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    v1.0.31
    OpenPayerPolicy UpdatesNephrologyAetna MIRCERA Prior Auth Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentAetnaPolicy N/A

    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.

    Policy Summary
    PayerAetna
    PolicyMIRCERA precertification coverage criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionComplete precertification form indicating initiation or continuation and include required clinical data (diagnosis, ESA history, TSAT, hemoglobin, and prescriber information).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2form length
    12 wkminimum ESA therapy
    30 dESA lookback
    TSAT & Hgbrequired labs

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    Coverage Criteria for MIRCERA

    Initiation Requests

    Covered when ALL of the following are met:

    Diagnosis: Patient has documented diagnosis of anemia due to chronic kidney disease (CKD)
    ESA Concomitant Use: Provider indicates whether the requested drug will be used concomitantly with other erythropoiesis-stimulating agents (ESAs)

    Concomitant use must be specified on the form

    Prior ESA in past month: Documentation whether patient received ESA therapy in the previous 30 dayswithin 30 days

    Indicate Yes or No on the form

    Prior ESA trial/contraindication: For initiation, indicate contraindication, intolerance, or ineffective response to Procrit and/or Aranesp when applicable

    Complete the applicable fields on the form

    Iron assessment: Patient assessed for iron deficiency; provide most recent TSAT value and date and indicate if receiving iron therapy

    Enter percent TSAT and date of test; indicate if on iron therapy

    Baseline hemoglobin: Provide pretreatment hemoglobin (Hgb) level and date (exclude values due to recent transfusion)

    Record Hgb and date on the form

    Continuation Requests

    Covered when ALL of the following are met:

    Duration of therapy: Patient has completed at least 12 weeks of erythropoiesis-stimulating agent (ESA) therapy>=12 weeks

    Provide number of weeks completed on the form

    Iron assessment: Patient assessed for iron deficiency; provide most recent TSAT value and date and indicate if receiving iron therapy

    Enter percent TSAT and date of test; indicate if on iron therapy

    Hemoglobin response: At any time since starting ESA therapy, the patient's hemoglobin (Hgb) increased by ≥ 1 g/dL≥ 1 g/dL change

    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 CPT codesCPT
    Administration code(s) (CPT):Place on form to specify applicable CPT administration codes
    Diagnosis ICD codesICD-10
    Primary ICD Code:Field for patient's primary diagnosis ICD code
    Secondary ICD Code:Field for additional ICD codes
    inv-06: Minimum ESA therapy duration for continuation
    Minimum duration required for continuationPatient has completed at least 12 weeks of ESA therapy (>= 12 weeks)
    Documentation requiredProvide number of weeks completed on form
    Related continuation criterionInclude most recent TSAT and Hgb values and dates per continuation requirements
    inv-07: Recent ESA therapy lookback
    Lookback period for prior ESA therapyDocumentation whether patient received ESA therapy in the previous month (within 30 days of request)
    ApplicabilityRequired for all requests (initiation and continuation) to indicate recent ESA exposure
    Form fieldCheckbox: Has the patient received ESA therapy in the previous month (within 30 days of request)?

    Provider Actions and Documentation Requirements

    Prior Authorization

    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
    Documentation Required

    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
    Documentation Required

    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
    Documentation Required

    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
    Denial Risk

    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

    inv-14: ESA — definition and examples (Procrit, Aranesp referenced)
    DefinitionErythropoiesis-stimulating agent (ESA): a medication that stimulates red blood cell production used to treat anemia associated with chronic kidney disease
    Examples referenced on formProcrit (epoetin alfa) and Aranesp (darbepoetin alfa) listed as alternative ESAs or prior therapies
    Context for useForm requests documentation of contraindication, intolerance, or ineffective response to Procrit or Aranesp for initiation requests when applicable
    inv-15: TSAT — Transferrin saturation lab definition and its role
    DefinitionTSAT (serum transferrin saturation): the percent transferrin saturation used to assess iron status prior to or during ESA therapy
    Required on formForm requests most recent TSAT level and date of test for all requests (initiation and continuation)
    Role in decision-makingTSAT is used to assess iron deficiency and whether patient is receiving iron therapy, which is required information for authorization
    Policy Summary
    PayerAetna
    PolicyMIRCERA precertification coverage criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionComplete precertification form indicating initiation or continuation and include required clinical data (diagnosis, ESA history, TSAT, hemoglobin, and prescriber information).
    SourceLink
    On This Page
    Coverage Criteria for MIRCERACoding and Claim-related DetailsProvider Actions and Documentation RequirementsBackgroundDefinitions