American Journal of Kidney Diseases
Volume 59, Issue 2 , Pages 312-314, February 2012

Commentary on ‘The DOPPS Practice Monitor for US Dialysis Care: Trends Through April 2011’: No Surprises Yet

  • Wolfgang C. Winkelmayer, MD, ScD

      Affiliations

    • Corresponding Author InformationAddress correspondence to Wolfgang C. Winkelmayer, MD, ScD, Division of Nephrology, Stanford University School of Medicine, 780 Welch Rd, Ste 106, Palo Alto, CA 94304

Stanford University School of Medicine, Palo Alto, California

Tufts Medical Center, Boston, Massachusetts

Article Outline

 

The initial announcement, finalization, and ultimate implementation of the end-stage renal disease prospective payment system (PPS),1 also called the expanded bundle, were accompanied by much angst in the nephrology community and agitation among high-profile stakeholders. Overnight, fee-for-service reimbursement by the US Centers for Medicare & Medicaid Services (CMS) to dialysis providers for many dialysis-related services, including most medications administered in the dialysis unit, was replaced by adjusted lump-sum payments for each hemodialysis treatment provided. Included in these new per-session payments were many of the most costly elements of dialysis care, including erythropoiesis-stimulating agents (ESAs), intravenous iron supplements, and intravenous vitamin D analogues, along with their oral equivalents. Other items also were newly included in the “bundled” payment, such as laboratory tests routinely used for the monitoring of patients receiving maintenance dialysis and elements of care associated with vascular access–related infections.2

This new reimbursement scheme exposes dialysis providers to a radically different incentive system. Whereas the previous fee-for-service system encouraged dialysis providers to use (and therefore bill) more previously unbundled goods and services, placing Medicare at risk of increased expenses, the expanded bundle reduces Medicare's exposure to financial risk and encourages providers to use less of the goods and services that are now included in the capitated payment. Accordingly, whereas the old system risked overuse, the new scheme could lead to underuse of relevant aspects of care. However, due to the lack of high-quality evidence for important aspects of care that may be affected by the expanded bundle, the “sweet spot” in which use and patient outcomes are optimized is unknown. The situation is complicated further because the new reimbursement scheme was not pilot tested, as usually is done with such deeply penetrating payment policy changes. Thus, the US Government Accountability Office was particularly concerned that systems be put in place that monitor the impact of the PPS on health care use and—more importantly—patient outcomes.3

The Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor (DPM) is the most visible surveillance system to date. It is funded by industry and established and administered by Arbor Research, an experienced group that has managed the multinational DOPPS and, until recently, the Scientific Registry of Transplant Recipients, and that has been involved in development and evaluation of end-stage renal disease quality measures for the CMS. The DPM project applies this expertise to reviewing the effects of implementation of the expanded bundle on clinical practice and patient outcomes. Details about the design and application of the DPM were published recently in the American Journal of Kidney Diseases,4 and we now have partnered with our colleagues at Arbor Research to provide a forum for the publication of relevant findings from the DPM in a timely manner. Our colleagues at Arbor Research will provide concise summaries of relevant findings and the editors of AJKD will provide accompanying commentaries.

The inaugural publication of findings from the DPM focuses on trends in pertinent laboratory indicators of anemia and bone mineral disease, as well as in the use of medications for treatment for these 2 domains. As expected,2 the mean hemoglobin concentration for hemodialysis patients decreased between August 2010 and April 2011 by 0.1 g/dL on average, with the monthly mean hemoglobin concentrations seemingly stable until November 2010 and then abruptly decreasing to reach a new plateau in February 2011. During the same time, average doses of ESAs (mostly epoetin alfa) have decreased by 3%. The authors provided additional data indicating that although the population mean values for both hemoglobin concentration and ESA dose have decreased, these changes were driven by disproportional decreases at the upper end of the distribution curves, with the proportion of patients with hemoglobin levels <9 g/dL remaining constant. These changes should be viewed within the long-term trend of decreasing mean hemoglobin concentrations since the publication of the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) and CREATE (Cardiovascular Risk Reduction by Early Anemia Treatment With Epoetin Beta) trials in 2006,5, 6 before which the mean hemoglobin concentration in the US hemodialysis population reached 12 g/dL. The most recent data from the US Renal Data System indicate that a lower plateau at ∼11.5 g/dL had been reached in late 2008.7 The present data from the DPM seem to indicate that, abruptly and temporally related to the launch of the PPS, an additional adjustment of dosing behavior occurred. However, the changes in both ESA dose and hemoglobin concentration were relatively modest; this may be explained by the Quality Improvement Program (QIP) that will accompany the PPS starting in 2012 and reflect data collected 2 years earlier.8 During the first year of the QIP, minimizing the proportion of patients with a hemoglobin concentration <10 g/dL constitutes half the potential QIP penalty, thus serving to deter providers from decreasing ESA doses even further. In sum, one may conclude that the combination of the expanded bundle and the QIP have resulted in relatively modest changes in anemia practice during the early months of the PPS.

Viewed within this context, it is concerning that the US Food and Drug Administration (FDA) changed the label for ESAs drastically in June 2011, removing the concept of a hemoglobin treatment target range.9 Shortly after this label change, the CMS followed the FDA's conclusions when they released the proposed rule for QIP years 2013 and 2014.10 Beginning in January 2013 (and applying to practices in 2011), the proposed QIP eliminates the quality indicator pertaining to hemoglobin level <10 g/dL, with no new system-based safeguards in place to address potential further decreases in ESA dosing and subsequent decreases in hemoglobin concentrations that may increase the number of red blood cell transfusions. Evaluating the effects of these policy changes will be an important test of the DPM system.

Regarding mineral bone disease care, parathyroid hormone (PTH) concentrations have increased markedly between August 2010 and April 2011, increasing by ∼100 pg/mL on average. These changes appear almost linear and were not accompanied by apparent changes in serum calcium or phosphorus concentrations or vitamin D administration, although more recent data through June 2011 (available on the DPM website) indicate increased use and higher doses of intravenous vitamin D agonists, perhaps a reaction to the increase in PTH concentrations over time. Clearly, more data and detailed investigation are necessary to understand the full context of the increasing PTH concentrations between August 2010 and April 2011, particularly given the vagaries of PTH assays.11

The DPM also provides data broken down by important patient strata, such as race. The original model used to develop the PPS and identify relevant adjusters found that African Americans had higher costs compared with other groups; however, for various reasons, African American race was not included among the payment adjusters by the CMS. Thus, many in the community had feared that African Americans would be affected disproportionately by the PPS.2, 12 Preliminary results from the DPM indicate that such fears may be justified: African Americans had a more pronounced decrease in hemoglobin concentrations and experienced higher increases in PTH concentrations over time. Although such racial differences are important to note, it is unclear how these changes may affect more relevant outcomes, such as transfusions, parathyroidectomy rates, and other morbidity and mortality outcomes. High vigilance and scrutiny are warranted through continued monitoring and systematic evaluation, both through the DPM and by other means.

In sum, the DPM has offered an important window into the early changes in the medical management of hemodialysis patients that have occurred in the setting of the implementation of the expanded bundle. In this early period, these changes are largely unsurprising, but data are lacking for more concrete outcomes. As the expanded bundle matures and treatment changes equilibrate, it will be interesting to see if the trends noted to date accelerate or stabilize and if these have an effect on patient outcomes.

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Acknowledgements 

Financial Disclosure: Dr Weiner is a medical director of a Dialysis Clinic Inc unit. Dr Winkelmayer has served as an advisor to Affymax/Takeda, Amgen, Astellas/Fibrogen, Fresenius/Vifor, Glaxo-SmithKline, and Sandoz/Hexal and has received research support from Fibrogen.

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References 

  1. Medicare Program; End-Stage Renal Disease Prospective Payment System. 42 CFR Part 410, 413 and 414. [CMS-1418-F] RIN 0938-AP57, Department of Health and Human Services, Centers for Medicare & Medicaid Services, pp 49030-49214.
  2. Winkelmayer WC , Chertow GM . The 2011 ESRD prospective payment system: an uncontrolled experiment . Am J Kidney Dis . 2011;57:542–546
  3. US Government Accountability Office . End-stage renal disease—CMS should monitor access to and quality of dialysis care promptly after implementation of new bundled payment system (GAO-10-295). http://www.gao.gov/new.items/d10295.pdf March 2010; Accessed November 16, 2011
  4. Robinson 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;57:822–831
  5. Singh AK , Szczech L , Tang KL , et al.  Correction of anemia with epoetin alfa in chronic kidney disease . N Engl J Med . 2006;355:2085–2098
  6. Drueke TB , Locatelli F , Clyne N , et al.  Normalization of hemoglobin level in patients with chronic kidney disease and anemia . N Engl J Med . 2006;355:2071–2084
  7. US Renal Data System . USRDS 2011 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States . Am J Kidney Dis . 2012;59(1(suppl 1)):e1–e420
  8. Medicare Program; End-Stage Renal Disease Quality Incentive Program. 42 CFR Part 413. [CMS-3206-F] RIN 0938-AP91, Department of Health and Human Services, Centers for Medicare & Medicaid Services, pp 628-646.
  9. US Food and Drug Administration . FDA 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.htm Accessed October 23, 2011
  10. Medicare Program; Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014; Ambulance Fee Schedule; and Durable Medical Equipment. 42 CFR Parts 413 and 414. [CMS-1577-P] RIN 0938–AQ27, Department of Health and Human Services, Centers for Medicare & Medicaid Services, pp 40498-40550.
  11. Joly D , Drueke TB , Alberti C , et al.  Variation in serum and plasma PTH levels in second-generation assays in hemodialysis patients: a cross-sectional study . Am J Kidney Dis . 2008;51:987–995
  12. Roach JL , Turenne MN , Hirth RA , Wheeler JR , Sleeman KS , Messana JM . Using race as a case-mix adjustment factor in a renal dialysis payment system: potential and pitfalls . Am J Kidney Dis . 2010;56:928–936

PII: S0272-6386(11)01561-7

doi:10.1053/j.ajkd.2011.11.006

Refers to article:

  • The DOPPS Practice Monitor for US Dialysis Care: Trends Through April 2011 , 12 December 2011

    Bruce M. Robinson, Douglas S. Fuller, Brian A. Bieber, Marc N. Turenne, Ronald L. Pisoni
    American Journal of Kidney Diseases February 2012 (Vol. 59, Issue 2, Pages 309-312)

American Journal of Kidney Diseases
Volume 59, Issue 2 , Pages 312-314, February 2012

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