CurrentBlue Shield of CaliforniaPolicy N/A

epoetin alfa

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This commercial medical benefit drug policy governs coverage and medical necessity requirements for epoetin alfa and epoetin alfa-epbx, including prior authorization, dosing, administration, and diagnosis coding. It applies to Blue Shield of California members, with self-administration potentially managed under the Pharmacy Benefit.

Policy Summary

PayerBlue Shield of California

Policyepoetin alfa

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective Date10/01/2026

Next Review DateN/A

Key ActionObtain prior authorization or preservice review for conditions addressed by this policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Conditions listed

Hgb <10Initial CKD threshold

YearlyCoverage period

2Assigned HCPCS codes

3x weekly

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CurrentBlue Shield of CaliforniaPolicy N/A

epoetin alfa

Customize your policy alerts

Sign up for all blue_shield_of_california policy alerts

Know when blue_shield_of_california releases new policies or updates existing guidance.

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Policy Summary

PayerBlue Shield of California

Policyepoetin alfa

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective Date10/01/2026

Next Review DateN/A

Key ActionObtain prior authorization or preservice review for conditions addressed by this policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Conditions listed

Hgb <10Initial CKD threshold

YearlyCoverage period

2Assigned HCPCS codes

3x weekly

CKD dosing frequency

Coverage Criteria

Anemia Due to CKD — Initial

Covered when all of the following are met:

Initial therapy criteria

Patient has anemia due to chronic kidney disease.
Hemoglobin is less than 10 g/dL.Hgb <10 g/dL
Patient is not receiving hemodialysis or peritoneal dialysis.
If the patient is receiving hemodialysis or peritoneal dialysis, the dialysis center must supply and administer the drug.
Both the primary and secondary ICD-10 codes listed in the policy are met.

Anemia Due to CKD — Reauthorization

Covered when all of the following are met:

Reauthorization criteria

Patient is not receiving hemodialysis or peritoneal dialysis.
Hemoglobin is less than or equal to 11 g/dL.Hgb ≤11 g/dL

Anemia Secondary to Zidovudine Therapy in HIV-Infected Patients

Covered when all of the following are met:

Zidovudine-associated anemia criteria

Patient is receiving zidovudine therapy for HIV.
Hemoglobin is less than 10 g/dL.Hgb <10 g/dL
Both the primary and secondary ICD-10 codes listed in the policy are met.

Pre-Operative Prevention in Anemic Patients

Medical necessity is met when all of the following are met:

Pre-operative prevention criteria

Patient's hemoglobin is less than or equal to 13 g/dL.Hgb ≤13 g/dL
Patient is scheduled to undergo elective, non-cardiac, or non-vascular surgery.
Patient is at high risk for perioperative transfusion with significant anticipated blood loss and is not a candidate for blood transfusion.Anticipated blood loss of 2 units of blood or more

For CKD-related anemia, provider-administered coverage is not available when the patient is receiving hemodialysis or peritoneal dialysis. In those cases, the dialysis center must supply and administer epoetin alfa. For eligible patients not receiving dialysis, initial therapy requires hemoglobin less than 10 g/dL and the policy-specified primary and secondary ICD-10 codes. Reauthorization requires that the patient remain off dialysis and have hemoglobin of ≤ 11 g/dL.

Coding and Clinical Thresholds

HCPCSHCPCS

J0885	Injection, epoetin alfa, (for non-esrd use), 1000 units
Q5106	Injection, epoetin alfa-epbx, biosimilar, (Retacrit) (for non-esrd use), 1000 units

Anemia Due to Chronic Kidney Disease (CKD)ICD-10Covered

D63.1
N18
N18.1
N18.2
N18.3
N18.30
N18.31
N18.32
N18.4
N18.5

1–10 of 12

1/2

Anemia Secondary to Zidovudine Therapy in HIV-Infected PatientsICD-10Covered

B20
D61.1

ICD-10ICD-10

B20
D61.1

ICD-10ICD-10

D64.9

Initial CKD Therapy

Hemoglobin requirementHgb less than 10 g/dL

Dialysis statusPatient is not on hemodialysis or peritoneal dialysis

Coding requirementBoth primary and secondary ICD-10 codes listed in the policy must be met

CKD Reauthorization

Hemoglobin requirementHgb ≤ 11 g/dL

Dialysis statusPatient is not on hemodialysis or peritoneal dialysis

Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization/preservice review is required for epoetin alfa and epoetin alfa-epbx for the conditions addressed by this policy. Obtain approval before treatment is provided.

Note

Submit Through CarePro

For PPO, Direct Contract HMO, and when applicable ASO and Shared Advantage products, submit the request through Evolent's CarePro Provider Portal.

Documentation Required

Medical Necessity Documentation

Submit documentation sufficient to establish that all medical necessity requirements are met, including office chart notes, laboratory results, and other relevant clinical information.

Clinical Background

Epoetin alfa is an erythropoiesis-stimulating agent used to treat selected forms of anemia. This policy addresses anemia associated with chronic kidney disease, anemia secondary to zidovudine therapy in HIV-infected patients, and pre-operative prevention in anemic patients scheduled for eligible elective, non-cardiac, or non-vascular surgery.

Drug Definitions

Epoetin Alfa Classification

DrugEpoetin alfa

Mechanism of actionErythropoiesis-stimulating agent (ESA)

Therapeutic classificationErythropoiesis-stimulating agent

USP Category

USP categoryBlood products and modifiers

DrugEpoetin alfa

Related classificationErythropoiesis-stimulating agent (ESA)

Initial Therapy

CKD Initial Therapy

For anemia due to chronic kidney disease, initial therapy is covered when all of the following are met:

CKD initial therapy criteria

Patient has anemia due to chronic kidney disease.
Hemoglobin is less than 10 g/dL.Hgb <10 g/dL
Patient is not receiving hemodialysis or peritoneal dialysis.
If the patient is receiving hemodialysis or peritoneal dialysis, the dialysis center must supply and administer the drug.
Both the primary and secondary ICD-10 codes listed in the policy are met.

Continuation and Reauthorization

CKD Reauthorization

For CKD-related anemia reauthorization, coverage is provided when all of the following are met:

Continuation therapy criteria

Patient is not receiving hemodialysis or peritoneal dialysis.
Hemoglobin is less than or equal to 11 g/dL.Hgb ≤11 g/dL
Maintenance dosing is individualized to target a hemoglobin level greater than 11 g/dL.Target Hgb >11 g/dL

Dosing and Quantity Limits

Epoetin Alfa Quantity Limit

Quantity limitUp to 600 units/kg

ScheduleWeekly for 4 doses

Administration routeSubcutaneously or intravenously

Epoetin Alfa Quantity Limit

Quantity limitUp to 300 units/kg

ScheduleDaily for 15 days

Administration routeSubcutaneously or intravenously

Administration Settings

Note

Home infusion is an allowed setting

Epoetin alfa may be administered through home infusion when home administration is appropriate under the member's benefit.

Note

Hospital administration is an allowed setting

Epoetin alfa may be administered in a hospital outpatient setting.

Note

Infusion-center administration is an allowed setting

Epoetin alfa may be administered in an infusion center.

Note

Office administration is an allowed setting

Biosimilar Relationship

Billing Rule

Recognize the Retacrit biosimilar

The policy identifies epoetin alfa-epbx (Retacrit) as the biosimilar associated with epoetin alfa (Procrit, Epogen). Use the applicable assigned HCPCS code and corresponding NDC when billing.

Epoetin alfa: Procrit, Epogen
Epoetin alfa-epbx: Retacrit
Assigned HCPCS codes: J0885 and Q5106

Policy Summary

PayerBlue Shield of California

Policyepoetin alfa

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective Date10/01/2026

Next Review DateN/A

Key ActionObtain prior authorization or preservice review for conditions addressed by this policy.

SourceLink

On This Page

Maintenance targetMaintenance dosing is individualized to target a hemoglobin level greater than 11 g/dL

Initial CKD Dose

DoseUp to 100 units/kg

Frequency3 times per week

Administration routeSubcutaneously or intravenously

Zidovudine-Associated Anemia Dose

DoseUp to 900 units/kg

FrequencyWeekly

Administration routeSubcutaneously or intravenously

Pre-Operative Hemoglobin Requirement

Hemoglobin requirementHgb less than or equal to 13 g/dL

Surgery typeElective, non-cardiac, or non-vascular surgery

Transfusion riskPatient is at high risk for perioperative transfusion with significant anticipated blood loss and is not a candidate for blood transfusion

Pre-Operative Blood Loss Requirement

Anticipated blood loss2 units of blood or more

Risk levelHigh risk for perioperative transfusion with significant anticipated blood loss

Transfusion eligibilityPatient is not a candidate for blood transfusion

Include: office chart notes, lab results, and other pertinent clinical information.

Note

Unlisted or Off-Label Indication

An indication not listed in the policy requires review to confirm medical necessity. For an FDA-unapproved, off-label use, the criteria in California Health and Safety Code section 1367.21 must also be met.

Unlisted conditions require medical-necessity review.
Off-label indications must satisfy Health and Safety Code § 1367.21.

Billing Rule

Incorrect Billing Code

Bill the drug using its assigned HCPCS code from the drug policy together with the corresponding NDC. Do not use an unlisted, unspecified, or miscellaneous code when a specific drug code is available.

Submit the assigned HCPCS code and corresponding NDC.
Prohibited: unlisted, unspecified, or miscellaneous coding when a specific code is assigned.

Denial Risk

Failure to Meet Pre-Operative Criteria

Pre-operative use meets medical necessity only when all three criteria are satisfied. Failure to meet any criterion may result in denial.

Hemoglobin is ≤ 13 g/dL.
The patient is scheduled for elective, non-cardiac or non-vascular surgery.
The patient is at high risk for perioperative transfusion with significant anticipated blood loss (2 or more units) and is not a candidate for blood transfusion.

Zidovudine-Associated Anemia

For anemia secondary to zidovudine therapy in HIV-infected patients, coverage is provided when all of the following are met:

Zidovudine-associated anemia criteria

Patient is receiving zidovudine therapy for HIV.
Hemoglobin is less than 10 g/dL.Hgb <10 g/dL
Both the primary and secondary ICD-10 codes listed in the policy are met.

Pre-Operative Prevention

Medical necessity is met when all of the following are met:

Pre-operative prevention criteria

Patient's hemoglobin is less than or equal to 13 g/dL.Hgb ≤13 g/dL
Patient is scheduled to undergo elective, non-cardiac, or non-vascular surgery.
Patient is at high risk for perioperative transfusion with significant anticipated blood loss and is not a candidate for blood transfusion.Anticipated blood loss of 2 units of blood or more

Epoetin alfa may be administered in a physician office.