The Impact of Bundling on Clinical Practice
Jay B. Wish, MD
|Indicator|| August 2010
| Mean hemoglobin (g/dL)
| Percentage of patients receiving ESAs
| Median weekly epoetin dose (1000 units)
| Upper 90th percentile weekly epoetin dose (1000 units)
| Percent of patients receiving IV iron in past month
| Median monthly IV iron dose prescribed (mg)
| Upper 90th percentile monthly IV iron dose (mg)
| Median serum ferritin (ng/mL)
| Upper 90th percentile serum ferritin (ng/mL)
| Median PTH (pg/mL)
| IV vitamin D use (percent of patients)
| Oral active vitamin D use (percent of patients)
| Cinacalcet use (percent of patients)
| 30-day annualized hospitalization rate
*ESAs = erythropoiesis stimulating agents; IV = intravenous; PTH = parathyroid hormone
Changes in Hb levels
DOPPS reports data on a stratified random sample of 145 U.S. dialysis facilities that are representative of a national sample by facility type (dialysis organization size, rural/urban, free standing/hospital based). The data are collected monthly and the DOPPS Practice Monitor (www.dopps.org/dpm), a website reporting data trends over the prior 12 months, is updated quarterly. The key findings from the DOPPS Practice Monitor are summarized on Table 1.
The most recent data are through August 2011 and show a decrease in the mean Hb only from 11.5 to 11.4 g/dL between August 2010 and July 2011, but a decrease to 11.2 g/dL in August 2011 following the change in the FDA product information on ESAs and the discontinuation of the target Hb floor for the QIP by CMS.
In addition, the mean Hb level fell from 11.2 to 10.9 g/dL between June and August 2011 among dialysis providers with 10 or more facilities, but only from 11.3 to 11.2 g/dL during the same period among dialysis providers with fewer than 10 facilities. This suggests that the larger dialysis organizations are more nimble in adapting to regulatory changes. There was a 15% decrease in the median dose of ESA prescribed among all the providers in the DOPPS sample between August 2011 and 2011, but the 90th percentile of ESA dose decreased by 23% during this period. It can be inferred that a ceiling on ESA dosing among patients with “ESA resistance” is driving much of the decrease in the mean dose.
Subcutaneous EPO dosing
Since smaller dialysis organizations may be under increased cost pressures from bundling than their larger counterparts with economies of scale, SC EPO dosing has increased to 15% of patients in dialysis organizations with fewer than 10 facilities, while it remains less than 2% among patients in dialysis organizations with 10 or more facilities. IV iron use peaked in June 2011 prior the changes in FDA and CMS QIP policy regarding target Hb levels. The median monthly IV iron dose has increased only 1% between August 2010 and August 2011 to 199 mg.
Nonetheless, the median serum ferritin level has increased 17% during that period to 646 ng/mL, and 34% of patients had serum ferritin levels greater than 800 ng/mL in August 2011.
Active vitamin D
Although anemia management was expected to undergo the greatest change under bundling because ESAs are the biggest ticket item that was previously separately billable by dialysis providers, other aspects of clinical practice have also undergone changes. According to the BioTrends survey of nephrologists in December 2011, there has been very little change in the use of active vitamin D since the onset of bundling, although many providers have changed the brand of active vitamin D used because of more favorable contracting terms.
Cinacalcet use was expected to increase in 2011-2013 (the period during which active vitamin D is in the bundle but cinacalcet is not) due to its vitamin D sparing properties, but a significant increase in cinacalcet use has failed to materialize according to the BioTrends survey. This is confirmed by the DOPPS Practice Monitor, which also demonstrates a small but significant trend towards the increased use of oral as opposed to IV active vitamin D agents, especially marked among patients in dialysis organizations with fewer than 10 facilities where the use of oral active vitamin D approaches 20%.
Phosphate binder use
The DOPPS Practice Monitor does not show a significant change in phosphate binder use, choice of phosphate binder agent, serum phosphorus levels, or serum calcium levels since the onset of bundling. Serum parathyroid hormone (PTH) levels are rising, which may be due to the adoption of the more liberal international KDIGO range for PTH (around 100-500 pg/mL) compared with the U.S. KDOQI range for PTH (150-300 pg/mL) as well as cost-containment efforts directed at active vitamin D use.
Of some concern is an increase in hospitalization rate reported by DOPPS from around 1.5 events per year in August 2010 to around 1.9 events per year in August 2011. The reason for this is not clear since the trend predates the decrease in mean Hb levels that occurred in July and August 2011.
According to the Fistula First dashboard, central venous catheter (CVC) prevalence has remained stable at around 20% between September 2010 and September 2011. Since CVCs are expensive to the dialysis provider under bundling due to the use of antibiotics for infection, thrombolytics for flow problems and missed treatments due to hospitalizations, there had been some concern that the prevalence of arteriovenous grafts (AVGs) might rise under bundling in an attempt to decrease CVC prevalence, since AVGs mature more rapidly than do arteriovenous fistulas (AVFs).
Fortunately, this has not proved to be the case, as the prevalent AVG rate has continued to decrease slightly between 2010 and 2011 and the prevalent AVF rate continues to increase.
The shift of many items such as ESAs, IV iron, active vitamin D, thrombolytics for CVCs and ESRD-related antibiotics from a profit center under fee-for-service to a cost center under bundling has decreased the use of some of these agents, as was intended. The challenge to providers is to provide smarter, more cost-effective care with improved patient outcomes and satisfaction.
The full impact of bundling on clinical practice has yet to be seen, since national claims data are incomplete, most providers are receiving total payments comparable to pre-bundling, and the reduction in payments from the QIP just began. Many of the more radical predictions regarding extensive SC ESA use, greater AVG prevalence, and increased patient complaints/grievances to the ESRD Networks have not been borne out. The increase in hospitalizations does provide some cause for concern and needs to be investigated thoroughly. Otherwise, for most patients and providers, it's been pretty much business as usual.
Jay B. Wish, MD, is Medical Director, Dialysis Program, University Hospitals Case Medical Center, and Professor of Medicine at Case Western Reserve University in Cleveland.