Page 77 - Medicare Benefit Policy Manual

The dialysis facility, or the physician responsible for all dialysis-related services
furnished to the patient, must make a comprehensive assessment that includes the
following:

1. Preselection Monitoring

The patient’s hematocrit (or hemoglobin), serum iron, transferrin saturation, serum
ferritin, and blood pressure must be measured.

2 Conditions the Patient Must Meet

The assessment must find that the patient meets the following conditions:

a. Is a dialysis patient;

b. Has a hematocrit (or comparable hemoglobin level) that is as follows:

• For a patient who is initiating EPO treatment, no higher than 30
percent unless there is medical documentation showing the need
for EPO despite a hematocrit (or comparable hemoglobin level)
higher than 30 percent. Patients with severe angina, severe
pulmonary distress, or severe hypotension may require EPO to
prevent adverse symptoms even if they have higher hematocrit or
hemoglobin levels.

• For a patient who has been receiving EPO from the facility or the
physician, between 30 and 36 percent.

c. Is under the care of:

• A physician who is responsible for all dialysis-related services and
who prescribes the EPO and follows the drug labeling instructions
when monitoring the EPO home therapy; and

• A renal dialysis facility that establishes the plan of care and
monitors the progress of the home EPO therapy.

3. The assessment must find that the patient or a caregiver meets the following
conditions:

• Is trained by the facility to inject EPO and is capable of carrying out the
procedure;

• Is capable of reading and understanding the drug labeling; and

• Is trained in, and capable of observing, aseptic techniques.