MIR-2006-10AB, October 2006

Revisions to the Epoetin (EPO) and Aranesp Monitoring Policy (MM5251)

Provider Types Affected
Renal dialysis facilities billing Medicare fiscal intermediaries (FIs) for services related to erythropoietin (EPO) and darbepoetin (Aranesp) for ESRD patients

Background
Change Request (CR) 4135 titled, “National Monitoring Policy for Erythropoietin (EPO) and Aranesp® for End Stage Renal Disease (ESRD) Patients Treated in Renal Dialysis Facilities,” inadvertently did not exempt claims for Method 1 home dialysis patients who self-administer EPO or Aranesp®.

Consequently, some claims for home dialysis patients may receive an inappropriate 25-percent reduction in payment. Claims for home dialysis patients who self-administer these drugs in the home should not have been included in the requirements for CR 4135. Claims for patients who normally perform home dialysis and self-administration of EPO or Aranesp® and who need to receive back-up services in-facility should also be exempt.

In addition, CR4135 announced that Medicare would not apply a 25-percent payment reduction on claims for EPO or Aranesp® when a GS modifier was reported on the claim. The GS modifier was defined as “Dosage of EPO or Darbepoetin Alfa has been reduced 25 percent of preceding month’s dosage.” This definition of the GS modifier precluded providers from informing Medicare when they made a dose reduction in EPO or Darbepoetin Alfa but the total billed EPO or Darbepoetin Alfa reported was not 25 percent less than the preceding month’s billed units.

Key Points

• CR4135 is to be applied to patients who receive their EPO or Aranesp® in the renal dialysis center.
• CR4135, effective for services furnished on or after April 1, 2006, implemented a national claims monitoring policy for EPO and Aranesp® in the Medicare ESRD in-facility dialysis population.
• For dates of service April 1, 2006 and later, claims for patients who have opted to receive home dialysis under Method 1 or Method 2 and are self- administering the EPO or Aranesp® in their home are exempt from the policy and therefore, are not subject to automatic monitoring or the automatic 25-percent payment reduction as described in CR 4135.
• Providers should report condition code 70 on claims to identify home dialysis patients who self-administer EPO or Aranesp®, and condition code 76 for the home dialysis patients who received back-up services in the facility.
• Upon implementation of this instruction on January 1, 2007, providers may request claim adjustments for home dialysis claims that received an inappropriate 25-percent reduction in payment.
• Medicare requested and received a revised definition of the GS modifier to enable providers to inform Medicare when a hematocrit or hemoglobin level responsive dose reduction occurred and was maintained.
• Effective October 1, 2006, the revised definition of the GS modifier is, “Dosage of EPO or Darbepoetin Alfa has been reduced and maintained in response to hematocrit or hemoglobin level.”
• Providers should include the GS modifier on the claim when the reported hematocrit level is above 39.0 percent (hemoglobin 13.0g/dL) and a corresponding dose reduction was made and maintained.

Implementation
The implementation date for this instruction is October 2, 2006 for the new modifier definition; January 1, 2007 for the Method 1 exclusion.

Additional Information
If you have questions, please contact your Medicare FI at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip  on the CMS Web site.

For complete details, please see the official instruction issued to your FI regarding this change. The revised coverage rules for EPO are explained in the Medicare Benefit Policy Manual, Chapter 11, Section 60.4, which is included in the official instruction attachment. That instruction may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R1043CP.pdf on the CMS Web site.

Disclaimer
This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents.

Related Change Request (CR) #: 5251
MLN Matters Number: MM5251
Related CR Release Date: August 25, 2006
Related CR Transmittal #: R1043CP
Effective Date: October 1, 2006 for new modifier definition; April 1, 2006 for Method 1 exclusion
Implementation Date: October 2, 2006 for new modifier definition; January 1, 2007 for Method 1 exclusion