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Erythropoiesis Stimulating Agents: Clinical Indications and Coverage Criteria Overview 

This article provides an overview of clinical indications and coverage criteria for ESAs. Please refer to the following sources for additional comprehensive information on this topic:

Drugs and Dosage

  • Both the LCD and NCD apply to darbepoetin alfa, epoetin (alfa and beta)
  • Darbepoetin (Aranesp) has the same acting mechanism as epoetin (Epogen or Procrit) but is a longer lasting version of the drug
  • When administering ESAs, the dosage should be calculated to the lowest dose that effectively increases the hemoglobin (Hgb) concentration to the lowest level sufficient to avoid the need for red blood cell transfusion. ESAs may be administered by intravenous or subcutaneous routes
Covered Conditions
Anemia associated with the following clinical conditions
Noncovered Conditions
May have an adverse effect and not deemed medically reasonable and necessary
Chronic renal failure, for both dialyzed and non-dialyzed patients Anemia in cancer patients due to folate deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis
Non-myeloid malignancies where anemia is due to the effect of chemo Anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML), or erythroid cancers
Induced by AZT and/or other Nucleoside Reverse Transcriptase Inhibitors (NRTI) used in treatment of HIV/AIDS Anemia of cancer not related to cancer treatment or anemia associated only with radiotherapy
Myelodysplastic Syndrome for selected situations Prophylactic use to prevent chemotherapy-induced anemia or reduce tumor hypoxia
Perisurgical adjuvant therapy (epoetin alfa only) Patients with erythropoietin-type resistance due to neutralizing antibodies
Selected chronic diseases: rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel diseases, and hepatitis C undergoing treatment. Anemia due to cancer treatment if patients have uncontrolled hypertension.

Conditions Requiring Prior Therapy

When anemia is caused by any of the following conditions, other medically corrective treatments should be administered and documented before starting ESA therapy:

  • Iron deficiency
  • Underlying infection or inflammatory process
  • Underlying hematological disease
  • Hemolysis
  • Vitamin deficiencies (e.g., folic acid or B12)
  • Blood loss
  • Aluminum intoxication

Expected Laboratory Results

  • Administration of supplemental iron during ESA therapy, lab values must demonstrate transferrin saturation greater than 20% and/or serum ferritin levels greater than 100 ng/ml
  • During chemotherapy for non-myeloid malignancies, ESA therapy will be reimbursed only when the hemoglobin (Hgb) is less than 10 g/dL or the Hematocrit (Hct) is less than 30%
  • ESA us for all other indications Hgb target range is 10-12g/dl and Hct of 30-36%
  • ESA therapy need not be stopped completely simply due to the achievement of the target Hgb and/or Hct. Dose adjustments are expected to avoid harmful increases in Hgb and Hct levels
  • Risk is associated with Hgb greater than 12g/dl or Hct greater than 36%, so the medical record must fully support the reason for ESA usage in these circumstances.
  • When cardiac, pulmonary or other medical conditions warrant use of ESAs to maintain a Hgb/Hct higher than the target level, documentation must support the reasoning. This does not apply to ESA therapy for anemia related to cancer chemotherapy, which follows the rules mandated by the national coverage decision.

Bill Types and Revenue Codes

Please refer to NGS LCD L33617 for full instructions on Bill Type and Revenue Code usage.

CPT/HCPCS Codes

Please refer to NGS LCD L33617 for full information on appropriate CPT/HCPCS codes. Note: HCPCS code J0886 was deleted on 12/31/2015.

ICD -10 Codes Supporting Medical Necessity

Please refer to NGS LCD L33617 for full information on appropriate diagnostic coding. An ICD-10 search tool is also available via the LCD, to help providers determine coverage.

Documentation Requirements

  • ESRD facilities (submit with all claims):   
    • Hemoglobin and/or hematocrit value
    • Route of administration using Modifier JA (intravenous) or JB (subcutaneous)
    • Kt/V calculations based on the dialytic modality when entering Value Code D5 on ESRD claims
  • Medical record documentation - all ESA patients:
    • Dialysis schedule
    • Hgb/Hct immediately prior to billing period
    • History, examination and laboratory findings supporting medical necessity for ESA
    • Legible documentation with each entry signed by the performing provider
    • Patient’s weight in kilograms
    • ESA units administered per kilogram of body weight
    • Justification for administration of ESAs exceeding usual doses or when laboratory values are beyond those included in the LCD
  • Home dialysis, add:
    • Care plan with evidence of home monitoring
    • Record of ESA supplied to the patient and a record of dose administered
    • Patient instructions and patient selection protocol
  • Non-dialysis with CKD, add: 
    • Serum creatinine
    • Creatinine clearance, or Glomerular Filtration Rate (GFR)
  • Myelodysplastic Syndrome (MDS), add:
    • Bone marrow biopsy report or clear documentation of the bone marrow biopsy result
    • Date of initiation of ESA therapy, and response to ESA administration
    • Hgb/Hct and/or transfusion requirements
Erythropoiesis Stimulating Agents: Clinical Indications and Coverage Criteria Overview
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