Background

The Centers for Medicare and Medicaid Services (CMS) issued Change Request 4135, the 'National Monitoring Policy for EPO and AranespĀ® for End Stage Renal

Disease (ESRD) Patients Treated in Renal Dialysis Facilities' in Transmittal 751 on November 10, 2005. This CMS EPO Monitoring Policy (EMP) took effect on April 1, 2006. 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.

This analysis of the effect of the EMP on hemoglobin outcomes is limited to the dialysis facilities which were owned by Fresenius Medical Care North America (FMCNA) prior to the acquisition of Renal Care Group (RCG) in March 2006. RCG facilities were not included because the EMP rules were implemented differently in the RCG information system. In the FMCNA system, the computer system was set up to prevent entry of physician orders or administration of doses which would exceed the 500,000 IU limit. The maximum allowable dose per administration depends on the frequency of the medication order, i.e., 35,000 U 3x/week dosing, 50,000 IU 2x/ week dosing, and 100,000 IU 1x/week dosing.

While the EMP policy allows the use of HGB or HCT, for simplicity the remaining discussion will focus on HGB values. The FMCNA recommended anemia management algorithm continues to encourage physicians to modify dose to achieve a target HGB of 11-12 g/dl. However, if a patient's latest HGB in the prior month is >13 g/dl, then the FMCNA computer system requires that the dose in the EPO prescription be reduced by 25%

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Ā© 2007 S. Karger AG, Basel 0253-5068/07/0251-0031$23.50/0

Norma J. Ofsthun, PhD

Fresenius Medical Care North America

95 Hayden Ave.

Lexington, MA 02420 (USA)

Tel. +1 781 402 9553, Fax +1 781 402 9727, E-Mail [email protected]

on the first of the following month. Approximately 10 days before the end of the month, the system provides a report on which patients require dose changes. Immediately prior to the end of the month, any of those physician orders which have not been reduced by at least 25% are terminated by automatic entry of an end-of-the-month stop date in the order. For patients with an HGB of >13 g/dl, the computer system will not accept a new physician's order for EPO that does not meet the mandatory minimum dose reduction. A validation process run each day makes sure that the administered doses are equal to the ordered doses. After any data entry errors have been corrected, clinical variances must be documented for any remaining discrepancies. Thus, the computer system essentially has enforced the new CMS rules. While minimum and maximum dose limits had previously been used to catch data entry errors for doses which were substantially (typically 3 times) outside the expected range, never before has the FMCNA computer system been used to restrict physician orders.

It should be mentioned that the requirement to change doses effective on the first of the month was a change in clinical practice for the 1,100+ legacy FMCNA facilities. This requirement stemmed from the fact that the fiscal intermediaries who process bills to Medicare could only evaluate dose reductions on a month-to-month basis. Even ignoring the issue of differences in the number of days in consecutive calendar months, if a physician were to reduce the dose per treatment by 25%, from 4,000 to 3,000 U/Rx halfway through the month (on the 7th of 12 treatments in month 1), the apparent dose reduction on a month-to-month basis would be given by:

(Total month 1 dose - total month 2 dose)/total month 1 dose =

Because this would appear to be less than the required 25% dose reduction, the fiscal intermediary would pay for only 75% of the 36,000 IU billed in month 2, which clearly would be a tremendous financial burden for the dialysis provider. By delaying the dose reduction until the first of the month, the total month 1 dose is 48,000 IU, and the month-to-month dose reduction is exactly 25%. On Friday, August 25, 2006, in Transmittal 1043, CMS released Change Request 5251 which changed the EMP rules effective on October 1, 2006. The change request eliminates the reference to a specific minimum dose reduction of 25%, and requires the provider to indicate whether the dose has been 'reduced and maintained in response to a hematocrit or hemoglobin level'. The same document states: 'Providers are reminded that CMS ex pects that as the hematocrit approaches 36.0% (hemoglobin 12.0 g/dl), a dosage reduction occurs. Providers are expected to maintain hematocrit levels between 30.0 to 36.0% (hemoglobin 10.0-13.0 g/dl).' As of September 1, 2006, FMCNA is awaiting further clarification and has not changed its implementation of the April version of the EMP rules.

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