Discarded Erythropoietin Stimulating Agents for Home Dialysis

40.1 - Discarded Erythropoietin Stimulating Agents for Home Dialysis (Rev. 1581; Issued: 08-29-08; Effective/Implementation Date: 12-01-08) Multiuse vials are not subject to payment for discarded amounts of drug or biological, with the exception of self administered erythropoietin stimulating agents (ESAs) by Method I home dialysis patients. The renal facility must bill the program using the modifier JW for the amount of ESAs appropriately discarded if the home dialysis patient must discard a portion of the ESA supply due to expiration of a vial, because of interruption in the patient’s plan of care, or unused ESAs on hand after a patient’s death. Specific instructions are found in chapter 8 of this manual, §60.4.4.1 “Self Administered EPO Supply”, and §60.7.4 “Darbepoetin Alfa (Aranesp) Furnished to Home Patients”. This applies only to home dialysis patients who meet the Method I conditions described in Pub 100-2 Benefits Policy Manual, chapter 11, §90 “Epoetin (EPO)”, and does not apply to Method II home dialysis patients. Supplies of ESAs for self administration are billed according to the pre-determined plan of care schedule provided to home dialysis patients that meet the criteria for self administered ESAs discussed in chapter 8 of this manual, §60.4 “Epoetin Alfa (EPO) For ESRD Patients” and §60.7 “Darbepoetin Alfa (Aranesp) for ESRD Patients”. The renal facility, through the amounts prescribed in the plan of care, shall ensure the patient’s ESA on hand at any time does not exceed a 2-month supply. CMS expects the facility to minimize excess dispensing of the ESAs for self administration based on the patient’s plan of care.