Requirements for Medicare Coverage for EPO

50.5.2.1 - Requirements for Medicare Coverage for EPO (Rev. 1, 10-01-03) B3-2049.5 Medicare covers EPO and items related to its administration for dialysis patients who use EPO in the home when the following conditions are met: A. Patient Care Plan A dialysis patient who uses EPO in the home must have a current care plan (a copy of which must be maintained by the designated backup facility for Method II patients) for monitoring home use of EPO that includes the following: 1. Review of diet and fluid intake for aberrations as indicated by hyperkalemia and elevated blood pressure secondary to volume overload; 2. Review of medications to ensure adequate provision of supplemental iron; 3. Ongoing evaluations of hematocrit and iron stores; 4. Reevaluation of the dialysis prescription taking into account the patient’s increased appetite and red blood cell volume; 5. Method for physician and facility (including backup facility for Method II patients) follow-up on blood tests and a mechanism (such as a patient log) for keeping the physician informed of the results; 6. Training of the patient to identify the signs and symptoms of hypotension and hypertension; and 7. The decrease or discontinuance of EPO if hypertension is uncontrollable. B. Patient Selection 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. 4. Care and Storage of Drug The assessment must find that EPO can be stored in the patient’s residence under refrigeration and that the patient is aware of the potential hazard of a child’s having access to the drug and syringes. C. Responsibilities of Physician or Dialysis Facility The patient’s physician or dialysis facility must: • Develop a protocol that follows the drug label instructions; • Make the protocol available to the patient to ensure safe and effective home use of EPO; • Through the amounts prescribed, ensure that the drug on hand at any time does not exceed a 2-month supply; • Maintain adequate records to allow quality assurance for review by the Network and State Survey Agencies. For Method II patients, current records must be provided to and maintained by the designated backup facility; and • The dialysis facility must submit claims for EPO, if the facility provides it. See the Medicare Claims Processing Manual, Chapter 11, “End Stage Renal Disease,” for instructions for billing and processing claims for EPO under Method 1 and Method 2. Note that hematocrit readings are required on claims. It is expected that the ESRD facility or hospital outpatient department will maintain the following information in each patient’s medical record to permit the review of the medical necessity of EPO. 1. Diagnostic coding; 2. Most recent creatinine prior to initiation of EPO therapy; 3. Date of most recent creatinine prior to initiation of EPO therapy; 4. Most recent hematocrit (HCT) prior to initiation of EPO therapy; 5. Date of most recent hematocrit (HCT) prior to initiation of EPO therapy; 6. Dosage in units/kg; 7. Weight in kgs; and 8. Number of units administered.