Coverage for Epoetin alfa (EPO) is determined according to individual or group customer benefits. EPO is eligible for the following indications:

1. End stage renal disease (ESRD)(585.6)

   Patients with this condition include those with end-stage renal disease (ESRD), requiring dialysis.

   Those patients with end-stage renal disease and with symptomatic anemia considered for EPO therapy should have an initial hematocrit of less than 30.0% or an initial hemoglobin less than 10.0 g/dl.

   EPO administered on the same day as dialysis is considered an integral part of the dialysis. It is not eligible as a separate and distinct service. If EPO is reported on the same day as dialysis, and the charges are itemized, combine the charges and pay only the dialysis. Payment for the dialysis performed on the same date of service includes the allowance for the EPO. A participating, preferred, or network provider cannot bill the member separately for EPO in this case.

   If the EPO is given independently, process it under the appropriate code.

   However, when EPO is not a benefit (i.e., contractually excluded), it is not covered. A participating, preferred, or network provider can bill the member for the denied service.

2. Chronic renal failure, not on dialysis

   Those patients with chronic renal failure (585.1, 585.2, 585.3, 585.4, 585.5, 585.9) with symptomatic anemia considered for EPO therapy should have an initial hematocrit of less than 30.0% or an initial hemoglobin less than 10.0 g/dl.

   For patients with chronic renal failure, EPO therapy on subsequent claims is covered when the patient's hematocrit is less than 36.0%. However, all claims with a hematocrit of 36.0% and above, or hemoglobins exceeding 12.0 g/dl that are submitted with appropriate medical documentation should be referred for medical review.

3. Renal tubular damage secondary to cisplatin chemotherapy
4. Treatment of anemia associated with documented multiple myeloma
5. Anemia induced by cancer chemotherapy
6. Anemia secondary to AZT therapy for AIDS
7. Anemia secondary to myelodysplasia when symptomatic and/or the erythropoietin level is below 500
8. Anemia of prematurity
9. Anemia due to chronic disease
10. Anemic patients scheduled for surgery
    
    

    EPO will be eligible when provided for patients who meet all of the following indications:

    • hemoglobin level between 10.0 and 13.0 g/dl
      

      and

    • scheduled to undergo either total knee replacement or total hip replacement

      and

    • at risk for perioperative transfusions due to significant, anticipated blood loss. This includes those patients who are expected to require >2 units of blood, and who are not able or willing to participate in an autologous blood donation program.
    
    

NOTE:

The only indications that apply for treatment with darbepoetin alfa (Aranesp™) are:

1. End stage renal disease (ESRD);
   

   Aranesp administered on the same day as dialysis is considered an integral part of the dialysis. It is not eligible as a separate and distinct service. If Aranesp is reported on the same day as dialysis, and the charges are itemized, combine the charges and pay only the dialysis. Payment for the dialysis performed on the same date of service includes the allowance for the Aranesp. A participating, preferred, or network provider cannot bill the member separately for Aranesp in this case.

   If the Aranesp is given independently, process it under the appropriate code.

   However, when Aranesp is not a benefit (i.e., contractually excluded), it is not covered. A participating, preferred, or network provider can bill the member for the denied service.

2. Chronic renal failure, not on dialysis; or
3. Anemia induced by cancer chemotherapy.

Under these conditions:

• Injections can be given up to three times a week to maintain a Hgb/Hct which obviates symptomatology.
• If there is no significant response after three (3) months of treatment at maximum recommended doses, the drug should be discontinued and no reimbursement allowed.
• In myelodysplasia, if after three (3) months of treatment there is not a significant increase in the Hgb/Hct and/or a significant decrease in transfusion requirements, erythropoietin should be stopped.
• In anemia of chronic diseases, the presence of a debilitating disease and lack of response to treatment must be documented. If after three (3) months of treatment, there is not a significant increase in the Hgb/Hct level and/or a significant decrease in transfusion requirements, erythropoietin should be stopped.

EPO is not covered for the following:

1. To increase the amount of blood which can be drawn for auto-donation prior to surgery;
2. For preoperative patients that do not meet the criteria under number 10 of the eligible indications.
   

NOTE:

Use code J0881 for darbepoetin alfa for non-ESRD use.

Use code J0882 for darbepoetin alfa for ESRD on dialysis.

Use code J0885 for epoetin alfa for non-ESRD use.

Use code J0886 or Q4081 for epoetin alfa for ESRD on dialysis.

NOTE:

See Medical Policy Bulletin G-16 on Chemotherapy for Malignant Disease.

Description

Epoetin alfa, also known as Epogen, is a glycoprotein which stimulates red blood cell production. It is produced by the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. Epoetin alfa is formulated as a sterile, colorless, preservative-free liquid for intravenous or subcutaneous administration. Epoetin alfa is indicated to elevate or maintain the red blood cell level and to decrease the need for transfusions in selected patients.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

PRN References

08/2000, Additional indications for coverage, coding guidelines for Erythropoietin (EPO)
10/2002, Report EPO with code Q0136