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      Impact of the Change in CMS Billing Rules for Erythropoietin on Hemoglobin Outcomes in Dialysis Patients


      Blood Purification

      S. Karger AG

      Anemia, Dialysis, Erythropoietin, Hemoglobin, Medicare

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          On April 1, 2006, new Centers for Medicare and Medicaid Services (CMS) rules for billing erythropoietin (EPO) for dialysis patients went into effect. Two key provisions of the rules were to cap the dose for a single patient at 500,000 IU/month and to mandate a 25% reduction in dose for patients whose latest hemoglobin (HGB) or hematocrit (HCT) in the prior month exceeded 13 g/dl or 39%, respectively. The purpose of this article is to document the effect of the rules change on HGB outcomes in a single large dialysis provider whose computer system was modified to enforce the rules. HGB and EPO doses for 5 months following the implementation were analyzed retrospectively. The most noteworthy observation is that while the rule appears to have reduced the percentage of patients with an HGB of >13 g/dl slightly, it has also increased the percentage of patients with HGB in the medically undesirable range of <11 g/dl.

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          Most cited references 3

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          Effect of variability in anemia management on hemoglobin outcomes in ESRD.

          Hemoglobin (Hgb) levels fluctuate in patients with end-stage renal disease over time. This study quantified Hgb level variability and the likelihood of falling within the Hgb level goal range of 11 to 12 g/dL. Implications on the percentage of patients exceeding 3-month rolling average Hgb levels of 12, 12.5, and 13 g/dL were determined. Phase I (n = 65,009) tracked patients with Hgb values initially outside the goal range ( 12 g/dL) during 2000. Correlation with facility-specific thresholds also was evaluated. Phase II (n = 48,133) quantified variation in 3-month rolling average Hgb levels in a subset with greater than 10 months of data (mean Hgb, 11.4 +/- 1.3 g/dL). A total of 24,948 patients (38.4%) had Hgb levels between 11 and 12 g/dL. In only 8% did Hgb levels consistently remain less than 11 g/dL, and in 18%, greater than 12 g/dL all year. Twenty-nine percent (18,633 patients) moved from below to above target range or vice versa. Greater mean facility Hgb level correlated with a greater percentage of patients with Hgb levels greater than 10 g/dL (R2 = 0.49) and greater than 12.5 g/dL (R2 = 0.61). For facilities to have 90% or greater of patients with 3-month rolling average Hgb levels greater than 10 g/dL, 13% to 31% of patients will have 3-month rolling average Hgb values greater than 12.5 g/dL. The average individual patient is expected to have a +/-1.4-g/dL fluctuation in 3-month rolling average Hgb levels per year. Despite increased mean Hgb levels and erythropoietin (EPO) and iron use, the spread of the Hgb distribution curve remained unchanged in the last 6 years. Variability caused by laboratory assays, biological factors, and therapeutic response determines patient Hgb level variability. Improving factors that can be manipulated (eg, standardizing EPO and iron algorithms) and adjustment of the target Hgb level range, specifically, by increasing the upper bound, likely will decrease the observed variability and further enhance the quality of anemia management. Copyright 2003 by the National Kidney Foundation, Inc.
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            A pharmacodynamic model of erythropoietin therapy for uremic anemia.

            Fifty-seven patients receiving chronic high-flux hemodialysis began receiving recombinant alpha-human erythropoietin (rHuEPO). The mean initial rHuEPO dose used in 54 evaluable patients was 9963 +/- 4364 U/week; the final dose was 8972 +/- 4058 U/week. Treatment over a mean period of 154 +/- 40 days (84 to 224 days) resulted in an average increase in hematocrit from 24.7% +/- 3.7% to 32.5% +/- 4.4%. We present a model for these data that describes changes in hematocrit during rHuEPO therapy and that allows simultaneous estimation of red blood cell lifespan and rHuEPO-induced increases in red blood cell production rate. Analysis of the hematocrit values of the patients with the model, by use of NONMEM, a computer program for analysis of population data, reveals a nonlinear dose-response relationship with large interindividual variability (coefficient of variation) of about 50%. The estimated mean red blood cell lifespan is 64 days, with interindividual variability of about 30% (coefficient of variation). The intraindividual random variability in hematocrit about its prediction is +/- 5% of the prediction. For clinical dose adjustment, we present a method that uses only simple calculations.
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              Trends in anemia treatment with erythropoietin usage and patient outcomes.

              Recombinant erythropoietin, first approved for Medicare reimbursement in June 1989, was prescribed at initial doses for dialysis patients of 2,500 to 2,700 U per administration independent of hematocrit level. By 1997, however, patients with hematocrits less than 30% were administered 6,000 U/dose, compared with 4,500 U administered to patients with hematocrits of 33% to 36%. Since 1990, the percentage of patients with hematocrits less than 30% decreased from 60% to 22% in 1997, whereas the percentage of patients with hematocrits of 33% to 36% increased from 10% to 30%. In 1997, Medicare initiated the Hematocrit Measurement Audit (HMA) policy, which was directed at reducing the percentage of claims for hematocrits greater than 36% and increasing the stability of the hematocrit levels. The policy change achieved the initial effect but resulted in a reduction of the mean hematocrit as well. The policy was changed in 1998 in response to patient and provider concerns. Mortality studies show that hematocrits less than 30% (or hemoglobin levels < 110 g/L) are associated with an 18% to 40% increased associated risk for death. Higher hematocrits of 33% to 36% appear to be associated with a 7% reduced risk for death. The risk for hospitalization parallels that of mortality. Patients with sustained hematocrits of 33% to 36% over 1 year appear to have the best outcome compared with patients with hematocrits that decrease. The latter are at greater risk than those patients in whom the hematocrits increase. In conclusion, dramatic improvements in hemodialysis patient hematocrits have occurred since 1989. Mortality and hospitalization studies support the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF DOQI) target hematocrit range of 33% to 36% as providing the best associated outcomes.

                Author and article information

                Blood Purif
                Blood Purification
                S. Karger AG
                December 2006
                14 December 2006
                : 25
                : 1
                : 31-35
                Fresenius Medical Care North America, Lexington, Mass., USA
                96394 Blood Purif 2007;25:31–35
                © 2007 S. Karger AG, Basel

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                Page count
                Figures: 5, References: 4, Pages: 5
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                Cardiovascular Medicine, Nephrology

                Hemoglobin, Erythropoietin, Medicare, Dialysis, Anemia


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