice Monitor for US Dialysis Care: Trends Through December 2011

The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor1 (DPM) was developed to inform the dialysis community of contemporary trends in dialysis treatment practices and patient outcomes, with the launch in 2010 timed to follow care before and after implementation of the end-stage renal disease prospective payment system (PPS) by the US Centers for Medicare & Medicaid Services (CMS) in January 2011. Publicly available updates are provided every 4 months at the DPM website (www.dopps.org/DPM).

Financial Implications of Choice of Dialysis Type of the Revised Medicare Payment System: An Economic Analysis

In 2011, the Medicare Improvements for Patients and Providers Act replaced the case-mix-adjusted composite payment system for Medicare outpatient dialysis facilities with a bundled end-stage renal disease prospective payment system (PPS). We assessed the economic implications for modality choice of the revised Medicare payment system. Microeconomic analyses. Patients eligible for dialysis in the United States. The perspective of this analysis is that of a financial administrator of a representative dialysis center in the United States. Data were obtained from the Medicare Payment Advisory Commission, the US Renal Data System, the DOPPS (Dialysis Outcomes and Practice Patterns Study) Practice Monitor, the US Bureau of Labor Statistics, and Medicare fee schedules. Recently implemented end-stage renal disease PPS versus the prior case-mix composite payment system. Medicare payment per month, center fixed and variable costs per month, net difference in revenue and variable costs (direct contribution), and net difference in revenue and total costs (operating margin). The direct contribution and operating margin for in-center hemodialysis and peritoneal dialysis are expected to be positive under the new bundled PPS. For Medicare fiscal intermediaries/administrators, paid treatments for home hemodialysis vary from 3.2 to more than 4.8 per week. The direct contribution and operating margin are expected to be negative for home hemodialysis if the number of paid treatments is similar between in-center and home hemodialysis; they are almost identical when the number of paid treatments increases for home hemodialysis by approximately 1 per week. Experience across centers and intermediaries/administrators may vary. Sensitivity analyses were conducted to assess the robustness of findings and determine which variables most influenced results. The new bundled PPS created a financial incentive for increased use of peritoneal dialysis. Use of home hemodialysis may be influenced by number of paid treatments per week.

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

A new initiative of the US Dialysis Outcomes and Practice Patterns Study (DOPPS), the DOPPS Practice Monitor (DPM), provides up-to-date data and analyses to monitor trends in dialysis practice during implementation of the new Centers for Medicare & Medicaid Services (CMS) end-stage renal disease Prospective Payment System (PPS; 2011-2014). We review DPM rationale, design, sampling approach, analytic methods, and facility sample characteristics. Using stratified random sampling, the sample of ~145 US facilities provides results representative nationally and by facility type (dialysis organization size, rural/urban, free standing/hospital based), achieving coverage similar to the CMS sample frame at average values and tails of the distributions for key measures and patient characteristics. A publicly available web report (www.dopps.org/DPM) provides detailed trends, including demographic, comorbidity, and dialysis data; medications; vascular access; and quality of life. Findings are updated every 4 months with a lag of only 3-4 months. Baseline data are from mid-2010, before the new PPS. In sum, the DPM provides timely representative data to monitor effects of the expanded PPS on dialysis practice. Findings can serve as an early warning system for possible adverse effects on clinical care and as a basis for community outreach, editorial comment, and informed advocacy.

The D&amp;T Report

Dialysis & TransplantationVolume 38, Issue 11 p. 436-441 D&T ReportFree Access The D&T Report First published: 26 November 2009 https://doi.org/10.1002/dat.20381AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat The rapid increase in the population of people aged 65 or older is a testament to the success of medical and public-health advances developed over the past century. According to at least one estimate, people 75 and older constitute the fastest-growing age group of people initiating dialysis.1 This phenomenon isn't limited to the United States: Reports from several other industrialized nations have also commented on the growing numbers of older kidney patients and the challenges they present to the health systems of those countries.2 In 2003, an editorial in the British Medical Journal noted that, of the one million people in the world then on dialysis, more than half were older than 65, as were 10% of the people waiting for cadaveric kidney donations.3 Geriatric nephrology actually was first established as a subspecialty in the 1980s, and knowledge in the area has accrued steadily in the two decades since.4 Recently, the American Council of Graduate Medical Education (ACGME) made geriatric nephrology a requirement in nephrology fellowship programs, and the American Society of Nephrology (ASN) added a course in geriatric nephrology to the agenda of its 2009 annual meeting. “Nephrologists are being inundated with patients 80, 85, 90, 95 who have renal failure,” the course leader, Dimitrious Oreopoulos, MD, PhD, professor of medicine at the University of Toronto, D&T editorial board member, and a specialist in geriatric nephrology, said in an ASN Kidney News podcast recorded before the meeting.5 A Heterogeneous Population The U.S. has seen at least one previous population explosion among the elderly. Between 1900 and 1930, the American life expectancy jumped 10 years—the largest single increase in life span in recorded history.6 The result: a surge in the numbers of older Americans, just in time for the Great Depression. Impoverished citizens in their 60s and 70s wrote President Franklin Roosevelt, begging for relief. Finally, in January of 1935, Roosevelt signed into law the Social Security Act, providing a safety net for retired workers aged 65 and older.6 Thus, 65 was designated as the age at which one officially becomes “elderly” nearly a century ago, and has not changed since. But 65 today is not the same as 65 in 1930.“In 2009, the cutoff of 65 may be ready for review, because people are living longer,” says Mark Swidler, MD, assistant professor of nephrology, geriatrics, and palliative care at Mount Sinai School of Medicine in New York. “So 65 to 75 is probably closer to a younger person, and really the most challenges we are seeing are in patients over the age of 80.” Essentially, functional or biological age is more important than a patient's chronological age, says Dr. Swidler. For example, someone with a chronological age of 50 but who is severely diabetic and has undergone one or more amputations or has a history of myocardial infarction, heart failure, or other forms of cardiovascular disease may have a functional age of 75 or 80. In fact, he says, “ESRD or progressive CKD may be seen as forms of accelerated aging.” Functional status and quality of life are the two main considerations to keep in mind when evaluating an older person for dialysis —Mark Swidler, MD Dr. Swidler adds that functional status and quality of life are the two main considerations to keep in mind when evaluating an older person for dialysis. It is also important to distinguish normal, age-related changes in renal function from those that reflect some type of pathology: Even healthy people experience a decline of about 1% per year in renal function after age 40, but more rapid deterioration due to diabetes or hypertension should not be viewed simply as an inevitable consequence of getting old.5 Cognitive function is an important concern among older dialysis patients and should be evaluated regularly. Indeed, there is some evidence that poor kidney function may hasten cognitive decline. Aron Buchman, MD, a neuroscientist at Rush University Medical Center in Chicago, and colleagues studied renal cognitive function in 886 cognitively normal, community-dwelling patients with a mean age of 81, all of whom were participating in the Rush Memory and Aging Project. After a baseline evaluation, the investigators followed the patients annually for up to six years. They found that a baseline estimated glomerular filtration rate (eGFR) one standard deviation below the mean (equivalent to 15/ml/min/1.73m2 less than the mean eGFR) correlated with a baseline age three years higher in terms of cognitive decline. They concluded that impaired kidney function was associated with a faster rate of cognitive deterioration in older age.7, 8 When Not to Dialyze At some point, clinicians who care for elderly people with ESRD inevitably must face the challenge of determining whether dialysis simply is inappropriate. That healthcare providers often find this topic agonizing was reflected in the findings of a survey of 393 nephrology nurses: Respondents felt that 15% of their patients aged 65 and older should not be on dialysis, and 80% were troubled by the decision to start dialysis for some elderly patients.9 Dr. Swidler recommends that clinicians approach the topic with the patient and loved ones as early as possible. “If you wait, it becomes much more difficult to develop a good plan that respects the patient's quality of life and looks at benefits versus burden.” In general, he says, poor candidates for dialysis include people with terminal diseases, end-stage dementia or coma, or anyone for whom dialysis might significantly impair quality of life (for example, someone for whom vascular access might be extremely difficult). “There's no black or white; it's shared decision-making and trying to arrive at a consensus among everyone involved,” he says. Bottom Line As 60 becomes “the new 40,” individual assessment of each patient is increasingly important in the care of older people with kidney disease. Clinicians must remain sensitive to the wishes of the patient and his or her family, while not denying the reality of that patient's clinical status. As Dr. Swidler says, “The tenet in geriatrics is quality of life, and quality of life is measured by functional level and cognitive function. Everything revolves around functionality and a good brain.” The Senate Finance Committee has approved a new healthcare plan, making it the last of five committees to present Congress with some type of health-reform proposal. Most participants in the debate agree that reform is necessary; beyond that, the various factions differ sharply on the type of reform that is needed and how it should be achieved. But, one group has reached near-unanimity on something: Dialysis and transplantation patients and their advocates agree that a new policy governing payment for immunosuppressive agents following a transplant is essential. So a health-reform bill developed earlier this year by the House Ways and Means Committee got their attention. Officially introduced on July 14, America's Affordable Health Choices Act of 2009, also known as HR 3200, contains, in its 1,000-plus pages, a “miscellaneous improvement” that extends the current 36-month limitation on Medicare coverage of immunosuppressant drugs for kidney transplant recipients.1 Whether or not the recently approved Senate bill contains similar language is uncertain. A Long Battle For years, advocacy groups representing transplant recipients have been lobbying Congress in the hopes of extending the limit. Currently, the drugs cost between $1,000 and $3,000 per month, or up to $36,000 per year. Arbitrary as it seems, the 36-month limit is already a victory of sorts: When Medicare first began paying for immunosuppressive agents in 1988, it did so for only 12 months, then increased the period to 36 months in 1993. Various Congressional leaders have proven sympathetic to arguments in favor of rescinding the limit altogether, until they run up against brutal fiscal realities: According to estimates by the Congressional Budget Office (CBO), unlimited immunosuppressive coverage would add $100 million a year to the Medicare kidney program, which already costs $23 billion annually. Still, as detailed in a recent article in the New York Times, the CBO's objection seems shortsighted: The U.S. Renal Data System estimates that Medicare currently spends an average of $17,000 annually on care for renal transplant recipients, the lion's share of which goes toward anti-rejection drugs, compared with an average of $71,000 a year on dialysis and $106,000 for a kidney transplant.2 Allowing transplant recipients unlimited access to anti-rejection medication would not only keep them off dialysis, it could help many of them avoid the trauma and expense of another transplant if the first kidney is rejected because the patient cannot afford the immunosuppressant drugs. At least one state has already made some changes in its coverage policies. In June, Florida governor Charlie Crist signed a bill allowing ESRD patients in the state to qualify for Medigap policies that could help them obtain the anti-rejection drugs. The bill was named after basketball star Alonzo Mourning, who presented his case on Capitol Hill, arguing that allowing dialysis and transplant patients to keep their private insurance for 42 months instead of the 30 months now required before transitioning onto Medicare could save Medicare as much as $1.2 billion.3 Bottom Line Lifting the limit on Medicare coverage of immunosuppressive agents makes sense, but such proposals may get lost this year in the larger complexities of overall healthcare reform. Indeed, the Senate and the House of Representatives both introduced bills specifically for that purpose in March. However, as the website Govtrack.us states bleakly, “The majority of bills and resolutions never make it out of committee.”4 D&T Briefs ASSOCIATIONS AKF Testifies at CMS Town Hall Meeting In late October, the American Kidney Fund (AKF) submitted testimony at a Centers for Medicare and Medicaid Services town hall meeting on the End-Stage Renal Disease Prospective Pay-ment System Proposed Rule. LaVarne A. Burton, president and chief executive officer of the American Kidney Fund, addressed the organization's concerns with three areas of the proposed rule: drug bundling, cost sharing, and disparities. Burton said the AKF believes that including oral drugs that do not have intravenous equivalents in the payment bundle Part D will have an adverse impact on patients. They also have major concerns regarding patient cost sharing. The proposed payment structure will be burdensome for patients and significantly increase patient out-of-pocket payments. The AKF is also concerned about the lack of adequate case-mix adjustors for race. Despite the fact that CMS has historically acknowledged that African-American patients require higher doses of ESAs in order to control anemia, CMS does not account for race as a case mix adjustor for the payment structure. While the AKF recognizes that there are challenges in the data used to evaluate race as an adjustor, they recommend that CMS refine its data sources and commit to a definite timeframe for completing this work so that a race/ethnicity adjustor may be factored into the reimbursement policy. In the meantime, CMS should not go forward with the proposed rule without some placeholder mechanism to recognize the impact of race on the cost of dialysis. CLINICAL New International Guideline Offers Direction for Care of Kidney Transplant Recipients For the first time in almost a decade, a new set of evidence-based recommendations has been released for the monitoring and treatment of kidney transplant recipients. The KDIGO Clinical Practice Guideline for the Care of the Kidney Transplant Recipients was developed by an international group of experts and an evidence-review team who screened more than 15,000 clinical studies to create the guideline, which is the first to focus on long-term patient care. It was published as a supplement of the October issue of the American Journal of Transplantation. The guideline encourages transplant worldwide by defining minimum standards, removing misconceptions and barriers, and calls for research, when evidence is poor. The guideline covers five major areas, including: Induction therapy and immunosuppression Graft monitoring and infectious diseases Cardiovascular disease risk management Malignancy Other complications For more information on the guidelines, visit www.kdigo.org. PATIENTS RSN Creates Online Forum for Proposed Rule Discussion The Renal Support Network (RSN) has created an online forum to help people with CKD, family members, and healthcare professionals learn about pending reimbursement changes for patients on dialysis. The forum is dedicated to the Proposed Rule for reimbursing dialysis, and is organized by topics such as: laboratory testing, medications, share of costs, home dialysis, quality of care incentives, and access to care. Users can click on these links for information on how each topic will be affected by the proposed bundled reimbursement program. The RSN will be developing a position paper on the Proposed Rule to CMS, and will use the comments posted on the online forum as a vital information source. A toll-free number dedicated to the Proposed Rule has been created for patients, and can be reached at 877/543-6353. The online forum is located at www.kidneypublicpolicy101.com. References 1 How can the nephrology community meet the needs of the growing population of elderly patients [Press Release]? Available at: www.newswise.com/articles/view/555206?print-article October 1, 2009. Accessed October 21, 2009. Google Scholar 2 Brunori G, Viola, BF, Maiorca P, Cancarini G., How to manage elderly patients with chronic renal failure: conservative management versus dialysis. Blood Purif. 2008; 26 1 36– 40. CrossrefPubMedWeb of Science®Google Scholar 3 Sims RJ, Cassidy MJ, Masud T., The increasing number of older patients with renal disease. BMJ 2003; 327: 463– 464. CrossrefCASPubMedWeb of Science®Google Scholar 4 Schlanger LE, Bailey JL, Sands JM., Geriatric nephrology: old or new subspecialty. Clin Geriatr Med. 2009; 25 3 311– 324. CrossrefPubMedWeb of Science®Google Scholar 5 Geriatric Nephrology [Podcast]. ASN Kidney News; August 13, 2009. Available at: http://asn-online.org/publications/kidneynews/podcast.aspx Accessed October 1, 2009. Google Scholar 6 DeWitt L., Historical Background and Development of Social Security. Social Security Administration website. www.ssa.gov/history/brief history3.html Accessed October 21, 2009. Google Scholar 7 Buchman AS, Tanne D, Boyle PA, Shah RC, Leurgans SE, Bennett DA., Kidney function is associated with the rate of cognitive decline in the elderly. Neurology 2009; 73 12 920– 927. CrossrefPubMedWeb of Science®Google Scholar 8 Impaired kidney function linked to cognitive decline in elderly [Press Release]. Chicago, IL: Rush University Medical Center; September 28 2009. Google Scholar 9 Badzek LA, Cline HS, Moss AH, Hines SC., Inappropriate use of dialysis for some elderly patients: nephrology nurses' perceptions and concerns. Nephrol Nurs J. 2000; 27 5 462– 470. CASPubMedGoogle Scholar 1 HR 3200: America's Affordable Health Choices Act of 2009. OpenCongress website. www.open congress.org/bill/111-h3200/text Accessed October 21, 2009. Google Scholar 2 Sack K., U.S. cost-saving policy forces new kidney transplant. New York Times. September 13, 2009. www.nytimes.com/2009/09/14/health/policy/14kidney.html?_r=4&hp Accessed October 21, 2009. Google Scholar 3 NBA All-Star Alonzo Mourning takes Capitol Hill by storm, urging Congress to support health care reform that improves choice, access in care for kidney patients [Press Release]. Available at: www.prnewswire.com/news-releases/ nba-all-star-alonzo-mourning-takes-capitol-hill-by-storm-urging-congress-to-supporthealth-care- reform-that-improves-choice-access-in-care-for-kidney-patients-64017262.html. Accessed October 21, 2009. Google Scholar 4 H.R. 1458: Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009. GovTrack.us website. www.govtrack.us/congress/bill.xpd?bill=h111-1458&tab=summary. Accessed October 21, 2009. Google Scholar Volume38, Issue11November 2009Pages 436-441 ReferencesRelatedInformation