Highmark Commercial Medical Policy - Pennsylvania


 
Printer Friendly Version

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: 

  • Chronic kidney disease, whether or not on dialysis, to decrease the need for red blood cell transfusion; or
  • Renal tubular damage secondary to cisplatin chemotherapy; or
  • Treatment of anemia in individuals with nonmyeloid malignancies where;
    • Anemia is due to the effect of concomitant myelosuppressive chemotherapy; and
    • Upon initiation, there is a minimum of two additional months of planned chemotherapy; and
    • Myelosuppressive therapy is not for curative intent; or
    • Are undergoing palliative treatment; or
  • Treatment of anemia in individuals with cancer who have ANY of the following:
    • Have moderate to severe chronic kidney disease; or
    • Are undergoing palliative treatment; or
    • Are receiving myelosuppressive chemotherapy and have no other identifiable cause of anemia; or
    • Refuse blood transfusions in select cases; or
  • HIV infection or AIDS-Related Complex (ARC) receiving Zidovudine (AZT) therapy. ALLof the following indications should apply:
    • AZT doses of 4200 mg or less/week; and
    • Endogenous levels of erythropoietin of 500 MU/ml or less; and
    • Treatment lasting no longer than three months following the discontinuation of the AZT; or
  • Myelodysplastic Syndrome when ANY of the following:
    • Treatment of lower risk* disease associated with symptomatic anemia, no del(5q) with or without other cytogenetic abnormalities, serum erythropoietin levels less than or equal to 500 mU/mL, and
      • Ring sideroblasts less than 15% as a single agent;or
      • Ring sideroblasts greater than or equal to 15% in combination with a granulocyte-colony stimulating factor (G-CSF) (target hemoglobin range 10 to 12 g/dL; not to exceed 12 g/dL); or
    • Treatment of lower risk* disease associated with symptomatic anemia, no del(5q) with or without other cytogenetic abnormalities, serum erythropoietin levels less than or equal to 500 mU/mL in combination with lenalidomide with or without G-CSF following no response to hematopoietic cytokines alone (target hemoglobin range 10 to 12 g/dL; not to exceed 12 g/dL); or
    • Alternative to lenalidomide as initial treatment of lower risk* disease associated with symptomatic anemia, del(5q) with or without one other cytogenetic abnormality (except those involving chromosome 7), and serum erythropoietin levels less than or equal to 500 mU/mL (target hemoglobin range 10 to 12 g/dL; not to exceed 12 g/dL); or
  • Management of myelofibrosis-associated anemia with serum EPO less than 500 mU/mL; or
  • Anemia of prematurity; or
  • Reduction of allogeneic red blood cell transfusions in individuals when ALL of the following apply:
    • Individual is undergoing elective noncardiac/nonvascular surgery; and
    • Individual is not a candidate for autologous blood transfusion preoperatively; and
    • Individual is expected to lose two or more units of blood during surgery; and
    • Individual presents with perioperative hemoglobin levels of greater than 10 g/dL up to 13 g/dL; and
    • Antithrombotic prophylaxis should be strongly considered for concurrent use; or
  • Individuals who will not or cannot receive blood products for treatment of acute hemorrhage or blood loss; or
  • Individuals with anemia secondary to combination of ribavirin and interferon-alfa therapy in patients with hepatitis C; or
  • Allogeneic bone marrow transplantation; or
  • For the treatment of neonates with hypoxic-ischemic encephalopathy (HIE);

AND

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

  • The hematocrit (HCT) is less than or equal to 30%; or
  • The hemoglobin (Hgb) is less than or equal to 10g/dL plus adequate iron.

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:

  • For the treatment of anemia associated with chronic kidney disease, whether on dialysis or not; or
  • For pediatric individuals age 5 to 17 years on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA;

AND when ONE of the following criteria is met:

  • The hematocrit (HCT) is less than or equal to 30%; or
  • The hemoglobin (Hgb) is less than or equal to 10g/dL plus adequate iron.

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:

  • Chronic kidney disease, whether or not on dialysis, to decrease the need for red blood cell transfusion; or
  • HIV infection or ARC receiving AZT therapy. ALLof the following patient indications should apply:
    • AZT doses of 4200 mg or less/week; and
    • Endogenous levels of erythropoietin of 500 MU/ml or less; and
    • Treatment lasting no longer than three months following the discontinuation of the AZT; or
  • Treatment of anemia in individuals with nonmyeloid malignancies when:
    • Anemia is due to the effect of concomitant myelosuppressive chemotherapy; and
    • Upon initiation, there is a minimum of two additional months of planned chemotherapy; and
    • Myelosuppressive therapy is not for curative intent; or
    • Are undergoing palliative treatment; or
  • Reduction of allogeneic red blood cell transfusions in individuals when ALL of the following apply:
    • Individual is undergoing elective noncardiac/nonvascular surgery; and
    • Individual is not a candidate for autologous blood transfusion preoperatively; and
    • Individual is expected to lose two or more units of blood during surgery; and
    • Individual presents with perioperative hemoglobin levels of greater than 10 g/dL up to 13 g/dL; and
    • Antithrombotic prophylaxis should be strongly considered for concurrent use;

AND

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

  • The hematocrit (HCT) is less than or equal to 30%; or
  • The hemoglobin (Hgb) is less than or equal to 10g/dL plus adequate iron.

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.

Links





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.

Discrimination is Against the Law
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:
  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages
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.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



back to top