MIRCERA (methoxy polyethylene glycol-epoetin beta) Medication Precertification Request Coverage Criteria
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This form governs Aetna precertification requests for MIRCERA (an ESA) indicating required patient, prescriber, diagnosis, and clinical information for start or continuation of therapy; it applies to Aetna members seeking coverage authorization.
No material clinical or coverage changes in this revision.
Coverage Criteria for MIRCERA
Initiation Requests
Covered when ALL of the following are met:
Concomitant use must be specified on the form
Indicate Yes or No on the form
Complete the applicable fields on the form
Enter percent TSAT and date of test; indicate if on iron therapy
Record Hgb and date on the form
Continuation Requests
Covered when ALL of the following are met:
Provide number of weeks completed on the form
Enter percent TSAT and date of test; indicate if on iron therapy
Provide current Hgb and date (exclude values due to recent transfusion)
The following coverage criteria must be documented for all precertification requests: a diagnosis of anemia due to chronic kidney disease (CKD), whether the requested drug will be used concomitantly with other erythropoiesis-stimulating agents (ESAs), and whether the patient received ESA therapy within the prior 30 days. Initiation requests must additionally document any contraindication, intolerance, or ineffective response to Procrit or Aranesp, assessment for iron deficiency with most recent TSAT and date, whether the patient is receiving iron therapy, and the pretreatment hemoglobin (Hgb) and date. Continuation requests must document completion of at least 12 weeks of ESA therapy, a recent TSAT and date, whether the patient is on iron therapy, and whether Hgb increased by ≥1 g/dL since starting ESA therapy along with current Hgb and date.
Coding and Claim-related Details
| Administration code(s) (CPT): | Place on form to specify applicable CPT administration codes |
| Primary ICD Code: | Field for patient's primary diagnosis ICD code |
| Secondary ICD Code: | Field for additional ICD codes |
Provider Actions and Documentation Requirements
Prior Authorization Required
Precertification is required for this medication. Complete and legible completion of the precertification request form is required for review. Incomplete documentation may result in denial of the request.
- Use Aetna Precertification Notification: Phone 1-866-752-7021 (TTY: 711); FAX 1-888-267-3277
- For Medicare Advantage Part B, use the Medicare Request Form
Prior ESA trial / contraindication
For initiation of therapy, document that the patient has a contraindication, intolerance, or ineffective response to alternative ESAs (e.g., Procrit, Aranesp) when applicable. Indicate whether the patient received ESA therapy within the prior 30 days and whether the requested drug will be used concomitantly with other ESAs.
- Document specifics of contraindication/intolerance or clinical rationale for switching
- State whether prior ESA therapy occurred within 30 days
Required clinical documentation
Required clinical documentation (must be completed in full for all requests): diagnosis of anemia due to CKD; prior ESA history (dates, agents, responses); assessment for iron deficiency anemia; most recent serum transferrin saturation (TSAT) with test date; indication if patient is receiving iron therapy; pretreatment hemoglobin (Hgb) for initiation requests (date of test); for continuation requests: duration of ESA therapy (weeks completed), most recent TSAT and date, current Hgb (date), and whether Hgb has increased ≥1 g/dL since starting ESA therapy.
- Diagnosis: anemia due to chronic kidney disease (CKD) — yes/no and supporting documentation
- ESA history: agents used (e.g., Procrit, Aranesp), dates, reason for discontinuation or inadequate response
- Iron assessment: TSAT (%) and date; note if receiving iron therapy
- Hemoglobin values: pretreatment Hgb with date (exclude post-transfusion values); current Hgb with date for continuation requests
- For continuation: documentation of ≥12 weeks of ESA therapy when applicable, and number of weeks completed
Provider and administration details
Provide complete prescriber and administration/dispensing details: prescriber name, professional designation (M.D., D.O., N.P., P.A.), specialty, address, phone, fax, state license number, NPI, DEA/UPIN if applicable, provider email, and office contact name/phone. For dispensing and administration indicate place of administration (self-administered, physician office, outpatient infusion center, home infusion), dispensing provider/pharmacy details (name, address, phone, fax, TIN/PIN), and any administration CPT code(s).
- Prescriber: full name, license type, state license #, NPI #, specialty, contact phone/fax, email
- Administration: place of administration and center/agency name and phone
- Dispensing provider/pharmacy: name, address, phone, fax, TIN/PIN, patient-selected dispensing choice
Incomplete documentation may lead to denial
Incomplete or missing required fields (diagnosis, required labs and dates, ESA history, prescriber identifiers, administration/dispensing details, or signature/date on the request) may lead to denial. The plan may request additional information or clarification if needed to evaluate the request.
- Ensure signature and date on Section H (Acknowledgement)
- All required clinical fields in Section G must be filled with dates and numeric values where requested (TSAT %, Hgb, test dates)
- Include prescriber NPI and state license number to avoid processing delays
Background
MIRCERA (methoxy polyethylene glycol-epoetin beta) is an erythropoiesis-stimulating agent (ESA) used to manage anemia associated with chronic kidney disease. Clinical evaluation for MIRCERA precertification requires assessment of iron status (most recent TSAT) and hemoglobin measurements before and during therapy. For initiation, prior exposure or intolerance to alternative ESAs (Procrit, Aranesp) should be noted; for continuation, document at least 12 weeks of ESA therapy and a qualifying hemoglobin response (increase of ≥1 g/dL) when applicable.
Definitions
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