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Figure 1 shows the distribution of 3-month average HGB immediately before and after the implementation of the EMP on April 1, 2006. It is not surprising that there is a relatively small difference between the two distributions, given that the lifespan of the red blood cell in dialysis patients averages 64 days [1]. Overall, there was a 0.2% decrease in the percentage of patients with a 3-month average HGB of >13 g/dl. On the other hand, there was a 1.1% increase in the percentage of patients with a 3-month average HGB of <11 g/dl. An HGB of <11 g/dl has previously been shown to be associated with a greater risk of mortality and hospitalization [2, 3].

Figure 2 shows the distribution of the 3-month average HGB 3 months before and 2 months after the rules were changed. Due to the publishing schedule, only 5 months of follow-up could be included. With the longer follow-up time, the percentage of patients with a 3-month average HGB of <11 g/dl increased (2.0% in 5 months), but surprisingly the percentage of patients with a 3-month average HGB of >13 g/dl actually increased by 0.7%, rather than decreasing further. Closer inspection reveals that a rise of 1.0% occurred between Q2 2006 and June-August 2006, c

3-Month average HGB

Q12006

Q2 2006

Change

<11 g/dl Target range 11-12 g/dl >12-13 g/dl >13 g/dl

17.76% 35.15% 31.90% 15.19%

18.84% 35.83% 30.37% 14.97%

+ 1.1% +0.7% -1.5% -0.2%

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3-Month average hemoglobin, rounded to nearest 0.1 g/dl

Fig. 1. Distribution of 3-month average hemoglobin immediatelybefore and after implementation of the CMS EPO monitoring policy on April 1, 2006.

3-Month average HGB

Target range 11-12 g/dl >12-13 g/dl

Q4 2005 June-August 2006

3-Month average HGB

Target range 11-12 g/dl >12-13 g/dl

Q4 2005 June-August 2006

3-Month average hemoglobin, rounded to nearest 0.1 g/dl rN^rvqcoprN^rvqcoorN cdcdcdcdo^o^o^o^o^oo

3-Month average hemoglobin, rounded to nearest 0.1 g/dl

Fig. 2. Distribution of 3-month average hemoglobin 3 months before and 2 months after implementation of the CMS EPO monitoring policy on April 1, 2006.

Fig. 3. Trend in 3-month average hemoglobin before and after implementation of the CMS EPO monitoring policy on April 1, 2006. ▲ = Mean 8 SD of 3-month average HGB; • = SD of 3-month average HGB.

13.0

12.0

10.0

Cg O

Q3 2005

Q4 2005

Q1 2006

Q2 2006 June-Aug 2006

Fig. 4. A transient drop in the monthly mean hemoglobin followed a transient drop in the mean in-center EPO dose after implementation of the CMS EPO monitoring policy on April 1, 2006. • = Mean incenter EPO dose; ■ = mean HGB.

8,100

8,000

7,800

7,700

7,600

7,500

8,000

7,800

7,700

7,600

7,500

12.02

12.00

11.98

11.96

11.94 ra

11.92

7,400 11.90

Jan 2006 Feb 2006 Mar 2006 Apr 2006 May 2006 June 2006 July 2006 Aug 2006

12.04

12.02

12.00

11.98

11.96

11.94 ra

11.92

7,400 11.90

Jan 2006 Feb 2006 Mar 2006 Apr 2006 May 2006 June 2006 July 2006 Aug 2006

suggesting that physicians' attempts to counteract falling HGB values resulted in overshooting the target, and reduced the percentage of patients in the two central regions of the bell curve (i.e. 11-13 g/dl) by 2.7% over 5 months.

Figure 3 shows the trend in the 3-month average HGB over a 14-month period. A relatively small drop in mean HGB is noted after April 1, 2006. The standard deviation of the population is shown to be quite stable at 1.2 g/dl, consistent with previous data [4]. If anything, there ap pears to be a small rise in standard deviation in the latest period shown, suggesting a slight widening of the distribution, the exact opposite of the desired effect.

The immediate impact of the EMP is more clearly seen in figure 4, which shows monthly data for the average incenter EPO dose and the average HGB. An immediate drop in dose is seen in April, while a drop in HGB follows in May 2006. The mean dose begins to rise in May, and continues to rise through August 2006. This suggests that physicians

Fig. 5. Movement among hemoglobin categories for 73,002 patients with at least one HGB value in each of three months (March 2006, May 2006, July 2006). The stacked bars containing solid colors represent the percent of patients categorized by their latest HGB in each month: pink for latest HGB <11, green for latest HGB in the target range of 11-12, blue for latest HGB >12-13, and yellow for HGB >13 g/dl. The two-tone bars represent patients who moved from one category to another, with the left-hand color chosen to denote the prior HGB category.

Fig. 5. Movement among hemoglobin categories for 73,002 patients with at least one HGB value in each of three months (March 2006, May 2006, July 2006). The stacked bars containing solid colors represent the percent of patients categorized by their latest HGB in each month: pink for latest HGB <11, green for latest HGB in the target range of 11-12, blue for latest HGB >12-13, and yellow for HGB >13 g/dl. The two-tone bars represent patients who moved from one category to another, with the left-hand color chosen to denote the prior HGB category.

1 April 2006 EMP

responded to reduced outcomes with higher EPO doses. After a 3-month fall, the monthly mean HGB returns to its March/April level in August 2006. One might expect that the higher dose observed in August 2006 will cycle back down in response to the rebound in HGB values.

One might ask why the company's strict enforcement of the mandatory dose reduction required by the EMP did not substantially reduce the percent of patients with HGB in that range. This can be best understood by examining the movement of patients among HGB categories, as shown in figure 5. This analysis includes 73,002 patients with at least one HGB value in each of three separate months (March 2006, May 2006, and July 2006). The stacked bars containing solid colors represent the percent of patients categorized by their latest HGB in each month: pink for latest HGB <11, green for latest HGB in the target range of 11-12, blue for latest HGB >12-13, and yellow for HGB >13 g/dl. The two-tone bars represent patients who moved from one category to another, with the left-hand color chosen to denote the prior HGB category. While the percent of the subgroup of patients with latest HGB >13 g/dl dropped only slightly (21.1% to 20.2% to 19.2%), only 2.6% of the patients present in all 3 months remained in the HGB >13 group throughout. Further analysis reveals that the majority of these patients received little or no EPO.

In summary, 5 months of follow-up data show that the April 2006 EMP rules appear to have reduced the percentage of patients with a HGB of >13 g/dl slightly, but with the side effect of putting a greater percentage of patients into HGB categories of <11 g/dl. Given the observed intra-patient HGB variability, it is unrealistic to expect that the percentage of patients >13 g/dl will be reduced substantially using current anemia algorithms without increasing the percentage of patients with HGB <11 g/dl. Furthermore, it remains to be seen whether there will be an overall savings in EPO costs for dialysis patients as a result of the EMP. More up-to-date data will be presented at the conference in January 2007.

References

1 Uehlinger DE, Gotch FA, Sheiner LB: A pharmacodynamic model of erythropoietin therapy for uremic anemia. Clin Pharmacol Ther 1992;51:76-89.

2 Ofsthun N, Labrecque J, Lacson E, Keen M, Lazarus JM: The effects of higher hemoglobin levels on mortality and hospitalization in hemodialysis patients. Kidney Int 2003; 63: 1908-1914.

3 Collins AJ, Ma JZ, Xia A, Ebben J: Trends in anemia treatment with erythropoietin usage and patient outcomes. Am J Kidney Dis 1998;32(6 suppl 4):S133-S141.

4 Lacson E Jr, Ofsthun N, Lazarus JM: Effect of variability in anemia management on hemoglobin outcomes in ESRD. Am J Kidney Dis 2003;41:111-124.

Blood Purif 2007;25:36-38 DOI: 10.1159/000096395

Published online: December 14, 2006

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