CurrentAetnaPolicy N/A

MIRCERA (methoxy polyethylene glycol-epoetin beta) Medication Precertification Request Coverage Criteria

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

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

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

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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