Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-7-032
Topic: Erythropoiesis Stimulating Agents
Section: Injections
Effective Date: August 20, 2018
Issue Date: August 20, 2018
Last Reviewed: July 2018

An erythropoiesis-stimulating agent (ESA), is a medicine similar to erythropoietin, which stimulates red blood cell production (erythropoeisis).

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.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Darbepoetin Alfa (Aranesp®) and Epoetin Alfa (Epogen®, Procrit®) may be considered medically necessary for the treatment of anemia associated with ANY of the following conditions when reversible causes of anemia are identified and managed: 

AND

Erythropoiesis stimulating agents (ESAs) may be initiated when ONE of the following criteria is met:

Treatment should be stopped when the hematocrit is greater than or equal to 34% or the hemoglobin is greater than or equal to 11.5g/dL. Erythropoiesis stimulating agents will be considered not medically necessary when the hematocrit or hemoglobin are greater than or equal to these stated levels.

Procedure Codes
J0881, J0882, J0885, Q4081


Epoetin beta-methoxy polyethylene glycol (Mircera) may be considered medically necessary for ANY the following:

AND when ONE of the following criteria is met:

Treatment should be stopped when the hematocrit is greater than or equal to 34% or the hemoglobin is greater than or equal to 11.5g/dL. ESAs will be considered not medically necessary when the hematocrit or hemoglobin are greater than or equal to these stated levels.

Procedure Codes
J0887, J0888


Epoetin alfa-epbx (Retacrit™) may be considered medically necessary for the treatment of anemia associated with ANY of the following conditions when reversible causes of anemia are identified and managed:

AND

Erythropoiesis stimulating agents (ESAs) may be initiated when ONE of the following criteria is met:

Treatment should be stopped when the hematocrit is greater than or equal to 34% or the hemoglobin is greater than or equal to 11.5g/dL. Erythropoiesis stimulating agents will be considered not medically necessary when the hematocrit or hemoglobin are greater than or equal to these stated levels.

Procedure Codes
Q5105, Q5106


ESAs administered on the same day as dialysis are considered an integral part of the dialysis. It is not eligible as a separate and distinct service. If ESAs are 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 erythropoiesis stimulating agents.  

If the ESAs are given independently, process it under the appropriate code.
Modifier 59 may be reported with ESAs to identify it as a significant, separately identifiable service from the dialysis. When the 59 modifier is reported, the patient's records must clearly document that erythropoiesis stimulating agents were given independently.

ESAs are not recommended when myelosuppressive chemotherapy is given with curative intent, for patients with cancer who are not receiving therapy, or for patients receiving non-myelosuppressive therapy.

*Note: Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), WPSS (Very Low, Low, Intermediate).


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



Place of Service: Inpatient/Outpatient

The administration of ESAs (Darbepoetin alfa [Aranesp], Epoetin alfa [Epogen, Procrit]), Epoetin beta-methoxy polyethylene glycol (Mircera), and Epoetin alfa-epbx (Retacrit) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

A network provider cannot bill the member for the non-covered service.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer: If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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