Page 78 - Medicare Benefit Policy Manual

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.

50.5.2.2 - Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative
Use
(Rev. 1, 10-01-03)
PM-AB-99-59, Dated 8/1/99