CMS Pub. 100-04, ch. 17, § 40.1

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.